chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received  0.25ml  instead of 0.5ml for bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.  On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 15-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose).    The age of patient was more than 18 years.  The patient had 2 primary and 2 monovalent booster of Moderna COVID-19 Vaccine.  No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 3rd of 7 adult patients described by the reporter.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648798:
Sex: U
Vaccine: COVID19
Symptoms: Carditis
Clinical narrative: Handful of men experienced heart inflammation; This serious initial spontaneous safety report was received by Novavax on 15-SEP-2022 from a consumer.  A male of an unspecified age was vaccinated with intramuscular Novavax Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine unspecified dose on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date, after vaccination, the individual reported that a handful of men experienced heart inflammation (PT: Carditis) (Serious: Medically Significant).  At the time of reporting, the event outcome of Carditis was unknown.  Lot number was not provided in the report.; Sender's Comments: This male of an unspecified age experienced: Carditis after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL.  The event Carditis was reported as serious.  Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported event was assessed as Possible.
Sex: U
Vaccine: PNC20
Symptoms: No adverse event, Product contamination physical, Product quality issue
Clinical narrative: White particulate matter in the product; White particulate matter in the product; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 13Sep2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FF8006) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT QUALITY ISSUE (non-serious), PRODUCT CONTAMINATION PHYSICAL (non-serious), outcome "unknown" and all described as "White particulate matter in the product". Additional information: NDC number of Prevnar 20: 00005200010. The reporter went to open a box, then opened two boxes to check them both. She went to put the syringe on and noticed that the product has particulate matter in it. States that they all have the same Lot Number and have white particulate matter in them. Caller states that she called other stores and they said they haven't had that issue. No patients have received the affected vaccines. The reporter has 17 affected vaccines; all from the same Lot Number. A sample of the product available to be returned, if requested.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Limb discomfort, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer.), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "her sister is complaining of the same symptoms she is"; ARTHRALGIA (non-serious), outcome "unknown", described as "Her arm is hurting and shoulder also"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "her sister is having a lot of problems with her arm".  Additional information: She was just in the drug store, her husband was getting the flu shot. she was talking with someone who works there, her and her sister got the booster shot and her sister is complaining of the same symptoms she is having a lot of problems with her arm. Caller is going to give the phone number to this person to report. Her arm is hurting and shoulder also. Caller states, I just found out about this today. Caller states she did not provide this information to the safety agent she was just speaking with. Caller is going to call her and states, "I'll give her the number to call, and asks, what option should she select. Oct will be a year. Can't get the second booster because my arm is sore. Can't do anything because my arm is sore.  Caller received the first booster dose. no lot number available. Does not know which Pfizer covid 19 vaccine formulation she received. Maybe the nerve was hit and just have been putting heat and muscle cream on it. The pharmacist said don't put ice on it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Immunisation, Muscle spasms, Off label use, Product use issue
Clinical narrative: Diarrhea; Complaints of cramping; dose number: 5; dose number: 5; Other vaccine same date vaccine date: 14Sep2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 21:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 78 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose: 2; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 14Sep2022, outcome "unknown", described as "Other vaccine same date vaccine date: 14Sep2022"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 14Sep2022 at 21:00, outcome "unknown" and all described as "dose number: 5"; MUSCLE SPASMS (non-serious) with onset 16Sep2022 at 17:00, outcome "not recovered", described as "Complaints of cramping"; DIARRHOEA (non-serious) with onset 16Sep2022 at 17:00, outcome "not recovered", described as "Diarrhea". Therapeutic measures were not taken as a result of diarrhoea, muscle spasms.  Additional information: The patient had no known allergies. The patient did not received any other vaccines within 4 weeks. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Adverse event: Diarrhea 2 days later around 5pm. Complaints of cramping on the day after that. She does take other medication, but I don't have a list. If treatment ae: No.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Menstrual disorder
Clinical narrative: Menstrual bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing); "asthma" (unspecified if ongoing); "migraine" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: QVAR; ATENOLOL; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; MUCINEX. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, Primary Immunization completed), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 booster, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 17Sep2022 at 15:00, outcome "recovering", described as "Menstrual bleeding". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for adverse event. No known allergies are reported. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Discomfort
Clinical narrative: Extreme diarrhea; extreme discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 91-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 91 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Lot Number: EL1233, No. of Previous Doses: 0), administration date: 19Jan2021, when the patient was 89-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, single, Lot Number: EL9269, No. of Previous Doses: 1), administration date: 09Feb2021, when the patient was 89-year-old, for Covid-19 immunization; BNT162b2 (Dose 3 (Booster), single, No. of Previous Doses: 2), administration date: 20Aug2021, when the patient was 89-year-old, for Covid-19 immunization; BNT162b2 (Dose 4 (Booster), single, Lot Number: FK9729, No. of Previous Doses: 3), administration date: 21Feb2022, when the patient was 90-year-old, for Covid-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 15Sep2022, outcome "recovered" (18Sep2022), described as "Extreme diarrhea"; DISCOMFORT (non-serious) with onset 15Sep2022, outcome "recovered" (18Sep2022), described as "extreme discomfort". Therapeutic measures were taken as a result of diarrhoea, discomfort. Additional information: Patient stated that, he took a pill of Diphenoxylate/Tropine that stopped the diarrhea, medication was effective and diarrhea started to stop after an hour or so. He was used Kaopectate first for the diarrhea, but didn't work. He was used over the counter product, states distributer as (Name withheld), but unknown manufacturer 2 tablespoons each dose. Patient stated, he was fine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: When the needle was removed, a stream of blood came out that ran down to my elbow; They inserted the needle slowly which caused much pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Sep2022, outcome "unknown", described as "They inserted the needle slowly which caused much pain"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 12Sep2022, outcome "unknown", described as "When the needle was removed, a stream of blood came out that ran down to my elbow".  Additional Information: I received the updated booster on 12Sep2022. The person giving the vaccination was not very skilled. They inserted the needle slowly which caused much pain. When the needle was removed, a stream of blood came out that ran down to my elbow. My questions: 1) Could enough of the vaccine have come out to compromise its effectiveness? 2) Would a second dose of the vaccine be recommended?. Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater or equal to 12 years - 15/15 mcg per dos.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, SARS-CoV-2 test
Clinical narrative: Fatigue; muscle aches; headache; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Drug Allergy", notes: Known allergies: Amoxicillin. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, (DOSE: 3)), for COVID-19 Immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, (DOSE: 2, 1)), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 18Sep2022, outcome "recovering"; HEADACHE (non-serious) with onset 18Sep2022, outcome "recovering"; MYALGIA (non-serious) with onset 18Sep2022, outcome "recovering", described as "muscle aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, myalgia, headache.  Additional information: Facility type vaccine: Pharmacy or Drug Store. Lot unknown reason: Not available/provided to reporter at the time of report completion, Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination.Patient received dose more than 3. Patient tested covid(Nasal Swab) post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Lip swelling, Swelling face
Clinical narrative: She also had flushing with 3 of them. Just right cheek would flush real red. She had with the first 3, she could have had for the last one; Half her face swollen from all of these vaccines; her lip and face were a little swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 2, single (Lot number: EM9809), in right arm for covid-19 immunisation. The patient's relevant medical history included: "tumor Giant cell" (unspecified if ongoing), notes: She has a tumor Giant cell in her back . She had her injection Friday afternoon and does not think it caused it.; "Stated she is fat" (ongoing), notes: Illness/AE: Stated she is fat, Onset Date: 20-25 years. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EL1283; expiration date: unknown; Anatomical location: right arm), administration date: Jan2022, for COVID-19 Immunization, reaction(s): "flushing/ just right cheek would flush real red", "her lip and face were a little swollen", "Half her face swollen from all of these vaccines/ It was her left side". The following information was reported: SWELLING FACE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Half her face swollen from all of these vaccines"; FLUSHING (non-serious) with onset 2021, outcome "unknown", described as "She also had flushing with 3 of them. Just right cheek would flush real red. She had with the first 3, she could have had for the last one"; LIP SWELLING (non-serious) with onset 2021, outcome "unknown", described as "her lip and face were a little swollen".  Additional information: It was reported that half her face was swollen from all of the vaccines. It was her left side. Recovered completely. It took a long time for the face to be normal. It was not swollen real big, but her lip and face were a little swollen. She told she already takes allergy pills. She also had flushing with 3 of them. Just right cheek would flush real red. She had with the first 3, she could have had for the last one. She took her normal medications. She had a tumor Giant cell in her back. She had her injection Friday afternoon and did not think it caused it.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201173786 same patient/drug/events, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Lip swelling, Swelling face
Clinical narrative: She also had flushing with 3 of them; Half her face swollen from all of these vaccines; her lip and face were a little swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot number: EM9809, Anatomical location: Right arm), administration date: 11Feb2021, when the patient was 72-year-old, for COVID-19 immunisation, reaction(s): "She also had flushing with 3 of them. Just right cheek would flush real red. She had with the first 3, she could have had for the last one", "Half her face swollen from all of these vaccines", "her lip and face were a little swollen"; Bnt162b2 (DOSE 1, SINGLE, Administration date: 21Jan2021 or 20Jan2021, Lot number: EL1283, Anatomical location: Right arm), for COVID-19 immunisation, reaction(s): "She also had flushing with 3 of them. Just right cheek would flush real red. She had with the first 3, she could have had for the last one", "her lip and face were a little swollen", "Half her face swollen from all of these vaccines". The following information was reported: FLUSHING (non-serious), outcome "unknown", described as "She also had flushing with 3 of them"; SWELLING FACE (non-serious), outcome "recovered", described as "Half her face swollen from all of these vaccines"; LIP SWELLING (non-serious), outcome "unknown", described as "her lip and face were a little swollen". The events "she also had flushing with 3 of them", "half her face swollen from all of these vaccines" and "her lip and face were a little swollen" required physician office visit.  Additional information: It was reported that half of her face was swollen from all of these vaccines. It was her left side and recovered completely. It took a long time for the face to be normal. It was not swollen real big, but her lip and face were a little swollen. The first one she had, the doc onsite said to take Benadryl and she told him she already takes allergy pills. She took Benadryl when she got home. She also had flushing with 3 of them. Just right cheek would flush real red. She had with the first 3, she could have had for the last one. She took her normal medications.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201173786 same patient/drug/events, different dose;
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Pain in extremity, X-ray
Clinical narrative: had shoulder pain/it hurt up to his toe or finger, the big one, and starts from his elbow; pain went down a little bit because it hurt up to his toe or finger, the big one, and starts from his elbow; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious) with onset May2021, outcome "not recovered", described as "had shoulder pain/it hurt up to his toe or finger, the big one, and starts from his elbow"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "pain went down a little bit because it hurt up to his toe or finger, the big one, and starts from his elbow". The events "had shoulder pain/it hurt up to his toe or finger, the big one, and starts from his elbow" and "pain went down a little bit because it hurt up to his toe or finger, the big one, and starts from his elbow" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, pain in extremity; patient was given unspecified treatment. Additional information: It was reported that the patient had shoulder pain on May2021 and still has it, the pain was not big but he has it day and night. It was also reported that on an unspecified date in 2021 patient's pain went down a little bit because it hurt up to his toe or finger, the big one, and starts from his elbow. Patient was given unspecified treatment for the events reported.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Pain, Tinnitus
Clinical narrative: high blood pressure; body pain; tinnitus; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "psoriasis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure"; PAIN (non-serious), outcome "unknown", described as "body pain"; TINNITUS (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the patient who received 2nd dose of covid vaccine (not sure which formulation of the adult vaccine) had experienced high blood pressure, body pain and tinnitus for 3 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain
Clinical narrative: sore when she first got it, but not real sore, but kinda sore/ some soreness over the weekend; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset Sep2022, outcome "recovering", described as "sore when she first got it, but not real sore, but kinda sore/ some soreness over the weekend".  Additional information: The reporting patient, her husband, and daughter got the shot on Friday; it was a booster dose, the one that just came out, Pfizer's. She said that she's not very sore, she was sore when she first got it, but not real sore, but kinda sore. Then when she went to sit down and wait for them (husband and daughter), it wasn't sore. As the days went on, the reporting patient and her husband weren't real sore; she could still feel it. The patient was asking if it was supposed to be real sore. The patient didn't have a lot of pain; she (the person who administered it) pulled it together, and the patient didn't have the pain over the weekend, just had some soreness over the weekend. The patient's husband didn't have a lot of pain either. It's not like when you get a flu shot its really sore. The patient couldn't remember if it was sore the last time. She was wondering with these new shots if they were really sore and if not real sore, if they were doing their job. The patient further stated that she wasn't sore, her daughter wasn't sore, and was wondering if it was working on them. For the patient, it was tested wrong and it was very important to know if it was working. The patient was asking what Pfizer would be going to do about the individuals who got the vaccine and it didn't work. The patient further asked if it was working or not. She had some soreness, but not a lot of soreness, like when she got a flu shot that was a lot of soreness. She never had a lot of soreness. Most of her soreness was gone. The patient asked if that was how this booster was working.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201174174 same reporter, product, and event; different patient;US-PFIZER INC-202201177556 same reporter, product, and event; different patient;
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: feeling pretty awful; tired; loss of appetite; feel hot; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious) with onset Sep2022, outcome "unknown", described as "feel hot"; FEELING ABNORMAL (non-serious) with onset Sep2022, outcome "unknown", described as "feeling pretty awful"; DECREASED APPETITE (non-serious) with onset Sep2022, outcome "unknown", described as "loss of appetite"; FATIGUE (non-serious) with onset Sep2022, outcome "unknown", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received a dose of the Pfizer COVID-19 vaccine bivalent booster on 11Sep2022. She had been feeling pretty awful ever since. Her symptoms were being tired, loss of appetite, and she felt hot even though the thermometer says she has a normal temperature.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Body aches and fatigue/these are the same symptoms that she had with her previous doses of the Pfizer Covid Vaccines; Body aches and fatigue/these are the same symptoms that she had with her previous doses of the Pfizer Covid Vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59-year-old female patient received BNT162b2 (COMIRNATY), on 27May2021 as dose 1, single (Lot number: EW0183) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 09Sep2009 (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Body aches and fatigue/these are the same symptoms that she had with her previous doses of the Pfizer Covid Vaccines".
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Body aches and fatigue/these are the same symptoms that she had with her previous doses of the Pfizer Covid Vaccines; Body aches and fatigue/these are the same symptoms that she had with her previous doses of the Pfizer Covid Vaccines; This is a spontaneous report received from contactable reporter (Consumer or other non HCP), Program ID). The reporter is the patient.  A 60-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), on 23Jun2021 as DOSE 2, SINGLE (Lot number: EW0183) at the age of 59 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Breast cancer", start date: 09Sep2009 (unspecified if ongoing), notes: Ibrance that she is prescribed for breast cancer. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Received by the caller on 27May2021; Lot Number: EW0183; Administered in the caller's left arm; NDC and Expiry Date are unknown.), administration date: 27May2021, when the patient was 59-year-old, for COVID-19 Immunization, reactions: "Body aches and fatigue/these are the same symptoms that she had with her previous doses of the Pfizer Covid Vaccines". The following information was reported: PAIN (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Body aches and fatigue/these are the same symptoms that she had with her previous doses of the Pfizer Covid Vaccines". Additional information: Transferring agent states that the caller is asking about Ibrance that she was prescribed for breast cancer. The caller mentioned that she got the Bivalent Covid Booster Vaccine last Friday (16Sep2022). She wants to know if there is a certain time after having the vaccine that she should wait to start her Ibrance? Caller states that she has not started taking the Ibrance yet. Since she got the new booster vaccine she wanted to double check about starting it. The patient experienced body aches and fatigue for a couple of days. Caller states that these are the same symptoms that she had with her previous doses of the Pfizer Covid Vaccines. States that it was nothing major. Caller states that with this Bivalent booster dose of the vaccine the fatigue is more intense. Caller states that prior to this dose of the vaccine she had just finished radiation that caused an infection. Caller states that due to that infection she had stopped eating and had lost about 5 pounds. States that the fatigue this time with the vaccine is just more intense. Since she has never taken Ibrance, the caller is anxious that she will get over these symptoms and possible have new ones to deal with when she starts the Ibrance. Caller states that she has some questions about Ibrance also before she starts it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201173720 same patient, different vaccine(different dose), different event;
Sex: M
Vaccine: COVID19-2
Symptoms: Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset Sep2022, outcome "unknown", described as "had a little more pain, but not a lot of pain either". Additional information: The patient got the shot on 16Sep2022. The patient had a little more pain, but not a lot of pain either. As the days went on, the patient was not real sore. The patient didn't have a lot of pain. The reporter was wondering to know whether these new shots were really sore and whether the vaccine were doing their job if not real sore. If it did not work, what Pfizer would do about it. The patient did not have any soreness (as reported). The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest discomfort, Chest pain
Clinical narrative: chest pain, a very tight feeling in my chest; chest pain, a very tight feeling in my chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GJ2526) at the age of 58 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (first Booster Dose; Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious), outcome "recovered", CHEST DISCOMFORT (non-serious), outcome "unknown" and all described as "chest pain, a very tight feeling in my chest". Therapeutic measures were taken as a result of chest pain, chest discomfort.  Follow-Up (22Sep2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm skin
Clinical narrative: I had a friend who had something similar that's growing underneath her one arm/she had a lump on her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM SKIN (non-serious), outcome "unknown", described as "I had a friend who had something similar that's growing underneath her one arm/she had a lump on her arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Has patient ever had Covid positive test or diagnosis; Has patient ever had Covid positive test or diagnosis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-023857 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and in Jul2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes (controlled with diet)" (unspecified if ongoing), notes: diabetes (controlled with diet); "Allergies: Sulfa" (unspecified if ongoing), notes: Allergies: Sulfa. The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Allergies: Tetracycline", notes: Allergies: Tetracycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Has patient ever had Covid positive test or diagnosis". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2021) Positive, notes: Has patient ever had COVID positive test or diagnosis? Jun2021 and Oct2021; (Oct2021) Positive, notes: Has patient ever had COVID positive test or diagnosis? Jun2021 and Oct2021.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient. A 52-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2022 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; INSULIN; LANTUS; LIPITOR. The patient received PAXLOVID from 12Sep2022 to 17Sep2022 for the treatment of COVID-19 noted in 2022 (with positive COVID-19 test). Outcome of the events was unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Product: COVID 19 Treatment; Positive, notes: Rebound with new positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 05Jan2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 treatment brand was PAXLOVID,  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details included COVID 19 Treatment Paxlovid from 11Sep2022 to 15Sep2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Depression in remission" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: ESCITALOPRAM; TOPIRAMATE; RIZATRIPTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ ritonavir (PAXLOVID) from 09Sep2022 to 14Sep2022; completed 5-day course of PAXLOVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]; CENTRUM A TO ZINC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Indication=Treatment of COVID-19; (Sep2022) Positive, notes: tested positive after taking Paxlovid. Therapeutic measure, Paxlovid from 08Sep2022 to 12Sep2022, was taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Heart rate, Heart rate increased
Clinical narrative: Rapid heartbeat; Dizziness; Blood pressure went to 200/104; Trigger thumb; right hand ring finger became trigger; Both palms of hand and fingers became very painful; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 at 10:00 as dose 1, single (Lot number: ER8733) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Degenerated disk disease" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Allergies to eggs" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; LISINOPRIL; HYDROCHLOROTHIAZIDE; NAPROX [NAPROXEN]. Past drug history included: Codeine, reaction(s): "Drug allergy"; Demerol, reaction(s): "Drug allergy"; Morphine, reaction(s): "Drug allergy"; Loritab, reaction(s): "Drug allergy". The patient had no other vaccine in four weeks. The following information was reported: BLOOD PRESSURE INCREASED (disability) with onset 05Jul2021 at 08:00, outcome "recovered", described as "Blood pressure went to 200/104"; PAIN IN EXTREMITY (disability) with onset 05Jul2021 at 08:00, outcome "not recovered", described as "Both palms of hand and fingers became very painful"; DIZZINESS (disability) with onset 05Jul2021 at 08:00, outcome "recovered"; HEART RATE INCREASED (disability) with onset 05Jul2021 at 08:00, outcome "recovered", described as "Rapid heartbeat"; TRIGGER FINGER (disability) with onset 05Jul2021 at 08:00, outcome "not recovered", described as "Trigger thumb; right hand ring finger became trigger". The events "rapid heartbeat", "dizziness", "blood pressure went to 200/104", "trigger thumb; right hand ring finger became trigger" and "both palms of hand and fingers became very painful" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (05Jul2021) 200/104; Heart rate: (05Jul2021) Rapid. Therapeutic measures were taken as a result of trigger finger. Per clinical course, the patient experienced rapid heartbeat, dizziness, and blood pressure went to 200/104 on 05Jul2021. On 05Jul2021, the patient had trigger thumb (R hand), orthopedic injected steroid shot in Sep2021. Following month (Aug2021), left thumb became trigger thumb, another steroid shot. In Dec2021, right hand ring finger became trigger, another steroid shot. Within a month, both palms of hand and fingers became very painful (starting on 05Jul2021) and are getting worse. The patient had seen other doctors including RA physicians on 08Sep2022 with no results. The patient did not suffer any of this until she had the vaccine.