chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: Pain & swelling in left under arm (lymph node); Pain & swelling in left under arm (lymph node); Discomfort; Swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Oct2021 20:15 (Lot number: FF2589) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN A [RETINOL]; VIT D [COLECALCIFEROL]; PROBIOTICS; CIPLOX [CIPROFLOXACIN HYDROCHLORIDE] taken for eye injury, start date: 27Sep2021, stop date: 03Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 11:00), administration date: 22Mar2021, when the patient was 53 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 11:00), administration date: 01Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 05Oct2021 19:00, outcome "recovered" (Oct2021) and all described as "Pain & swelling in left under arm (lymph node)"; DISCOMFORT (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Discomfort"; SWELLING (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Swelling". Therapeutic measures were taken as a result of lymph node pain, lymphadenopathy.  Additional information: The patient had no covid prior vaccination. The patient did not tested covid post vaccination. No known allergies were reported.  The patient had Motrin/rest.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Oropharyngeal pain, Pyrexia
Clinical narrative: second dose: fever; second dose: chills; second dose: sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 18:30 (Lot number: 30155BA) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Pfizer COVID First dose: 10Sep2021, LOT: FD08CG, states she doesn't understand the writing, because the letters are all together, Expiry Date: Unknown, NDC: Unknown, Injection, left arm, unknown dosage, injection), administration date: 10Sep2021, when the patient was 18 years old, for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset 02Oct2021, outcome "recovered" (02Oct2021), described as "second dose: fever"; CHILLS (non-serious) with onset 02Oct2021, outcome "recovered" (02Oct2021), described as "second dose: chills"; OROPHARYNGEAL PAIN (non-serious) with onset 02Oct2021, outcome "recovered" (02Oct2021), described as "second dose: sore throat".   Additional information: She states he got the, well they all got the second dose of the vaccine on Friday, but he got fever, chills, sore throat, fever; chills; sore throat: Confirms began about 6 hours after getting the shot. He got it about 5:30 in the afternoon and started feeling that way over night, so confirms began 02Oct2021 and was just a one day thing and confirms recovered completely 02Oct2021. Pfizer COVID 19 Vaccine: Indication: They all decided to because they have a 7-year-old at home and he works so hopefully it will help protect him better from it. She confirms the product the patient received is the Pfizer COVID 19 Vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Slight fever 3 days in a row; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 (Lot number: FF8839) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension; METOPROLOL TARTRATE taken for hypertension; TRIAMTERENE taken for hypertension. Vaccination history included: Bnt162b2 (Lot: Unknown, 1st dose), for COVID-19 immunisation; Bnt162b2 (Lot: Unknown, 2nd dose), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset 03Oct2021, outcome "not recovered", described as "Slight fever 3 days in a row". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Consumer stated, still experiencing the problem and took temperature at 8:15 tonight. Patient took Tylenol for 2 days in a row and don't know if took anything today. Patient got the Pfizer booster on Saturday and had a slight fever for like 3 days in a row now. Consumer confirmed the name of the product as Pfizer Covid19 vaccine.  Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46 year-old male patient received bnt162b2 (BNT162B2), administration date 19Sep2021 (Lot number: FF2588) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. he following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "Joint pain". Therapeutic measures were not taken as a result of arthralgia.  Additional information: The report was not related to study or programme. Reporter (patient's partner) mentioned that the patient had received his first dose not too long ago and now he had joint pain, where its onset was reported as two days ago (date unspecified). Patient had received only the first dose and had not received the second dose. Reporter stated no trial vaccinations was received when asked about prior vaccination details. No lab test and investigation assessment was reported.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: little bit of a fever and tired; little bit of a fever and tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 75 year-old male patient received bnt162b2 (BNT162B2), administration date 04Feb2021 (Lot number: EM9810) at the age of 75 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "little bit of a fever and tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received second dose of vaccine (LOT-Unknown, Second Dose 25Feb2021)  Dosages and Expiration Dates of vaccines unknown.  No follow-up attempts are possible. No further information is expected.          Follow-Up (13Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Pain in extremity, Peripheral swelling
Clinical narrative: arm was swollen; The injection hurt my shoulder; weak; Pain increased in the arm; feverish; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "stent in iliac vein" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; GABAPENTIN; TRAMADOL; ELIQUIS; ASPIRIN (E.C.). Past drug history included: Codeine, reaction(s): "Allergies: Codeine"; Cymbalta, reaction(s): "Allergies: cymbalta"; Lyrica, reaction(s): "Allergies: lyrica". Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 06Oct2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), when the patient was 69 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "arm was swollen"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovering", described as "The injection hurt my shoulder"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weak"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "Pain increased in the arm"; PYREXIA (non-serious) with onset 2021, outcome "recovering", described as "feverish". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, arthralgia, asthenia, pain in extremity, pyrexia.  Additional Information: Physician reported in response to the HCP letter sent that included: We did not give her the vaccine and we did not treat her for this (name withheld) MD. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. No tested covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: arm was swollen; The injection hurt my shoulder; weak; Pain increased in the arm; feverish; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "stent in iliac vein" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; GABAPENTIN; TRAMADOL; ELIQUIS; ASPIRIN (E.C.). Past drug history included: Codeine, reaction(s): "Allergies: Codeine"; Cymbalta, reaction(s): "Allergies: cymbalta"; Lyrica, reaction(s): "Allergies: lyrica". Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 06Oct2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), when the patient was 69 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "arm was swollen"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovering", described as "The injection hurt my shoulder"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weak"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "Pain increased in the arm"; PYREXIA (non-serious) with onset 2021, outcome "recovering", described as "feverish". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, arthralgia, asthenia, pain in extremity, pyrexia.  Additional Information: Physician reported in response to the HCP letter sent that included: We did not give her the vaccine and we did not treat her for this (name withheld) MD. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. No tested covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Hypoaesthesia, Vaccination site erythema
Clinical narrative: numb arm; little tired; just aching little bit in knee; I have red area that is red looking at the site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Oct2021 08:30 (Lot number: FF8839) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for Covid-19 immunization; Bnt162b2 (dose 2), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "little tired"; ARTHRALGIA (non-serious) with onset Oct2021, outcome "unknown", described as "just aching little bit in knee"; VACCINATION SITE ERYTHEMA (non-serious) with onset Oct2021, outcome "unknown", described as "I have red area that is red looking at the site"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numb arm". Therapeutic measures were not taken as a result of fatigue, arthralgia, vaccination site erythema, hypoaesthesia.  Additional information: It was reported that report not related to a study or program. In response to file the safety report, (Privacy) stated that she did not had a bad experience (incomplete sentence). She just want to see what she need to do about this numb arm. No prior vaccination was reported. Further probing could not be done as (Privacy) was unwilling to further answer the questions. Hence, other details were unknown and limited information was available over the call. She took the Booster Shot (COVID-19 Vaccine) on yesterday here at the Clinic and she felt still ok, just little tired, just aching little bit in knee, her joints and 'stuff' (Not clarified) when she came home today from work, she noticed that she had red area that was red looking at the site and it looked absolute 'rough' (Not clarified).  Causality: (Privacy) stated, "Yes because I am having it in my arm, yes."  Follow-up attempts are completed. No further information is expected
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: Rash and swelling under his arm in which he received the injection; rash under his left arm in the armpit and there is swelling as well; Rash and swelling under his arm in which he received the injection; rash under his left arm in the armpit and there is swelling as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 68-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 09:50 (Lot number: FD8448) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure. Concomitant medication(s) included: AMLODIPINE [AMLODIPINE BESILATE] taken for hypertension. Vaccination history included: Bnt162b2 (DOSE :1), for Covid-19 immunization; Bnt162b2 (DOSE:2), for Covid-19 immunization. The following information was reported: RASH (non-serious), SWELLING (non-serious) all with onset 05Oct2021, outcome "unknown" and all described as "Rash and swelling under his arm in which he received the injection; rash under his left arm in the armpit and there is swelling as well". Therapeutic measures were taken as a result of rash, swelling.  Additional information: Therapeutic measures were taken as a result of the events with two Advil (200 mg). The patient did not receive any other vaccines prior to the COVID vaccine. Reporter further stated, "He is actually going to see his primary doctor tomorrow. So, we will ask him if there is anything else that should be done. We just wanted to make sure that it was reported to Pfizer."  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Experienced sore throat in between doses; Mild cold symptoms; little bit of a cough; Runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 (Lot number: FD8448) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 05Oct2021, outcome "unknown", described as "Experienced sore throat in between doses"; NASOPHARYNGITIS (non-serious) with onset 05Oct2021, outcome "unknown", described as "Mild cold symptoms"; COUGH (non-serious) with onset 05Oct2021, outcome "unknown", described as "little bit of a cough"; RHINORRHOEA (non-serious) with onset 05Oct2021, outcome "unknown", described as "Runny nose". Therapeutic measures were not taken as a result of oropharyngeal pain, nasopharyngitis, cough, rhinorrhoea.  Additional information: The report was related to a study or program. Number and expiry date were reported as unknown. No investigation assessment. He wanted to know if he can take the second dose of the COVID-19 vaccine. He had no fever but didn't know if it was okay to get the shot or if he should wait till symptoms go away.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Illness
Clinical narrative: chest pain, sharp pain on left side; sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 19 year-old male patient received bnt162b2 (COMIRNATY), administration date 05Oct2021 (Lot number: FC8839) at the age of 19 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 06Oct2021, outcome "unknown", described as "chest pain, sharp pain on left side"; ILLNESS (non-serious) with onset 06Oct2021, outcome "unknown", described as "sick".  Additional information: It was reported that Her son and she has not been vaccinated since the covid pandemic. She has been working and she has been tested constantly and she has not caught the virus. Further clarified that her son was vaccinated yesterday, and her son is sick now, something is going on. He got the vaccine yesterday. He has always been a healthy kid. A day after he received the vaccine, he left work and he is on the floor right now in pain and he is having chest pain, sharp pain and he is pointing towards his left side. The patient was advised to contact hcp or seek medical care.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fatigue, Muscle spasms, Pain
Clinical narrative: Joint pain right shoulder towards my back all the way down to my feet; always cramps with lost of feelings now and then when the pain sercomedI; always cramps with lost of feelings now and then when the pain sercomedI; always cramps with lost of feelings now and then when the pain sercomedI; I notice breading been difficult especially after the second dose; Feeling tired when I haven't been doing anything all day is what I've notice after the vaccines.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 10:15 (Lot number: 9492577) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: None.  The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Joint pain right shoulder towards my back all the way down to my feet"; MUSCLE SPASMS (non-serious), SENSORY LOSS (non-serious), PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "always cramps with lost of feelings now and then when the pain sercomedI"; DYSPNOEA (non-serious) with onset 2021, outcome "not recovered", described as "I notice breading been difficult especially after the second dose"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Feeling tired when I haven't been doing anything all day is what I've notice after the vaccines.". Therapeutic measures were not taken as a result of arthralgia, muscle spasms, sensory loss, pain, dyspnoea, fatigue.  Additional information: No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Not tested for covid post vaccination. No known allergies. No other medical history.   Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory loss
Clinical narrative: Joint pain right shoulder towards my back all the way down to my feet; always cramps with lost of feelings now and then when the pain sercomedI; always cramps with lost of feelings now and then when the pain sercomedI; always cramps with lost of feelings now and then when the pain sercomedI; I notice breading been difficult especially after the second dose; Feeling tired when I haven't been doing anything all day is what I've notice after the vaccines.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 10:15 (Lot number: 9492577) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: None.  The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Joint pain right shoulder towards my back all the way down to my feet"; MUSCLE SPASMS (non-serious), SENSORY LOSS (non-serious), PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "always cramps with lost of feelings now and then when the pain sercomedI"; DYSPNOEA (non-serious) with onset 2021, outcome "not recovered", described as "I notice breading been difficult especially after the second dose"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Feeling tired when I haven't been doing anything all day is what I've notice after the vaccines.". Therapeutic measures were not taken as a result of arthralgia, muscle spasms, sensory loss, pain, dyspnoea, fatigue.  Additional information: No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Not tested for covid post vaccination. No known allergies. No other medical history.   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, SARS-CoV-2 test
Clinical narrative: Persistent headache since receiving vaccine; fatigue; fall asleep multiple times a day and cannot stay awake; nausea; joint pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Sep2021 09:00 (Lot number: Ew0191) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "IBS" (unspecified if ongoing); "known allergies: kiwi" (unspecified if ongoing); "known allergy: Dairy" (unspecified if ongoing); "known allergy: pine nuts and cashews" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 26Sep2021 08:00, outcome "not recovered", described as "Persistent headache since receiving vaccine"; FATIGUE (non-serious) with onset 26Sep2021 08:00, outcome "not recovered", described as "fatigue"; SOMNOLENCE (non-serious) with onset 26Sep2021 08:00, outcome "not recovered", described as "fall asleep multiple times a day and cannot stay awake"; NAUSEA (non-serious) with onset 26Sep2021 08:00, outcome "not recovered", described as "nausea"; ARTHRALGIA (non-serious) with onset 26Sep2021 08:00, outcome "not recovered", described as "joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, fatigue, somnolence, nausea, arthralgia.  Additional information: The patient had not received other vaccine in 4 weeks and had not received other medications in 2weeks. Patient had not had COVID-19 prior to vaccination. Patient had been tested post vaccination for COVID as Nasal Swab with test name was PCR, Covid test and result was negative on 29Sep2021.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Persistent headache since receiving vaccine; fatigue; fall asleep multiple times a day and cannot stay awake; nausea; joint pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Sep2021 09:00 (Lot number: Ew0191) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "IBS" (unspecified if ongoing); "known allergies: kiwi" (unspecified if ongoing); "known allergy: Dairy" (unspecified if ongoing); "known allergy: pine nuts and cashews" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 26Sep2021 08:00, outcome "not recovered", described as "Persistent headache since receiving vaccine"; FATIGUE (non-serious) with onset 26Sep2021 08:00, outcome "not recovered", described as "fatigue"; SOMNOLENCE (non-serious) with onset 26Sep2021 08:00, outcome "not recovered", described as "fall asleep multiple times a day and cannot stay awake"; NAUSEA (non-serious) with onset 26Sep2021 08:00, outcome "not recovered", described as "nausea"; ARTHRALGIA (non-serious) with onset 26Sep2021 08:00, outcome "not recovered", described as "joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, fatigue, somnolence, nausea, arthralgia.  Additional information: The patient had not received other vaccine in 4 weeks and had not received other medications in 2weeks. Patient had not had COVID-19 prior to vaccination. Patient had been tested post vaccination for COVID as Nasal Swab with test name was PCR, Covid test and result was negative on 29Sep2021.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Emotional poverty, Fatigue, Inflammation
Clinical narrative: I notice breathing been difficult especially after the second dose; throat irritation and inflammation; throat irritation and inflammation; Feeling tired; Joint pain right shoulder towards my back all the way down to my feet; always cramps; lost of feelings; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 10:15 (Lot number: 9900325) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Previous dose details:, Prev dose product: COVID 19, Prev dose Brand: Pfizer , Prev dose Brand unknown: False , Prev dose Lot number: 9492577, Prev dose Lot unknown: False, Prev dose Administration date: 09Apr2021, Prev dose Administration time: 10:15 AM, Prev dose Dose number: 1, Prev dose Vaccine location: Right arm), administration date: 09Apr2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 07May2021 02:00, outcome "not recovered", described as "I notice breathing been difficult especially after the second dose"; THROAT IRRITATION (non-serious), INFLAMMATION (non-serious) all with onset 07May2021 02:00, outcome "not recovered" and all described as "throat irritation and inflammation"; FATIGUE (non-serious) with onset 07May2021 02:00, outcome "not recovered", described as "Feeling tired"; ARTHRALGIA (non-serious) with onset 07May2021 02:00, outcome "not recovered", described as "Joint pain right shoulder towards my back all the way down to my feet"; MUSCLE SPASMS (non-serious) with onset 07May2021 02:00, outcome "not recovered", described as "always cramps"; EMOTIONAL POVERTY (non-serious) with onset 07May2021 02:00, outcome "not recovered", described as "lost of feelings". Therapeutic measures were not taken as a result of dyspnoea, throat irritation, inflammation, fatigue, arthralgia, muscle spasms, emotional poverty.  Additional information: No other vaccine in four weeks. No Other medications in two weeks. Adverse event: Joint pain right shoulder towards his back all the way down to my feet and always cramps with lost of feelings now and then when the pain sercomed he notice breathing been difficult especially after the second dose with throat irritation and inflammation. Feeling tired when he haven't been doing anything all day was what he have notice after the vaccines. He had no Covid prior vaccination. He had no Covid tested post vaccination. He had None Known allergies and Other none medical history    Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Throat irritation
Clinical narrative: I notice breathing been difficult especially after the second dose; throat irritation and inflammation; throat irritation and inflammation; Feeling tired; Joint pain right shoulder towards my back all the way down to my feet; always cramps; lost of feelings; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 10:15 (Lot number: 9900325) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Previous dose details:, Prev dose product: COVID 19, Prev dose Brand: Pfizer , Prev dose Brand unknown: False , Prev dose Lot number: 9492577, Prev dose Lot unknown: False, Prev dose Administration date: 09Apr2021, Prev dose Administration time: 10:15 AM, Prev dose Dose number: 1, Prev dose Vaccine location: Right arm), administration date: 09Apr2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 07May2021 02:00, outcome "not recovered", described as "I notice breathing been difficult especially after the second dose"; THROAT IRRITATION (non-serious), INFLAMMATION (non-serious) all with onset 07May2021 02:00, outcome "not recovered" and all described as "throat irritation and inflammation"; FATIGUE (non-serious) with onset 07May2021 02:00, outcome "not recovered", described as "Feeling tired"; ARTHRALGIA (non-serious) with onset 07May2021 02:00, outcome "not recovered", described as "Joint pain right shoulder towards my back all the way down to my feet"; MUSCLE SPASMS (non-serious) with onset 07May2021 02:00, outcome "not recovered", described as "always cramps"; EMOTIONAL POVERTY (non-serious) with onset 07May2021 02:00, outcome "not recovered", described as "lost of feelings". Therapeutic measures were not taken as a result of dyspnoea, throat irritation, inflammation, fatigue, arthralgia, muscle spasms, emotional poverty.  Additional information: No other vaccine in four weeks. No Other medications in two weeks. Adverse event: Joint pain right shoulder towards his back all the way down to my feet and always cramps with lost of feelings now and then when the pain sercomed he notice breathing been difficult especially after the second dose with throat irritation and inflammation. Feeling tired when he haven't been doing anything all day was what he have notice after the vaccines. He had no Covid prior vaccination. He had no Covid tested post vaccination. He had None Known allergies and Other none medical history    Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pyrexia
Clinical narrative: she still feels a little droggy.; fever; chills; 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 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Oct2021 12:45 (Lot number: FF8841) at the age of 76 years as 'dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1 : given on 09Feb2021, lot: EN53T8), administration date: 09Feb2021, when the patient was 75 years old, for COVID-19 immunization; Bnt162b2 (Dose 2 : given on 27Feb2021, lot: EN6202), administration date: 27Feb2021, when the patient was 75 years old, for COVID-19 immunization; Flu shot (Prior Vaccinations (within 4 weeks): She had flu shot last Monday. It was on either 27Sep2021 or 28Sep2021.), administration date: 27Sep2021. The following information was reported: PYREXIA (non-serious) with onset 07Oct2021 06:00, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 07Oct2021 06:00, outcome "unknown", described as "chills"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she still feels a little droggy." Additional information:No Other Products were reported.AE(s) doesn't  require a visit to Emergency Room or Physician Office. Patient doesn't have any  AE(s) following prior vaccination. No Medical History was reported. Family Medical History Relevant to AE(s) was not Provided. No relevant test were reported. Patient asking is it safe to take Tylenol after receiving the Booster shot.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Malaise, Nausea, Pyrexia
Clinical narrative: sometimes the fever would get worse/Feeling weak was reported as worsened; does not feel well; Feeling nauseated; Feeling weak/ Feeling weak was reported as worsened.; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101333008 (Pfizer).  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 15:30 (Lot number: FF8839) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Drug(s) Information 1, Characterization of drug role:Suspect, Proprietary medicinal product name: Pfizer BioNTech Covid-19 Vaccine, Batch/lot number: EW0185, dosage text: Unknown Dose. Injected in left arm., ), administration date: 13Sep2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 05Oct2021, outcome "not recovered", described as "Fever"; NAUSEA (non-serious) with onset 07Oct2021, outcome "recovering", described as "Feeling nauseated"; ASTHENIA (non-serious) with onset 05Oct2021, outcome "not recovered", described as "Feeling weak/ Feeling weak was reported as worsened."; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "sometimes the fever would get worse/Feeling weak was reported as worsened"; MALAISE (non-serious), outcome "unknown", described as "does not feel well".  Additional information: The child reports the mother got second dose of Pfizer COVID 19 vaccine this past Monday and a day and half later, she had side effects as follows: Fever, feeling nauseated and feeling weak. Regarding the fever, he said it is the same overall, but sometimes the fever would get worse. Prior Vaccinations (within 4 weeks) none. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. Provide other relevant medical history including but not limited to these conditions included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: diabetes. Family Medical History Relevant to AE(s) was none. The other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebro-spinal fluid culture, pleural fluid culture, urine culture, diagnostic imaging, (e.g., chest X-ray, MRI) was none. She does not feel well. She has a fever, feels nauseated and weak. It started about a day and a half after getting the vaccine. Vaccine not Administered at a Facility.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Small bruises in both arms. Disappears after 2 weeks and then i get them; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EN6208) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "Upper respiratory tract infection" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; MONTELUCAST; BREO ELLIPTA. The following information was reported: CONTUSION (non-serious) with onset 10Apr2021 08:00, outcome "not recovered", described as "Small bruises in both arms. Disappears after 2 weeks and then i get them". The event "small bruises in both arms. disappears after 2 weeks and then i get them" was evaluated at the physician office visit. Therapeutic measures were taken as a result of contusion.  Additional Information: Facility type vaccine reported as other. Patient had not taken any other vaccine in four weeks. Other medications in two weeks provided as losartan, montelucast, breo. Adverse event reported as small bruises in both arms. Disappears after 2 weeks and then patient get them. Adverse event treatment was blood work. No covid prior vaccination. And patient covid tested and result is negative.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: then developed hives--full body hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 27 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 24Sep2021 18:00 (Lot number: FC3183) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BUPROPION HCL, start date: 08Sep2021. Vaccination history included: Bnt162b2 (First dose, given in the afternoon in the left arm , Lot- FC3183), administration date: 31Aug2021, when the patient was 27 years old, for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 25Sep2021, outcome "recovering", described as "then developed hives--full body hives".  Additional Information: It was reported that, Caller was inquiring about side effect information for the Pfizer Covid-19 vaccine. Caller reports she received the vaccine and then developed hives-full body hives. Caller asked was this a commonly reported side effect. Caller asked as far as the hives-it's been like a week-is that common. Hives was reported as worsened. No Investigation Assessment was reported. Caller reporting on the Covid vaccine and who explains she wanted to report and ask a question. Starting about 12 hours after the vaccine she experienced full body hives and has had that every day since getting the shot; it has been about a week. Caller would like to know if this was something that was commonly reported after the second shot. Caller is a medical speech therapist. The hives are worse than when they started, they started on 25Sep2021. She started a new medication on 08Sep2021. It Bupropion HCL 75mg, Manufacturer- Heritage Pharma, No NDC, Lot, or Expiry. She was also wondering about a possible interaction with the vaccine and this product. It was reported that, Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. No emergency room visit. Did a virtual visit to physician office. Prior Vaccinations (within 4 weeks), AE(s) following prior vaccinations, Patients Medical History (including any illness at time of vaccination) and relevant Tests were reported as none. Patient was not received other product.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Computerised tomogram
Clinical narrative: Chest discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) reported in response to the Non-HCP letter sent in cross referenced case. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 08:30 (Lot number: ERC208) at the age of 72 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHEST DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "Chest discomfort". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient age at time of vaccination was 72 years. Patient Medical History (including any illness at time of vaccination) was reported as None. Patient concomitant medications were reported as None. Vaccination Facility Type was reported as Hospital. Vaccine was not administered at a Facility. Patient did not receive any other vaccination within 4 weeks of vaccination. Chest discomfort in Mar2021 and Apr2021. On Blood Thinner now (as reported). On 05Apr2021 08:30 (the day of second vaccination), the patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ERB732) via an unspecified route of administration in left arm as dose 2, single for COVID-19 immunisation. Relevant Tests included CAT Scan on 08Jun2021 with result as 2 Blood clots in Lung.   No follow-up attempts are possible. No further information is expected.  Follow-up (20Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Peripheral swelling, Vaccination site bruising, Vaccination site pain
Clinical narrative: left under arm tenderness, pain, and swelling; left under arm tenderness, pain, and swelling; Swollen under arm lymph nodes; soreness of injection site & bruising; soreness of injection site & bruising; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 12:00 (Lot number: 30135BA) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergic to shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number=1, dose product=COVID 19, dose brand=Pfizer, dose lot number=EK5730, dose administration date=21Dec2020, dose vaccine location=Left arm), administration date: 21Dec2020, when the patient was 24 years old, for Covid-19 immunization; Bnt162b2 (dose number=2, dose product=COVID 19, dose brand=Pfizer, dose lot number=EK9231, dose administration date=11Jan2021, dose vaccine location=Left arm), administration date: 11Jan2021, when the patient was 24 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 05Oct2021, outcome "not recovered" and all described as "left under arm tenderness, pain, and swelling"; LYMPHADENOPATHY (non-serious) with onset 05Oct2021, outcome "not recovered", described as "Swollen under arm lymph nodes"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE BRUISING (non-serious) all with onset 05Oct2021, outcome "not recovered" and all described as "soreness of injection site & bruising". Therapeutic measures were taken as a result of pain in extremity, peripheral swelling, lymphadenopathy, vaccination site pain, vaccination site bruising.  Additional information: 24 hours after receiving 3rd dose of COVID vaccine (booster) in left arm, left under arm tenderness, pain, and swelling. Swollen under arm lymph nodes. 48 hours after vaccine, continuing to experience significant pain in arm pit with swelling & tenderness (Also experienced side effects of soreness of injection site & bruising) What treatment received for the adverse event? Comfort measure treatments (meds &heat/ice). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID- 19. Since the vaccination, the patient has not been tested for COVID-19. No other vaccine was administered in four weeks.  Follow-up attempts are completed. No further information is expected.