chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu symptoms 2 days; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Aug2021 10:00 (Lot number: EW0176) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "pulmonary artery aneurysm", start date: Nov2020 (unspecified if ongoing), notes: N/A monitoring every 6. The patient's concomitant medications were not reported.  The following information was reported: INFLUENZA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu symptoms 2 days".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Antibody test negative
Clinical narrative: negative test result on his antibody test; 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 58 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) 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: 1st), for COVID-19 immunization; Bnt162b2 (Dose: 2nd), for COVID-19 immunization. The following information was reported: ANTIBODY TEST NEGATIVE (non-serious), outcome "unknown", described as "negative test result on his antibody test". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Patient reports a negative test result on his antibody test, following full vaccination (primary series and booster dose) of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap). Patient stated: "he took an immunosuppressant [CellCept] and he did an antibody test following my full vaccination with the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap)". Patient asked "If get a negative antibody test result does that mean he was totally unprotected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (21Jan2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19, FLUX, HEP, PPV, VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Vomiting
Clinical narrative: I am having headache, it feels like migraine headache; Upset stomach; Vomiting; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81-year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE) (Batch/Lot number: unknown); hepatitis b vaccine (HEPATITIS B VACCINE) (Batch/Lot number: unknown); varicella zoster vaccine (VARICELLA ZOSTER VACCINE) (Batch/Lot number: unknown); influenza vaccine (INFLUENZA VACCINE) (Batch/Lot number: unknown). Relevant medical history included: "Schizoaffective disorder" (not ongoing), notes: diagnosed by years ago but I no longer have this.; "Manic depressive illness" (not ongoing), notes: diagnosed by years ago but I no longer have this. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "I am having headache, it feels like migraine headache"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Upset stomach"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea". Therapeutic measures were not taken as a result of headache, abdominal discomfort, vomiting, diarrhoea.  Additional information: The reporter stated that, I am calling you is I am having side effects from the vaccine adverse COVID-19 shots that I have had. The vaccine, I had 3 of them and I am having headache, it feels like migraine headache, I am also having upset stomach, vomiting and diarrhea at this time". Concomitant medications: Consumer stated, "I am taking about 15 medications (Further clarifications unknown). And I also had the Hepatitis B vaccine which they gave me, I have had the Pneumococcal (Unspecified Pneumococcal vaccine), I have had the Flu Shot (Unspecified flu vaccine), I have had the Shingles shot (Unspecified Shingles shot) (Further clarifications unknown if the vaccine was administered within 4 weeks of COVID 19 Vaccine hence captured as suspect conservatively)." LOT#/ Batch# and date of the shots for the vaccines (Hepatitis B vaccine, Unspecified Pneumococcal vaccine, Unspecified flu vaccine, Unspecified shingles shot):   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: before he has asthma but after taking the second dose he is virtually asthma-free.; 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 66-year-old male patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: He was asthmatic before. Concomitant medication(s) included: XOLAIR taken for asthma. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 06Feb2021, for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Feb2021, outcome "unknown", described as "before he has asthma but after taking the second dose he is virtually asthma-free.".   Additional Information: Caller's concern: Caller wants Pfizer to know that he extremely got a successful side effect for the Pfizer covid vaccine. He mentioned that he already took, first, second, and booster doses for the vaccine and before he has asthma but after taking the second dose he is virtually asthma-free. Resolution: Gathered information (name, phone number and zip code). Advised that I will transfer the call to Pfizer. Verbatim and Event Description: Suspect Product(s): Pfizer COVID-19 Vaccine: Start Date: 06Feb2021, Stop Date: 27Feb2021. Caller called in because he wants to share his good experience after taking the 2nd dose of Pfizer Covid-19 vaccine. He mentioned that he already got the 1st, 2nd and booster dose. The 1st shot was taken on 06Feb2021, the 2nd dose on 27Feb2021 and the booster shot on 18Aug2021. He asked if he could take the fourth shot. He was asthmatic before but after taking the 2nd dose he is already asthma free. He has taken Xolair before but now there is no need for him to take it that often. He also mentioned that he had a sore arm but only for a couple of hours. He mentioned that he is a Pfizer fan. Resolution: Gathered caller's concern. Gathered caller's demographics. Isi not read, caller mentioned he only got 3 minutes left on the phone. PMI number and hoo not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergy; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergy".  Additional Information: Unable to obtain patient age and gender.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I had the first shot with mild symptoms.; 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 52-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I had the first shot with mild symptoms.".  Additional information: The patient wanted to share her experience with Pfizer Covid vaccine series for your research. She was normally healthy 52-year-old woman. She had the first shot with mild symptoms.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Severe pain at the base of my next between both shoulders. Happened with the second shot and now the booster. The pain lasted for months after the second shot.; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 09:15 (Lot number: EW0191) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Right, Vaccine Administration Time: 11:45 AM), administration date: 23Apr2021, when the patient was 52 years old, for Covid-19 immunization, reaction(s): "The pain lasted for months after the second shot"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 02Apr2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: Back pain(non-serious) with onset 21Dec2021, outcome "not recovered", described as "Severe pain at the base of my next between both shoulders. Happened with the second shot and now the booster. The pain lasted for months after the second shot.". Therapeutic measures were not taken as a result of back pain.  Additional information: No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: only the arm where I got the shot was sore.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "only the arm where I got the shot was sore.".  Additional information: Subject: Patient Assistance Customer Verbatim: patient  had received two shots of the Pfizer COVID vaccine. After receiving the first shot, patient  had minimal symptoms only the arm where got the shot was sore. After receiving the second shot, I had flu-like symptoms and a fever for approximately ten days. Patient went to personal physician and received negative results for a flu test and COVID test. Does Pfizer recommend that patient get the booster shot. Patient should not get the COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer BioNTech COVID-19 Vaccine if had a severe allergic reaction after a previous dose of this vaccine or if  had a severe allergic reaction to any ingredient of this vaccine. Patient should get a booster: At least 6 months after completing your primary COVID-19 vaccination series.Referred to HCP to assess and give recommendations for booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: spells of dizziness after the first dose; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: DIZZINESS (non-serious), outcome "unknown", described as "spells of dizziness after the first dose".  Additional information: I took the first two doses of the covid 19 vaccination, as recommended. I had spells of dizziness after the first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pyrexia, Vomiting
Clinical narrative: Stomach pain; fever; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07May2021 16:45 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Immune Compromised" (unspecified if ongoing); "Phempagus Vulgaris" (unspecified if ongoing). Concomitant medication(s) included: MYCOPHENOLATE; LEXAPRO. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not sure batch, Location of injection: Arm Right, Vaccine Administration Time: 04:45 PM), administration date: 16Apr2021, when the patient was 51 years old, for COVID-19 immunization.  The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "recovering", described as "Stomach pain"; PYREXIA (non-serious) with onset 2021, outcome "recovering", described as "fever"; VOMITING (non-serious) with onset 2021, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of abdominal pain upper, pyrexia, vomiting.  Additional Information: The patient had no known allergies. Prior to vaccination, patient has not been diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for COVID-19 was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101857211 same patient/event, different dose of vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Therapeutic response unexpected
Clinical narrative: This is a spontaneous report received from a contactable physician. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced alopecia (lost hair on her head; it is growing back somewhat; her dermatologist said he's seen this a lot), with outcome of unknown. Additional information: The patient experienced hair loss at the top of her head, eyelashes and eyebrows after receiving the Pfizer-BioNTech COVID-19 vaccine. Reporter said their friend's dermatologist said he's seen lots of cases involving hair loss in many patients who had the COVID-19 vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging, Pain assessment
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101863708 (Pfizer).  A 32-year-old male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: My son has suffered with a headache since a week after having his second Pfizer vaccine shot in May2021. As a result, he refuses to get a booster. He has had an MRI and his brain looked normal thankfully. On a scale of 0- 10, he would rate the headache a consistent 4/5.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Investigation, Thyroid function test
Clinical narrative: significant hair loss; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "significant hair loss". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After the second dose, the patient had significant hair loss. The patient PC checked hormonal levels, thyroid and looked for vitamin deficiency everything came back normal. However the hair loss continued. After a few months the hair loss subsided and the patient began to regrow hair.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101863626 same drug and patient, different event and drug dose
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 42-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 41, in left arm, on Mar 31, 2021, at 03:00, single dose, for COVID-19 immunisation. The patient's medical history not reported. There were no concomitant medications. The patient experienced a menstrual disorder/menstrual cycle - increased cramping, dysmenorrhea and heavy menstrual bleeding/heavier than normal bleeding; all onset Apr 14, 2021, at 12:00, with outcome of recovering. No therapeutic measures taken. Additional information: Patient did not receive other vaccine in four weeks. She had increased cramping, and heavier than normal bleeding, 2-3 months after both shots and booster. She never had this issue before. Symptoms seemed to subside after first 2-3 months after each shot. No COVID-19 prior vaccination. No COVID-19 test post vaccination. Patient did not have any known allergies. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: excessive itching on my left arm by the injection site; 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 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Graves' disease" (unspecified if ongoing), notes: Verbatim: Graves' disease; "hyperthyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hyperthyroidism; VENLAFAXINE.  The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "excessive itching on my left arm by the injection site". Therapeutic measures were not taken as a result of vaccination site pruritus.  Additional information: Patient takes generic of Synthroid, the levothyroxine for hyperthyroidism. No prior vaccination (within 4 weeks). The patient would like to know if somebody going to contact her because she likes to know what to do about the itching or does, she needs to get any medical doctor. Because its so bad that she has to take a sharp object in order to feel any relief. She is embarrassed to say that she take the steak knife out of the drawer in the kitchen because it has sharp tip on it and she was using to scratch it and she has scratched her arm so bad that she left with bleeding and left mark on it and it has not gone away. And it flare up may be once or twice a day obviously not everyday, but every other day may be once or twice a day. And so, again she has to take something like fork and she has to use that because it's sharp. She need some help with what to do to get this look at.   Follow-up attempts have been completed and information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Nervousness, Rash, Swelling
Clinical narrative: out break on his waist so his waist is really very swollen; out break on his waist so his waist is really very swollen; Nervous; 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 parent.  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Psoriasis" (unspecified if ongoing), notes: Verbatim: Psoriasis; "voice incomprehensive" (unspecified if ongoing), notes: He got some (voice incomprehensive),. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1 of Pfizer COVID-19 vaccine.), for COVID-19 Immunization.  The following information was reported: RASH (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "out break on his waist so his waist is really very swollen"; NERVOUSNESS (non-serious), outcome "unknown", described as "Nervous".  Additional information: Start date ,NDC number , Expiry date  and UPC number of COVID-19 Vaccine was unknown. No lot number was reported. The parent did not know how much her son weighed and  mentioned that after receiving Pfizer COVID-19 vaccine, her son had some side effects. So,she was already asking assistance to different doctors in regards with the swollen waist and she was reporting a side effect that her son got form the COVID-19 vaccine. He was so nervous that she could not say one talk to him.Reporter seriousness for out break on his waist so his waist is really very swollen and nervous was unspecified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: HIV test, HIV test positive
Clinical narrative: Two test for HIV and it is showing positive and she never had a HIV or having the positive before the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 27 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 (Dose 1 (So, her 1st dose was 30Oct (not clarified further))). The following information was reported: HIV TEST POSITIVE (non-serious), outcome "unknown", described as "Two test for HIV and it is showing positive and she never had a HIV or having the positive before the vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated patient was scheduled for surgery tomorrow morning (further not clarified) and they did blood work panel today and she took two test for HIV and it was showing positive and she never had a HIV or had the positive before the vaccine. Plan for this surgery of course she was not HIV positive and then they tested it again twice and it was showing two tested HIV positive so, of course the surgery was cancelled but (incomplete sentence). They did a complete blood panel like checking every (further not clarified therefore not captured in the tab). No treatment she took and test for the Covid vaccine today (not clarified further).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin discomfort
Clinical narrative: she mentioned that while getting the other two vaccines, they kind of pinch your skin and this one here, she just put it straight through.; 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 female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "very bad back" (unspecified if ongoing), notes: the joint pain cause we have a third back. The patient's concomitant medications were not reported. The following information was reported: SKIN DISCOMFORT (non-serious), outcome "unknown", described as "she mentioned that while getting the other two vaccines, they kind of pinch your skin and this one here, she just put it straight through.".  Additional information: While reporting for her husband, she mentioned that while getting the other two vaccines,  they kind of pinch your skin and this one here, she just put it straight through. This report completed for her injection going straight through. Caller reported, "we have that anyway, the joint pain cause we have a third back, or very bad back, and we've had them before, the day we got shot, he got back pain and pain shooting on his legs after we got them"  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Pyrexia
Clinical narrative: not feel well; fever; felt flu-like; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: MALAISE (non-serious), outcome "recovered", described as "not feel well"; PYREXIA (non-serious), outcome "recovered", described as "fever"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "felt flu-like".  Additional information: It was reported that a family member received the 1st dose of the Pfizer COVID 19 vaccine about 6 months ago. For a few days after the dose, they did not feel well, ran a little bit of a fever and felt flu-like. The family member hasn't felt up to getting the 2nd dose. Caller states the patient is in their mid 60's. The caller states mid 60's, age 63 years or 64 years. Caller considers the event insignificant. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: severally heavy to the point I could not leave my house; changes to my menstruation/became irregular; some bleeding in the middle of my cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "severally heavy to the point I could not leave my house"; MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "changes to my menstruation/became irregular "; INTERMENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "some bleeding in the middle of my cycle".  Additional information: After each of her vaccination with the Pfizer round, patient had big changes to her menstruation. The month due after the injection it was severally heavy to the point that she could not leave her house. It also became irregular and had some bleeding in the middle of her cycle. Patient's booster was Moderna, this time as suggested the same thing happened again. It has not be normal since her first vaccines. Patient alternatively looked at her hormones, all were fine so far.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Inflammation, Tinnitus
Clinical narrative: she started having congestion and 'noise' in her ears; she started having congestion and 'noise' in her ears; some inflammation of the vascular system or nerve in that area; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: EAR CONGESTION (non-serious), TINNITUS (non-serious), outcome "unknown" and all described as "she started having congestion and 'noise' in her ears"; INFLAMMATION (non-serious), outcome "unknown", described as "some inflammation of the vascular system or nerve in that area". Therapeutic measures were taken as a result of ear congestion, tinnitus, inflammation.  Additional information: It was reported that the patient had seen a number of doctors and no one could help. The patient had tried steroids, antibiotics, physical manipulation in case it was a kinked nerve, had two wisdom teeth removed as source of inflammation. The reporter also stated that the patient did fine after the first vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Breast tenderness
Clinical narrative: left breast tenderness/tenderness in her breast; 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 55 year-old female patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cholesterol was high" (unspecified if ongoing), notes: Verbatim: Cholesterol was high.; "She is pre-diabetic" (unspecified if ongoing), notes: Verbatim: She is pre-diabetic. The patient's concomitant medications were not reported. The following information was reported: BREAST TENDERNESS (non-serious) with onset 2021, outcome "unknown", described as "left breast tenderness/tenderness in her breast". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that she got the first dose, waited the recommended 7 weeks and got the second dose on 01Dec2021. Patient was experienced tenderness in her breast after the first dose. Stated that the week after the second dose she had chest pain. Patient went to her doctor and got an EKG. Stated that her blood pressure was normal but she still has chest pain. Patient has a doctor's appointment at 1:30 and does not know if she needed to go on a beta blocker. Patient cannot get a cardiologist appointment because everyone is backed up for a month. Patient was upset that she went to the vaccine place and they give you documents and they should have this noted on first page and it was on the third page. Patient thought that pain would go away and it has not. It has been three weeks. The other women only had breast tenderness and she has heart constrictions and cannot sleep at night. Tenderness with the first dose was in her left breast on the side. Stated that she now has chest pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101878670 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202101878669 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202101878634 Same reporter/ drug/ event for different patients.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Tachycardia
Clinical narrative: real bad periods of tachycardia and sob; real bad periods of tachycardia and sob; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in left upper deltoid, administration date 04Apr2021 (Lot number: EW0150) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dry eyes" (unspecified if ongoing); "GERD", start date: 18Sep2018 (ongoing); "Lyme", start date: 18Sep2018, stop date: 18Oct2018. Concomitant medication(s) included: FISH OIL taken for dry eye; LUMIGAN; VITAMIN D3; VITAMIN B COMPLEX. The patient had no prior vaccinations within 4 weeks but received a Flu shot in Oct2021. The patient reported having "real bad (severe) periods of tachycardia and shortness of breath (SOB), after receiving the 1st dose. The patient spoke to the doctor and told her that this was not an immediate response as this happened 4 or 5 hours later, and the patient thought it was more like an adverse reaction. It was real bad with the 1st dose, and mild with the second dose. With the first one, she was seriously considering running to the emergency room (ER), it kicked and then calmed down, it kicked in and calm down, it was like a cycling kinda thing, and then it finally go away. She said she got the vaccine like about 2  in the afternoon. She later stated it kicked in like 2:30, then 7:30/8:00. She was like yikes, woah, and it kept happening. It would calm down and then come again. She told her husband that she was having a crazy rapid heart beat, and shortness of breath and if continued would need to go to the Emergency Room. She decided to wait it out and just drank a lot to hydrate and it then calmed down. The patient reportedly had a cardiology consult. The patient asked if she should get the booster dose in light of the side effects she experienced. The patient did not require the emergency Room because it calmed down. At first, she thought she was going to. She was concerned now about getting the booster. Now everyone is aware of the Adverse Events and making people aware and unsure if should get the booster, this not an allergic reaction, but more an allergic reaction. Therapeutic measures were not taken as a result of tachycardia. The event "real bad periods of tachycardia and sob" and "real bad periods of tachycardia and sob" was evaluated at the physician office visit.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Illness
Clinical narrative: First Dose: was kind of sick at first and it subsided; slept for days; 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 female patient received bnt162b2 (COMIRNATY), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing), notes: The caller clarifies and confirms that she has COPD, fibromyalgia, and is a type 2 diabetic. The caller was diagnosed with all of these conditions prior to receiving any of the Pfizer covid 19 vaccine.; "fibromyalgia" (unspecified if ongoing), notes: The caller clarifies and confirms that she has COPD, fibromyalgia, and is a type 2 diabetic. The caller was diagnosed with all of these conditions prior to receiving any of the Pfizer covid 19 vaccine.; "type 2 diabetic" (unspecified if ongoing), notes: The caller clarifies and confirms that she has COPD, fibromyalgia, and is a type 2 diabetic. The caller was diagnosed with all of these conditions prior to receiving any of the Pfizer covid 19 vaccine. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "First Dose: was kind of sick at first and it subsided"; HYPERSOMNIA (non-serious), outcome "unknown", described as "slept for days".  Additional Information: The caller has breathing problems, she was diabetic, and is in home healthcare. The caller took the first and second dose of the Pfizer covid 19 vaccine. The caller clarifies and confirms that she has COPD, fibromyalgia, and is a type 2 diabetic. The caller was diagnosed with all of these conditions prior to receiving any of the Pfizer covid 19 vaccine. Because of these conditions the caller was in the red zone and so she had to go get the vaccines. After the first dose the caller was kind of sick at first and it subsided and with the second dose she didn't feel effects. The caller got both doses in the left arm. After the first dose the caller slept for days and didn't feel too bad. When the caller got the second one she was fine and doing everything the next day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Nasopharyngitis, Pain, SARS-CoV-2 test
Clinical narrative: enlarged heart; just a little achy feeling; bad bronchial cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 75 year-old female patient received bnt162b2 (COMIRNATY), administration date Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Jan2021, when the patient was 74 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2), administration date: Feb2021, when the patient was 74 years old, for COVID-19 immunization.  The following information was reported: CARDIOMEGALY (non-serious) with onset 2021, outcome "unknown", described as "enlarged heart"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "just a little achy feeling"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "bad bronchial cold". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller states she is calling regarding the booster shot for Covid. She states that she does not know if this has anything to do with the Covid shot but, it was a pattern with both her sister and her husband. Nobody had a sore arm, just a little achy feeling for about a day, then was fine. The caller states that this week, both her sister and her husband came up with this and it seems to be a bad bronchial cold. Caller states that her sister's Covid test was negative. She states that her sister got her booster maybe a week after they go their booster. She wouldn't even think about this being a possible side effect except that her sister just came back saying she had an enlarged heart. Caller's husband has an enlarged heart, so it made her think about that.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: BREAST TENDERNESS (non-serious), outcome "unknown", described as "Breast tenderness". Additional information: Caller stated that she has three other women that have had breast tenderness from this. Is for the Pfizer Covid vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101878669 Same reporter/ drug/ event for different patients.; US-PFIZER INC-202101878670 Same reporter/ drug/ event for different patients.; US-PFIZER INC-202101877385 Same reporter/ drug/ event for different patients.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate increased, Lymphadenopathy, Tremor
Clinical narrative: Racing heart rate; Shaking; Headache; Chills; Swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date 15May2021 (Batch/Lot number: unknown) at the age of 27 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: HEART RATE INCREASED (non-serious) with onset 15May2021, outcome "recovering", described as "Racing heart rate"; TREMOR (non-serious) with onset 15May2021, outcome "recovering", described as "Shaking"; HEADACHE (non-serious) with onset 15May2021, outcome "not recovered", described as "Headache"; CHILLS (non-serious) with onset 15May2021, outcome "recovering", described as "Chills"; LYMPHADENOPATHY (non-serious) with onset 15May2021, outcome "recovering", described as "Swollen lymph nodes".  Additional Information: There were not any Prior vaccinations within four weeks prior to the first administration date of the suspect vaccine and no Adverse event following prior vaccinations. Patient had the following: Headache, chills, shaking, racing heart rate and terrible headache. Her chills were so bad, she was under the cover shaking. 1st day she had the headache was the day after the vaccine, and it was a headache like never before. It was on approximately 15May2021. Chills got worse before they got better and the lymph nodes got worse before they got better. It took about a week for her to feel better. Racing heart rate got worse before it got better. Everything got worse those few days and slowly got better. She got her vaccine in the evening and by the morning, her neck was twice the size that it usually is. Most of her symptoms started then. She did not have an exact time for any of the following: Headache, chills, shaking, racing heart rate, swollen lymph nodes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness
Clinical narrative: Breast tenderness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: BREAST TENDERNESS (non-serious), outcome "unknown", described as "Breast tenderness". Additional information: Reason for no lot number of Pfizer Covid vaccine reporter unwilling to complete the report. The patient had no other products. Investigation assessment was not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101878634 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202101878669 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202101877385 Same reporter/ drug/ event for different patients.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling of body temperature change, Headache, Malaise, Speech disorder
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 64 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: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "extreme cramping in my stomach area"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "unknown", described as "initially hot and cold"; MALAISE (non-serious), outcome "unknown", described as "I do not feel really well; do not feel 100%"; SPEECH DISORDER (non-serious), outcome "unknown", described as "I do not really feel like talking and answering lots of questions". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.