chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: I developed a little psoriasis on my ankle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "auto immune disease" (unspecified if ongoing), notes: with extra cell growth; "rash" (unspecified if ongoing), notes: after my first or second Pfizer vaccine (unspecified vaccine). , developing a rash on my right ankle. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Jan2021, for Covid-19 Immunization; Bnt162b2 (Dose 2), administration date: Feb2021, for Covid-19 Immunization. The following information was reported: PSORIASIS (non-serious), outcome "unknown", described as "I developed a little psoriasis on my ankle". Therapeutic measures were taken as a result of psoriasis.  Additional Information: Concern: Consumer stated, "I am not sure but I just wanted some verification. I received my first Pfizer Feb, end of Jan, second Pfizer in Feb and then I just received my booster few weeks ago. I noticed that I cannot tell after the first or second one that I developed a little psoriasis on my ankle. The pictures online shows that it is obviously psoriasis it has all the side effects of psoriasis and it is an auto immune disease with extra cell growth. So could Pfizer, I doesn't have it before. I have it there before the vaccine. Is it possible this vaccine exacerbated the extra cell growth? Consumer added, "After receiving my, I am not sure but it was after my first or second Pfizer vaccine (unspecified vaccine). I began developing a rash on my right ankle on the back of my right ankle above the heel of my foot and I thought my gosh what is this and so when I went to see the doctor who recommended that I use some Hydrocortisone cream (Intent treatment) on it and I have being doing that but it kept me just thinking whether or not is this a side effects because psoriasis is, because it is not just a rash it is looks like psoriasis according to all the pictures on the internet and the doctors that saw me. So is this, because it is an auto immune disease, psoriasis is an auto immune disease that is cause because of extra growth of cells. Is it possible that the Pfizer exacerbated the growth of the cells so that it came out as psoriasis on the my ankle? That's what I am wondering."  Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Disturbance in attention, Fatigue, Influenza like illness
Clinical narrative: It was very similar to flu; very low energy. I didnt have any vomiting or diarrhea but it was very low energy and very hard; could not concentrate; and very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 03Nov2021 11:00 (Lot number: FDO809) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart Attack", start date: 17Dec2017 (unspecified if ongoing); "Asthma" (unspecified if ongoing), notes: Childhood. Concomitant medication(s) included: FLU taken for immunisation; ATORVASTATIN taken for myocardial infarction, start date: 2017 (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] taken for myocardial infarction (ongoing); MONTELUCAST taken for asthma. Vaccination history included: Bnt162b2 (1st dose, Consumer further stated, "Anyway I just wanted to report that I had very strong reaction and I didnt have any reaction to the first two Pfizer shots.", Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot no# EL9261), administration date: 10Feb2021, for Covid-19 Immunization; Bnt162b2 (2nd dose, Consumer further stated, "Anyway I just wanted to report that I had very strong reaction and I didnt have any reaction to the first two Pfizer shots.", Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot no# EN6205), administration date: 10Mar2021, for Covid-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "It was very similar to flu"; ASTHENIA (non-serious), outcome "unknown", described as "very low energy. I didnt have any vomiting or diarrhea but it was very low energy and very hard"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "could not concentrate"; FATIGUE (non-serious), outcome "unknown", described as "and very tired". Relevant laboratory tests and procedures are available in the appropriate section. Additional information:: The patient had very strong reaction. It was very similar to flu, very low energy. The patient did not had any vomiting or diarrhea but it was very low energy and very hard, could not concentrate and very tired. So the patient wanted to report that  very strong reaction and didnt had any reaction to the first two Pfizer shots. When reading the papers and reading that the formula used is same. It made me wonder if that is why the patient  had such a strong reaction."  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: experienced soreness in arm the day after receiving the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 9 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 9 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "experienced soreness in arm the day after receiving the vaccine".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product quality issue
Clinical narrative: Mild arm pain; The vial is too small and it's hard for them to get all of the dosage out of the vial once they diluted; potential quality issue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Mild arm pain"; PRODUCT QUALITY ISSUE (non-serious), outcome "unknown", described as "The vial is too small and it's hard for them to get all of the dosage out of the vial once they diluted; potential quality issue".  Additional information: Reporter stated, I am calling because so my son had the Covid vaccine yesterday and I already went online and reported his mild arm pain same day he reported this morning so, that's covered he didn't have any side effects, but I wanted to pass along some feedback of the Health care professionals administering the vaccine and there wasn't a spot to do that online because that's not an adverse event. It's a packaging kind of feedback, potential quality issue but more of just like a packaging thing. So I don't have a specific Lot. I know the Lot my son received, but I don't know the Lot. It just applies to every Lot. It's probably around all the vaccine just similar but the feedback that the vaccine administrators, the Healthcare providers provided is that the vial is too small and it's hard for them to get all of the dosage out of the vial once they diluted it with whatever they diluted with and I told them, I will pass the feedback along. Actually, it's possible if you need it. I took a picture of the vial because I never seen one in person working on the vaccine, but the clinical trial not the actual manufacturing. I might have a picture of the Lot if that matters. Reporter stated, "No, again I only know my son's Lot number. I do not know the Lot numbers of every batch they got and again this is a general comment about all of the vials.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 11 year-old 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in arm".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain
Clinical narrative: body pain/pain; headache; can't sleep, pain is keeping her awake; 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 69 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 26Oct2021 09:55 (Lot number: EN6199) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Back surgeries" (unspecified if ongoing), notes: Has had back pain and has had 3 back surgeries; "Depression" (unspecified if ongoing); "Nerves" (unspecified if ongoing); "Has had back pain" (unspecified if ongoing), notes: Has had back pain and has had 3 back surgeries; "cigarettes smoker" (unspecified if ongoing), notes: she had 3 puffs left that she had one night. Concomitant medication(s) included: DULOXETINE [DULOXETINE HYDROCHLORIDE] taken for depression (ongoing); GABAPENTIN taken for nerve injury (ongoing). Vaccination history included: Bnt162b2 (First dose, Anatomical Location: left arm), administration date: 05Mar2021, when the patient was 69 years old, for Covid-19 Immunisation; Bnt162b2 (Second dose, Anatomical Location: left arm), administration date: 26Mar2021, when the patient was 69 years old, for Covid-19 Immunisation. The following information was reported: PAIN (non-serious) with onset 27Oct2021, outcome "not recovered", described as "body pain/pain"; HEADACHE (non-serious) with onset Oct2021, outcome "not recovered", described as "headache"; INSOMNIA (non-serious) with onset 2021, outcome "not recovered", described as "can't sleep, pain is keeping her awake". Therapeutic measures were taken as a result of pain, headache, insomnia.  Additional information: Caller recieved her Pfizer Covid 19 Vaccine Booster on the. She has experienced pain, headache, body pain.  She wants to know how long the side effects will last. She wants to know when these pains are going to go away because she can't sleep at night. The pain started the day after she got the shot. After 2 or 3 days, the headaches and small body aches came and then quit. The next day, they started hurting and then quit. She states that the only reason she is calling because it hurts. Can't sleep at night: It started about 4 days after the shot. Caller states she has had bad sleeping before but now the pain was keeping her awake and it was bad. She takes marijuana and it expired. She had cigarettes left over from the last one, she had 3 puffs left that she had one night. States that she has not had any other medication. Her doctor won't give her nothing and she has not had any pain medication in a while.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Diagnosed with shingles; I noticed a red rash on the left side of my torso; It followed in a straight lint and itched; Was painful; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Oct2021 10:30 (Lot number: FH8020) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM. The following information was reported: HERPES ZOSTER (non-serious) with onset 03Nov2021 12:00, outcome "not recovered", described as "Diagnosed with shingles"; RASH ERYTHEMATOUS (non-serious) with onset 03Nov2021 12:00, outcome "not recovered", described as "I noticed a red rash on the left side of my torso"; RASH PRURITIC (non-serious) with onset 03Nov2021 12:00, outcome "not recovered", described as "It followed in a straight lint and itched"; RASH (non-serious) with onset 03Nov2021 12:00, outcome "not recovered", described as "Was painful". The events "diagnosed with shingles", "i noticed a red rash on the left side of my torso", "it followed in a straight lint and itched" and "was painful" were evaluated at the physician office visit.  Additional information: Dose received -2: Most recent dose details: product=COVID 19, brand=Pfizer, lot number= FG3527, administration date=06Nov2021, administration time-10:45, vaccine location=left arm. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: Escitalopram. Reported Event: After the first dose of the vaccine About a week after patient noticed a red rash on the left side of his torso. It followed in a straight lint and itched and was painful. On 08Nov2021, 5 days after I noticed the rash he saw his primary care physician and was diagnosed with shingles. If covid prior vaccination: no. If covid tested post vaccination: no. Known allergies -no. Other medical history- none. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Device Date: 08Nov2021.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Fatigue; Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 25Oct2021 (Lot number: FH8020) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TRI LO MARZIA (ongoing). Vaccination history included: Bnt162b2 (Dose number: 1, Anatomical site of injection: Arm, Batch/lot number: EL3247, Resolved within 24 hours with no further action taken, no medication used), administration date: 01Mar2021, for COVID-19 immunization, reaction(s): "pain was in the arm of vaccine injection"; Bnt162b2 (Dose number: 2, Anatomical site of injection: Arm, Batch/lot number: EP6955, Resolved within 24 hours with no further action taken, no medication used), administration date: 24Mar2021, for COVID-19 immunization, reaction(s): "pain was in the arm of vaccine injection". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Oct2021 20:00, outcome "recovered" (26Oct2021), described as "Injection site pain"; FATIGUE (non-serious) with onset 26Oct2021, outcome "recovered" (26Oct2021), described as "Fatigue". Therapeutic measures were not taken as a result of vaccination site pain, fatigue.  Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Moderate headache; Some chills; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Nov2021 12:30 (Lot number: FF2589) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing), notes: Verbatim: High blood pressure; "High cholesterol" (ongoing), notes: Verbatim: High cholesterol. Concomitant medication(s) included: BENAZEPRIL HCL taken for hypertension (ongoing); LIPTOR [ATORVASTATIN] taken for blood cholesterol (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 13:45, Anatomical site of injection: Left Arm/ Shoulder, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 24Feb2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Time: 9:30, Anatomical site of injection: Left Arm/ Shoulder, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 16Mar2021, when the patient was 59 years old, for COVID-19 immunization, reaction(s): "Chills", "Fatigue", "moderate headache".  The following information was reported: FATIGUE (non-serious) with onset 03Nov2021 23:00, outcome "recovered" (Nov2021), described as "Fatigue"; HEADACHE (non-serious) with onset 04Nov2021, outcome "recovered" (Nov2021), described as "Moderate headache"; CHILLS (non-serious) with onset 03Nov2021 23:00, outcome "recovered" (Nov2021), described as "Some chills". Therapeutic measures were not taken as a result of fatigue, chills. Therapeutic measures were taken as a result of headache.  Additional information: Patient had no Prior vaccinations and no relevant tests. Chills and fatigue started about 11 hours after the booster shot. I had a mild to moderate headache starting the morning after the booster shot for about a two-day period. Patient took acetaminophen for two days until the headache subsided. I was back to normal after two days. No other issues. I was able to work during this two-day period.  No follow-up attempts are possible. No further information is expected.
Age: 95.0
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Cough, Hypoacusis, Ophthalmological examination, Pain, Rhinorrhoea
Clinical narrative: Runny nose that wouldn''t stop; when I was at rest it was well, sitting up wasn''t much help but if I lay down it kind of quit too though I get ''that'' a little bit; I always have a little cough; the cough got worse; whole upper body achy; can't hear/hearing problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 95 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Nov2021 (Lot number: FF8841) at the age of 95 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU) (Lot number: Unknown). Relevant medical history included: "Blood cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol. Concomitant medication(s) included: LOSARTAN taken for blood cholesterol. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose that wouldn''t stop; when I was at rest it was well, sitting up wasn''t much help but if I lay down it kind of quit too though I get ''that'' a little bit"; COUGH (non-serious), outcome "unknown", described as "I always have a little cough; the cough got worse"; PAIN (non-serious), outcome "unknown", described as "whole upper body achy"; HYPOACUSIS (non-serious), outcome "unknown", described as "can't hear/hearing problem". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for influenza vaccine was unknown. Therapeutic measures were taken as a result of rhinorrhoea. Additional information: I finally got a antihistamine (treatment) yesterday and that's help my nose." When confirmed if had a flu shot before vaccine: Consumer stated, "Yes, but not that day I had that a few weeks ago  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: generally felt bad; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 09:00 (Lot number: EW0167) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRESTOR; D3 VITAMIN. Past drug history included: Septra, reaction(s): "Known allergies: Allergy". The following information was reported: MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "generally felt bad"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm".  Additional information: It was reported that, after 1st shot sore arm, generally felt bad for a few days. COVID-19 vaccine was administered: Public Health Clinic. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Oral mucosal eruption, Pruritus, Rash erythematous
Clinical narrative: He has a rash which is around his mouth area; It looks like an allergic reaction. It''s not very itchy, it''s not life threating or anything like that but it''s rash; It looks like an allergic reaction. It''s not very itchy, it''s not life threating or anything like that but it''s rash; It''s couple inches long and about half a inch wide almost like ''mangochi'' except it''s red rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Nov2021 (Lot number: FK5127) at the age of 7 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "he has allergies" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, administration date 12Oct2021.  The following information was reported: ORAL MUCOSAL ERUPTION (non-serious) with onset Nov2021, outcome "unknown", described as "He has a rash which is around his mouth area"; HYPERSENSITIVITY (non-serious), PRURITUS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "It looks like an allergic reaction. It''s not very itchy, it''s not life threating or anything like that but it''s rash"; RASH ERYTHEMATOUS (non-serious) with onset Nov2021, outcome "unknown", described as "It''s couple inches long and about half a inch wide almost like ''mangochi'' except it''s red rash". Therapeutic measures were taken as a result of oral mucosal eruption, hypersensitivity, pruritus, rash erythematous.  Additional information: Reporter stated that his 7 year son received COVID-19 vaccine on Thursday. Reporter went online not seeing what was happening with him, asked if it was an adverse reaction. There was nothing else that was making sense. Everything else was standard in his life. On paraphrasing the concern: Reporter stated that Yes he did. It was a day after, so it was a delayed reaction. Like no new food, no new allergy, no nothing. It was strange. He was not stressed, which we were curious about because he was a kid was there a different set of symptoms or side effects that we can find. Prior vaccination (within 4 weeks) included Flu shot about 4 weeks ago."  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Parotid gland enlargement, Salivary gland pain, Swelling face
Clinical narrative: bilateral parotid glands began to swell; parotid glands began to swell, became painful; swelling under the jaw & behind the ear; swelling under the jaw; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Sep2021 13:00 (Lot number: 301458A) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Crohns dx" (unspecified if ongoing); "hyperthyroidism" (unspecified if ongoing); "high output ileostomy" (unspecified if ongoing); "daily IV hydration therapy/IV mg replacement" (unspecified if ongoing); "Mumps" (unspecified if ongoing), notes: mumps years before on the left; "known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAROTID GLAND ENLARGEMENT (non-serious) with onset Oct2021, outcome "recovering", described as "bilateral parotid glands began to swell"; SALIVARY GLAND PAIN (non-serious) with onset Oct2021, outcome "recovering", described as "parotid glands began to swell, became painful"; EAR SWELLING (non-serious) with onset Oct2021, outcome "recovering", described as "swelling under the jaw & behind the ear"; SWELLING FACE (non-serious) with onset Oct2021, outcome "recovering", described as "swelling under the jaw". Therapeutic measures were taken as a result of parotid gland enlargement, salivary gland pain, ear swelling, swelling face.  Additional Information: Seriousness criteria Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect was none. Patient also took dose 2 on 16Nov2021, brand Pfizer, lot number 301458a. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Other medications within 2 weeks of vaccination. This was the first dose, after 8-9 days the bilateral parotid glands began to swell, became painful & swelling was significant on the right parotid with swelling under the jaw & behind the ear. The overall duration was about 9 days with the pain lessening after 4. The lt. parotid gland was less painful with less swelling. Took the second dose 16Nov2021 and 14 days later started having the same issue but this time the swelling was more prominent on the left side, behind the ear & neck. Currently still having the pains & swelling after the second dose given had the mumps years before on the left & the swelling was similar to that & the pain. The doctor thought it's vaccine related & not the mumps. Other AEs were fatigue, chills & aching. Used Voltaren.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Bedridden
Clinical narrative: her arthritis got really bad; could barely get out of bed; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "her arthritis got really bad"; BEDRIDDEN (non-serious), outcome "unknown", described as "could barely get out of bed".  Additional information: The patient took Xeljanz XR 11mg tablet (30s), 1 tablet daily since 01Jan2013 for rheumatoid arthritis. The patient had to go off Xeljanz for a week when she got her covid booster.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Fatigue, Pain in extremity, Ultrasound scan, X-ray limb
Clinical narrative: Sore arm, after  first and second dose; Tired after first and second doses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 14:00 (Lot number: FC3183) at the age of 64 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: PAIN IN EXTREMITY (non-serious) with onset 16Sep2021 17:00, outcome "recovered" (18Sep2021), described as "Sore arm, after first and second dose"; FATIGUE (non-serious) with onset 16Sep2021 17:00, outcome "recovered" (18Sep2021), described as "Tired after first and second doses". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The report not related to a study or programme. No other products and investigation assessment. Reporter was calling about the vaccine for Covid and she is having an adverse reaction to the vaccine. She states that her first dose was 16Sep2021, and second dose 07Oct2021. She reported that she had a knee replacement of her left knee back in May2021. Reporter states she is going for an MRI on 09Nov2021. She states she thinks this is a reaction from the vaccine. She agrees to file a safety report. 3 hours after each vaccine she reported she experienced sore arm and Tired, after first and second dose and ended after two days after both vaccines. Patient received second dose on 07Oct2021 at 10:00 with lot FF2590 in left arm. She states she was having an MRI on 09Nov2021. Vaccination facility type was pharmacy. Vaccine not administered at military facility. No additional vaccines administered on same date of the pfizer suspect. No Prior vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). AE(s) following prior vaccinations reported as none. Family Medical History Relevant to AE(s) was not provided.   Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site swelling
Clinical narrative: arm has gotten swollen more each day; started with a small red circle that got bigger and spread; red circle and swelling are worse now than when it began.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 12:00 (Lot number: FF8841) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lupus", start date: 2014 (ongoing), notes: Verbatim: Lupus. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, lot: FN6200), administration date: 02Mar2021, when the patient was 34 years old, for Covid-19 immunization; Bnt162b2 (Dose:2, Lot: EN6205), administration date: 26Mar2021, when the patient was 34 years old, for Covid-19 immunization; Flu vaccine (Anatomical location : Left arm), administration date: Oct2021. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "arm has gotten swollen more each day"; VACCINATION SITE ERYTHEMA (non-serious), outcome "not recovered", described as "started with a small red circle that got bigger and spread"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "red circle and swelling are worse now than when it began.".  Additional information: It was reported that on 05Nov2021 she had the booster dose and then the swelling began and started with a small red circle that got bigger and spread and it was her left arm that is the same side she had the vaccine booster administered and the red circle and swelling are worse now than when it began. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as None. It was reported that patient had no emergency room visit and no physician office visit. Adverse events following prior vaccinations and Family Medical History Relevant to adverse events reported as None.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: My mom is having a bit of anxiety after the vaccine; 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: ANXIETY (non-serious), outcome "unknown", described as "My mom is having a bit of anxiety after the vaccine".  Additional information: Reporter wanted to know if it was okay to take the anti-anxiety medication after having the vaccine for the patient. Reporter hung up the call abruptly, further probing could not be done. Hence, limited information available over the call.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: Experienced an elongated menstrual cycle going from an average of 28 days to 35 days for next 6 months.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: EL3247, Expiration Date: May2021) as dose 2, single and administered in arm left, administration date 11Mar2021 (Lot number: EL3247, Expiration Date: May2021) 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: OLIGOMENORRHOEA (non-serious) with onset May2021, outcome "recovered", described as "Experienced an elongated menstrual cycle going from an average of 28 days to 35 days for next 6 months."  Additional Information: After two doses of Pfizer Covid vaccine in Mar and Apr the patient experienced an elongated menstrual cycle going from an average of 28 days to 35 days for next 6 months. COVID-19 vaccine dose 2 resulted in disruption to menstrual cycle previous menstrual cycle length of 26-28 days for past 12 month and very regular cycle starting may2021 (after 2nd vaccine) menstrual cycle elongated by an extra week May-32 days, June-34 days, July-35, August-34, September-31 days. No other changes to patients lifestyle daily exercise etc. patient is not on any other medications and does not take birth control and does not have an IUD.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypersomnia, Somnolence
Clinical narrative: Feel like a zombie: can't stay awake, after booster; Feel like a zombie: can''t stay awake, after booster; feel tired; sleep more; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 70 year-old male patient received bnt162b2 (BNT162B2), administration date 30Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "severe diabetic" (unspecified if ongoing); "kidney transplant" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: had Covid around one year ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: Mar2021, for COVID-19 immunization; Bnt162b2 (Dose 2, single), administration date: Apr2021, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Feel like a zombie: can't stay awake, after booster"; SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "Feel like a zombie: can''t stay awake, after booster"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "feel tired"; HYPERSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "sleep more".  Additional information: Caller stated that, they both had the Booster dose and after that they feel tired all the time. It worn them all, it was hard to keep going feeling all tired all the time and they sleep more. Is report related to a study or programme: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Jan 2021 and Feb 2021, single dose, for COVID-19 immunisation. Medical history included COVID-19, start date: Dec 2020 (unspecified if ongoing), notes: Patient had COVID-19 last December. Concomitant medications not reported. The patient experienced hypoesthesia oral (she has a numb lip feeling, no swollen visible just the feeling), onset 2021, with outcome of unknown. Additional information: Patient did not wish to be contacted any further. She stated she felt anxious, after the booster shot. She was freezing cold for 24 hours, extremely tired and she didn't sleep well for the first 5 days. She had COVID-19 last December. After those doses, she doesn't remember which one, she had a numb lip feeling. Not swollen visible just the feeling. No follow-up attempts possible. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Pain in extremity, Pyrexia
Clinical narrative: tinge of a fever; Felt warm in face and on forehead; Extreme arm(shoulder) pain/soreness; Extreme arm(shoulder) pain/soreness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Oct2021 12:00 (Lot number: FE3590) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: other medical history: Anxiety; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Cephalosporins, Penicillin. Concomitant medication(s) included: FLU, start date: 22Oct2021, stop date: 22Oct2021. Past drug history included: Cephalosporins, reaction(s): "known allergies: Cephalosporins", notes: known allergies: Cephalosporins, Penicillin. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 27Oct2021, outcome "recovered" (2021) and all described as "Extreme arm(shoulder) pain/soreness"; PYREXIA (non-serious) with onset 03Nov2021, outcome "recovered" (2021), described as "tinge of a fever"; FEELING HOT (non-serious) with onset 27Oct2021, outcome "recovered" (2021), described as "Felt warm in face and on forehead". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, pyrexia, feeling hot.  Additional information: facility type vaccine Doctor's office/urgent care. If other vaccine in four weeks: Yes. Other medications in two weeks: No. Extreme arm(shoulder) pain/soreness for at least 2 days (but that's normal, I think); unable to lift arm fully due to extreme soreness. A tinge of a fever on Weds, 03Nov in the evening but no other symptoms. No chills, no muscle aches or pains, no malaise. Felt warm in face and on forehead, but otherwise fine. If covid prior vaccination: No. If covid tested post vaccination: No  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Lip blister, Lip dry, Lip erythema
Clinical narrative: My lips broke out and blisters and turned red and dry; My lips broke out and blisters and turned red and dry; My lips broke out and blisters and turned red and dry; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) at the age of 73 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 (1st dose of covid vaccine), for COVID-19 immunization. The following information was reported: LIP BLISTER (non-serious), LIP ERYTHEMA (non-serious), LIP DRY (non-serious) all with onset 03Mar2021, outcome "recovered" (2021) and all described as "My lips broke out and blisters and turned red and dry".  Additional information :after the second Pfizer shot my lips broke out and blisters and turned red and dry and they have lasted for about a month and a half and then it cleared up and then after my booster shot on 07Oct2021 that night my lips turned red and blisters broke out a the next day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Feeling abnormal
Clinical narrative: the day one and one and a half were absolutely awful; 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) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE) (Batch/Lot number: unknown). Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Bipolar disorder" (unspecified if ongoing), notes: Verbatim: Bipolar disorder; "Obesity" (unspecified if ongoing), notes: Verbatim: Obesity; "immunocompromised" (unspecified if ongoing), notes: I am immunocompromised because I am on lot of medication and high risk. Concomitant medication(s) included: ADVAIR; PRISTIQ; LEUCOVORIN CALCIUM; VALIUM; AMBIEN; ZAPONEX; ADDERALL; SINGULAIR; ABILIFY. Vaccination history included: Flu vaccine (I had the Flu vaccine probably about a month earlier), for immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "the day one and one and a half were absolutely awful". Additional information: Patient don't have that. can give the pharmacy information and they will be able to provide it to you. That is on the vaccine card. My spouse has that. I don't have that information on hand. My doctor provided me that. I do not know that. It was the, they would know. I am not sure if I am actually at the right place. to report an adverse event following a booster vaccine. Would that be able to work for you or should I go to another website. one of the outlier' of groups you could say, and that I was affected with COVID prior to the vaccine being on the market. So that makes me sort of a 'quarter' case here. I received Pfizer vaccine across this spectrum. The first dose was, the day one and one and a half were absolutely awful. That is not really what's important. Reporter stated, "During the first vaccine. had side effects.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101545735 similar report from same reporter
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Hypoaesthesia, Malaise
Clinical narrative: Dizzy; Diarrhea; Have been having like dizziness to a point where my left side of my body goes numb for a second and it comes back and it does it like periodically, every now and then; I am not feeling good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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: Bnt162b2 (Dose 1, Single), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Have been having like dizziness to a point where my left side of my body goes numb for a second and it comes back and it does it like periodically, every now and then"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling good".  Additional information: Consumer stated, the patient took Pfizer, the second shot on Saturday and had been feeling dizzy, had been having diarrhea but most importantly, had been having like dizziness to a point where left side of body goes numb for a second and it comes back and it does it like periodically, every now and then. So, was trying to see what need to do."  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.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Molluscum contagiosum, SARS-CoV-2 test
Clinical narrative: Molluscum breakouts 1 month after each dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single, administered in arm left, administration date 20Jan2021 12:00 (Batch/Lot number: unknown) as dose 2, single and administered in arm left, administration date 18Dec2020 16:00 (Batch/Lot number: unknown) 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: MOLLUSCUM CONTAGIOSUM (non-serious), outcome "not recovered", described as "Molluscum breakouts 1 month after each dose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of molluscum contagiosum.  Additional information: Facility where the most recent COVID-19 vaccine was administered at Hospital. Patient was not received any other vaccine four weeks prior vaccination and patient did not receive any medication two weeks prior vaccination. Patient not diagnosed with covid-19 prior to vaccination. Patient tested for COVID-19 after vaccination. The patient had no known allergies.  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-202101603076 similar report from same reporter