chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Vertigo
Clinical narrative: bruised the side of his underarm okay; that night, in bed he experienced severe vertigo; light headedness; dizziness; This is a spontaneous report from contactable consumer. This consumer reported for a 66-year-old male (Husband) patient.   A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6207, Expiration Date: 31Jul2021) via an unspecified route of administration on 13Mar2021 at 10:13 (at the age of 66-years-old) as dose number unknown, single for covid-19 immunization. Patient medical history included acid reflux disease from an unknown date and unknown if ongoing. Concomitant medications included omeprazole; sertraline and ascorbic acid, tocopherol (VITAMIN C AND E). Reporter stated that well, she was calling on behalf of her husband, who received the Pfizer vaccine on 13Mar2021, 10:13 in the morning, that night, in bed patient experienced severe vertigo, when he rolled over he thought the bed was going to flip over, patient got up the next morning and did not say anything to her, she did not know what happened patient went to sit down on the toilet, it happened again and he fell into the vanity and bruised the side of his underarm okay (14Mar2021), he has had on and off vertigo, light headedness (Mar2021), dizziness (Mar2021), since he got the shot, she was trying to find out, if this was going to go away, he had doctor's appointment on Friday which she was not sure what they are going to tell them if this was the result of shot or if there was anything he can do, but they both felt that this was the result of the shot within 24 hours patient had been experiencing that, she was, from what she could see online on message boards there were many people that have experiencing that. Reporter stated, that would be, it would be going to bed on 13Mar2021 and waking up in the middle of the night and experiencing that, so within 24 hours that's why she can't help but thought that these were related and then he had periodic episode of these for the last week since he had it. Reporter stated, it has been 8 days now, she was trying to report a problem that healthy man has experienced in 24 hours of getting the shot and now the problem was, she does not know whether or not when this was going to go away patient experienced dizziness he can't drive, he has like vertigo situation. Reporter stated that the events had improved somewhat and want to know was this common or does it go away in a week. It was stated that other vaccine people were fine within day or two, now they are on day 8 and this was reporter concern why the events had not gone, and patient felt little off since he had the vaccine. Therapeutic measures were taken as a result of the event vertigo and reporter stated all he has taken was over the counter, Meclizine it was motion, it was over the counter, no prescription, since patient could not get the doctor appointment until Friday. Outcome of all the events was recovering.  No follow-up attempts are Possible. No further Information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Sneezing, Vaccination site pain
Clinical narrative: Inability to focus thinking; Sore arm around injection site; tired; sneezing; This is a spontaneous report from a contactable Pharmacist (parent). A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via intramuscular route of administration in right arm on 20Mar2021 at 16:00 (at the age of 26-year-old) as dose 1, single for COVID-19 immunisation at other facility. Medical history was not reported. Concomitant medications included loratadine taken for an unspecified indication, start and stop date were not reported; multivitamins [vitamins nos] taken for an unspecified indication, start and stop date were not reported; birth control pill taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no known allergies. The patient experienced sore arm around injection site, tired on 21Mar2021 at 20:00, sneezing on 21Mar2021 and inability to focus thinking on 22Mar2021 at 10:30. The ice and acetaminophen were given as treatment for soreness. The outcome of sore arm around injection site, tired, sneezing was resolving and inability to focus thinking was resolved on an unknown date.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Lymph node pain, Lymphadenopathy, Nasopharyngitis, Nausea
Clinical narrative: Same side received the vaccine arm pit, groin lymph node are swelled, annoying and it's painful; multiple nodes in my arm pits; I have two lumps and stuffs; Same side received the vaccine arm pit, groin lymph node are swelled, annoying and it's painful; multiple nodes in my arm pits; I have two lumps and stuffs; It feels like you got something in between your legs when you are walking because it's swollen; Felt sick; Cold; it's like nausea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EN6207) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's family history included patient's brother has Lymphedema really bad, so his body, he had Lymphedema was really bad Lymphedema and patient's mother had Lymphedema in her leg where it's the stuff, so patient don't know if it's family history or patient have the side effects. The thing was patient's family had the problem with but patient don't know if that was why patient was getting this because patient don't know. On an unspecified date, when probed for the concern, consumer stated, So, patient was reporting, patient took the Pfizer vaccine on Sympatric spe (not clarified) and patient was reporting that patient had the side effects. patient had the swollen arm pit and on the same side on groin, the lymph node all swelled and on the same side as (received the vaccine) but it's pretty annoying. It's painful and then the groin was where your leg was swollen in bigger, it feels like you got something in between your legs when you are walking because it's swollen and your arms, in fact in it's multiple, so it's multiple nodes in my arm pits, so not just one it's two, patient had two lumps and stuffs, you wouldn't read the paper before you got shot and it's like nausea. Patient felt sick this morning like that patient woke up and had a cold and patient was seeing all that but this, want to know this stuff was a bigger issue on the symptoms. When probed to confirm the concern, consumer stated, "Well, I do. I want to know do I take this, what can it happen when I take the second shot in 21 days because I already got this". The outcome of events was unknown.                 No follow-up attempts are possible. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Same side received the vaccine arm pit, groin lymph node are swelled, annoying and it's painful; multiple nodes in my arm pits; I have two lumps and stuffs; Same side received the vaccine arm pit, groin lymph node are swelled, annoying and it's painful; multiple nodes in my arm pits; I have two lumps and stuffs; It feels like you got something in between your legs when you are walking because it's swollen; Felt sick; Cold; it's like nausea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EN6207) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's family history included patient's brother has Lymphedema really bad, so his body, he had Lymphedema was really bad Lymphedema and patient's mother had Lymphedema in her leg where it's the stuff, so patient don't know if it's family history or patient have the side effects. The thing was patient's family had the problem with but patient don't know if that was why patient was getting this because patient don't know. On an unspecified date, when probed for the concern, consumer stated, So, patient was reporting, patient took the Pfizer vaccine on Sympatric spe (not clarified) and patient was reporting that patient had the side effects. patient had the swollen arm pit and on the same side on groin, the lymph node all swelled and on the same side as (received the vaccine) but it's pretty annoying. It's painful and then the groin was where your leg was swollen in bigger, it feels like you got something in between your legs when you are walking because it's swollen and your arms, in fact in it's multiple, so it's multiple nodes in my arm pits, so not just one it's two, patient had two lumps and stuffs, you wouldn't read the paper before you got shot and it's like nausea. Patient felt sick this morning like that patient woke up and had a cold and patient was seeing all that but this, want to know this stuff was a bigger issue on the symptoms. When probed to confirm the concern, consumer stated, "Well, I do. I want to know do I take this, what can it happen when I take the second shot in 21 days because I already got this". The outcome of events was unknown.                 No follow-up attempts are possible. No further information was expected.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: reports on more redness / swelling of Prevnar 13 on fourth dose of Prevnar 13 administered in arm; reports on more redness / swelling of Prevnar 13 on fourth dose of Prevnar 13 administered in arm; This is a spontaneous report from a contactable nurse via a sales representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration in arm on an unspecified date (Batch/Lot number was not reported) as dose 4, single and doses 1, 2 and 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) in thigh as single dose for immunization for immunization. The patient medical history and concomitant medications were not reported.. The nurse reports on more redness / swelling of Prevnar 13 on fourth dose of Prevnar 13 administered in arm. As compared to previous 1st 3 doses in thigh. Event took place after use of product. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. A 48-year-old patient, of an unspecified gender, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported, expiry date: unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient experienced headache, fever and body aches for 36 hours; with outcome of recovered on unspecific date. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Swelling
Clinical narrative: facial eruptions, redness; facial eruptions, redness; Swelling; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. A female patient of an unspecified age received bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 12Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Mar2021, patient experienced facial eruptions, redness. Swelling and redness persist as of 18Mar2021. Patient was treated with benadryl and steroids by PCP who immunized patient Guidance on cause effect management, and need for second vaccination requested. Patient stayed on Pfizer Med info for about 5hours without a response. Therapeutic measures were taken as a result of facial eruptions, redness and swelling and patient was treated with benadryl and steroids. The outcome of facial eruptions, redness (rash) was unknown while the outcome of the events facial eruptions, redness (erythema) and swelling was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: fever/his highest fever is 101.5; chills; This is a spontaneous report from a contactable consumer (patient's wife). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Mar2021 at 11:45 (lot number: EN6207; expiry date: 03Jul2021) at the of 67-years-old, as dose number unknown, single, for Covid-19 immunisation. Medical history included blood pressure high. Concomitant medications included amlodipine besylate; hydrochlorothiazide; clomiphene citrate; tadalafil taken for unspecified indications, start and stop dates were not reported. On unspecified date in Mar2021, the patient experienced chills. On 19Mar2021, the patient experienced fever, his highest fever was 101.5. Outcome of the event his highest fever is 101.5 was not recovered, while for the other event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: foggy; dizzy; hurt; got a bump near where she had the vaccine that itched like crazy; got a bump near where she had the vaccine that itched like crazy; hive; This is a spontaneous report from a contactable consumer reported for herself. A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 01Mar2021 (age at vaccination was 73 years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. On an unspecified date the patient experienced foggy, dizzy, hurt, got a bump near where she had the vaccine that itched like crazy and hive. Patient had the usual symptoms and was foggy, dizzy, she hurt, and was out of it. Patient said that Saturday night she got a bump near where she had the vaccine that itched like crazy. Patient took 2 Benadryl to treat it, the next day she took a Benadryl and the day after that she took a Benadryl and it went away. Patient said that it was like a itchy bumpy hive. Patient was told to come back on 29Mar2021 but she found one to where she could get it on 23Mar2021. Patient was able to get a second Pfizer dose scheduled for Tuesday 24Mar2021. Therapeutic measures were taken as a result of got a bump near where she had the vaccine that itched like crazy and hive. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: foggy; dizzy; hurt; got a bump near where she had the vaccine that itched like crazy; got a bump near where she had the vaccine that itched like crazy; hive; This is a spontaneous report from a contactable consumer reported for herself. A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 01Mar2021 (age at vaccination was 73 years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. On an unspecified date the patient experienced foggy, dizzy, hurt, got a bump near where she had the vaccine that itched like crazy and hive. Patient had the usual symptoms and was foggy, dizzy, she hurt, and was out of it. Patient said that Saturday night she got a bump near where she had the vaccine that itched like crazy. Patient took 2 Benadryl to treat it, the next day she took a Benadryl and the day after that she took a Benadryl and it went away. Patient said that it was like a itchy bumpy hive. Patient was told to come back on 29Mar2021 but she found one to where she could get it on 23Mar2021. Patient was able to get a second Pfizer dose scheduled for Tuesday 24Mar2021. Therapeutic measures were taken as a result of got a bump near where she had the vaccine that itched like crazy and hive. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling in my nose and around my mouth, it begin slowly and it didn't get too big; This is spontaneous report from a contactable consumer (Patient). A 65-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9267), via an unspecified route of administration on 23Feb2021(at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney disease, atrial fibrillation (all from an unknown date and unknown if ongoing). On 23Feb2021, the patient experienced Swelling in my nose and around my mouth, it begin slowly and it didn't get too big. It was reported that I just wanted to report that when I took the shot on 23Feb, I have swelling in my nose and around my mouth and the first 15 minutes is when it begin slowly and it didn't get too big. But I am wrinkly and my wrinkle were like I took 'Botox', it was very 'cool' (voice not clear) I must say. And so, I got the e-mail to take my second dose I thought I better call you and might e-mail that I had an adverse reaction. But it went away. I just got the e-mail yesterday telling me I could take the second dose, given me a day which is Tuesday and I think may be I shouldn't take it because of the swelling.  Consumer was informed the role of Pfizer Medical Information and offered the number. Consumer was informed about Pfizer Drug Safety. Patient stated that event was gone that same day. Patient stated about concomitant product Lot, yes. Therapeutic measures were taken as a result of adverse event and treatment included Benadryl, Benadryl actually its not adult Benadryl, its Benadryl. The clinical outcome of the events was recovered on an unknown date 2021.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Fatigue; Chills; Body aches; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm left on 24Feb2021 14:15 as dose 1, single (age at vaccination: 48 years) for COVID-19 immunisation. Medical history included Known allergies: Sulfa from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing If covid prior vaccination: Yes. Concomitant medications included paracetamol (TYLENOL), multi vitamin taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. COVID prior vaccination and did not tested COVID post vaccination. On an unspecified date 2021, the patient experienced fever, fatigue, chills, body aches after both vaccines. No treatment was received. The clinical outcome of the events on an unspecified date 2021 was resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: one other person had a nosebleed too; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown, single for COVID-19 immunization. Vaccination facility type was reported as Pharmacy/drug store. Patient medical history and concomitant medications were not reported. The pharmacy said they did not think that was a reaction, but they thought it was odd because one other person had a nosebleed too. The outcome of the events was unknown.   No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Vaccination site pain, Vaccination site swelling
Clinical narrative: pain and swelling where she got the shot; Weakness; Dizziness; pain and swelling where she got the shot; This is a spontaneous report from a contactable other hcp (nurse) reporting for herself. A 99-year-old female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported, Expiry date: not provided), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medication was not reported. On an unspecified date, the patient experienced pain and swelling where she got the shot, weakness and dizziness. Caller stated that last monday afternoon the caller got the second dose of the pfizer covid vaccine and she felt fine until the evening when she had pain and swelling where she got the shot. The next day the caller was so weak she couldn't do anything. Today the dizziness has gone away, and the caller is considerably better. The caller wanted to know how long to expect these symptoms. The clinical outcome of the events pain and swelling where she got the shot and weakness was reported as unknown and dizziness was reported as recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose Bleed/almost daily/same after second dose of shot. Both times acute reaction to shot; This is a spontaneous report from a contactable other health care professional (patient herself). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection and Lot Number: EL1283, expiry date: unknown) intramuscular, in Left Arm on 15Jan2021 as dose 1, single for COVID-19 immunization (Age at time of vaccination: 49 years-old). The patient had not received other vaccines prior to the vaccination. Medical history included asthma. Concomitant medications included salbutamol sulfate (ALBUTEROL SALBUTAMOL SULFATE]) and fluticasone propionate salmeterol (WIXELA INHUB) taken for asthma. Both were taken from an unspecified start date and ongoing. Patient took Hydrochlorothiazide 25mg Tab, and Diphenhydramine 25 mg as needed. On an unspecified date the patient experienced nosebleed/almost daily/same after second dose of shot. both times acute reaction to shot. On 11Mar2021 the patient underwent lab tests and procedures which included COVID-19 which was negative. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: I started to have a shoulder and the neck sore and this I couldn't turn my head aside evenly; I started to have a shoulder and the neck sore and this I couldn't turn my head aside evenly; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 06Mar2021 (Lot Number: EN6199) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.The patient had the vaccine on 06Mar2021 and on 16Mar2021, started to have a shoulder and the neck sore and patient couldn't turn head aside evenly. So that last till the time of reporting, it had been 4 days. The outcome of the event unknown.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Investigation, Pruritus, Rash
Clinical narrative: Rash on chest; it was kind of warm to the touch; it was a little itchya and kind of felt itchy all over; This is a spontaneous report from a contactable consumer (patient) reporting for self. A 55-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, Lot Number: ER2613; Expiration Date: 31Jul2021, PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 19Mar2021 as dose 1, single (at the age of 55 year) for covid-19 immunisation (CDC). Medical history included ongoing seizure, ongoing cholesterol and ongoing allergy, Heart stent and epilepsy. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)) at 81 mg; escitalopram oxalate (LEXAPRO) at 10 mg; ezetimibe (ZETIA) taken for cholesterol, at 10 mg; montelukast sodium (SINGULAIR) taken for allergy, at 10 mg; omeprazole (PROTONIX) taken stomach, start and stop date were not reported; alirocumab (PRALUENT) at 75 mg, zonisamide (ZONEGRAN) taken for seizure; cyclobenzaprine hydrochloride (FLEXERIL) taken as muscle relaxant, at 10 mg. The patient experienced rash on chest, it was kind of warm to the touch and it was a little itchy and kind of felt itchy all over on 20Mar2021 with outcome of unknown. Patient underwent laboratory test and procedures reported as popped up today and now have noticed one in leg on 20Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Agitation, Feeling abnormal, Flushing, Mydriasis
Clinical narrative: severe brain fog; body high; dilated pupils; flushed skin; acting "silly"; This is a spontaneous report from a contactable consumer (Patient's daughter). An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. The patient previously received Valium and was extremely hyper. The patients concomitant medications were not reported. On an unknown date after vaccination, the patient had severe brain fog, body high, dilated pupils, flushed skin and acting silly. The outcome of the events was unknown at the time of report.  No follow-up attempts are needed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash
Clinical narrative: I noticed a rash  across my ribs from one side to other flat non itchy rash across my stomach; One side form my  left side of my waist to right side like under my breast right to my navel right in that area; This is a spontaneous case received from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot: EL9266) via an unspecified route of administration on 15Mar2021 as DOSE 2, SINGLE (age at vaccination 70-year-old) for COVID-19 immunisation. The patient medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication included METOPROLOL 25 mg for blood pressure from unspecified date in 2020 to unknown stop date. The patient historical vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot: EN5318) via an unspecified route of administration on 22Feb2021 for COVID-19 immunisation. On 17Mar2021, the patient reported that she noticed a rash across her ribs from one side to other, flat non-itchy rash across her stomach and one side form my left side of my waist to right side like under my breast right to my navel right in that area. Therapeutic measures were taken as a result of the events which included treatment with Benadryl cream. The outcome of the events was recovering.  No follow-up attempts are possible. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Eyelid irritation, Hypersensitivity, Lip swelling, Swelling face
Clinical narrative: I did get an allergy started from underneath from where tears comes up bottom of eye, eye lid was uncomfortable; I did get an allergy started from underneath from where tears comes up bottom of eye, eye lid was uncomfortable; felt cheek little hard and bone little tougher; An allergy reaction on corner right side of lip that side I received vaccine, not thicker but different; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration, in right side, on 18Mar2021, as dose number unknown, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021, after receiving the COVID vaccine, the patient experienced an allergy it was not severe, was like a mild allergy, started from underneath eye lid, from where the tears come up bottom of eye, and was little like uncomfortable. After 40 minutes taking the vaccine, the corner of right side of lip was like the little, not thicker but, different and then felt cheek a little hard and on cheek bone just like a little tougher. It was reported that, the patient does not know how to explain it. The patient called doctor and she recommended to take Benadryl and she said that was a reaction, because that was not really swollen it was tiny. The patient didn't take anything. The patient woke up on 19Mar2021 (reported as today) in the morning and it was little bit swollen. So, the patient took Benadryl. The patient asked how long this would stay, for how long to be taken the Benadryl. The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Slight rash around her neck; Little soreness in her arm; This is a spontaneous report from a contactable consumer (patient's parent). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534), via an unspecified route of administration on 17Mar2021 (at the age of 62 year old) as dose number unknown, single for COVID-19 immunisation. Medical history included thyroid, rashes, rash from penicillin (sensitivity), Concomitant medications included levothyroxine sodium for an unspecified indication. On an unspecified date in Mar2021, the patient experienced slight rash around her neck and little soreness in her arm. No other reported side effects. At the time of report, rash disappeared. No treatment was received for the events. The outcome of the event slight rash around neck was recovered and of other event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea
Clinical narrative: now my husband has the cough, it's just that he is not he is not blowing his nose that much, but we both had our shot on same day.; now my husband has the cough, it's just that he is not he is not blowing his nose that much, but we both had our shot on same day.; This is a spontaneous report from a contactable consumer (Reporter's husband). An 80-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for Injection, Batch/Lot number: unknown) via unspecified route of administration on 17Mar2021 (at the age of 80-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was reported as none. The patient received unspecified concomitant medications. On an unspecified date in 2021, the patient experienced now my husband has the cough, it's just that he is not he is not blowing his nose that much, but we both had our shot on same day. This is the second case out of two cases in which reporter is reporting for her husband. Reporter stated, well, we got our final shot on the 17th and I had a cold when I went in or when they called me about it, anyway when I went in, I told them I had a cold, they say no come-on in we can still give you the shot. Then when I got in there, I told them I so had cold and they checked with the pharmacist and he said that would be okay, but then I also got a cough and now my husband has the cough, it's just that he is not he is not blowing his nose that much, but we both had our shot on same day. And I don't think I have run a fever with it all. I did have a fever when they gave me the shot. And then I am just wondering if this a reaction to some of the Pfizer. Reporter added, no fever and I went in with the cold and then my husband come down with the cough now and we both got them on 17th and we got the second one. I have a cough too. When confirmed that the reporter wanted to know if this is the side effect from the Pfizer COVID 19 Vaccine, reporter stated, right. LOT: Reporter stated, I don't see a LOT over here, EN6207, this is for me, and my husband had the same one. When confirmed if it is for the Reporter or her husband, Reporter stated, this is for me, and my husband had the same one (Further clarification unknown hence not captured in tab). Expiration date: Reporter stated, I do not know what date that is. Where would that be. It just says 17MAR2021 at (name). Concomitant medication: Reporter stated, yes. Name of the medication: Reporter stated, no, I don't know them. Outcome of all the events was unknown.  No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Movement disorder
Clinical narrative: I am feeling a little bit of pain in just one knee; my left knee and today I cannot even move it. It is so swelled up; my left knee and today I cannot even move it. It is so swelled up; This is a spontaneous report from a contactable consumer (patient). A 67-year-old patient of an unspecified gender received first dose of bnt162b2 (Pfizer covid-19 vaccine, solution for injection, Batch/lot number: EN6205, Expiry date: unknown), via an unspecified route on 25Feb2021 and second dose of bnt162b2 (Pfizer covid-19 vaccine, solution for injection, Lot number: EN6206, Expiry date: unknown), via an unspecified route on 18Mar2021 (age at vaccination: 67-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had the vaccine on Thursday and on an unknown date on Friday patient was feeling a little bit of pain in just one knee, left knee and today patient cannot even move it. It was so swelled up and it was just left knee. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Gait inability, Headache
Clinical narrative: Fever; feeling very week; very bad chills; body aches so bad that she was unable to walk on Sunday/she could not get up because everything hurt; body aches so bad that she was unable to walk on Sunday; could not sleep; Headache; Her legs and everything hurt; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number, expiration date, NDC number were reported as unknown), via an unspecified route of administration, administered in left arm on 20Mar2021 at 11:50 (at the age of 53 years) as dose 1, single for covid-19 immunization. Patient's medical history, prior vaccinations (within 4 weeks), adverse events following prior vaccinations, family medical history, additional vaccines administered on same date of the Pfizer suspect were reported as none. No history of all previous immunization with the Pfizer vaccine considered as suspect. There were no concomitant medications. On 21Mar2021, the patient experienced very bad chills at 02:00, felt very week at 08:30, and fever at 12:00. On an unknown date in Mar2021, the patient experienced body aches so bad that she was unable to walk on Sunday. It was reported that, she took vaccination on Saturday and was ok. On Sunday, she was very weak and was still weak at the time of reporting. She also had headache. In the morning, she could not get up because everything hurt. She could not sleep and was in bed. Her legs and everything hurt. The patient underwent lab tests and procedures which included body temperature: one time she took it, and it was 100.2 and another time it was 99.2 degrees Fahrenheit in Mar2021. She wanted to know if she would be ok if she takes the second dose of vaccine with symptoms. She was much better than Sunday, but she was weak. No ER or physician's office required. She felt bad but did not go anywhere. She had read on the paper that said she may have some of the events. The outcome of the events very bad chills, feeling very week, and fever was recovering, and for all other events was unknown.  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: Insomnia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; feeling very week; very bad chills; body aches so bad that she was unable to walk on Sunday/she could not get up because everything hurt; body aches so bad that she was unable to walk on Sunday; could not sleep; Headache; Her legs and everything hurt; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number, expiration date, NDC number were reported as unknown), via an unspecified route of administration, administered in left arm on 20Mar2021 at 11:50 (at the age of 53 years) as dose 1, single for covid-19 immunization. Patient's medical history, prior vaccinations (within 4 weeks), adverse events following prior vaccinations, family medical history, additional vaccines administered on same date of the Pfizer suspect were reported as none. No history of all previous immunization with the Pfizer vaccine considered as suspect. There were no concomitant medications. On 21Mar2021, the patient experienced very bad chills at 02:00, felt very week at 08:30, and fever at 12:00. On an unknown date in Mar2021, the patient experienced body aches so bad that she was unable to walk on Sunday. It was reported that, she took vaccination on Saturday and was ok. On Sunday, she was very weak and was still weak at the time of reporting. She also had headache. In the morning, she could not get up because everything hurt. She could not sleep and was in bed. Her legs and everything hurt. The patient underwent lab tests and procedures which included body temperature: one time she took it, and it was 100.2 and another time it was 99.2 degrees Fahrenheit in Mar2021. She wanted to know if she would be ok if she takes the second dose of vaccine with symptoms. She was much better than Sunday, but she was weak. No ER or physician's office required. She felt bad but did not go anywhere. She had read on the paper that said she may have some of the events. The outcome of the events very bad chills, feeling very week, and fever was recovering, and for all other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Nausea, Pyrexia
Clinical narrative: I had severe headaches; Nausea; Inability to walk; Fever; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6206) via an unspecified route of administration on 15Mar2021 as dose number unknown, single for COVID-19 immunization (at the age of 74-year-old). Medical history included thyroid disorder and hormone therapy. Concomitant medications included levothyroxine taken for thyroid disorder; estradiol taken for hormone therapy, start and stop date were not reported. The patient experienced i had severe headaches, nausea, inability to walk and fever on 18Mar2021. It was reported that, patient had the Pfizer vaccine, week ago today, she had an undiagnosed case of Covid and when she was checked with 7 different doctor's they all said there was nothing wrong with her, then she came down with long-hauler syndrome for months and quite miserable that there was nothing wrong with her, she would up getting the same symptoms 3 days after, had the injection Monday, she had severe headaches, nausea, Inability to walk, fever those were the main things. Patient still had the headache and got low grade fevers. The patient did not receive any treatment for the events. The outcome of the event fever was recovering, severe headache was not recovered and for nausea and inability to walk was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Epistaxis
Clinical narrative: Nose bleeds; This is a spontaneous report from a contactable Pharmacist reported for consumer (Patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization (age at vaccination was 54 years). The patient medical history included Penicillin allergy. Concomitant medication was none. On an unknown date, after receiving first dose patient had a minor nosebleed that night and then had 3 nose bleeds in the days after. The event was considered as non-serious. Upon the latest nosebleed the physician drew blood work, and everything was normal. The patient is worried about the 2nd dose. The patient underwent lab tests and procedures which included blood test: normal   on unspecified date. Follow-up (11May2021): Follow-up attempts completed. No further information expected. Upon follow up on 24Mar2021new information has been updated. This is a follow up spontaneous report from a contactable consumer. This consumer reported for a female patient about drug information (Pfizer Biontech covid 19 vaccine, dosage text about 1st dose, action(s) taken with drug was unknown, dates, NDC number, Expiry Date for Pfizer was unknown), reason for no lot number of Pfizer covid19 vaccine states student pharmacist who was calling on behalf of patient female he has no lot, expiry date or NDC for the patient's Pfizer COVID19 Vaccine. Patient history was not provided. Investigation assessment was not provided. The outcome of the event was not recovered.  Follow up (24Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported for a female patient that This is a follow up spontaneous report from a contactable consumer. This consumer reported for a female patient about drug information (Pfizer Biontech covid 19 vaccine, dosage text about 1st dose, action(s) taken with drug was unknown, dates, NDC number, Expiry Date for Pfizer was unknown), reason for no lot number of Pfizer covid19 vaccine states student pharmacist who was calling on behalf of patient female he has no lot, expiry date or NDC for the patient's Pfizer COVID19 Vaccine. Patient history was not provided. Investigation assessment was not provided.  Follow-up attempts are completed. No further information is expected
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gout, X-ray
Clinical narrative: Saturday, 20Mar2021 was when I had noticed the same adverse event (joint pain) on my left foot after I had received the 2nd dose of Pfizer vaccine on Thursday, 18Mar2021; Another flare up (worse than 1st time) occurred after the 2nd vaccine shot - within 2 days; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6199), via an unspecified route, administered in Left Arm on 18Mar2021 (48-year-old at vaccination) as Dose 2, Single for COVID-19 immunization. Facility type vaccine was reported as Workplace clinic. The patient's medical history was concomitant medications within two weeks was reported as none. No known allergies. The patient had not received any other vaccine within four weeks to prior vaccination. The patient was not diagnosed with COVID prior vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN 5318), via an unspecified route, administered in Left Arm on 24Feb2021 at 3:30 PM as Dose 1, Single for COVID-19 immunization. Left foot joint pain (gout) several days after receiving 1st vaccine shot. Another flare up (worse than 1st time) occurred after the 2nd vaccine shot - within 2 days. On 20Mar2021 at 12:00 (Saturday), the patient experienced the same adverse event joint pain on his left foot. The patient underwent lab test and procedure which included X-ray left foot: unknown results. Post vaccination the patient was not tested for COVID. The patient was prescribed Colchicine for resulted events. Clinical outcome of the events was reported as not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inner ear disorder, Penile curvature
Clinical narrative: Extreme joint pain for several weeks; Water in the inner ear; Curvature of the penis; This is a spontaneous report received from a non-contactable nurse, (patient himself). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 62-years-old) as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On an unspecified date, the patient experienced extreme joint pain for several weeks, water in the inner ear, curvature of the penis. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received vitamin d, pain killers as treatment medications for the resulted events. The outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.