chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Arm of the injection site became red, swollen, and hot to touch from the shoulder down to hand.; Arm of the injection site became red, swollen, and hot to touch from the shoulder down to hand.; Arm of the injection site became red, swollen, and hot to touch from the shoulder down to hand.; Arm of the injection site became red, swollen, and hot to touch from the shoulder down to hand.; Arm of the injection site became red, swollen, and hot to touch from the shoulder down to hand.; Arm of the injection site became red, swollen, and hot to touch from the shoulder down to hand.; This is a spontaneous report from a contactable nurse (patient herself). A 47-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 03Aug2021 16:00 as dose 1, single (at the age of 47-years-old) for COVID-19 immunization. Vaccination facility type was reported as Pharmacy/drug store. Patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. Patient was not pregnant at the time of vaccination. Patient medical history included hypothyroidism. Patient had known allergies to latex sensitivity, environmental allergies and flu shot. The concomitant medications included birth control, biotin, Cytomel and Synthroid. Patient experienced arm of the injection site became red, swollen, and hot to touch from the shoulder down to hand on 03Aug2021 18:00. Patient received Benadryl 50 mg as treatment. The outcome of the event was resolved on an unspecified date in Aug2021.  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 have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Swollen tongue
Clinical narrative: her tongue really hurts; started to experience tongue swelling on Friday/tongue felt swollen/ tongue swelled up big/ tongue swells up big and it's humongous; taste funny; This is a spontaneous report from a contactable consumer, the patient's mother. A 27-years-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 29Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient started to experience tongue swelling on 30Jul2021 (friday) and since she took it every couple days her tongue swelled up big. It was reported that the patient's tongue swells up big and it's humongous, that she woke up and her tongue felt funny, tasted funny on an unknown date in 2021 and tongue felt swollen and that it really hurts on 05Aug2021 and it was so swollen, it kept swelling up with her teeth biting into it. It was reported that the patient went through that all day then it kind of went down. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Illness, Limb discomfort
Clinical narrative: I have been sick; running nose; Coughing; very tired/Fatigue; Dizzy; Fever; have a reaction in my arm; I still have a small lumps in my arms; This is a spontaneous report from a contactable consumer (patient, self-reported). A 29-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration, on 30July2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 30July2021, Patient experienced have a reaction in my arm and I still have a small lump in my arms. It was reported that Consumer stated, I was having a hard time finding out information on the side effects other than those main side effects which I know you guys are happy to record what people experiencing so I am happy to share that with you, but I wanted to know. I know it can cause tiredness, start nausea, throwing up, fever(Not clarified hence not captured in tab) things like that but what about running nose and coughing was that common as well because I did receive my first dose and I did have a reaction in my arm which I was told was common and I have been sick all week but days later and there was a concern may be I have Covid (Not clear hence not captured in tab) but maybe it was just from the vaccine and no one seems to know if the running nose or coughing was also a side effects in vaccine and I can't find it listed anywhere. Consumer stated, the reaction in my arm was immediate that was the 30Jul2021 and then next day I still have a small lump in my arms but that happened immediately after and on a following day I did fall under the weather but nothing horrible just a very tired, fatigue, I felt dizzy and on Sunday two days later I started feeling better and then last night I started getting sick again and I woke up very and I have been sick since. Consumer stated, No, I have talked with my doctor let know her and I was taking Tylenol to trying to get my fever down. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Skin swelling
Clinical narrative: I have been sick; running nose; Coughing; very tired/Fatigue; Dizzy; Fever; have a reaction in my arm; I still have a small lumps in my arms; This is a spontaneous report from a contactable consumer (patient, self-reported). A 29-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration, on 30July2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 30July2021, Patient experienced have a reaction in my arm and I still have a small lump in my arms. It was reported that Consumer stated, I was having a hard time finding out information on the side effects other than those main side effects which I know you guys are happy to record what people experiencing so I am happy to share that with you, but I wanted to know. I know it can cause tiredness, start nausea, throwing up, fever(Not clarified hence not captured in tab) things like that but what about running nose and coughing was that common as well because I did receive my first dose and I did have a reaction in my arm which I was told was common and I have been sick all week but days later and there was a concern may be I have Covid (Not clear hence not captured in tab) but maybe it was just from the vaccine and no one seems to know if the running nose or coughing was also a side effects in vaccine and I can't find it listed anywhere. Consumer stated, the reaction in my arm was immediate that was the 30Jul2021 and then next day I still have a small lump in my arms but that happened immediately after and on a following day I did fall under the weather but nothing horrible just a very tired, fatigue, I felt dizzy and on Sunday two days later I started feeling better and then last night I started getting sick again and I woke up very and I have been sick since. Consumer stated, No, I have talked with my doctor let know her and I was taking Tylenol to trying to get my fever down. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report from a contactable consumer. This consumer (patient's grandmother) reported for a male patient (reporter's grandson). A male patient of an unknown age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and Expiration Date: not reported) via an unspecified route of administration, on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patients medical history and concomitant medication(s) are not reported. The patient previously took first vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and Expiration Date: not reported) via an unspecified route of administration, on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date the caller reported that her grandson got the second shot, they did get sick. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (16Sep2021):  Information about lot/batch number cannot be obtained. No further information expected
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Pain in extremity
Clinical narrative: The caller got a third dose yesterday; The caller got a third dose yesterday; Arm is a lot sorer than the first two shots; This is a spontaneous report received from Pfizer Sponsored Program. A contactable 73-year-old female consumer (patient) reported for herself that a 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 04Aug2021 12:00 (at the age of 73-year-old) (Batch/Lot Number: RC3180) as dose 3, single for covid-19 immunisation. The patient medical history included diabetes mellitus, overweight and immunodeficiency. The patient concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on end of Jan2021 (Batch/Lot Number: unknown) as dose 1, single and dose 2 via an unspecified route of administration on mid Feb2021 (Batch/Lot Number: unknown) as dose 2, single for covid-19 immunisation. 04Aug2021 12:00 the caller got her third dose of the vaccine and then went to breakfast. The patient arm was a lot sorer than the first two shots on 04Aug2021. This started 2-3 hours after the shot and it got progressively worse at night. The caller made it her business not to sleep on that arm. The clinical outcome of event arm was a lot sorer than the first two shots was not recovered.  Follow-up activities closed. Batch/lot number not available for BNT162B2.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Fever; In my vaccinated arm, under my arm started to swell and it is still swollen under my arm; This is a spontaneous report from a contactable consumer. This consumer(patient) reported that, A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm on an unspecified date (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Reason for not providing lot number of Covid-19 Vaccine: Other: Consumer stated, it is PP136782 something like that, it is the only number on this paper and expiry date was unknown.The patient medical history and concomitant medications were not reported. The patient experienced fever and in my vaccinated arm, under my arm started to swell and it is still swollen under my arm on an unspecified date. The number of Covid-19 Vaccine is Unknown. When probed for the concern, consumer stated that, I received my second dose of Pfizer on Tuesday and like I had fever like that stuff that it's ok now, however since yesterday afternoon under my arm in my vaccinated arm, it started to swell and right now when I woke up it's still swollen under my arm. I do not know if it's like one of the side effects of my vaccine or not, this is the first time happened. My arm didn't swell or anything before, so I would like to know if it is ok. When paraphrased the concern, consumer stated, Yes, just after (vaccination) like the next day. Consumer was informed about the Role of Pfizer Drug Safety and Pfizer Medical Information Department and stated, I just need to know why it is swollen and if it is okay or not. Consumer was provided with the number of Pfizer Medical Information # #and was requested to select option 3 and timings as 8 am to 8 pm from Monday to Friday as per (EST). As consumer was not willing to proceed the call. Product details (Expiration date, number), Pharmacy details and treatment could not be probed over the call. Limited information available over the call. This report is not related to a study programme. When probed for vaccine LOT#, consumer stated, it is PP136782 something like that, it is the only number on this paper and When probed for consumer's mailing address, consumer stated, it is 2237, why do need that, I don't want to provide my any personal information. Vaccine name (Both doses vaccine): Pfizer, Covid-19 Vaccine. Outcome of the events was Unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pyrexia
Clinical narrative: softball size knot on her arm that's red; feverish; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) dose unknown via an unspecified route of administration on unspecified date in as dose number unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. On specified date patient had softball size knot on her arm that's red and feverish. The outcome of the events was unknown.  Lot number/Batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: I started to cramp and my cycle was VERY heavy and lasted for 1 day. It usually last 3 days and is very light. I am still cramping even after my cycle is over; and my cycle was VERY heavy and lasted for 1 day. It usually last 3 days and is very light. I am still cramping even after my cycle is over; my cycle was VERY heavy and lasted for 1 day. It usually last 3 days and is very light. I am still cramping even after my cycle is over; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch no/ Lot Number: unknown; expiration date: unknown) via an unspecified route of administration on 09Jul2021 at 01:00 PM (at the age of 35-years-old) as dose 1, single for COVID-19 immunization. The patient medical history, allergies and concomitant medications were not available. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient wasn't COVID-19 positive prior to vaccination and was not tested for COVID-19 post vaccination. On 31Jul2021 at 08:00 AM, patient experienced that after two weeks of vaccination, she started to cramp, and her cycle was very heavy and lasted for 1 day. It usually last 3 days and was very light. She still cramping even after her cycle was over. No treatment was received in response to events. Outcome of the event Cramps menstrual was not recovered and other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Vaccination site swelling
Clinical narrative: had swelling at the injection site and arm pain for 3 or 4 days.; had swelling at the injection site and arm pain for 3 or 4 days.; feeling kind of dizzy that night; This is a spontaneous report from a Pfizer sponsored program. A contactable 61-year-old female consumer (patient) reported for herself. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered anatomical location not reported on unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose and is due to receive second dose next week and is looking for specific statistics of side effects. The patient asked about the percentages of diarrhea for her age group. The Regulatory Authority support gave patient some information but that didn't give percentages for after both the first and second dose. In response information was shared through email and read from attached PI under Table 4: Study 2 - Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose - Participants 56 Years of Age and Older - Reactogenicity Subset of the Safety Population under Diarrhea for both first and second dose. The patient asked about once you get the second dose, do they include that day for the 14 days or after this to be considered fully vaccinated. In response information was shared through email and read from attached doc when does the vaccine start protecting me against covid-19 (v4.0). The patient reported after receiving first dose she experienced some events and asked if this is a reported side effect. In response information was shared through email and read from attached PI under What are the risks of the Pfizer-BioNTech COVID-19 Vaccine and read from attached VR-Consumer Inquiry Management (Off-Label or No Info) (v15.0) under adverse reactions or side effects for dizziness. On unspecified date, after receiving first dose patient experienced started feeling kind of dizzy that night, had swelling at the injection site and arm pain. The outcome of event after receiving first dose started feeling kind of dizzy that night was recovered next day. The outcome of events swelling at the injection site and arm pain was recovered after 3 or 4 days.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Movement disorder, Pain in extremity
Clinical narrative: sore on her left arm (especially the left hand). Soreness later crafted the right hand and could not move it well.; sore on her left arm (especially the left hand). Soreness later crafted the right hand and could not move it well  and struggles rolling over her bed.; trouble with breathing; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: not reported), via an unspecified route of administration on 15Jul2021as dose 1, single for covid-19 immunization. Medical history included migraine, asthma, allergies, Epstein-Barr, all were ongoing (pre-existing conditions). She has never been free from Epstein-Barr and this EBV was recurring and never goes away. The patient concomitant medication was not reported. The patient previously took Allegra once (20 years ago) and had been suffering from migraine since then. The patient said that she was not the type of person who usually took drugs. The patient was saying that on 15Jul2021, she received the 1st dose of our COVID-19 vaccine. On an unknown date in 2021, the patient was experiencing a sore on her left arm (especially the left hand). Soreness later crafted the right hand and could not move it well. She was also having trouble with breathing and struggles rolling over her bed also mentioned experiencing a headache. The patient was scheduled for the 2nd dose on 12Aug2021. The outcome of the events was unknown.  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 have been completed and no further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Gastrooesophageal reflux disease
Clinical narrative: Acid reflux/indigestion; Acid reflux/indigestion/having really bad acid indigestion/developed really bad acid indigestion two-three days after getting the second dose; This is a spontaneous report from contactable consumer (patient, self-reported). A 75-year-old-female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 29Jul2021 (age at vaccination: 75 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0170 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 07Jul2021 (age at vaccination: 75 years), as a single dose for COVID-19 immunization and no events reported. Vaccine was not administered at Facility. The patient reported that on an unspecified date in 2021, she began experiencing acid reflux/indigestion which was still on going. There was no report related to a study or programme. The patient also had acid reflux/indigestion/having really bad acid indigestion/developed really bad acid indigestion two-three days after getting the second dose. The patient asked if this could be from the vaccine. The adverse events required a visit to emergency room and physician office. Outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: constipation; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support from a contactable female consumer (patient). A female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 24Jul2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. Within a week after the patient experienced Constipation and patient wanted to know if this is a normal side effect and if this has been reported with the vaccine. Spoken from attached VR-Consumer Inquiry Management. A review of the Prescribing Information did not find information regarding constipation as a reported side effect. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. Patient referred HCP for further guidance. The clinical outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to chemicals, Arthralgia, Condition aggravated, Depression, Fatigue
Clinical narrative: Continued joint pain; intestinal issues; continued very fatigued; heart palpitations; severe depression; very sensitive to chemicals; vaccine has magnified them severely; This is a spontaneous report from a contactable consumer (patient, self-reported). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 12Mar2021 (age at vaccination: 68 years), as a single dose for COVID-19 immunization at public health clinic/veterans. The patient's medical history included depression, MCS, and all chemicals allergy. Concomitant medications included alprazolam (XANAX) and metropropol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on an unspecified date, as a single dose for COVID-19 immunization at public health clinic/veterans. The patient received second dose of other vaccine in 4 weeks after vaccination in left arm on 03Apr2021. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. On 01Apr2021, the patient experienced continued joint pain, intestinal issues, continued very fatigued, heart palpitations, severe depression, very sensitive to chemicals. All these conditions he already have, but the vaccine has magnified them severely. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The patient underwent lab test and procedure included COVID (nasal swab) with negative result on 05Aug2021. Outcome of the events was not recovered.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Palpitations, SARS-CoV-2 antibody test
Clinical narrative: Continued joint pain; intestinal issues; continued very fatigued; heart palpitations; severe depression; very sensitive to chemicals; vaccine has magnified them severely; This is a spontaneous report from a contactable consumer (patient, self-reported). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 12Mar2021 (age at vaccination: 68 years), as a single dose for COVID-19 immunization at public health clinic/veterans. The patient's medical history included depression, MCS, and all chemicals allergy. Concomitant medications included alprazolam (XANAX) and metropropol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on an unspecified date, as a single dose for COVID-19 immunization at public health clinic/veterans. The patient received second dose of other vaccine in 4 weeks after vaccination in left arm on 03Apr2021. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. On 01Apr2021, the patient experienced continued joint pain, intestinal issues, continued very fatigued, heart palpitations, severe depression, very sensitive to chemicals. All these conditions he already have, but the vaccine has magnified them severely. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The patient underwent lab test and procedure included COVID (nasal swab) with negative result on 05Aug2021. Outcome of the events was not recovered.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pruritus, Rash pruritic, Vaccination site reaction
Clinical narrative: pruritic papular skin eruption starting in her occipital scalp but over the succeeding days/weeks this extended to areas on her trunk and extremities; Itching; injection site skin reaction; only mild arm discomfort; This is a spontaneous report from a contactable physician (Patient's Husband). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19, solution for injection), via an unspecified route of administration, on 25Mar2021  (Batch/Lot Number: Unknown) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The Physician reported that, approximately 7 days following inoculation, his wife began developing a very pruritic papular skin eruption starting in her occipital scalp, but over the succeeding days/weeks this extended to areas on her trunk and extremities. She had very little, if any, injection site skin reaction (only mild arm discomfort). They consulted with a local dermatologist (3 weeks after onset) and a clinical allergist/immunologist (6 weeks after onset). The dermatologist advised to get the second dose and thought this would resolve with time, the immunologist advised against a second dose but also thought it would resolve with time. Over time, the eruption has cleared in many areas but new has emerged in other areas and now over 4 months later she still has some areas of involvement, albeit the itching is less than before. She had no prior history of any kind skin disease or atopy. There was some thought this was a T-cell activation syndrome of some sort, but he thought it would have resolved by now. Outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: had fever; threw up; This is a spontaneous report from a contactable consumer (patients mother).   A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number and Expiration date were not provided), via an unspecified route of administration in Arm Left on 05Aug2021 13:00 (age at vaccination13-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient healthy before vaccination. The patient's concomitant medications were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number and Expiration date were not provided), via an unspecified route of administration in Arm Right on 15Jul2021 as dose 1, single for COVID-19 immunization. States her son just had his 2nd dose of the Pfizer COVID shot 05Aug2021 (yesterday) and at 20:00 had fever and all these things she knows are part of some of the side effects after the 2nd dose; states she does not think it was anything serious for her son and was not an allergy but he had a temperature and threw up and in the packet they gave her it said some of the side effects could occur and she is not worried.  States the patient's first dose was administered 15Jul2021 and she has no lots, expiry dates or NDC numbers to provide for the patient's Pfizer COVID doses of the vaccine. States the first dose was administered to the patient's right arm and the 2nd dose to his withheld and the symptoms began yesterday around 20:00pm and he had the shot at 13:00pm; states the last time he threw up was at 11:00am today and she was giving him Tylenol every 4 hours of 30mL and the temperature is under control and it was regular strength Tylenol; states she has no lots, expiry dates or UPC numbers for the Tylenol. The outcome of the events was unknown.    No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Hypoaesthesia, Tenderness
Clinical narrative: My arms are little numb and tender, now I have symptoms spreading up to my neck and above my left ear which is the shoulder I got my shot in; My arms are little numb and tender, now I have symptoms spreading up to my neck and above my left ear which is the shoulder I got my shot in; My left eye is like swollen; This is a spontaneous report from a contactable consumer.   A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 06Aug2021 (vaccination at the age of 58 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. consumer stated, "I only take like Tylenol or Ibuprofen, no I mean they were quite often, just not take daily, probably 3-4 days but that's over the counter." The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On06Aug2021, the patient had experienced my arms are little numb and tender, now I have symptoms spreading up to my neck and above my left ear which is the shoulder I got my shot in and my left eye is like swollen. At the time of reporting, the outcome of the events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: strange bruises on both of her arms, mainly on the arm that was injected; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, administered on 27Jul2021, as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, after the first dose of vaccine, the patient experienced strange bruises on both of her arms, mainly on the arm that was injected. Patient was due for the second on 07Aug2021. She may not take her second dose, as she got complication from first dose. Patient was hesitant with the first because she doesn't trust it. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Feeling hot, Paraesthesia, Swelling face
Clinical narrative: The tingling only lasted for a few minutes, and it felt warm, very warm.; face started to tingle on left side; Facial swelling; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 87-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 05Aug2021 11:00 (at the age of 87-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing arthritis diagnosed about 20 years ago, blood pressure from an unknown date and unknown if ongoing. The patient got the first dose yesterday. After she was home about an hour, her face started to tingle on the left side and started to swell and on the right side of her face it was also a little swollen on 05Aug2021. Reports that almost any medication that she takes she cannot take because it makes her face swell up. She was hesitant about getting the second dose in three weeks and was afraid she will swell and her throat will swell. She does not have high blood pressure or high cholesterol but does have arthritis. The tingling only lasted for a few minutes, and it felt warm, very warm. Her face was still swollen. She wears a mask and it cannot be seen. She does not take blood pressure medicine because it makes her face swell. She controls her blood pressure by not eating salt and using no salt. The patient underwent lab tests and procedures which included her body height shrunk an inch on an unspecified date. Patient declines any treatment. The outcome of the event face started to tingle on left side was recovered on 05Aug2021, facial swelling was not recovered while the outcome of remaining event was unknown.     Information about Lot/Batch has been requested
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Paraesthesia, Swelling face
Clinical narrative: This is a spontaneous report from a contactable physician. A 19-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; solution for injection, batch/lot# unknown), via unspecified route of administration, on Jul 20, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medication not reported. The reporter stated on an unspecified date, patient experienced tingling and swelling of her lower face about 1-2 hours after her injection. The patient has no throat swelling or difficulty breathing at that time. Patient given Benadryl by her mother and reactions resolved within a couple of hours. Patient queried regarding the second dose. The reporter was trying to determine whether patient's reaction constitutes a severe allergic reaction, which patient already reported at the end of July (exact date unknown). Outcome for the severe allergic reaction unknown and for other two reported events recovered. Information on the lot/batch number requested.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: He had ringing in the ear that is tinnitus; This is a spontaneous report from a contactable pharmacist.A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient had ringing in the ear that was tinnitus. The outcome of event was unknown. . 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 have been completed and no further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Prenatal screening test, Pyrexia, Ultrasound scan
Clinical narrative: Fever; This is a spontaneous report from a contactable physician. A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 31 years), dose 1 via intramuscular on 18Mar2021 as dose 1, single; and then dose 2 via intramuscular on 15Apr2021 as dose 2, single for COVID-19 immunisation. Medical history included rheumatoid arthritis from 2010 to an unspecified date and anxiety from 2009 to an unspecified date. EDC (Estimated date of confinement) is 04Dec2021. Doc is 13Mar2021. LMP (Last menstrual period) is 27Feb2021. Concomitant medication(s) included acetylsalicylic acid (BABY ASPIRIN) taken for pre-eclampsia from 04Jun2021 to an unspecified stop date; caffeine (COFFEE) from 29May2021 to an unspecified stop date; hydroxychloroquine sulfate taken for rheumatoid arthritis from 01Jul2016 to an unspecified stop date; minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01Jul2018 to an unspecified stop date; sulfasalazine taken for rheumatoid arthritis from 21Jul2021 to an unspecified stop date; doxylamine succinate (UNISOM 2) taken for nausea from 17Apr2021 to an unspecified stop date; vitamin b6 (VITAMIN B6) taken for nausea from 17Apr2021 to an unspecified stop date. The patient experienced fever from 18Mar2021 to 21Mar2021 after the first dose and from 15Apr2021 to 18Apr2021 for the second dose. The patient reported she became pregnant while taking bnt162b2.The patient was due to delivery, patient underwent lab tests and procedures which included prenatal screening test (OTH) NIPT (Non-invasive prenatal test) unknown result on 15May2021, ultrasound scan: unknown results on 10Apr2021, 24Apr2021, 15May2021, 10Jul2021, 31Jul2021. The outcome of the event was resolved on 18Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick and could not make it to the appointment date.; This is a spontaneous report from a contactable consumer or other non-hcp (patient himself). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on 14Jul2021 (Lot number and expiry date was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after the first COVID-19 vaccine, the patient got sick and could not make it to the appointment date of second dose. He was supposed to get the second dose of the vaccine on 04Aug2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Illness, Muscular weakness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection,  batch/lot# not reported), via an unspecified route of administration, on Jul 29, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Previously patient received her first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unknown date in 2021, single dose, for COVID-19 immunization. On an unknown date in 2021, patient was severely ill, couldn't walk and still weak in the legs. The outcome of the events unknown. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick afterwards; This is a spontaneous report received from a Pfizer-sponsored program. A contactable pharmacist reported for a patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: was not reported) via an unspecified route of administration, administered on an unspecified date of Jan2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine last January 2021, and on an unspecified date patient had gotten sick after the vaccine and was now inquiring about the second dose of vaccine. Patient was wondering about the window and was informed by transfer agent it's only 21 days. The outcome of the event was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Pregnancy test, SARS-CoV-2 test
Clinical narrative: Second dose I am 8 days late; This is a spontaneous report from a contactable consumer (patient). A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration (Age at time of vaccination: 24) in Apr2021, as dose 2, single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration (Age at time of vaccination: 24) in Mar2021, as dose 1, single dose for COVID-19 immunisation. After the first dose patient's periods was 3 days late and very light. Patient reported past drug history as no. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. Prior to vaccination patient was not diagnosed with COVID-19 reported as no and after vaccination patient was tested for COVID-19 reported as yes. After second dose in May, the patient experienced periods was 8 days late. The patient underwent lab tests and procedures which included pregnancy test: negative, on 2021 patient had taken 4 pregnancy test and sars-cov-2 test: negative on Apr2021, post vaccination. The patient had a physician office visit. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Inflammation, Loss of personal independence in daily activities, Nausea, Vomiting
Clinical narrative: sick; nausea; vomiting; inflammation; have not been able to work; 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), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, on an unspecified date in 2021, the patient was sick with nausea, vomiting and inflammation uncontrolled to the point patient had not been able to work. Patient's doctors could not find anything in the tests they had ran, and they were saying it was from the vaccine. They was reporting several patients with the same symptoms that appeared after getting the 2nd dose. Outcome of all events were unknown.   The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract infection viral, SARS-CoV-2 antibody test
Clinical narrative: respiratory virus; This is a spontaneous report from a contactable consumer. This consumer reported for his wife (patient) in response to non-health care professional letter. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch / Lot Number: not reported), via an unspecified route of administration on 08Feb2021 (age at vaccination was 51 years) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 on 18Jan2021 (age at vaccination was 51 years) for Covid-19 immunization. Beginning on 17May2021, the patient contracted a respiratory virus. On an unspecified date the patient tested negative for Covid-19 (PCR and rapid) during their periods of infection and not tested for Covid 19. Outcome of the event was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Inflammation, Inflammation scan
Clinical narrative: all over bruises; inflammation; This is a spontaneous report from contactable reporter. This reporter reported for her daughter (patient) that:  A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on an unspecified date of 2021 as a dose 1, single for COVID-19 immunization. The patient medical history included anemia since age 14. The concomitant medication of the patient was not reported. The reporter stated that on an unspecified date of 2021 patient had "all over" bruises. The patient went to her doctor and did inflammation test. The doctor was going to do autoimmune testing but didn't because the inflammation testing came back high. The patient told the doctor that she's been anemic since age 14. Doctor stated that he didn't know, and that maybe medications did it, but she'd been on them for a long time, so he doesn't know if vaccine or not. She was still getting bruises. The reporter queried if other people also experienced bruising, after the vaccine. Outcome of the all over bruises event was not recovered and of inflammation was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.