chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: had a "golf ball sized" bubble or lump appear on her arm where she received the injection; administration error from the injection/does not know if she received the full first dose of the vaccine or if it would be counted as a valid dose; really tired, like too tired to play with my kids because I did not even want to get out of the chair; I did not even want to get out of the chair; some body aches; chills; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID19 SOLUTION FOR INJECTION), dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, on 2021, The patient experienced had a "golf ball sized" bubble or lump appear on her arm where she received the injection administration error from the injection/does not know if she received the full first dose of the vaccine or if it would be counted as a valid dose, really tired, like too tired to play with my kids because did not even want to get out of the chair on,  did not even want to get out of the chair, some body aches, chills  with outcome of unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: cough; runny nose; over the counter COVID test came back positive; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 19Aug2021 (Batch/Lot Number: FC3181; Expiration Date: 31Oct2021) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included cold (She wonders if she may have gotten the COVID vaccine too soon after having a cold and that's why she thinks that the test may can come out with a false positive after her COVID vaccine). Concomitant medication(s) included budesonide (RHINOCORT [BUDESONIDE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced over the counter covid test came back positive on 21Aug2021 with cough, runny nose on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 21Aug2021 (She says, what if the positive result is from the COVID vaccine since it is an antigen that she is getting and the test tests for antigens). The outcome of events was unknown.  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot FC3181 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FC3181, fill lot EY0567, and the formulated drug product lot FE3195. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colonoscopy, Precancerous condition, Psoriasis, Vaccination site pain
Clinical narrative: Precancerous polyps; Breakthrough psoriasis on ankle; soreness at injection site on arm; This is a solicited report from a non-Interventional study received from a contactable consumer (patient) based on information received by Pfizer from (manufacturer control number: 21K-163-4144451-00). A 59-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Apr2021 (at the age of 59-year-old) as dose 2, single for COVID-19 vaccination, and she started to receive risankizumab (SKYRIZI), subcutaneous from unspecified date for moderate to severe chronic plaque psoriasis. The patient's medical history included moderate to severe chronic plaque psoriasis from unspecified date and ongoing. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient previously received BNT162b2, intramuscular on Mar2021 as dose 1, single for COVID-19 immunisation.  The patient experienced precancerous polyps and non-serious soreness at injection site on arm and breakthrough psoriasis on ankle with SKYRIZI (risankizumab). Pfizer-BioNTech COVID-19 vaccine was also considered suspect. It was reported that precancerous cells were present. The patient had minor breakthrough psoriasis on ankle. She had minor soreness at the injection site after COVID-19 injection. In Jun2021, she had precancerous polyps removed on colonoscopy. The patient underwent lab tests and procedure which included Colonoscopy (precancerous polyps removed on colonoscopy) on Jun2021. The outcome of the events was unknown.   The reporter's assessment of causal relationship of the events with suspect drug BNT162b was reported as possible while it was not reported with suspect drug risankizumab. The company manufacturer assessment of causal relationship with suspect drug risankizumab was reported as not assessable for precancerous polyps and as no reasonable possibility for injection site pain and psoriasis flare-up. The company (AbbVie) assessment of causal relationship of the events with suspect COVID-19 vaccine was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events Precancerous polyps, Psoriasis breakthrough, Vaccination site pain and suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: He had COVID; He had COVID; This is a spontaneous report from a contactable consumer (parent). A 29-year-old (also reported as 30) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 2, single, via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient had no medical history and concomitant medications. No treatment was received. The patient received two Pfizer vaccine doses about ten months ago then he had COVID. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Immunisation, Myalgia, Nausea
Clinical narrative: Severe body ache; muscle pain throughout entire body; Nausea; headaches; difficulty walking; booster; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE), at the age of 66 years old, dose 3 via an unspecified route of administration in right arm on 25Oct2021 at 16:00 (Lot Number: FE3590) as dose 3 (booster), single for COVID-19 immunisation. Patient was not pregnant. Patient was not diagnosed with COVID-19 prior vaccination. Patient had not been tested for COVID-19 post vaccination. Medical history included fibromyalgia, known allergies to sulfites, wheat, strawberries, mold. The patient did not receive other vaccine in four weeks. Concomitant medications in two weeks included prescribed medications. Historical vaccine included BNT162B2, dose 1 (Lot Number: EN6201) on 23Feb2021 at 11:00 and dose 2 (Lot Number: EN6207) on 17Mar2021 at 13:00, both at the age of 65 years old, in right arm as single dose for COVID-19 immunisation. The patient previously took morphine, erythromycin and experienced known allergies. The patient experienced severe body ache and muscle pain throughout entire body, nausea, headaches and difficulty walking on 25Oct2021 at 18:00. Events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Therapeutic measures were taken as a result of events and included treatment with increase in pain medication. Outcome of event booster was unknown, of other events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Severe body ache; muscle pain throughout entire body; Nausea; headaches; difficulty walking; booster; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE), at the age of 66 years old, dose 3 via an unspecified route of administration in right arm on 25Oct2021 at 16:00 (Lot Number: FE3590) as dose 3 (booster), single for COVID-19 immunisation. Patient was not pregnant. Patient was not diagnosed with COVID-19 prior vaccination. Patient had not been tested for COVID-19 post vaccination. Medical history included fibromyalgia, known allergies to sulfites, wheat, strawberries, mold. The patient did not receive other vaccine in four weeks. Concomitant medications in two weeks included prescribed medications. Historical vaccine included BNT162B2, dose 1 (Lot Number: EN6201) on 23Feb2021 at 11:00 and dose 2 (Lot Number: EN6207) on 17Mar2021 at 13:00, both at the age of 65 years old, in right arm as single dose for COVID-19 immunisation. The patient previously took morphine, erythromycin and experienced known allergies. The patient experienced severe body ache and muscle pain throughout entire body, nausea, headaches and difficulty walking on 25Oct2021 at 18:00. Events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Therapeutic measures were taken as a result of events and included treatment with increase in pain medication. Outcome of event booster was unknown, of other events was not recovered.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Dizziness, Electroencephalogram, Eye haemorrhage, Headache
Clinical narrative: deep eye bleed; Headache; Dizziness; This is a spontaneous report from a contactable consumer (patient husband). An 82-year-old female patient (reporter's wife) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: ER8730) at single dose in right arm on 29Mar2021 at the age of 81-year-old for COVID-19 immunisation. The first dose was on 27Feb2021 (Lot number: EN6202) at the age of 81-year-old administered in right arm. Medical history and concomitant medication were none. Patient had experienced headaches, dizziness, and had a specialist evaluation of her eyes. She had a deep eye bleed which occurred around 01Sep2021. She had had EEG, MRI, and MRA testing done in 2021, all unknown results. Her headaches and dizziness started the last of Jul2021 to the first of Aug2021. It was ongoing, and had stayed the same. It was unpredictable. She had her last EEG today. The outcome of event deep eye bleed was unknown. The outcome of rest events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: deep eye bleed; Headache; Dizziness; This is a spontaneous report from a contactable consumer (patient husband). An 82-year-old female patient (reporter's wife) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: ER8730) at single dose in right arm on 29Mar2021 at the age of 81-year-old for COVID-19 immunisation. The first dose was on 27Feb2021 (Lot number: EN6202) at the age of 81-year-old administered in right arm. Medical history and concomitant medication were none. Patient had experienced headaches, dizziness, and had a specialist evaluation of her eyes. She had a deep eye bleed which occurred around 01Sep2021. She had had EEG, MRI, and MRA testing done in 2021, all unknown results. Her headaches and dizziness started the last of Jul2021 to the first of Aug2021. It was ongoing, and had stayed the same. It was unpredictable. She had her last EEG today. The outcome of event deep eye bleed was unknown. The outcome of rest events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Immunisation, Peripheral swelling
Clinical narrative: Left leg swelled up; just got the booster; This is a spontaneous report from a contactable consumer (patient's mother). A 64-year-old male patient received the first dose of BNT162B2 at 64-year-old, via an unspecified route of administration on an unspecified date at single dose, and the second dose via an unspecified route of administration on an unspecified date at single dose, and the third dose via an unspecified route of administration on an unspecified date in 2021 at single dose (booster) for COVID-19 immunisation. Medical history included patient's grandparents both had heart attacks. The patient's concomitant medications were not reported. 7 days after he received his fist dose of the vaccine his left leg swelled up. He had gone to 3 specialists so far and they couldn't find out what caused it, but reporter reported that it had to be from the vaccine. Exactly date he got his first dose of the vaccine was unknown, but it was when the vaccine first came out. His left leg swelled up 7 days after the first dose and the swelling had never gone away. He had since gotten his second dose, and just got the booster. Patient had a CT scan of his leg, but unknow if there was anything found on it. He had 3 different types of testing done on his leg already and the doctors hadn't been able to find anything wrong with his leg or figure out why he still had the swelling. He called his Primary care doctor who sent him to 3 different specialists but they couldn't find anything, so he would be going to a 4th specialist next week, on 23Nov2021. Outcome of the event was not resolved.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: Positive COVID test; Positive COVID test; Is pregnant: Yes Gestational period: 20; This is a spontaneous report from a contactable consumer. A 31-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified route of administration in Aug2021 at single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified route of administration on 28Aug2021 at single dose for COVID-19 immunisation. The patient was pregnant at the time of vaccination (gestational period: 20 weeks). The patient had no known allergies. Relevant medical history was none. Concomitant medications were not reported. The patient had no COVID prior vaccination but was tested post vaccination. On 04Nov2021 the patient started having symptoms of congestion, sore throat, cough, loss of taste resulting in doctor or other healthcare professional office/clinic visit. The patient had positive nasal swab on 05Nov2021. Vaccination failure/COVID-19 was resolving, outcome for exposure during pregnancy was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report from a contactable nurse (parent). The reporter reported 2 cases. This is the case for the son. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter (nurse) experienced covid positive and mentioned her son also had the same symptoms, a split case is necessary. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Limb mass, Pruritus
Clinical narrative: DOSE 3 (BOOSTER; Got a huge lump on her arm; It was red and itched; It was red and itched; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION), dose 3 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, The patient experienced got a huge lump on her arm, it was red and itched, it was red and itched on 2021 with outcome of recovered, dose 3 (booster) on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of got a huge lump on her arm (limb mass), it was red and itched (erythema), it was red and itched (pruritus).  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal tenderness, Constipation, Nausea
Clinical narrative: belly tenderness; nausea; constipation; belly pain; This is a spontaneous report received from a contactable consumer. A 9-year-old female patient received BTN162b2 (PFIZER-BIONTECH COVID-19 VACCINE) 10 ug, as dose number unknown, single on 04Nov2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that starting on 06Nov2021 she reported belly tenderness, nausea, constipation, and belly pain. Emergency room ruled out appendicitis. Seems better the day of the present report 08Nov2021 and she will return to school the day after this report (09Nov2021). Event took place after use of product. The outcome of the event was resolving.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Her friends mom had a stroke and had the vaccine; This is a spontaneous report from a contactable consumer. A female patient (reporter friend's mother) received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown) at single dose for COVID-19 immunisation on unknown date in 2021. Relevant history and concomitant drug was unknown.  The patient had a stroke on unknown date in 2021. Outcome of the event was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dermatitis, Gait disturbance, Inflammation, Mixed connective tissue disease
Clinical narrative: Overall increased issues associated with mctd; Overall increased issues associated with mctd; Major muscle spasms developed in her back along spine bur throughout; could not walk; Skin inflamed to point of peeling  and continues be inflamed and peel; Skin inflamed to point of peeling and continues be inflamed and peel; overall increased inflammation and pain; overall increased inflammation and pain; This is a spontaneous report from a contactable other hcp (patient). A 68-year-old female patient received BNT162B2 (PFZIER COVID-19 VACCINE), at the age of 68 years old, dose 2 via an unspecified route of administration in left arm on 23Apr2021 (Lot Number: ew0172) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included mixed connective tissue disease (MCTD), thyroid cancer (thyCa), hypertension, extensive back surgery, known allergies scallops. Patient had a back fusion in Jan2021 and had had 5 prior back surgeries. Patient was not diagnosed with COVID-19 prior vaccination. Patient had not been tested for COVID-19 post vaccination. Historical vaccine included BNT162B2, at the age of 68 years old, dose 1 via an unspecified route of administration in left arm on 02Apr2021 (Lot Number: ew0153) as single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. Concomitant medications in two weeks included olmesartan, diltiazem, metoprolol, more. Major muscle spasms developed in her back along spine bur throughout, could not walk, general overall increased inflammation and pain. Skin inflamed to point of peeling and continued be inflamed and peel. Overall increased issues associated with MCTD. Adverse events start date was May2021. Events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. It was unknown if treatment received. Outcome of events was unknown.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Skin exfoliation
Clinical narrative: Overall increased issues associated with mctd; Overall increased issues associated with mctd; Major muscle spasms developed in her back along spine bur throughout; could not walk; Skin inflamed to point of peeling  and continues be inflamed and peel; Skin inflamed to point of peeling and continues be inflamed and peel; overall increased inflammation and pain; overall increased inflammation and pain; This is a spontaneous report from a contactable other hcp (patient). A 68-year-old female patient received BNT162B2 (PFZIER COVID-19 VACCINE), at the age of 68 years old, dose 2 via an unspecified route of administration in left arm on 23Apr2021 (Lot Number: ew0172) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included mixed connective tissue disease (MCTD), thyroid cancer (thyCa), hypertension, extensive back surgery, known allergies scallops. Patient had a back fusion in Jan2021 and had had 5 prior back surgeries. Patient was not diagnosed with COVID-19 prior vaccination. Patient had not been tested for COVID-19 post vaccination. Historical vaccine included BNT162B2, at the age of 68 years old, dose 1 via an unspecified route of administration in left arm on 02Apr2021 (Lot Number: ew0153) as single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. Concomitant medications in two weeks included olmesartan, diltiazem, metoprolol, more. Major muscle spasms developed in her back along spine bur throughout, could not walk, general overall increased inflammation and pain. Skin inflamed to point of peeling and continued be inflamed and peel. Overall increased issues associated with MCTD. Adverse events start date was May2021. Events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. It was unknown if treatment received. Outcome of events was unknown.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Joint range of motion decreased, Memory impairment
Clinical narrative: permanent pain on her fingers/on her feet, particularly toes and ankles; Permanent pain on her feet, particularly toes and ankles; permanent pain on her fingers with difficulty to bend them; Gain of weight (suddenly and quickly); Permanent headache; Permanent fatigue; Memory issues; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE), at the age of 49 years old, dose 2 via an unspecified route of administration in left arm on 23Jul2021 at 12:00 (Lot Number: FA6780) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history was none. Patient had no known allergies. Patient was not diagnosed with COVID-19 prior vaccination. Patient had not been tested for COVID-19 post vaccination. The patient previously received BNT162B2, dose 1 via an unspecified route of administration in left arm on an unspecified date at 12:00 (Lot Number: EW0196) as single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks or other medications in two weeks. The patient experienced permanent pain on her fingers with difficulty to bend them. Huge pain and struggle when she had to put pressure (e.g., opening a bottle or opening doors with keys). Permanent pain on her feet, particularly toes and ankles. Gain of weight (suddenly and quickly). Permanent headache. Permanent fatigue. Memory issues. Events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No treatment received. Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Weight increased
Clinical narrative: permanent pain on her fingers/on her feet, particularly toes and ankles; Permanent pain on her feet, particularly toes and ankles; permanent pain on her fingers with difficulty to bend them; Gain of weight (suddenly and quickly); Permanent headache; Permanent fatigue; Memory issues; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE), at the age of 49 years old, dose 2 via an unspecified route of administration in left arm on 23Jul2021 at 12:00 (Lot Number: FA6780) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history was none. Patient had no known allergies. Patient was not diagnosed with COVID-19 prior vaccination. Patient had not been tested for COVID-19 post vaccination. The patient previously received BNT162B2, dose 1 via an unspecified route of administration in left arm on an unspecified date at 12:00 (Lot Number: EW0196) as single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks or other medications in two weeks. The patient experienced permanent pain on her fingers with difficulty to bend them. Huge pain and struggle when she had to put pressure (e.g., opening a bottle or opening doors with keys). Permanent pain on her feet, particularly toes and ankles. Gain of weight (suddenly and quickly). Permanent headache. Permanent fatigue. Memory issues. Events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No treatment received. Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Cough, Decreased appetite, Illness, Syncope
Clinical narrative: he was in and out like faint, like he would go in and out and faint out and faint in; Coughing; Confusion; his appetite was poor; he was too sick.; This is a spontaneous report from contactable nurse (Patient's wife). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 69-year-old on an unspecified date at single dose for covid-19 immunisation. Medical history and concomitant medications were none. The reporter said that her husband was having coughing, confusion, he was in and out like faint, like he would go in and out and faint out and faint in and his appetite was poor. Inquired for when these began and she states right after he took the COVID vaccine. She thinks that it was serious because before they got this they didn't have that. Inquired if her husband's side effects are still ongoing and she states yes, he was definitely still experiencing some. She said no not anything really but he was just confused and he was sometimes confused with the medicine and maybe a little down. Reporter confirmed and clarified that these were experienced after her husband had the Pfizer COVID vaccine. She stated that she found a card and it said when to get the 2nd dose but it has (withheld) on there with the COVID 19 and a date. Inquired if there was an NDC, lot number or expiry date on that card and she said that all there was # and 26Nov2021 for when he was supposed to get the 2nd dose he hadn't gotten the 2nd dose because he was too sick. The outcome of events was not recovered. Event relatedness was reported as COVID vaccine was related to event "he was in and out like faint, like he would go in and out and faint out and faint in" and "his appetite was poor".  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "syncope" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: paralyzed; This is a spontaneous report from a contactable other Health Care Professional (HCP). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose (dose number unknown) for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced paralyzed on an unspecified date. The event was serious for being medical significant. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event paralysis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Pain, Vaccination site pain
Clinical narrative: it was the booster; Achiness; Tiredness; Headache; little bit of injection site pain; This is a spontaneous report from a contactable consumer or other non hcp.    A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, The patient experienced it was the  achiness, tiredness, headache, little bit of injection site pain, booster dose on an unspecified date with outcome of unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Immunisation, Pharyngeal swelling
Clinical narrative: 24 hours after my booster my throat was swollen shut; rapid heart rate; shortness of breath; broke out into hives; booster; This is a spontaneous report from a contactable Other healthcare professional (patient). A 27-year-old female patient received third dose of BNT162B2 on 05Nov2021 06:30 pm at single dose on left arm for COVID-19 Immunization. Known allergies: Amoxicillin. Medical history included Shrimp. Concomitant medications were none. No other vaccine in four weeks. No other medications in two weeks. The patient previously took Amoxicillin and Known allergies: Amoxicillin. Historical vaccine included BNT162B2 dose 1 on 02Feb2021 (at age of 27 years old, fever and body soreness) 10:00 am on arm left for COVID-19 Immunization and experienced fever and body soreness, dose 2 on 22Feb2021 (at age of 27 years old, fever and body soreness) 10:00 am on left arm for COVID-19 Immunization and experienced fever and body soreness. Facility type vaccine: Pharmacy or Drug store. After dose 1 and 2 she had a fever and body soreness. 24 hours after her booster (06Nov2021 6:30 pm) her throat was swollen shut, rapid heart rate, shortness of breath, and broke out into hives. AE resulted in: [Emergency room/department or urgent care]. The outcome of the events was recovering. AE treatment: Emergency care in hospital and medicine. No COVID prior vaccination. Covid test post vaccination: Covid test type post vaccination= Nasal Swab, Covid test name post vaccination= Rapid, Covid test date= 06Nov2021, Covid test result= Negative.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up .; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: 24 hours after my booster my throat was swollen shut; rapid heart rate; shortness of breath; broke out into hives; booster; This is a spontaneous report from a contactable Other healthcare professional (patient). A 27-year-old female patient received third dose of BNT162B2 on 05Nov2021 06:30 pm at single dose on left arm for COVID-19 Immunization. Known allergies: Amoxicillin. Medical history included Shrimp. Concomitant medications were none. No other vaccine in four weeks. No other medications in two weeks. The patient previously took Amoxicillin and Known allergies: Amoxicillin. Historical vaccine included BNT162B2 dose 1 on 02Feb2021 (at age of 27 years old, fever and body soreness) 10:00 am on arm left for COVID-19 Immunization and experienced fever and body soreness, dose 2 on 22Feb2021 (at age of 27 years old, fever and body soreness) 10:00 am on left arm for COVID-19 Immunization and experienced fever and body soreness. Facility type vaccine: Pharmacy or Drug store. After dose 1 and 2 she had a fever and body soreness. 24 hours after her booster (06Nov2021 6:30 pm) her throat was swollen shut, rapid heart rate, shortness of breath, and broke out into hives. AE resulted in: [Emergency room/department or urgent care]. The outcome of the events was recovering. AE treatment: Emergency care in hospital and medicine. No COVID prior vaccination. Covid test post vaccination: Covid test type post vaccination= Nasal Swab, Covid test name post vaccination= Rapid, Covid test date= 06Nov2021, Covid test result= Negative.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up .; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19; tested positive for Covid 19; This is a spontaneous report from a contactable consumer (patient).    59-year-old feAmale patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on Feb2021 as DOSE 2, SINGLE, and first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on Jan2021 as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for covid 19 on 30Oct2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 30Oct2021. The outcome of the event Covid-19 was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative, Immunisation, Interchange of vaccine products, Off label use, Pain in extremity
Clinical narrative: He received booster dose COVID-19 Vaccine manufactured by Pfizer; patient received 1st dose COVID-19 Vaccine manufactured by Johnson and Johnson. He received booster dose COVID-19 Vaccine manufactured by Pfizer; He received booster dose COVID-19 Vaccine manufactured by Pfizer.; felt about to have ulcerative colitis flare up; sore arm; This is a non-interventional study report received from a contactable consumer or other non hcp.    A 42-years-old male patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot number was not reported), dose 3 intramuscularly on 2021 as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for colitis ulcerative. The patient medical history and concomitant medications were not reported.  It was reported that, on unknown dates, the patient experienced felt about to have ulcerative colitis flare up and sore arm. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Johnson and Johnson. He received booster dose COVID-19 Vaccine manufactured by Pfizer with outcome of unknown.  The reporter's causality for the event(s) of felt about to have ulcerative colitis flare up with Humira  (Adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of sore arm with Humira (Adalimumab) was no reasonable possibility The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  ; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events  and the suspect drug BNT162B2  cannot be ruled out.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: had to have emergency appendicectomy due to acute appendicitis; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 11May2021 (at 39 years old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history was not reported. Concomitant medication included desloratadine (CLARINEX) taken for an unspecified indication. The patient had no history of COVID prior vaccination. The patient was COVID tested post vaccination. On 05Oct2021, the patient had to have emergency appendicectomy due to acute appendicitis on 04Oct2021. The patient was hospitalized due to the events for 3 days. The event resulted in an emergency room/department or urgent care visit, hospitalization; and was reported as a life-threatening illness (immediate risk of death from the event). Treatment for the event included emergency care and surgery (appendectomy). The patient underwent PCR test (Nasal Swab): both negative on 09Oct2021 and on 14Oct2021. The outcome of the event was recovering.   Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: having covid and being in the hospital; having covid and being in the hospital; This is a spontaneous report from a contactable nurse and a contactable consumer (patient). A 64-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation and tofacitinib citrate (Xeljanz XR, Prolonged-release tablet, Batch/Lot number and Expiration date was not reported), via oral route from Aug2017, at a dose of 11 mg, daily for rheumatoid arthritis. The patient medical history included ongoing rheumatoid arthritis. Concomitant medications included atorvastatin calcium, duloxetine hydrochloride (HCl), gabapentin, levothyroxine, lisinopril, metformin HCl, methotrexate and omeprazole (all taken for an unspecified indication, start and stop date were not reported). On Sep2021, patient had COVID-19 and was hospitalized for 5 days for COVID-19 on an unspecified date of 2021. The action taken for tofacitinib citrate was permanently withdrawn on an unspecified date Sep2021 due to COVID-19 and being in the hospital. The outcome of the events was unknown.  The lot number for the vaccine, BNT162b2 was not provided and will be requested during follow up
Sex: U
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: My cousin almost died; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization.  Medical history and concomitant medications were not reported.  The reporter asked on how to know if the vaccine was close to the expiration date and if there was a possibility of something happening to the vaccine (does it form a fungus). The reporter also asked what happen when vaccine was stored outside of recommendation. As it was stated that the reporter's cousin almost died on unknown date. Outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Echocardiogram, Fatigue
Clinical narrative: Tiredness; atrial fibrillation; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-115049).   A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Sep2021 (at the age of 79-years-old) as dose 2, single for COVID-19 immunisation.  Medical history included ongoing hypothyroidism, ongoing hypertension, Goiter, radiotherapy (20 years ago), macular degeneration (she was receiving unspecified shots for 3 years), ongoing back arthritis, cyst removal from 2021 to an unknown date (in private area - this past summer), cyst (in private area), swollen arm (arm got real red), feverish, chest pain, ongoing eye bleeding and eyeglasses wearer. Concomitant medications included unspecified shots for macular degeneration. The patient experienced atrial fibrillation on Oct2021 and tiredness on an unspecified date.  It was reported that patient received 2 doses of the COVID vaccine with the 2nd dose administered on 27Sep2021 and stated she had a reaction to the 2nd dose. Patient was wandering if it could have caused her atrial fibrillation. Patient slept for a week. Patient got hurt in her chest and got short winded and told her husband to take her to ER and that was when they diagnosed her with atrial fibrillation (AFIB). Patient went to the ER on 24Oct2021. The consumer reported that she had an echocardiogram of her heart while she was in the hospital and they told her that heart was strong, no damage and her lungs were clear. The consumer reported that she got shots in her eyes for macular degeneration and received a shot in her eye today (29Oct2021). She reported that she had bleeding in her eye so bad. The outcome of events was unknown.