chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Myalgia, Vaccination site pain, Vaccination site warmth
Clinical narrative: general feeling unwell; chills; tiredness; she was trying to do a walk but could not; pain at injection site; pain at injection site; That side was hot; headache got worse after getting the COVID 19 vaccine; joint pain; muscle pain continued to get worse; preventing her from sleeping/ she could not sleep; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at the left arm on 18Jan2021 13:33 at a single dose for COVID-19 immunization. Medical history included back pain (a lot of time due to physical work). She had COVID in Aug2020 and she had muscle pain and was sick. The patient also had headache started initially the day before got the vaccine on 17Jan2021. The patient also has ongoing grass allergy. Concomitant medication included acetylsalicylic acid (ASPIRIN), ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and unspecified pain medicine for back pain. She had the flu shot and Tetanus shot 2 months ago (2020) both for immunization. The patient started to notice the muscle pain on 18Jan2021 while diving back from the place she received the vaccination. She normally has muscle pain, but she thought this was something normally occurring. However, the muscle pain continued to get worse. She went to sleep, and the muscle pain continued to occur when she was trying to sleep. The muscle pain was occurring in the middle of the night and she was in so much pain it was preventing her from sleeping. She took a muscle relaxant for the pain and felt better. She noticed the pain at injection site initially around 6PM on 18Jan2021 but noticed it more when she was going to bed like 11PM. She tried to sleep on that side and it hurt. That side was hot, so she placed some ice on it. The headache started initially the day before got the vaccine 17Jan2021, but it got worse after getting the COVID 19 vaccine. It was worse on 18Jan2021, on 19Jan2021 it was better. She noticed the joint pain on 18Jan2021 but does not know really what time. She thinks it was around time noticed muscle pain. She woke up at 3AM something from the pain because she could not sleep. The chills started 4AM or 5AM on 19Jan2021. She noticed she felt tired, so tired when she woke up on 19Jan2021. She mentioned she was trying to do a walk but could not on 19Jan2021. She also mentioned she works at 1PM and would have to call out 2 hours before. She commented she needed her glasses to read the lot written on the patient card. Also was feeling unwell on an unspecified date. The events did not require Emergency Room nor Physician Office visit.  The outcome of the events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: general feeling unwell; chills; tiredness; she was trying to do a walk but could not; pain at injection site; pain at injection site; That side was hot; headache got worse after getting the COVID 19 vaccine; joint pain; muscle pain continued to get worse; preventing her from sleeping/ she could not sleep; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at the left arm on 18Jan2021 13:33 at a single dose for COVID-19 immunization. Medical history included back pain (a lot of time due to physical work). She had COVID in Aug2020 and she had muscle pain and was sick. The patient also had headache started initially the day before got the vaccine on 17Jan2021. The patient also has ongoing grass allergy. Concomitant medication included acetylsalicylic acid (ASPIRIN), ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and unspecified pain medicine for back pain. She had the flu shot and Tetanus shot 2 months ago (2020) both for immunization. The patient started to notice the muscle pain on 18Jan2021 while diving back from the place she received the vaccination. She normally has muscle pain, but she thought this was something normally occurring. However, the muscle pain continued to get worse. She went to sleep, and the muscle pain continued to occur when she was trying to sleep. The muscle pain was occurring in the middle of the night and she was in so much pain it was preventing her from sleeping. She took a muscle relaxant for the pain and felt better. She noticed the pain at injection site initially around 6PM on 18Jan2021 but noticed it more when she was going to bed like 11PM. She tried to sleep on that side and it hurt. That side was hot, so she placed some ice on it. The headache started initially the day before got the vaccine 17Jan2021, but it got worse after getting the COVID 19 vaccine. It was worse on 18Jan2021, on 19Jan2021 it was better. She noticed the joint pain on 18Jan2021 but does not know really what time. She thinks it was around time noticed muscle pain. She woke up at 3AM something from the pain because she could not sleep. The chills started 4AM or 5AM on 19Jan2021. She noticed she felt tired, so tired when she woke up on 19Jan2021. She mentioned she was trying to do a walk but could not on 19Jan2021. She also mentioned she works at 1PM and would have to call out 2 hours before. She commented she needed her glasses to read the lot written on the patient card. Also was feeling unwell on an unspecified date. The events did not require Emergency Room nor Physician Office visit.  The outcome of the events was recovering.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Irritability, Malaise, Paraesthesia
Clinical narrative: Headache; fever; rash on forearms; tingling feeling on arms and back of neck; burning sensation on arms; irritability; General unwell feelings; Patient felt like the shot rendered his paroxetine hydrochloride useless for 5 days. Felt like he quit paroxetine hydrochloride cold turkey; This is a spontaneous report from a contactable consumer. A 50-year-old male patient to received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730), via an unspecified route of administration on 13Jan2021 13:00 at single dose on right arm for covid-19 immunisation. The patient medical history was not reported.  Concomitant medication included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]) at 30 mg daily for unknown indication. The patient previously took aspirin [acetylsalicylic acid] and experienced allergies. Patient experienced headache, fever, rash on forearms, tingling feeling on arms and back of neck, burning sensation on arms, irritability and general unwell feelings. Patient felt like the shot rendered his paroxetine hydrochloride useless for 5 days. Felt like he quit paroxetine hydrochloride cold turkey. All started on 13Jan2021 at 16:00. Nasal swab on 19Jan2021 was negative. No treatment was received. Outcome of the events was resolved. This case was reported as non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: Headache; fever; rash on forearms; tingling feeling on arms and back of neck; burning sensation on arms; irritability; General unwell feelings; Patient felt like the shot rendered his paroxetine hydrochloride useless for 5 days. Felt like he quit paroxetine hydrochloride cold turkey; This is a spontaneous report from a contactable consumer. A 50-year-old male patient to received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730), via an unspecified route of administration on 13Jan2021 13:00 at single dose on right arm for covid-19 immunisation. The patient medical history was not reported.  Concomitant medication included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]) at 30 mg daily for unknown indication. The patient previously took aspirin [acetylsalicylic acid] and experienced allergies. Patient experienced headache, fever, rash on forearms, tingling feeling on arms and back of neck, burning sensation on arms, irritability and general unwell feelings. Patient felt like the shot rendered his paroxetine hydrochloride useless for 5 days. Felt like he quit paroxetine hydrochloride cold turkey. All started on 13Jan2021 at 16:00. Nasal swab on 19Jan2021 was negative. No treatment was received. Outcome of the events was resolved. This case was reported as non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: knot under her right arm (the side she received her vaccine) and she was assuming it was a swollen lymph node; assuming it was a swollen lymph node, it was real sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration (reported as injection in the right arm) on 09Jan2021 at single dose for Covid-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. It was reported that the patient received the first dose of the Covid vaccine and now (10Jan2021) has a knot under her right arm (the side she received her vaccine) and she was assuming it was a swollen lymph node. The patient added that it was real sore but now it is not quite as sore, it doesn't hurt. The patient asked if it could be from the vaccine and how long should it be there. She also asked if she should still get her second dose on the 30th (30Jan2021). The outcome of events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Cough, Discomfort
Clinical narrative: waking up at 3 am/she was having trouble sleeping and was uncomfortable.; waking up at 3 am/she was having trouble sleeping and was uncomfortable.; headache; feeling chills; muscle soreness; a lot of fatigue; cough; her temperature was at 98.7 when it is usually at 97.2 in the morning; arm swelling, soreness and a warm feeling; arm swelling, soreness and a warm feeling; arm swelling, soreness and a warm feeling; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 14Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included covid-19 from Dec2020 to an unknown date, fatigue from Dec2020 to Jan2021 and cough from Dec2020 to an unknown date, it was reported that she further described the fatigue as the one experienced from getting COVID, 26 days prior to her injection; she mentioned that it was at day 20 post infection that she regained energy from this profound fatigue. She also mentioned that the cough she had during her infection with COVID was back. She then summarized her experience as COVID symptoms but not as severe as when she had it. The patient's concomitant medications were not reported. The patient explained waking up at 3 am, 15 hours post-injection (on 15Jan2021), not knowing how she felt but knew that she was having trouble sleeping and was uncomfortable. She added taking a sleeping pill to help her fall back asleep and woke up at 5:30am. That same day, she said that she experienced: a headache, feeling chills, muscle soreness, a lot of fatigue, and a cough. She specified that her temperature was at 98.7 when it is usually at 97.2 in the morning, as she attributed the rise of temperature to her chills. She said that her fatigue was to the point where it was an effort for her to go up and walk. She then explained that she started to feel better the evening of that first day post injection; and that by the following day, Saturday (on 16Jan2021), the headache was gone and she felt less fatigued. She added also having arm swelling, soreness and a warm feeling in Jan2021. She stated that now 5 days later, her arm was barely tender and was therefore resolving fine. The outcome of the event "having trouble sleeping and was uncomfortable, cough" was not recovered; of the event "headache" was recovered on 16Jan2021; of the events "feeling chills, muscle soreness, a lot of fatigue, arm swelling, soreness and a warm feeling" was recovering; of the rest events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Insomnia, Myalgia
Clinical narrative: waking up at 3 am/she was having trouble sleeping and was uncomfortable.; waking up at 3 am/she was having trouble sleeping and was uncomfortable.; headache; feeling chills; muscle soreness; a lot of fatigue; cough; her temperature was at 98.7 when it is usually at 97.2 in the morning; arm swelling, soreness and a warm feeling; arm swelling, soreness and a warm feeling; arm swelling, soreness and a warm feeling; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 14Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included covid-19 from Dec2020 to an unknown date, fatigue from Dec2020 to Jan2021 and cough from Dec2020 to an unknown date, it was reported that she further described the fatigue as the one experienced from getting COVID, 26 days prior to her injection; she mentioned that it was at day 20 post infection that she regained energy from this profound fatigue. She also mentioned that the cough she had during her infection with COVID was back. She then summarized her experience as COVID symptoms but not as severe as when she had it. The patient's concomitant medications were not reported. The patient explained waking up at 3 am, 15 hours post-injection (on 15Jan2021), not knowing how she felt but knew that she was having trouble sleeping and was uncomfortable. She added taking a sleeping pill to help her fall back asleep and woke up at 5:30am. That same day, she said that she experienced: a headache, feeling chills, muscle soreness, a lot of fatigue, and a cough. She specified that her temperature was at 98.7 when it is usually at 97.2 in the morning, as she attributed the rise of temperature to her chills. She said that her fatigue was to the point where it was an effort for her to go up and walk. She then explained that she started to feel better the evening of that first day post injection; and that by the following day, Saturday (on 16Jan2021), the headache was gone and she felt less fatigued. She added also having arm swelling, soreness and a warm feeling in Jan2021. She stated that now 5 days later, her arm was barely tender and was therefore resolving fine. The outcome of the event "having trouble sleeping and was uncomfortable, cough" was not recovered; of the event "headache" was recovered on 16Jan2021; of the events "feeling chills, muscle soreness, a lot of fatigue, arm swelling, soreness and a warm feeling" was recovering; of the rest events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: waking up at 3 am/she was having trouble sleeping and was uncomfortable.; waking up at 3 am/she was having trouble sleeping and was uncomfortable.; headache; feeling chills; muscle soreness; a lot of fatigue; cough; her temperature was at 98.7 when it is usually at 97.2 in the morning; arm swelling, soreness and a warm feeling; arm swelling, soreness and a warm feeling; arm swelling, soreness and a warm feeling; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 14Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included covid-19 from Dec2020 to an unknown date, fatigue from Dec2020 to Jan2021 and cough from Dec2020 to an unknown date, it was reported that she further described the fatigue as the one experienced from getting COVID, 26 days prior to her injection; she mentioned that it was at day 20 post infection that she regained energy from this profound fatigue. She also mentioned that the cough she had during her infection with COVID was back. She then summarized her experience as COVID symptoms but not as severe as when she had it. The patient's concomitant medications were not reported. The patient explained waking up at 3 am, 15 hours post-injection (on 15Jan2021), not knowing how she felt but knew that she was having trouble sleeping and was uncomfortable. She added taking a sleeping pill to help her fall back asleep and woke up at 5:30am. That same day, she said that she experienced: a headache, feeling chills, muscle soreness, a lot of fatigue, and a cough. She specified that her temperature was at 98.7 when it is usually at 97.2 in the morning, as she attributed the rise of temperature to her chills. She said that her fatigue was to the point where it was an effort for her to go up and walk. She then explained that she started to feel better the evening of that first day post injection; and that by the following day, Saturday (on 16Jan2021), the headache was gone and she felt less fatigued. She added also having arm swelling, soreness and a warm feeling in Jan2021. She stated that now 5 days later, her arm was barely tender and was therefore resolving fine. The outcome of the event "having trouble sleeping and was uncomfortable, cough" was not recovered; of the event "headache" was recovered on 16Jan2021; of the events "feeling chills, muscle soreness, a lot of fatigue, arm swelling, soreness and a warm feeling" was recovering; of the rest events was unknown.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, SARS-CoV-2 test
Clinical narrative: Flu like symptoms; This is a spontaneous report from a contactable consumer reported for herself. A 68-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration at Left arm on 12Jan2021 16:00 at SINGLE DOSE for covid-19 immunization. Medical history included Hypo-Thyroid and gastrooesophageal reflux disease. No known allergies, not allergies to medications, food, or other products. The patient received other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced non-serious flu like symptoms three days after vaccine on 15Jan2021 at 04:00 PM, lasted for 4 days. No treatment received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid (Nasal Swab) tested on 19Jan2021 post vaccination but the result was pending. The outcome of the event was recovering.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, COVID-19, Exposure to SARS-CoV-2, Feeling hot, SARS-CoV-2 test positive
Clinical narrative: initial exposure to coronavirus; COVID-19 PCR test positive; COVID-19 PCR test positive; when he woke up the next morning he had a 5 minute interval of indescribable burning sensation on the face and upper torso/being hot; This is a spontaneous report from a contactable physician from a Pfizer-sponsored program. A 28-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly on 31Dec2020 in arm at a single dose to prevent COVID. There were no medical history or no concomitant medications. He confirmed he is the physician and the primary doctor for the patient. The patient is a pharmacist and he received the first dose of the Pfizer COVID vaccine on 31Dec2020. The next day (01Jan2021), he woke up with a 5-minute interval of indiscernible burning sensation on his face and upper torso that went away after about 5 minutes. The patient reported being hot for a few seconds after taking the Pfizer COVID vaccine. The patient came in to contact with some with coronavirus and then the patient tested positive for coronavirus on 17Jan2021 with a PCR test. He had no symptoms since a week after his initial exposure to coronavirus. No adverse reactions but turned up with infection. The outcome of event burning sensation on the face and upper torso was recovered on 01Jan2021, outcome of the other events was unknown.   Reporter assessed seriousness for burning sensation on face and upper torso: Medically significant. Causality between burning sensation on face and upper torso and bnt162b2 was related by Primary Source Reporter per Global Introspection.         Information on the batch number/lot number has been requested.; Sender's Comments: Based on the current available information , Exposure to SARS-CoV-2 is most likely related to an intercurrent condition which is not related to the suspected drug. Based on the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of other events cannot be totally excluded.  The case will be reassessed if additional information becomes 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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: low grade fever of 99.6 Fahrenheit and 99.7 Fahrenheit. She said it was 100.1 Fahrenheit only once; chills; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3247) via an unspecified route of administration on the arm left on 18Jan2021 11:00 at single dose for COVID-19 immunisation. Medical history included thyroid. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid and ongoing. The patient did not receive other Vaccinations within 4 weeks. The patient had low grade fever of 99.6 Fahrenheit and 99.7 Fahrenheit. She said it was 100.1 Fahrenheit only once on 19Jan2021, chills on 19Jan2021. The event did not require a visit to physician or emergency room (ER). The caller stated she took the first dose of the vaccine yesterday (18Jan2021) and today (19Jan2021) has had a low grade fever of 99.6 Fahrenheit and 99.7 Fahrenheit. She said it was 100.1 Fahrenheit only once. Fever was reported as worsened. Today 19Jan2021, she first noticed the chills, now she did not have chills but she had a fever that was going up. She is scheduled to receive the next dose of the vaccine 08Feb2021. The outcome of the event fever was not recovered, of the event chills was recovered on 19Jan2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Right arm was sore for about 3 days; This is a spontaneous report from a contactable consumer reporting for a patient. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant at the time of vaccination. The facility type vaccine was hospital. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced right arm was sore for about 3 days on an unspecified date with outcome of recovered. Patient didn't receive treatment for the adverse events. The event was reported as non-serious.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Nausea
Clinical narrative: headache; Nausea; Abdominal Cramping; This is a spontaneous report from a non-contactable physician (reporting for himself). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 14Jan2021 (10:30) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had other unspecified medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 (20:30) the patient experienced headache, nausea and abdominal cramping. There was no treatment received for the adverse events. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  No follow-up attempts are not possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fear, Hallucination, visual, Headache, Hypoaesthesia
Clinical narrative: hallucinations; having stroke like symptoms; having intense headaches; felt exhausted; has pain in her arm; her vision affected/wavy lines throughout her eyes; numbness in her face, hands, and lips; This is a spontaneous report from contactable Nurse reporting for herself. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Patient age at time of vaccination was 65 years. The patient did not have reactions with other immunizations except a severe reaction with the measles, mumps, and rubella (MMR) vaccine when she was younger. She had seizures after receiving the MMR vaccine. The patient's concomitant medications were not reported. The patient mentioned she had a severe reaction. She described her adverse reaction by having intense headaches, having stroke-like symptoms in which she described as she cannot speak, having headaches, having numbness in her hands, face, and lips. She also felt exhausted. She also had some pain in her arm that she is not concerned about. She mentioned that she also has her vision affected, she couldn't drive, there were wavy lines all though her eyes. She started to have hallucinations such as seeing people that weren't there, seeing snow storms, and seeing things whipping throughout the wind. All the events started on 04Jan2021. She reported she was very sick in the hospital and is now getting well. However it was unknown if she was admitted to hospital (clarification pending). She wanted to know recommendations about the second shot of the COVID-19 vaccine because with her experience, she is not comfortable having the second shot of the COVID-19 vaccine.   Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded.  The case will be reassessed if additional information becomes 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Impaired driving ability, Malaise, Neurological symptom, Pain in extremity
Clinical narrative: hallucinations; having stroke like symptoms; having intense headaches; felt exhausted; has pain in her arm; her vision affected/wavy lines throughout her eyes; numbness in her face, hands, and lips; This is a spontaneous report from contactable Nurse reporting for herself. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Patient age at time of vaccination was 65 years. The patient did not have reactions with other immunizations except a severe reaction with the measles, mumps, and rubella (MMR) vaccine when she was younger. She had seizures after receiving the MMR vaccine. The patient's concomitant medications were not reported. The patient mentioned she had a severe reaction. She described her adverse reaction by having intense headaches, having stroke-like symptoms in which she described as she cannot speak, having headaches, having numbness in her hands, face, and lips. She also felt exhausted. She also had some pain in her arm that she is not concerned about. She mentioned that she also has her vision affected, she couldn't drive, there were wavy lines all though her eyes. She started to have hallucinations such as seeing people that weren't there, seeing snow storms, and seeing things whipping throughout the wind. All the events started on 04Jan2021. She reported she was very sick in the hospital and is now getting well. However it was unknown if she was admitted to hospital (clarification pending). She wanted to know recommendations about the second shot of the COVID-19 vaccine because with her experience, she is not comfortable having the second shot of the COVID-19 vaccine.   Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded.  The case will be reassessed if additional information becomes 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Visual impairment
Clinical narrative: hallucinations; having stroke like symptoms; having intense headaches; felt exhausted; has pain in her arm; her vision affected/wavy lines throughout her eyes; numbness in her face, hands, and lips; This is a spontaneous report from contactable Nurse reporting for herself. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Patient age at time of vaccination was 65 years. The patient did not have reactions with other immunizations except a severe reaction with the measles, mumps, and rubella (MMR) vaccine when she was younger. She had seizures after receiving the MMR vaccine. The patient's concomitant medications were not reported. The patient mentioned she had a severe reaction. She described her adverse reaction by having intense headaches, having stroke-like symptoms in which she described as she cannot speak, having headaches, having numbness in her hands, face, and lips. She also felt exhausted. She also had some pain in her arm that she is not concerned about. She mentioned that she also has her vision affected, she couldn't drive, there were wavy lines all though her eyes. She started to have hallucinations such as seeing people that weren't there, seeing snow storms, and seeing things whipping throughout the wind. All the events started on 04Jan2021. She reported she was very sick in the hospital and is now getting well. However it was unknown if she was admitted to hospital (clarification pending). She wanted to know recommendations about the second shot of the COVID-19 vaccine because with her experience, she is not comfortable having the second shot of the COVID-19 vaccine.   Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded.  The case will be reassessed if additional information becomes 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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the left arm on 14Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications both reported as none. The patient had no recent other vaccinations. The patient experienced headaches on 15Jan2021. She said she got the vaccine last Thursday (14Jan2021) and started having a really bad headache the next day on Friday (15Jan2021), and the headache was still there, it was not going away, nothing helps. She said she was wondering if she got that from the vaccine. She also explained that her appointment with her healthcare professional (HCP) is next Friday, and asked how to manage her symptom in the meantime. No treatment received for the event. She said that the headache had not worsened or improved, it stayed the same. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain, Pyrexia
Clinical narrative: Nausea; Fever; neck pain; Pain/ "aces" and pains; This is a spontaneous report from a non-contactable consumer. An adult female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient experienced nausea, fever, neck pain, aces and pains, all on an unspecified date with outcome of recovered. Prior to vaccination, the patient not diagnosed with COVID-19.  No follow-up attempts possible. No further information expected.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: legs hurting; This is a spontaneous report from a contactable consumer. A 92-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 vaccination. Calling on behalf of 92-year-old uncle received first dose of vaccine. The patient's medical history and concomitant medications were not reported. The patient had complaining of legs hurting on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ear disorder, Eye pruritus, Hypersensitivity, Lacrimation increased, Pain in extremity
Clinical narrative: runny nose; itchy watery eyes, like allergies; itchy watery eyes, like allergies; fluid in her ears; allergies; only had a sore arm for a day; This is a spontaneous report from a non-contactable consumer reporting for herself. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 14Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated she received her first Covid19 vaccine on the 14Jan2021 and everything has been great. She stated she only had a sore arm for a day, but now 5 days later (19Jan2021) she has a runny nose, itchy watery eyes, like allergies, and fluid in her ears. She stated she feels it was just allergies because she can take a Benadryl and it makes it quit. She stated Benadryl knocks her out though. She stated she would like to know if these side effects have been mentioned by others and being 5 days after given the dose. Therapeutic measures (Benadryl ) were taken as a result of runny nose, itchy watery eyes, like allergies and fluid in her ears. The outcome of the event sore arm for a day was recovered while other events were unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; itchy watery eyes, like allergies; itchy watery eyes, like allergies; fluid in her ears; allergies; only had a sore arm for a day; This is a spontaneous report from a non-contactable consumer reporting for herself. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 14Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated she received her first Covid19 vaccine on the 14Jan2021 and everything has been great. She stated she only had a sore arm for a day, but now 5 days later (19Jan2021) she has a runny nose, itchy watery eyes, like allergies, and fluid in her ears. She stated she feels it was just allergies because she can take a Benadryl and it makes it quit. She stated Benadryl knocks her out though. She stated she would like to know if these side effects have been mentioned by others and being 5 days after given the dose. Therapeutic measures (Benadryl ) were taken as a result of runny nose, itchy watery eyes, like allergies and fluid in her ears. The outcome of the event sore arm for a day was recovered while other events were unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: Fever/ running temperature; felt worn out; Generally feeling like crap; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the first dose of BNT162B2  on unspecified date for COVID-19 immunisation. The patient got the second shot of the Pfizer COVID Vaccine yesterday, 18Jan2021. On unspecified date in Jan2021, he had a running temperature and felt worn out. He had a fever and was generally feeling like crap. The temperature was almost gone. He was sure that it's a side effect. He was calling to see if he can take Advil for the fever or not. He wanted to make sure that it would not interfere with the vaccine. He says that yesterday, last night was more intense. It was almost like it was gone, but he still has a little fever. The patient asked if he can use antipyretics after vaccination with the Pfizer-BioNTech COVID-19 vaccine and how long can the symptoms last. The outcome of the event fever/ running temperature was recovering and unknown for the other events.  Information about lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Gait inability, SARS-CoV-2 test
Clinical narrative: Back pain/it hurt so bad; could not walk; This is a spontaneous report from a contactable healthcare professional reported for himself. A 60-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscularly on 30Dec2020 13:00 at single dose, left arm for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included diabetes and high blood pressure, both controlled. The patient's concomitant medications were not reported. On 02Jan2021, the patient experienced back pain, started slowly peaking on January 7 to where he could not walk, it hurt so bad. Events were non-serious. No treatment received for the adverse event. The outcome of the events was recovered. Prior to vaccination,  the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Test Name was Nasal Swab.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling
Clinical narrative: Numbness noted right side of upper mouth /progressed to numbness of mouth/lips; Mild lip swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female nurse (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246) at right arm via an unspecified route of administration on 14Jan2021 16:15 at single dose for COVID-19 immunization. Medical history included none. Concomitant medications included unspecified medications. The patient previously received the first dose of bnt162b2 (lot number: EH9899) at right arm via an unspecified route of administration on 21Dec2020 18:15 at single dose for COVID-19 immunization. The patient experienced numbness noted right side of upper mouth day after 2nd injection on 15Jan2021 16:00. It has progressed to numbness of mouth/lips 5 days post injection. Mild lip swelling on 15Jan2021 16:00. No difficulty breathing etc. Very noticeable with eating and talking in appearance like she have been to the dentist and given novocaine. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment received. The reporter considered the events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Bone pain, Myalgia
Clinical narrative: every bone and muscle in her body hurts, bad; every bone and muscle in her body hurts, bad; This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3249/expiration date: not provided), via an unspecified route of administration, on 16Jan2021 (at the age of 69 years old) as a single dose in the left arm for L121. Relevant medical history included lung cancer 10 or 11 years ago and she only has one lung that breathes well, pneumonitis due to radiation to her right lung which damaged the lining in her right lung, ongoing high cholesterol since 10 to 12 years ago, and high iron content due to simvastatin. Concomitant medication included simvastatin 20mg once daily orally since an unknown date for years, for high cholesterol. On 17Jan2021, the patient experienced every bone and muscle in her body hurts, bad and was worsened. The outcome of the events every bone and muscle in her body hurts, bad was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Hyperaesthesia, Swelling
Clinical narrative: left armpit and under arm became swollen and tender to the touch; left armpit and under arm became swollen and tender to the touch; arm remained somewhat sensitive to the touch; Patient was also extremely tired; This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL1284, on 06Jan2021 09:30 Intramuscular at single dose in left arm for COVID-19 immunization. Medical history included Anxiety and depression, Chronic pain in right foot, tendinopathy of right foot since 2015, Derangement of medial meniscus, Environmental allergies, Fatty liver H/O, hypothyroidism since 25Jan2013, Health care maintenance, Hyperlipidemia since May2016, thyroid nodule since 25Jan2013, Obesity, Prediabetes. Concomitant medications included salbutamol (ALBUTEROL), levothyroxine and omeprazole. The patient previously received first dose of BNT162B2 lot number=EH9899 on 16Dec2020 11:00 AM via Intramuscular at left arm at 56-year-old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately 24 hours after receiving the vaccine, left armpit and under arm became swollen and tender to the touch on 07Jan2021 08:00. Notified primary care physician during routine visit, PCP advised to notify her if symptoms did not resolve. Swelling resolved 4 days after onset, arm remained somewhat sensitive to the touch. Patient was also extremely tired for 2 days after the vaccine but otherwise fine. No treatment was received for all events. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The outcome of all events was resolved.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Arthralgia, Body temperature, Chills, Headache
Clinical narrative: fever 102.9; Severe joint pain; body aches; headache; chills; weird vivid dreams; nausea; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL1284/expiration date: unknown), via an unspecified route of administration, on 16Jan2021 09:45 AM (at the age of 52 years old) as a single dose on left arm for COVID-19 immunisation. Relevant medical history was none. Historical vaccine history included first dose of BNT162B2 vaccine (Pfizer product) on 26Dec2020 (lot number: EL1284) on right arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included  amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), ergocalciferol (VIT D), ascorbic acid (VIT C) and Zinc. The patient did receive other vaccines within 4 weeks prior to the COVID vaccine. On 16Jan2021 05:30 PM, the patient experienced severe joint pain, body aches, headache, fever 102.9, chills, weird vivid dreams, nausea. No treatment was received. The outcome of the events severe joint pain, body aches, headache, fever 102.9, chills, weird vivid dreams, nausea was not recovered.