chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Headache, Mobility decreased, Muscular weakness, Pruritus
Clinical narrative: Stroke; Itchiness on the back of the head; Bad headache; Lost mobility on one side; Muscles went all mushy; A spontaneous report was received from a consumer regarding a 66 year old, elderly male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had his muscles went all mushy/muscle weakness, lost mobility on one side/mobility decreased , stroke/cerebrovascular accident, itchiness on the back of the head/pruritus and bad headache.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included an unspecified blood pressure medication and clopidogrel busulfate.    On 10 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 048A21A) in left non dominant arm for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced Itchiness on the back of the head and bad headache. On 20 Mar 2021, the patient's muscles went all mushy and lost mobility on one side. On 23 Mar 2021, the patient was hospitalized for stroke. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event bad headache was not resolved and outcome of Itchiness on the back of the head, muscles went all mushy, lost mobility on one side and stroke was unknown at the time of this report. .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Gastrointestinal disorder, Scan brain, Vomiting
Clinical narrative: Stroke; throwing up all night; Gut problem; A spontaneous report was received from a consumer  concerning a 75-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced gut problem,stroke and throwing up all night.   The patient's medical history, as provided by the reporter, included stroke.Concomitant medications was not provided by the reporter.  On 03 Mar 2021 prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch number: unknown)  for prophylaxis of COVID-19 infection.   After receiving mRNA-1273, on 14 Mar 2021, the patient was hospitalized for "gut problems" and throwing up all night, and was treated with antibiotics.  On 17 Mar 2021 patient experienced the event stroke .Lab tests done included brain scan ,no bleeding found.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events gut problem,stroke and throwing up all night was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest discomfort
Clinical narrative: Felt like she was having a heart attack; Had pressure from chest down to her stomach; A spontaneous report was received from a consumer concerning herself, a 60-year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and she felt like she was having a heart attack / myocardial infraction and had pressure from chest down to her stomach / chest discomfort.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 17 Mar 2021, approximately six days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 23 Mar 2021, the patient felt like she was having a heart attack and had pressure from chest down to her stomach.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event(s), felt like she was having a heart attack and had pressure from chest down to her stomach, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke, Magnetic resonance imaging, Thrombosis
Clinical narrative: Ischemic stroke; Right side of brain and blood vessels affected badly and found blood clots because of ischemic stroke; A spontaneous report was received from a consumer concerning an 89-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced ischemic stroke and right side of brain and blood vessels affected badly and found blood clots because of ischemic stroke/thrombosis.  The patient's medical history included hearing issue. Concomitant medication included losartan.  On 24 Feb 2021, approximately 12 days prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 001A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 08 Mar 2021, the patient got ischemic stroke. The patient was in hospital for 3 days and doctor put him on blood thinner. MRI (magnetic resonance imaging) of his upper body revealed his right side of brain and blood vessels affected badly and found blood clots because of ischemic stroke. Treatment for the event included blood thinner.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events ischemic stroke and right side of brain and blood vessels affected badly and found blood clots because of ischemic stroke was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Heart rate increased, Myalgia, Transient global amnesia, Transient ischaemic attack
Clinical narrative: Heartbeat thing; High BP; ministroke; transient global amnesia; sore arm; A Spontaneous report  was sent by Consumer concerning a 55 year female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild stroke, transient global amnesia, heart rate increased and blood pressure is high.  No medical history was reported. Concomitant medications was not reported.  22 Jan 2021, prior to the onset of the events, the patient received the first dose of mRNA-1273 for prophylaxis of COVID-19 infection and experienced sore arm in the evening. She took Tylenol and Motrin.  On 02 Mar 2021 the patient received the second dose of vaccine and experienced sore arm before she received the shot.   On 21 Mar 2021 she had mild stroke, and she was diagnosed with Transient global amnesia. Which they said is precursor to stroke. On 22 Mar 2021, patient experienced heartbeat thing; blood pressure recorded high.The patient has undergone MRI, CAT scan, EKG, Chest x-ray done and blood drawn in ER. Laboratory details are not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   At the time of this report, the outcome of the events, mild stroke, transient global amnesia, heart rate increased and blood pressure is high was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Dysphonia, Oropharyngeal pain, Syncope, Tinnitus
Clinical narrative: Fainted; Vomited; Ringing in ears; Injection site was slightly sore; Sore throat; Hoarseness; Dry eyes; A spontaneous report was received from a consumer, concerning herself a  71 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fainted/Syncope, Vomiting, Ringing in ears/, injection site was slightly sore/Vaccination site pain, Sore throat, Hoarseness, Dry eyes.  The patient's medical history was not provided, concomitant medication was not provided by reporter.  On 14Jan2021, prior to the onset of events patient received her first dose of two planned doses of mRNA-1273 (lot number: 028L20A) via unknown route on right arm for COVID-19 infection prophylaxis.  On 15 Jan 2021 she experienced fainted, She was taken to the Emergency Room by ambulance. She was vomiting in route to the hospital. She also complained that she had ringing in her ears, & admits that she still had it. At the hospital, they performed a CAT scan & a MRI of her "stomach." They wanted to admit her, but she was fearful she would contract Covid during her hospital stay. The injection site was slightly sore. She admits she developed a sore throat & hoarseness that day, & has I've had it since then. On 01March 2021, her eye Dr diagnosed her with dry eyes. The seriousness for fainted, Vomiting, Ringing in ears, injection site was slightly sore, Sore throat, Hoarseness considered as hospitalization.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, fainted, Vomiting, Ringing in ears, injection site was slightly sore, Sore throat, Hoarseness, Dry eyes was unknown at time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Fainted; Vomited; Ringing in ears; Injection site was slightly sore; Sore throat; Hoarseness; Dry eyes; A spontaneous report was received from a consumer, concerning herself a  71 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fainted/Syncope, Vomiting, Ringing in ears/, injection site was slightly sore/Vaccination site pain, Sore throat, Hoarseness, Dry eyes.  The patient's medical history was not provided, concomitant medication was not provided by reporter.  On 14Jan2021, prior to the onset of events patient received her first dose of two planned doses of mRNA-1273 (lot number: 028L20A) via unknown route on right arm for COVID-19 infection prophylaxis.  On 15 Jan 2021 she experienced fainted, She was taken to the Emergency Room by ambulance. She was vomiting in route to the hospital. She also complained that she had ringing in her ears, & admits that she still had it. At the hospital, they performed a CAT scan & a MRI of her "stomach." They wanted to admit her, but she was fearful she would contract Covid during her hospital stay. The injection site was slightly sore. She admits she developed a sore throat & hoarseness that day, & has I've had it since then. On 01March 2021, her eye Dr diagnosed her with dry eyes. The seriousness for fainted, Vomiting, Ringing in ears, injection site was slightly sore, Sore throat, Hoarseness considered as hospitalization.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, fainted, Vomiting, Ringing in ears, injection site was slightly sore, Sore throat, Hoarseness, Dry eyes was unknown at time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Dyspnoea, Palpitations
Clinical narrative: Dizziness; Trouble breathing; Rapid heart beat; Issues with stomach; A spontaneous report  was received from a consumer concerning a 72-year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed rapid heartbeat (palpitations), dizziness, trouble breathing (dyspnoea) and issues with stomach (abdominal discomfort).  The patient's medical history was not provided. Concomitant medications were not provided.  On 18 Feb 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch number: unknown) in the left arm for the prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient received their second of the two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection.  On 21 Mar 2021, patient experienced a rapid heartbeat, dizziness, trouble breathing, issues with stomach. Patient was hospitalized at Memorial Hospital where he was kept overnight. No discharge date provided.  The events rapid heartbeat, dizziness, trouble breathing and issues with stomach resulted in hospitalization.   Treatment information was not provided. Lab tests not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the events, rapid heartbeat, dizziness, trouble breathing and issues with stomach was considered unknown. .; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Sudden hearing loss
Clinical narrative: Sudden deafness; A spontaneous report was received from a 45-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden deafness/sudden hearing loss  The patient's medical history, was not provided. Products known to have been used by the patient, within two weeks prior to the event, included prednisone,mycophenolate mofetil,hydroxychloroquine sulphate and lisinopril.  On 04 Mar 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:0271921a ) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 16 Mar 2021, after receiving the first dose, the patient experienced complete hearing loss all at once in right ear. She was diagnosed with sudden deafness on 23 Mar 2021. Treatment medication included unspecified steroid shots in the ear drum.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event sudden deafness was not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Computerised tomogram, Culture stool, Diarrhoea
Clinical narrative: Severe and continuing diarrhoea; Intestinal problem/unusual rare side effect in the Intestinal tract; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 10Nov2015 (Batch/Lot Number: M13068; Expiration Date: 20Apr2016) as 0.5 ml, single for immunisation. Medical history included Heart attack. Concomitant medications included metoprolol succinate (unspecified date) tablet, oral, from/to an unspecified date, at 45 mg daily (1 tab daily), for heart attack; simvastatin (unspecified trade name) tablet, oral, at 20 mg daily (1 tab daily), for heart attack; acetylsalicylic acid (ASPIRIN), at 81 mg daily (1 daily), for heart attack and clopidogrel bisulfate (PLAVIX) tablet, oral, at 75 mg daily, for heart attack. Within 10 hours from administration of the vaccine the patient experienced severe and continuing diarrhoea on 10Nov2015 that continued to be a problem for month with outcome of unknown and intestinal problem on 10Nov2015 with outcome of not recovered. Patient had a very unusual rare side effect to Pfizer's Pneumo Vaccine Prevnar in the Intestinal tract. Patient want to wait to get Covid-19 until more info had been provided on side effects. Patient said she need to know if there had been side effects which impact like the effects of Prevnar. Patient want to know if there were any reports from the Covid-19 Vaccine in the intestinal tract. The patient underwent numerous unspecified tests and have not found any other reason for the adverse events except for Prevnar 13. The patient underwent lab tests and procedures which included blood test: normal on 03May2016 and on 24May2016, CT scan: normal on 22Dec2015, stool analysis: normal on 22Dec2015. Therapeutic measures were taken as a result of the events and included treatment with diphenoxylate-atropine tablet 2.5 mg, oral, at 1 DF 4x/day as needed and eluxadoline (VIBERZI). After 10 days on eluxadoline the patient experienced an unspecified side effect. In response to the adverse effect eluxadoline was stopped.  Follow-up (25Jul2016): New information reported from a contactable consumer includes: reporter's information, lot number and expiry date of PREVNAR 13.   Follow-up attempts completed. No further information expected.  Follow-up (16Feb2021): New information received from a contactable consumer (patient) via a Pfizer sponsored program  included: event details updated.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain
Clinical narrative: Grade 3 chills; body aches/pain; left underarm lymphnode swelling; This is a spontaneous report from a contactable other hcp (patient). A 50-years-old- non- pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: El9265, Expiration Date: unknown) via unspecified route administration in arm left on 08Feb2021 12:30 as a single dose for covid-19 immunisation. Medical history included allergies: PCN and first dose of covid vaccine received on 18Jan2021 at 12:00. Prior to the vaccination patient was not diagnosed with covid-19. Since the vaccination the patient had not been tested for Covid-19. The patient's concomitant medications were not reported. On 09Feb2021 at 02:00 the patient experienced Grade 3 chills, body aches, left underarm lymphnode swelling and pain. Patient had not been treatment for the adverse event. The outcome of the event was recovered.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: antibody test was negative; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number; Unknown) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The reporter stated that a few weeks after receiving the second dose, he obtained an antibody test from his doctor to see if he had developed antibodies after the vaccine. He says his antibody test was negative but doesn't know which antibody test was used because the lab won't tell him. He is looking for any guidance on this subject and would like to know if he is immune. The outcome of the event was reported as unknown.   Information on the lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Sneezing
Clinical narrative: sneezing; runny nose; This is a spontaneous report from a contactable consumer or other health Care Professional. A 80-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EL3424) via an unspecified route of administration on 05Feb2021 13:00 at single dose for COVID-19 immunization. Medical history included hypothyroidism, she took thyroid pill in the morning. The concomitant medication was not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Jan2021. On 08Feb2021 16:00 she started sneezing for the next 2 hours with a runny nose, she thinks that she had a reaction after 72 hours of receiving the vaccine, she went for 2 hours sneezing, and sneezing repeatedly and also had a runny nose, she then thought it was was a cold, dummy her, took 1 Nyquil and laid down for 4 hours after that she was good. She had no vaccines on the same day as her covid vaccine, and had no vaccines in the 4 weeks prior to the vaccine. She had not to go to the Emergency room or see a physician for her sneezing and runny nose. Therapeutic measures were taken as a result of sneezing and runny nose. The event considered non serious. The outcome of the events was resolved on 08-FEB-2021 18:00.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swollen occipital lymph node on left side; swollen, painful, occipital lymph node on left side; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL-9269 and expiration date: not available), via an unspecified route of administration in the left arm on 08Feb2021 at 11:30 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included Diabetes Type II and chronic Depression. The patient had no known allergies. The patient had no other vaccine in four weeks. It was reported that patient took concomitant medications in two weeks. On 09Feb2021 at 02:00 the patient experienced swollen, painful, occipital lymph node on left side. The patient not had covid prior vaccination; not tested covid post vaccination. The patient did not receive any treatment for the events. The outcome of the events was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Muscular weakness
Clinical narrative: she experienced Diarrhea; she had muscle weakness in both legs and back; legs felt weak; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 05Feb2021 13:40 (Batch/Lot Number: EM9810) as single dose for covid-19 immunisation. Medical history included Diabetes from Mar1964, she does some exercise after the shower for the hip surgery done prior to the vaccine. Concomitant medication included insulin lispro (HUMALOG) uses with a pump taken for diabetes mellitus. Caller stated she received her first dose of the Pfizer covid vaccine on Friday, and yesterday morning 09Feb2021 she experienced Diarrhea and then later on she had muscle weakness in both legs and back. She does some exercise after the shower for the hip surgery done prior to the vaccine and uses a cane to walk. She said she is a little better today and wanted to know if that was due to the vaccine. Outcome of the event she had muscle weakness in both legs and back was unknown. Outcome of the other events was recovered on 10Feb2021.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain
Clinical narrative: leg cramping/severe leg cramps/pain; leg cramping/severe leg cramps/pain; This is a spontaneous report from a contactable consumer. A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9264), intramuscular, administered in Arm Left on 09Feb2021 12:15 as single dose for covid-19 immunisation. Medical history included blood cholesterol increased, anxiety, thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included Rosuvastatin (Tablet), orally ongoing at 20 mg once daily taken for blood cholesterol increased, Levothyroxine (Tablet), orally ongoing at 50 ug once daily taken for thyroid disorder and Sertraline (Tablet) orally ongoing at 50 mg once daily taken for anxiety. On 10Feb2021 09:00, the patient experienced leg cramping/severe leg cramps/pain. The action taken in response to the events for BNT162B2 was not applicable. The outcome of event was not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Oropharyngeal pain, Pain
Clinical narrative: body aches; sore throat; dry cough; Headache; This is a spontaneous report from a contactable consumer. This 44-year-old female consumer reported that she received bnt162b2 (BNT162B2, Solution for injection, Lot# EM9810), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 12:45 (Batch/Lot Number: EM9810) as SINGLE DOSE for an unspecified indication. The patient medical history and concomitant medications was not reported. On 08Feb2021 the patient experienced headache, body aches, sore throat, dry cough. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chest pain, Ear discomfort, Ear pain
Clinical narrative: Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe neck pain; right cheek numb/sometimes left cheek numb feeling in lower cheeks/numbness in chin; hot flash in ears; chest pain; intense shoulder/shoulder pain/elbow pain; feels like it runs up the nerves; Pain in shot site left arm and pain in right arm in the same; severe headache/intense headache/pressure headache/bad headache; body pain at night; Pain in shot site left arm and pain in right arm in the same; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm at the age of 55-years (non-pregnant at the time of vaccination), on 06Feb2021 at 01:45 PM at a single dose for COVID-19 immunisation. The patient's medical history included diabetes, high blood pressure, lacunar infarct, anemia, and non-rheumatic mitral regurgitation. The patient had no known allergies. Concomitant medications included losartan, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and acetaminophen. The patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. It was reported that Immediately after the shot, severe neck pain that wrapped up my face, right cheek numb, hot flash in ears, chest pain, intense shoulder, elbow pain, feels like it runs up the nerves, severe headache, ear pressure, lymph node swollen behind right ear on 06Feb2021 at 01:45 PM. Headache, body pain at night on 06Feb2021. O7Feb2021, numbness in right cheek, sometimes left cheek numb feeling in lower cheeks and intense headache. On 08Feb2021, ear pain, pressure headache, shoulder pain, cheeks numb left work early not feeling good at all headache very bad with acetaminophen (TYLENOL). Second vaccine shockingly painful side effects day of shot and days after. Pain in shot site left arm and pain in right arm in the same. Temp elevated night 100.9 F. On 09Feb2021, Off work vice grip headache, ear pain. On 10Feb2021, bad headache, numbness in cheeks remain, numbness in chin. The outcome of the events was recovering. It was also reported that post vaccination, the patient had not been tested for COVID.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Hypoaesthesia, Lymphadenopathy, Neck pain
Clinical narrative: Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe neck pain; right cheek numb/sometimes left cheek numb feeling in lower cheeks/numbness in chin; hot flash in ears; chest pain; intense shoulder/shoulder pain/elbow pain; feels like it runs up the nerves; Pain in shot site left arm and pain in right arm in the same; severe headache/intense headache/pressure headache/bad headache; body pain at night; Pain in shot site left arm and pain in right arm in the same; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm at the age of 55-years (non-pregnant at the time of vaccination), on 06Feb2021 at 01:45 PM at a single dose for COVID-19 immunisation. The patient's medical history included diabetes, high blood pressure, lacunar infarct, anemia, and non-rheumatic mitral regurgitation. The patient had no known allergies. Concomitant medications included losartan, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and acetaminophen. The patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. It was reported that Immediately after the shot, severe neck pain that wrapped up my face, right cheek numb, hot flash in ears, chest pain, intense shoulder, elbow pain, feels like it runs up the nerves, severe headache, ear pressure, lymph node swollen behind right ear on 06Feb2021 at 01:45 PM. Headache, body pain at night on 06Feb2021. O7Feb2021, numbness in right cheek, sometimes left cheek numb feeling in lower cheeks and intense headache. On 08Feb2021, ear pain, pressure headache, shoulder pain, cheeks numb left work early not feeling good at all headache very bad with acetaminophen (TYLENOL). Second vaccine shockingly painful side effects day of shot and days after. Pain in shot site left arm and pain in right arm in the same. Temp elevated night 100.9 F. On 09Feb2021, Off work vice grip headache, ear pain. On 10Feb2021, bad headache, numbness in cheeks remain, numbness in chin. The outcome of the events was recovering. It was also reported that post vaccination, the patient had not been tested for COVID.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe neck pain; right cheek numb/sometimes left cheek numb feeling in lower cheeks/numbness in chin; hot flash in ears; chest pain; intense shoulder/shoulder pain/elbow pain; feels like it runs up the nerves; Pain in shot site left arm and pain in right arm in the same; severe headache/intense headache/pressure headache/bad headache; body pain at night; Pain in shot site left arm and pain in right arm in the same; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm at the age of 55-years (non-pregnant at the time of vaccination), on 06Feb2021 at 01:45 PM at a single dose for COVID-19 immunisation. The patient's medical history included diabetes, high blood pressure, lacunar infarct, anemia, and non-rheumatic mitral regurgitation. The patient had no known allergies. Concomitant medications included losartan, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and acetaminophen. The patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. It was reported that Immediately after the shot, severe neck pain that wrapped up my face, right cheek numb, hot flash in ears, chest pain, intense shoulder, elbow pain, feels like it runs up the nerves, severe headache, ear pressure, lymph node swollen behind right ear on 06Feb2021 at 01:45 PM. Headache, body pain at night on 06Feb2021. O7Feb2021, numbness in right cheek, sometimes left cheek numb feeling in lower cheeks and intense headache. On 08Feb2021, ear pain, pressure headache, shoulder pain, cheeks numb left work early not feeling good at all headache very bad with acetaminophen (TYLENOL). Second vaccine shockingly painful side effects day of shot and days after. Pain in shot site left arm and pain in right arm in the same. Temp elevated night 100.9 F. On 09Feb2021, Off work vice grip headache, ear pain. On 10Feb2021, bad headache, numbness in cheeks remain, numbness in chin. The outcome of the events was recovering. It was also reported that post vaccination, the patient had not been tested for COVID.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Really Sore Injection Site (Right Arm); Headache post-injection; This is a spontaneous report received from a contactable consumer (patient himself). A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247) via an unspecified route of administration on 10Feb2021 12:30 to the right arm at single dose for COVID-19 immunization. Patient medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT). Patient received Zoloft 200mg daily within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (Pfizer COVID 19, Solution for injection, lot number: EL3247 via an unspecified route of administration on 20Jan2021 at 11:00 AM on the right arm as a single dose). Patient did not receive any other vaccine in four weeks. On 10Feb2021 at 13:30 PM, patient had really sore injection site (right arm) and headache post-injection. No treatment was provided for the event. Outcome of the events was reported as recovering.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Extremely sore joints, particularly shoulder; Profound fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received first dose bnt162b2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 14:00 (Batch/Lot Number: EN5318) as single dose for covid-19 immunisation. Medical history included allergies extensive. Concomitant medication included thyroid, metformin and celecoxib (CELEBREX). The patient experienced on 11Feb2021 07:00 Extremely sore joints, particularly shoulder. Profound fatigue. The outcome of the events unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Gastrointestinal disorder, Headache
Clinical narrative: feeling strange; ill; headache; chills; intestinal issues; tiredness; nausea; This is a spontaneous report from a contactable Consumer (patient herself). A 65-year-old female non pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via left arm on 09Feb2021 11:00, as a single dose for COVID-19 immunization in hospital. Patient's medical history included Multiple myeloma (in remission for the past seven years) and hemochromatosis. Concomitant medication include verapamil and reyvow. On 09Feb2021 12:00, the patient started feeling strange within one hour from receiving the vaccination. As the day progressed, the patient became ill and experienced horrible headache, chills, intestinal issues, tiredness nausea. Patient did not receive any treatment for the adverse event. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination was not diagnosed with COVID-19. Since the vaccination patient had not tested for COVID-19. Patient had not allergies to medications, food, other products. The outcome of the events was recovered on 11Feb2021.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: feeling strange; ill; headache; chills; intestinal issues; tiredness; nausea; This is a spontaneous report from a contactable Consumer (patient herself). A 65-year-old female non pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via left arm on 09Feb2021 11:00, as a single dose for COVID-19 immunization in hospital. Patient's medical history included Multiple myeloma (in remission for the past seven years) and hemochromatosis. Concomitant medication include verapamil and reyvow. On 09Feb2021 12:00, the patient started feeling strange within one hour from receiving the vaccination. As the day progressed, the patient became ill and experienced horrible headache, chills, intestinal issues, tiredness nausea. Patient did not receive any treatment for the adverse event. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination was not diagnosed with COVID-19. Since the vaccination patient had not tested for COVID-19. Patient had not allergies to medications, food, other products. The outcome of the events was recovered on 11Feb2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: she slept quite a bit; This is a spontaneous report received from a contactable consumer (patient herself). An unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL9264) via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunization and clopidogrel (strength: 75mg) via an unspecified route of administration on an unspecified at 75mg for an unspecified indication. Patient medical history and concomitant medications were not reported. She got the first dose of the Pfizer COVID shot on Monday. She is doing fine. She reads on the fact sheet about things that should be mentioned to the vaccine provider and she cannot remember if she told the provider she is on Clopidogrel 75mg, a blood thinner. She is asking if this is ok since she is scheduled to get her second dose in three weeks. She slept quite a bit on 08Feb2021. After she came home from getting the vaccine, she slept the whole day and the next day she was fine. States it might have not been from the vaccine since she stayed up late the night before. Outcome of event was recovered on 08Feb2021.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Epistaxis, Fatigue, Headache
Clinical narrative: Nose bleed; Joint pain; Headache; Tired; This is a spontaneous report from a contactable Other HCP. A 49-year-old female (non-pregnancy) female patient receive second dose of bnt162b2 (BNT162B2, Solution for injection), via unknown route of administration on Left arm on unknown date at single dose for covid-19 immunisation. The patient's medical history includes Asthmatic, and known allergies includes shellfish, and Penicillin, and Historical Vaccine includes first dose of BNT162B2 (Lot number: El1283) on 05Feb2021 08.00 AM on left arm. Concomitant medications were not reported. It was reported that patient experienced Nosebleed, headache, tired, joint pain on 13Feb2021 04.00 AM and did not received any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The outcome of events was "Recovering".
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pain in extremity, Sneezing
Clinical narrative: headache; cough; sneezing; difficulty lifting right arm; This is a spontaneous report from a contactable Consumer (Patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Arm Right on 12Feb2021 15:00 as single dose for covid-19 immunization at Pharmacy. Medical history included hypertension, gastroesophageal reflux disease and neoplasm malignant from an unknown date and unknown if ongoing. Concomitant medications included fish oil, omeprazole, lisinopril, methenamine mandelate, methionine (G). On 13Feb2021 10:00, The patient experienced headache, cough, sneezing, difficulty lifting right arm. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: 1st dose Vaccine on Monday, super tired on Thursday; This is a spontaneous report from a contactable consumer (Patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot unknown reason=Not available/provided to reporter at the time of report completion), via an unspecified route of administration, administered in Left Arm on 25Jan2021 17:00 as SINGLE DOSE for covid-19 immunisation. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: N/A. The patient medical history and concomitant medications was not reported. If other vaccine in four weeks: No, Other medications in two weeks: No. Facility type vaccine: School or Student Health Clinic. The patient experienced 1st dose vaccine on Monday, super tired on Thursday (fatigue) (non-serious) on 28Jan2021 13:00. If treatment AE: No. It was also provided as product=COVID 19, brand=Pfizer, lot unknown=False, administration date=25Jan2021, administration time=05:00 PM, dose number=2. The outcome of event was recovered on an unspecified date in 2021.  Information on batch/lot number was requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Fatigue, Headache
Clinical narrative: Extreme fatigue and whole body weakness; Body aches, especially in my back; Body aches, especially in my back; Nausea; Chills; headache; Extreme fatigue and whole body weakness; This is a spontaneous report from a contactable Consumer (Patient). A 25-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in Arm Right on 12Feb2021 07:00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in Arm Right on 21Jan2021 07:00 as single dose for covid-19 immunisation. On 13Feb2021 04:00, The patient experienced body aches, especially in my back, nausea, chills, headache, extreme fatigue and whole body weakness. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Extreme fatigue and whole body weakness; Body aches, especially in my back; Body aches, especially in my back; Nausea; Chills; headache; Extreme fatigue and whole body weakness; This is a spontaneous report from a contactable Consumer (Patient). A 25-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in Arm Right on 12Feb2021 07:00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in Arm Right on 21Jan2021 07:00 as single dose for covid-19 immunisation. On 13Feb2021 04:00, The patient experienced body aches, especially in my back, nausea, chills, headache, extreme fatigue and whole body weakness. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Paranasal sinus discomfort
Clinical narrative: exhaustion - couldn't move from the couch for over 24 hours; Joint pain in both hips & left knee; sinus pressure; This is a spontaneous report from a contactable consumer. A 46-years-old non pregnant female patient received first dose of BNT162B2 (COMIRNATY, formulation solution for injection, Lot Number: EL9267), via an unspecified route of administration, in left arm on 12Feb2021 09:45 as single dose for covid-19 immunisation. It was reported that patient was covid prior vaccination. The patient had sulphur allergies. The patient's concomitant medications were not reported. On 13Feb2021 12:30 the patient experienced exhaustion couldn't move from the couch for over 24 hours, joint pain in both hips and left knee and sinus. The patient did not received treatment for the events. The patient was not covid tested post vaccination. The patient did not received other vaccine in fourweeks. The outcome of the events was not recovered.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Tiredness and exhaustion in general/exhaustion/feeling like I am completely drained of energy; muscle and joint pain; muscle and joint pain; Pain in my arms and legs; Pain in my arms, back, and legs; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiration date not provided), via an unspecified route of administration on 05Jan2021, 10:30 in right arm and then via unspecified route of administration (Lot Number: EL8982, Expiration date not provided) on 25Jan2021, 07:30 in the right arm both for COVID-19 immunization. The patient's medical history included very slight allergy to Kiwi fruit. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient had not been diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 26Jan2021, the patient experienced tiredness and exhaustion in general, performing any physical activity that requires a minor amount of effort leads to muscle and joint pain and exhaustion, while walking around the store pushing the cart has ended him calling out of work sick the next day due to pain in arms, back, and legs as well as feeling like he was completely drained of energy. It was reported that all events listed happened with the first shot and continued after the second dose but more severe. The patient had not received any treatment for the events. Outcome of the events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: itchy hive at injection site; This is a spontaneous report from a contactable female consumer (patient herself) of 65-years-old received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number EL9269) via an unspecified route of administration on 05Feb2021 at 04:45pm in right arm as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Patient was reported to known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was on Lexipro and Pravistatin within two weeks of vaccination. On 12Feb2021, approximately day 8 patient experienced an itchy hive at injection site. No therapeutic measures were taken. The outcome of the event was not recovered.