chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Oropharyngeal pain, Oxygen saturation, Pain in extremity
Clinical narrative: COVID-19 pneumonia; Fever (body temperature at 102.7 Fahrenheit); Threw up; littles scratchy throat; Cough; Sore throat; Dizzy spells; Runny nose /nose was a faucet; Little sore arm; Fatigue; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient).   A 48-year-old female patient (weight: 148.32 kg, height: 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL9262) intramuscularly, in the left arm, at single dose, on 28Jan2021, at 13:30, for COVID-19 immunisation. Relevant medical history included light Crohn's disease from an unspecified date. Concomitant medications included oral fexofenadine hydrochloride (ALLEGRA) 60 mg, twice daily (60 mg, 1 tablet every 12 hours), from 02Feb2021 to 05Feb2021, for nasal congestion; oral paracetamol (TYLENOL, capsule) 500 mg capsule (she took 2 as needed), from 02Feb2021 and ongoing, for fever and headache; salbutamol (ALBUTEROL) 90 mcg, 2 puffs every 4-6 hours as needed, from 06Feb2021 and ongoing, for breathing problems and oral benzonatate 100 mg, thrice daily (100 mg capsules, 1 by mouth three times daily as needed) from 06Feb2021 and ongoing, for cough. On an unspecified date, in Feb2021, the patient developed little sore arm and fatigue. On 01Feb2021, the patient experienced runny nose, nose was a faucet. On 02Feb2021, she had little scratchy throat, cough, sore throat and dizzy spells. On 04Feb2021, she threw up and on 05Feb2021, the patient experienced fever (she had temperature at 102.7 Fahrenheit) and then was hospitalized. Post the vaccination, the patient has been tested for COVID-19 on 05Feb2021 and resulted positive and pneumonia requiring hospitalization. She was admitted on the 05Feb2021 discharged on the 09Feb2021. Chest x-ray and CT chest performed on 05Feb2021 showed pneumonia. Body temperature on 05Feb2021, at night, was 102.8 Fahrenheit. Oxygen saturation (pulse ox) showed the following value: 80s, 84 and 93 on an unspecified date, in Feb2021. Emergency Room Visit and Physician Office Visit required for runny nose, throat irritation, cough, sore throat and pneumonia. Treatment was received for COVID-19 pneumonia, fever, runny nose, throat irritation, cough and sore throat. She was supposed to get the second vaccine on the 18Feb2021. The patient recovered from fever on 07Feb2021, did not recover from dizzy spells, while clinical outcome of the other events was unknown at time of this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Throat irritation, Vomiting
Clinical narrative: COVID-19 pneumonia; Fever (body temperature at 102.7 Fahrenheit); Threw up; littles scratchy throat; Cough; Sore throat; Dizzy spells; Runny nose /nose was a faucet; Little sore arm; Fatigue; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient).   A 48-year-old female patient (weight: 148.32 kg, height: 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL9262) intramuscularly, in the left arm, at single dose, on 28Jan2021, at 13:30, for COVID-19 immunisation. Relevant medical history included light Crohn's disease from an unspecified date. Concomitant medications included oral fexofenadine hydrochloride (ALLEGRA) 60 mg, twice daily (60 mg, 1 tablet every 12 hours), from 02Feb2021 to 05Feb2021, for nasal congestion; oral paracetamol (TYLENOL, capsule) 500 mg capsule (she took 2 as needed), from 02Feb2021 and ongoing, for fever and headache; salbutamol (ALBUTEROL) 90 mcg, 2 puffs every 4-6 hours as needed, from 06Feb2021 and ongoing, for breathing problems and oral benzonatate 100 mg, thrice daily (100 mg capsules, 1 by mouth three times daily as needed) from 06Feb2021 and ongoing, for cough. On an unspecified date, in Feb2021, the patient developed little sore arm and fatigue. On 01Feb2021, the patient experienced runny nose, nose was a faucet. On 02Feb2021, she had little scratchy throat, cough, sore throat and dizzy spells. On 04Feb2021, she threw up and on 05Feb2021, the patient experienced fever (she had temperature at 102.7 Fahrenheit) and then was hospitalized. Post the vaccination, the patient has been tested for COVID-19 on 05Feb2021 and resulted positive and pneumonia requiring hospitalization. She was admitted on the 05Feb2021 discharged on the 09Feb2021. Chest x-ray and CT chest performed on 05Feb2021 showed pneumonia. Body temperature on 05Feb2021, at night, was 102.8 Fahrenheit. Oxygen saturation (pulse ox) showed the following value: 80s, 84 and 93 on an unspecified date, in Feb2021. Emergency Room Visit and Physician Office Visit required for runny nose, throat irritation, cough, sore throat and pneumonia. Treatment was received for COVID-19 pneumonia, fever, runny nose, throat irritation, cough and sore throat. She was supposed to get the second vaccine on the 18Feb2021. The patient recovered from fever on 07Feb2021, did not recover from dizzy spells, while clinical outcome of the other events was unknown at time of this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Angina unstable, Chest discomfort, Coronary artery disease, Dyspnoea, Eructation
Clinical narrative: SV for unstable angina; CAD; Tachycardia; Nausea; Belching; SOB; Chest heaviness, chest pressure, chest tightness; Pain; This is a spontaneous report from a non-contactable other HCP. A 70-year-old female patient received the first dose of bnt162b2 (lot number EN6205) via unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not provided. Upon 15 minutes after injection, she noted nausea with belching and had some SOB. Symptoms worsened as she ambulated over to the medical bay along with her chest pressure. She denied rash, hives, welts, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient reported recently admitted for unstable angina and CAD with tachycardia. Patient had elevated d-dimer and blood clot was ruled out. Patient discontinued on new medication, beta blocker. Since discharge this Sunday 21Feb2021, she reported chest heaviness as if she has "cardboard on chest." Can slightly increase with going up and down stairs or increased activity. She states she had reached out to her cardiologist via an online site but has not heard back. Patient stated her pain is about the same today. Patient complains of chest tightness and shortness of breath. The outcome of events was unknown.   No Follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of events unstable angina and tachycardia cannot be excluded. The patient's age and suspected cardiac condition are risk factors. The event CAD, given its progressive nature, is most likely an underlying condition, thus unrelated to the suspect drug.   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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Nausea, Pain, Tachycardia
Clinical narrative: SV for unstable angina; CAD; Tachycardia; Nausea; Belching; SOB; Chest heaviness, chest pressure, chest tightness; Pain; This is a spontaneous report from a non-contactable other HCP. A 70-year-old female patient received the first dose of bnt162b2 (lot number EN6205) via unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not provided. Upon 15 minutes after injection, she noted nausea with belching and had some SOB. Symptoms worsened as she ambulated over to the medical bay along with her chest pressure. She denied rash, hives, welts, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient reported recently admitted for unstable angina and CAD with tachycardia. Patient had elevated d-dimer and blood clot was ruled out. Patient discontinued on new medication, beta blocker. Since discharge this Sunday 21Feb2021, she reported chest heaviness as if she has "cardboard on chest." Can slightly increase with going up and down stairs or increased activity. She states she had reached out to her cardiologist via an online site but has not heard back. Patient stated her pain is about the same today. Patient complains of chest tightness and shortness of breath. The outcome of events was unknown.   No Follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of events unstable angina and tachycardia cannot be excluded. The patient's age and suspected cardiac condition are risk factors. The event CAD, given its progressive nature, is most likely an underlying condition, thus unrelated to the suspect drug.   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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Allergic reaction to excipient, Asthenia, Bowel movement irregularity, Diarrhoea
Clinical narrative: nauseated; feeling weak and not well; feeling weak and not well; allergic to an ingredient in the vaccine: polyethylene glycol; rectal bleeding which then became rectal hemorrhage; stomach cramps; bowel movements; diarrhea; This is a spontaneous report from a contactable consumer. A 76 years old female consumer reported that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on the 12Feb2021 at around 04:30PM single dose for COVID-19 immunisation. Medical history and concomitant drugs were not provided. At midnight that same day on 12Feb2021, she started getting stomach cramps, bowel movements, diarrhea, rectal bleeding which then became rectal hemorrhage. She did not go to the hospital. She said the effects dissipated; however, she still felt nauseated today (26Feb2021). The patient was currently taking ondansetron (ZOFRAN). She has been feeling weak and not well. She had a colonoscopy planned soon. She's concerned about receiving the second dose. She mentioned as well that she believed she was allergic to an ingredient in the vaccine: "polyethylene glycol". Outcome of nausea was not recovered. Outcome of other events was unknown.  Information about lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Rectal haemorrhage
Clinical narrative: nauseated; feeling weak and not well; feeling weak and not well; allergic to an ingredient in the vaccine: polyethylene glycol; rectal bleeding which then became rectal hemorrhage; stomach cramps; bowel movements; diarrhea; This is a spontaneous report from a contactable consumer. A 76 years old female consumer reported that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on the 12Feb2021 at around 04:30PM single dose for COVID-19 immunisation. Medical history and concomitant drugs were not provided. At midnight that same day on 12Feb2021, she started getting stomach cramps, bowel movements, diarrhea, rectal bleeding which then became rectal hemorrhage. She did not go to the hospital. She said the effects dissipated; however, she still felt nauseated today (26Feb2021). The patient was currently taking ondansetron (ZOFRAN). She has been feeling weak and not well. She had a colonoscopy planned soon. She's concerned about receiving the second dose. She mentioned as well that she believed she was allergic to an ingredient in the vaccine: "polyethylene glycol". Outcome of nausea was not recovered. Outcome of other events was unknown.  Information about lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheaded/Dizziness within a few minutes of injection; This is spontaneous report from a contactable healthcare professional. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EN6205, unknown expiration), intramuscular in right arm on 26Feb2021 12:00 PM at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced lightheaded/dizziness within a few minutes of injection on 26Feb2021 at 12:00 PM.  The event resulted in emergency room/department or urgent care visit. The patient received unspecified treatment for the event following evaluation/transport to hospital. It was unknown if the patient received other vaccine in four weeks. It was unknown if patient had COVID prior to vaccination and if tested for COVID post vaccination. Outcome of the event was unknown. The event was assessed as serious (hospitalization).   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for event dizziness. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; Shin hurt; heart burn; This is a spontaneous report from a contactable consumer (patient's son). A 63-year-old female patient (mom) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration in arm in Feb2021 (reported as in the first week of Feb2021) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 in Jan2021 for COVID-19 immunization. Reporter (patient's son) received his first dose of Pfizer COVID vaccine on Wednesday and wanted to know if this vaccine could cause blood clot. He stated his mom (patient) in the hospital due to pulmonary embolism from 24Feb2021, 2.5 weeks after her second shot. He stated his anxiety levels were higher than normal. He had strong response to flu vaccine this year and experienced chill, shakes, fever, received antibiotic, and loss sense of taste from the flu vaccine. Reporter read online that some people commented that they have DVTs (deep vein thrombosis) and blood clots from the Pfizer COVID vaccine. Patient experienced blood clots in the lung in Feb2021 and hospitalized on 24Feb2021. Patient got her second shot about 2 weeks before and she ended up in the hospital with pulmonary embolism. They looked at her lungs and found all the blood clots. Patient had really bad shortness of breath, headache, her jaw hurt, and her shin hurt. She was helping out at vaccine clinic and she was out of breath, she said the old people in strollers were passing her. Patient began to make complaints about how she was feeling in mid of Feb2021. Patient said in rare cases 2 weeks after the second dose reactions could happen. Patient got done working in ICU, and helped with PPE, then at 11 she left work at the hospital, she was experiencing heart burn for 3 days and so she thought had a heart attack drove to an ER (emergency room) on the way home, and then was admitted to the hospital on that same day 24Feb2021, she was supposed to be discharged today (26Feb2021). Patient had been feeling out of breath for past 2 month, it was possible it might seem like it was related to the vaccine but it could also not be related. Reporter stated that on the internet he saw how a 1000 deaths happened after the vaccine, it was all old people, but in the autopsies there was no link to the vaccine, they were going to die regardless. Lab data included: She did get a test before for Factor 5 Leiden but it was negative. They did test for COVID, it was negative, while in the hospital. In the hospital they were also testing her again for the Factor 5 Leiden, the results hadn't come back yet. They did test for blood clots, they did an MRI (magnetic resonance imaging) in Feb2021, it was positive for blood clots (blood clots in the lungs). When she was admitted her oxygen was 85%. Outcome of the events was unknown.  Information on lot and batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety disorder, Dizziness
Clinical narrative: lightheadedness/dizziness; Vaccine-Related Anxiety; This is a spontaneous report from a non-contactable healthcare professional.  A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  During her 30-minute waiting period after the injection, the patient began to experience lightheadedness and dizziness. Treatment included water and snacks. Follow-up response to treatment was excellent. Patient discharged (pending clarification), she was stable to go home and follow-up with PCP. Differential diagnosis reported as vaccine-related anxiety (include misc mental health) and systemic reaction (hypoglycemia, hypotension, generalized rash). Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 0.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Breath sounds abnormal, Dyspnoea
Clinical narrative: Choking sounds; Difficulty breathing; This is a spontaneous report from a contactable other healthcare professional. A 3-month-old female patient received the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: CD0412, expiration date: 31Jan2022), intramuscularly on 28Jan2021 at single dose for immunisation, hib vaccine conj (crm197) (HIB TITER), via an unspecified route of administration on 28Jan2021 at unknown dose for immunisation. Medical history included eczema. There were no concomitant medications. Clinical course: the patient had difficulty breathing and had choking sounds; caller states the patient's father said when the patient went home from the HCP office on 28Jan2021, within give or take 15-30 minutes the patient had difficulty breathing and had the choking sounds that lasted a few hours. The baby was fine and on 25Feb2021 was smiling, laughing, had gained weight, the baby was happy and not crying; the baby gained a pound and grew not quite an inch on 25Feb2021, the baby was drinking 6 ounces every four hours and was rolling over. The patient was given the other vaccines of Rotavirus vaccine and the DTaP vaccine on 25Feb2021. The outcome of events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "difficulty breathing and had the choking sounds" with PREVNAR 13 use can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: Right eye on right side of cornea is completely red.  It looks like a broken blood vessel.  There was no trauma associated with this.; This is a spontaneous report from a contactable consumer (patient herself). This 64-year old female patient, not pregnant, received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EN6203), via unspecified route of administration on the left arm on 23Feb2021 at 01:00 PM (at the age of 64-year old) at single dose for COVID-19 immunization at Doctor's office/urgent care. Relevant medical history included allergy to codeine. Concomitant medications were not reported. On 25Feb2021 at 12:00 AM the patient noticed that right eye on right side of cornea was completely red. It looked like a broken blood vessel. There was no trauma associated with this. The patient did not receive any treatment due to the event. The patient was not recovered from the event.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia areata, Pruritus
Clinical narrative: Felt intense itching on face; Developed alopecia barbae approximately 1 week from second dose/subsequent hair loss has remained permanent since; This is a spontaneous report from a contactable physician. A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration on 09Jan2021 14:00 at a single dose on left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: K5730), on 19Dec2021 at 02:00 PM, on right arm, for COVID-19 immunization. The patient experienced developed alopecia barbae in Jan2021 approximately 1 week from second dose. After the shot (24h) the patient felt intense itching on face on 10Jan2021; subsequent hair loss has remained permanent since. The event alopecia barbae was reported to have resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No treatment was given for the events. The outcome of the events was not recovered. The patient did not have COVID prior vaccination and was not COVID tested post vaccination.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cytokine storm, Fatigue, Feeling abnormal, Pain
Clinical narrative: She still has fatigue; The extreme pain, mental fog, and disconnect that came with it has all subsided; The extreme pain, mental fog, and disconnect that came with it has all subsided; Cytokine storm; extreme chills with teeth chattering; This is a spontaneous report from contactable consumer. A 68-year-old female patient the second dose of BNT162B2 (Batch/lot number: EN5318) on 04Feb2021 at 1:00 on Left arm for covid-19 immunization. Medical history was ongoing Arachnoiditis (this is a spinal cord disease). Concomitant drugs were not reported. Historical Vaccine was 1st dose of BNT162B2 (Lot Number: EL1283) on 15Jan2021 administered in left arm for covid-19 immunization. She was calling to report a severe reaction that occurred after the second injection. On 05Feb2021 she started to have extreme chills with teeth chattering at 3 AM. She knew this could be part of the symptoms. At 6 AM on 05Feb2021 she got up and with her husband's assessment who is also is a doctor it was determined by her husband she was in a cytokine storm that attacked her spinal cord disease. The extreme chills ended within a couple of hours on 05Feb2021. The cytokine storm has pretty much resolved. It is still there, but better. She still has fatigue. However, the extreme pain, mental fog, and disconnect that came with it has all subsided. Caller stated she knows from research and talking to other people most people might have the chills after the COVID Vaccine. The chills is not the severe side effect she is referencing as severe. The Cytokine storm reaction for her wit her spinal cord disease is unexpected and not normal. This was the severe event. No Emergency Room visited. Physician's Office visited for Cytokine Storm. She should have gone to the hospital, but she did not want to go. Seven days after event started, she went to her physician. This was as soon as she was able to get up and get out of the house. Treatment was mainly self-treating. Her husband is a doctor and they did what they needed to do at home. These side effects were pretty horrific. Outcome of the event cytokine storm was recovering, for fatigue was not recovered, for other events was recovered.  No follow-up attempts are possible. No further information expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Body temperature increased, Headache, Pain in extremity
Clinical narrative: It is the ringing in the ear; felt like a siren was going both of his ears; Headache; His arm was hurting; Throwing up; losing his balance; He was running a temperature; This is a spontaneous report from a contactable consumer. This consumer reported that a 38-year-old male patient (son) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for Covid-19 immunization on 19Feb2021. Relevant history and concomitant drugs were unknown.  Relevant concomitant drugs were unknown.  The patient previously received the first dose of BNT162B2 in 05Feb2021 for Covid-19 immunization on, when he received the first one he felt headache a little bit and his arm was hurting and all of a sudden he suffered from tinnitus in his ear. He had lost 8 pounds in like 4 days since he got that shot. He weighs not like a 117-118 pounds. When he received the second shot he experienced headache, tinnitus in his ears, which became so worse that he felt like a siren was going both of his ears and he landed up in the hospital plus he was throwing up and he was losing his balance and he was running a temperature and he was still in the hospital. It was the ringing in the ear; felt like a siren was going both of his ears. His arm was hurting. He was in the hospital since Tuesday and ringing in his ear, it would not stop. He said it was started, he always had this but not to this extent he started after the first vaccine that he had. He wanted to know because his ear nose and throat doctor said that another patient had the same reaction (Further clarification was unknown, hence split was not captured) and he wanted to know why is that not listed on the reactions. The outcome of events tinnitus and throwing up was not resolved. Outcome of other events was unknown.  Information on the lot/ batch number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vomiting
Clinical narrative: It is the ringing in the ear; felt like a siren was going both of his ears; Headache; His arm was hurting; Throwing up; losing his balance; He was running a temperature; This is a spontaneous report from a contactable consumer. This consumer reported that a 38-year-old male patient (son) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for Covid-19 immunization on 19Feb2021. Relevant history and concomitant drugs were unknown.  Relevant concomitant drugs were unknown.  The patient previously received the first dose of BNT162B2 in 05Feb2021 for Covid-19 immunization on, when he received the first one he felt headache a little bit and his arm was hurting and all of a sudden he suffered from tinnitus in his ear. He had lost 8 pounds in like 4 days since he got that shot. He weighs not like a 117-118 pounds. When he received the second shot he experienced headache, tinnitus in his ears, which became so worse that he felt like a siren was going both of his ears and he landed up in the hospital plus he was throwing up and he was losing his balance and he was running a temperature and he was still in the hospital. It was the ringing in the ear; felt like a siren was going both of his ears. His arm was hurting. He was in the hospital since Tuesday and ringing in his ear, it would not stop. He said it was started, he always had this but not to this extent he started after the first vaccine that he had. He wanted to know because his ear nose and throat doctor said that another patient had the same reaction (Further clarification was unknown, hence split was not captured) and he wanted to know why is that not listed on the reactions. The outcome of events tinnitus and throwing up was not resolved. Outcome of other events was unknown.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Throat clearing
Clinical narrative: voice hoarseness; throat clearing; This is a spontaneous report from Pfizer-sponsored program  from a contactable consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 24Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the vaccine on Wednesday (24Feb2021) and after getting the first dose he was experiencing voice hoarseness and throat clearing in 2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Myalgia
Clinical narrative: back pain; Muscles hurt in her back; Fatique; This is a spontaneous report from a Pfizer Sponsored Program . A contactable consumer (patient) reported that a female patient of an unspecified age received the 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 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced back pain, muscles hurt in her back, fatigue on an unspecified date. The outcome of events wsa unknown.    Information on the lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Haemoglobin, Haemoglobin decreased, Lymphoedema, Oxygen saturation
Clinical narrative: she passed away on 19Feb as she had a HGB of 5; O2 sats were in 70s; she had a HGB of 5; on the same side the patient hand started swelling; lymphedema from L breast; swelling all over; This is a spontaneous report from a contactable consumer reporting on behalf of the mother. An 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 at 13:45, at single dose, in left arm, for COVID-19 immunization. No other vaccine was given in four weeks. Medical history included chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). Known allergies: none. The patient had no COVID prior vaccination and was not tested after vaccination. Concomitant medications were not reported, however, the patient received other medications in two weeks. On 05Feb2021 at 09:00, on the same side the patient hand started swelling and doctor gave her some furosemide (LASIX). One week from vaccination she started having lymphedema from L breast and started noticeably swelling all over. On 18Feb2021 she was taken to the hospital as O2 sats were in 70s. She passed away on 19Feb2021 as she had a HGB of 5. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization for 1 day. No treatment was received. No autopsy was performed. Low oxygen saturation, hand swelling, lymphedema from L breast and swelling all over final outcome was unknown. Information on Lot/Batch number has been requested.; Reported Cause(s) of Death: she passed away on 19Feb as she had a HGB of 5; she had a HGB of 5
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Peripheral swelling, Swelling
Clinical narrative: she passed away on 19Feb as she had a HGB of 5; O2 sats were in 70s; she had a HGB of 5; on the same side the patient hand started swelling; lymphedema from L breast; swelling all over; This is a spontaneous report from a contactable consumer reporting on behalf of the mother. An 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 at 13:45, at single dose, in left arm, for COVID-19 immunization. No other vaccine was given in four weeks. Medical history included chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). Known allergies: none. The patient had no COVID prior vaccination and was not tested after vaccination. Concomitant medications were not reported, however, the patient received other medications in two weeks. On 05Feb2021 at 09:00, on the same side the patient hand started swelling and doctor gave her some furosemide (LASIX). One week from vaccination she started having lymphedema from L breast and started noticeably swelling all over. On 18Feb2021 she was taken to the hospital as O2 sats were in 70s. She passed away on 19Feb2021 as she had a HGB of 5. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization for 1 day. No treatment was received. No autopsy was performed. Low oxygen saturation, hand swelling, lymphedema from L breast and swelling all over final outcome was unknown. Information on Lot/Batch number has been requested.; Reported Cause(s) of Death: she passed away on 19Feb as she had a HGB of 5; she had a HGB of 5
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 26-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/ non-health care professional.  This case involved a patient of unknown age who had a flu (influenza), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient who experienced a flu (influenza), (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This case was reported by a lawyer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intravenous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced Bell's palsy. The action taken with Shingrix was unknown. On an unknown date, the outcome of the Bell's palsy was unknown.   It was unknown if the reporter considered the Bell's palsy to be related to Shingrix.  Additional information:The patient had Shingrix and experienced Bell's palsy.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Subcutaneous injection; A spontaneous report was received on 23 Feb 2021 from a healthcare professional for a male patient of an unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and it was given incorrect via subcutaneous as oppose to intramuscular  The patient's medical history was not provided. No concomitant product use was reported.  On 22 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) subcutaneously for prophylaxis of COVID-19 infection. The patient's skin was pinched, and vaccine was injected subcutaneously as oppose to intramuscularly.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, incorrect subcutaneous vaccine shot as oppose to intramuscular, was considered resolved on 22 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had a positive Covid test; had a positive Covid test; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that that an 88-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration, on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to receiving BNT162B2. Medical history and concomitant medications were none. The consumer reported that her husband is due to have his second Pfizer vaccine on 10Feb2021, but he just had a positive Covid test on 06Feb2021. He tested positive after receiving the first dose of the vaccine. She asked if he still can get the second dose of the vaccine. The patient has kept in touch with his doctor while he has been recuperating. Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: he has experienced tingling sensation in his fingertips and his nails; weakness in his arms; This is a spontaneous report from a Contactable consumer. A male consumer (patient) of an unspecified age received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247 and Expiry date: Unknown), via an unspecified route of administration from 27Jan2021 as a SINGLE DOSE for covid-19 immunisation.  Medical history included covid-19 from Nov2020.  By 02Dec2020 he was fine and back to work.  The patient's concomitant medications were not reported.  The patient experienced tingling sensation in his fingertips and his nails on 28Jan2021 with outcome of unknown and, weakness in his arms on 28Jan2021 with outcome of unknown.  He says it takes extra effort to move his arms.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pain, Pyrexia
Clinical narrative: Nausea; dry heaving; Temp climbed to102/ Fever broke at 630 am; chills came on; body aches; This is a spontaneous report from a non-contactable consumer. This 59-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) , via an unspecified route of administration on unspecified date at 4:00PM at single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient reported that temperature started at 11:30, "temp climbed to102 and fever broke at 06:30AM with Tylenol" (onset date not reported) with outcome of recovered, then chills came on on an unspecified date with outcome of unknown. The patient also continued having body aches on an unspecified date with outcome of not recovered, dry heaving on an unspecified date with outcome of not recovered and nausea on an unspecified date with outcome of unknown. Her doctor prescribed Zofran because the nausea and dry heaving was awful. The patient stated she was "down in bed for 2 days and missed 2 days of work". Lab tests and procedures included body temperature of 102 (no units provided) on unknown date.  Therapeutic measures were taken as a result of "temp climbed to102/ fever broke at 6:30 AM, dry heaving and nausea.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: Nausea; dry heaving; Temp climbed to102/ Fever broke at 630 am; chills came on; body aches; This is a spontaneous report from a non-contactable consumer. This 59-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) , via an unspecified route of administration on unspecified date at 4:00PM at single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient reported that temperature started at 11:30, "temp climbed to102 and fever broke at 06:30AM with Tylenol" (onset date not reported) with outcome of recovered, then chills came on on an unspecified date with outcome of unknown. The patient also continued having body aches on an unspecified date with outcome of not recovered, dry heaving on an unspecified date with outcome of not recovered and nausea on an unspecified date with outcome of unknown. Her doctor prescribed Zofran because the nausea and dry heaving was awful. The patient stated she was "down in bed for 2 days and missed 2 days of work". Lab tests and procedures included body temperature of 102 (no units provided) on unknown date.  Therapeutic measures were taken as a result of "temp climbed to102/ fever broke at 6:30 AM, dry heaving and nausea.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness 2nd shot; This is a spontaneous report received from a contactable consumer (patient). An 84-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9243), via an unspecified route of administration on 02Feb2021 at the age of 84-year-old in Left Arm at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 84 years old on 12Jan2021 for Covid-19 immunization and the following morning on 13Jan2021, he experienced headache and loose stools/ had really loose stool and was squirting liquid/diarrhea. The patient experienced arm soreness on an unspecified date which the patient was admitted to hospital.  The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021050412 Same patient/drug, different dose
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Back injury, Body temperature decreased, Chills, Fall, Seizure
Clinical narrative: On September 1, 2020, I had a seizure that lasted about 20 minutes. Following the seizure, I had a temp of 95.8 and chills. I was not aware of falling, but when I woke up, I was on the floor, and it took some time before I could get up. I had hit my back on the corner of the wall, and had to wrap my ribs with elastic bandages while it got better.  I had what was probably Covid-19 in April, 2020. I have never had this type of reaction to a flu shot before, only some slight pain where the shot was injected.   When I had this "different flu" in April, I had hollowness around my eyes, severe headaches, chills, diarrhea, and some vomiting. I felt like I had to gasp for air, but I could breathe well enough to stay home. I had no elevation in my temperature. I haven't had a problem with temperature since I started taking my chemo therapy medication. I later decided I must have had Covid-19, and my immune system must have changed from the covid-19.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Dyspnoea, Pain
Clinical narrative: Temp of 102.5.   Aches Chills Short breath (spouse opinion)
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Pregnancy test
Clinical narrative: missed period with confirmed negative pregnancy tests x2. course has not ended as period has yet to return.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Nausea, Pain
Clinical narrative: I was slightly dizzy about 5 minutes after but then was fine. 10 days later I was fatigued, dizzy, nauseous and had the chills. Body ache and fatigue only lasted a few days but the dizzy and nausea remained on and off for next few weeks. Today it has been 38 days later and the dizzy has subsided over past week but I continue to experience nausea on and off and this is very worrisome. Due to this I have not had the second shot because I feel unwell. I saw my primary doctor and did not find anything wrong.  I also have not heard of anyone who has had this same experience so I am scared to have the other shot even though I know I need it.  I just need some answers.  Thanks for responding.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Sleep disorder
Clinical narrative: Persistent swollen lymph nodes in armpit region on both left and right sides. Swelling causes notable persistent pain and has interrupted normal sleep pattern.  No treatment sought.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Muscular weakness, Nausea
Clinical narrative: I lost muscle control while playing tennis for about 5 minutes.  After that I felt very tired, queezy, dizzy for about two days.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Nausea
Clinical narrative: Dizzy, slight confusion, nausea (history of vasovagal). BP 144/92 (pulse 97), O2 sat 100%.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Muscular weakness
Clinical narrative: Sudden loss of strength in left hand/arm involving wrist extention and radial deviation and grip strength. Normal range of motion is still present but stregth is significantly diminished and has reurtned only minimally.  Right arm is normal.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Pain in extremity
Clinical narrative: Arm soreness lasting 3 days, starting 12 hours after inejection. First day was the worst.   Headache, nausea and diarrhea starting 72 hours after infection and lasting 24 hours.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain
Clinical narrative: I became lightheaded/dizzy within the first few minutes.  Symptom subsided but came back in a mild way.  When I came home and after Seventeen (17) hours, I am still lightheaded, I have body aches and chills.  I have no fever.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 12 days post vaccine my left arm became swollen and red around the injection site (about two inches around).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysmenorrhoea, Presyncope
Clinical narrative: Dizzy, near syncopal. BP 108/71 (pulse 110), O2 sat 99%. First day of menstrual cycle with painful cramps.