chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Vaccination complication
Clinical narrative: Bilateral pneumonia; strong reaction; A spontaneous report was received from a consumer concerning a female patient of unknown age , who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced bilateral pneumonia and "strong Reaction".  The patient's medical history was not provided by the reporter. Concomitant product use was not provided.   On unspecified date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route and site for prophylaxis of COVID-19 infection.   On an unspecified date the patient experienced bilateral pneumonia and a "strong reaction". No treatment medication was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The events bilateral pneumonia and strong reaction were considered not resolved during 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Bloody diarrhea; A spontaneous report was received from a consumer concerning a 79-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bloody diarrhea/diarrhoea haemorrhagic.   The patient's medical history was not reported. Concomitant product use was not provided by the reporter.  On 01 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 030L20A) via unknown route in right arm for COVID-19 infection prophylaxis.  On 02 Mar 2021, prior to the onset of event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 031M20A) via unknown route for prophylaxis of COVID-19 infection.  On 05 Mar 2021, the patient experienced bloody diarrhea. The event was considered as medically significant. No treatment information was 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 event, bloody diarrhea was resolved on 06 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Stroke; Blood clots in his brain; Limited motion on the left side of the face and arm; Turned my life upside down; A spontaneous report was received from a consumer concerning a 73 -year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported events blood clots in brain/ cerebral thrombosis, stroke/ cerebrovascular accident, turned life upside down/loss of personal independence in daily activities and limited motion on the left side of the face and arm/mobility decreased.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received the first of the two planned doses of mRNA-1273 (lot/batch number: 041L2A) on 08 Jan 2021. On 05 Feb 2021, prior to the onset of the events, the patient received their second of the two planned doses of mRNA-1273(lot/batch: 01020A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 26 Feb 2021, the patient experienced blood clots in brain, stroke and he patient woke up in the morning with limited motion on the left side and was subsequently hospitalized for two days. The patient's life upside down. Treatment information included blood thinners, small dose of acetyl salicylic acid, rosuvastatin, CoQ and Vitamin D3.  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 blood clots in brain, stroke, turned life upside down and limited motion on the left side of the face was not reported.; Reporter's Comments: This case concerns a 73 -year-old, male patient, who reported  cerebral thrombosis, stroke, loss of personal independence, and mobility decreased. Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: Angina happened in jaw and chest; A spontaneous was received from a consumer, concerning herself, a 75 years old female patient who received Moderna's COVID-19 vaccine and experienced angina/angina pectoris.   The patient's medical history included open heart surgery for cardiovascular problems. Concomitant medications prn nitro sublingual.     On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273. On 25-MAR-2021, the patient received their second of two planned doses of mRNA-1273 (Batch no: 006B21A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 25 Mar 2021, 20 minutes after the second dose of vaccine, while driving patient experienced chest and jaw pain, self treated with nitro under the tongue and it went away after 15 min and was able to continue driving. The angina made her tired, restless and was afraid that she might have another one.  Action taken with mRNA-1273 in response to event was not applicable.  The outcome of the event angina was considered resolved.; Reporter's Comments: Based on reporter's complaints and history of heart surgery with recurrent angina the event is assessed as unlikely related to mRNA-1273. Further information has been requested.; Sender's Comments:  MOD-2021-057914:Case for first dose
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Finger deformity, Hyperhidrosis, Musculoskeletal discomfort, Musculoskeletal stiffness
Clinical narrative: shoulder pain; could not turn his neck for about 3 weeks; Fingers are really bad; fingers bent down at night and he had to pull them and straighten them up; Could not walk because his toes and fingers hurt; All his blood work for the rheumatoid markers were elevated; Severe neck pain; it aggravated his Rheumatoid Arthritis; sweats; low grade fever; A spontaneous  report was received from a consumer concerning a- 53 Years old, Male patient who experienced aggravated Rheumatoid Arthritis.   The patient's medical history included that he has had Rheumatoid Arthritis for a couple of years Products known to have been used by the patient, within two weeks prior to the event, included Prednisone and Leflunomide   On 15 Jan 202, the patient received their first of two planned doses of mRNA-1273 (Batch number: [0126ZOA])  On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: [013L20A]) for prophylaxis of COVID-19 infection.   On 12 FEB 2021, the patient experienced low grade fever and sweats. On an unknown date, the patient experienced flare up of his Rheumatoid Arthritis with shoulder pain, severe neck pain and was unable to turn his neck for about 3 weeks, fingers were really bad, bent down at night and he had to pull to straighten them up and was not walk because his toes and fingers were hurting. Blood work for the rheumatoid markers were elevated. Treatment included prednisone and leflunomide.  Action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, low grade fever, sweats were Recovered/Resolved. The outcome of the other events were were not known.; 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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Peripheral swelling, Pyrexia, Rheumatoid arthritis
Clinical narrative: shoulder pain; could not turn his neck for about 3 weeks; Fingers are really bad; fingers bent down at night and he had to pull them and straighten them up; Could not walk because his toes and fingers hurt; All his blood work for the rheumatoid markers were elevated; Severe neck pain; it aggravated his Rheumatoid Arthritis; sweats; low grade fever; A spontaneous  report was received from a consumer concerning a- 53 Years old, Male patient who experienced aggravated Rheumatoid Arthritis.   The patient's medical history included that he has had Rheumatoid Arthritis for a couple of years Products known to have been used by the patient, within two weeks prior to the event, included Prednisone and Leflunomide   On 15 Jan 202, the patient received their first of two planned doses of mRNA-1273 (Batch number: [0126ZOA])  On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: [013L20A]) for prophylaxis of COVID-19 infection.   On 12 FEB 2021, the patient experienced low grade fever and sweats. On an unknown date, the patient experienced flare up of his Rheumatoid Arthritis with shoulder pain, severe neck pain and was unable to turn his neck for about 3 weeks, fingers were really bad, bent down at night and he had to pull to straighten them up and was not walk because his toes and fingers were hurting. Blood work for the rheumatoid markers were elevated. Treatment included prednisone and leflunomide.  Action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, low grade fever, sweats were Recovered/Resolved. The outcome of the other events were were not known.; 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test positive
Clinical narrative: Covid-19 Pneumonia; Covid-19 Positive; A spontaneous report was received from a consumer concerning an 80-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and diagnosed covid-19 positive and covid-19 pneumonia.  The patient's medical history not reported. Concomitant medications was not reported.  On 03 Mar 2021 prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 002A21A) for prophylaxis of COVID-19 infection   On 15 Mar 2021, patient diagnosed with COVID-19 positive and COVID-19 pneumonia (medically significant), he was hospitalized for both events.  Treatment information was not provided for the treatment for covid-19 pneumonia infection.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events were unknown.; Reporter's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of Covid-19 test positive and Covid-19 Pneumonia after vaccination, these events are assessed as unlikely related to mRNA-1273.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; A spontaneous report was received from a consumer, concerning herself, a 62-years-old, male patient, who received Moderna's COVID-19 vaccine and experienced event Bell's palsy.   The patient's medical history included Hypertension. Products known to have been used by the patient, within two weeks prior to the event, included Amlodipine, Valsartan 5mg /320mg indicated for Blood Pressure, megarad to lower cholesterol.  On 2 Mar 2021, approximately 2-3 weeks prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) via unknown route in left arm for COVID-19 infection prophylaxis.   On 17 Mar 2021, The patient experienced Bell's Palsy. The patient felt sore in mouth. on 18 Mar 2021, it was full paralysis of mouth and the drooping face. Eventual diagnosis made was Bell's Palsy.   Treatment information included 80 mg of prednisone once a day for about 7 days and valacyclovir hcl 1gm tablet - TID for 7 days  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event Bell's palsy 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cardiac flutter, Dizziness, Hyperhidrosis, Ventricular extrasystoles
Clinical narrative: heart fluttering, a really bad one; premature ventricular contractions; all sweat; dizziness; weakness; A spontaneous report, was received from a consumer, concerning himself, a 59 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial flutter and PVCs.  The patient's medical history included bladder surgery. concomitant medications was not included by the reporter.  On 24 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 003B21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 24 MAR 2021, 10 hours after first dose, the patient experienced sweats, dizziness, fluttering heart/increased heart rate  and was seen at the ER  and  then transferred to ICU, she was told that she had 360 bpm atrial heart rate and PVCs.  The patient stated that two years ago he was under anesthesia for bladder surgery and had something similar where the patient had rapid atrial heart beat which wasn't this long and the doctor stated that it was related to the anesthesia .  The action taken with mRNA-1273 was not reported.   The outcome of the events was considered as 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; A spontaneous report was received from a health care professional concerning a 45-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction.   The patient's medical history was not provided. Concomitant medications reported included levothyroxine sodium for unknown indication.  On 14 Jan 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A)  in the right  arm for prophylaxis of COVID-19 infection.   On 14 Jan 2021, prior to receiving mRNA-1273, the patient felt anaphylactic reaction and was medically significant. Patient received treatment in Hospital ER and got discharged after 10 hours of observation.  Treatment for the events included  intravenous steroid, Pepcid ,Oxygen and Benadryl.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event anaphylactic reaction 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Not being able to breathe; Could not smell; Positive covid test; A spontaneous report  was received from a consumer concerning a 60 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and could not smell, positive COVID test, and not being able to breathe.   The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient included blood thinner.  On 4 Mar 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 002a21a) through intramuscular route at unspecified site for prophylaxis of COVID-19 infection.  On 6 Mar 2021, the patient was tested positive for COVID and could not smell. On 9 Mar 2021, the patient was hospitalized because of her not being able to breathe. On 15 Mar 2021, patient was released from the hospital.   Treatment activities for event was done with regeneron, dexamethasone, remdesivir.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event could not smell, positive COVID test, not being able to breathe was unknown.; Reporter's Comments: COVID-19 In this patient is unlikely to be due to Moderna's mRNA-1273 vaccine. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Epstein-Barr virus infection reactivation
Clinical narrative: Possible reactivateds Epstein-Barr virus ill, not feeling great, described as malaise/low-grade fever and feeling off; A spontaneous report  was received from a consumer concerning a 51- year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed possible reactivated Epstein-Barr virus, Ill, described a low-grade fever and feeling off (pyrexia) and is ill, not feeling great, described as malaise (malaise).  The patient's medical history mentioned history Epstein-Barr virus. Concomitant medications were not provided.  On 27 Feb 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch number: 003A21A) in the left arm for the prophylaxis of COVID-19 infection.  Patient was ill stating that she started not feeling great, described as malaise, and feeling off and feeling a little feverish on 14 Mar 2021. A low-grade fever did not start until 16 Mar 2021. The symptoms were ongoing. She had already spoken with her primary care provider who did some tests, and it is possible that it could be reactivated Epstein-Barr virus.  The event, possible reactivated Epstein-Barr virus, was deemed as a medically significant event.   Treatment information not provided. Lab tests mention tests NOS done by HCP that could imply reactivated Epstein-Barr virus.  Action taken with respect to mRNA-1273 was not reported.  The outcome of the events, developed possible reactivated Epstein-Barr virus, Ill, described a low-grade fever and feeling off and is ill, not feeling great, described as malaise 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 of Reactivated Epstein Barr Virus Infection, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Myalgia
Clinical narrative: Pneumonia viral; Vomiting mucus; Cough; Vomiting; Chills; Body aches; High fever of 101°F; Fatigue; A spontaneous report was received from a consumer concerning a 64 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, body aches, high fever, fatigue, cough, vomiting mucus, vomiting, and pneumonia.  The patient's medical history was not provided. The patient had allergic to ciprofloxacin, shellfish, soy, and levofloxacin. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: Batch number not provided) on 18 Feb 2021, prior to the onset of the symptoms via an unknown route in the left arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021 evening patient experienced chills, body aches, & a high fever of 101°F and fatigue. On 19 Feb 2021 patient had a cough, vomiting and was vomiting mucus. On 20 Feb 2021 patient took a Covid-19 test, which was negative.  On 21 Feb 2021 patient was treated with azithromycin. On 21 Feb 2021, patient was diagnosed with viral pneumonia.  On 24 Feb 2021 chest X-Ray was performed.  Action taken with the drug in response to the events were not reported.  The outcome of the events chills, body aches, high fever, fatigue, cough, vomiting mucus, vomiting, and pneumonia were unknown.; Reporter's Comments: This case concerns a 64 Y/O F with a serious unexpected event of pneumonia viral, and nonserious unexpected secretion discharge, cough, and expected vomiting, pyrexia, chills, fatigue, myalgia.  Event onset the same day as first dose mRNA-1273. Treated with azithromycin. Event outcomes unknown. Based on 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia viral, Pyrexia, Secretion discharge, Vomiting
Clinical narrative: Pneumonia viral; Vomiting mucus; Cough; Vomiting; Chills; Body aches; High fever of 101°F; Fatigue; A spontaneous report was received from a consumer concerning a 64 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, body aches, high fever, fatigue, cough, vomiting mucus, vomiting, and pneumonia.  The patient's medical history was not provided. The patient had allergic to ciprofloxacin, shellfish, soy, and levofloxacin. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: Batch number not provided) on 18 Feb 2021, prior to the onset of the symptoms via an unknown route in the left arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021 evening patient experienced chills, body aches, & a high fever of 101°F and fatigue. On 19 Feb 2021 patient had a cough, vomiting and was vomiting mucus. On 20 Feb 2021 patient took a Covid-19 test, which was negative.  On 21 Feb 2021 patient was treated with azithromycin. On 21 Feb 2021, patient was diagnosed with viral pneumonia.  On 24 Feb 2021 chest X-Ray was performed.  Action taken with the drug in response to the events were not reported.  The outcome of the events chills, body aches, high fever, fatigue, cough, vomiting mucus, vomiting, and pneumonia were unknown.; Reporter's Comments: This case concerns a 64 Y/O F with a serious unexpected event of pneumonia viral, and nonserious unexpected secretion discharge, cough, and expected vomiting, pyrexia, chills, fatigue, myalgia.  Event onset the same day as first dose mRNA-1273. Treated with azithromycin. Event outcomes unknown. Based on 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Dizziness
Clinical narrative: She lost hearing in her right ear; Dizzy; A spontaneous report was received from a consumer concerning a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lost hearing in her right ear, dizziness.   The patient's medical history was not provided. Concomitant product use was unknown by the reporter.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route and site for prophylaxis of COVID-19 infection.   On an unspecified date, the patient received their second dose of mRNA-1273 (Lot number: unknown) via unknown route and site for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced lost hearing in her right ear, dizziness.   Treatment for the events included prednisolone.  Action taken with mRNA-1273 in response to the events is not applicable.   The outcome of events, lost hearing in her right ear, dizziness were unknown.; Reporter's Comments: Very limited information regarding the events have been provided at this time.  Patient's medical history, therapy dates, onset dates of events, clinical evaluation are lacking  Further information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Herpes zoster, Immunoglobulin therapy
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number was not reported), via an unspecified route of administration in 2007 as a single dose for immunization. Medical history included cancer survivor and ongoing immunocompromised. The patient's concomitant medications were not reported. The patient experienced shingles in 2007. She took the Prevnar 13 in 2007 and had a really bad reaction that put her in the hospital for 7 days. She had shingles, was in isolation for 4 days. She stated she reported about this. Her doctors didn't think its due to the Prevnar 13 vaccine, but she stated she knew its due to the vaccine as that was the only medication she took per her doctors suggestion. She was started on IVIG after the Prevnar 13. She is cancer survivor, taking IVIG infusion and she is immunocompromised. The outcome of event was unknown.   Information on the batch/lot number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Lumbar puncture, Magnetic resonance imaging, Pain assessment
Clinical narrative: headache; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL8982, via an unspecified route of administration, administered in left arm on 10Feb2021 as single dose for COVID-19 immunisation. Medical history included COVID-19 from Oct2020 (tested positive for Covid). Concomitant medications were not reported. The patient is not pregnant. On 16Feb2021, the patient started to develop a headache. This headache increased substantially to a 10 out of 10 on a pain scale. On Sunday, 21Feb2021, the patient went into the ER. Again, on 26Feb2021 after consult with neurologist. Current headache has started to subside, the patient received second dose on 04Mar2021. Relevant lab test and procedures were done on an unspecified date which included computerised tomogram (CT), magnetic resonance imaging (MRI) and spinal tap; all unknown results. The patient has tested negative for COVID-19 test on 26Feb2021. The patient received unspecified pain meds and blood pressure medication as treatment. The outcome of the event was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: headache; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL8982, via an unspecified route of administration, administered in left arm on 10Feb2021 as single dose for COVID-19 immunisation. Medical history included COVID-19 from Oct2020 (tested positive for Covid). Concomitant medications were not reported. The patient is not pregnant. On 16Feb2021, the patient started to develop a headache. This headache increased substantially to a 10 out of 10 on a pain scale. On Sunday, 21Feb2021, the patient went into the ER. Again, on 26Feb2021 after consult with neurologist. Current headache has started to subside, the patient received second dose on 04Mar2021. Relevant lab test and procedures were done on an unspecified date which included computerised tomogram (CT), magnetic resonance imaging (MRI) and spinal tap; all unknown results. The patient has tested negative for COVID-19 test on 26Feb2021. The patient received unspecified pain meds and blood pressure medication as treatment. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: had a severe reaction, had to call a code and her heart stopped; This is a spontaneous report from a contactable consumer (Patient) via a Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot number: Not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included shock her heart 5 times, Had reactions to IVP with contrast that has Iodine, allergic to sulfa antibiotics, acute renal failure, partial bowel blockage, renal insufficiency scared her right (ACE inhibitor and simvastatin works well and gives her lungs more protection), asthma and allergies. Concomitant medication were not reported. The patient previously took epinephrine and had reactions, bactrim and was allergic, flu shot and got sick in 2016. She can't have the contrast test. Had a severe reaction, had to call a code and her heart stopped on an unspecified date. Was put on IV and gave epinephrine and shock her heart 5 times. Called CDC and ask if there's any contraindication on getting the vaccine. Got a shot in 2016 and found out was getting sick from flu shot. Can't get flu shots anymore may be because egg content. Also had the Shingles vaccine had mild reactions to it took Benadryl and steroids and the follow up dose had to be pretreated because shingles break out. Reaction might be from the binders. Also took Versed and made her quit breathing and cannot get it. The outcome of the event was unknown.  Information on Lot/Batch has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Monoparesis, Pain, Pain in extremity, Sjogren's syndrome
Clinical narrative: right arm was paralyzed; Caller experienced pain in her Rt arm on Friday, 12March2021 (injection was in Lt arm); Caller also noticed  pain in her breast/stinging pain in breast; aggrevated joint pain; She reports a diagnosis of Sjogren's; This is a spontaneous report from a contactable consumer (patient) via medical information team. An 83-year-old female patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206, Expiration date was not reported), via an unspecified route of administration in left arm on 11Mar2021 02:00 as single dose for covid-19 immunisation. Medical history included blood pressure high. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was none and additional vaccines administered on same date of the Pfizer Suspect reported as none. Patient received the Covid-19 vaccine. Patient had a really bad reaction to it and has to have an ultrasound. Patient has been having problems with joint pain. Patient has Sjogren's Disease on Mar2021. patient had the vaccine last Thursday. Patient woke at 2:00 in the morning and her right arm was paralyzed on 12Mar2021. Patient took Motrin for that. On Friday patient felt a stinging pain in her right breast and pain in her Rt arm (injection was in Lt arm) on 12Mar2021. patient felt better after taking Motrin. Her doctor advised her to have an ultrasound. She typically has joint pain. After having the vaccine it was aggravated on 12Mar2021. patient was unsure if patient should have the second dose. patient saw her doctor on Monday. She will need to have an ultrasound of her right breast. She takes two blood pressure medications and other medications. Therapeutic measures were taken as a result of right arm was paralyzed (monoparesis). The outcome of the event breast pain was recovered on 12Mar2021, right arm paresis was recovered on Mar2021 and unknown for other events.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Dizziness, Drug hypersensitivity, Fatigue, Somnolence
Clinical narrative: His nape and upper back area felt sunburnt and tender.; felt dizzy and almost fainted; felt dizzy and almost fainted; severe allergic reaction; broke out in cold sweat; fatigued; slept 60% of the time; His nape and upper back area felt sunburnt and tender.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Not reported) via an unspecified route of administration on 15Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Mar2021, 10 minutes after the vaccination the patient broke out in cold sweat, he felt dizzy and almost fainted, experienced severe allergic reaction. He was given Benadryl by his vaccination provider and made him stay for another 20 minutes. He felt better after that and drove home and slept for 4 hours. After 54 hours after getting the shot that was on Mar2021, he was fatigued and he slept 60% of the time. His nape and upper back area felt sunburnt and tender on an unknown date in Mar2021. The patient received Benadryl as a treatment to felt dizzy and almost fainted, severe allergic reaction, broke out in cold sweat. He wanted to know if his adverse reactions are expected of the vaccine and if his immediate adverse event would warrant him not getting the second dose of the vaccine due to severe allergic reaction. The outcome of the event felt dizzy and almost fainted, severe allergic reaction, broke out in cold sweat was recovering while for other events was unknown.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sunburn, Syncope, Tenderness
Clinical narrative: His nape and upper back area felt sunburnt and tender.; felt dizzy and almost fainted; felt dizzy and almost fainted; severe allergic reaction; broke out in cold sweat; fatigued; slept 60% of the time; His nape and upper back area felt sunburnt and tender.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Not reported) via an unspecified route of administration on 15Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Mar2021, 10 minutes after the vaccination the patient broke out in cold sweat, he felt dizzy and almost fainted, experienced severe allergic reaction. He was given Benadryl by his vaccination provider and made him stay for another 20 minutes. He felt better after that and drove home and slept for 4 hours. After 54 hours after getting the shot that was on Mar2021, he was fatigued and he slept 60% of the time. His nape and upper back area felt sunburnt and tender on an unknown date in Mar2021. The patient received Benadryl as a treatment to felt dizzy and almost fainted, severe allergic reaction, broke out in cold sweat. He wanted to know if his adverse reactions are expected of the vaccine and if his immediate adverse event would warrant him not getting the second dose of the vaccine due to severe allergic reaction. The outcome of the event felt dizzy and almost fainted, severe allergic reaction, broke out in cold sweat was recovering while for other events was unknown.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Neuralgia, Pain in extremity
Clinical narrative: His nape and upper back area felt sunburnt and tender.; felt dizzy and almost fainted; felt dizzy and almost fainted; severe allergic reaction; broke out in cold sweat; fatigued; slept 60% of the time; His nape and upper back area felt sunburnt and tender.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Not reported) via an unspecified route of administration on 15Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Mar2021, 10 minutes after the vaccination the patient broke out in cold sweat, he felt dizzy and almost fainted, experienced severe allergic reaction. He was given Benadryl by his vaccination provider and made him stay for another 20 minutes. He felt better after that and drove home and slept for 4 hours. After 54 hours after getting the shot that was on Mar2021, he was fatigued and he slept 60% of the time. His nape and upper back area felt sunburnt and tender on an unknown date in Mar2021. The patient received Benadryl as a treatment to felt dizzy and almost fainted, severe allergic reaction, broke out in cold sweat. He wanted to know if his adverse reactions are expected of the vaccine and if his immediate adverse event would warrant him not getting the second dose of the vaccine due to severe allergic reaction. The outcome of the event felt dizzy and almost fainted, severe allergic reaction, broke out in cold sweat was recovering while for other events was unknown.  Information on Lot/Batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood creatinine increased, Hypophagia, Lymphopenia, Pancytopenia
Clinical narrative: rise in Cr; Developed decreased PO intake; mild acute kidney injury; pancytopenia; lymphopenia; thrombocytopenia; This is a spontaneous report from a contactable Physician. A 78-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 10Mar2021, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient had unspecified concomitant medications. The patient had the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for Covid-19 Immunisation. On 13Mar2021, the patient developed decreased PO intake, then mild acute kidney injury with rise in Cr and pancytopenia/lymphopenia/thrombocy topenia. The events caused hospitalization. Treatment for the events were IV fluids, Hematology consult. The outcome of the events was recovered. The patient had negative covid swab test on 12Mar2021.; Sender's Comments: Based on the narrative information provided, a causal association between the reported events and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thrombocytopenia
Clinical narrative: rise in Cr; Developed decreased PO intake; mild acute kidney injury; pancytopenia; lymphopenia; thrombocytopenia; This is a spontaneous report from a contactable Physician. A 78-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 10Mar2021, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient had unspecified concomitant medications. The patient had the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for Covid-19 Immunisation. On 13Mar2021, the patient developed decreased PO intake, then mild acute kidney injury with rise in Cr and pancytopenia/lymphopenia/thrombocy topenia. The events caused hospitalization. Treatment for the events were IV fluids, Hematology consult. The outcome of the events was recovered. The patient had negative covid swab test on 12Mar2021.; Sender's Comments: Based on the narrative information provided, a causal association between the reported events and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Head injury, Influenza like illness
Clinical narrative: passed out; Unfortunately hit my head.; felt light headed; slightly nauseous; intense right knee pain; temperature of 99.6; flu-like symptoms; This is a spontaneous report from a contactable Other Health Professional (patient). A 63-year-old non-pregnant female patient received bnt162b2 (Pfizer Brand COVID 19), dose 2 intramuscular, administered in left arm on 26Feb2021 12:00 (Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient was not diagnosed of Covid prior vaccination and has not been tested for Covid post vaccination. The patient has no known allergies. Concomitant medication included levothyroxine, liothyronine (NP THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Pfizer Brand COVID 19), dose 1 intramuscular, administered in left arm on 05Feb2021 11:30 AM, (Lot Number: EM9810) for COVID-19 immunisation. There was no other vaccine in four weeks. On 27Feb2021 07:45, the patient passed out, unfortunately hit head, felt light headed and slightly nauseous. It was also reported that patient had intense right knee pain, a temperature of 99.6 and flu-like symptoms. The events were also described as follows: 18hrs after the injection, I had intense right knee pain that lasted for 24hrs. Also in that same time period, I felt a huge rush of energy come over me and passed out. Unfortunately hit my head. I had a temperature of 99.6 and flu-like symptoms that lasted 24hrs. For 4 days I felt light headed and slightly nauseous but that could have been due to hitting my head. Called 911, EMT evaluation and the patient received treatment for events. Outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events and other events.  There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Pyrexia
Clinical narrative: passed out; Unfortunately hit my head.; felt light headed; slightly nauseous; intense right knee pain; temperature of 99.6; flu-like symptoms; This is a spontaneous report from a contactable Other Health Professional (patient). A 63-year-old non-pregnant female patient received bnt162b2 (Pfizer Brand COVID 19), dose 2 intramuscular, administered in left arm on 26Feb2021 12:00 (Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient was not diagnosed of Covid prior vaccination and has not been tested for Covid post vaccination. The patient has no known allergies. Concomitant medication included levothyroxine, liothyronine (NP THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Pfizer Brand COVID 19), dose 1 intramuscular, administered in left arm on 05Feb2021 11:30 AM, (Lot Number: EM9810) for COVID-19 immunisation. There was no other vaccine in four weeks. On 27Feb2021 07:45, the patient passed out, unfortunately hit head, felt light headed and slightly nauseous. It was also reported that patient had intense right knee pain, a temperature of 99.6 and flu-like symptoms. The events were also described as follows: 18hrs after the injection, I had intense right knee pain that lasted for 24hrs. Also in that same time period, I felt a huge rush of energy come over me and passed out. Unfortunately hit my head. I had a temperature of 99.6 and flu-like symptoms that lasted 24hrs. For 4 days I felt light headed and slightly nauseous but that could have been due to hitting my head. Called 911, EMT evaluation and the patient received treatment for events. Outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events and other events.  There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, as appropriate.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Hypokinesia, Malaise, Pain, Vomiting
Clinical narrative: Coughed to the point of throwing up; encrediably sore; could barely move; sick; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via socian media.  This case involves patient (unknown demographics) who experienced sick (illness), coughed to the point of throwing up (cough), encrediably sore (pain) and could barely move (hypokinesia), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (within 2 hours) following the administration of INFLUENZA VACCINE.  On an unknown date, the patient developed a non-serious coughed to the point of throwing up (cough), encrediably sore (pain) and could barely move (hypokinesia), (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that last one patient had made me sick within 2 hours. To the point patient was considering going to the emergency room. Sick for 3 days. Coughed to the point of throwing up and was so encrediably sore pateint could barely move. Even my doctor told me patient should not get them.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Malaise
Clinical narrative: Patient was tired and not feeling very well; Patient was tired and not feeling very well; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a male patient who was tired (fatigue) and not feeling very well (malaise), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was tired (fatigue) and not feeling very well (malaise), (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that he did, will see how he does. So far, not so good.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.