chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: felt sick; Sore arm; This case was reported by a consumer and described the occurrence of feeling unwell in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine and shingles.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced feeling unwell and pain in arm. On an unknown date, the outcome of the feeling unwell and pain in arm were recovered/resolved.   It was unknown if the reporter considered the feeling unwell and pain in arm to be related to Shingrix.   Additional details were provided as follows: A patient received 1st dose of Shingrix about 6 months ago from the date of reporting, and experienced a sore arm and felt sick for a few days, and symptoms were resolved. The reporter did not consent to follow-up. For tolerance in 2nd dose refer case US2021AMR063718.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063718:same patient, same reporter
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash /after first Shingrix shot; This case was reported by a consumer via call center representative and described the occurrence of rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included penicillin allergy (no milk allergy was reported).   On 16th March 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In March 2019, 2 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The patient reported rash on chest few days after first dose of Shingrix which was administered a few years ago from reporting day.  The patient did not get rash with second dose of Shingrix. The reporter consented to follow up. Discrepancy: the event onset date and outcome date were reported as 16th March 2019 which was same as vaccination date however TTO was captured as 2 days as per both source document field and narrative information.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: They got very sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, after receiving second dose they got very sick. The detail of how they got sick was not reported not provide name, demographic information or any other information regarding the incident because it happened long time ago.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063860:Same country, Same product
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Headache, Paraesthesia oral, Sensation of foreign body
Clinical narrative: tingling in her mouth and lips; lump in throat; dizziness; tunnel vision; shaking; headache; anaphylaxis; A spontaneous report was received from a physician concerning a 26-year-old female patient who received Moderna (mRNA-1273) vaccine and experienced Anaphylactic reaction, having tingling in patient's mouth and lips and a lump in their throat, very bad headache, dizziness, tunnel vision and shakiness.  The patient's medical history included: allergy to azithromycin and penicillin. Concomitant product use was not provided by the reporter.    On 19 Feb 2021, approximately four minutes prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 031L20A) for prophylaxis of COVID-19 infection.    On 19 Feb 2021 at 14.09, the patient had tingling in their mouth and lips and a lump in their throat. The patient's heart rate noted was 130s. The patient also reported very bad headache dizziness and tunnel vision. The patient developed shakiness which was noted on exam. The reporter reported for an anaphylaxis reaction .  The patient's Blood pressure reported was 156/80. At 14.29, the patient's Blood pressure reported was 176/87.  Treatment information provided included EpiPen (0.3mg) given Intramuscularly to right thigh at 14.22 and supplemental O2 provided. The reporter stated ambulance was called, husband of the patient was called. Reports were given to ambulance services. The systolic BP upon transport was 168.  Action taken with mRNA-1273 in response to the event(s) was Not applicable.  On 19 Feb 2021, the outcome of the events, having tingling in patient's mouth and lips and a lump in their throat, very bad headache, dizziness and tunnel vision were considered resolved and the outcome of the event, shakiness was considered not resolved.  On an unknown date, the outcome of the event, Anaphylactic reaction was considered 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 se events, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Tunnel vision
Clinical narrative: tingling in her mouth and lips; lump in throat; dizziness; tunnel vision; shaking; headache; anaphylaxis; A spontaneous report was received from a physician concerning a 26-year-old female patient who received Moderna (mRNA-1273) vaccine and experienced Anaphylactic reaction, having tingling in patient's mouth and lips and a lump in their throat, very bad headache, dizziness, tunnel vision and shakiness.  The patient's medical history included: allergy to azithromycin and penicillin. Concomitant product use was not provided by the reporter.    On 19 Feb 2021, approximately four minutes prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 031L20A) for prophylaxis of COVID-19 infection.    On 19 Feb 2021 at 14.09, the patient had tingling in their mouth and lips and a lump in their throat. The patient's heart rate noted was 130s. The patient also reported very bad headache dizziness and tunnel vision. The patient developed shakiness which was noted on exam. The reporter reported for an anaphylaxis reaction .  The patient's Blood pressure reported was 156/80. At 14.29, the patient's Blood pressure reported was 176/87.  Treatment information provided included EpiPen (0.3mg) given Intramuscularly to right thigh at 14.22 and supplemental O2 provided. The reporter stated ambulance was called, husband of the patient was called. Reports were given to ambulance services. The systolic BP upon transport was 168.  Action taken with mRNA-1273 in response to the event(s) was Not applicable.  On 19 Feb 2021, the outcome of the events, having tingling in patient's mouth and lips and a lump in their throat, very bad headache, dizziness and tunnel vision were considered resolved and the outcome of the event, shakiness was considered not resolved.  On an unknown date, the outcome of the event, Anaphylactic reaction was considered 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 se events, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Aphasia, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: Unable to speak; A spontaneous report was received from a nurse concerning an eighty-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the event unable to speak (aphasia).  The patient's ongoing medical conditions included congestive heart failure (CHF), hypertension, hyperlipidemia, diverticulitis, asthma, osteoarthritis, allergy to prednisone and allergy to tape.   Relevant concomitant medications included acetaminophen, amlodipine, cetirizine, colace with senna, fish oil, furosemide, gabapentin, glucosamine, meloxicam, hydrocodone/acetaminophen, metaxalone, montelukast, multivitamin, occuvite, omeprazole, sertraline and trazodone.  On 06-Feb-2021, approximately two days prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Batch# 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07-Feb-2021, the patient stated they were fine.  On 08-Feb-2021, the patient was found by their daughter in the evening unable to speak.  The patient was brought to the ED (emergency department) where they were later admitted for one day. The patient underwent a CT(computerized tomogram) scan on 08-FEB-2021 which showed no evidence of bleed  On 09-FEB-2021, the patient had an MRA (magnetic resonance angiogram) done which showed no aneurysm, dissection or stenosis. An MRI done on 09-Feb-2021 showed multiple areas of acute ischemia in a left MCA distribution and no hemorrhagic transformation.  Lab work performed yielded no significant findings. The reported stated the patient may be transferred to a higher level of care.  No further treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event, unable to speak, was not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage, Dizziness, Headache, Insomnia, Nausea
Clinical narrative: loopy; difficult sleeping; achy feeling in both legs and buttocks; ruptured blood vessel in left eye; arm inflamed; arm hot; Arm red; arm itchy; mild headache; queasy GI symptoms; achy pain at injection site; A spontaneous report was received from a consumer concerning a 72-years-old  elder female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events achy pain at injection site, mild headache, queasy gi symptoms, arm itchy, arm inflamed, arm red, arm hot, achy feeling in both legs and buttocks, loopy, difficult sleeping, ruptured blood vessel in left eye.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the event(s) achy pain at injection site,On 19 Feb 2021, the patient experienced the event(s) mild headache, queasy gi symptoms. On 28 Feb 2021, the patient experienced the event(s) arm itchy, arm inflamed, arm red, arm hot. On an unknown date, the patient experienced the event(s) achy feeling in both legs and buttocks, loopy, difficult sleeping. On 3 Mar 2021, the patient experienced the events ruptured blood vessel in left eye which was considered as seriousness criteria.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event(s), achy pain at injection site, mild headache, queasy gi symptoms, arm itchy, arm inflamed, arm red, arm hot, achy feeling in both legs and buttocks, loopy, difficult sleeping, ruptured blood vessel in left eye 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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: loopy; difficult sleeping; achy feeling in both legs and buttocks; ruptured blood vessel in left eye; arm inflamed; arm hot; Arm red; arm itchy; mild headache; queasy GI symptoms; achy pain at injection site; A spontaneous report was received from a consumer concerning a 72-years-old  elder female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events achy pain at injection site, mild headache, queasy gi symptoms, arm itchy, arm inflamed, arm red, arm hot, achy feeling in both legs and buttocks, loopy, difficult sleeping, ruptured blood vessel in left eye.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the event(s) achy pain at injection site,On 19 Feb 2021, the patient experienced the event(s) mild headache, queasy gi symptoms. On 28 Feb 2021, the patient experienced the event(s) arm itchy, arm inflamed, arm red, arm hot. On an unknown date, the patient experienced the event(s) achy feeling in both legs and buttocks, loopy, difficult sleeping. On 3 Mar 2021, the patient experienced the events ruptured blood vessel in left eye which was considered as seriousness criteria.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event(s), achy pain at injection site, mild headache, queasy gi symptoms, arm itchy, arm inflamed, arm red, arm hot, achy feeling in both legs and buttocks, loopy, difficult sleeping, ruptured blood vessel in left eye 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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: loopy; difficult sleeping; achy feeling in both legs and buttocks; ruptured blood vessel in left eye; arm inflamed; arm hot; Arm red; arm itchy; mild headache; queasy GI symptoms; achy pain at injection site; A spontaneous report was received from a consumer concerning a 72-years-old  elder female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events achy pain at injection site, mild headache, queasy gi symptoms, arm itchy, arm inflamed, arm red, arm hot, achy feeling in both legs and buttocks, loopy, difficult sleeping, ruptured blood vessel in left eye.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the event(s) achy pain at injection site,On 19 Feb 2021, the patient experienced the event(s) mild headache, queasy gi symptoms. On 28 Feb 2021, the patient experienced the event(s) arm itchy, arm inflamed, arm red, arm hot. On an unknown date, the patient experienced the event(s) achy feeling in both legs and buttocks, loopy, difficult sleeping. On 3 Mar 2021, the patient experienced the events ruptured blood vessel in left eye which was considered as seriousness criteria.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event(s), achy pain at injection site, mild headache, queasy gi symptoms, arm itchy, arm inflamed, arm red, arm hot, achy feeling in both legs and buttocks, loopy, difficult sleeping, ruptured blood vessel in left eye 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.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Aggression, Asthenia, Hallucination, Hypersomnia
Clinical narrative: Very violent behavior; Very weak; Started saying crazy stuff that did not make sense; Slept a lot; Severe dreams; Hallucinations; A spontaneous report was received from a consumer concerning an 89-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and started saying crazy stuff that did not make sense (speech disorder), slept a lot (hypersomnia), had severe dreams (abnormal dreams), hallucinations, very violent behavior (aggression) and was very weak (asthenia).  The patient's medical history, as provided by the reporter, included COVID-19 in Mar-2020.  Products known to have been used by the patient, within two weeks prior to the event, included gabapentin, apixaban, pantoprazole, furosemide, carvedilol, tamsulosin, potassium, hydrocodone, metformin, zinc, vitamin d3, vitamins NOS, ascorbic acid, rosa canina fruit, magnesium and probiotics NOS.  On 06-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 016M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    With the first dose of the vaccine, the patient experienced the patient experienced delirium, hallucinations and confusion.  On 06-Mar-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 029A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 06-Mar-2021, within four hours after the 2nd vaccination, the patient started saying crazy stuff that didn't make sense, slept a lot and had severe dreams and hallucinations. The patient had very violent behavior and was reaching for things and eating things that were not there and was very weak.   No treatment information was provided.  Laboratory information included CT scans.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events, saying crazy stuff that did not make sense (speech disorder), slept a lot (hypersomnia), had severe dreams (abnormal dreams), hallucinations, very violent behavior (aggression) and was very weak (asthenia), were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Very violent behavior; Very weak; Started saying crazy stuff that did not make sense; Slept a lot; Severe dreams; Hallucinations; A spontaneous report was received from a consumer concerning an 89-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and started saying crazy stuff that did not make sense (speech disorder), slept a lot (hypersomnia), had severe dreams (abnormal dreams), hallucinations, very violent behavior (aggression) and was very weak (asthenia).  The patient's medical history, as provided by the reporter, included COVID-19 in Mar-2020.  Products known to have been used by the patient, within two weeks prior to the event, included gabapentin, apixaban, pantoprazole, furosemide, carvedilol, tamsulosin, potassium, hydrocodone, metformin, zinc, vitamin d3, vitamins NOS, ascorbic acid, rosa canina fruit, magnesium and probiotics NOS.  On 06-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 016M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    With the first dose of the vaccine, the patient experienced the patient experienced delirium, hallucinations and confusion.  On 06-Mar-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 029A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 06-Mar-2021, within four hours after the 2nd vaccination, the patient started saying crazy stuff that didn't make sense, slept a lot and had severe dreams and hallucinations. The patient had very violent behavior and was reaching for things and eating things that were not there and was very weak.   No treatment information was provided.  Laboratory information included CT scans.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events, saying crazy stuff that did not make sense (speech disorder), slept a lot (hypersomnia), had severe dreams (abnormal dreams), hallucinations, very violent behavior (aggression) and was very weak (asthenia), were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Hypoaesthesia
Clinical narrative: Severe allergic reaction;anaphylaxis; Dizzy; Shortness of breath; Numbness; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness, severe allergic reaction, shortness of breath, numbness, anaphylaxis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received a dose of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date in Dec-2020 the patient felt dizzy, had severe allergic reaction, shortness of breath, numbness, and anaphylaxis. Treatment details included diphenhydramine and immune medications.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, dizzy, severe allergic reaction, shortness of breath, numbness, anaphylaxis, 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.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Clostridium difficile colitis, Dehydration, Diarrhoea, Hypertension, Nephrostomy
Clinical narrative: My husband has kidney problems that have nothing to do with the vaccine; C-diff infection; My husband has a tube connected to his kidneys.; My husband had diarrhea not sure if it is due to the vaccine or not; My husband has had issues with hypertension; My husband has had dehydration; husband would be missing his scheduled 2nd dose; A spontaneous report was received from a consumer concerning her husband, an 80-year-old, male patient who missed their second scheduled dose of Moderna (mRNA-1273) vaccine. The patient was admitted into the hospital.  The patient's medical history provided included the patient was diagnosed with urine cancer when the patient was 57-year-old, had ongoing Hypertension and Kidney issues. Concomitant products known to have been used by the patient was not provided.  The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unknown date.  On 10 Mar 2021, the patient missed his second scheduled dose of mRNA-1273. The patient was hospitalized due to the kidney problem, C-diff infection and had diarrhea and not sure if it is due to the vaccine or not. Patient had ongoing issues with hypertension. The reporter stated that the patient might have had dehydration and had diarrhea that also lead to having kidney issues, the patient's numbers went down due to dehydration. The Patient had a bag connected to his kidney and a tube, the patient had blockage and the bag was to clear out the patient's urine. Due to prolongation of hospitalization the patient missed the scheduled second dose of vaccine administration.  The patient was still in hospital. No laboratory details were provided.  Treatment information was unknown since the patient medical issues were still ongoing.  Action taken with mRNA-1273 in response to the event(s) was unknown.  On an unknown date, the outcome of the events were considered Not resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Reporter stated that the events were not related to the vaccine and the patient has hx of hypertension and kidney issues  Further information has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Renal disorder
Clinical narrative: My husband has kidney problems that have nothing to do with the vaccine; C-diff infection; My husband has a tube connected to his kidneys.; My husband had diarrhea not sure if it is due to the vaccine or not; My husband has had issues with hypertension; My husband has had dehydration; husband would be missing his scheduled 2nd dose; A spontaneous report was received from a consumer concerning her husband, an 80-year-old, male patient who missed their second scheduled dose of Moderna (mRNA-1273) vaccine. The patient was admitted into the hospital.  The patient's medical history provided included the patient was diagnosed with urine cancer when the patient was 57-year-old, had ongoing Hypertension and Kidney issues. Concomitant products known to have been used by the patient was not provided.  The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unknown date.  On 10 Mar 2021, the patient missed his second scheduled dose of mRNA-1273. The patient was hospitalized due to the kidney problem, C-diff infection and had diarrhea and not sure if it is due to the vaccine or not. Patient had ongoing issues with hypertension. The reporter stated that the patient might have had dehydration and had diarrhea that also lead to having kidney issues, the patient's numbers went down due to dehydration. The Patient had a bag connected to his kidney and a tube, the patient had blockage and the bag was to clear out the patient's urine. Due to prolongation of hospitalization the patient missed the scheduled second dose of vaccine administration.  The patient was still in hospital. No laboratory details were provided.  Treatment information was unknown since the patient medical issues were still ongoing.  Action taken with mRNA-1273 in response to the event(s) was unknown.  On an unknown date, the outcome of the events were considered Not resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Reporter stated that the events were not related to the vaccine and the patient has hx of hypertension and kidney issues  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal bacterial infection
Clinical narrative: Intestinal bacterial infection; A spontaneous report was received from a consumer concerning a male patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized for intestinal bacterial infection/gastrointestinal bacterial infection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient was hospitalized for the event intestinal bacterial infection and was considered medically significant. Treatment for the event included antibiotics. The due date for second dose is on 08 MAR 2021 and the hospital physician  recommended to wait for "minimum 10 days."  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, hospitalized for intestinal bacterial infection, was considered to be resolved on 09 Mar 2021.  Consent granted for safety to follow up.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Cancer diagnosis; A spontaneous report was received from a consumer concerning an unspecified year old, unknown gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cancer diagnosis (Neoplasm malignant) with medically significant.   The patient's medical history, as provided by the reporter, included surgery on 15 Mar 2021 - 6 weeks in between doses. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, patient experienced cancer diagnosis.  Lab details was not provided by the reporter.  Treatment for the events was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, cancer diagnosis was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; A spontaneous report was received from a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Three to four days after receiving the vaccine, the left side of the patient's face was frozen. The patient was rushed to the emergency room because he thought it was a stroke. The physician confirmed that was not a stroke, and diagnosed Bells' palsy. The patient reported that he spent 6 hours in the hospital and the doctor prescribed him prednisone and valacyclovir. The patient reported feeling better now.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event, Bell's palsy, was considered recovering.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: very large red rash at the injection site; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL9265), via an unspecified route of administration in the left arm on 29Jan2021 1:00 PM a single dose for COVID-19 immunisation. The vaccine was administered at a hospital. The patient did not receive any other vaccines in four weeks prior to receiving BNT162B2. The patient was not pregnant. Medical history included seizure disorder. The patient did not have covid prior to vaccination. She had no known allergies. On 06Feb2021, the patient had a very large red rash at the injection site 8 days after vaccination. It was not particularly itchy or uncomfortable. It seemed notable only because it was over a week later. The patient did not receive any corrective treatment for the event. Outcome of the event was recovered on an unspecified date. The patient was not tested for covid post vaccination.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Contusion, Muscle spasms, Vaccination site pain, Wound
Clinical narrative: a bruise on her ankle and it split open; a bruise on her ankle it split open; soreness of her arm where she got the injection after the first dose; back spasms pain; back spasms pain; This is a spontaneous report from a contactable consumer (the patient) via the Pfizer-sponsored program. A 95-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date (at the age of 95-year-old) as single dose for COVID-19 immunization. Medical history included using a wheelchair. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced soreness of her arm where she got the injection after the first dose at 12 noon and then at 10 pm she had the pain. On an unspecified date, she had a bruise on her ankle and it split open so she put POLYSPORIN (bacitracin and polymyxin B) on it. Then she bruised it again on her wheelchair. She also reported experiencing bad back spasms pain for 3-4 days which happens periodically (unspecified date). The clinical outcomes of the soreness of her arm where she got the injection, back spasms pain and a bruise on her ankle it split open were unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fall, Fatigue, Loss of consciousness
Clinical narrative: Brief loss of consciousness/fall when getting up in the middle of the night for water; Brief loss of consciousness/fall when getting up in the middle of the night for water; Severe chills without fever; overall temperature dysregulation; Nausea (no vomiting or diarrhea); Notable pain in injected arm; Muscle and joint pains over body with focused pain in left knee (not a site of prior injury); Muscle and joint pains over body with focused pain in left knee (not a site of prior injury); fatigue; This is a spontaneous report from a contactable Consumer. A 43-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 01Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included seborrhoeic dermatitis from an unknown date. The patient's concomitant medications were not reported. The patient experienced brief loss of consciousness/fall when getting up in the middle of the night for water, severe chills without fever, overall temperature dysregulation, nausea, notable pain in injected arm, muscle and joint pains over body with focused pain in left knee (not a site of prior injury) and fatigue all on 01Mar2021 at 22:00. Outcome of overall temperature dysregulation was recovered on an unspecified date in Mar2021. all the other events was recovered on 02Mar2021.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Temperature regulation disorder, Vaccination site pain
Clinical narrative: Brief loss of consciousness/fall when getting up in the middle of the night for water; Brief loss of consciousness/fall when getting up in the middle of the night for water; Severe chills without fever; overall temperature dysregulation; Nausea (no vomiting or diarrhea); Notable pain in injected arm; Muscle and joint pains over body with focused pain in left knee (not a site of prior injury); Muscle and joint pains over body with focused pain in left knee (not a site of prior injury); fatigue; This is a spontaneous report from a contactable Consumer. A 43-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 01Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included seborrhoeic dermatitis from an unknown date. The patient's concomitant medications were not reported. The patient experienced brief loss of consciousness/fall when getting up in the middle of the night for water, severe chills without fever, overall temperature dysregulation, nausea, notable pain in injected arm, muscle and joint pains over body with focused pain in left knee (not a site of prior injury) and fatigue all on 01Mar2021 at 22:00. Outcome of overall temperature dysregulation was recovered on an unspecified date in Mar2021. all the other events was recovered on 02Mar2021.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: Had stroke; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9269) via an unspecified route of administration, administered in Arm Right on 15Feb2021 (12:00) as SINGLE DOSE for covid-19 immunisation, at 70 years old. Medical history included Cad atrial fibrillation (atrial fibrillation), Cad atrial fibrillation (Coronary Artery Disease), CHF kidney disease (congestive heart failure), CHF kidney disease (kidney disorder) from unspecified dates. No other vaccines in four weeks. No COVID prior vaccination. Concomitant medications included verapamil; alprazolam (XANAX); allopurinol (ZYLOPRIM); furosemide (LASIX); potassium; and mirtazapine (REMERON), all taken for an unspecified indication, start and stop date were not reported. The patient previously took antihistamines and experienced allergies (Known allergies: Antihistamine). The patient experienced had stroke on 19Feb2021. The patient required emergency room visit and was hospitalized for had stroke for 4 days from 2021 to 2021. Treatment reported as unknown. The patient underwent lab tests and procedures which included investigation: SARS-CoV-2 test (Nasal Swab): negative on 19Feb2021. Event outcome was recovering.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Erythema multiforme, Joint swelling
Clinical narrative: Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg; Oral ulcer; Chill; Body ache; Joint pain; Joints swelling; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201), via unspecified route of administration in the left arm on 17Feb2021 as single dose for COVID-19 immunization. Medical history included hyperlipidemia. The patient had no known allergies. The patient is not pregnant. There were no vaccine in four weeks. Other medications in two weeks included cholesterol med. The previously received the first dose of BNT162B2 on 26Jan2021 12:00 intramuscular at left arm (lot number: EL9262) for COVID-19 immunization. The patient was seen at urgent care on 04Mar2021 due to 4 days progressive worsened skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg from 28Feb2021 (12:00 AM). Patient presented with chill, body ache, joint pain, joints swelling and diarrhea since second dose of vaccine on 17Feb2021. She also has oral ulcer at the same time when rash started on 28Feb2021. Vital sign was stable, no shortness of breath (SOB) and no chest pain. Events resulted in Doctor or other HCP office/clinic visit. The treatment for the events included Hydroxyzine 25 mg prn. It was unknown if patient had COVID prior vaccination or if COVID tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Erythema multiforme cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration, Pain, Vital signs measurement
Clinical narrative: Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg; Oral ulcer; Chill; Body ache; Joint pain; Joints swelling; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201), via unspecified route of administration in the left arm on 17Feb2021 as single dose for COVID-19 immunization. Medical history included hyperlipidemia. The patient had no known allergies. The patient is not pregnant. There were no vaccine in four weeks. Other medications in two weeks included cholesterol med. The previously received the first dose of BNT162B2 on 26Jan2021 12:00 intramuscular at left arm (lot number: EL9262) for COVID-19 immunization. The patient was seen at urgent care on 04Mar2021 due to 4 days progressive worsened skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg from 28Feb2021 (12:00 AM). Patient presented with chill, body ache, joint pain, joints swelling and diarrhea since second dose of vaccine on 17Feb2021. She also has oral ulcer at the same time when rash started on 28Feb2021. Vital sign was stable, no shortness of breath (SOB) and no chest pain. Events resulted in Doctor or other HCP office/clinic visit. The treatment for the events included Hydroxyzine 25 mg prn. It was unknown if patient had COVID prior vaccination or if COVID tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Erythema multiforme cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Skin abrasion
Clinical narrative: blacked out; scraped his face; light headaches; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 17Feb2021 03:00 (batch/lot number was not reported) as a single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus from 2008 and ongoing and reported that it's under control. The patient's concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. The patient was calling because he got his shot through the (facility name withheld) on the 17Feb2021 around 3:00. The caller goes for walks, and one week later he had a blackout, about the same time he got the shot 3:00 or 3:15 on 24Feb2021. The caller blacked out and he broke his glasses, scraped his face, all that stuff. All the scrapes were healing. The weirdest thing was it happened almost exactly a week later. The caller asked was it possible that this could be related to the vaccine. For the following two days after the vaccine the caller had 2 light headaches on 18Feb2021 and then they were gone on 19Feb2021. This blackout event happened one time. Caller mentioned the headaches were nothing to be concerned about. The caller was not given a vaccination card at the (facility name withheld) and does not know the lot number, NDC number, or expiration date. This was the caller's first dose of the vaccine. The caller mentioned that 11Mar2021 was his next appointment for the second dose of the vaccine. The caller has never had a black out episode or dizziness before. The caller said he licked his wounds and will be okay. No visit to the emergency room and physician's office required. No prior vaccinations (within 4 weeks). No relevant tests done. The outcome was recovered on 19Feb2021 for the event Headache; and recovering for the other events.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: cancer; This is a spontaneous report 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 number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was reported to have not started chemotherapy yet and wants to know if he can get vaccine before or after starting chemotherapy for cancer. I was not reported if patient had cancer prior to taking the first dose of the vaccine. The patient has an appointment to get the second dose and was told to bring gatorade and take ibuprofen not acetaminophen. The outcome of the event was unknown.  Information about lot/batch has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Joint swelling, Lymphadenopathy, Malaise, Peripheral swelling
Clinical narrative: all of his lymph nodes were swollen under his arm and in his neck; joints were swollen; Huge bump on his arm at the injection site; his fingers are swollen; fever of 101; General feeling of unwell and malaise; This is a spontaneous report from a contactable healthcare professional (patient's wife). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the left arm on 03Mar2021 at about 15:00 (lot number: EN6201 and expiration date: 30Jun2021) at a single dose, received at the hospital for COVID-19 vaccination. Medical history included chronic inflammatory demyelinating polyradiculoneuropathy and patient was immunocompromised. The patient's concomitant medications included immunoglobulin human normal (IMMUNOGLOBULIN [IMMUNOGLOBULIN HUMAN NORMAL]) from 02Mar2021 to 02Mar2021 for chronic inflammatory demyelinating polyradiculoneuropathy. The patient previously received flu vaccine on 15Oct2020. The patient's wife called to report on the side effects that the patient was experiencing after he received the Covid-19 Vaccine. The patient had a fever of 101 started at about 23:00 on 03Mar2021 (his regular base temp is about 97). At midnight of 04Mar2021, all of his lymph nodes were swollen under his arm and in his neck; even in his fingers were swollen. Also noticed that his joints were swollen and had a huge bump on his arm at the injection site on 04Mar2021 after midnight last night. The reported added that patient also had a general feeling of unwell and malaise on 03Mar2021. The patient received treatment for the events. Outcome of the events was not recovered. The events were reported as serious (other medically important condition) and considered related to COVID-19 vaccine (source of assessment was primary source reporter and method of assessment was global introspection).; Sender's Comments: Based on available information, a possible contributory role between BNT162B2 vaccine and the reported events can not be excluded due to temporal relationship and current known drug safety profile.   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.