chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Gallbladder oedema, Hydronephrosis, Pancreatitis
Clinical narrative: Severe pain in abdomen; pancreatitis; Swelling in gallbladder; Swelling in kidney; weakness; A Spontaneous report was received from a Consumer concerning a male patient of 78-year-old who received a dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pancreatitis, Asthenia, Abdominal pain, Gall bladder edema, Hydernephrosis.  The patient's medical history included heart problems, 13 stents, high blood pressure, high cholesterol, borderline diabetic, thyroidectomy (28 years), bilateral knee replacement, and arthritis. Allergy history included sulfa.  Concomitant medications included metformin, metoprolol, lisinopril, levothyroxine, clopidogrel for unknown indication.  On 25 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 023M20A) on left arm for prophylaxis of COVID-19 infection.   The patient had experienced difficulty in exercise and weakness, after first dose of vaccination.  On 17Mar2021 he had severe pain in abdomen and hospitalized for seven days until 23 MAR 2021. The patient was diagnosed with pancreatitis and the patient also had swelling in gallbladder and kidney. The patient was treated with intravenous fluids but other meds were not reported. Laboratory details were not provided.   Action taken with mRNA-1273 in response to the events was not reported.  On date of this report, the outcome of the events Pancreatitis, Asthenia, Abdominal pain, Gall bladder edema, Hydernephrosis unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Dyspnoea, Hallucination
Clinical narrative: Patient developed Covid; Breathing dificulties; Hallucinating; Legs felt like rubber; Coughing; 104 fever; 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 developed COVID, 104 fever (pyrexia), hallucinating, legs felt like rubber (skin atrophy), coughing and breathing difficulties (dyspnoea).  The patient's medical history was not provided. Concomitant medications were not provided.  On 05 Feb 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 18 Feb 2021, patient was hospitalized for Covid infection. He had a fever of 104, hallucinating, legs felt like rubber, coughing, and breathing difficulties. Labs and treatment information was not reported.  Action taken with response to mRNA-1273 was not reported.  The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin atrophy
Clinical narrative: Patient developed Covid; Breathing dificulties; Hallucinating; Legs felt like rubber; Coughing; 104 fever; 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 developed COVID, 104 fever (pyrexia), hallucinating, legs felt like rubber (skin atrophy), coughing and breathing difficulties (dyspnoea).  The patient's medical history was not provided. Concomitant medications were not provided.  On 05 Feb 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 18 Feb 2021, patient was hospitalized for Covid infection. He had a fever of 104, hallucinating, legs felt like rubber, coughing, and breathing difficulties. Labs and treatment information was not reported.  Action taken with response to mRNA-1273 was not reported.  The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immune thrombocytopenia, Petechiae, Platelet count
Clinical narrative: ITP; Petechial rash around injection site and mouth; Petechial rash around injection site and mouth; Extreme headaches; Fatigue; A spontaneous report was received from a pharmacist concerning a patient of an unknown age and gender who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed immune thrombocytopenic purpura (ITP) (Immune thrombocytopenia), petechial rash around injection site and mouth (Petechiae), petechial rash around injection site and mouth (Vaccination site rash), extreme headaches (Headache) and fatigue (Fatigue).    The patient's medication history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the events, the patient received their planned dose (unknown dose number) of mRNA-1273 (Batch number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date the patient experienced ITP, petechial rash around injection site and mouth, extreme headaches and fatigue. On an unknown date, patient found to have platelet count of 2000.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of ITP, petechial rash around injection site and mouth, extreme headaches and fatigue was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: ITP; Petechial rash around injection site and mouth; Petechial rash around injection site and mouth; Extreme headaches; Fatigue; A spontaneous report was received from a pharmacist concerning a patient of an unknown age and gender who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed immune thrombocytopenic purpura (ITP) (Immune thrombocytopenia), petechial rash around injection site and mouth (Petechiae), petechial rash around injection site and mouth (Vaccination site rash), extreme headaches (Headache) and fatigue (Fatigue).    The patient's medication history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the events, the patient received their planned dose (unknown dose number) of mRNA-1273 (Batch number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date the patient experienced ITP, petechial rash around injection site and mouth, extreme headaches and fatigue. On an unknown date, patient found to have platelet count of 2000.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of ITP, petechial rash around injection site and mouth, extreme headaches and fatigue was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced stroke/cerebrovascular accident.  The patient's medical history was not provided. Concomitant product use was not provided.  On an unspecified date, prior to the onset of the symptoms, the patient received their mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  On an unknown date, the patient had stroke. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event stroke was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bell's palsy; A spontaneous report from was received from a Consumer concerning a 62-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bells palsy.    The patient had a history of Bells palsy in the last five years. No relevant concomitant medications were reported.    On 07 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 25 Mar 2021, the patient experienced the event Bells palsy.   Laboratory details was not provided.  Treatment medication included prednisone and valacyclovir.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was unknown.; 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 of facial paralysis, a causal relationship cannot be excluded. Patient's prior history of Bell's palsy is considered a risk factor.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: headache; fatigue; sore arm; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose via intramuscular at left upper arm on 21Jan2021 3:00 pm (lot number: EL1283 and expiry date: 30Apr2021); second dose via intramuscular at left upper arm on 11Feb2021 5:20 pm (lot number: EL9267 and expiry date: 31May2021), both at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications reported as none. After the first dose, the patient experienced minor headache, moderate fatigue, minor sore arm, all on 21Jan2021 and recovered on 23Jan2021. After the second dose, the patient experienced moderate headache, severe fatigue, moderate sore arm, all on 11Feb2021 and recovered on 14Feb2021. The events were considered as non-serious. The outcome of the events was recovered on 14Feb2021.  Follow-up (08Mar2021): New information received from a contactable consumer include: new events headache, fatigue, sore arm were added, product dosage and details (lot number, expiry date, clinical details) were added.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Fatigue
Clinical narrative: tiredness; diarrhea; chills; coughing; This is a spontaneous report from a contactable consumer (patient). A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), at 83 years of age, via an unspecified route of administration on 29Jan2021 at single dose, for COVID-19 immunization. The patient medical history was not reported. Patient taking other medication which were not reported. On 29Jan2021, the patient experienced diarrhea, chills, coughing and tiredness. The events were considered as non-serious. Patient was taking cough drops for coughing. The outcome of the events was recovering.   Information on the Lot/Batch Number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Slight arm pain; Flu-like symptoms; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on [22Mar2021], this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in Left Arm on 11Feb2021 12:45 pm at a SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: Penicillin, prostate cancer, IBS, skin cancer and Allergies. If Covid prior vaccination: No, If Covid tested post vaccination: No. Concomitant medication(s) included atorvastatin (LIPITOR), loratadine (CLARITIN), fluticasone propionate (FLONASE), atropine sulfate, diphenoxylate hydrochloride (LOMOTIL). The patient previously took historical vaccine, first dose of BNT162B2 (lot number: EL9262) for COVID-19 immunisation on 21Jan2021 01:00 PM on Left arm. Facility type vaccine was Other. If other vaccine in four weeks: No. The patient experienced flu-like symptoms (non-serious) on 11Feb2021, slight arm pain (non-serious) on 12Feb2021. After second dose, slight arm pain following morning which dissipated in 4 hours. Flu-like symptoms the day following the 2nd dose but no fever and Ok the next day. The outcome of event slight arm pain recovered on 12Feb2021.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got covid a week after her first dose of the vaccine; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 08Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN5318), intramuscular, administered in the left upper arm, near shoulder on 29Jan2021 at a single dose for COVID-19 immunization.  Medical history included ongoing anxiety. Concomitant medications included bupropion hydrochloride (BUPROPION HCL XL) taken for depression related to vicarious trauma; lorazepam (manufacturer unknown) taken for anxiety and insomnia related to secondary trauma and zolpidem (manufacturer unknown) taken for insomnia related to secondary trauma all from an unspecified start date and ongoing. On 02Feb2021 the patient's fiance tested positive for covid19. On 03Feb2021 she was tested and she just got the results back as negative. The patient stated that she might still have COVID so she did get retested on 08Feb2021 and is waiting for results. She is scheduled to get her second dose on 21Feb2021. The patient then reported that she got COVID a week after her first dose of the vaccine (as reported) on an unspecified date in 2021, and wanted to know what to do if she had to reschedule her second shot. She had called Pfizer because it was the only phone number on her paperwork, and learned that I needed to call the convention center where I got the shot with her question. Ultimately, she didn't have to reschedule and received her second dose of the vaccine as scheduled.  No follow-up attempts possible. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID + 17Feb; COVID + 17Feb; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, on 11Jan2021 07:00 AM at a single dose for COVID-19 immunization. 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 COVID prior vaccination. The patient had no known allergies and no other relevant medical history to report. Concomitant medications were not reported. The patient experienced "COVID + 17Feb". She tested positive for COVID via Nasal Swab on 17Feb2021. She did not receive any corrective treatment for the adverse event. Outcome of the event was not recovered.  Information on lot/ batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 11Jan2021, and tested positive for the virus (COVID-19) on 17Feb2021.  Based on information available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  However, no complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anaphylactic reaction, Depressed level of consciousness, Dysphonia, Dyspnoea
Clinical narrative: Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM.  Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Heart rate, Lip swelling, Ocular hyperaemia, Paraesthesia
Clinical narrative: Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM.  Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory distress, Respiratory tract oedema, Shock, Swollen tongue, Tachycardia
Clinical narrative: Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM.  Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM.  Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Insomnia, Pain in extremity, Pruritus, Rash
Clinical narrative: he is not getting any sleep; he had a rash and hives all over his body; itching; he had a rash and hives all over his body; sore arm; This is a spontaneous report from a contactable consumer reported for self. This 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 in the morning on Arm right at single dose (Lot # EN6205) for COVID Prevention. Medical history included ongoing leukemia CML from 2013, ongoing chronic lymphocytic leukemia from 2013, prostate cancer, white blood cell count runs high anyway, PSA (prostate specific antigen) last time he had blood work done, was 5.1. Concomitant therapy was none. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 26Feb2021 in the morning, in the evening (26Feb2021), he had a rash and hives all over his body, he also experienced sore arm. He states that he had itching sooner. He also has leukemia CML, his oncologist told him to receive the vaccine. He would like to know if he should receive the second dose of the vaccine, and get ready for rashes. He broke out in hives and it was really uncomfortable, and he was not getting any sleep. He states that the hives got so bad, it looks like he has alligator skin. He states that he took Benadryl (UPC: 81131 07825, Lot number: P113775, Expiry: Oct2020, he has been using the product since the expiry date) and used Cortisone, and it helped but did not work 100%, but it helped enough he got some sleep. He stated that he felt like it is getting better, but he was taking Benadryl, and when the Benadryl wears off, it starts doing it again, but it was bad at first, like alligator skin, so he does feel like it is improving some. Outcome of the event hives was recovering. Outcome of other events was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, White blood cell count
Clinical narrative: he is not getting any sleep; he had a rash and hives all over his body; itching; he had a rash and hives all over his body; sore arm; This is a spontaneous report from a contactable consumer reported for self. This 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 in the morning on Arm right at single dose (Lot # EN6205) for COVID Prevention. Medical history included ongoing leukemia CML from 2013, ongoing chronic lymphocytic leukemia from 2013, prostate cancer, white blood cell count runs high anyway, PSA (prostate specific antigen) last time he had blood work done, was 5.1. Concomitant therapy was none. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 26Feb2021 in the morning, in the evening (26Feb2021), he had a rash and hives all over his body, he also experienced sore arm. He states that he had itching sooner. He also has leukemia CML, his oncologist told him to receive the vaccine. He would like to know if he should receive the second dose of the vaccine, and get ready for rashes. He broke out in hives and it was really uncomfortable, and he was not getting any sleep. He states that the hives got so bad, it looks like he has alligator skin. He states that he took Benadryl (UPC: 81131 07825, Lot number: P113775, Expiry: Oct2020, he has been using the product since the expiry date) and used Cortisone, and it helped but did not work 100%, but it helped enough he got some sleep. He stated that he felt like it is getting better, but he was taking Benadryl, and when the Benadryl wears off, it starts doing it again, but it was bad at first, like alligator skin, so he does feel like it is improving some. Outcome of the event hives was recovering. Outcome of other events was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Flushing, Hypoaesthesia, Mobility decreased
Clinical narrative: girl giving the vaccines  was rolling the vials back in forth in her hands/Received the vaccine from a vial that had been manually warmed by the woman who was administering the product; girl giving the vaccines  was rolling the vials back in forth in her hands/Received the vaccine from a vial that had been manually warmed by the woman who was administering the product; veins in my right hand started popping out; flush; temperature was but she told me it was very high; right arm is numb/complete numbness from my shoulder where my shot was put on and till my fingers/no feeling in my right arm; right arm is numb/she can raise it slowly.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in arm right on 28Feb2021 15:00 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization. Medical history included breast cancer for over 30 years. The patient also had left sided mastectomy and 11 lumpectomies on the right side. She had large tumor removed from her abdomen with stoma creation on 30Sep2020. There were no concomitant medications.  The patient described that she noticed the girl who was giving the vaccines was rolling the vials back in forth in her hands. She read that vaccines were kept in extreme cold. She received the vaccine from a vial that had been manually warmed by the woman who was administering the product on 28Feb2021. On that same day of 28Feb2021, the veins in her right hand were almost wanting to pop out of her hand (looked like when pregnant which the veins come completely out). The patient also asked them to take her temperature and the woman who gave the vaccine told her that she looked flush and asked her to drink a bottle of water as fast as she can. The vaccinating woman also mentioned that her temperature was very high as she looked flush. The patient also mentioned that her right arm was numb on that same day on 28Feb2021. She elaborated it as a complete numbness from her shoulder where her shot was put on until fingers. She has no feeling in her right arm while putting her sweater on it using her left arm. She can raise it slowly and was trying to hold a pencil and to try to exercise it. She put warm water in her hands as she no feeling with her right hand. The patient did not receive any treatment for the events of mobility decreased, flushing, body temperature increased, and vein disorder. The patient did not recover from numbness of upper extremities while unknown for the remaining events.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product preparation error, Vein disorder
Clinical narrative: girl giving the vaccines  was rolling the vials back in forth in her hands/Received the vaccine from a vial that had been manually warmed by the woman who was administering the product; girl giving the vaccines  was rolling the vials back in forth in her hands/Received the vaccine from a vial that had been manually warmed by the woman who was administering the product; veins in my right hand started popping out; flush; temperature was but she told me it was very high; right arm is numb/complete numbness from my shoulder where my shot was put on and till my fingers/no feeling in my right arm; right arm is numb/she can raise it slowly.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in arm right on 28Feb2021 15:00 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization. Medical history included breast cancer for over 30 years. The patient also had left sided mastectomy and 11 lumpectomies on the right side. She had large tumor removed from her abdomen with stoma creation on 30Sep2020. There were no concomitant medications.  The patient described that she noticed the girl who was giving the vaccines was rolling the vials back in forth in her hands. She read that vaccines were kept in extreme cold. She received the vaccine from a vial that had been manually warmed by the woman who was administering the product on 28Feb2021. On that same day of 28Feb2021, the veins in her right hand were almost wanting to pop out of her hand (looked like when pregnant which the veins come completely out). The patient also asked them to take her temperature and the woman who gave the vaccine told her that she looked flush and asked her to drink a bottle of water as fast as she can. The vaccinating woman also mentioned that her temperature was very high as she looked flush. The patient also mentioned that her right arm was numb on that same day on 28Feb2021. She elaborated it as a complete numbness from her shoulder where her shot was put on until fingers. She has no feeling in her right arm while putting her sweater on it using her left arm. She can raise it slowly and was trying to hold a pencil and to try to exercise it. She put warm water in her hands as she no feeling with her right hand. The patient did not receive any treatment for the events of mobility decreased, flushing, body temperature increased, and vein disorder. The patient did not recover from numbness of upper extremities while unknown for the remaining events.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood potassium, Blood potassium decreased, Muscular weakness, Paraesthesia
Clinical narrative: muscle weakness; "severe" tingling/muscle tingling on face and arms, sometimes face, most of the time it's limbs; weak because of the tingling and, it was limiting; potassium which was at 3.4; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262), via an unspecified route of administration, on 15Feb2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 24Jan2021 for covid-19 immunization and experienced felt some tingling and the next day it was "rather severe" and it weakened her up - she went to ER and everything seemed okay. After the second dose, the patient developed muscle weakness and "severe" tingling. She was not sure if it was related to the vaccine, but she has felt this almost every other day. She was weak because of the tingling and, it was limiting and has been there for some time on her face. The tingling increased at night. She had muscle tingling on face and arms, most of the time it's limbs, further reported muscle weakness, muscle tingling on face and arms, sometimes face, most of the time it's limbs. Due to these, she went to the ER again the day before yesterday and the doctor found everything was normal; except the potassium which was at 3.4 ("limit 3.5") and she thinks it may not be related. After that, she started taking potassium supply tablets but they didn't help; she did not know the manufacturer of the potassium tablets. All the adverse events happened on an unspecified date in 2021 with outcome of unknown. She asked if muscle weakness and tingling were reported as side effects and; how many days after receiving the vaccine was fatigue reported. She wanted to get some advice on what's going on.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events  due to temporal relationship  Additional information is needed to better assess the case, including complete medical history, diagnostics including serum potassium at baseline, counteractive treatment measures and concomitant medications.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Ear discomfort, Headache, Hypoaesthesia, Limb discomfort
Clinical narrative: 12 years ago her mother had facial neuritis and her symptoms are similar to what she experienced then; 12 years ago her mother had facial neuritis and her symptoms are similar to what she experienced then; back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable; back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable; back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable; back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable; three fingers of both hands from thumb to middle finger with numbness,half of index finger on right hand with numbness; both temples and upper lips feels uncomfortable; both temples and upper lips feels uncomfortable; stuffy nose; injection site uncomfortable along the nerves; injection site uncomfortable along the nerves; This is a spontaneous report from a contactable consumer (patient's daughter). A 66-year-old female patient received BNT162B2, dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included facial neuritis from 2009 (12 years ago her mother had facial neuritis and her symptoms are similar to what she experienced then), breast cancer from 2014 (states 7 years ago her mother had breast cancer), nerves were hurt after treatment of cancer. The patient's concomitant medications were not reported. The patient previously received BNT162B2, dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization and experienced 'both elbows were uncomfortable'. The patient's daughter stated her mother (the patient) received the second dose of the vaccine on 20Feb2021 in her left arm. Side effects were stronger this time and were on the back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable, three fingers of both hands from thumb to middle finger with numbness, half of index finger on right hand with numbness, both temples and upper lips feels uncomfortable. Her mother also has a stuffy nose and injection site uncomfortable along the nerves. Twelve (12) years ago her mother had facial neuritis and her symptoms are similar to what she experienced then. Her grandmother (patient's mother) had strokes in the past and she just wanted to share that family history in relation to nerves. Patient's daughter states 7 years ago her mother had breast cancer and her nerves were hurt after treatment of cancer and she went to the hospital and the doctor said everything was okay no problems and she never had problems after having facial neuritis. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Nasal congestion, Neuralgia, Neuritis, Oral discomfort
Clinical narrative: 12 years ago her mother had facial neuritis and her symptoms are similar to what she experienced then; 12 years ago her mother had facial neuritis and her symptoms are similar to what she experienced then; back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable; back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable; back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable; back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable; three fingers of both hands from thumb to middle finger with numbness,half of index finger on right hand with numbness; both temples and upper lips feels uncomfortable; both temples and upper lips feels uncomfortable; stuffy nose; injection site uncomfortable along the nerves; injection site uncomfortable along the nerves; This is a spontaneous report from a contactable consumer (patient's daughter). A 66-year-old female patient received BNT162B2, dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included facial neuritis from 2009 (12 years ago her mother had facial neuritis and her symptoms are similar to what she experienced then), breast cancer from 2014 (states 7 years ago her mother had breast cancer), nerves were hurt after treatment of cancer. The patient's concomitant medications were not reported. The patient previously received BNT162B2, dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization and experienced 'both elbows were uncomfortable'. The patient's daughter stated her mother (the patient) received the second dose of the vaccine on 20Feb2021 in her left arm. Side effects were stronger this time and were on the back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable, three fingers of both hands from thumb to middle finger with numbness, half of index finger on right hand with numbness, both temples and upper lips feels uncomfortable. Her mother also has a stuffy nose and injection site uncomfortable along the nerves. Twelve (12) years ago her mother had facial neuritis and her symptoms are similar to what she experienced then. Her grandmother (patient's mother) had strokes in the past and she just wanted to share that family history in relation to nerves. Patient's daughter states 7 years ago her mother had breast cancer and her nerves were hurt after treatment of cancer and she went to the hospital and the doctor said everything was okay no problems and she never had problems after having facial neuritis. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Vaccination site discomfort
Clinical narrative: 12 years ago her mother had facial neuritis and her symptoms are similar to what she experienced then; 12 years ago her mother had facial neuritis and her symptoms are similar to what she experienced then; back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable; back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable; back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable; back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable; three fingers of both hands from thumb to middle finger with numbness,half of index finger on right hand with numbness; both temples and upper lips feels uncomfortable; both temples and upper lips feels uncomfortable; stuffy nose; injection site uncomfortable along the nerves; injection site uncomfortable along the nerves; This is a spontaneous report from a contactable consumer (patient's daughter). A 66-year-old female patient received BNT162B2, dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included facial neuritis from 2009 (12 years ago her mother had facial neuritis and her symptoms are similar to what she experienced then), breast cancer from 2014 (states 7 years ago her mother had breast cancer), nerves were hurt after treatment of cancer. The patient's concomitant medications were not reported. The patient previously received BNT162B2, dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization and experienced 'both elbows were uncomfortable'. The patient's daughter stated her mother (the patient) received the second dose of the vaccine on 20Feb2021 in her left arm. Side effects were stronger this time and were on the back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable, three fingers of both hands from thumb to middle finger with numbness, half of index finger on right hand with numbness, both temples and upper lips feels uncomfortable. Her mother also has a stuffy nose and injection site uncomfortable along the nerves. Twelve (12) years ago her mother had facial neuritis and her symptoms are similar to what she experienced then. Her grandmother (patient's mother) had strokes in the past and she just wanted to share that family history in relation to nerves. Patient's daughter states 7 years ago her mother had breast cancer and her nerves were hurt after treatment of cancer and she went to the hospital and the doctor said everything was okay no problems and she never had problems after having facial neuritis. The outcome of the events was unknown.  Information on the lot/batch number has been requested.