chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory failure, Sepsis, Sudden death
Clinical narrative: sepsis; respiratory failure; Fever; Unresponsive; A spontaneous report was received from Pfizer concerning a 56-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced respiratory failure, sepsis, fever and sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient began to have a fever. She was sent to the emergency room for evaluation. That evening, she died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 11 Jan 2021. The cause of death was reported as respiratory failure and sepsis. Plans for an autopsy were unknown/not provided.; Reporter's Comments: This is a case of 56-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sepsis, fever, respiratory failure and sudden death. Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Respirtory Failure; Sepsis
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Unresponsive; A spontaneous report was received from Pfizer concerning a 58-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the patient died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 04 Jan 2021. The cause of death was unknown/not reported. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Sudden death; A spontaneous report was received from Pfizer concerning a 60-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) for prophylaxis of COVID-19 infection.  On 08 Jan 2021, the patient died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 08 Jan 2021. The cause of death was unknown/not reported. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Sudden death; A spontaneous report was received from Pfizer concerning a 60-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient was found to be deceased at 3:00 am. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 13 Jan 2021. The cause of death was unknown/not reported. Plans for an autopsy were unknown/not provided. .; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site induration, Injection site pruritus, Injection site warmth, Lip pruritus
Clinical narrative: lip swelling and itchy; lip swelling and itchy; Injection site hot to the touch; Injection site itchy; Injection site hard like a baseball; Cellulitis; A spontaneous report was received from a consumer who was also a 40-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced cellulitis, injection site hot to the touch, injection site itchy, and injection site hard like a baseball, lip swelling and lip itchy.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   On 28 Jan 2021, approximately 19 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 010M20A) in the left arm for prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient's injection site was hot to the touch, itchy, and hard like a baseball. On the same day patient went to the doctor diagnosed the symptoms as cellulitis. On 15 Feb 2021, the patient had lip swelling which was itchy. The patient also stated that patient took almonds but does not think patient had nut allergy. Treatment for the event included antibiotics, Trimethoprim at eight hundred mg and Sulfamethoxazole for injection site hotness, itchiness, and hardness which was stopped on 13 Feb 2021 and had Zyrtec for itchy lip swelling.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was unknown.; Reporter's Comments: This case concerns a 40 Y/O F female with a medically significant and serious unexpected event of Cellulitis and NS unexpected lip swelling and lip pruritus, with injection site warm, itchy, and hard. The events occurred 13 days after the first dose of mRNA-1273. Treated with antibiotics. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: lip swelling and itchy; lip swelling and itchy; Injection site hot to the touch; Injection site itchy; Injection site hard like a baseball; Cellulitis; A spontaneous report was received from a consumer who was also a 40-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced cellulitis, injection site hot to the touch, injection site itchy, and injection site hard like a baseball, lip swelling and lip itchy.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   On 28 Jan 2021, approximately 19 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 010M20A) in the left arm for prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient's injection site was hot to the touch, itchy, and hard like a baseball. On the same day patient went to the doctor diagnosed the symptoms as cellulitis. On 15 Feb 2021, the patient had lip swelling which was itchy. The patient also stated that patient took almonds but does not think patient had nut allergy. Treatment for the event included antibiotics, Trimethoprim at eight hundred mg and Sulfamethoxazole for injection site hotness, itchiness, and hardness which was stopped on 13 Feb 2021 and had Zyrtec for itchy lip swelling.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was unknown.; Reporter's Comments: This case concerns a 40 Y/O F female with a medically significant and serious unexpected event of Cellulitis and NS unexpected lip swelling and lip pruritus, with injection site warm, itchy, and hard. The events occurred 13 days after the first dose of mRNA-1273. Treated with antibiotics. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Confusional state, Eating disorder, Fall, Syncope
Clinical narrative: she had not been eating properly; she was found lying on floor of her house - likely having been there for 3 hours. Next morning found lying on the floor of the bathroom; On helping up she was confused but otherwise ok; she was found lying on floor of her house - likely having been there for 3 hours. Next morning found lying on the floor of the bathroom; This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose of bnt162b2 (Formulation: Solution for injection, Lot number: EK1768), via an unspecified route of administration, on 15Jan2021 at single dose for COVID-19 immunisation. Medical history included t2diabetes, hypertension, arthritis, previous episodes of falling. The patient's concomitant medications included rampril, glimepiride, gabapentin, sitagliptin, atorvastatin, tolterodine l-tartrate (PREBLACON) all at unspecified doses. It was reported that on 16Jan2021 at around 6pm she was found lying on floor of her house - likely having been there for 3 hours. On helping up she was confused but otherwise ok (as reported). She remained ok for several hours before going to bed. Next morning found lying on the floor of the bathroom. It was reported that ambulance was called but did not go to hospital due to COVID risk and overcrowding. It was reported that blood sample was taken on an unknown date in 2021 and analysed. The doctor called and reported no abnormal findings in blood sample. Suggested possibility that she had not been eating properly. The outcome of the event she had not been eating properly was unknown, while for other events was recovering.  The events occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event Syncope cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: injection site soreness; if he squeezed something it would hurt in his wrist; This is a spontaneous report from a contactable pharmacist.  A 73-years-old male patient started to receive bnt162b2 (Pfizer-BIONTECH Covid-19 Vaccine,), intramuscular on 23Jan2021 (at the age of 73) as a single dose for COVID-19 vaccination. Medical history was not reported.  There were no concomitant medications.  The patient previously took TYLENOL.  On 26Jan2021, the patient reported that he experienced  mild side effects included injection site soreness that lasted for one day and in one of his joints, it wasn't any soreness, but in his wrist, if he squeezed something it would hurt. Both of these symptoms lasted one day. The pain was mild.. He clarifies the soreness lasted for 2 days, Sunday and Monday, and was gone by yesterday. The clinical outcome of the events was recovered, the outcome of the event of took TYLENOL was unknown.  Information about batch lot number has been requested  Amendment: This follow-up is being submitted to amend previously reported information: event was deleted.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I am feeling very ill; This is a spontaneous report from a Pfizer-sponsored program received from a contactable Consumer reporting for herself.  A 77 year old female patient  received the first dose of  bnt162b2 (BNT162B2) , via an unspecified route of administration on 27Jan2021 at single dose for covid-19 immunisation .  Medical history included ongoing osteoarthritis, and ongoing autoimmune disorder(have 3 autoimmune diseases and just went through chemotherapy).  Concomitant medication included propranolol hydrochloride (INDERAL), gabapentin (NEURONTIN), aciclovir (CYCLOVIR), vitamin C (ASCORBIC ACID), vitamin D  (VITAMIN D NOS) , danazol (DANAZOL), hydrocortisone (HYDROCORTISONE), ibuprofen (IBUPROFEN), levothyroxine sodium (SYNTHROID), prednisone (PREDNISONE) , vitamin A  (VITAMIN A RETINOL).  The patient was feeling very ill  in Jan2021 with outcome of unknown.    The patient is wondering if her regular medication  will interfere with the effectiveness of vaccine and if the reported event is  because of vaccine or her other conditions.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vision blurred
Clinical narrative: blurry vision; headache; This is a spontaneous report from a contactable consumer (patient) via a medical information team. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on 29Jan2021, at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 29Jan2021, patient had blurry vision and headache. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Musculoskeletal stiffness, Nausea, Pain in extremity
Clinical narrative: face/head was numb on and off for just over 2 hours; Severe arm soreness stiffness for 2 days; Severe arm soreness stiffness for 2 days; fatigue; nausea; This is a spontaneous report from a contactable consumer.  A 22-years-old non-pregnant female patient received BNT162b2 (Pfizer-BIONTECH Covid-19 Vaccine) Lot number=EL9262, via an unspecified route of administration in left arm,  on 25Jan2021 at 09:00 ( at the age of 22) as a single dose  for covid-19 immunisation.   There were no other vaccinations within 4 weeks. Medical history included Asthma, rheumatoid arthritis, and insomnia.  Concomitant medication included ethinylestradiol, levonorgestrel (DAYSEE).  On 25Jan2021, the patient experienced severe arm soreness stiffness for 2 days, fatigue for 2 days, nausea, and on day 4 (29Jan2021) face/head was numb on and off for just over 2 hours. No issues with speech or motor function, but the numbness came and went in various parts of her face, scalp, and outer ears for 2 hours. The outcome of the events was recovered. It was unknown if the patient tested for COVID-19 post-vaccination.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: right arm which the vaccine was injected into became extremely sore and was unable to move it without feeling pain.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247, expiry date not reported), via an unspecified route of administration on the right arm on 28Jan2021 13:00 at single dose for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported experiencing right arm which the vaccine was injected into became extremely sore and was unable to move it without feeling pain on 29Jan2021 05:00. No treatment was received for the event. The patient recovered from the event on an unspecified date.  No follow up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on neck and chest; This is a spontaneous report from a contactable consumer (patient).  A non-pregnant 67-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9262), via an unspecified route of administration in the left arm on 30Jan2021 at 08:00 at 67-years-old at a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 09Jan2021 at 67-years-old (lot number=EL1284; vaccine location=Left arm; first dose; administration time: 08:00).  On 31Jan2021 at 21:00, the patient experienced rash on neck and chest (non-serious). The clinical outcome of the event, rash on neck and chest, was not recovered. Since the vaccination, the patient has not been tested for COVID-19.   The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Gastric disorder, Pain, Pain in extremity
Clinical narrative: Chills; Stomach issues; Fever of 100.4; Sort of feeling achy; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported), intramuscularly on the left arm on 25Jan2021 (13:45) at a single dose for COVID-19 immunization at the university clinic (not a military facility). Medical history allergy to penicillin; allergy to bees; allergy to environmental grass and ragweed; and was in muscle relaxant therapy. Concomitant medications included cannabidiol (CBD OIL) as muscle relaxer; and estrogens conjugated, medroxyprogesterone acetate (PREMPRO). The patient previously took SHINGRIX on 18Oct2019 (when the patient was 71 years old) for shingles vaccine, and had subacute thyroiditis, enlarged thyroid and glands, rash from wrist to arm and shoulder, swollen and sore arm, and swollen neck glands and thyroid around left side. The patient previously took codeine, and had allergy. On 25Jan2021 (20:00), the patient had sore arm. The sore arm improved the next day. On 30Jan2021 (between 18:00 and 19:00), the patient was "sort of" feeling achy. On 30Jan2021 (23:00), the patient had fever of 100.4 (unit was not provided). The patient took paracetamol (TYLENOL) as treatment for the fever, and started getting better. The patient got tested as a precaution, and was negative for COVID-19 test on 31Jan2021. On 31Jan2021 (between 08:00 and 09:00), the patient had stomach issues. On 31Jan2021 (13:00), the patient had chills. The outcome of the events, 'sore arm', 'achy', 'fever', 'stomach issues' and 'chills', was recovering. The patient was due to the second dose of vaccination on 15Feb2021, and wanted to know if it would be okay for her to get it.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; Stomach issues; Fever of 100.4; Sort of feeling achy; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported), intramuscularly on the left arm on 25Jan2021 (13:45) at a single dose for COVID-19 immunization at the university clinic (not a military facility). Medical history allergy to penicillin; allergy to bees; allergy to environmental grass and ragweed; and was in muscle relaxant therapy. Concomitant medications included cannabidiol (CBD OIL) as muscle relaxer; and estrogens conjugated, medroxyprogesterone acetate (PREMPRO). The patient previously took SHINGRIX on 18Oct2019 (when the patient was 71 years old) for shingles vaccine, and had subacute thyroiditis, enlarged thyroid and glands, rash from wrist to arm and shoulder, swollen and sore arm, and swollen neck glands and thyroid around left side. The patient previously took codeine, and had allergy. On 25Jan2021 (20:00), the patient had sore arm. The sore arm improved the next day. On 30Jan2021 (between 18:00 and 19:00), the patient was "sort of" feeling achy. On 30Jan2021 (23:00), the patient had fever of 100.4 (unit was not provided). The patient took paracetamol (TYLENOL) as treatment for the fever, and started getting better. The patient got tested as a precaution, and was negative for COVID-19 test on 31Jan2021. On 31Jan2021 (between 08:00 and 09:00), the patient had stomach issues. On 31Jan2021 (13:00), the patient had chills. The outcome of the events, 'sore arm', 'achy', 'fever', 'stomach issues' and 'chills', was recovering. The patient was due to the second dose of vaccination on 15Feb2021, and wanted to know if it would be okay for her to get it.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). An 83 -year-old male patient receieved bnt162b2 (BNT162B2) , intramuscular on 2Jan2021 09:30 toat SINGLE DOSE for an COVID-19 immunizattion.  Medical history included lung disorder from an unknown date and unknown if ongoing had some lung issues in the past. She said that he was hospitalized in Jan2020 for something really odd , cough, pulmonary oedema  , atypical pneumonia, mycobacterial infection; Couple of years ago and had to take some IV medications through a PICC line and that was about 2 years ago and it has cleared up.  There were no concomitant medications.  The patient experienced nausea and  dizziness on 13Jan2021 04:00 The outcome of events was recovered.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Nausea
Clinical narrative: they gave her some IV because she was dehydrated; high blood pressure; felt like she was getting a migraine; she started getting dizzy; she has never had a hangover but it felt like she had a hangover; she didn't feel good; she was sick on her stomach; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. Patient received the first dose of the COVID vaccine and was experiencing high blood pressure on an unspecified date in Jan2021. Patient went to the ER and they told her something in the vaccine made it go up. Patient would like to know what in the vaccine would cause her blood pressure to go up and if any has experienced high blood pressure as a side effect of the vaccine. Patient reported that she didn't feel good, felt like she was getting a migraine and after that she started getting dizzy and she thought she was going to help herself and lay down on the bed for about 45 minutes and then she got up after that and walked around on Jan2021. She felt like, she has never had a hangover but it felt like she had a hangover, that was what it felt like, and she thought she hopes that doesn't last and she got up Wednesday morning (Jan2021) and went to her podiatrist appointment. She didn't feel good but she was okay so she went to the podiatrist and then later she was fixing supper and she had some grease in a pan that she fried something in and she thought she wanted to get some water in it so she went to go with the pan and she got to the door and took 3 steps back and she thought good Lord, there is something is wrong here. She did empty the water and the grease and she thought well it is going to have to stay there, it was right at the back door so anyway. Her son came home from work and she got him get the blood pressure cuff and take her pressure and it was 158/98 and she thought, this was not good. She said she will just go lay down for a while and she went on to bed. The patient was taken into the hospital via an ambulance. She sat there until about 4-5 hours and later they got to take her blood pressure and result was 189/92 on Jan2021. They gave her some IV because she was dehydrated and she got home, she lives about 30 miles form the hospital so they got home about 3 o'clock and next day she didn't feel good but she felt better. She confirmed she was not admitted to the hospital it was an ER visit and they sent her home. She felt Thursday was not a good day she came down off of what had her up. She was going to say no to the second dose because she was sick on her stomach and drunk as a dog, she was really dizzy, very dizzy and she just had to sit down quiet her self. She was supposed to have surgery but because of COVID it has been cancelled 3 times. The outcome of the events were unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site bruising, Vaccination site coldness, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: bleeding at injection site; large bruise; sensation of chill/cold at vaccination site at time of injection; soreness; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3249), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:00 (at the age of 71-years-old) at a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within 2 weeks of vaccination, included tamsulosin (MANUFACTURER UNKNOWN), finasteride (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN). The patient experienced bleeding at injection site, large bruise, sensation of chill/cold at vaccination site at time of injection, and soreness on 15Jan2021 13:00. The events were reported as non-serious. The clinical course was reported as: The bleeding at injection site saturated the Band-Aid, but subsided quickly; the large bruise, which was now diminished, but still exists some 17 days later (as reported); sensation of chill/cold at vaccination site at time of injection; and soreness, although not significant, it still persists to this date of reporting. The patient underwent lab tests and procedures which included nasal swab: negative on 26Jan2021. The patient did not receive any treatment for the events. The clinical outcome of bleeding at injection site was recovered on an unspecified date, sensation of chill/cold at vaccination site at time of injection was recovered on 15Jan2021, and large bruise and soreness was recovering.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Oropharyngeal discomfort, Pruritus, Swelling face, Tongue discomfort
Clinical narrative: numbness in her lips; swelling in her face; her tongue was feeling funny; her throat was feeling strange; she had itchiness to her right hand; started to develop hives; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 01Feb2021 at 09:00 (at the age of 61-years-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. The patient experienced numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives on 01Feb2021. The clinical course was reported as follows: Approximately 3 hours after receiving the vaccine, the patient started to experience numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, and she had itchiness to her right hand and started to develop hives. The patient stated that she cannot take diphenhydramine hydrochloride (BENADRYL), but she did take cetirizine hydrochloride (ZYRTEC) to help with the symptoms. The patient was still having symptoms at the time of reporting. Therapeutic measures were taken as a result of all of the events as aforementioned. The clinical outcome of numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives was not recovered.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: numbness in her lips; swelling in her face; her tongue was feeling funny; her throat was feeling strange; she had itchiness to her right hand; started to develop hives; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 01Feb2021 at 09:00 (at the age of 61-years-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. The patient experienced numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives on 01Feb2021. The clinical course was reported as follows: Approximately 3 hours after receiving the vaccine, the patient started to experience numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, and she had itchiness to her right hand and started to develop hives. The patient stated that she cannot take diphenhydramine hydrochloride (BENADRYL), but she did take cetirizine hydrochloride (ZYRTEC) to help with the symptoms. The patient was still having symptoms at the time of reporting. Therapeutic measures were taken as a result of all of the events as aforementioned. The clinical outcome of numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives was not recovered.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Product use issue, Pyrexia, Vaccination site erythema
Clinical narrative: Fever; joint & muscle pain; joint & muscle pain; Injection site - large red spot (about 4 inches in diameter); swollen; hot to touch; other vaccine same date dose number 6; This is a spontaneous report from a contactable healthcare professional (patient). This 63-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; EL3247) via an unspecified route of administration in the left arm on 29Jan2021 at 14:15 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included allergy to shellfish and allergy to eggs, both from unknown dates and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EL0142) in the left arm on 11Jan2021; codeine from an unknown date for an unknown indication and experienced allergy; celecoxib (CELEBREX) from an unknown date for an unknown indication and experienced allergy; and alendronate sodium (FOSAMAX) from an unknown date for an unknown indication and experienced allergy. The patient reported fever, joint and muscle pain 24 hours after the vaccine and stated it lasted about 18 hours. She also reported about the injection site that it was a large red spot (about 4 inches in diameter), it was swollen and hot to touch starting about 24 hours after vaccination. She reported 3 days later it was still red, swollen and hot to touch. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of fever, joint and muscle pain were recovered on 31Jan2021. The clinical outcomes of large red spot (about 4 inches in diameter), swollen, hot to touch were not recovered. The clinical outcome of other vaccine same date dose number 6 was unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Fever; joint & muscle pain; joint & muscle pain; Injection site - large red spot (about 4 inches in diameter); swollen; hot to touch; other vaccine same date dose number 6; This is a spontaneous report from a contactable healthcare professional (patient). This 63-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; EL3247) via an unspecified route of administration in the left arm on 29Jan2021 at 14:15 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included allergy to shellfish and allergy to eggs, both from unknown dates and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EL0142) in the left arm on 11Jan2021; codeine from an unknown date for an unknown indication and experienced allergy; celecoxib (CELEBREX) from an unknown date for an unknown indication and experienced allergy; and alendronate sodium (FOSAMAX) from an unknown date for an unknown indication and experienced allergy. The patient reported fever, joint and muscle pain 24 hours after the vaccine and stated it lasted about 18 hours. She also reported about the injection site that it was a large red spot (about 4 inches in diameter), it was swollen and hot to touch starting about 24 hours after vaccination. She reported 3 days later it was still red, swollen and hot to touch. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of fever, joint and muscle pain were recovered on 31Jan2021. The clinical outcomes of large red spot (about 4 inches in diameter), swollen, hot to touch were not recovered. The clinical outcome of other vaccine same date dose number 6 was unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Nausea
Clinical narrative: stomach cramps; massive diarrhea; nausea; headache; This is a spontaneous report from a contactable consumer (patient). This 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot EK9231) via an unspecified route of administration in the left arm on 22Jan2021 at 17:15 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history included anal cancer from 2009 and unknown if ongoing; and cancer Non-Hodgkin's lymph from 1993 and unknown if ongoing. The patient had no allergies to medications, foods or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included sertraline 100 mg from an unknown date for an unknown indication; rosuvastatin 5 mg from an unknown date for an unknown indication and cetirizine hydrochloride (ZYRTEK) from an unknown date for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported on the fifth day (27Jan2021) she had stomach cramps, massive diarrhea, nausea and headache and had to lay down; lasting from about 09:00 to 18:00. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of stomach cramps, massive diarrhea, nausea and headache were recovered on 27Jan2021 at 18:00. It was also reported the patient was not tested for COVID-19 since vaccination.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) via an unspecified route of administration on 21Jan2021 (at the age of 67-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included "thyroid," high blood pressure, depression, anxiety, and osteoporosis. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. It was unknown if the patient had any allergies to medications, food, or other products. The patient received unspecified concomitant medications. The patient did not receive any pother vaccines within 4 weeks prior to the vaccine. On 21Jan2021, the patient experienced left arm red, hot, and raised at first. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcome of left arm raised was recovered. The outcomes of left arm hot and red was not recovered; left arm was still red and hot and it was day 12. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu symptoms; This is a spontaneous report from contactable consumer via Pfizer Sales Representative. A female patient of age 08 decades (reported as late 70s) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as single dose on an unknown date for COVID-19 immunization. Medical history included: thyroid condition. On an unknown date patient felt like she had flu symptoms. Outcome of event was unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate irregular, Tachycardia
Clinical narrative: Blood pressure spiked to 159/98 and 169/92; tachycardia (pulse rate 152); irregular rhythm; This is a spontaneous report from a contactable consumer (patient). An adult female patient received (BNT162B2, Solution for injection, Lot: ENS318), via an unspecified route of administration on Jan2021 in left arm at single dose for covid-19 immunisation. Medical history included Allergies to medications, food, or other products: Yes, and had severe adverse reaction to an unrelated vaccine in 1988 that resulted in epi-pen administration. The patient previously took epi-pen. On Jan2021, the patient stated that roughly 7 minutes in, she began experiencing tachycardia (pulse rate 152). She requested help and doctors examined her, it was nothing. She also had an irregular rhythm. Blood pressure spiked to 159/98 and 169/92. Bp and pulse came down somewhat over the next 90 minutes, but remained significantly higher than normal for 11 hours (bp: 140s-150s/high 80s-low 90s compared to high-end norm of 110-120/65-70); pulse: 112-114 sitting compared to high-end norm of low 70s). More importantly, the irregular rhythm had continued for 10 days now and she was being followed by a cardiologist. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient was treated for the adverse event. But not so much treatment, as much as monitoring. The outcome of the event irregular rhythm was not recovered and rest of the events was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash pruritic, Urticaria
Clinical narrative: Rash that itches; Hives are still bright and red, they are not on my face anymore or my neck, just my chest; Scalp itches something awful/back of legs itch/ankles itch/fingers itch; Redness on my arms; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. Medical history included high blood pressure from an unknown date. Concomitant medication included losartan and atorvastatin for blood pressure high. The patient reported that they were having a mild, they believe reaction. They were not in anaphylactic shock, their face hasn't swollen 'up to size' (not clarified), nothing like that. They have a rash that itches, have hives on their chest, but their scalp itches something awful, the back of their legs itch, their ankles itch, and their fingers itch. They don't have any swelling, but they do have redness on their arms, well they did last night. The redness of their arms is gone, but the hives are still bright and red and they are not on their face anymore or neck, just the chest. The events occurred on 30Jan2021. The patient took antihistamine as treatment for the events. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: tongue feels a bit swollen; This is a spontaneous report from a contactable consumer (patient). A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL3249 and expiration date unknown) via an unspecified route of administration on 27Jan2021 (at 92 years old) at a SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications were unspecified; patient is taking a lot of medications. The patient stated that she just had the vaccine on Wednesday, 27Jan2021 and her tongue feels a bit swollen on an unspecified date in Jan2021. But it was getting better now. Patient asked what she should take as it seems to lighten a little bit. Since then it was quite bad, it is still swollen but not as bad as it was. Outcome of the event was recovering.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Hyperhidrosis, Nausea
Clinical narrative: fever at 100.4; Headache; Nausea; Sniffles; Chills; he was beated down with sweat; body aches; does not have an appetite; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, intramuscular in the left arm, on 08Jan2021 16:30 at 0.3 mL, single for COVID-19 immunization.  Medical history included ongoing high blood pressure and spinal surgery in Jan2019. Patient's eyesight was not the greatest. Patient previously received flu vaccine on an unspecified date (the last couple of years). Concomitant medication included amlodipine besilate for blood pressure. He was scheduled to get second dose on 29Jan2021. The Saturday before he was scheduled to get the second dose (23Jan2021), he started feeling sniffles and stuff. He went to urgent care and he was tested for covid and the test came back negative. He then kept feeling bad. He clarified that on 24Jan2021, he had headache and nausea. He had chills and he was beated down with sweat; body aches which are constant and he  would try to blame it on the position he was laying in while on the couch and it was not that; and does not have an appetite on an unspecified day in Jan2021. He has been in really bad shape for the last 9 or 10 days. When he went to go get his second shot, they would not give it to him due to his symptoms that he was experiencing since she had a fever at 100.4 the night before (28Jan2021). They scheduled him to get his second dose the following which was this Friday. He was asking if his side effects are totally normal. He cannot even sleep, reported that he will sleep an hour and then up for two or three hours. It really has him, and he feels miserable. The outcome of events Chills, nausea and fever at 100.4 was not recovered. Outcome of sniffles was recovered in Jan 2021 while the outcome of the remaining events was unknown. Therapeutic measures were taken as a result of sniffles; he went to urgent care and they gave him something like zyrtec, states it was an allergy medication and it wiped out the sniffles for fever, he will take Tylenol and it will break the fever for a few hours and then his fever comes right back.  Follow-up attempts are completed. The information on the batch/lot number has been obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 antibody test
Clinical narrative: fever at 100.4; Headache; Nausea; Sniffles; Chills; he was beated down with sweat; body aches; does not have an appetite; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, intramuscular in the left arm, on 08Jan2021 16:30 at 0.3 mL, single for COVID-19 immunization.  Medical history included ongoing high blood pressure and spinal surgery in Jan2019. Patient's eyesight was not the greatest. Patient previously received flu vaccine on an unspecified date (the last couple of years). Concomitant medication included amlodipine besilate for blood pressure. He was scheduled to get second dose on 29Jan2021. The Saturday before he was scheduled to get the second dose (23Jan2021), he started feeling sniffles and stuff. He went to urgent care and he was tested for covid and the test came back negative. He then kept feeling bad. He clarified that on 24Jan2021, he had headache and nausea. He had chills and he was beated down with sweat; body aches which are constant and he  would try to blame it on the position he was laying in while on the couch and it was not that; and does not have an appetite on an unspecified day in Jan2021. He has been in really bad shape for the last 9 or 10 days. When he went to go get his second shot, they would not give it to him due to his symptoms that he was experiencing since she had a fever at 100.4 the night before (28Jan2021). They scheduled him to get his second dose the following which was this Friday. He was asking if his side effects are totally normal. He cannot even sleep, reported that he will sleep an hour and then up for two or three hours. It really has him, and he feels miserable. The outcome of events Chills, nausea and fever at 100.4 was not recovered. Outcome of sniffles was recovered in Jan 2021 while the outcome of the remaining events was unknown. Therapeutic measures were taken as a result of sniffles; he went to urgent care and they gave him something like zyrtec, states it was an allergy medication and it wiped out the sniffles for fever, he will take Tylenol and it will break the fever for a few hours and then his fever comes right back.  Follow-up attempts are completed. The information on the batch/lot number has been obtained.