chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: EW0150) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 on unspecified date after getting the first dose of PFIZER-BIONTECH COVID-19 MRNA VACCINE. He added he has completed his 10-day quarantine yesterday. He explained that he should receive a confirmation email for the completed isolation today. He asked if he could get the second dose of the vaccine tomorrow, as initially scheduled. He then stated since a lost smell persists longer than other symptoms, is it included in the interim considerations from the CDC under their no symptoms criteria. The patient's second shot was scheduled on 27th of April. The outcome of the event was unknown.  No further information is expected; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Headache
Clinical narrative: The first shot I had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards; The first shot I had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards; This is a spontaneous report from a contactable consumer.   A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), dose 1 via an unspecified route of administration, administered in the left arm on 20Mar2021 as single dose for covid-19 immunization.  The patient medical history was not reported. Concomitant medication included etonogestrel (IMPLANON) taken for an unspecified indication, start and stop date were not reported; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; ashwagandha (ASHWAGANDHA) taken for an unspecified indication, start and stop date were not reported. The patient was also taking unspecified multivitamins. No other vaccines were administered within four weeks of vaccination.  On an unspecified date in 2021, the patient noted with the first shot I had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards. Details were as follows: patient noted that she never had period due to birth control methods. Following the  first shot, she had a slight headache hours after the shot, and then got light embryos bleeding a few day afterwards.  No treatment was given for the events. No COVID infection was noted prior to the vaccination, no COVID test was performed post vaccination. The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on 16Apr2021 with outcome of unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Dyspnoea, Dyspnoea exertional, Erythema, Fatigue
Clinical narrative: blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; cold sore; super red and itchy; super red and itchy; tongue started to get itchy; the lymph nodes in her neck were really swollen; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0153, first dose, expiration date 31Jul2021) solution for injection intramuscular in the left arm on 16Apr2021 at 15:45 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included acid reflux, latex (allergy), sulfa based medicine (allergy), and pineapple (allergy). Concomitant medications included ongoing lansoprazole (PREVACID) for acid reflux, ongoing montelukast sodium (SINGULAIR) for seasonal allergy, ongoing fluticasone propionate (FLONASE) for seasonal allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 16Apr2021, the patient experienced metallic taste (5 seconds after vaccination), hives on face and neck (45 minutes after), shortness of breath walking resulting on doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care which included treatment with steroid shot and BENADRYL shot. On 17Apr2021, the patient experienced exhausted and winded. In Apr2021, the patient experienced cold sore, was super red and itchy, tongue started to get itchy, the lymph nodes in her neck were really swollen that included unspecified treatment. On 24Apr2021, the patient experienced blisters in her mouth and used hydrogen peroxide 3% to clean. The outcome of the events metallic taste, hives on face and neck, shortness of breath walking was recovering. The outcome of the events cold sore, super red and itchy, exhausted and winded, tongue started to get itchy, the lymph nodes in her neck were really swollen was unknown. The outcome of the event blisters in her mouth was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Oral herpes, Oral mucosal blistering, Pruritus, Tongue pruritus
Clinical narrative: blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; cold sore; super red and itchy; super red and itchy; tongue started to get itchy; the lymph nodes in her neck were really swollen; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0153, first dose, expiration date 31Jul2021) solution for injection intramuscular in the left arm on 16Apr2021 at 15:45 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included acid reflux, latex (allergy), sulfa based medicine (allergy), and pineapple (allergy). Concomitant medications included ongoing lansoprazole (PREVACID) for acid reflux, ongoing montelukast sodium (SINGULAIR) for seasonal allergy, ongoing fluticasone propionate (FLONASE) for seasonal allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 16Apr2021, the patient experienced metallic taste (5 seconds after vaccination), hives on face and neck (45 minutes after), shortness of breath walking resulting on doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care which included treatment with steroid shot and BENADRYL shot. On 17Apr2021, the patient experienced exhausted and winded. In Apr2021, the patient experienced cold sore, was super red and itchy, tongue started to get itchy, the lymph nodes in her neck were really swollen that included unspecified treatment. On 24Apr2021, the patient experienced blisters in her mouth and used hydrogen peroxide 3% to clean. The outcome of the events metallic taste, hives on face and neck, shortness of breath walking was recovering. The outcome of the events cold sore, super red and itchy, exhausted and winded, tongue started to get itchy, the lymph nodes in her neck were really swollen was unknown. The outcome of the event blisters in her mouth was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; cold sore; super red and itchy; super red and itchy; tongue started to get itchy; the lymph nodes in her neck were really swollen; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0153, first dose, expiration date 31Jul2021) solution for injection intramuscular in the left arm on 16Apr2021 at 15:45 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included acid reflux, latex (allergy), sulfa based medicine (allergy), and pineapple (allergy). Concomitant medications included ongoing lansoprazole (PREVACID) for acid reflux, ongoing montelukast sodium (SINGULAIR) for seasonal allergy, ongoing fluticasone propionate (FLONASE) for seasonal allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 16Apr2021, the patient experienced metallic taste (5 seconds after vaccination), hives on face and neck (45 minutes after), shortness of breath walking resulting on doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care which included treatment with steroid shot and BENADRYL shot. On 17Apr2021, the patient experienced exhausted and winded. In Apr2021, the patient experienced cold sore, was super red and itchy, tongue started to get itchy, the lymph nodes in her neck were really swollen that included unspecified treatment. On 24Apr2021, the patient experienced blisters in her mouth and used hydrogen peroxide 3% to clean. The outcome of the events metallic taste, hives on face and neck, shortness of breath walking was recovering. The outcome of the events cold sore, super red and itchy, exhausted and winded, tongue started to get itchy, the lymph nodes in her neck were really swollen was unknown. The outcome of the event blisters in her mouth was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Oral mucosal blistering, Urticaria
Clinical narrative: blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; cold sore; super red and itchy; super red and itchy; tongue started to get itchy; the lymph nodes in her neck were really swollen; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0153, first dose, expiration date 31Jul2021) solution for injection intramuscular in the left arm on 16Apr2021 at 15:45 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included acid reflux, latex (allergy), sulfa based medicine (allergy), and pineapple (allergy). Concomitant medications included ongoing lansoprazole (PREVACID) for acid reflux, ongoing montelukast sodium (SINGULAIR) for seasonal allergy, ongoing fluticasone propionate (FLONASE) for seasonal allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 16Apr2021, the patient experienced metallic taste (5 seconds after vaccination), hives on face and neck (45 minutes after), shortness of breath walking resulting on doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care which included treatment with steroid shot and BENADRYL shot. On 17Apr2021, the patient experienced exhausted and winded. In Apr2021, the patient experienced cold sore, was super red and itchy, tongue started to get itchy, the lymph nodes in her neck were really swollen that included unspecified treatment. On 24Apr2021, the patient experienced blisters in her mouth and used hydrogen peroxide 3% to clean. The outcome of the events metallic taste, hives on face and neck, shortness of breath walking was recovering. The outcome of the events cold sore, super red and itchy, exhausted and winded, tongue started to get itchy, the lymph nodes in her neck were really swollen was unknown. The outcome of the event blisters in her mouth was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Dyspnoea, Dyspnoea exertional, Erythema, Fatigue
Clinical narrative: blisters inside and outside the mouth; hives; metallic taste; This is a spontaneous report received from a contactable consumer, the patient. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as a single dose (at the age of 44 years-old) for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced blisters inside and outside the mouth, hives, metallic taste all on an unspecified dates.  Therapeutic measures were taken as a result of hives and included the patient received a steroid shot. The outcome of the events blisters inside and outside the mouth, hives, and metallic taste was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Oral herpes, Oral mucosal blistering, Pruritus, Tongue pruritus
Clinical narrative: blisters inside and outside the mouth; hives; metallic taste; This is a spontaneous report received from a contactable consumer, the patient. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as a single dose (at the age of 44 years-old) for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced blisters inside and outside the mouth, hives, metallic taste all on an unspecified dates.  Therapeutic measures were taken as a result of hives and included the patient received a steroid shot. The outcome of the events blisters inside and outside the mouth, hives, and metallic taste was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: blisters inside and outside the mouth; hives; metallic taste; This is a spontaneous report received from a contactable consumer, the patient. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as a single dose (at the age of 44 years-old) for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced blisters inside and outside the mouth, hives, metallic taste all on an unspecified dates.  Therapeutic measures were taken as a result of hives and included the patient received a steroid shot. The outcome of the events blisters inside and outside the mouth, hives, and metallic taste was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Oral mucosal blistering, Urticaria
Clinical narrative: blisters inside and outside the mouth; hives; metallic taste; This is a spontaneous report received from a contactable consumer, the patient. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as a single dose (at the age of 44 years-old) for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced blisters inside and outside the mouth, hives, metallic taste all on an unspecified dates.  Therapeutic measures were taken as a result of hives and included the patient received a steroid shot. The outcome of the events blisters inside and outside the mouth, hives, and metallic taste was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Flu coming on; Sore arm; Did not feel quite right/feeling funny; This is a spontaneous report from a contactable consumer via Medical Information Team. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose for COVID-19 immunization. Patient stated that he received the first dose of the PFIZER BIONTECH COVID-19 mRNA VACCINE 3.5 weeks ago and the second dose last Wednesday (21Apr2021). Patient stated that after the first dose he had a sore arm, stated did not feel quite right, nothing major, like the flu coming on but no fever, stated feeling funny. Patient stated that nothing happened to him on the first, second or third day after the second dose of the vaccine side effect wise noting nothing like on the first dose. Patient stated he was concerned about the second dose not going in because he is not having any side effects. Patient stated the nurse stung him the first time and said nothing is coming out and the nurse stung him again and the patient stated he felt wetness on his arm. Patient stated the nurse did not squeeze up his arm and put it right in.  Patient stated the nurse said to him she did not like the "syringes" and the patient is thinking that the needle was bent. Patient stated he asked the nurse did everything go in and the nurse told him yes and sent him on his way. Patient stated his wife and mother had the second dose and had the same symptoms but stronger than the first dose. Patient stated his wife had the second dose Saturday and reported soreness stronger than the first time and body ached a little bit, not feeling ok, nothing major, patient stated yesterday her arm was still a little sore but today she is better. Patient reported his mother got the second dose on Saturday and reported about the same as his wife noting soreness in the arm and pain in the legs stating it is gone now. Patient stated he is not happy about the answer he received and stated he did not want to report anything to DSU. Patient hung up on agent before any demographics could be obtained, side effect reports verified and survey offered. Patient asked is there a test for antibodies to see if his vaccine worked. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dysgeusia, Hallucination, Parosmia
Clinical narrative: minor hallucinations; metallic taste; horrible smell that she experiences in which it makes her not want to eat or drink; chills; joint pain; tissue tender; This is a spontaneous report from a contactable nurse (patient).  An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN9581), via an unspecified route of administration, administered in deltoid right on 12Feb2021 (at the age of 80-years-old) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 22Jan2021 for COVID-19 immunisation. The reporter stated that since then (having both doses of the vaccine), she has been to the emergency room 4 different times experiencing side effects. She has a metallic taste and horrible smell that she experienced in which it made her not want to eat or drink. She has minor hallucinations, chills, joint pain, and her tissue is tender. Her joint pain has improved. Then stated, "I'm afraid I'm going to die from it." She asked if anyone has reported these reactions previously and what should she do about them. Her family physician's nurse looked up a study in which 11% of the patients were experiencing a metallic taste. Also stated, "This is very discouraging and depressing." The outcome of the event joint pain was recovering while of the rest was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of minor hallucinations cannot be excluded due to temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: minor hallucinations; metallic taste; horrible smell that she experiences in which it makes her not want to eat or drink; chills; joint pain; tissue tender; This is a spontaneous report from a contactable nurse (patient).  An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN9581), via an unspecified route of administration, administered in deltoid right on 12Feb2021 (at the age of 80-years-old) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 22Jan2021 for COVID-19 immunisation. The reporter stated that since then (having both doses of the vaccine), she has been to the emergency room 4 different times experiencing side effects. She has a metallic taste and horrible smell that she experienced in which it made her not want to eat or drink. She has minor hallucinations, chills, joint pain, and her tissue is tender. Her joint pain has improved. Then stated, "I'm afraid I'm going to die from it." She asked if anyone has reported these reactions previously and what should she do about them. Her family physician's nurse looked up a study in which 11% of the patients were experiencing a metallic taste. Also stated, "This is very discouraging and depressing." The outcome of the event joint pain was recovering while of the rest was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of minor hallucinations cannot be excluded due to temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Blood pressure decreased, Chest pain, Investigation, Pain in jaw
Clinical narrative: blood pressure drop; nearly fainted; chest pain; jaw pain; loss of vision; Multiple bilateral pulmonary embolisms in my lungs; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 39 years of age), via an unspecified route of administration, administered in arm left on 04Feb2021 (Batch/Lot Number: EN6202) as 2nd dose, single for COVID-19 immunisation. Medical history included MTHFR blood clotting gene mutation. Concomitant medications included citalopram, metoprolol, omeprazole and minastein fe24, all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (lot number: EN9581) dose 1 on an unknown date (also reported as 04Feb2021) 01:00 PM in left arm for COVID-19 immunisation. The patient was not pregnant. The patient did not have any other vaccine within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 prior since vaccination. It was reported that 6 weeks after the second dose on 21Apr2021 12:00, the patient had a blood pressure drop, nearly fainted, chest pain, jaw pain, loss of vision. She went to emergency room (ER), they did tests and found multiple bilateral pulmonary embolisms in her lungs. The adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events, Eliquis (reported as 'Eloquis') blood thinners given. The patient was hospitalized for the events for one day. The outcome of the events was not recovered. Information on the batch lot/batch number has been obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Pulmonary embolism
Clinical narrative: blood pressure drop; nearly fainted; chest pain; jaw pain; loss of vision; Multiple bilateral pulmonary embolisms in my lungs; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 39 years of age), via an unspecified route of administration, administered in arm left on 04Feb2021 (Batch/Lot Number: EN6202) as 2nd dose, single for COVID-19 immunisation. Medical history included MTHFR blood clotting gene mutation. Concomitant medications included citalopram, metoprolol, omeprazole and minastein fe24, all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (lot number: EN9581) dose 1 on an unknown date (also reported as 04Feb2021) 01:00 PM in left arm for COVID-19 immunisation. The patient was not pregnant. The patient did not have any other vaccine within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 prior since vaccination. It was reported that 6 weeks after the second dose on 21Apr2021 12:00, the patient had a blood pressure drop, nearly fainted, chest pain, jaw pain, loss of vision. She went to emergency room (ER), they did tests and found multiple bilateral pulmonary embolisms in her lungs. The adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events, Eliquis (reported as 'Eloquis') blood thinners given. The patient was hospitalized for the events for one day. The outcome of the events was not recovered. Information on the batch lot/batch number has been obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dermatitis, Flatulence, Headache
Clinical narrative: Vomiting; chills; sweating; fever; extreme joint pain (especially in my knees); extreme skin inflammation pain; pain; restlessness; nausea; gassiness; piercing headache; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 15Apr2021 11:00 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation. Medical history included bipolar 2, allergies to red dyes, and detergents. The patient is not pregnant at time of vaccination. Concomitant medication included lamotrigine (LAMICTAL); trazodone; fluoxetine and multiv. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, administered in arm left on 25Mar2021 11:00 (Batch/Lot Number: ER2613) for covid-19 immunisation. The patient experienced vomiting, chills, sweating, fever, extreme joint pain (especially in her knees), extreme skin inflammation pain, restlessness, nausea, gassiness, piercing headache, muscle aches all on 15Apr2021 19:00. Symptoms onset 8 hours post second dose, went away by hour 20 post second dose, except for splitting headache which lingered for several days. Tylenol taken on regular schedule didn't kill pain. Alternated rosin salt bath/hot shower through the night. No treatment was received for other events. All events were serious. Prior to vaccination, no patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks. The outcome of event headache was unknown, while other outcomes of events were recovered.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Vomiting; chills; sweating; fever; extreme joint pain (especially in my knees); extreme skin inflammation pain; pain; restlessness; nausea; gassiness; piercing headache; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 15Apr2021 11:00 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation. Medical history included bipolar 2, allergies to red dyes, and detergents. The patient is not pregnant at time of vaccination. Concomitant medication included lamotrigine (LAMICTAL); trazodone; fluoxetine and multiv. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, administered in arm left on 25Mar2021 11:00 (Batch/Lot Number: ER2613) for covid-19 immunisation. The patient experienced vomiting, chills, sweating, fever, extreme joint pain (especially in her knees), extreme skin inflammation pain, restlessness, nausea, gassiness, piercing headache, muscle aches all on 15Apr2021 19:00. Symptoms onset 8 hours post second dose, went away by hour 20 post second dose, except for splitting headache which lingered for several days. Tylenol taken on regular schedule didn't kill pain. Alternated rosin salt bath/hot shower through the night. No treatment was received for other events. All events were serious. Prior to vaccination, no patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks. The outcome of event headache was unknown, while other outcomes of events were recovered.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, Vomiting
Clinical narrative: Vomiting; chills; sweating; fever; extreme joint pain (especially in my knees); extreme skin inflammation pain; pain; restlessness; nausea; gassiness; piercing headache; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 15Apr2021 11:00 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation. Medical history included bipolar 2, allergies to red dyes, and detergents. The patient is not pregnant at time of vaccination. Concomitant medication included lamotrigine (LAMICTAL); trazodone; fluoxetine and multiv. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, administered in arm left on 25Mar2021 11:00 (Batch/Lot Number: ER2613) for covid-19 immunisation. The patient experienced vomiting, chills, sweating, fever, extreme joint pain (especially in her knees), extreme skin inflammation pain, restlessness, nausea, gassiness, piercing headache, muscle aches all on 15Apr2021 19:00. Symptoms onset 8 hours post second dose, went away by hour 20 post second dose, except for splitting headache which lingered for several days. Tylenol taken on regular schedule didn't kill pain. Alternated rosin salt bath/hot shower through the night. No treatment was received for other events. All events were serious. Prior to vaccination, no patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks. The outcome of event headache was unknown, while other outcomes of events were recovered.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Blood pressure increased, Blood pressure measurement, Dizziness
Clinical narrative: weakness; Right arm sore at injection site; Body started shaking uncontrollably; she felt faint; she felt like she was going to pass out; feeling off kilter; nauseous; a stiffness in the back of her neck; she checked her blood pressure and it elevated; Felt jumpy; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0153) via an unspecified route of administration, administered into right arm on 11Apr2021 as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications include vitamins and supplements (unspecified). On 14Apr2021, patient felt jumpy. On 15Apr2021, patient felt faint, she felt like she was going to pass out as she was feeling off kilter, she was nauseous, had a stiffness in the back of her neck, she checked her blood pressure and it was elevated. On an unspecified date, she experienced weakness, right arm sore at injection site and her body started shaking uncontrollably. Outcome of events was unknown.  No follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nausea, Nervousness, Presyncope, Tremor
Clinical narrative: weakness; Right arm sore at injection site; Body started shaking uncontrollably; she felt faint; she felt like she was going to pass out; feeling off kilter; nauseous; a stiffness in the back of her neck; she checked her blood pressure and it elevated; Felt jumpy; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0153) via an unspecified route of administration, administered into right arm on 11Apr2021 as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications include vitamins and supplements (unspecified). On 14Apr2021, patient felt jumpy. On 15Apr2021, patient felt faint, she felt like she was going to pass out as she was feeling off kilter, she was nauseous, had a stiffness in the back of her neck, she checked her blood pressure and it was elevated. On an unspecified date, she experienced weakness, right arm sore at injection site and her body started shaking uncontrollably. Outcome of events was unknown.  No follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: weakness; Right arm sore at injection site; Body started shaking uncontrollably; she felt faint; she felt like she was going to pass out; feeling off kilter; nauseous; a stiffness in the back of her neck; she checked her blood pressure and it elevated; Felt jumpy; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0153) via an unspecified route of administration, administered into right arm on 11Apr2021 as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications include vitamins and supplements (unspecified). On 14Apr2021, patient felt jumpy. On 15Apr2021, patient felt faint, she felt like she was going to pass out as she was feeling off kilter, she was nauseous, had a stiffness in the back of her neck, she checked her blood pressure and it was elevated. On an unspecified date, she experienced weakness, right arm sore at injection site and her body started shaking uncontrollably. Outcome of events was unknown.  No follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Vaginal haemorrhage
Clinical narrative: post menopausal vaginal bleeding; vaginal hemorrhage; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Apr2021 as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 24Mar2021 for COVID-19 immunization. Patient stated she had already reported this, did not confirm a reference, did not provide her age or prescribing physician's information. She asked if there were reports of "post menopausal vaginal bleeding or vaginal hemorrhage". She received Pfizer-BioNTech COVID-19 Vaccine. She stated "I found it reported online, I researched it, post menopausal vaginal bleeding/ vaginal hemorrhage. I'm in a terrible situation." The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: not feeling well; received the first dose of the Pfizer vaccine on 19Mar2021. I received the second dose of the vaccine on 09Apr2021. I tested positive for COVID on 18Apr2021.; received the first dose of the Pfizer vaccine on 19Mar2021. I received the second dose of the vaccine on 09Apr2021. I tested positive for COVID on 18Apr2021.; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 09Apr2021 as 2nd dose, single 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 VACCINE) on 19Mar2021. The patient stated that she received the first dose of the Pfizer vaccine on 19Mar2021. She received the second dose of the vaccine on 09apr2021. She tested positive for COVID on 18Apr2021 (also reported as 21Apr2021, pending confirmation). The patient was not feeling well on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 18Apr2021. The outcome of the events was unknown. The patient wanted to know if she can et the COVID-19 infection from the vaccine. She also wanted to know if the vaccine can cause a false positive result. The patient was questioning if she tested positive due to the vaccine.  Information on the batch/lot number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic dysreflexia, Chills, Feeling abnormal, Headache, Heart rate increased
Clinical narrative: autonomic dysreflexia; vomiting; chills; sweating; muscle pain/I still have muscle pain in my shoulders and neck; my head and heart were pounding; my head and heart were pounding; felt bad; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received second dose of BNT162B2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Lot Number: EN6201) at age of 31 years as single dose for covid-19 immunisation. Medical history included spinal cord injury due to MVA in 2012, neurogenic (incontinent) bladder and bowel, bladder augmentation and mitrofanoff, chronic neuropathic pain, dependent of wheelchair. Patient had no known allergies. Concomitant medications included lavender oil (lavender, helichrysum, jasmine). Historical vaccine included first dose of BNT162B2 administered in Arm Left on 28Jan2021 01:45 PM (Lot Number: EL8982) at age of 31 years as single dose for covid-19 immunisation and no reaction on previous exposure to drug. With first menstrual period after receiving vaccine patient had vomiting, chills, sweating, muscle pain, and her head and heart were pounding. It felt bad enough to go to emergency room but she waited it out at home and it lasted a few hours. Patient had a spinal cord injury so the symptoms were similar to what she got with autonomic dysreflexia, but this was the worst case of it she had ever had. She hadn't vomited in 10 years (or before her spinal cord injury). Patient still had muscle pain in her shoulders and neck. Adverse event start date was on 25Apr2021 12:00. No treatment received. No covid prior vaccination. No covid tested post vaccination. Outcome of events was recovered.; Sender's Comments: Based on the current available information, the event Autonomic dysreflexia is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.  Medical history of spinal cord injury due to MVA in 2012 may provide a plausible explanation for the event. The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Vomiting
Clinical narrative: autonomic dysreflexia; vomiting; chills; sweating; muscle pain/I still have muscle pain in my shoulders and neck; my head and heart were pounding; my head and heart were pounding; felt bad; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received second dose of BNT162B2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Lot Number: EN6201) at age of 31 years as single dose for covid-19 immunisation. Medical history included spinal cord injury due to MVA in 2012, neurogenic (incontinent) bladder and bowel, bladder augmentation and mitrofanoff, chronic neuropathic pain, dependent of wheelchair. Patient had no known allergies. Concomitant medications included lavender oil (lavender, helichrysum, jasmine). Historical vaccine included first dose of BNT162B2 administered in Arm Left on 28Jan2021 01:45 PM (Lot Number: EL8982) at age of 31 years as single dose for covid-19 immunisation and no reaction on previous exposure to drug. With first menstrual period after receiving vaccine patient had vomiting, chills, sweating, muscle pain, and her head and heart were pounding. It felt bad enough to go to emergency room but she waited it out at home and it lasted a few hours. Patient had a spinal cord injury so the symptoms were similar to what she got with autonomic dysreflexia, but this was the worst case of it she had ever had. She hadn't vomited in 10 years (or before her spinal cord injury). Patient still had muscle pain in her shoulders and neck. Adverse event start date was on 25Apr2021 12:00. No treatment received. No covid prior vaccination. No covid tested post vaccination. Outcome of events was recovered.; Sender's Comments: Based on the current available information, the event Autonomic dysreflexia is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.  Medical history of spinal cord injury due to MVA in 2012 may provide a plausible explanation for the event. The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: developed bell palsy after the first covid vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's parent) reported a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed bell palsy after the first covid vaccine on an unspecified date. The reporter was inquiring how to receive the second dose. The outcome of the event was unknown.  Information on batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: major stroke; This is a spontaneous report from a contactable consumer (patient's husband) via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was in the hospital due to a major stroke on an unspecified date. She can't move her right arm, right leg and she cannot talk. Patient's 2nd dose was due on 27Apr2021 and she can't continue to have the vaccine. Outcome of the event was unknown.