chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Diagnosis of covid (despite negative test); Diagnosis of covid (despite negative test); Fever; Chills; Exhaustion; Body aches; Stomach ache; Diarrhea; Coughing; Headache; Short of breath; Elevated blood pressure; This is a spontaneous report from a contactable consumer (reporting for herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 08:45 (Batch/Lot Number: EN8730) 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 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Mar2021 (lot number: EN6206, administration time: 08:45 AM) for COVID-19 immunization. On 18Apr2021 at 12:00, the patient experienced fever, chills, exhaustion, body aches, stomach ache, diarrhea, coughing, headache, short of breath, elevated blood pressure.   The patient underwent lab tests and procedure which included 2 negative COVID tests on 19Apr2021 and 23Apr2021 respectively and flu test: negative on an unspecified date. The patient was diagnosis of COVID (despite negative test) received on 23Apr2021. The events resulted in emergency room/department visit or urgent care. The patient did not received treatment for the events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Fatigue, Haemorrhage, Headache
Clinical narrative: bruising with blood under the skin; scratched right leg and it bled profusely; scratched right leg and it bled profusely; Low grade fever; Face, Neck and Ears turned bright red; headaches; fatigue; This is a spontaneous report from a contactable healthcare professional.   A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered on right arm on 22Apr2021 10:30 (Batch/Lot Number: EW0169) as 2nd dose, single (at the the age of 49 years old) for covid-19 immunisation.  The patient medical history was not reported. allergies: Tetanus, metronidazole. Concomitant medications included levonorgestrel (I PILL) taken for an unspecified indication, start and stop date were not reported.  The patient previously took tetanus (TETANUS TOXOID) and metronidazole and experienced known allergies; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered on right arm on 01Apr2021 12:00 PM (Batch/Lot Number: R8733) (at the the age of 49 years old) for covid-19 immunisation and no reaction on previous exposure to drug. The patient experienced low grade fever on 27Apr2021. Face, Neck and Ears turned bright red, headaches and fatigue on 23Apr2021.  Day 4 after injection (26Apr2021), scratched right leg and it bled profusely, with difficulty stopping the bleeding. Day 5 after injection (27Apr2021), had blood drawn from left hand with butterfly needle. When it was removed immediate bruising with blood under the skin, larger then a half dollar coin. Hospital added to check platelet count specimen order.  The patient stated that this is very abnormal for her. Prior to vaccination, was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. It was unknown if the patient received treatment for the events. The outcome of the events was unknown.   No follow up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Pyrexia, Scratch
Clinical narrative: bruising with blood under the skin; scratched right leg and it bled profusely; scratched right leg and it bled profusely; Low grade fever; Face, Neck and Ears turned bright red; headaches; fatigue; This is a spontaneous report from a contactable healthcare professional.   A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered on right arm on 22Apr2021 10:30 (Batch/Lot Number: EW0169) as 2nd dose, single (at the the age of 49 years old) for covid-19 immunisation.  The patient medical history was not reported. allergies: Tetanus, metronidazole. Concomitant medications included levonorgestrel (I PILL) taken for an unspecified indication, start and stop date were not reported.  The patient previously took tetanus (TETANUS TOXOID) and metronidazole and experienced known allergies; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered on right arm on 01Apr2021 12:00 PM (Batch/Lot Number: R8733) (at the the age of 49 years old) for covid-19 immunisation and no reaction on previous exposure to drug. The patient experienced low grade fever on 27Apr2021. Face, Neck and Ears turned bright red, headaches and fatigue on 23Apr2021.  Day 4 after injection (26Apr2021), scratched right leg and it bled profusely, with difficulty stopping the bleeding. Day 5 after injection (27Apr2021), had blood drawn from left hand with butterfly needle. When it was removed immediate bruising with blood under the skin, larger then a half dollar coin. Hospital added to check platelet count specimen order.  The patient stated that this is very abnormal for her. Prior to vaccination, was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. It was unknown if the patient received treatment for the events. The outcome of the events was unknown.   No follow up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: unprovoked DVT of Right lower leg; This is a spontaneous report from a contactable physician. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in Arm Left on 15Apr2021 14:00 (Batch/Lot Number: ER873I) as 1st dose, single for covid-19 immunization. Medical history included Crohn's, HTN and ADHD. Concomitant medications included spironolactone and alfetamine aspartate, alfetamine sulfate, dexamphetamine saccharate, dexamphetamine sulfate (ADDERALL).CHLORPERAZINE EDISYLATE]) and experienced allergies. The  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took prochlorperazine (COMPAZINE [PROpatient experienced unprovoked DVT of right lower leg on 23Apr2021 08:00. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of unprovoked DVT of right lower leg including Xarelto 15 mg bid. The outcome of the event was not recovered.; Sender's Comments: The reported deep vein thrombosis leg was more likely an intercurrent disease, and less likely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Presyncope
Clinical narrative: on the verge of passing out; Dizzy; Nausea; This is a spontaneous report from a contactable consumer (patient). A 37-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 03Apr2021 08:00 (36-years-old) as 2nd dose, single for COVID-19 immunization. Medical history included Known allergies to Milk and casein. Facility type vaccine, other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 on 14Mar2021 08:00 AM (36-years-old) on Left arm for COVID-19 immunization. The patient's concomitant medications were not reported. The patient experienced on the verge of passing out, dizzy, and nausea on 05Apr2021 19:00. The outcome of the events was not recovered.    Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Patient developed B/L LE DVT 1 week s/p 2nd vaccine; This is a spontaneous report from a contactable physician. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Apr2021 (Batch/Lot number was not reported) as 2nd dose single for covid-19 immunisation. The patient medical history was not reported. Patient was not pregnant. Concomitant medication included estradiol taken for menopausal symptoms, start and stop date were not reported; acetylsalicylic acid taken for an unspecified indication, start and stop date were not reported. No other vaccines received withing 4 weeks. The patient developed B/L LE DVT 1 week s/p 2nd vaccine on 27Apr2021. Event resulted in physician's clinic visit and was given anticoagulation. Outcome of the events was recovering. Patient was not diagnosed with COVID prior to vaccination and had not been tested post-vaccination.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported DVT and the use of BNT162B2 cannot be fully  excluded. However, the age of the patient and use of estradiol may confound the reported drug event pair. The case will be assessed further upon receipt of additional information.  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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Throat irritation, Tongue discomfort, Tonsillar disorder
Clinical narrative: Tonsil kinda of closes so that i could not breath well for a few seconds; Tonsil kinda of closes so that i could not breath well for a few seconds; Burning of the tongue from the tip then to the middle and towards the throat; Burning of the tongue from the tip then to the middle and towards the throat; This is a spontaneous report from a contactable healthcare professional.  A non-pregnant 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered on left arm on 08Apr2021 12:00 (Batch/Lot Number: Unknown) as unknown, single (at the age of 54-year-old) for COVID-19 immunisation.  Medical history included undifferentiated connective tissue disorder and allergy to dust and pollen.  The patient's concomitant medications were not reported. The patient stated on 08Apr2021 12:00, "burning of the tongue from the tip then to the middle and towards the throat. Tonsil kind of closes so that I could not breath well for a few seconds. They put me on oxygen, gave me Benadryl and Tacid". Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19.  The outcome of the events was recovered on an unspecified date.   No follow up attempts are possible; information on the lot/batch number cannot be obtained.; Sender's Comments: Based on information available, the reported tonsillar disorder with symptom of dyspnea was likely related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Ovarian cyst ruptured
Clinical narrative: Ovarian cyst formed and ruptured within 1 week of vaccination; This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 29-year-old, via an unspecified route of administration on 14Apr2021 (Lot number and expiration date was not reported) unknown, single for COVID-19 immunization. Medical history included rheumatoid arthritis, fibromyalgia, postural orthostatic tachycardia syndrome (POTS), endometriosis, asthma, chronic anemia, and known allergies to gluten, dairy, corn, soy, eggs, and leuprorelin (LUPRON). The patient was not pregnant at the time of vaccination. Concomitant medications included diphtheria vaccine toxoid, tetanus vaccine toxoid (TETANUS DIPHTHERIA) administered at the left arm and pneumococcal vaccine administered at the right arm; both on 23Mar2021. The patient experienced ovarian cyst formed and ruptured within 1 week of vaccination on Apr2021. This was a known personal inflammatory response, as she has rheumatoid arthritis and endometriosis. No treatment was received for the event. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Severe chest pain; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 20Apr2021 13:00 as 1st dose, single for COVID-19 immunization. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included buspirone hydrochloride (BUSPIROL); and medroxyprogesterone acetate (DEPO PROGESTIN), both taken for an unspecified indication. The patient experienced severe chest pain (medically significant) on 22Apr2021 16:30. The adverse event resulted in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the adverse event was pain medication. The outcome of the event was not recovered.   Information on the batch/lot number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Erythema, Eye oedema, Facial pain, Pain in jaw
Clinical narrative: a large bump (about 3/4 inch diameter) on the right side of her temple. The swelling has elongated down the cheek bone. it is still slightly puffy, but not sore; The swelling has elongated down the cheek bone, It was sore to the touch, throbbed; It was sore to the touch, throbbed, and my jaw and ear hurt; It was sore to the touch, throbbed, and my jaw and ear hurt; red puffy place under my eye; Had a red puffy place under my eye; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25Jan2021 11:00 (Batch/Lot Number: EN5318) as 2ND DOSE, SINGLE for covid-19 immunisation, at 74 years old, at hospital. Patient is not pregnant. Medical history included blood pressure (abnormal), migraines, back surgery from an unknown date. The patient received the first dose of BNT162B2 on 04Jan2021 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported.  On 12Feb2021, the patient experienced a large bump (about 3/4 inch diameter) on the right side of her temple. The swelling has elongated down the cheek bone. it is still slightly puffy, but not sore. It was sore to the touch, throbbed, and her jaw and ear hurt. Patient couldn't lie on the right side. Patient also had a red puffy place under her eye. Events required physician office visit. Dermatologist and PCP gave her steroids for a month. The bump improved, but still present and less sore.  Patient was sent to allergist. Together they put her on antihistamines (Zyrtec -24 hrs. Tablets twice a day,) Pepcid and lisinopril 5 mg. Patient only took lisinopril for 5 days. Patient is still taking the antihistamine and Pepcid. Patient have only had 1 filler in that area in October 2020 (as reported). Outcome of the events was reported as not recovered.  No follow-up attempts are needed; information on lot number has been obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: a large bump (about 3/4 inch diameter) on the right side of her temple. The swelling has elongated down the cheek bone. it is still slightly puffy, but not sore; The swelling has elongated down the cheek bone, It was sore to the touch, throbbed; It was sore to the touch, throbbed, and my jaw and ear hurt; It was sore to the touch, throbbed, and my jaw and ear hurt; red puffy place under my eye; Had a red puffy place under my eye; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25Jan2021 11:00 (Batch/Lot Number: EN5318) as 2ND DOSE, SINGLE for covid-19 immunisation, at 74 years old, at hospital. Patient is not pregnant. Medical history included blood pressure (abnormal), migraines, back surgery from an unknown date. The patient received the first dose of BNT162B2 on 04Jan2021 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported.  On 12Feb2021, the patient experienced a large bump (about 3/4 inch diameter) on the right side of her temple. The swelling has elongated down the cheek bone. it is still slightly puffy, but not sore. It was sore to the touch, throbbed, and her jaw and ear hurt. Patient couldn't lie on the right side. Patient also had a red puffy place under her eye. Events required physician office visit. Dermatologist and PCP gave her steroids for a month. The bump improved, but still present and less sore.  Patient was sent to allergist. Together they put her on antihistamines (Zyrtec -24 hrs. Tablets twice a day,) Pepcid and lisinopril 5 mg. Patient only took lisinopril for 5 days. Patient is still taking the antihistamine and Pepcid. Patient have only had 1 filler in that area in October 2020 (as reported). Outcome of the events was reported as not recovered.  No follow-up attempts are needed; information on lot number has been obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Cold sweat, Dizziness
Clinical narrative: To check if it was blood clot; Intermittent long-lasting palpitations; Lymph discomfort in one leg; Severe pain of bones in chest; Joint pains; Severe shooting intermittent head pain; Cold sweat; Felt like she was going to faint; COVID arm popped out; Severe nerve pain behind ear same side as vaccine; Exacerbated back pain; Bad menstrual cramps; This is spontaneous report from contactable consumer (patient). A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 31Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included fibromyalgia, complex regional pain syndrome (CRPS), lymphedema (previously resolved), mild asthma, osteoporosis, herniated discs, allergies, and menopause. The patient's concomitant medications included unspecified vitamins. The patient had no other vaccine in four weeks (however, it was also reported that other vaccine was administered in same date, 31Mar2021; pending clarification). The patient was not diagnosed with COVID-19 prior vaccination. On 03Apr2021 at 02:00 AM, the patient experienced intermittent long-lasting palpitations, lymph discomfort in one leg for which they went to check if it was blood clot. On 03Apr2021 at 02:00 AM, the patient also had severe pain of bones in chest, joint pains, severe shooting intermittent head pain, cold sweat, felt like she was going to faint, COVID arm popped out (nite 8; as reported), severe nerve pain behind ear same side as vaccine, exacerbated back pain, and bad menstrual cramps for 2 mornings 11 years post-menopause. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the adverse events. The events were considered non-serious. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Headache, Joint dislocation, Lymph node pain, Neuralgia
Clinical narrative: To check if it was blood clot; Intermittent long-lasting palpitations; Lymph discomfort in one leg; Severe pain of bones in chest; Joint pains; Severe shooting intermittent head pain; Cold sweat; Felt like she was going to faint; COVID arm popped out; Severe nerve pain behind ear same side as vaccine; Exacerbated back pain; Bad menstrual cramps; This is spontaneous report from contactable consumer (patient). A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 31Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included fibromyalgia, complex regional pain syndrome (CRPS), lymphedema (previously resolved), mild asthma, osteoporosis, herniated discs, allergies, and menopause. The patient's concomitant medications included unspecified vitamins. The patient had no other vaccine in four weeks (however, it was also reported that other vaccine was administered in same date, 31Mar2021; pending clarification). The patient was not diagnosed with COVID-19 prior vaccination. On 03Apr2021 at 02:00 AM, the patient experienced intermittent long-lasting palpitations, lymph discomfort in one leg for which they went to check if it was blood clot. On 03Apr2021 at 02:00 AM, the patient also had severe pain of bones in chest, joint pains, severe shooting intermittent head pain, cold sweat, felt like she was going to faint, COVID arm popped out (nite 8; as reported), severe nerve pain behind ear same side as vaccine, exacerbated back pain, and bad menstrual cramps for 2 mornings 11 years post-menopause. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the adverse events. The events were considered non-serious. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Thrombosis
Clinical narrative: To check if it was blood clot; Intermittent long-lasting palpitations; Lymph discomfort in one leg; Severe pain of bones in chest; Joint pains; Severe shooting intermittent head pain; Cold sweat; Felt like she was going to faint; COVID arm popped out; Severe nerve pain behind ear same side as vaccine; Exacerbated back pain; Bad menstrual cramps; This is spontaneous report from contactable consumer (patient). A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 31Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included fibromyalgia, complex regional pain syndrome (CRPS), lymphedema (previously resolved), mild asthma, osteoporosis, herniated discs, allergies, and menopause. The patient's concomitant medications included unspecified vitamins. The patient had no other vaccine in four weeks (however, it was also reported that other vaccine was administered in same date, 31Mar2021; pending clarification). The patient was not diagnosed with COVID-19 prior vaccination. On 03Apr2021 at 02:00 AM, the patient experienced intermittent long-lasting palpitations, lymph discomfort in one leg for which they went to check if it was blood clot. On 03Apr2021 at 02:00 AM, the patient also had severe pain of bones in chest, joint pains, severe shooting intermittent head pain, cold sweat, felt like she was going to faint, COVID arm popped out (nite 8; as reported), severe nerve pain behind ear same side as vaccine, exacerbated back pain, and bad menstrual cramps for 2 mornings 11 years post-menopause. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the adverse events. The events were considered non-serious. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Pruritus, Swollen tongue
Clinical narrative: Bell's Palsy; swollen tongue; itchiness; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 28Jan2021 14:30 (Batch/Lot Number: EL9262) (at the age of 32 years) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included immunoglobulin g4 related disease (IGG4-RD) and rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously took rituximab (RITUXAN) and experienced drug allergy and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1686) in the left arm on 07Jan2021 at 02:30 pm for COVID-19 immunization and experienced rash in face and back. 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. The patient was not pregnant at the time of vaccination. On 01Apr2021, the patient experienced Bell's Palsy, swollen tongue and itchiness. The events resulted in emergency room/department or urgent care.  The patient was hospitalized for the events for 3 days. The patient received treatment for the reported events. Since the vaccination, it was unknown if patient has been tested for COVID-19. The outcome of the events was recovering.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Noninfective encephalitis, SARS-CoV-2 test, Seizure
Clinical narrative: Brain inflammation; Stroke like event/seizure; Stroke like event/seizure; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration, administered in left arm on 19Apr2021 16:00 (Lot Number: ER8731) 2ND DOSE, single for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received 1st dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, lot number: EP6955) on 29Mar2021 01:00 PM in the left arm for COVID-19 immunization and experienced stroke like event/seizure. The patient had stroke like event/seizure following first and second injections. The patient also had brain inflammation. Events onset date reported as 22Apr2021 11:00. The events were reported as serious due to hospitalization in Apr2021 for 5 days. Events resulted in doctor or other healthcare professional office/clinic visit and a visit to emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient been tested for COVID-19 since the vaccination. Outcome of events was unknown. The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Apr2021. No treatment received for the events.  Further information has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Disease recurrence
Clinical narrative: Bell's palsy symptoms started up a few hours after the shot/had it two years ago; Bell's palsy symptoms started up a few hours after the shot/had it two years ago; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 26Apr2021 14:00, as 2nd dose, single, for COVID-19 immunisation. Medical history included Bell's palsy in 2019 (had it two years ago). The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC); and cimetidine (TAGAMET), both taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported) at age 55 years, administered in the left arm, on 05Arp2021 14:00, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Bell's palsy symptoms started up a few hours after the shot, on 26Apr2021 at 16:00. The patient had it two years ago. The patient was recovering from the event (reported as subsiding 24 hours later).  Follow-up needed. Information about batch/lot number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Extreme fatigue; fever; headache; migraine; swollen lymph nodes; dizziness; weakness; nausea; high heart rate; inflammation in joints and spine; inflammation in joints and spine; high ESR; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 17:30 (at the age of 39-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included autoimmune disorder, anemia and hypothyroidism. Patient was not pregnant. The patient's concomitant medications were not reported. The patient previously took cephalexine and experienced drug allergy. On 09Apr2021 21:00, patient experienced extreme fatigue, fever, headache, migraine, swollen lymph nodes, dizziness, weakness, nausea, high heart rate, inflammation in joints and spine and high ESR (erythrocyte sedimentation rate). The event extreme fatigue was reported as serious, medically significant. The events resulted in emergency room and physician office visit. It was also reported that the patient was treated with IV fluids, ondansetron (ZOFRAN) and ketorolac (TORADOL). The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 24Apr2021. Outcome of events was recovering.   Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Lymphadenopathy, Migraine, Nausea
Clinical narrative: Extreme fatigue; fever; headache; migraine; swollen lymph nodes; dizziness; weakness; nausea; high heart rate; inflammation in joints and spine; inflammation in joints and spine; high ESR; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 17:30 (at the age of 39-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included autoimmune disorder, anemia and hypothyroidism. Patient was not pregnant. The patient's concomitant medications were not reported. The patient previously took cephalexine and experienced drug allergy. On 09Apr2021 21:00, patient experienced extreme fatigue, fever, headache, migraine, swollen lymph nodes, dizziness, weakness, nausea, high heart rate, inflammation in joints and spine and high ESR (erythrocyte sedimentation rate). The event extreme fatigue was reported as serious, medically significant. The events resulted in emergency room and physician office visit. It was also reported that the patient was treated with IV fluids, ondansetron (ZOFRAN) and ketorolac (TORADOL). The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 24Apr2021. Outcome of events was recovering.   Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased, SARS-CoV-2 test, Spondylitis
Clinical narrative: Extreme fatigue; fever; headache; migraine; swollen lymph nodes; dizziness; weakness; nausea; high heart rate; inflammation in joints and spine; inflammation in joints and spine; high ESR; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 17:30 (at the age of 39-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included autoimmune disorder, anemia and hypothyroidism. Patient was not pregnant. The patient's concomitant medications were not reported. The patient previously took cephalexine and experienced drug allergy. On 09Apr2021 21:00, patient experienced extreme fatigue, fever, headache, migraine, swollen lymph nodes, dizziness, weakness, nausea, high heart rate, inflammation in joints and spine and high ESR (erythrocyte sedimentation rate). The event extreme fatigue was reported as serious, medically significant. The events resulted in emergency room and physician office visit. It was also reported that the patient was treated with IV fluids, ondansetron (ZOFRAN) and ketorolac (TORADOL). The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 24Apr2021. Outcome of events was recovering.   Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Epistaxis, Fatigue, Haematemesis
Clinical narrative: tiredness; headache; nausea; feeling of her lungs swelling and expanding in her thorax; terrible back pain; dry and bloody mucus in her nose; dry and bloody mucus in her nose; bloody mucus from her mouth; chills; fever; This is a spontaneous report from a contactable consumer (patient) reported that a 48-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER8729), via an unspecified route of administration, administered in the left arm on 22Apr2021 as a single dose for COVID-19 immunization. Medical history included menstrual irregularity and tear meniscus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received he first dose of BNT162B2 (lot number: ER8737) on 31Mar2021 on 24:00 on the left arm for COVID-19 immunization and after 8 days, the patient had scleritis. It was reported that on 22Apr2021 at 23:45 the same day that the patient received the second dose, she had chills and fever. The next day, 23Apr2021, the patient had tiredness, headache, nausea, feeling of her lungs swelling and expanding in her thorax and terrible back pain. The patient could not use a bra for two days, there was bloody mucus from her mouth, dry and bloody mucus in her nose. The patient stated that all side effects stayed for two days except for the fever which was only for one and a half. The patient was tested for any cause of sickness in the blood test on an unknown date and everything was negative. The events resulted in a visit to the doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization on an unspecified date. The patient received prednisolone eye drops and Atrophine sulfate eye D as treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lung disorder, Nasal dryness, Nausea, Pyrexia
Clinical narrative: tiredness; headache; nausea; feeling of her lungs swelling and expanding in her thorax; terrible back pain; dry and bloody mucus in her nose; dry and bloody mucus in her nose; bloody mucus from her mouth; chills; fever; This is a spontaneous report from a contactable consumer (patient) reported that a 48-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER8729), via an unspecified route of administration, administered in the left arm on 22Apr2021 as a single dose for COVID-19 immunization. Medical history included menstrual irregularity and tear meniscus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received he first dose of BNT162B2 (lot number: ER8737) on 31Mar2021 on 24:00 on the left arm for COVID-19 immunization and after 8 days, the patient had scleritis. It was reported that on 22Apr2021 at 23:45 the same day that the patient received the second dose, she had chills and fever. The next day, 23Apr2021, the patient had tiredness, headache, nausea, feeling of her lungs swelling and expanding in her thorax and terrible back pain. The patient could not use a bra for two days, there was bloody mucus from her mouth, dry and bloody mucus in her nose. The patient stated that all side effects stayed for two days except for the fever which was only for one and a half. The patient was tested for any cause of sickness in the blood test on an unknown date and everything was negative. The events resulted in a visit to the doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization on an unspecified date. The patient received prednisolone eye drops and Atrophine sulfate eye D as treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Scleritis
Clinical narrative: i had scleritis; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 31Mar2021 12:00 (Batch/Lot Number: ER8737) as 1st dose, single for Covid-19 immunisation. Medical history included tear meniscus and menstural irregularity. Concomitant medications were not reported. On an unspecified date, the patient had scleritis. She was tested for any cause of sickness in blood test and everything was negative. The outcome of the event was unknown.   Follow up attempts are possible. Further information is requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Discomfort, Fatigue, Feeling cold
Clinical narrative: my arm hurt; I was hallucinating; my body was convulsing/having a literal seizure; uncomfortable; thirsty and craved water; tired; couldn't get up; felt freezing because I was so cold; teeth were chattering extremely fast; my teeth were chattering extremely fast like I had hypothermia; became very hot; shaking involuntary; This is a spontaneous report from non-contactable consumer (patient). An adult female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm on Apr2021 (Batch/Lot Number: EW0110) as second dose, single for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin; spironolactone; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE); all taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. Patient historically took the first dose of BNT162B2 (lot number: EW0150) on the left arm on Apr2021 for COVID-19 Immunization. On 27Apr2021, patient went to bed at like 1200 and her arm hurt but she didn't take any medication. Then, patient like woke at about 1:47 and was shaking involuntary, everything was so uncomfortable and she was hallucinating trying to connect all her limbs - like she grew extra arms and legs and she had like her hands had mini hands and a friend that she hadn't seen in a while (who was not there) was holding her head up. She was very thirsty and craved water so bad but she was so tired and shaking that she couldn't get up. After about 30 minutes, she got up and her body was convulsing while standing and her room which is typically warm felt freezing because she was so cold and her teeth were chattering extremely fast like she had hypothermia. She got water, took some ibuprofen and she got back in her bed. she texted a friend at  2 something in the morning because she thought she was having a literal seizure like she couldn't control her body at all. Then, her body eventually stopped shaking on Apr2021 and she was just above sleep level for another hour or two and then became very hot. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included covid-19: negative on Apr2021. The outcome of the event 'having a literal seizure' and 'shaking involuntary' was recovered on Apr2021, while for the other events, it was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hallucination, Hypothermia, Mobility decreased, Pain in extremity
Clinical narrative: my arm hurt; I was hallucinating; my body was convulsing/having a literal seizure; uncomfortable; thirsty and craved water; tired; couldn't get up; felt freezing because I was so cold; teeth were chattering extremely fast; my teeth were chattering extremely fast like I had hypothermia; became very hot; shaking involuntary; This is a spontaneous report from non-contactable consumer (patient). An adult female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm on Apr2021 (Batch/Lot Number: EW0110) as second dose, single for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin; spironolactone; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE); all taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. Patient historically took the first dose of BNT162B2 (lot number: EW0150) on the left arm on Apr2021 for COVID-19 Immunization. On 27Apr2021, patient went to bed at like 1200 and her arm hurt but she didn't take any medication. Then, patient like woke at about 1:47 and was shaking involuntary, everything was so uncomfortable and she was hallucinating trying to connect all her limbs - like she grew extra arms and legs and she had like her hands had mini hands and a friend that she hadn't seen in a while (who was not there) was holding her head up. She was very thirsty and craved water so bad but she was so tired and shaking that she couldn't get up. After about 30 minutes, she got up and her body was convulsing while standing and her room which is typically warm felt freezing because she was so cold and her teeth were chattering extremely fast like she had hypothermia. She got water, took some ibuprofen and she got back in her bed. she texted a friend at  2 something in the morning because she thought she was having a literal seizure like she couldn't control her body at all. Then, her body eventually stopped shaking on Apr2021 and she was just above sleep level for another hour or two and then became very hot. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included covid-19: negative on Apr2021. The outcome of the event 'having a literal seizure' and 'shaking involuntary' was recovered on Apr2021, while for the other events, it was unknown.  No follow-up attempts are possible. No further information is expected.