chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ear disorder, Eyelid rash, Headache, Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: It has been about 7 weeks since the first; Missed dose of the Vaccine; Rash on her face; Shingles; Rash on her eyebrow and near the eye; Ear bothering her; Persistent headaches; This is a spontaneous Initial report from a contactable consumer (patient) reported for herself. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot/Batch number: EN6207, Expiration date: Unknown), via an unspecified route in left arm on 17Mar2021 (age at vaccination: 41-year-old), as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included multivitamins started taking about 5 years ago for good health, prenatal and general women's health vitamin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 01Apr2021 (three week after the vaccine), started getting persistent headaches, on 03Apr2021, early evening around 17:00 or 18:00, patient experienced pain started, thought she had an ear infection or something, ear bothering her, the pain started, thought she had an ear infection or something and on 06Apr2021 (2 weeks later) when she woke up in the morning on Tuesday, patient developed shingles/herpes zoster, rash on her face and around her eyes (on her eyebrow near her eye). Patient was wondering when she can get second injection. It has been about 7 weeks since the first (missed dose of the Vaccine). The eye doctor she went to said to wait 2-3 months to give body time to heal and make sure her immune system would be strong for the second Pfizer covid-19 injection. Patient is fine waiting for the next vaccine. Her eye doctor told her to wait but, she called Pfizer wondering if there are any guidelines. She wants her immune system to recover from this and this be out her system. She went to Urgent Care and was prescribed Valtrex (antiviral) as treatment and she finished taking Valtrex. For the shingles rash on her face for over a week, about 7 days. She had blisters that opened and then they scabbed. They are not visible but, she can still see what is left of them. It was a week or two ago they started to go away she believes. Adverse events did not result in emergency room visit. She needs to make a decision on whether she should get the next dose or not. The clinical outcome of the event ear bothering her was recovered on 10Apr2021, persistent headaches was recovered on 14Apr2021, shingles, rash on face, rash on her eyebrow was recovered on 21Apr2021 and missed second dose was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Rash
Clinical narrative: It has been about 7 weeks since the first; Missed dose of the Vaccine; Rash on her face; Shingles; Rash on her eyebrow and near the eye; Ear bothering her; Persistent headaches; This is a spontaneous Initial report from a contactable consumer (patient) reported for herself. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot/Batch number: EN6207, Expiration date: Unknown), via an unspecified route in left arm on 17Mar2021 (age at vaccination: 41-year-old), as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included multivitamins started taking about 5 years ago for good health, prenatal and general women's health vitamin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 01Apr2021 (three week after the vaccine), started getting persistent headaches, on 03Apr2021, early evening around 17:00 or 18:00, patient experienced pain started, thought she had an ear infection or something, ear bothering her, the pain started, thought she had an ear infection or something and on 06Apr2021 (2 weeks later) when she woke up in the morning on Tuesday, patient developed shingles/herpes zoster, rash on her face and around her eyes (on her eyebrow near her eye). Patient was wondering when she can get second injection. It has been about 7 weeks since the first (missed dose of the Vaccine). The eye doctor she went to said to wait 2-3 months to give body time to heal and make sure her immune system would be strong for the second Pfizer covid-19 injection. Patient is fine waiting for the next vaccine. Her eye doctor told her to wait but, she called Pfizer wondering if there are any guidelines. She wants her immune system to recover from this and this be out her system. She went to Urgent Care and was prescribed Valtrex (antiviral) as treatment and she finished taking Valtrex. For the shingles rash on her face for over a week, about 7 days. She had blisters that opened and then they scabbed. They are not visible but, she can still see what is left of them. It was a week or two ago they started to go away she believes. Adverse events did not result in emergency room visit. She needs to make a decision on whether she should get the next dose or not. The clinical outcome of the event ear bothering her was recovered on 10Apr2021, persistent headaches was recovered on 14Apr2021, shingles, rash on face, rash on her eyebrow was recovered on 21Apr2021 and missed second dose was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Confusional state, Feeling abnormal, Formication, Headache
Clinical narrative: Severe Anxiety after second; feeling of eyes dilated; nausea; worse confusion; head crawling; head pain; havent been able to sneeze after second; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0153) dose 2 via an unspecified route of administration in right arm on 07Apr2021 at 10:00 (at the age of 58-year-old) as single dose for COVID-19 immunization. Medical history included Hepatitis B inactive, Hepatitis C cured, Genital Herpes, gastroparesis, IBS/ Irritable bowel syndrome, arthritis, allergies to steroids, Codene. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol, omeprazole, alprazolam (XANAX), macrogol 3350 (PEG3350), all in two weeks. No other vaccine received in four weeks. The patient previously took ciprofloxacin and had allergy. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8732) dose 1 in right arm on an unspecified date as single dose for Covid-19 immunization and experienced anxiety week after first, confusion, sweat. On 13Apr2021 at 07:00AM, the patient had severe anxiety after second, feeling of eyes dilated, nausea, worse confusion, head crawling, head pain, still having side effects. It always started a week later. She was having MRI and MRA done this Friday. Didn't realize till after second shot, it was all from vaccine, thought she was having other problems, but now know it was from vaccine after second wave of side effects, hit her like a freight train all at once. Also haven't been able to sneeze after second, had to several times, but was not able to do it anymore. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if received treatment for events. The outcome of events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Mydriasis, Nausea
Clinical narrative: Severe Anxiety after second; feeling of eyes dilated; nausea; worse confusion; head crawling; head pain; havent been able to sneeze after second; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0153) dose 2 via an unspecified route of administration in right arm on 07Apr2021 at 10:00 (at the age of 58-year-old) as single dose for COVID-19 immunization. Medical history included Hepatitis B inactive, Hepatitis C cured, Genital Herpes, gastroparesis, IBS/ Irritable bowel syndrome, arthritis, allergies to steroids, Codene. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol, omeprazole, alprazolam (XANAX), macrogol 3350 (PEG3350), all in two weeks. No other vaccine received in four weeks. The patient previously took ciprofloxacin and had allergy. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8732) dose 1 in right arm on an unspecified date as single dose for Covid-19 immunization and experienced anxiety week after first, confusion, sweat. On 13Apr2021 at 07:00AM, the patient had severe anxiety after second, feeling of eyes dilated, nausea, worse confusion, head crawling, head pain, still having side effects. It always started a week later. She was having MRI and MRA done this Friday. Didn't realize till after second shot, it was all from vaccine, thought she was having other problems, but now know it was from vaccine after second wave of side effects, hit her like a freight train all at once. Also haven't been able to sneeze after second, had to several times, but was not able to do it anymore. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if received treatment for events. The outcome of events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Aspartate aminotransferase, Asthenia, Blood test, Discomfort, Fatigue
Clinical narrative: Hypertension; Tiredness; Weakness; losing some muscles; He is also experiencing muscle deterioration (no muscle pain); he's been feeling a light body (not hard to move); elevated liver enzymes; he told him he doesn't get enough sleep; nervous; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration on 22Apr2021 (at the age of 44-year-old) as dose 2, single for covid-19 immunisation. Medical history included, hypertension from 29Apr2021 to an unknown date, glucose tolerance impaired from 2010 to an unknown date Verbatim: Prediabetes, haemorrhoids from 09Mar2021 to an unknown date Verbatim: Hemorrhoids, hypovitaminosis from an unknown date and unknown if ongoing, asthenia from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) taken for haemorrhoids, pain, start and stop date were not reported; ascorbic acid, biotin, folic acid, iron, nicotinic acid, pantothenic acid, pyridoxine, riboflavin, vitamin b1 nos, vitamin b12 nos, vitamin e nos (CENTRUM ADULT B+ IRON) taken for hypovitaminosis from an unspecified start date and ongoing; ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) taken for covid-19 immunisation from an unspecified start date and ongoing; vitamin b complex (VITAMIN B) taken for asthenia from an unspecified start date and ongoing. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration on 01Apr2021 (at the age of 44-year-old) as dose 1, single for covid-19 immunisation. On 25Apr2021, patient experienced losing some muscles, 0n 26Apr2021, patient experienced weakness, on 27Apr2021, patient experienced tiredness, on 29Apr2021, patient experienced hypertension. on an unspecified date in 2021, patient experienced muscle deterioration, he's been feeling a light body, elevated liver enzymes, he told him he doesn't get enough sleep, nervous. The patient underwent lab tests and procedures which included aspartate aminotransferase: 28 on 22Sep2020 Normal, aspartate aminotransferase: 46 on 30Apr2021 slightly elevated, blood test: elevated liver enzymes on 30Apr2021. Therapeutic measures were taken as a result of hypertension included losartan 25mg. The outcome of the events losing some muscles, tiredness, weakness were not recovered and the outcome of the remaining events were unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatic enzyme increased, Hypertension, Insomnia, Muscle atrophy, Nervousness
Clinical narrative: Hypertension; Tiredness; Weakness; losing some muscles; He is also experiencing muscle deterioration (no muscle pain); he's been feeling a light body (not hard to move); elevated liver enzymes; he told him he doesn't get enough sleep; nervous; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration on 22Apr2021 (at the age of 44-year-old) as dose 2, single for covid-19 immunisation. Medical history included, hypertension from 29Apr2021 to an unknown date, glucose tolerance impaired from 2010 to an unknown date Verbatim: Prediabetes, haemorrhoids from 09Mar2021 to an unknown date Verbatim: Hemorrhoids, hypovitaminosis from an unknown date and unknown if ongoing, asthenia from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) taken for haemorrhoids, pain, start and stop date were not reported; ascorbic acid, biotin, folic acid, iron, nicotinic acid, pantothenic acid, pyridoxine, riboflavin, vitamin b1 nos, vitamin b12 nos, vitamin e nos (CENTRUM ADULT B+ IRON) taken for hypovitaminosis from an unspecified start date and ongoing; ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) taken for covid-19 immunisation from an unspecified start date and ongoing; vitamin b complex (VITAMIN B) taken for asthenia from an unspecified start date and ongoing. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration on 01Apr2021 (at the age of 44-year-old) as dose 1, single for covid-19 immunisation. On 25Apr2021, patient experienced losing some muscles, 0n 26Apr2021, patient experienced weakness, on 27Apr2021, patient experienced tiredness, on 29Apr2021, patient experienced hypertension. on an unspecified date in 2021, patient experienced muscle deterioration, he's been feeling a light body, elevated liver enzymes, he told him he doesn't get enough sleep, nervous. The patient underwent lab tests and procedures which included aspartate aminotransferase: 28 on 22Sep2020 Normal, aspartate aminotransferase: 46 on 30Apr2021 slightly elevated, blood test: elevated liver enzymes on 30Apr2021. Therapeutic measures were taken as a result of hypertension included losartan 25mg. The outcome of the events losing some muscles, tiredness, weakness were not recovered and the outcome of the remaining events were unknown.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Feeling abnormal, Pain in extremity, Palpitations
Clinical narrative: Heart and lung feels weird, and has heart palpitations; Heart or lungs feel weird; Never had asthma but it feels like asthma; Little bit difficult catching his breath; Arm pain; This is a spontaneous report from a contactable consumer. A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 26Apr2021 16:15 (at the age of 19-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not take any other vaccines within four weeks prior vaccination. On 26Apr2021, patient experienced arm pain. On 27Apr2021, patient experienced heart and lung feels weird, and has heart palpitations, never had asthma but it feels like asthma, little bit difficult catching his breath. The events did not result in emergency room and physician office visit. The outcome of the event arm pain was recovered on 28Apr2021 while other events were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuralgia, Paraesthesia
Clinical narrative: Numbing on right side of body; Pins and needles sensation; Nerve pain all over body; This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 30-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0171; Expiration Date: unknown), via an unspecified route of administration in Arm Left on 21-APR-2021 16:00 (age at the time of vaccination 30-years-old), as a single dose for COVID-19 immunization. The patient's medical history includes birth control pill. The concomitant medication included BALCOLTRA (ETHINYLESTRADIOL, FERROUS BISGLYCINATE, LEVONORGESTREL) for Oral contraception. 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 had no known allergies. On 22Apr2021 21:30, the patient experienced Numbing on right side of body, Pins and needles sensation, and Nerve pain all over body. The patient visited to the emergency room for adverse events. No treatment received for the adverse events. Upon follow-up (21May2021), Company aware date: 21May2021, no new event coded, lot number of first dose, History, and Concomitant Products. Caller stated, she had terrible adverse effects from the COVID vaccine. The outcome for all the events was not recovered.  Follow-up (PRD 21May2021): This is a Follow up spontaneous report received from a contactable consumer. This 30-year-old female consumer (patient) reported for herself that included: Company aware date: 21May2021, no new event coded, lot number of first dose, History, and Concomitant Products, she had terrible adverse effects from the COVID vaccine, case reference number of 245, there is no product complaint to report and there is medical information request.  Information on Lot/Batch number was available. Additional information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Fall, Malaise
Clinical narrative: felt dizzy; disoriented; fell of his bike for the first time; he still feels unwell; This is a spontaneous report from a contactable consumer or other non-HCP (patient). An 84-year-old male patient received first dose of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE mRNA, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 13May2021 (age at the time of vaccination 84-year-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced felt dizzy, disoriented, fell of his bike for the first time, and he still feels unwell. Consumer stated, he is not going to take the 2nd dose anymore because he does not think it will help him. Consumer was informed about the Pfizer Medical Information Department and telephone number was shared. Consumer hung up the call abruptly, hence further probing could not be done. Limited information available over the call. The outcome for all the events was unknown.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: having break through periods after the second vaccine. As often as every other day, will have bleeding from an hour to several hours to a full day; causing cramping to happen at the same time; This is a spontaneous report received from a contactable consumer (patient, self-reported). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8734 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 16Apr2021 at 14:45 (age at vaccination: 52 years), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included ongoing high blood pressure and diabetes, high cholesterol, endometriosis, and known allergies: dairy, tetanus. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP7534 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 26Mar2021 at 14:45 (age at vaccination: 52 years), as a single dose for COVID-19 immunization. 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 was not tested for COVID-19. The patient reported that on 19Apr2021, she started having break through periods after the second vaccine. As often as every other day, she will have bleeding from an hour to several hours to a full day. It was causing cramping to happen at the same time. The patient did not receive any treatment for the events. Outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Myalgia, Neuralgia, Rash, Rash macular
Clinical narrative: rash became more and in a few more places on my right leg; Shingles; blistered after 2 days.; Nerve pain; muscle soreness; pain in my Hip Flexor tendon and in my quardiceps tendon; few spots on my thigh; This is a spontaneous report from a contactable consumer or other non hcp.     A 41-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 26Apr2021 15:45 as 1st dose, single for covid-19 immunisation. Medical history included hypothyroidism ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE); thyroid (ARMOUR THYROID). The patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, Received first dose of Pfizer on 26Apr2021. On 13May, she started developing nerve pain, muscle soreness, pain in my Hip Flexor tendon and in my quadriceps tendon. I also had a few spots on my thigh. As the next 4 days progressed, the rash became more and in a few more places on my right leg. Became blistered after 2 days. Went to the doctor on 17May and was diagnosed with Shingles. The nerve pain on, muscle soreness, pain in my hip flexor tendon and in my quadriceps tendon, few spots on my thigh on 13May2021 08:00 with outcome of recovering, rash became more and in a few more places on my right leg on 17May2021 with outcome of recovering, blistered after 2 days, on 15May2021 with outcome of recovering , shingles on 17May2021 with outcome of recovering. Therapeutic measures were taken Antiviral meds as a result of nerve pain (neuralgia), muscle soreness (myalgia), pain in my hip flexor tendon and in my quadriceps tendon (tendon pain), few spots on my thigh (rash macular), rash became more and in a few more places on my right leg (rash) , blistered after 2 days. (rash vesicular), shingles (herpes zoster).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Rash vesicular, Tendon pain
Clinical narrative: rash became more and in a few more places on my right leg; Shingles; blistered after 2 days.; Nerve pain; muscle soreness; pain in my Hip Flexor tendon and in my quardiceps tendon; few spots on my thigh; This is a spontaneous report from a contactable consumer or other non hcp.     A 41-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 26Apr2021 15:45 as 1st dose, single for covid-19 immunisation. Medical history included hypothyroidism ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE); thyroid (ARMOUR THYROID). The patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, Received first dose of Pfizer on 26Apr2021. On 13May, she started developing nerve pain, muscle soreness, pain in my Hip Flexor tendon and in my quadriceps tendon. I also had a few spots on my thigh. As the next 4 days progressed, the rash became more and in a few more places on my right leg. Became blistered after 2 days. Went to the doctor on 17May and was diagnosed with Shingles. The nerve pain on, muscle soreness, pain in my hip flexor tendon and in my quadriceps tendon, few spots on my thigh on 13May2021 08:00 with outcome of recovering, rash became more and in a few more places on my right leg on 17May2021 with outcome of recovering, blistered after 2 days, on 15May2021 with outcome of recovering , shingles on 17May2021 with outcome of recovering. Therapeutic measures were taken Antiviral meds as a result of nerve pain (neuralgia), muscle soreness (myalgia), pain in my hip flexor tendon and in my quadriceps tendon (tendon pain), few spots on my thigh (rash macular), rash became more and in a few more places on my right leg (rash) , blistered after 2 days. (rash vesicular), shingles (herpes zoster).
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, SARS-CoV-2 test negative
Clinical narrative: Major pain in my left lower stomach before and after bowel movement.; Major pain in my left lower stomach before and after bowel movement.; This is a spontaneous report from a contactable consumer. This 37-year-old male consumer (patient) reported for himself. A 37-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8736) via an unspecified route of administration in arm left on 23Apr2021 as single dose and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EWC177) via an unspecified route of administration in arm right on 14May2021 08:30 as single dose for COVID-19 immunization. The patient medical history was not reported. 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 was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. The patient experienced major pain in left lower stomach before and after bowel movement on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal swab): negative on unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.   Follow-up (18Jun2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Feeling hot, Swelling
Clinical narrative: Painful in my armpit, in my arm.; It's extremely swollen or just painful in my armpit..; I was trying to see my lymph, warm.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0185, Expiry date: unknown), dose 2 via an unspecified route of administration on 14May2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine of BNT162B2 for COVID-19 immunization as first dose. The patient experienced painful in armpit, in the arm, it's extremely swollen or just painful in armpit and patient was trying to see lymph, warm on an unspecified date. The patient had actually received last vaccine, the second one on Friday, that was 14 and was trying to see and looked at the paper work it said some of the side effects could be swollen lymph nodes and pain that mentioned. So, I was trying to see my lymph, warm. Patient was done with both shots and it was extremely swollen or just painful in armpit. In the arm was trying to see how long this side effect, would last. When probed whether the adverse events are from the second shot, patient stated, yes. Patient stated, on the vaccination card. Yeah, You need my card. That's what I can make it out. It was just for first one then I have for second one. Patient stated, on the vaccination card. Yeah, You need my card. Patient would like to talk to someone else. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer. A 63-year-old female consumer (patient) reported for herself that: A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 10:15 (Batch/Lot Number: ER8727) as DOSE 1, SINGLE for Covid-19 immunisation. Medical history included Asthma and Hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced Shingles on 30Apr2021. There was no Covid prior vaccination and the patient was not tested for Covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for Shingles was Antivirals. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of event was recovering.   Follow-up (19Jul2021): New information received to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: she had 4 cycles in a month.; This is a spontaneous report from a contactable female consumer. This consumer is reporting for 5 Patients. These one of the 5 reports (Sister's friend).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date, the reporter stated that "Her sister's friend is a nurse and said she experienced the same after the 2nd dose: she had 4 cycles in a month". The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Ear pain, Fatigue, Hypoacusis, Nasal congestion
Clinical narrative: Fever (104); achy; sore throat; congestion; ear pain; difficulty hearing (said it was muffled); tired; This is a spontaneous report from a contactable other HCP. This 13-year-old other- HCP (patient) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on May2021 12:30 PM (at the age of 13-years-old) (Batch/Lot Number: EW0177) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included penicillin, prior EM reaction when on Penicillin and received: 2 vaccines at 1 year of age and autism (high functioning) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient previously took intuniv 2 mg for autism spectrum disorder. The patient experienced Fever (104), achy, sore throat, congestion, ear pain, difficulty hearing (said it was muffled), tired.  Fever improved with Tylenol Started with sore throat 15 hours after injection.  Symptoms began to improve 40 hours after injection on unspecified date on May2021 03:00 AM.The patient took treatment for fever with treatment drug as tylenol and no other treatment were taken for other events. The patient underwent lab test body temperature with result Fever (104) (unspecified date in May2021). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient did received other medication within 2 weeks of vaccination. The patient prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not tested for COVID-19. The outcome of all events was recovering.   Information on the lot/batch is available. Other information is expected
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever (104); achy; sore throat; congestion; ear pain; difficulty hearing (said it was muffled); tired; This is a spontaneous report from a contactable other HCP. This 13-year-old other- HCP (patient) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on May2021 12:30 PM (at the age of 13-years-old) (Batch/Lot Number: EW0177) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included penicillin, prior EM reaction when on Penicillin and received: 2 vaccines at 1 year of age and autism (high functioning) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient previously took intuniv 2 mg for autism spectrum disorder. The patient experienced Fever (104), achy, sore throat, congestion, ear pain, difficulty hearing (said it was muffled), tired.  Fever improved with Tylenol Started with sore throat 15 hours after injection.  Symptoms began to improve 40 hours after injection on unspecified date on May2021 03:00 AM.The patient took treatment for fever with treatment drug as tylenol and no other treatment were taken for other events. The patient underwent lab test body temperature with result Fever (104) (unspecified date in May2021). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient did received other medication within 2 weeks of vaccination. The patient prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not tested for COVID-19. The outcome of all events was recovering.   Information on the lot/batch is available. Other information is expected
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (Patient). A 63-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EW0153), via an unspecified route of administration, administered in Arm Left on 05May2021 at 18:00 as dose 1, single (at the age of 63 years) for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included vitamins nos (VITAMINS NOS). Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Vitamins within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10May2021 at 06:00 AM patient experienced Shingles. The patient received Famciclovir 500mg & Gabapentin 300mg as a treatment for event. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Dyspnoea, Erythema, Eye swelling
Clinical narrative: she had a fast heartbeat; can taste the medication in her mouth; her whole face became swollen, including her eyes.; her whole face became swollen, including her eyes.; also said she had hives all over her face and across her eyes; Shorter breath; high rash; Itching; Bad muscle pain; Weakness and Sleepiness.; Weakness and Sleepiness.; her face was red; tiredness; shoulder and arm pain; This is a spontaneous report from a contactable other HCP (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/lot number: EW0171, Expiration date: Unknown), via an unspecified route on an unknown date, as a single dose for covid-19 immunization. Medical history included she has a brain tumor and iodine reaction to the contrast when they do the MRI ever since (was allergic to the radiocontrast dye), high blood pressure, gall bladder removed, both knees replaced, sinus surgery, hysterectomy, cataract surgery and tonsil removed. Concomitant medications included levothyroxine, hydrocortisone, metoprolol, Vitamin D and magnesium. On an unknown date, patient experienced non-severe reaction to the Covid-19. When she first took the only one shot and they asked her to stick with 15 minute and she did that and a few minutes after she sat there may be about five minutes, she could taste them and can taste the medication in her mouth and asked if she supposed to be tasting the medication, they said nobody has ever said that now. She also said she felt as if her body was going through a change. She was given water which helped make her feel better. Then 4 or 5 days after, her whole face became swollen, including her eyes. She had a high rash, her face was red you know, itching oh bad. She also said she had hives all over her face and across her eyes. She also had the usual side effects, such as tiredness, weakness and sleepiness, bad muscle pain, shoulder and arm pain for a week. She had that contrast reaction and everything she said what kind of medications, she takes, she always has some type of reaction to it. That is why she was not sure if should take the mediation means take the vaccine so anyway, she took it and had that shorter breath, fast heartbeat. Patient do not want to take the second one and get more severe again because her face will get her eyes closed up. Therapeutic measures taken as a result of face was red and was itching so bad, she took Benadryl and Calamine lotion which helped with the swelling of her face. However, the itchiness and redness were still there. The patient underwent lab test and procedure which included blood work and magnetic resonance imaging (MRI). The clinical outcome of the whole face became swollen was recovering, itching and face was red were still there (not recovered) and for rest of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Heart rate increased, Magnetic resonance imaging, Myalgia, Pain in extremity
Clinical narrative: she had a fast heartbeat; can taste the medication in her mouth; her whole face became swollen, including her eyes.; her whole face became swollen, including her eyes.; also said she had hives all over her face and across her eyes; Shorter breath; high rash; Itching; Bad muscle pain; Weakness and Sleepiness.; Weakness and Sleepiness.; her face was red; tiredness; shoulder and arm pain; This is a spontaneous report from a contactable other HCP (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/lot number: EW0171, Expiration date: Unknown), via an unspecified route on an unknown date, as a single dose for covid-19 immunization. Medical history included she has a brain tumor and iodine reaction to the contrast when they do the MRI ever since (was allergic to the radiocontrast dye), high blood pressure, gall bladder removed, both knees replaced, sinus surgery, hysterectomy, cataract surgery and tonsil removed. Concomitant medications included levothyroxine, hydrocortisone, metoprolol, Vitamin D and magnesium. On an unknown date, patient experienced non-severe reaction to the Covid-19. When she first took the only one shot and they asked her to stick with 15 minute and she did that and a few minutes after she sat there may be about five minutes, she could taste them and can taste the medication in her mouth and asked if she supposed to be tasting the medication, they said nobody has ever said that now. She also said she felt as if her body was going through a change. She was given water which helped make her feel better. Then 4 or 5 days after, her whole face became swollen, including her eyes. She had a high rash, her face was red you know, itching oh bad. She also said she had hives all over her face and across her eyes. She also had the usual side effects, such as tiredness, weakness and sleepiness, bad muscle pain, shoulder and arm pain for a week. She had that contrast reaction and everything she said what kind of medications, she takes, she always has some type of reaction to it. That is why she was not sure if should take the mediation means take the vaccine so anyway, she took it and had that shorter breath, fast heartbeat. Patient do not want to take the second one and get more severe again because her face will get her eyes closed up. Therapeutic measures taken as a result of face was red and was itching so bad, she took Benadryl and Calamine lotion which helped with the swelling of her face. However, the itchiness and redness were still there. The patient underwent lab test and procedure which included blood work and magnetic resonance imaging (MRI). The clinical outcome of the whole face became swollen was recovering, itching and face was red were still there (not recovered) and for rest of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Somnolence, Swelling face, Taste disorder
Clinical narrative: she had a fast heartbeat; can taste the medication in her mouth; her whole face became swollen, including her eyes.; her whole face became swollen, including her eyes.; also said she had hives all over her face and across her eyes; Shorter breath; high rash; Itching; Bad muscle pain; Weakness and Sleepiness.; Weakness and Sleepiness.; her face was red; tiredness; shoulder and arm pain; This is a spontaneous report from a contactable other HCP (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/lot number: EW0171, Expiration date: Unknown), via an unspecified route on an unknown date, as a single dose for covid-19 immunization. Medical history included she has a brain tumor and iodine reaction to the contrast when they do the MRI ever since (was allergic to the radiocontrast dye), high blood pressure, gall bladder removed, both knees replaced, sinus surgery, hysterectomy, cataract surgery and tonsil removed. Concomitant medications included levothyroxine, hydrocortisone, metoprolol, Vitamin D and magnesium. On an unknown date, patient experienced non-severe reaction to the Covid-19. When she first took the only one shot and they asked her to stick with 15 minute and she did that and a few minutes after she sat there may be about five minutes, she could taste them and can taste the medication in her mouth and asked if she supposed to be tasting the medication, they said nobody has ever said that now. She also said she felt as if her body was going through a change. She was given water which helped make her feel better. Then 4 or 5 days after, her whole face became swollen, including her eyes. She had a high rash, her face was red you know, itching oh bad. She also said she had hives all over her face and across her eyes. She also had the usual side effects, such as tiredness, weakness and sleepiness, bad muscle pain, shoulder and arm pain for a week. She had that contrast reaction and everything she said what kind of medications, she takes, she always has some type of reaction to it. That is why she was not sure if should take the mediation means take the vaccine so anyway, she took it and had that shorter breath, fast heartbeat. Patient do not want to take the second one and get more severe again because her face will get her eyes closed up. Therapeutic measures taken as a result of face was red and was itching so bad, she took Benadryl and Calamine lotion which helped with the swelling of her face. However, the itchiness and redness were still there. The patient underwent lab test and procedure which included blood work and magnetic resonance imaging (MRI). The clinical outcome of the whole face became swollen was recovering, itching and face was red were still there (not recovered) and for rest of the events was unknown.  Follow-up attempts are completed. No further information is expected.