chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: first dose: swollen lymph node; first dose: arm hurt a little; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 25-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot number: EW0217, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 11Jun2021 (age at vaccination was 25 years) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient had cancer in her family. The patient's concomitant medications were not reported. The patient previously took prevenar 13 for pneumonia (last vaccine she got 6 months ago they actually they told her that this vaccine might have a chance of lesser mitigated side effects but that was not the case. She said that last one was Prevnar 13 for pneumonia) and flu vaccine (she was surprised because she has never had reactions. She said actually she reacted badly to the flu vaccine. She has not gotten the flu vaccine in 10 years because she reacts badly and she has not gotten the flu in 10 years). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines were administered on same date of the Pfizer Suspect. The patient said that the first vaccine was fine, her arm hurt a little. The swollen lymph nodes began after the first vaccine, she got the first dose on 11Jun2021 and maybe on 13Jun2021 she was in the shower and felt the lump and freaked out and began calling doctors and they said she had just got the vaccine and it could be that but she was still going to have it checked out because there was triple negative in her family and her lymph nodes were still swollen now and it has been over a month, they got even bigger with the second dose. They said a very low percentage have the swollen lymph nodes so she wanted to report. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot number: EW0196, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 02Jul2021 at 18:30 or 19:00 pm (age at vaccination was 25 years) as dose 2, single for COVID-19 immunization. No relevant tests were done. She asked whether there was going to be a third shot, like a booster. She said she just asked because she was dreading it since getting the second shot. The outcome of the event first dose: arm hurt a little was resolved on an unknown date in 2021. The outcome of the event first dose: swollen lymph node was not resolved.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Hair growth abnormal, Sleep disorder
Clinical narrative: My hair is growing extremely fast; Having sleep problems; I have like a sleep disorder; I cannot taste anything whatsoever; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 02Jun2021 (Batch/Lot number was not reported) as single dose and dose 2 via an unspecified route of administration on 06Jul2021 (Batch/Lot number was not reported) as single dose (at the age of 75-year-old) for covid-19 immunisation. Medical history included some blood pressure problem from an unknown date and unknown if ongoing and ongoing anxiety from an unknown. Concomitant medication(s) included alprazolam (ALPRAZOLAM) taken for anxiety, start and stop date were not reported. Patient reported since he got the Pfizer shot in his hair is growing extremely fast, he could not taste hardly anything, and he had sleep problems like a sleep disorder on unspecified date in 2021. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Facet joint syndrome
Clinical narrative: lumbar facet; This is a spontaneous report received from a contactable consumer, the patient. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient having epidural which was a steroid (Unspecified Medication) in his neck and patient had a lumbar facet (further clarifications were unknown). The clinical outcome of the event was unknown.  Information on Lot/Batch information has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Lip swelling, Peripheral swelling, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient himself). A 33-years-old male patient received (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration in arm left on 30May2021 at 11:00 (at the age of 33-years-old) (Lot Number: EW0175, Expiry date: Unknown) as dose 2, single for COVID-19 immunization. Vaccination Facility Type was pharmacy/ drug store. The patient medical history was reported as nothing. Concomitant medications included colecalciferol, dicalcium malate, durapatite, genistein, menaquinone-7, sodium phosphate dibasic, zinc bis glycinate chelate (FOSTEUM PLUS); colecalciferol (VITAMIN D) and probiotics both taken for an unspecified indication, start and stop date were not reported. Known allergies reported as no. Patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration in arm left on 09Apr2021 at 12:00 PM (at the age of 33-years-old) (Lot Number: EW0173, Expiry date: Unknown) as single for COVID-19 immunization and did not experience any adverse reaction. Patient did not have COVID prior vaccination and patient was not tested for COVID post vaccination. If other vaccine in four weeks was no. The patient experienced chronic urticaria, lips swollen, rash, hives, tiredness and swollen feet on 02Jun2021 05:00. The events resulted in doctor or other healthcare professional office/clinic visit. Patient was treated with Methylprednisolone in response to the events. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Urticaria chronic
Clinical narrative: This is a spontaneous report from a contactable consumer (patient himself). A 33-years-old male patient received (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration in arm left on 30May2021 at 11:00 (at the age of 33-years-old) (Lot Number: EW0175, Expiry date: Unknown) as dose 2, single for COVID-19 immunization. Vaccination Facility Type was pharmacy/ drug store. The patient medical history was reported as nothing. Concomitant medications included colecalciferol, dicalcium malate, durapatite, genistein, menaquinone-7, sodium phosphate dibasic, zinc bis glycinate chelate (FOSTEUM PLUS); colecalciferol (VITAMIN D) and probiotics both taken for an unspecified indication, start and stop date were not reported. Known allergies reported as no. Patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration in arm left on 09Apr2021 at 12:00 PM (at the age of 33-years-old) (Lot Number: EW0173, Expiry date: Unknown) as single for COVID-19 immunization and did not experience any adverse reaction. Patient did not have COVID prior vaccination and patient was not tested for COVID post vaccination. If other vaccine in four weeks was no. The patient experienced chronic urticaria, lips swollen, rash, hives, tiredness and swollen feet on 02Jun2021 05:00. The events resulted in doctor or other healthcare professional office/clinic visit. Patient was treated with Methylprednisolone in response to the events. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I started developing a rash about an hour ago; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0181; Expiration Date: 30Aug2021), via an unspecified route of administration, administered in arm left on 09Jul2021 at 15:30 (3:30) (at the age of 49-year-old) as dose 2, single for COVID-19 immunization. Medical history included sjogren's syndrome (patient have a type of arthritis it's called sjogren's syndrome), allergy. No family medical history related to AE (rash). The patient concomitant medications included meloxicam, cevimeline, rosuvastatin; levocetirizine taken for allergy. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0191; Expiration Date: 30Aug2021), via an unspecified route of administration on 18Jun2021 as dose 1, single for COVID-19 immunization (prior vaccinations (within 4 weeks)). The patient experienced I started developing a rash about an hour ago on 09Jul2021 at 20:45 (8:45). Patient stated, Well, I had the Pfizer, my second dose today about 3:30 itself today and right now it's almost 8:45 in here, where I live in withheld (Not spelled), and I have noticed that, I started developing a rash about an hour ago. So, I just want to know, if it's safe for me to take Benadryl because I realized that, when I got the first dose, I can correlate that. I had a rash back in to but I didn't correlate to the vaccination because I think it happen at the day after but right now with my second dose, I just realized that it's, I am getting the same rash again. So, I was just wondering if its okay to take Benadryl for them. Lot number, Expiration date, NDC number and UPC number for second shot: patient stated, So, it's Pfizer COVID-19 VACC MVV. Expiration 30Aug2021. Lot number EW0181. Patient stated, I take Meloxicam right now. I take Cevimeline and I take Levocetirizine for allergies and I take Rosuvastatin for, I guess cholesterol (as the patient was not sure about the Indication hence not captured in tab). Patient stated, I have to get some test done (further not clarified hence not captured in tab). The patient did not receive treatment for the event. Outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache/All she got was a headache; This is a spontaneous report received from contactable consumer (Patient's husband reported for female consumer reporter's wife). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA-1273 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Jul2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache/all she got was a headache on 08Jul2021. Reporter stated his wife got another vaccine. She got the Pfizer shot. All she got was a headache. Reporter wife received Pfizer Covid-19 vaccine. He reports she experienced a headache. Outcome of the event was unknown.  Follow-up attempts have been completed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: had an increase in Multiple sclerosis symptoms- numbness, weakness, tingling, and loss of strength in my left arm, hand and leg.; This is a spontaneous report from a contactable consumer, the patient herself. An adult non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown) via an unspecified route of administration in left arm on 26Jun2021 at 11:00 as single dose for Covid-19 immunization. The patient's medical history included ongoing multiple sclerosis. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that, after receiving the first dose, since an unknown date in 2021, she had an increase in her Multiple sclerosis symptoms: numbness, weakness, tingling, and loss of strength in her left arm, hand and leg. Reportedly, there was no hospitalization due to the event (Hospitalization Prolonged: No). The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. There was corrective treatment for the event and symptoms. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dysmorphism, Exophthalmos, Eye pain, Eye swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.   A 65-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jun2021 (Lot number: EW0191) (at the age of 65-year-old) as single dose for COVID-19 immunisation.  Medical history included glaucoma from an unknown date and unknown if ongoing. The patient's concomitant medication included brimonidine tartrate/brinzolamide (SIMBRINZA) taken for glaucoma, start and stop date were not reported. The patient previously received first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in left arm on 13May2021 (Lot number: ER8736) (at the age of 65-year-old) as single dose for COVID-19 immunisation and experienced bulging eyes, eye swelling and pain in eyes. The patient reported that:  she experienced swelling around and under her left eye which caused it to "bulge out".  The bulging was most notable in the mornings. The symptoms were worse after her second dose, that her "face is deformed a little bit". There was swelling in the tissue around her eye, the tissue around the outer part of her eye was swollen. It was not doing any of this before the vaccine. She stated that she was having sharp pain shooting through her eye. She said that it was from her eyebrow to the corner of her eye by her nose. The events required physician office visit. The patient outcome of the events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.   A 65-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jun2021 (Lot number: EW0191) (at the age of 65-year-old) as single dose for COVID-19 immunisation.  Medical history included glaucoma from an unknown date and unknown if ongoing. The patient's concomitant medication included brimonidine tartrate/brinzolamide (SIMBRINZA) taken for glaucoma, start and stop date were not reported. The patient previously received first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in left arm on 13May2021 (Lot number: ER8736) (at the age of 65-year-old) as single dose for COVID-19 immunisation and experienced bulging eyes, eye swelling and pain in eyes. The patient reported that:  she experienced swelling around and under her left eye which caused it to "bulge out".  The bulging was most notable in the mornings. The symptoms were worse after her second dose, that her "face is deformed a little bit". There was swelling in the tissue around her eye, the tissue around the outer part of her eye was swollen. It was not doing any of this before the vaccine. She stated that she was having sharp pain shooting through her eye. She said that it was from her eyebrow to the corner of her eye by her nose. The events required physician office visit. The patient outcome of the events was not recovered.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Nausea; Headache; Arm pain; Muscle aches; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not reported), via unspecified route, in right arm on 09Jul2021 as dose 1, single for COVID-19 immunization. Patient medical history included COVID-19. Concomitant medications included meningococcal vaccine for Meningitis. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab: results unknown on an unknown date. The patient experienced nausea, headache, arm pain and muscle aches in Jul2021. No seriousness criteria reported. No treatment was taken for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Keratosis pilaris, Paraesthesia, Pruritus, Rash, Rash papular
Clinical narrative: Raised rash; small bumps in large quantities spreading bilaterally from the hip, buttocks, back of the leg and down the side of the legs; tingly; itchy; whelped yup rash appeared on both arms around the elbow and wrists; This is a spontaneous report from a contactable other HCP (patient, self-reported). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0186 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 08Jul2021 at 15:30 PM (age at vaccination: 37 years), as a single dose for COVID-19 immunization at doctor's office/urgent care. The patient was not pregnant at the time of vaccination. The patient's medical history included Covid-19 (if covid prior vaccination: Yes). Past drug included known allergies: Sulfa, gluten, and hydrocodone. Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) and ibuprofen (MOTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 10Jul2021 at 09:00 AM, she experienced raised rash, small bumps in large quantities spreading bilaterally from the hip, buttocks, back of the leg and down the side of the legs. It was tingly and itchy, also a whelped yup rash appeared on both arms around the elbow and wrists but cleared within the night. The patient received Benadryl and hydrocortisone cream as treatment for the events. Outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Raised rash, Keratosis pilaris, Paraesthesia, Pruritus and rash cannot be excluded. 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Raised rash; small bumps in large quantities spreading bilaterally from the hip, buttocks, back of the leg and down the side of the legs; tingly; itchy; whelped yup rash appeared on both arms around the elbow and wrists; This is a spontaneous report from a contactable other HCP (patient, self-reported). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0186 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 08Jul2021 at 15:30 PM (age at vaccination: 37 years), as a single dose for COVID-19 immunization at doctor's office/urgent care. The patient was not pregnant at the time of vaccination. The patient's medical history included Covid-19 (if covid prior vaccination: Yes). Past drug included known allergies: Sulfa, gluten, and hydrocodone. Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) and ibuprofen (MOTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 10Jul2021 at 09:00 AM, she experienced raised rash, small bumps in large quantities spreading bilaterally from the hip, buttocks, back of the leg and down the side of the legs. It was tingly and itchy, also a whelped yup rash appeared on both arms around the elbow and wrists but cleared within the night. The patient received Benadryl and hydrocortisone cream as treatment for the events. Outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Raised rash, Keratosis pilaris, Paraesthesia, Pruritus and rash cannot be excluded. 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
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID-19 and had cold like symptoms and a stuffy nose; Patient tested positive for COVID-19 and had cold like symptoms and a stuffy nose; This is a spontaneous report from a contactable nurse (the patient).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via an unspecified route of administration, on an unspecified date, as dose number unknown, single for COVID-19 immunization. Patient's family was sick with COVID-19, family was unvaccinated. Concomitant medications were not reported. Patient received pfizer covid vaccine several months ago. Patient tested positive for COVID-19 and had cold like symptoms and a stuffy nose. Events took place after use of product. Patient underwent lab tests and procedures which included SARS-CoV-2 test and was positive on an unknown date.  Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: As there is limited information in the case provided, the causal association between the events, Covid 19 and Drug ineffective and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram, Laryngeal oedema, Myalgia, Throat tightness
Clinical narrative: Epiglottis; Developed tightness in my throat; Chills; Muscle aches; This is a spontaneous report from a contactable consumer. A female patient 60 years old female received BNT162B2 (PFIZER-BIONTECH COVID-VACCINE, Formulation was Solution for injection, Lot Number: EW0180), dose 2 via intramuscular in left arm on 08-Jul2021 11:30, DOSE 2, SINGLE as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient medical history and concomitant medications were not reported. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-VACCINE, Formulation was Solution for injection, Lot Number: EW0180), dose 2 via an unspecified route on 17Jun2021 01:30, DOSE 1, SINGLE as single dose for COVID-19 immunization. On 10Jul2021 04:00 AM patient developed tightness in her throat, and it felt like her airway on the right side was closing. This was after developing chills and muscle aches that began early on Friday morning, approximately 15 hours after her second Pfizer shot. She went to the emergency room and was diagnosed with epiglottis. She received two shots of epinephrine, an IV and CT scan and prescribed antibiotics, a steroid and antihistamine. She had only mild side effects after the 1st shot sore arm after the first shot. Patient was allergic to penicillin only. The outcome of all events were recovering.  Information on the lot/batch number has been requested.  Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy bone marrow, C-reactive protein, C-reactive protein increased, Headache, Laboratory test abnormal
Clinical narrative: inability to walk; sore throat; congestion; abnormal RH factor and elevated CReactive Protein and elevated sed rate all testing was negative for infectious disease process; Rheumatoid arthritis; severe nerve pain; peripheral neuropathy; abnormal RH factor and elevated CReactive Protein and elevated sed rate all testing was negative for infectious disease process; abnormal RH factor and elevated CReactive Protein and elevated sed rate all testing was negative for infectious disease process; headache; fever; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 64-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration on an unspecified date (at the age of 64-year-old) as single dose for COVID-19 immunisation. Medical history included bronchiectasis, hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included amoxicillin trihydrate, clarithromycin, esomeprazole magnesium (NEXIUM 1-2-3); estradiol. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took levaquin and experienced drug hypersensitivity, codeine and experienced drug hypersensitivity. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration on left arm as single dose for COVID-19 immunisation. On 19Mar2021, the patient experienced inability to walk, fever, sore throat, congestion, headache, abnormal rh factor and elevated C-reactive protein and elevated sed rate all testings were negative for infectious disease process, rheumatoid arthritis, severe nerve pain, peripheral neuropathy. Before Mar19, she was completely independent and very active with no health problems beside brochialstasis for which she did inhalers. The patient was hospitalized for inability to walk, fever, sore throat, congestion, headache for 7 days. The patient underwent lab tests and procedures which included biopsy bone marrow: negative, C-reactive protein: elevated polymerase chain reaction: negative on 05Apr2021 Nasal Swab, red blood cell sedimentation rate: elevated, sars-cov-2 test: positive on 05Apr2021 Nasal Swab. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Neuropathy peripheral, Oropharyngeal pain, Polymerase chain reaction, Pyrexia
Clinical narrative: inability to walk; sore throat; congestion; abnormal RH factor and elevated CReactive Protein and elevated sed rate all testing was negative for infectious disease process; Rheumatoid arthritis; severe nerve pain; peripheral neuropathy; abnormal RH factor and elevated CReactive Protein and elevated sed rate all testing was negative for infectious disease process; abnormal RH factor and elevated CReactive Protein and elevated sed rate all testing was negative for infectious disease process; headache; fever; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 64-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration on an unspecified date (at the age of 64-year-old) as single dose for COVID-19 immunisation. Medical history included bronchiectasis, hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included amoxicillin trihydrate, clarithromycin, esomeprazole magnesium (NEXIUM 1-2-3); estradiol. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took levaquin and experienced drug hypersensitivity, codeine and experienced drug hypersensitivity. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration on left arm as single dose for COVID-19 immunisation. On 19Mar2021, the patient experienced inability to walk, fever, sore throat, congestion, headache, abnormal rh factor and elevated C-reactive protein and elevated sed rate all testings were negative for infectious disease process, rheumatoid arthritis, severe nerve pain, peripheral neuropathy. Before Mar19, she was completely independent and very active with no health problems beside brochialstasis for which she did inhalers. The patient was hospitalized for inability to walk, fever, sore throat, congestion, headache for 7 days. The patient underwent lab tests and procedures which included biopsy bone marrow: negative, C-reactive protein: elevated polymerase chain reaction: negative on 05Apr2021 Nasal Swab, red blood cell sedimentation rate: elevated, sars-cov-2 test: positive on 05Apr2021 Nasal Swab. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Red blood cell sedimentation rate increased, Respiratory tract congestion, Rheumatoid arthritis, SARS-CoV-2 test
Clinical narrative: inability to walk; sore throat; congestion; abnormal RH factor and elevated CReactive Protein and elevated sed rate all testing was negative for infectious disease process; Rheumatoid arthritis; severe nerve pain; peripheral neuropathy; abnormal RH factor and elevated CReactive Protein and elevated sed rate all testing was negative for infectious disease process; abnormal RH factor and elevated CReactive Protein and elevated sed rate all testing was negative for infectious disease process; headache; fever; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 64-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration on an unspecified date (at the age of 64-year-old) as single dose for COVID-19 immunisation. Medical history included bronchiectasis, hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included amoxicillin trihydrate, clarithromycin, esomeprazole magnesium (NEXIUM 1-2-3); estradiol. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took levaquin and experienced drug hypersensitivity, codeine and experienced drug hypersensitivity. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration on left arm as single dose for COVID-19 immunisation. On 19Mar2021, the patient experienced inability to walk, fever, sore throat, congestion, headache, abnormal rh factor and elevated C-reactive protein and elevated sed rate all testings were negative for infectious disease process, rheumatoid arthritis, severe nerve pain, peripheral neuropathy. Before Mar19, she was completely independent and very active with no health problems beside brochialstasis for which she did inhalers. The patient was hospitalized for inability to walk, fever, sore throat, congestion, headache for 7 days. The patient underwent lab tests and procedures which included biopsy bone marrow: negative, C-reactive protein: elevated polymerase chain reaction: negative on 05Apr2021 Nasal Swab, red blood cell sedimentation rate: elevated, sars-cov-2 test: positive on 05Apr2021 Nasal Swab. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Walking disability
Clinical narrative: inability to walk; sore throat; congestion; abnormal RH factor and elevated CReactive Protein and elevated sed rate all testing was negative for infectious disease process; Rheumatoid arthritis; severe nerve pain; peripheral neuropathy; abnormal RH factor and elevated CReactive Protein and elevated sed rate all testing was negative for infectious disease process; abnormal RH factor and elevated CReactive Protein and elevated sed rate all testing was negative for infectious disease process; headache; fever; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 64-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration on an unspecified date (at the age of 64-year-old) as single dose for COVID-19 immunisation. Medical history included bronchiectasis, hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included amoxicillin trihydrate, clarithromycin, esomeprazole magnesium (NEXIUM 1-2-3); estradiol. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took levaquin and experienced drug hypersensitivity, codeine and experienced drug hypersensitivity. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration on left arm as single dose for COVID-19 immunisation. On 19Mar2021, the patient experienced inability to walk, fever, sore throat, congestion, headache, abnormal rh factor and elevated C-reactive protein and elevated sed rate all testings were negative for infectious disease process, rheumatoid arthritis, severe nerve pain, peripheral neuropathy. Before Mar19, she was completely independent and very active with no health problems beside brochialstasis for which she did inhalers. The patient was hospitalized for inability to walk, fever, sore throat, congestion, headache for 7 days. The patient underwent lab tests and procedures which included biopsy bone marrow: negative, C-reactive protein: elevated polymerase chain reaction: negative on 05Apr2021 Nasal Swab, red blood cell sedimentation rate: elevated, sars-cov-2 test: positive on 05Apr2021 Nasal Swab. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Feeling abnormal, Palpitations
Clinical narrative: A pounding or fluttering heartbeat; Heart inflammation; Chest pain; A feeling of breathlessness; A pounding or fluttering heartbeat; This is a spontaneous report from a Pfizer sponsored program  reported via consumer (patient's wife). A male patient (reporter's husband) received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on 29Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medications of the patient were not reported. On 02Jul2021, two days after receiving second dose of vaccination, patient experienced heart inflammation, which include chest pain, a feeling of breathlessness and a pounding or fluttering heartbeat. Patient went to seek an emergency, but they did not find anything causing these. Outcome of the events were unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: but tested positive for COVID; but tested positive for COVID; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on 26Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of the Pfizer COVID vaccine on 26Mar2021 but tested positive for COVID on 06Apr2021. The patient was positive on 14Apr2021 and tested negative on 22Apr2021. The outcome of COVID 19 was resolved in 22Apr2021 and outcome of drug ineffective was unknown.  Information about batch/ lot number has been requested.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported Lack of efficacy events  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
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Illness, Malaise, Nasopharyngitis
Clinical narrative: suffers from anxiety; not feeling well; she got sick, specifically she got a cold; she got sick, specifically she got a cold; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, on 23May2021 (about 50 days ago) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that, after the first dose, about a week or 10 days after the vaccine, on an unknown date in 2021 (not immediately after, like 10 days after), she got sick, specifically she got a cold. She confirmed it was not COVID 19. She told that, she went to public places after she got the dose and maybe that was why she caught a cold. She reported that, because she got sick, she waited, she did not take the second dose when it was scheduled, she waited until her immune system got stronger and now it was about 50 days from time of first dose. Reportedly, she went to the facility to take her second, and they refused to administer it. She stated that, she was super delayed, and since an unknown date, suffers from anxiety and was not feeling well. The outcome of the events was unknown at the time of report.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021880663 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Thrombosis
Clinical narrative: Also found a clot in my Left Leg.; developed bilateral PEs; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 02Jun2021 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient had her second Covid Vaccine on 02Jun2021. She did not know if this is coincidental, but she developed bilateral PEs on 15Jun2021. They also found a clot in her left Leg. The reported seriousness was non-serious. She was reaching out to us to see if anyone else had developed blood clots post vaccine. The outcome of the events was unknown.   Information about lot/batch number is requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast tenderness, Condition aggravated, Cyst, Dyspnoea
Clinical narrative: nodule under left armpit, very painful; nodule under left armpit, very painful was reported as worsened.; nodule under left armpit, very painful was reported as worsened.; states it keeps growing and growing and is now the size of a quarter, states it has developed like a head on it, like a cyst; hard time breathing; Fatigue; tender breasts and under left armpit; tender breasts and under left armpit/ arm pits were starting to hurt; This is a spontaneous report from a contactable consumer (Patient). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EW0198), dose 2 via an unspecified route of administration, administered in Arm Left on 29Jun2021 (at the age of 48 years) as dose 2, single for COVID-19 immunisation. Medical history included ongoing asthma diagnosed over 15 years ago. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot# EW0186), dose 1 via an unspecified route of administration in Left arm on 20May2021 (at the age of 48 years) for COVID-19 immunisation. Consumer stated, on 30Jun2021, the next day consumer was fatigued and her breasts were really tender and arm pits were starting to hurt. On an unspecified date consumer developed a small nodule under left armpit a few days later, it kept growing and growing and now the size of a quarter and it has developed like a head on it, like a cyst, today it had a whitehead on it, stuff started coming out of it, put some peroxide and Neosporin on it and it hurts really bad and also taking Aleve and Ibuprofen every 6 hours and was applying cold compress and warm compress to the site. Consumer stated that consumer was having a hard time breathing after second dose and treated with nebulizer, hydrated and was told that consumer could be fatigued. Consumer thought the cyst was from her skin rubbing. The outcome of event painful nodule and breathing difficult was not recovered and for all rest events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nodule, Pain
Clinical narrative: nodule under left armpit, very painful; nodule under left armpit, very painful was reported as worsened.; nodule under left armpit, very painful was reported as worsened.; states it keeps growing and growing and is now the size of a quarter, states it has developed like a head on it, like a cyst; hard time breathing; Fatigue; tender breasts and under left armpit; tender breasts and under left armpit/ arm pits were starting to hurt; This is a spontaneous report from a contactable consumer (Patient). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EW0198), dose 2 via an unspecified route of administration, administered in Arm Left on 29Jun2021 (at the age of 48 years) as dose 2, single for COVID-19 immunisation. Medical history included ongoing asthma diagnosed over 15 years ago. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot# EW0186), dose 1 via an unspecified route of administration in Left arm on 20May2021 (at the age of 48 years) for COVID-19 immunisation. Consumer stated, on 30Jun2021, the next day consumer was fatigued and her breasts were really tender and arm pits were starting to hurt. On an unspecified date consumer developed a small nodule under left armpit a few days later, it kept growing and growing and now the size of a quarter and it has developed like a head on it, like a cyst, today it had a whitehead on it, stuff started coming out of it, put some peroxide and Neosporin on it and it hurts really bad and also taking Aleve and Ibuprofen every 6 hours and was applying cold compress and warm compress to the site. Consumer stated that consumer was having a hard time breathing after second dose and treated with nebulizer, hydrated and was told that consumer could be fatigued. Consumer thought the cyst was from her skin rubbing. The outcome of event painful nodule and breathing difficult was not recovered and for all rest events was unknown.  No follow-up attempts are possible. No further information is expected.