chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Arthralgia, Autoimmune disorder, Inappropriate schedule of product administration
Clinical narrative: autoimmune disease; sore and swollen joints; sore and swollen joints; ANA screen positive; My right wrist is swollen and quasi immobile and my left hand also; My right wrist is swollen; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer.  A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0164), via an unspecified route of administration in left arm on an unspecified date (at the age of 64-years-old) as dose 2, single for COVID-19 immunisation. Patient medical history included thalassaemia minor. The patient had no known allergies. Concomitant medications included Venlafaxine Hydrochloride (EFFEXOR XR) and Trazadone. Other medications the patient received within 2 weeks of vaccination was trazadone and effexor XR. Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8733), via an unspecified route of administration in left arm on 16Apr2021 at 13:00 as dose 1, single for COVID-19 immunisation. 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 vaccination. On 01Jun2021 at 12:00, almost one month after the second dose, the patient developed autoimmune disease symptoms including sore and swollen joints. Patient received treatment for adverse events. Antinuclear antibody test (ANA) titer positive at 1:640 speckled and ANA screen positive. Erythrocyte Sedimentation Rate (ESR) and rheumatoid factor were normal. She never had such symptoms before. Her right wrist was swollen and quasi-immobile and left hand also. She was referred to a rheumatologist. Outcome of the events was not resolved on an unspecified date.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Joint swelling, Red blood cell sedimentation rate normal, Rheumatoid factor
Clinical narrative: autoimmune disease; sore and swollen joints; sore and swollen joints; ANA screen positive; My right wrist is swollen and quasi immobile and my left hand also; My right wrist is swollen; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer.  A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0164), via an unspecified route of administration in left arm on an unspecified date (at the age of 64-years-old) as dose 2, single for COVID-19 immunisation. Patient medical history included thalassaemia minor. The patient had no known allergies. Concomitant medications included Venlafaxine Hydrochloride (EFFEXOR XR) and Trazadone. Other medications the patient received within 2 weeks of vaccination was trazadone and effexor XR. Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8733), via an unspecified route of administration in left arm on 16Apr2021 at 13:00 as dose 1, single for COVID-19 immunisation. 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 vaccination. On 01Jun2021 at 12:00, almost one month after the second dose, the patient developed autoimmune disease symptoms including sore and swollen joints. Patient received treatment for adverse events. Antinuclear antibody test (ANA) titer positive at 1:640 speckled and ANA screen positive. Erythrocyte Sedimentation Rate (ESR) and rheumatoid factor were normal. She never had such symptoms before. Her right wrist was swollen and quasi-immobile and left hand also. She was referred to a rheumatologist. Outcome of the events was not resolved on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Immunosuppression
Clinical narrative: I am immunosuppressed; This is a spontaneous report from a Pfizer sponsored program from contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, on an unspecified date, as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, on an unspecified date, as single dose for covid-19 immunisation. It was reported that, when patient got two doses, patient had no symptoms at all. Patient was immunosuppressed on an unspecified date. The outcome of the event was unknown.  Information about batch/ lot number has been requested
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Chest X-ray, Computerised tomogram, Hypertension
Clinical narrative: wheezing upper respiratory; high blood pressure; bronchitis; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 67-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0153) via intramuscular route of administration (age at vaccination 67-year) in Left Arm on 14Apr2021 02:00 PM as dose 2, single for COVID-19 immunization. It was reported that the patient previously received the first dose of BNT162B2 (Lot number: ER8732) on 24Mar2021 in Left shoulder for COVID-19 immunization. Medical history included Illness: No illness at time of vaccine; Sometimes wheezing from change of seazures- pollen had very mild here and there but became chronic after vaccines for COVID-19 from an unknown date and unknown if ongoing No illness at time of vaccine. Concomitant medication included azithromycin taken for upper respiratory tract infection, bronchitis from 15Apr2021 and ongoing. On 15Apr2021 the patient experienced wheezing upper respiratory, high blood pressure. The patient underwent lab tests and procedures which included chest x-ray (Check for clots blood pressure): negative on 19Apr2021; computerised tomogram: check for clots foot swollen and previous knee fracture- swelling more-checked for clots 03May2021; COVID-19 (Wheezing upper respiratory Cushing- high blood pressure): negative on 19Apr2021; ultrasound scan (Check for clots blood pressure high): negative on 20Apr2021. The events were reported as serious (medically significant). AE required to visit physician office. Therapeutic measures were taken as a result of wheezing upper respiratory, high blood pressure. The clinical outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Ultrasound scan, Wheezing
Clinical narrative: wheezing upper respiratory; high blood pressure; bronchitis; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 67-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0153) via intramuscular route of administration (age at vaccination 67-year) in Left Arm on 14Apr2021 02:00 PM as dose 2, single for COVID-19 immunization. It was reported that the patient previously received the first dose of BNT162B2 (Lot number: ER8732) on 24Mar2021 in Left shoulder for COVID-19 immunization. Medical history included Illness: No illness at time of vaccine; Sometimes wheezing from change of seazures- pollen had very mild here and there but became chronic after vaccines for COVID-19 from an unknown date and unknown if ongoing No illness at time of vaccine. Concomitant medication included azithromycin taken for upper respiratory tract infection, bronchitis from 15Apr2021 and ongoing. On 15Apr2021 the patient experienced wheezing upper respiratory, high blood pressure. The patient underwent lab tests and procedures which included chest x-ray (Check for clots blood pressure): negative on 19Apr2021; computerised tomogram: check for clots foot swollen and previous knee fracture- swelling more-checked for clots 03May2021; COVID-19 (Wheezing upper respiratory Cushing- high blood pressure): negative on 19Apr2021; ultrasound scan (Check for clots blood pressure high): negative on 20Apr2021. The events were reported as serious (medically significant). AE required to visit physician office. Therapeutic measures were taken as a result of wheezing upper respiratory, high blood pressure. The clinical outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Adverse event, Incomplete course of vaccination, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: her left arm had become swollen, hard, turned red and got very hot; her left arm had become swollen, hard, turned red and got very hot; her left arm had become swollen, hard, turned red and got very hot; her left arm had become swollen, hard, turned red and got very hot; This is a spontaneous report received from Merck, form a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), first dose via an unspecified route of administration on 26Jan2018 as single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient mentioned that after receiving her first dose on 26Jan2018, she experienced an adverse event. It was reported that her left arm (injection site) had become swollen, hard, turned red, and got "very hot". She was taken to emergency clinic. She was advised not to receive the 2nd dose and had not received it. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: her left arm had become swollen, hard, turned red and got very hot; her left arm had become swollen, hard, turned red and got very hot; her left arm had become swollen, hard, turned red and got very hot; her left arm had become swollen, hard, turned red and got very hot; This is a spontaneous report received from Merck, form a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), first dose via an unspecified route of administration on 26Jan2018 as single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient mentioned that after receiving her first dose on 26Jan2018, she experienced an adverse event. It was reported that her left arm (injection site) had become swollen, hard, turned red, and got "very hot". She was taken to emergency clinic. She was advised not to receive the 2nd dose and had not received it. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Patient developed acute pericarditis Grade 2 per CTCAE V 4.03); This is a spontaneous report received from a contactable other health care professional. A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3302), via intramuscular route of administration on 15Jan2021 (at the age of 37-year-old ) as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included as multivitamins. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EJ1685, patient was 37-year-old at the time of vaccination), via intramuscular route of administration on 20Dec2020 as single dose for covid-19 immunisation and no event experienced. Patient had no underlying medical conditions, no history of cardiac events, or recent infections or trauma. No chronic health conditions or underlying medical history reported. No know allergies with past drug reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine, patient was not diagnosed with COVID-19 prior to vaccination, not tested for COVID-19 since the vaccination. On 15Jun2021 at 08:00, the patient experienced patient developed acute pericarditis grade 2 per ctcae v 4.03. Reported that event require emergency department visit after events experienced. The patient received treatment for event with Toradol 15mg IV, ASA 324 mg PO (orally). The outcome of event was not recovered.   Follow-up attempts are possible. Further information is expected.; Sender's Comments: As there is temporal relationship in the case provided, the causal association between the event and the suspect drug 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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product preparation error
Clinical narrative: Patient inadvertently received his first dose of the Pfizer-BioNTech COVID-19 vaccine diluted with sterile water rather than 0.9% sodium chloride; Patient inadvertently received his first dose of the Pfizer-BioNTech COVID-19 vaccine diluted with sterile water rather than 0.9% sodium chloride; This is a spontaneous report from a contactable Nurse. A contactable nurse reported for a 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8735 and expiry date: 24Jun2021), via Intramuscularly, in Deltoid Left, on 16Jun2021 (age at vaccination: 66 years), as a single dose, 0.3 ml, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that on 16Jun2021, the patient inadvertently received his first dose of the Pfizer-BioNTech COVID-19 vaccine diluted with sterile water rather than 0.9% sodium chloride. She asked if the dose should be repeated and what to clinically expect from the patient who inadvertently received his first dose of the Pfizer-BioNTech COVID-19 vaccine diluted with sterile water. Pfizer has not tested the effects of using sterile water for injection as the diluent for the current formulation of the Pfizer-BioNTech COVID-19 Vaccine. The diluted vaccine using sterile water for injection as the diluent should be appropriately discarded and not used for vaccination. If the vaccine that was diluted with sterile water for injection was inadvertently administered to individuals, a definitive statement on the quality and usability of the vaccine diluted in water cannot be made. The Pfizer-BioNTech COVID-19 Vaccine has not been tested with sterile water for injection as the diluent. Based on this lack of information, Pfizer was unable to definitively state if the vaccine dose was valid or invalid. Therefore, we kindly refer you to discuss revaccination need or timing. It was not within Pfizer's remit to recommend revaccination from FAQ-COVID-19 Vaccine-sterile water as diluent; - Off-label disclaimer and "Table 1. Interim Recommendations for COVID-19 Vaccine administration Errors and Deviations (ACIP)/Diluent" from Revaccination after administration of Invalid Dose. Outcome of the events was unknown.; Sender's Comments: Based on the information currently available, there is no relation between the suspect vaccine BNT162B2 and  the onset of poor quality product administered,product preparation error.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Breakthrough seizure; This is a spontaneous report from a contactable consumer. This consumer reported for a 16-year-old male patient (reporter's son) who received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EW0183 and expiration date was not reported), dose 1 via intramuscular route, administered in arm right on 08May2021 at 09:00 as dose 1, single and dose 2 via intramuscular route, administered in arm right on 29May2021 at 09:00 (lot number was EW0191 and expiration date was not reported) as dose 2, single for COVID-19 immunisation. Medical history included epilepsy. The additional information reported as: he had not a seizure in over an year until he got the vaccine. He was on medication and he has just got his level checked, a month before and they were fine, they were in range. The patient did not receive any other vaccination within 4 weeks prior to the first administration of the suspect vaccine. Concomitant medications included levetiracetam (KEPPRA) taken for an unspecified indication, start and stop date were not reported. On an unspecified date in May2021, the patient experienced breakthrough seizure. The clinical course of the event was reported as: The reporter was calling just to let know that, a week after each of the vaccine shot the reporter's son got, a week after each of those shots he had a bad seizure, a breakthrough seizure which was he was on his medication. His end level range and had seizure that whether it was the side effect from Pfizer or not the reporter just wanted to make aware it happened both times the first time was coincidence but happened twice, just wanted to make aware. 09 days after the first shot he got a seizure and then after his second shot, 12 days later he had a seizure. The reporter inquired if someone aware of it, in case someone else had the same thing. The outcome of the event was unknown.  Information on lot/batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased
Clinical narrative: her O2 levels have dropped, the lowest level reached was 72; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The medical history and concomitant medications were not reported. On 2021 the patient experienced her o2 levels have dropped, the lowest level reached was 72. The patient underwent lab tests and procedures which included oxygen saturation: 72 on 15Jun2021. The outcome of the event was unknown.   Information about the lot/batch number has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness, Tinnitus
Clinical narrative: severe ringing in his ear on Sunday June 6; he couldnt hear/he has significant hearing loss; This is a spontaneous report from a contactable consumer (patient's parent).  A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: unknown) via unspecified route of administration in left arm on 29May2021 at 14:00 (at the age of 16-year-old) as a dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history of the patient was not reported. Patient had no known allergies. Patient did not receive any other medications (concomitant) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 06Jun2021 (Sunday) at 08:00, patient started having severe ringing in his ear and could not hear. His parent took him to urgent care on June 9 and patient was prescribed a steroid, nothing changed after a week. Appointment was Scheduled with ENT where they did hearing test and said patient has significant hearing loss. Patient was getting an MRI tomorrow and going back to ENT to get a steroid shot in his ear to see if they can restore hearing loss. They mentioned they did have other patients that received COVID vaccine and now have hearing loss but are not 16 and were much older than patient (reporter son). They told us not to get second vaccine shot. The event resulted in doctor or other healthcare professional office/clinic visit along with visit to Emergency room/department or urgent care. The event as serious [Seriousness criteria-Disabling/Incapacitating]. Device date was 17Jun2021. Patient received steroid as a corrective treatment. Outcome of the events were not resolved on an unspecified date.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Magnetic resonance imaging abnormal, Quality of life decreased, Scan with contrast
Clinical narrative: severe ringing in his ear on Sunday June 6; he couldnt hear/he has significant hearing loss; This is a spontaneous report from a contactable consumer (patient's parent).  A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: unknown) via unspecified route of administration in left arm on 29May2021 at 14:00 (at the age of 16-year-old) as a dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history of the patient was not reported. Patient had no known allergies. Patient did not receive any other medications (concomitant) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 06Jun2021 (Sunday) at 08:00, patient started having severe ringing in his ear and could not hear. His parent took him to urgent care on June 9 and patient was prescribed a steroid, nothing changed after a week. Appointment was Scheduled with ENT where they did hearing test and said patient has significant hearing loss. Patient was getting an MRI tomorrow and going back to ENT to get a steroid shot in his ear to see if they can restore hearing loss. They mentioned they did have other patients that received COVID vaccine and now have hearing loss but are not 16 and were much older than patient (reporter son). They told us not to get second vaccine shot. The event resulted in doctor or other healthcare professional office/clinic visit along with visit to Emergency room/department or urgent care. The event as serious [Seriousness criteria-Disabling/Incapacitating]. Device date was 17Jun2021. Patient received steroid as a corrective treatment. Outcome of the events were not resolved on an unspecified date.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: severe ringing in his ear on Sunday June 6; he couldnt hear/he has significant hearing loss; This is a spontaneous report from a contactable consumer (patient's parent).  A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: unknown) via unspecified route of administration in left arm on 29May2021 at 14:00 (at the age of 16-year-old) as a dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history of the patient was not reported. Patient had no known allergies. Patient did not receive any other medications (concomitant) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 06Jun2021 (Sunday) at 08:00, patient started having severe ringing in his ear and could not hear. His parent took him to urgent care on June 9 and patient was prescribed a steroid, nothing changed after a week. Appointment was Scheduled with ENT where they did hearing test and said patient has significant hearing loss. Patient was getting an MRI tomorrow and going back to ENT to get a steroid shot in his ear to see if they can restore hearing loss. They mentioned they did have other patients that received COVID vaccine and now have hearing loss but are not 16 and were much older than patient (reporter son). They told us not to get second vaccine shot. The event resulted in doctor or other healthcare professional office/clinic visit along with visit to Emergency room/department or urgent care. The event as serious [Seriousness criteria-Disabling/Incapacitating]. Device date was 17Jun2021. Patient received steroid as a corrective treatment. Outcome of the events were not resolved on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal
Clinical narrative: She is not that stable today; She has like a chest pain; This is a spontaneous report from a contactable consumer (patient husband). An unspecified age female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown; formulation: solution for injection; expiration date: unknown), via an unspecified route of administration on 16Jun2021 as unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the consumer calling for his wife, she had the vaccine yesterday. consumer stated that both had the vaccine (Confirmed as Pfizer Covid 19 vaccine) yesterday, consumer feeling okay, a little fever but he is good, but patient has like chest pain. So, what we should do, should we wait drink some water or go to a like emergency room, is that normal. consumer stated that the patient has like a chest pain in Jun2021, and she was not that stable today on 17Jun2021. consumer stated that they do not think they have expiration date and lot. Yes, they have it, but consumer do not have it here with them. consumer stated that he will call the medical information department. What you think, what should we do, can we go to emergency room better, if we will spend time on phone, we do not know what is going to happen. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthropod bite, Erythema, Fatigue, Feeling abnormal, Herpes zoster
Clinical narrative: Bumps from the shingles and little redder around the edges; Bumps from the shingles and little redder around the edges; Barely had pain; Fever was still in the 99's. She normally ran low at 97.2 or 97.4; Slept for 18 hours; Tired/exhausted; Entire arm hurt so much; Was a little sick with both vaccines; flu-like symptoms; Didn't feel well; Thought she had 3 bug bites on arm; Felt like little person under the skin poking her with needles; This is a spontaneous report from a contactable consumer (patient herself). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in Upper left arm on 15May2021 15:00 or 15:30 (Lot number EW0177) as single dose and second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration Upper left arm on 07Jun2021 10:00 (Lot number EW0217) as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included Thyroid, Bipolar Depression, Anxiety, Ulcer, Hiatal Hernia, Jitteriness/Hand shaking, Back pain, threw back out all are ongoing and experienced Vitamin D low and Flu shot makes her sick for 24 hours. The patient's concomitant medications included Levothyroxine for Thyroid, Levonorgestrel (MIRENA IUD) for Birth Control, Dextroamphetamine Hydrochloride for Bipolar Depression, Bupropion Hydrochloride (WELLBUTRIN XL) for Bipolar Depression, Pantoprazole for Ulcer, Clonazepam for Anxiety and Bipolar Depression, Lamotrigine for Bipolar Depression, Oxcarbazepine for Bipolar Depression, Propranolol for Jitteriness, Metoclopramide for Nausea, Oxycodone for threw her back out, Tizanidine for Back issue, colecalciferol (VITAMIN D3) for Really tired and Folic Acid for Help regulate menstrual cycle. On an unspecified date 2021 patient experienced Tired/Exhausted, did not feel well, felt like little person under the skin poking her with needles, was a little sick with both vaccines and Entire arm hurt so much and flu-like symptoms. On 07Jun2021 she experienced fever for 24 hours and slept for about 18 hours. Her fever broke and Slept for 18 hours. On 12Jun2021 Thought she had 3 bug bites on arm and on 16Jun2021 she experienced bumps from the shingles she thought she had banged her arm on something when she was working on her apartment. She still had the bumps. They were getting slightly bigger and she still had pain. They were a little redder around the edges. Caller stated that the little dude under the skin was still poking. She said the pain medicine was working. She with the pain killers. Treatment of Shingles took an Antibiotics and pain medication. The outcome of events (pain, fever, shingles and Slept for 18 hours) was not recovered and unknown for other events.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Influenza like illness, Malaise, Pain, Pain in extremity
Clinical narrative: Bumps from the shingles and little redder around the edges; Bumps from the shingles and little redder around the edges; Barely had pain; Fever was still in the 99's. She normally ran low at 97.2 or 97.4; Slept for 18 hours; Tired/exhausted; Entire arm hurt so much; Was a little sick with both vaccines; flu-like symptoms; Didn't feel well; Thought she had 3 bug bites on arm; Felt like little person under the skin poking her with needles; This is a spontaneous report from a contactable consumer (patient herself). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in Upper left arm on 15May2021 15:00 or 15:30 (Lot number EW0177) as single dose and second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration Upper left arm on 07Jun2021 10:00 (Lot number EW0217) as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included Thyroid, Bipolar Depression, Anxiety, Ulcer, Hiatal Hernia, Jitteriness/Hand shaking, Back pain, threw back out all are ongoing and experienced Vitamin D low and Flu shot makes her sick for 24 hours. The patient's concomitant medications included Levothyroxine for Thyroid, Levonorgestrel (MIRENA IUD) for Birth Control, Dextroamphetamine Hydrochloride for Bipolar Depression, Bupropion Hydrochloride (WELLBUTRIN XL) for Bipolar Depression, Pantoprazole for Ulcer, Clonazepam for Anxiety and Bipolar Depression, Lamotrigine for Bipolar Depression, Oxcarbazepine for Bipolar Depression, Propranolol for Jitteriness, Metoclopramide for Nausea, Oxycodone for threw her back out, Tizanidine for Back issue, colecalciferol (VITAMIN D3) for Really tired and Folic Acid for Help regulate menstrual cycle. On an unspecified date 2021 patient experienced Tired/Exhausted, did not feel well, felt like little person under the skin poking her with needles, was a little sick with both vaccines and Entire arm hurt so much and flu-like symptoms. On 07Jun2021 she experienced fever for 24 hours and slept for about 18 hours. Her fever broke and Slept for 18 hours. On 12Jun2021 Thought she had 3 bug bites on arm and on 16Jun2021 she experienced bumps from the shingles she thought she had banged her arm on something when she was working on her apartment. She still had the bumps. They were getting slightly bigger and she still had pain. They were a little redder around the edges. Caller stated that the little dude under the skin was still poking. She said the pain medicine was working. She with the pain killers. Treatment of Shingles took an Antibiotics and pain medication. The outcome of events (pain, fever, shingles and Slept for 18 hours) was not recovered and unknown for other events.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Sleep apnoea syndrome
Clinical narrative: Bumps from the shingles and little redder around the edges; Bumps from the shingles and little redder around the edges; Barely had pain; Fever was still in the 99's. She normally ran low at 97.2 or 97.4; Slept for 18 hours; Tired/exhausted; Entire arm hurt so much; Was a little sick with both vaccines; flu-like symptoms; Didn't feel well; Thought she had 3 bug bites on arm; Felt like little person under the skin poking her with needles; This is a spontaneous report from a contactable consumer (patient herself). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in Upper left arm on 15May2021 15:00 or 15:30 (Lot number EW0177) as single dose and second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration Upper left arm on 07Jun2021 10:00 (Lot number EW0217) as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included Thyroid, Bipolar Depression, Anxiety, Ulcer, Hiatal Hernia, Jitteriness/Hand shaking, Back pain, threw back out all are ongoing and experienced Vitamin D low and Flu shot makes her sick for 24 hours. The patient's concomitant medications included Levothyroxine for Thyroid, Levonorgestrel (MIRENA IUD) for Birth Control, Dextroamphetamine Hydrochloride for Bipolar Depression, Bupropion Hydrochloride (WELLBUTRIN XL) for Bipolar Depression, Pantoprazole for Ulcer, Clonazepam for Anxiety and Bipolar Depression, Lamotrigine for Bipolar Depression, Oxcarbazepine for Bipolar Depression, Propranolol for Jitteriness, Metoclopramide for Nausea, Oxycodone for threw her back out, Tizanidine for Back issue, colecalciferol (VITAMIN D3) for Really tired and Folic Acid for Help regulate menstrual cycle. On an unspecified date 2021 patient experienced Tired/Exhausted, did not feel well, felt like little person under the skin poking her with needles, was a little sick with both vaccines and Entire arm hurt so much and flu-like symptoms. On 07Jun2021 she experienced fever for 24 hours and slept for about 18 hours. Her fever broke and Slept for 18 hours. On 12Jun2021 Thought she had 3 bug bites on arm and on 16Jun2021 she experienced bumps from the shingles she thought she had banged her arm on something when she was working on her apartment. She still had the bumps. They were getting slightly bigger and she still had pain. They were a little redder around the edges. Caller stated that the little dude under the skin was still poking. She said the pain medicine was working. She with the pain killers. Treatment of Shingles took an Antibiotics and pain medication. The outcome of events (pain, fever, shingles and Slept for 18 hours) was not recovered and unknown for other events.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Fatigue, Herpes zoster, Illness, Influenza like illness
Clinical narrative: Bumps from the shingles and little redder around the edges; Bumps from the shingles and little redder around the edges; Barely had pain; Fever was still in the 99's. She normally ran low at 97.2 or 97.4; Slept for 18 hours; Tired/exhausted; Entire arm hurt so much; Was a little sick with both vaccines; flu-like symptoms; Didn't feel well; Thought she had 3 bug bites on arm; Felt like little person under the skin poking her with needles; This is a spontaneous report from a contactable consumer (patient herself). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in Upper left arm on 15May2021 15:00 or 15:30 (Lot number EW0177) as single dose and second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration Upper left arm on 07Jun2021 10:00 (Lot number EW0217) as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included Thyroid, Bipolar Depression, Anxiety, Ulcer, Hiatal Hernia, Jitteriness/Hand shaking, Back pain, threw back out all are ongoing and experienced Vitamin D low and Flu shot makes her sick for 24 hours. The patient's concomitant medications included Levothyroxine for Thyroid, Levonorgestrel (MIRENA IUD) for Birth Control, Dextroamphetamine Hydrochloride for Bipolar Depression, Bupropion Hydrochloride (WELLBUTRIN XL) for Bipolar Depression, Pantoprazole for Ulcer, Clonazepam for Anxiety and Bipolar Depression, Lamotrigine for Bipolar Depression, Oxcarbazepine for Bipolar Depression, Propranolol for Jitteriness, Metoclopramide for Nausea, Oxycodone for threw her back out, Tizanidine for Back issue, colecalciferol (VITAMIN D3) for Really tired and Folic Acid for Help regulate menstrual cycle. On an unspecified date 2021 patient experienced Tired/Exhausted, did not feel well, felt like little person under the skin poking her with needles, was a little sick with both vaccines and Entire arm hurt so much and flu-like symptoms. On 07Jun2021 she experienced fever for 24 hours and slept for about 18 hours. Her fever broke and Slept for 18 hours. On 12Jun2021 Thought she had 3 bug bites on arm and on 16Jun2021 she experienced bumps from the shingles she thought she had banged her arm on something when she was working on her apartment. She still had the bumps. They were getting slightly bigger and she still had pain. They were a little redder around the edges. Caller stated that the little dude under the skin was still poking. She said the pain medicine was working. She with the pain killers. Treatment of Shingles took an Antibiotics and pain medication. The outcome of events (pain, fever, shingles and Slept for 18 hours) was not recovered and unknown for other events.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia, Somnolence, Weight increased
Clinical narrative: Bumps from the shingles and little redder around the edges; Bumps from the shingles and little redder around the edges; Barely had pain; Fever was still in the 99's. She normally ran low at 97.2 or 97.4; Slept for 18 hours; Tired/exhausted; Entire arm hurt so much; Was a little sick with both vaccines; flu-like symptoms; Didn't feel well; Thought she had 3 bug bites on arm; Felt like little person under the skin poking her with needles; This is a spontaneous report from a contactable consumer (patient herself). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in Upper left arm on 15May2021 15:00 or 15:30 (Lot number EW0177) as single dose and second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration Upper left arm on 07Jun2021 10:00 (Lot number EW0217) as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included Thyroid, Bipolar Depression, Anxiety, Ulcer, Hiatal Hernia, Jitteriness/Hand shaking, Back pain, threw back out all are ongoing and experienced Vitamin D low and Flu shot makes her sick for 24 hours. The patient's concomitant medications included Levothyroxine for Thyroid, Levonorgestrel (MIRENA IUD) for Birth Control, Dextroamphetamine Hydrochloride for Bipolar Depression, Bupropion Hydrochloride (WELLBUTRIN XL) for Bipolar Depression, Pantoprazole for Ulcer, Clonazepam for Anxiety and Bipolar Depression, Lamotrigine for Bipolar Depression, Oxcarbazepine for Bipolar Depression, Propranolol for Jitteriness, Metoclopramide for Nausea, Oxycodone for threw her back out, Tizanidine for Back issue, colecalciferol (VITAMIN D3) for Really tired and Folic Acid for Help regulate menstrual cycle. On an unspecified date 2021 patient experienced Tired/Exhausted, did not feel well, felt like little person under the skin poking her with needles, was a little sick with both vaccines and Entire arm hurt so much and flu-like symptoms. On 07Jun2021 she experienced fever for 24 hours and slept for about 18 hours. Her fever broke and Slept for 18 hours. On 12Jun2021 Thought she had 3 bug bites on arm and on 16Jun2021 she experienced bumps from the shingles she thought she had banged her arm on something when she was working on her apartment. She still had the bumps. They were getting slightly bigger and she still had pain. They were a little redder around the edges. Caller stated that the little dude under the skin was still poking. She said the pain medicine was working. She with the pain killers. Treatment of Shingles took an Antibiotics and pain medication. The outcome of events (pain, fever, shingles and Slept for 18 hours) was not recovered and unknown for other events.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Tremor, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: hardening as the site of the injection plus swollen.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Additional Details: Patient informed pharmacist of vasovagal history of passing out from vaccines. Patient passed out 3 minutes after administration and was layed to floor by pharmacist and her close friend. Patient possibly started to a 15 second tonic-clonic seizure from the vaccine. Previous history of seizures.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye movement disorder, Headache, Nervousness, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Additional Details: Mom stated pt felt lightheaded, her eyes rolled back, and fainted for a few seconds.  When we observed her, pt was ok but a little shaky.  The paramedics came and checked on her, but mother declined going to ER
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Additional Details: Mom stated pt felt lightheaded, her eyes rolled back, and fainted for a few seconds.  When we observed her, pt was ok but a little shaky.  The paramedics came and checked on her, but mother declined going to ER
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Patient passed out about 5 minutes after receiving the covid vaccine, he was sweaty, and recovered after a few minutes, we gave water and crackers
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Loss of consciousness, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Patient passed out about 5 minutes after receiving the covid vaccine, he was sweaty, and recovered after a few minutes, we gave water and crackers
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Nausea
Clinical narrative: Systemic: Nausea-Mild, Additional Details: PATIENT EXPERIENCED MILD NAUSEA IMMEDIATELY POST IMMUNIZATION. PARENT GAVE CHILD-PATIENT WATER. PARENT AND CHILD EXPRESSED IMPROVMENT PRIOR TO LEAVING PHARMACY. NO ONGOING CONCERNS.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Myalgia, Paraesthesia, Pregnancy test urine negative
Clinical narrative: 20 hours after vaccine began having copious vomiting, 2 episodes of diarrhea, myalgia, fatigue, and tingling to BUE
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vomiting
Clinical narrative: 20 hours after vaccine began having copious vomiting, 2 episodes of diarrhea, myalgia, fatigue, and tingling to BUE
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eye contusion, Face injury, Fall, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received covid vaccine, approximately 10 minutes after patient slumped foward in chair then fell out of the chair and struck there face on an unkown object, blacked eye and chipped patients tooth. I went to the pharmacist rushed to patient's side made sure they were awake, asked technician to call 911, assisted patient back in the chair. Had technician stay with patient got him a water and waited for paramedics to arrive. The paramedics determined patient could leave.