chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Palpitations, SARS-CoV-2 test, Skin disorder, Skin exfoliation
Clinical narrative: SCALP HAIR BECAME DRY, THIN, AND BRITTLE; SCALP HAIR BECAME DRY, THIN, AND BRITTLE; DIFFUSE SHEDDING OF SCALP HAIR; HEART PALPITATIONS; HOT FLASHES; INSOMNIA; FATIGUE AND WEAKNESS; FATIGUE AND WEAKNESS; CHEST PAIN; DIFFICULTY TAKING A DEEP BREATH; MOOD SWINGS; DIFFICULTY CONCENTRATING AND MEMORY LAPSES; DIFFICULTY CONCENTRATING AND MEMORY LAPSES; ACHING AND STIFFNESS IN KNEES, THIGHS, HIPS, AND LOWER BACK; ACHING AND STIFFNESS IN KNEES, THIGHS, HIPS, AND LOWER BACK; HAIR LOSS ON FOREARMS, EDGE OF EYEBROWS, AND LOWER LEGS/ DIFFUSE SHEDDING OF SCALP HAIR; HEAT INTOLERANCE; ELEVATED THYROID PEROXIDASE ANTIBODIES; GOITER / THYROIDITIS; GOITER / THYROIDITIS; NECK TENDERNESS IN THE AREA AROUND ADAM'S APPLE; This is a spontaneous report from a contactable consumer or other health care professional. A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), (Lot Number: EWO173, Expiry date not reported) via unspecified route of administration administered in left arm on 01May2021 at 15:30 (at age of 46-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient medical history and concomitant medications were not reported. Patient did not receive any other vaccine within four weeks. Patient received other medications in two weeks include dietary supplements. Patient previously took beta lactam antibiotics, azithromycin, ibuprofen, and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO150, Expiry date not reported) via unspecified route of administration, administered in left arm on 10Apr2021 at 15:30 (at age of 46-years-old) as single dose for COVID-19 Immunisation. On unspecified date in May2021 (after vaccination) patient experienced scalp hair became dry, thin and brittle, diffuse shedding of scalp hair, heart palpitations, hot flashes, insomnia, fatigue ,weakness, chest pain, difficulty taking a deep breath, mood swings, difficulty concentrating and memory lapses, aching and stiffness in knees, thighs, hips, and lower back, hair loss on forearms, edge of eyebrows, and lower legs, heat intolerance, elevated thyroid peroxidase antibodies, goiter / thyroiditis, neck tenderness in the area around adams apple. Patient did not receive treatment for the events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The Patient underwent lab test and procedures include PCR test was negative on 29Jun2021; Anti-thyroid antibody test result was elevated thyroid peroxidase antibodies on unspecified date in May 2021. The Outcome of the events was not recovered.   Follow-Up (06Sep2021): Follow-up attempts are completed. No further information is expected.   Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Temperature intolerance, Tenderness, Thyroiditis
Clinical narrative: SCALP HAIR BECAME DRY, THIN, AND BRITTLE; SCALP HAIR BECAME DRY, THIN, AND BRITTLE; DIFFUSE SHEDDING OF SCALP HAIR; HEART PALPITATIONS; HOT FLASHES; INSOMNIA; FATIGUE AND WEAKNESS; FATIGUE AND WEAKNESS; CHEST PAIN; DIFFICULTY TAKING A DEEP BREATH; MOOD SWINGS; DIFFICULTY CONCENTRATING AND MEMORY LAPSES; DIFFICULTY CONCENTRATING AND MEMORY LAPSES; ACHING AND STIFFNESS IN KNEES, THIGHS, HIPS, AND LOWER BACK; ACHING AND STIFFNESS IN KNEES, THIGHS, HIPS, AND LOWER BACK; HAIR LOSS ON FOREARMS, EDGE OF EYEBROWS, AND LOWER LEGS/ DIFFUSE SHEDDING OF SCALP HAIR; HEAT INTOLERANCE; ELEVATED THYROID PEROXIDASE ANTIBODIES; GOITER / THYROIDITIS; GOITER / THYROIDITIS; NECK TENDERNESS IN THE AREA AROUND ADAM'S APPLE; This is a spontaneous report from a contactable consumer or other health care professional. A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), (Lot Number: EWO173, Expiry date not reported) via unspecified route of administration administered in left arm on 01May2021 at 15:30 (at age of 46-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient medical history and concomitant medications were not reported. Patient did not receive any other vaccine within four weeks. Patient received other medications in two weeks include dietary supplements. Patient previously took beta lactam antibiotics, azithromycin, ibuprofen, and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO150, Expiry date not reported) via unspecified route of administration, administered in left arm on 10Apr2021 at 15:30 (at age of 46-years-old) as single dose for COVID-19 Immunisation. On unspecified date in May2021 (after vaccination) patient experienced scalp hair became dry, thin and brittle, diffuse shedding of scalp hair, heart palpitations, hot flashes, insomnia, fatigue ,weakness, chest pain, difficulty taking a deep breath, mood swings, difficulty concentrating and memory lapses, aching and stiffness in knees, thighs, hips, and lower back, hair loss on forearms, edge of eyebrows, and lower legs, heat intolerance, elevated thyroid peroxidase antibodies, goiter / thyroiditis, neck tenderness in the area around adams apple. Patient did not receive treatment for the events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The Patient underwent lab test and procedures include PCR test was negative on 29Jun2021; Anti-thyroid antibody test result was elevated thyroid peroxidase antibodies on unspecified date in May 2021. The Outcome of the events was not recovered.   Follow-Up (06Sep2021): Follow-up attempts are completed. No further information is expected.   Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Taste disorder
Clinical narrative: Most food (besides sweets) don't taste the same; Metallic taste in mouth at all times; This is a spontaneous report from a contactable consumer (patient, self-reported). A 42-year-old non pregnant female received second dose of f BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: Ew0171 and expiry date was not reported), intramuscularly in Arm Left, on 23Apr2021 at 02:30 PM (age at vaccination: 42 years), as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient did not test for COVID post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0150 and expiry date: 31Aug2021), intramuscularly in Arm Left, on 01Apr2021 at 07:30 AM, as dose 1, single for COVID-19 immunization. The patient reported that, on 02Jun2021, she had metallic taste in mouth at all times. Most food (besides sweets) did not taste the same and very metallic or ferric. She also experienced constant burning smell/taste. Sweet foods were ok, but any other food such as meat and vegetables taste like metal and were gross. This change in smell ability could be a serious issue if she would be unable to do her job as a scientist in a chemical lab since she cannot determine chemical potency. The patient did not receive any treatment for the events. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.  Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101128399 same patient, different dose/events
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Retching
Clinical narrative: nauseous; Fever; Dry heaves; This is a spontaneous report from a contactable Consumer (parent). A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 14 years), dose 1 intramuscular in Arm left on 30Jun2021 as dose 1, single and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0180, Expiry date: unknown, at the age of), dose 2 intramuscular on 26Jul2021 15:00 as dose 2, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Jul2021 the patient experienced fever and was nauseous with dry heaves after receipt of the Pfizer-BioNTech COVID-19 Vaccine and requested any management recommendations. She wanted to ask about use of Tylenol for the fever and anything to help with nausea. Early this morning, the patient's mother found the patient on bathroom floor next to toilet because of the nausea. This was the same reaction after she got her first dose on 30Jun2021. The outcome of the event nauseous was recovered on 01Jul2021 and that of fever and dry heaves was recovered on 02Jul2021.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: have a 12x12x5 mm Mass in the Back of my Left Breast / Right Under where the Shot was Given; My Vaccination Arm is Magnetic, when I hold a Fork above the Area given the Shot the Fork is Drawn to the Arm; This is a spontaneous report from a contactable consumer (patient herself). A 49-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 18Apr2021 16:00 (age at vaccination: 49 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included breast cancer last year but now its gone, latex and peanuts allergy. The patient's concomitant medications were not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number:ER8727) via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. On 02Aug2021 16:00, the patient had a 12x12x5 mm mass in the back of her left breast / right under where the shot was given, vaccination arm was magnetic, when she holds a fork above the area given the shot the fork is drawn to the arm. Leaning forward the fork doesn't fall off but It dangles from her arm. The patient did not receive any treatment for the adverse event. The patient did not have covid prior to vaccination not was tested since vaccination. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain
Clinical narrative: mouth sores; This is a spontaneous report from a contactable other HCP. A 47-years-old non pregnant female patient received (BNT162B2 formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in Arm Left on 30Jun2021 12:00PM (at the age of 47-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included asthma and Paper tape allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included salbutamol sulfate and montelukast sodium all for unknown indications from unknown dates and unknown if ongoing.The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported Dose 1 mouth sores and Multiple on each side of my mouth, Upper and lower. 6-8 at a time, They went away, Dose 2 mouth ulcers. she have been getting constant sore. As they heal she get new sores. she constantly have 2. she last dose was 14Jul2021. she at the end of 2. It seems though as she think they are gone a new one starts. The patient experienced mouth sores on 02Jul2021. The clinical outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Patient has a very very big rash its just growing its all over her back or her bottom, her arm and her hand; break into hives; This is a spontaneous report from a contactable nurse or other hcp (parent). A 17-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date (at the age of 17-years-old) as single dose for covid-19 immunization. Reporter stated regarding first dose date as there was about 4 to 6 weeks ago. The patient's medical history was not reported. The patient's concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. It was reported that its not helping, getting worse. On unspecified date 4 weeks ago, patient has a very big rash it's just growing it's all over her back or her bottom, her arm and her hand. Reporter stated that patient taken allegra but It's not getting any better we haven't she was never had a rash like this and also experienced hives on unspecified date in 2021. Consumer stated, she has 2 questions both mother and daughter have a very big rash on their back and is spreading to her bottom 4 weeks ago and they were supposed to get the second dose both. she guesses it has been about seven weeks then they have a very big rash. Further reporter stated, they will get second one but if she has this bad over result from it they would want me to DCA write right now until they should know what going on. She is having second dosages and she had all this fever and all that from the beginning of the first dose but now what we just break into hives mother and daughter, she has been on quinidine and everything shall three weeks. Reporter stated, yes please they probably call her because reporter want to know if they want to give the second one because I am still for the second one because it's been about 6 weeks. The outcome of the event hives was not recovered, and the outcome of event patient has a very big rash it's just growing it's all over her back or her bottom, her arm and her hand was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101015552 (same reporter, different patient, parent case)
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration, Stomatitis
Clinical narrative: Dose 2 mouth ulcers; I have been getting constant sore.As they heal I get new sores; This is a spontaneous report from a contactable other health care professional (patient). A 47-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 14Jul2021 (age at vaccination was 47 years and patient was not pregnant at the time of vaccination) as dose 2, single for COVID-19 immunisation at pharmacy or drug store. The patient's medical history included asthma and known allergies to paper tape. The patient's concomitant medications included fluticasone propionate (PROAIR) and montelukast sodium (SINGULAIR). The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported), via an unspecified route of administration, administered in arm left on 30Jun2021 12:00 PM (age at vaccination was 47 years) as dose 1, single for COVID-19 immunisation and experienced mouth sores, multiple on each side of her mouth, upper and lower, 6-8 at a time on 02Jul2021. They went away. After dose 2, She experienced mouth ulcers in Jul2021. She had been getting constant sore. As they healed, she got new sores. She constantly had 2. Her last dose was 14Jul2021. She was at the end of 2. It seemed though as she thought they were gone a new one started. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no hospitalization prolonged. The patient was not received any treatment for adverse events. Prior to vaccination, she was not diagnosed with COVID-19 and since the vaccination, she had not tested for COVID-19. Outcome of event at the time of last observation was not resolved.  No follow-up attempts were completed. No further information was expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Pain, Peripheral swelling
Clinical narrative: painful and swollen armpits, worse after the second shot; painful and swollen armpits, worse after the second shot; painful and swollen armpits, worse after the second shot; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: FA6780; Expiration date: unknown) via an unspecified route of administration on 17Jul2021 10:00 (at the age of 60-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had not any known allergies. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0198; Expiration date: unknown) via an unspecified route of administration on Arm right on 17Jul2021 10:00 as DOSE 1, SINGLE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced painful and swollen armpits, worse after the second shot on 08Aug2021. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The outcome of events was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Peripheral swelling
Clinical narrative: painful and swollen armpits, worse after the second shot; painful and swollen armpits, worse after the second shot; painful and swollen armpits, worse after the second shot; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: FA6780; Expiration date: unknown) via an unspecified route of administration on 17Jul2021 10:00 (at the age of 60-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had not any known allergies. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0198; Expiration date: unknown) via an unspecified route of administration on Arm right on 17Jul2021 10:00 as DOSE 1, SINGLE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced painful and swollen armpits, worse after the second shot on 08Aug2021. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The outcome of events was not recovered.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: getting a funny taste in her mouth/described as metallic; This is a spontaneous report received from a contactable consumer (Patient) reported for herself. A 86-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EL3247) via an unspecified route of administration on 19Jan2021 (at the age of 86-year-old) as dose 1, single and second dose of bnt162b2 ((Batch/Lot number was not reported) via an unspecified route of administration at left arm on 09Feb2021 as dose 2, single for COVID-19 immunisation. Medical history included Blood pressure high, bad back, Parkinson's disease, Neuropathy and acid reflux. Concomitant medications included hydralazine hydrochloride (HYDRALAZINE [HYDRALAZINE HYDROCHLORIDE]) taken for blood pressure measurement with a daily dose of 50 mg three times a day, gabapentin with a daily dose of 600 mg three times a day, carbidopa, levodopa one in the morning and afternoon and two at night, spironolactone with a daily dose of 25 mg once a day, famotidine with a daily dose of 1 capsule once a day, propranolol with a daily dose of 80 mg once a day, cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) with daily dose of 2500 mg ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE) with once daily, ascorbic acid (VIT C), calcium carbonate, colecalciferol (CALCIUM + D3 [CALCIUM CARBONATE;COLECALCIFEROL]) and omeprazole taken for Acid reflux. Patient did not receive any other vaccines within 4 weeks prior to this vaccine and patient do not have any adverse events prior to vaccination. It was none history of all previous immunization with the Pfizer vaccine considered as suspect and additional Vaccines Administered on Same Date of the Pfizer Suspect. It was reported that Caller is a 86 year-old female who received the first dose of the Pfizer Covid-19 vaccine on 19Jan2021 and the second dose on 09Feb2021. Before or after the second dose (Caller unable to state exactly when) the Caller started getting a funny taste in her mouth that she still experiences to this day when she puts food in her mouth on unspecified date in 2021. Caller states that the funny taste could possibly be described as metallic. HCP advised Caller to "double up" on her omeprazole due to possible increased acid reflux but Caller stated that she stopped using the omeprazole as advised by her HCP due to complaints of diarrhea. Caller is asking if the funny taste that she is experiencing has been reported as a side effect for the Pfizer Covid-19 vaccine? The caller got her last shot in Feb and she was not sure if it was before or after the second dose, she started to get this funny taste in her mouth and she still has it 6 months later. Has anyone else reported this. As soon as the caller puts food in her mouth she can taste this taste. Patient did not visit the emergency room but visits the physician office for the events. Outcome of event was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable other hcp (patient). This report was received via a sales representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced headache. It was reported that after shot 1 the patient experienced headache that would come and go and after shot 2 the patient also experienced a headache that would come and go and a little bit of chest pain after the second shot. It was reported that she received both shots in April 2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: mild itching; This is a spontaneous report from a contactable Other HCP (patient) via Medical Information Team. A patient of an unspecified gender and age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 29Dec2020 as a dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient received the Pfizer COVID-19 vaccine initially on 29Dec2020 and the final dose on 19Jan2021. After initial dose, patient had some mild itching a week after on an unspecified date in Jan2021. Suspected it was from the vaccine. Nevertheless, completed the second dose and a week after that the itching got worse with rashes then maculae and papulae. Went to see an allergist and he ruled possible allergy to the vaccine. After initial dose, patient experienced mild itching on an unspecified date in Jan2021 (reported as a week after). The outcome of the event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Condition aggravated, Paraesthesia, Sensory loss
Clinical narrative: had no smell; had no taste; Stated that he has sensations in his legs; he has sensations in his legs was reported as worsened; stated that when he walks that it is like pens and needles; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer (patient's mother) reported for a patient (reporter's son). A 19-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in Jul2021 (age at vaccination was 19 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was 19 years) as dose 1, single for COVID-19 immunization. It was unknown if there was history of any previous immunization with the Pfizer vaccine considered as suspect. It was unknown if any additional vaccines were administered on same date of the Pfizer suspect. The facility where the most recent COVID-19 vaccine was administered was Pharmacy/Drug Store. The vaccine was not administered at Military facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The caller reported that her son received his second Pfizer COVID 19 vaccine two weeks ago. The patient experienced side effects that were described as a unique situation. On an unspecified date in 2021, the patient had no smell, no taste, sensation in legs, when he walked it felt like pens and needles. The caller stated that the patient lost sense of smell and taste about a week ago. The caller stated that when the patient walked that it was like pens and needles and had sensations in his legs that started about 3-4 days ago. The caller stated that the sensations vary from day to day. The caller asked if the symptoms were normal and if the symptoms will go away. The caller stated that the patient went to urgent care and was given medication and recommended that he see a neurologist for walking like pens and needles. The caller stated that the patient stopped taking medication because he did not like the way it made him feel. The event did not require visit to Physician Office. No relevant tests were done. The outcome of the events was not resolved.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: high fever of 104 degrees for 2 days; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 79-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as DOSE 2 SINGLE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. It was reported that read that booster shot has same side effects as second shot. On unspecified date, she had after 2nd shot high fever of 104 degrees for 2 days and inquired that should he still get a booster shot since he was 79. The patient underwent lab tests and procedures which included body temperature: 104 degrees on unspecified date. The outcome of the event was unknown.  Information on lot number/batch number has been requested.   Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Flushing, Hyperhidrosis
Clinical narrative: Chest pain; Feeling flushed; Sweating; Anxious/She has anxiety so any little thing freaks her out; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 11Aug2021 (age at vaccination was unknown) 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 Pfizer COVID 19 vaccine yesterday 11Aug2021. On an unspecified date in Aug2021, the patient experienced chest pain, felt flushed and sweating. She had baseline anxiety and she shared she was anxious now as she was experiencing the side effects. She asked if that was normal. It felt like someone was sitting on her chest. She had anxiety so any little thing freaked her out. The patient asked if those were reported side effects from vaccine. She received the response stating that chest pain noted sweating, feeling flushed and anxiety are not listed as side effects. These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. The patient was referred to HCP for diagnosis and treatment. The case was assessed as non-serious. The outcome of the events was unknown  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Unexpected Therapeutic Effect: after both vaccines, Caller can now eat eggs, and dairy products, in which he was previously allergic to.; Unexpected Therapeutic Effect: after both vaccines, Caller can now eat eggs, and dairy products, in which he was previously allergic to.; This is a spontaneous report from a contactable consumer (patient) by Pfizer- sponsored program reported himself. This report was related to a study or programme. A 84-years-old male patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: ER2613, expiry date: unknown), via an unknown route of administration left arm on 06Apr2021 at afternoon (at the age of 84-years-old) as dose 1, single and received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EW, caller thinks it was a zero, 162, confirms numbers are handwritten on card. NDC/expiration: unknown), via an unknown route of administration in left arm on 27Apr2021 at afternoon (at the age of 84-years-old) as dos 2, single for COVID-19 immunisation at clinic. The patient's medical history included high blood pressure from probably 15 years ago, aortic stenosis from about 8 years ago, allergies, specified as food allergies (had allergies all of his life to eggs, gluten, and dairy products) started at 8 years old, and get worse, as he got older; all were ongoing. Asthma and polio from probably at 8-years-old. Caller stated the asthma specifically to mild may have ended 20 years ago, and he has not experienced asthma since he was in his 60's. Polio ended at 8-years-old. Concomitant medications included valsartan (VALSARTAN) and Amlodipine Besylate (AMLODIPINE BESYLATE) (Spelling of medication as reported by Caller); both were taken for high blood pressure from probably 10 years or more to ongoing. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. On an unknown date, unexpected therapeutic effect: after both vaccines, Caller can now eat eggs, and dairy products, in which he was previously allergic too. The patient completed his vaccine series with the Pfizer Covid vaccine, and now, he has been able to eat eggs, and dairy products, but caller added that he has not tried gluten yet, to report. His allergies have improved or disappeared. Caller states he was a PhD., and taught anatomy and physiology for 25 years. he stated this unexpected effect was very striking to him. Any event did not require a visit to emergency room or physician office. The outcome of the events was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Inappropriate schedule of product administration, Lymphadenopathy, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: inappropriate schedule of vaccine administered; Irregular menstrual cycle now; Swelling in lymph nodes; developed a wet, raspy cough; This is a spontaneous report from a contactable nurse (patient). A 45-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via an intramuscular route of administration, administered in left arm on 05Feb2021 09:00 (at the age of 45-years) as dose 1, single for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL1283), via unspecified route of administration, administered in left arm on 05Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications taken in two weeks included ibuprofen (MOTRIN) taken for an unspecified indication, start and stop date were not reported and PROBIOTIC taken for an unspecified indication, start and stop date were not reported. The patient previously took Augmentin and experienced drug hypersensitivity, Acrylic and experienced drug hypersensitivity, Demerol and experienced drug hypersensitivity, Dilaudid and experienced drug hypersensitivity. The patient did not receive any other vaccine in four weeks. Prior vaccination patient did not have COVID-19. On 11Feb2021, patient experienced swelling in lymph nodes, developed a wet raspy cough, Irregular menstrual cycle. The adverse events resulted in visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 17Mar2021, the patient underwent nasal swab (SARS-CoV-2 test), and the test result was negative. Patient did not received treatment for adverse events. The outcome of the events was not recovered.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: chest pain; chest pain, feels tight when breathing in and out; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 17-year-old non pregnant female patient received BNT162B2 (Solution for injection; Batch/Lot Number: FD8448, Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 17Aug2021 11:00 as DOSE 1, SINGLE for covid-19 immunization (at the age of 17-year-old). The patient had no known allergies and other medical history. The patient had not received any other vaccine within 4 weeks. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). The patient was not pregnant at time of vaccination. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. On 17Aug2021 16:30 the patient experienced chest pain, feels tight when breathing in and out. The patient received no treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea
Clinical narrative: Her breathing is little bit labored; Chills; This is a spontaneous report from a contactable consumer (Parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer stated that patient got the 2nd shot, 12 hours ago and she just woke up and told me that she has the chills and her breathing is little bit labored and consumer was trying to figure out should consumer get her to the hospital or not. The outcome of events was unknown.  The batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Electrocardiogram, SARS-CoV-2 antibody test
Clinical narrative: chest x-ray to check for blood clots. EKG showed abnormal results; Severe chest pains the next day that woke me up out of a dead sleep; Severe chest pains the next day that woke me up out of a dead sleep; This is a spontaneous report from a contactable consumer (patient herself). A 33 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FA7484) via an unspecified route of administration on Jul2021(33-year-old at vaccination) as Dose number unknown, single for Covid-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history was not reported. No known allergies. The patient's concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had severe chest pains the next day that woke her up out of a dead sleep. Continued to the point where she had to go to Urgent Care for an EKG, blood work, and chest x-ray to check for blood clots. EKG showed abnormal results. Now had to visit a cardiologist. These adverse event resulted emergency room/department or urgent care. Since the vaccination, patient had been tested for COVID-19 on Aug2021: result negative. Covid test post vaccination was reported as other. No treatment received for the event. The outcome of the event was not recovered.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Thrombosis
Clinical narrative: chest x-ray to check for blood clots. EKG showed abnormal results; Severe chest pains the next day that woke me up out of a dead sleep; Severe chest pains the next day that woke me up out of a dead sleep; This is a spontaneous report from a contactable consumer (patient herself). A 33 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FA7484) via an unspecified route of administration on Jul2021(33-year-old at vaccination) as Dose number unknown, single for Covid-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history was not reported. No known allergies. The patient's concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had severe chest pains the next day that woke her up out of a dead sleep. Continued to the point where she had to go to Urgent Care for an EKG, blood work, and chest x-ray to check for blood clots. EKG showed abnormal results. Now had to visit a cardiologist. These adverse event resulted emergency room/department or urgent care. Since the vaccination, patient had been tested for COVID-19 on Aug2021: result negative. Covid test post vaccination was reported as other. No treatment received for the event. The outcome of the event was not recovered.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Headache doesn't go away; Diarrhea; Joint pain; Muscle pain; I am tired and sleeping a lot; I am tired and sleeping a lot; I can't bent, I hardly get back up and if I stand over the floor it hurt so bad down in my joint area; Dizzy; My arm injection site got itching;  going get sick or my body is rejecting vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: Unknown), via an unspecified route of administration, administered in arm on 07Aug2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Addition context stated that the patient took the first dose of vaccine on 07Aug2021 and was having a lot of headache, diarrhoea, joint pain, muscle pain. The patient was tired and was sleeping a lot, headache didn't go away. Also reported that if the patient bent over it was like the patient couldn't, the patient hardly could get back up and if the patient stood over the floor it hurt so bad down in the joint area. The patient felt tired and dizzy. The reporter stated that when the pharmacist gave first shot, the patient's arm (injection) site got itching right away, so the pharmacist gave one allergy pills (unspecified) and it went right away. The patient questioned if going to get sick or the body is rejecting vaccine. Therapeutic measure included unspecified allergy pill for arm (injection) site itching. The outcome of the event headache was not recovered while other events was unknown.  New follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Somnolence, Vaccination site pruritus
Clinical narrative: Headache doesn't go away; Diarrhea; Joint pain; Muscle pain; I am tired and sleeping a lot; I am tired and sleeping a lot; I can't bent, I hardly get back up and if I stand over the floor it hurt so bad down in my joint area; Dizzy; My arm injection site got itching;  going get sick or my body is rejecting vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: Unknown), via an unspecified route of administration, administered in arm on 07Aug2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Addition context stated that the patient took the first dose of vaccine on 07Aug2021 and was having a lot of headache, diarrhoea, joint pain, muscle pain. The patient was tired and was sleeping a lot, headache didn't go away. Also reported that if the patient bent over it was like the patient couldn't, the patient hardly could get back up and if the patient stood over the floor it hurt so bad down in the joint area. The patient felt tired and dizzy. The reporter stated that when the pharmacist gave first shot, the patient's arm (injection) site got itching right away, so the pharmacist gave one allergy pills (unspecified) and it went right away. The patient questioned if going to get sick or the body is rejecting vaccine. Therapeutic measure included unspecified allergy pill for arm (injection) site itching. The outcome of the event headache was not recovered while other events was unknown.  New follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Discomfort, Feeling abnormal, Limb discomfort, Malaise
Clinical narrative: asthma; feeling weird sensations in my legs/feel something around my jaw and my chest; feeling weird sensations in my legs; feel uncomfortable; don't feel too well about that; This is a spontaneous report from a contactable consumer (Patient). A 15-years-old male patient received unknown dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On an unspecified date, Caller mother stated that her son was not feeling too well. He had asthma and never had asthma attack. Caller stated, when he first went in there, he did not feel anything. He was a little nervous because he did not like needles, but when she gave me the shot, he immediately started feeling weird sensations in his legs. And then after that, he started to feel something around his jaw and chest. He still feeling that way now. He feel uncomfortable. He did not know if this was supposed to happen after get the first vaccine. He really did not know. He did not feel too well about that. The clinical outcome of the events were unknown whereas he started to feel something around his jaw and chest was not recovered .  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.