chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received the vaccine at 7:00 a.m. on 2/3/21. I woke up at 1:00 a.m  on 2/4/21 with a racing heart, sweats, severe muscle/joint pain. According to my Watch app., the resting hear rate upon waking was 115.. I had a severe headache and generally felt awful. I took Aleve and did deep breathing to try to bring heart rate down. One hour later it was coming down, although still higher than my normal resting rate of 60.  The arm where the injection was given has been extremely sore with a rash, sore enough that it is hard to use the arm. It is now 3 days since the vaccine, my heart rate has been normal. My arm pain is reduced but still sore with a rash. I feel fatigued and foggy. The severe joint pain is less but still present.
Paralysis in leg; headache; difficult to walk; numbness in left  leg; pain in the left foot; frequent urination; hard time sleeping; This serious case was reported by a consumer via patient support programs and described the occurrence of leg paralysis in a adult female patient who received DTPa (Reduced antigen) (Boostrix) (batch number H242K, expiry date 09-JUN-2025) for prophylaxis.   On 07-APR-2023, the patient received Boostrix. On 07-APR-2023, 10 min after receiving Boostrix, the patient experienced headache (Verbatim: headache). On 10-APR-2023, the patient experienced leg paralysis (Verbatim: Paralysis in leg) (serious criteria disability and GSK medically significant). In APR-2023, the patient experienced walking difficulty (Verbatim: difficult to walk), numbness in leg (Verbatim: numbness in left  leg), foot pain (Verbatim: pain in the left foot), urinary frequency (Verbatim: frequent urination) and difficulty sleeping (Verbatim: hard time sleeping). The outcome of the leg paralysis, walking difficulty, numbness in leg, foot pain, urinary frequency and difficulty sleeping were not resolved and the outcome of the headache was resolved.   It was unknown if the reporter considered the leg paralysis, headache, walking difficulty, numbness in leg, foot pain, urinary frequency and difficulty sleeping to be related to Boostrix.     It was unknown if the company considered the leg paralysis, headache, walking difficulty, numbness in leg, foot pain, urinary frequency and difficulty sleeping to be related to Boostrix.   Linked case(s) involving the same patient:  US2023052563   Additional Information: GSK Receipt date:11-APR-2023. Patient stated 10 minutes after the shot she experienced headache.  Patient 1 to 2 hours after shot she states it was difficult to walk, she had numbness in left leg and pain in the left foot which has not resolved.  Patient also states she has frequent urination and a hard time sleeping the last few days.  Patient stated that reported similar reactions to GSK shingles shot. The reporter consent to follow up. The case was linked with case US2023052563, reported by same reporter.; Sender's Comments:  US-GSK-US2023052563:Same reporter
Chief Complaint: Fall.  The patient reports a runny nose, cough, and pain in her left shoulder.  Acute respiratory failure secondary to Pneumonia due to COVID-19 virus- currently on 2 L NC. Start IV Dexamethasone During her hospitalization she also experienced AFib RVR and Cardiology was consulted who adjusted her medications.  The rate of her atrial fibrillation improved with medication adjustments however her overall clinical status continued to decline.  She had an acute kidney injury and Nephrology was consulted without significant improvement in her creatinine.  On the night of 01/27/2022 the patient experienced dark bowel movements with concern for an upper GI bleed and GI was consulted.  They recommended no a aggressive intervention as the patient's son declined due to the patient's overall poor health.  She continued to decline and oxygen requirements increased steadily to 15 L non-rebreather.  With all the aforementioned issues the patient's son was contacted to have a discussion regarding goals of care.  He understood and stated "seems like she's shutting down and I wish you would let her". Hospice was consulted who recommended GIP hospice which was arranged with the help of case management and palliative care.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Weakness-Mild, Additional Details: patient was nervous and was hesistant about needles just prior to vaccination. as soon as the vaccinnation was done, patient became tense and seizure like activity for ~10 seconds, then he became coherent and was sweating/ pale/ feverish. Gave the patient water, ice packs, and offered to call 911 once he was coherent. Patient refused and then called friend to take him home.
Patient fell over forward while sitting on the floor 4 hours after vaccination. Found to be breathing but blue lips and non-responsive. Event lasted about about several (2-3) seconds, eyes rolled up during event. No shaking. Event resolved and patient recovered completely within a few hours. No fever. No treatment needed.
Ear infection; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Jul2021 at 10:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 03Aug2021 the patient experienced an ear infection. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ear infection was not recovered at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Several hours after injection very sore arm. Next day reports arm was red swollen hot and painful. Resolving the following day.
REALLY SLEEPY; SORE AT INJECTION SITE; REALLY TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced really sleepy. On MAR-2021, the subject experienced sore at injection site. On MAR-2021, the subject experienced really tired. The action taken with covid-19 vaccine was not applicable. The patient recovered from really sleepy, and really tired on MAR-2021, and sore at injection site on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210619423 and 20210619315.
Approximately 10 hours post injection developed extreme chills  temp (oral) 101.4 general feeling of weakness.   Tachycardia, dizziness , nausea .  Temp(oral) increased to 102.7 approximately 12 hours pst injection. Decreased to 101 w Tylenol. Sever days of low grade fever and muscle weakness followed. Negative PCR test 5 days post injection.
Patient received. HepB #1 8/10/05; Pediarix #1 10/21/05; Pediarix #2 12/23/05; Pediarix #3 3/3/06; all given of previous practice
rapid atrial fibrillation; chest pain and HR 220; diaphoretic; hypotension; This is a spontaneous report received from contactable reporter via COVID-19 Vaccine Adverse Event Self-Reporting Solution portal. The reporter is the patient.  A 60 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 12Jan2022 15:00 (Lot number: FJ5683) at the age of 60 years as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the hospital. Relevant medical history included: "former history of atrial fibrillation (fib)," start date: 2019 (unspecified if ongoing), notes: prior to ablation 3 years prior reporting (completely controlled after ablation); "ablation" (unspecified if ongoing); "hypertension (HTN)" (unspecified if ongoing). The patient had no known allergies. 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 took other unspecified concomitant medications within 2 weeks of vaccination. The following information was reported: ATRIAL FIBRILLATION (medically significant, life threatening) with onset 22Jan2022 09:30, outcome "not recovered," described as "rapid atrial fibrillation; chest pain and heart rate (HR) 220"; HYPERHIDROSIS (life threatening) with onset 22Jan2022 09:30, outcome "not recovered," described as "diaphoretic"; HYPOTENSION (life threatening) with onset 22Jan2022 09:30, outcome "not recovered," described as "hypotension." The events "rapid atrial fibrillation; chest pain and HR 220," "diaphoretic," and "hypotension" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: HR: (22Jan2022) 220 and Nasal Swab: (22Jan2022) negative. Therapeutic measures were taken as a result of atrial fibrillation, hyperhidrosis, and hypotension, which included rescue squad, intravenous (IV) fluids, and medication.; Sender's Comments: Based on available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be fully excluded.  However, the history of atrial fibrillation is confounding. 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.
On the evening of October 14th I started having trouble seeing and sensitivity to light. I went to the eye Dr and they believed it was a change in prescription. We tried new contacts over the course of two weeks. The vision in my left eye just became worse. Finally after putting dye in my eye the Dr discovered ?surface damage? to my eye. She said it is typically caused by an allergic reaction to a new medication. I haven?t been on any new medication. The only ?new? medication that I had recently was the Covid vaccine. I am now on neomycin & polymyxin eye drops to try and undo the damage. Outcome is to be determined
Woke up with chills and body aches which she thought was very difficult to deal with. She also had night sweats and couldn't sleep.
low grade fever; headaches; I was very tired, Tiredness; Injection site pain; site is red; slight swelling in the arm; muscle pain kind of all over; didn't feel well; whole arm was pain; had kind of few side effects for third shot; had kind of few side effects for third shot; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received third dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection, Batch/lot number: EW0168, Expiry date: unknown), via an unspecified route on 16Aug2021, as a single dose for covid-19 immunization. Medical history included Crohn's disease for which patient takes chemo drug to keep Crohn's under control, asthma and patient was immuno-compromised. Concomitant medications included mother drugs: pantoprazole, mild Calcium, alendronate sodium (FOSAMAX), mercaptopurine (PURINETHOL, 6-MP) and immuno-compromise drug, a chemodrug (further clarification unknown if patient was suffering from side effects hence captured as suspect of unspecified medication). Historical vaccine included first dose of bnt162b2 (Pfizer Covid Vaccine, Solution for injection, Lot number: EN5318) on 05Feb2021 and second dose of bnt162b2 (Pfizer Covid Vaccine, Solution for injection, Lot number: EN6201) on 26Feb2021 both as a single dose for covid-19 immunization and experienced no side effects. Patient did not receive any other vaccines prior to the COVID vaccine. On an unknown date (age at the time of onset of reaction/event: 65-year-old), patient experienced few side effects for third shot: injection site pain hurt for over a week/almost a week and half. Just was started feeling better. Patient was very tired/tiredness, had headaches and muscle pain kind of all over. Also, had a low-grade fever, slight swelling in the arm, site is red, didn't feel well and whole arm was pain. Patient guess would be that the first shot to the second shot was so bad that his body did not have the chance to build up antibodies and response. So, when the third shot came around, it was really worked. Patient did not receive any treatment for the events. He was just happy that he had response. The patient underwent lab test and procedure which included weight measurement of 295 Ibs on an unknown date and 290 lbs on 29Aug2021 (actually, she was 290, measured himself today 290, not confirmed). No blood work was done. The clinical outcome of the events following third dose was patient feeling fine now, it's just, patient was trying to report what he had.   Follow-up attempts are completed. No further information is expected.
Blisters break out; Great pain; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (patient was already getting shingles before the vaccine).   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced blister and pain. The patient was treated with ibuprofen (Advil), gabapentin and analgesic, nos (Pain Patch (Unknown)). On an unknown date, the outcome of the blister was unknown and the outcome of the pain was not recovered/not resolved.   The reporter considered the blister and pain to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that she received Shingrix vaccine on Monday and by Thursday she experienced blisters break out with great pain. The patient stated that it had been 9 weeks with still pain. The patient received Advil, Gabapentin and pain patches as a treatment. The patient stated that it was terrible. The physician stated that she was already getting shingles before the vaccine. The reporter considered the events might had been to be related to Shingrix. Follow-up would not possible as no contact details were available.
I was the administrator, have given two different patients in the last couple of months the shingles vaccination. On 8/25/07 I developed intense itching and burning of skin on abdomen, left side and on 8/27/07 was diagnosed with shingles. Concern that administrator may have gotten shingles from administrating "aerosol method" tx by LMD with acyclovir, and lyrica; still have post herpatic nerve pain, nausea
No adverse reactions from patient. Given 6 month through 11 year Moderna Spikevax vaccine .5ml 50 mcg  (full vial dose), not 12+ adult dose of .5 ml. 50 mcg. Patient was given the correct dosage of vaccine with correct mcg. Wrong vaccine vial was used.
This case was reported by a pharmacist via call center representative and described the occurrence of numbness in a 22-year-old male patient who received FLUARIX QUADRIVALENT (batch number BF7CA, expiry date 30th June 2018). On 23rd October 2017, the patient received FLUARIX QUADRIVALENT. On 23rd October 2017, 2 min after receiving FLUARIX QUADRIVALENT, the patient experienced numbness. On an unknown date, the outcome of the numbness was unknown. The reporter considered the numbness to be unrelated to FLUARIX QUADRIVALENT. Additional details were provided as follows: The healthcare professional reported that after administration of FLUARIX QUADRIVALENT, the patient experienced numbness in his right leg and hip. The healthcare professional did not know if numbness had resolved as the patient had left the clinic. The healthcare professional did not believe FLUARIX QUADRIVALENT administration was related to the patient's symptoms.
Pt's father check out increased irritability. Not responding to redirection physical aggression, agitation started 15 hours after dose. No treatment. Being seen by psychiatrist.
Rash at the injection site on the left arm, 5-6 inches long and 3-4 inches wide
Patient was given 0.25ml on 9/14/22, and came back to receive the full dose on 9/16/22 of 0.5ml.
This spontaneous report was received from a physician via a company representative refers to a 73 year old female patient. Approximately one year ago in May 2012, the patient was vaccinated with ZOSTAVAX (dose, route, lot and frequency not reported). Approximately 1 year ago in May 2012, the patient developed an acute case of shingles, after receiving in ZOSTAVAX vaccine through an unspecified pharmacy. The patient sought medical attention. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Dizziness, Nausea/Vomiting, hypotension, diaphoresis. Patient was laying down, oxygen was applied via nasal cannula at 2 liters. Signs and symptoms lasted for approximately 10 minutes.
Approximately 3" area of erythma  distal to injection site warm to touch no puritis. Likely local response. Rx x 5-10 days to cover unlikely 2" cellulitis.
Sweating / flu like / body aches. Felt terrible / stiff arm / stiff neck / firmness, swelling, pain at injection site. ER on 9/9/17. F/U here at 9/13/17, felt better arm still swollen. DX viral syndrome. TX with Benzonatate, Diclofenac; ZOFRAN.
missed 2 dose; my legs (below my knees) itched and ankles swelled; my legs (below my knees) itched and ankles swelled; hives; burning; prickling all over; itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (burning), PARAESTHESIA (prickling all over), PRURITUS (itching), URTICARIA (hives) and PRURITUS (my legs (below my knees) itched and ankles swelled) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN, OMEPRAZOLE, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and ASCORBIC ACID, BORAGO OFFICINALIS OIL, FISH OIL, MAGNESIUM, NICOTINAMIDE, PYRIDOXINE, ZINC (OMEGA-3 & -6 COMPLEX) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced BURNING SENSATION (burning), PARAESTHESIA (prickling all over) and PRURITUS (itching). On 05-Mar-2021, the patient experienced URTICARIA (hives). On 07-Apr-2021, the patient experienced PRURITUS (my legs (below my knees) itched and ankles swelled) and JOINT SWELLING (my legs (below my knees) itched and ankles swelled). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2 dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Burning skin, Prickling of hand and Itching, at a dose of bed time; LORATADINE (CLARITINE) for Hives, at a dose of 14 days at bed time; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 22-Mar-2021 for Itching and Burning skin, at a dose of 20 mg twice a day and FAMOTIDINE on 22-Mar-2021 for Hives and Itching, at a dose of 20 mg twice a day. At the time of the report, BURNING SENSATION (burning), PARAESTHESIA (prickling all over), PRURITUS (itching), URTICARIA (hives), PRURITUS (my legs (below my knees) itched and ankles swelled) and JOINT SWELLING (my legs (below my knees) itched and ankles swelled) had resolved and PRODUCT DOSE OMISSION ISSUE (missed 2 dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) negative. On an unknown date, SARS-CoV-2 antibody test: other IgG: Positive IgM: Positive IgA: Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is feeling good now.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Additional AE added, updated AE outcome, doctor's info updated
Metallic taste in my mouth; This spontaneous case was reported by a nurse and describes the occurrence of DYSGEUSIA (Metallic taste in my mouth) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2019.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced DYSGEUSIA (Metallic taste in my mouth). On 28-Dec-2020, DYSGEUSIA (Metallic taste in my mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No Treatment information was reported.   This case was linked to MOD-2021-353361 (Patient Link).
Per Emergency Department Report:84-year-old female with history of paroxysmal A. fib without anticoagulation due to fall risk, hypertension, hyperlipidemia, hypothyroidism, paranoid schizophrenia, diastolic heart failure long-term resident at DPC. Her caretaker is at bedside says she was concerned that the patient had an elevated heart rate, showed some confusion, and seemed to be breathing harder than usual. Patient review of systems positive for increased frequency and urinary incontinence, but she has no other complaints. She is not experience any chest pain, shortness of breath, palpitations, dizziness, syncopal symptoms, weakness, numbness, paresthesias.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 51-year-old male patient received, on an unknown date (on 01Jul of an unspecified year), PREVNAR 13 single dose. The patient was without spleen. Concomitant medications were unknown. On an unspecified date, he experienced high fever and night sweats. On 05Jul (of an unspecified year), the patient was admitted to the hospital and placed in the intensive care unit (ICU). He received his last pneumonia shot 10 years ago. The hospital doctors stated that he had pneumonia. Clinical outcome of the events was unknown at time of this report.