chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe asthmatic reaction; difficulty catching breath; 30 bpm increase in resting heart rate within 12 hrs of dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 16:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL. Vaccination history included: Covid-19 vaccine (primary immunization series and first booster dose complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 25Sep2022 at 07:00, outcome "recovering", described as "30 bpm increase in resting heart rate within 12 hrs of dose"; ASTHMA (medically significant) with onset 25Sep2022 at 07:00, outcome "recovering", described as "Severe asthmatic reaction"; DYSPNOEA (medically significant) with onset 25Sep2022 at 07:00, outcome "recovering", described as "difficulty catching breath". The events "severe asthmatic reaction", "difficulty catching breath" and "30 bpm increase in resting heart rate within 12 hrs of dose" required physician office visit. The patient underwent the following laboratory tests and procedures: Heart rate: (25Sep2022) 30 bpm increase, notes: 30 bpm increase in resting heart rate within 12 hrs of dose; SARS-CoV-2 test: (28Sep2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of asthma, dyspnea. Clinical course: Patient had severe asthmatic reaction with difficulty catching breath and 30 bpm increase in resting heart rate within 12 hours (as reported) of dose. Patient took three days to improve slightly, but required urgent care doctor visit for nebulizer breathing treatment and prednisone injection, followed by prednisone and albuterol home treatment for another five days. Eight (8) days out and still challenged with "normal" breathing despite treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy, and autoimmune, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient was previously treated with non company vaccine Pfizer Biontech Covid-19 Vaccine (dose number in series 1) (form of admin, route of admin and batch number were not reported) dose was not reported administered on 21-FEB-2021 10:00 in left arm for covid-19 prophylaxis. It was unknown if patient experienced any adverse event after Pfizer Biontech Covid-19 Vaccine (dose number in series 1). The patient received covid-19 vaccine ad26. cov2. s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 14-AUG-2021 11:00 in left arm for covid-19 prophylaxis. It was unknown if patient experienced any adverse event after covid-19 vaccine ad26. cov2. s (dose number in series 2). Past drug included EVUSHELD on 21-FEB-2022 10:00 at Gluteus Medius Left for unknown indication. The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 07-JUL-2022 12:00 in left arm for covid-19 prophylaxis. The drug was associated with Off label use. Age at time of vaccination 55 years old. The batch number was not reported and has been requested. Concomitant medications included calcium levomefolate, calcium/colecalciferol, calendula officinalis/carotenoids NOS/crocus sativus/phospholipids/Ribes nigrum, cetirizine hydrochloride, dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, magnesium, Oenothera biennis oil, Pancrelipase, retinol and thyroid for drug used for unknown indication. On an unspecified date in 2022, the patient experienced covid-19 (dose number in series 3). The patient received non company suspect Paxlovid (form of admin, route of admin and batch number were not reported) dose was not reported, administered from 27-JUL-2022 to 01-AUG-2022 for covid-19 treatment. On 04-AUG-2022 at 12:00, three and half days after completing 5 days Paxlovid treatment the patient experienced rebound Covid (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was drug discontinued on 01-AUG-2022. The patient had not recovered from covid-19 infection and Covid rebound, and the outcome of off label dosing frequency was not reported. This report was non-serious.
Abdominal pain within approximately two weeks after receiving shot.  Lasted for approximately 6-8 hours.  Eventually went away. Headache for approximately 18 hours five weeks after getting shot.  Reporting headache since I only will have infrequently and dull.  This was acute and lasted 18 hours.   Eventually went away.  Did not return.
2hrs post dizziness, vertigo, slowed speech, arm pain, arm rash near injection site  5hrs - 24 hrs post extreme chills, extreme muscle ache, joint pain, headache, had to lay on floor 24hrs - 48hrs post crushing chest pain , stomach pain  48hrs post eye inflammation right eye hurt to blink
Patient developed nausea within 15 minutes of receiving a dose of this vaccine. She feels bloated, stomach pain and has difficulty breathing. Previously she received the mRNA vaccine and developed nausea, diarrhea for a couple of days and stomach pain.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included flu vaccines with an associated reaction of headache (flu vaccines received in the past on an unknown date, refer case US2019GSK013000). On 12th August 2018, the patient received the 1st dose of SHINGRIX. On 12th August 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache, general body pain, upset stomach and tiredness. On an unknown date, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the pain in arm, headache, upset stomach and influenza-like symptoms were recovered/resolved and the outcome of the general body pain and tiredness were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, headache, general body pain, upset stomach, tiredness and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient who herself was the Nurse. On the same day of vaccination, at night the patient experienced arm hurts, headache, achy all over, upset stomach and tired. The patient also experienced mild flu like symptoms and which was lasted about 24 to 36 hours. The patient's arm really hurt when she tried to lift her arm and that did not go away until the fifth day or so. The patient did not want to provide her address. The reporter told that, the representative could call her if needed. The reporter consented to follow up. This is 1 of the 2 cases reported by same reporter.
my body started having swollen lymph nodes. three day later after the booster shot my joints were in so much pain. i went to the Emergency Room at the community hospital because of too much pain and my facial skin was braking as well the skin in my hands. i also was deaf in my left ear.. up today i am still in pain in my joint.
Crohn's disease aggravated; sore arm after pfizer vaccines; Vaccination site pain; Inflammatory marker increased; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4184013-00 (AbbVie).  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 14Jul2021 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single and intramuscular, administration date 23Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at unk (citrate free) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant) with onset 2021, outcome "not recovered", described as "Crohn's disease aggravated"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm after pfizer vaccines"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Vaccination site pain"; INFLAMMATORY MARKER INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Inflammatory marker increased". The patient underwent the following laboratory tests and procedures: inflammatory marker test: elevated. The action taken for adalimumab was unknown.  Additional information: On unknown dates, the patient experienced Inflammation Level Elevated And Crohn's Disease Flare Up. In 2021, the patient experienced Had Sore Arm After Pfizer Vaccines. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of had sore arm after Pfizer vaccines with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of inflammation level elevated was not provided. The reporter's causality for the event(s) of Crohn's Disease Flare Up with Humira (Adalimumab) was a reasonable possibility.  Causality for BNT162B2 Vaccination site pain was not reported, Inflammatory marker increased was not reported, Crohn's disease aggravated was not reported . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on information in the case  a possible causal association between the reported  events  and the suspect drug BNT162B2 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.
Routine Tetanus Prophylasix w/adult Td lt arm; 2 days later 5cm welt plus 30 cm shoulder erythema & stiffness;
small rashes on back & torso, not raised, no hives noticed;some small light rashes on extremities;has gotten better since yesterday;no temp elevated pretty happy;no unusual high pitch cry;
Patient had ED visit 31 days after receiving the second COVID-19 shot. Patient hospitalized 34 days after receiving the second COVID-19 shot.
Marked local reaction, with induration, erythema; Warmth to the entire lateral thigh with swelling of the thigh 2x the other side (I am a physician and also her mother; and have never seen such a dramatic reaction before). It almost looks vasculitic.
pt recvd DTP/OPV/MMR 1015AM @ approx 1PM pt started vomiting, diarrhea & t101 according to mom pt cont w/vomiting & diarrhea all noc & t103.8 oral; p/vomiting pt would shake arms & legs; also lethargic; parents took pt to ER;
Pain swelling to site, following that, redness, pain swelling and heat. Dr prescribed RX for Keflex for infection.
On July 11, jumped down out of a high chair and my legs cramped up and I felt like I broke my hips. My parents, ER HCPs, they said I was in Rhabdomyolysis. They didn't know the cause of it. I hadn't overexerted myself before that. They gave me IV fluids and making sure that my kidneys were functioning normally. No other treatment for it. I was in hospital two days. Legs swelled up when I was in bedrest and stayed swollen for thirty days. They continue to cramp up to this day. I use to waitress and I can't do that anymore and lift everything. Physical therapy two times a week, that isn't really helping; Rheumatologist, I am waiting to get into this doctor. I take a whole bunch of supplements, magnesium, iron (I'm anemic now); B12 and potassium and vit D.
JYNNEOS  I got no reaction whatsoever.  None.  Everyone else I know who got this vaccine, had at least a minor reaction. I have a 1/2 deletion of the CCR5/Delta32 gene mutation, so that is the likely reason. My childhood smallpox vaccinations never caused reactions either and I was given 3 shots of those. I am not complaining about this, but just thought you should know.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 08:50 the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505:
deyhdrated; lethargic; weak; very severe dizziness; diarrhea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very severe dizziness), DEHYDRATION (deyhdrated), DIARRHOEA (diarrhea), LETHARGY (lethargic) and ASTHENIA (weak) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage 1. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage 2. On 23-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 24-Feb-2021, the patient experienced DIZZINESS (very severe dizziness). On 02-Mar-2021, the patient experienced LETHARGY (lethargic) and ASTHENIA (weak). On an unknown date, the patient experienced DEHYDRATION (deyhdrated). At the time of the report, DIZZINESS (very severe dizziness), DEHYDRATION (deyhdrated), DIARRHOEA (diarrhea), LETHARGY (lethargic) and ASTHENIA (weak) outcome was unknown.            Concomitant medications were not reported. The patient received unspecified medication as a treatment for dizziness.
Two days after the second dose of Moderna, I got a rash on my arm at the injection site.  It lasted about three days.  I am reporting this only because after the first injection I had "COVID arm".  That rash came 9 days after the injection and lasted 7 days.  I had the second shot in the other arm.  The rash came sooner and was gone longer.
Information has been received from a Medical Assistant concerning a 12 month old male patient with no pertinent medical history who on an unspecified dated was vaccinated with 0.5 mL dose of RECOMBIVAX HB. It was reported that eh patient's mother noticed after her child received RECOMBIVAX HB at 9 months of age the child did not "talk" again for two weeks. It was reported that the child received hepatitis B as a part of a combination vaccine (name and manufacturer unknown) for the initial two doses in the series. It was reported that this lasted for two weeks then the child began to speak again. The patient sought medical attention at the office. Follow-up information was received from an unknown reporter who stated that he had no knowledge of this reaction. The reporter also stated that the patient was not his. No further information is available.
Patient received her vaccine with little hesitation or issue. She stood up after her vaccine and felt fine, no lightheadedness or dizziness. Her mother and her walked away with no issues. After they were out of sight of the pharmacy and patient started to not feel so well. Her mom took her out to the car so that she could sit down and had the air conditioner on her. A few moments after getting the patient into the car the mother stated that the patient had 2 seizures. Her mother called 911 and had the paramedics take her vitals. Patient's vitals were not alarming and she was taken home by her father.  Her mother stated that the seizures could be due to a vasovagal reaction since the patient was nervous and anxious about her vaccine. The Patient has been monitored by her family since the event occured with no continued issues or new events arising.
An itchy pink bump appeared on the upper right side of my neck on 06/29/2021. Over the next three days the area became painful and vesicular lesions appeared. I was seen in the on 07/02/2021 where I as was diagnosed with shingles and begun on valacyclovir 1gm tid for 7 days.
Had fever on the first day after receiving vaccines. Reported red band around the upper arm below the injection site. Denies any fever, pain or swelling now. The red band is increasing, warm to touch according to the client's daughter.
No adverse events resulted from the event. This person received the J&J vaccine inadvertently as the 2nd dose. This person should have received her 2nd dose of  Moderna in her series.
Narrative:  61 year old male who presented to ED on 12/29/2021 with complaints of cough and chest congestion. Dx with COVID pneumonia. PMH of DM, obesity, sleep apnea, HTN, and depressive disorder. admitted and treated with dexamethasone (12/29-12/31) Discharged on 12/31/21 with dexamethasone 6mg PO daily for 5 days.
Headache & Myalgia Narrative: dose 2-day 2-ha bodyache; day 2 ha
Left arm pain, left sided facial flushing, fevers up to 100.8 degrees orally after vaccine given.  Also noted left supra - clavicular lymphadenopathy.  Full recovery within 72 hrs after receiving vaccine.
I contracted covid-19 as well which caused my immune system to react badly to vaccines as a whole even new pneumonia. I had a fever of 100.6, very bad chills and muscle aches felt like whip lash, decap shot and pneumonia shots were in opposite arm all symptoms lasted about two days arm is still swollen itchy and red.
Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 11-Aug-2022; No adverse event; Patient administered vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 11-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 11-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 11-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 11-Aug-2022).    No concomitant medications was provided by the reporter. The vial did not undergo the temperature excursion. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. No treatment medications was provided by the reporter.
Patient was fine before receiving the vaccine...we gathered our things and began walking to the car.  As we got closer to the car he said his ears were ringing and his vision was fuzzy.  He sat down in the van and within seconds said.."Somethings wrong..I'm going to go..."  He bagan staring off to the left and did not respond to his name..after 5-8 seconds staring he bagan shaking his arms and legs uncontrollably...seizure like activity.  That last about 10 seconds and then his body went limp and he stared off to the left again...after calling his name 4 times he finally responded and said "What, what...what happened?" Someone in the parking lot ran and brought a nurse to us and then we brought him in to the clinic to be checked out.  He had a terrible headache for 36 hours after the shot that was managed with Advil and ibuprofen.
Her left shoulder is sore and swollen during palpation, but she didn?t lose her strength and/or sensibility.
Case number PHEH2016US018453, is an initial spontaneous report received from a pharmacist on 21 Jul 2016. This report refers to a 31 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX vaccine (manufacturer unknown, batch number: 174274 and expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly on 21 Jul 2016. It was reported that, the pharmacist technician administered expired vaccine to the patient. No adverse event was reported following this administration error.