chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12 hours post injection patient experienced body aches; Chills lasting around 24 hours; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 19Apr2021 at 10:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and eggs allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 29Mar2021 at 12:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 22:00, 12 hours post vaccination, the patient experienced body aches and chills lasting around 24 hours. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches and chills lasting was recovered on 20Apr2021 after a duration of 24 hours.  No follow-up attempts are needed. No further information is expected.
Presenting symptom palpitations.   Elevated troponin, diagnosed with myocarditis
Pt had adverse drug reaction of fever, diarrhea, N/V, Myalgia, Headache, Dizziness/Vertigo and induration at site.
Got vaccinated still got shingles/ suspected Vaccination failure; Got vaccinated still got shingles; hurt like no bodies business; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient got vaccinated with shingles vaccine still got shingles, not a raging case non the less got them and it hurt like nobody's business. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with M-M-R II lot # L043704, expiration date 04-NOV-2017, by intramuscular routed instead of subcutaneous route. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. Additional information has been requested.
11/19/12 patient received 5 vaccines prior to going to help with agency. He received FLUVIRIN, PNEUMOVAX, BOOSTRIX (left arm), and ENGERIX B and HAVRIX (right arm). States that had a burning sensation on one of the vaccines in the left arm. Patient reports of having convulsions Saturday night November 10, while on a trip and did not remember much of the trip (due to high fever). Nov 11 (Sunday) he reports of not being able to sleep through the night; waking up every 40 minutes and having weird dreams. Monday Nov 12; still complaining of fever and chills (continuous shaking) but was taking TYLENOL, ibuprofen and BENADRYL. Patient and his wife called Nov 13 (Tuesday) to complain of symptoms and was advised to see MD right away. Due to the situation patient is in, patient is unable to see an MD at this time. Nov 14 (Wednesday) pt reports feeling better, still a little bit of a fever, but still a 5 inch diameter of redness of the left arm (injection site). Still is weak and has no strength. There is also a hard lump (was the size of a softball) in the area, getting softer as the days have gone on. Also advised patient again to see MD as soon as possible to find out what type of reaction he may have received from the vaccinations.
This case was reported by a nurse via a company representative and described the occurrence of an injection site reaction in a child who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Concurrent medications/vaccines, concurrent medical conditions and medical history were not provided. On an unspecified date, the patient received the booster dose of Infanrix in the deltoid. At an unspecified time post immunization, the patient developed an injection site reaction characterized by swelling and redness. The outcome of the event was unknown. Comment: The reporter indicated that three additional patient's experienced the same events following receipt of Infanrix during the same week. Each patient received the 18 month or 4 year dose of vaccine. Identifiers are currently available for only one of these three patients.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 18-MAY-2011, a physician administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 23-MAR-2015, the patient was treated by a healthcare provider for herpes zoster ophthalmicus. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Upon internal review herpes zoster ophthalmicus was considered medically significant. Additional information has been requested.
This young man received, Varicella, Meningococcal and Hepatitis A vaccines on Aug 9, 2011. He was re-administered the same vaccines on 02/02/12 inadvertently. He has not had an adverse reaction.
Local allergic reaction to upper arm. Developed 24-36 hours after shot. No systemic symptoms.
Beginning about 10 hours after injection was very sleepy/tired.  Lasted about 24 hours and then no symptoms.
Bloody nose 2am 11/20/08 stopped has had no relapse no other adverse events noted.
The patient was expecting to receive a Prevnar 20 vaccine but we accidentally gave her a second Covid vaccine (Spikevax) on 10/20/23.  She had already received a Spikevax vaccine on 9/25/23 at our pharmacy.
Pt received Pneumovax on 10/6 and reported to primary care clinic on 10/7 c/o erythema, fatigue, myalgia, and nausea from previous day, and pain on right side of arm to neck. Pt did not report SOB, pruritis, or rash. Unable to differentiate whether actual allergic reaction to Pneumovax vs. local allergic reaction. Pt was given outpt rx for Cephalexin 500mg QID x 10 days and Tylenol QID x 2 days and instructed to go to ER if symptoms persist/worsens. Pt presented to ER with persistent fever and increased RUL swelling and tenderness. Pt admitted to hospital for IV antibiotics x 9 days. Needed for pain. Sunscreen lotion paba-free SPF 15, Bupropion HCL 75mg tab take tow tablets by mouth twice a day take at 8am and 2pm, Trazodone HCL 50mg take one tablet by mouth three times per day and take 2-4 tablets at bedtime, Lisinopril 40mg take one tablet by mouth daily, multivitamin/minerals take 1 tablet by mouth daily, ammonium lactate 12% lotion, Verapamil HCL 240mg SA take one tablet by mouth twice a day, Hydrocortisone/Pramoxine rect foam 1%, hemorrhoidal supp, hydroxyzine pamoate 25mg take one capsule by mouth twice a day as needed, aspirin 81mg EC take one tablet by mouth daily, hydrochlorothiazide 25mg take one-half tablet by mouth daily, Terazosin HCL 2mg take one capsule by mouth at bedtime. Pt ended up with diagnosis of cellulitis in right arm where vaccine given.
already received an unspecified hepatitis A vaccine in 2013 (dose 1) /again in 2016 (dose 2); already received an unspecified hepatitis A vaccine in 2013 (dose 1) /again in 2016 (dose 2); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 16-year-old female patient who received HAV (Havrix 720) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hepatitis A vaccine for prophylaxis.   Previously administered products included Hepatitis A vaccine (received 1st dose in 2013).   On 5th December 2021, the patient received the 3rd dose of Havrix 720 (intramuscular) .5 ml and Havrix Pre-Filled Syringe Device. On an unknown date, the patient received the 2nd dose of Hepatitis A vaccine. On 5th December 2021, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device and not applicable after receiving Hepatitis A vaccine, the patient experienced extra dose administered. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that the patient got an injection with Havrix yesterday (from the day of reporting) at a local pharmacy. The reason the dose was given was because the patient got a job at and the vaccine was recommended/suggested/mandated to her as an employee. Reporter did not have the lot number of the product given yesterday (from the day of reporting) but did provide the phone number for the pharmacy where it was administered.  The reporter did not know for sure if the injection was given intramuscularly but he assumes that it was injected into the muscle. The NDC of the product administered was 58160-0825-52 = Havrix. It was the pediatric dose: 720 ELU/0.5 ml given via (pre-filled) syringe. The reporter consented to follow up.
Had a knot on it; splotches that ran about 8 inches on my arm; allergic reaction; rash; A spontaneous report was received from a consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced had a knot on it, rash, and splotches that ran about 8 inches on my arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events had a knot on it . On 13 Jan 2021, the patient experienced the events rash. splotches that ran about 8 inches on my arm.  Treatment details included Patient put Benadryl cream and ice and took Zyrtec.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events had a knot on it, rash, splotches that ran about 8 inches on my arm was not reported.; Reporter's Comments: This case concerns a 80-year-old female who experienced NS unexpected events of "had a knot in it" (mass) and NS expected events of allergic reaction, rash and erythema.  Event onset occurred XX as / after the first dose of mRNA-1273. Treatment included Benadryl cream and Zyrtec. Events resolved/ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Approx 3 hours after receiving vaccine - face became red and facial whelts-- itchy. Denied use of any other meds or supplements --OTC or prescribed. Pt used allegra and the sx subsided by next am-- no office visit indicated -- telephone triage.
FELT HORRIBLE; BODY ON FIRE; MASSIVE FEVER; This spontaneous report received from a patient via a company representative 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced felt horrible, body on fire, and massive fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt horrible, massive fever and body on fire was not reported. This report was non-serious.
got the flu; Initial information received on 31-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who got the flu while receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. Information on batch number was requested.  On an unknown date the patient got the flu (influenza) (unknown latency). Reportedly Don't believe in the flu shot I've had one in the 60 years I've been alive and it's the only time I got the flu.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu).  At time of reporting, the outcome was Unknown for the event got the flu.
This spontaneous report as received from a physician via company representative refers to multiple patients of unknown age and gender. Approximately on 11-FEB-2014 23 hours ago, the patients were vaccinated with ZOSTAVAX vial (strength, dose number, dose unit, lot# and expiry date, route unknown). Approximately on 11-FEB-2014 23 hours ago patients who have received ZOSTAVAX have developed shingles at a later, but the episodes of shingles post-vaccination were less severe than shingles usually was. VZV packet declined for the physician by the representative because the physician does not have a patient who is currently experiencing shingles after receiving ZOSTAVAX. The outcome of shingles is unknown. No additional information provided. Additional information has been requested.
pains; aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains), PAIN (aches) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 13-Mar-2021, the patient experienced PAIN (pains), PAIN (aches) and HEADACHE (headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, PAIN (pains), PAIN (aches) and HEADACHE (headache) outcome was unknown. Not Provided          Reporter did not allow further contact
Not able to eat much; Constant stomach aches; Nausea; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was EN6204), via an unspecified route of administration, in Left arm on 26Mar2021 at 15:30 (at the age of 65-years-old) at 2ND DOSE, single for COVID-19 immunization.  Medical history included IBD with Constipation, high cholesterol, and nickel allergy. Concomitant medications included doxycycline hyclate; lansoprazole and rosuvastatin calcium (CRESTOR) received within 2 weeks of vaccination. The patient previously took amoxicilin, azulfidine, asacol, clindamycin hydrochloride (CLEOCIN), darvocet, neomycin and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and expiration date were not reported) via an unspecified route of administration on an unspecified date at 1st dose, single for COVID-19 immunization. On 30Mar2021, since the second shot, patient's stomach has been in flux further described as not able to eat much and it was as if system needed a reboot. Additionally, the patient experienced constant stomach aches and nausea on 30Mar2021. The patient underwent lab tests and procedures which included COVID-19 test: negative on an unspecified date. The events were reported as non-serious. Patient was recommended pepto for the events but not effective at all. The outcome of the events was not recovered.  No follow-up attempts are needed. no further information is expected.
High fever 104' - fever for 6 hours even after Tylenol & Motrin given Headache - for an hour
Patient has fever and body aches, a swollen red hot arm and headache .cannot go to work
Vaccine syringe leaked a detectable amount during administration. Pharmacist gave the amount lost in a different syringe using the same vial the first dose was pulled from. The dose given collectively is correct. No adverse events, just the dose was given in two syringes at the same time.
WHILE WALKING TO PARKING LOT, LEGS BECAME "WOBBLY" AND HIS GAIT BECAME UNSTEADY. CODE GREEN CALLED, VSS, SYMPTOMS IMPROVED, REFUSED TRANSPORT.
Fever; Chills; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experience fever and chills on unspecified dates. The outcome of the events was recovered on unspecified dates.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.
Tachycardia for a few hours, starting almost 12 hours after vaccine.  Resolved spontaneously by the morning.  Also fatigue & chills
Itchy scaley rash face, neck, hands, ear lobes. Extremely puffy eyes and runny nose.  Jitters.
After 9AM on 30 July 2021 I started to have a runny nose persisted for three days. Later the same day I developed a left sided headache and left back pain and left arm pain that radiated up the side f my back very sharp pain. Left sided pain that occurred at the left side of my neck to just beneath my scapula on the left side. On the 01 August 2021 I felt extremely weak and my my heart beat were and still are erratic I have been having uncomfortable heart rhythm since 30 July. They are worse at night. I have this really unusual feeling in my head and I feel horrible and weak.
Swollen and itchy rash in back of head above hairline.  Migrated down arms and hands became extremely swollen, painful, and had a maddening itch.  Also appeared in blotches on torso.  Urgent care doctor was not sure what it was and prescribed Clobetasol Propionate Cream and said to see my dermatologist.  In the meantime it got worse and I saw the dermatologist the next day, 20April.  He prescribed a short course of Prednisone.  The symptoms have now greatly diminished.
I had my first shot on Dec 22nd, 2020. I had my second shot on Jan 12th 2021.  On May 7th, 2021 I started a period 6 years or so menopaused.  This is not normal.  I am seeking treatment from my OB dr.  2 weeks after the 2nd shot, I noticed my shoulder was not getting much better, it was achy still.  I started to have more shoulder pain. It has continued to get worse.  I now have been diagnosed with bursitis at the place where they inserted the needle for the 2nd shot. It continues to alter my way of life, as It is hard to get ready in the morning, and also hard to use my arm to pick things up and bring back to me. So extending my arm out in front of me and brining it back, to drink a cup of coffee gives me much pain.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient experienced chills, dizziness, lightheadedness, sweating, nausea. Patient lied down flat on chair bed with legs elevated. Water was given since patient asked for it. After 20 minutes, she felt much better and can walk on her own. She said she is fine and her relative will drive her home.
Booster reactions: Covid-like symptoms: Fever, chills, body aches, loss of apetite, "brain-fog."
Information has been received from a licensed practical nurse concerning a 67 year old female patient with allergic reactions to CELEBREX and Darvocet who on 03-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot# 662842/1296X) SQ in her left arm. On 04-SEP-2009 the patient experienced left arm swollen, redness and pain at the injection site. The patient was told to apply cold pack and take TYLENOL and MOTRIN to lighten the feeling of pain. Medical attention was sought. At the time of the report, the patient recovered. This is one of several reports from the same source. Additional information is not expected.
pt recv vax 28MAy96 & 01JUN96 pt exp itching & a drug rxn type rash which covered pt from head to toe;when the rash first started pt face was bright red;tx w/DPH
Redness and pain. started night of 8/29/19. pain lasted for 5 days then went away then went back with more prominent pain and redness