chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe body pains and aches; Headache; Chills; Nausea; Fever (100 degrees F); This is a spontaneous report from a contactable consumer (patient) reported that a 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262), second dose via an unspecified route of administration in left arm on 03Feb2021 at 03:15 PM at single dose for COVID-19 immunization. The patient's medical history was none. Patient has no known allergies. Concomitant medication included ibuprofen for minor pains (received within 2 weeks of vaccination). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) in left arm on 13Jan2021 at 03:15 PM at the age of 26 years for COVID-19 immunization. No other vaccines were given on the same date. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 04Feb2021 at 12:30 AM, 10 hours post injection, the patient experienced severe body pains and aches, headache, chills, nausea, and fever (100 degrees F). No treatment was received for the adverse events. Patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Erytyemic reaction to Pneumovax-extensive swelling entire deltoid area with erythema and heat palpate.  Complained of pain entire upper arm/shoulder and axilla.  Applied ice at home unable to sleep last PM. Benadryl 25mg given and advised to take it every 8 hours for 48 hours.  Apply ice as much as possible and office visit any worsening. Consider abscess formation if progression.
Well-baby exam 11/22/2010 with mom reporting red bumps on child's arms, legs, and buttock. Child given sweet potatoes and used new diapers 3 days prior to bumps onset (11/19/2010). Providers documented a few "blanchable lesions on lower extremities and buttocks with papular rash in axilla and inguinal areas" otherwise a normal exam-diagnosed with Intertrigo and vaccinated with influenza vaccine and HIB #3 to right leg (approximately 9-9:30 am). Approximately 1.5 hours later mom noted some redness and bumps (like mosquito bites) to upper right thigh (at vaccine sites) and to posterior upper thighs R>L. Over then next several hours, this single macular red rash spread to both legs and feet with subjective swelling to bilateral anterior feet (per mom). Mom did not remember any rash to soles of feet. There was no fever, irritability, vomiting, dysphagia, respiratory distress, swelling, or rash to torso, hands, back or face. Child was treated that evening at nearby ER about 1900 hours for "hives" with oral BENADRYL and prednisone (approximately 10 hour post vaccination). Rash resolved after given BENADRYL (11/22/2010). Follow up evaluation 11/24/2010 noted a few "blanchable lesions on lower extremities and buttock" otherwise normal exam. Mom advised no exposure to new detergents, cloths, cleansing washes/soaps, or powders. She was using new diaper and no change in diet (liquids) other than adding pureed foods (sweet potato 11/19/2010). Mom advised this rash reflared 11/25/2010 (day 3) as small red pimp-like macules that progressed to hives (nickel-quater sized red raised areas) again on legs, buttock and a few on his forearms. Mom restarted the steroids and BENADRYL (per phone consult with HCP) stopping the steroids after 24 hours. She continued the BENADRYL x 5 days with resolution of symptoms. This rash re-flared 12/5/2010 and 12/13/2010 each lasting 1-5 days with BENADRYL use. Mom advised the rash began on the child's upper thighs with 2 episodes having raised lesion to bilateral forearms and once with 1 bump to face. Mom advised child appears to be in no distress, not fussy, no fever, or other systemic symptoms. Mom had been trying new food group such as carrots and squash (week of 12/13/2010) when she noticed reflare of the above rash; however, she does not remember the exact timing of the rash in relation to feeding her child. Mom also advised child had been off BENADRYL for a few days. Child was given other food groups such as banana (11/30/2010) and green beans (week of 12/13/2010) without reaction. Rash fully resolved w/o reflare as of 12/18/2010. Follow up vaccinations resulted no no rash or any adverse event.
Patient c/o of pain. Right arm when picked up at end of end.  No treatment given, patient had c/o increase pain, swelling right arm, above elbow following day.  Advised to call pediatrician.   Also c/o "heat" at injection site surrounding area.
Almost exactly 24 hours after injection sudden onset profound fatigue, severe muscle joint aches, headache, hypersensitivity to sight & sound. Unknown if I was sleeping or hallucinating.  Bizarre, vivid dreams.  Don't know if febrile as I became dehydrated & hypotensive, was unable to transfer from lying to sitting to standing without near falling.  Hadn'tfelt si profoundly ill since had Flu in 1988.  Sxs lasted 8 hrs &completely gone.  I do have preexisting IgA deficiency.
Patient was given an expired pneomoccocal polysaccharide vaccine 2 days after expiration date . patient was fine after 15 minutes and was called the next day to inform her she would need to come back for another on. no adverse reactions
Swelling of throat, but could still breathe & swallow.  Took store brand Benadryl for next 24 hours to keep swelling  under control.  Did not require medical attention at either hospital or doctor office visit.  Symptoms subsided after 24-26 hours after injection.  Called appointment for second dose per guidance of CDC and doctor.
pt devel sore throat & arthralgia w/fever;devel purple-pink rash on eyelids, rash on both elbows, active inflammation in wrists,elbow, ankles;synovitis in joints;knee swollen;muscle weakness;diff climbing stairs;T100;
Information hs been received from a registered nurse concerning a female with sulfanomide allergy who was vaccinated with a dose of GARDASIL on an unspecified date. Subsequently the patient had a "reaction" after receiving GARDASIL. No other detail information was provided. The outcome was unknown at time of reporting. The patient sought unspecified medical attention. Additional information has been requested.
Drooping and closed left eyelid/third nerve ocular palsy paralysis; Headache; Sandy eyes; This is a spontaneous report received from a contactable consumer (Patient) reporting for himself. A 73-year-old patient received second dose of BNT162B2 0.3ml on 26Feb2021 at 12:00 pm (Lot no: EN6203, Expiration date: unknown) via intramuscularly route of administration in right arm as SINGLE DOSE for covid-19 immunization. The patient does not have cardiovascular disease, he just had a blockage at one time. The patient had one stent put in and low dose to preventative for plaque buildup in veins. The patient's concomitant medications included Simvastatin for mild heart attack in 2013. The patient previously vaccinated with first dose of BNT162B2 on 05Feb2021 at 13:00 pm and 5 days later got sandy eye. It was reported that, on 04Mar2021 (3 weeks later of second dose) the patient experienced blurred vision and drooping, closed left eyelid which were diagnosed as third nerve ocular palsy paralysis on 08Mar2021.  It was reported that the patient still gets Headaches periodically. The outcome of the events was not recovered.  Follow attempts are requested. Further information is expected.
Drainage, sore throat, and laryngitis (completely lost voice to whisper for 4 straight days until I received a steroid shot)
Soreness in arm - 3 days, warm wash cloth, Fatigue  1.5 days, rest, Vertigo/Dizziness- 7 days (still experiencing symptom), chiropractic visit,
Severe headache, extreme fatigue that lasted 3 weeks, immobility of my left arm. I couldn't raise it further than 90°.
Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium
Case number PHEH2015US024665, is an initial spontaneous report from a pharmacist received on 20 Nov 2015. This report refers to a 6 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514801) 0.5 ml intramuscular on 19 Nov 2015. It was reported that the patient received FLUVIRIN that was exposed to temperatures up to 28 F for up to 8 hours before vaccination. The case was assessed as non-serious. No adverse event was reported.
by evening pain @ site & axilla x 2 days;has had occurrence w/activity & exercise since;no med eval yet sought;referred to PMD;
Large red spot; Swelling; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a 13-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 13th August 2020, the patient received Bexsero. In August 2020, less than a week after receiving Bexsero, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were not recovered/not resolved.   It was unknown if the reporter considered the erythema and swelling to be related to Bexsero.  Additional details were provided as follows: The case was reported by the parent of the patient. The age at vaccination was not reported. The patient received Bexsero booster 2 days ago and had a large red spot and swelling. The reporter wanted to know should he/she should be alarmed.
Hives on thighs, torso and neck. Started on 3/5/10. All above navel from jaw down.
Initially after vaccine within an hour I felt fatigue(drained within 1 hour of receiving vaccine). Within 8 hours of receiving the vaccine I was having fever, chills, body aches, nausea, and vomiting, and diarrhea and dizziness and weakness and heart palpitations(probably related to dehydration). Symptoms remained for 3 days. Unable to hold down anything. Felt like I had covid all over again just without the respiratory issues and loss of taste and smell. Arm was very sore almost like a deep bone bruise. Brain fog developed again like after initially recovering from covid as did the fatigue. Still having lingering fatigue and now carpal tunnel like symptoms in both hands, slight weakness and numbness at times in right upper arm where vaccine was given. Reported event to Pharmacist to administered the vaccine and the CDC.
This spontaneous report received from a nurse refers to a patients with unknown demographics. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On 08-JAN-2016, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB; dose, route and frequency: unknown) (lot # L030870, expiry date: 11-JUN-2018). The temperature excursion details for vaccine were as follows: temperature 33.6 degrees Fahrenheit (F), time frame: 6 hours, 4 minutes. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Bloated; Gassy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (Bloated) and FLATULENCE (Gassy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced ABDOMINAL DISTENSION (Bloated) and FLATULENCE (Gassy). At the time of the report, ABDOMINAL DISTENSION (Bloated) and FLATULENCE (Gassy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Headache, joint pain, back pain. Swelling of joints on left side, which is the side immunization was received.  Entire upper arm where injection was received is sore all the way to elbow. Elbows and knees hurt like they were hyperextended. These symptoms started at 1000 am the day after the immunization.
spontaneous abortion @ 8 wk on 27MAY95; LMP 19MAR95; vax given 24MAR95
This case was reported by a physician via call center representative and described the occurrence of general body pain in a 60-year-old male patent who received FLUARIX QUADRIVALENT (batch number 4M4FS, expiry date 28th June 2016). On 6th October 2015, the patient received FLUARIX QUADRIVALENT. On 6th October 2015, 12 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced general body pain and chills. On an unknown date, the outcome of the general body pain and chills were recovered/resolved. It was unknown if the reporter if the reporter considered the general body pain an chills to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: The patient experienced body aches and chills. At the time of reporting, the patient was asymptomatic. The reporter did not ask for patient's initials.
SWELLING OF LEGS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included used to getting high, and concurrent conditions included citrus acid allergy. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced swelling of legs. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swelling of legs was not reported. This report was non-serious.
Rt upper arm cellulitis (swelling, erythema, pain) took approximately 9d to resolve.
Extremely sleepy; nausea; headaches; This is a spontaneous report from a contactable consumer. This 77-year-old female consumer reported for herself that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Feb2021 10:15 (Batch/Lot Number: EN6201) as SINGLE D0SE for covid-19 immunisation. Medical history included diabetes mellitus, rheumatoid arthritis, pulmonary hypertension, fibromyalgia, dermatitis contact, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included chlorthalidone (CHLORTHALIDONE) taken for an unspecified indication; lansoprazole (LANSOPRAZOLE) taken for an unspecified indication; macitentan (MACITENTAN) taken for an unspecified indication; rosuvastatin calcium (ROSUVAS) taken for an unspecified indication, start and stop date were not reported. The patient previously took betadine [povidone-iodine] and experienced drug hypersensitivity, spironolactone and experienced drug hypersensitivity. On 08Feb2021 15:00 the patient experienced extremely sleepy, nausea, headaches. Extremely sleepy into the 3rd week now. Sleep night and day naps. Used 5 night hours, no day naps. 3rd week. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was not recovered.
periorbital edema, facial edema, conjunctivitis, photophobia, transient facial numbness & tingling; these sx began w/in 12 hrs p/vax later in day felt tenderness in jaw, blister inside mouth on lip
Narrative:  COVID infection following COVID vaccine series 01/26, Pfizer, dose #1 02/17, Pfizer, dose #2 09/30, Pfizer, dose #3 08/24 pt cc: rhinorrhea, dyspnea exposure: unknown 08/24 COVID swab, result: detected 09/14 COVID swab, result: not detected
Swollen glands, nausea, sore neck, rash mostly at injection site, had temperature of 100-101 symptoms starting afternoon of 08/23/2006 per mother.  Mother advised to call family physician.
30 hours after vaccination pt noted raised red crash, hot and puffy with serious itch on upper left chest, neck and chin. Has taken 5 days to resolve without treatment.
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored doses of VAQTA (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
vaccine booster event was organized for IMSA boosters approved at time for only 18 plus. pt is not yet 18. Parent was contacted and notified of vaccination. Father was not concerned. Stated patient was fine and no issues.
congestion and runny nose; congestion and runny nose; This is a spontaneous report from a contactable consumer (reporting for herself). This consumer reported similar events for two patients (herself and her husband). This is the first of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA 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 experienced congestion and runny nose on an unspecified date. The clinical outcome of congestion and runny nose was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021042601 same drug/events/reporter, different patient
Hosp @ Riverside Community Hospital from 10/27 to 11/5 // Per MR: Pt notes recent URI sx which resolved approx; had flu-like sx in mid-september 2009; pt had URI sx with mild cough, mild sore throat, low grade fever.  2days after flu shot, experienced paresthesia/numbness in fingers, toes, lips, extending to hands/wrists.  Generalized weakness, esp RL, & falling.  Ordered to get IVIG.  Dx to acute rehab facility in good condition. Patient's niece hx GBS severe case but never resolved 100%.  CDPH GBS Surveillance neuro consult classify this patient as GBS Level 2.
This case was reported by a healthcare professional (nurse and GSK employee) and described the occurrence of general feeling of weakness in a 34-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included diabetes and migraine. Concurrent medications included IMITREX. On 9 October 2013 at 13:10 the subject received a dose of FLUARIX (.5 ml, unknown route, left arm). On 9 October 2013, at 15:25, 2 hours and 15 minutes after vaccination with FLUARIX, the subject experienced general feeling of weakness, numb (arm and leg) (described as "left arm" and "left leg" were numb) and tingling in leg ("left leg"). The subject mentioned that she had taken an IMITREX dose the night before taking the FLUARIX vaccine. The subject and the nurse did not feel like IMITREX "had anything to do with the symptoms happened soon after receiving the FLUARIX injection." Relevant test results included: The nurse stated that "she checked the patient's hand grasp which was equal and strong: she also checked her blood pressure and it was 120/92 which the patient considered normal. The patient's blood sugar was 85 which the patient considered normal." At the time of reporting the outcome of the events were unknown.
This is a spontaneous report from a contactable consumer. A currently 82-year-old female patient received pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced allergic to it (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein)). The action taken in response to the event for pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) was unknown. The clinical outcome for the event was unknown. Pfizer is marketing authorization holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities. No follow up attempts are needed. No further information is expected.
I know 4 ppl myself you got shingles from the shot/ Suspected vaccination failure; know 4 ppl myself you got shingles FROM the shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I know 4 ppl myself you got shingles from the shot/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: know 4 ppl myself you got shingles FROM the shot). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-JUN-2023 The case was received from the consumer interactive digital media. The reporter stated that he/she know 4 people and himself/herself who got shingles from the shot and in one instance they lasted over a year, debilitating for sure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This was 4 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR082853:same reporter US-GSK-US2023AMR082851:same reporter