chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; Chills; FACIAL NUMBNESS; DIZZINESS; ACHES; JOINT PAIN; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 165 pounds, and height was 66.5 inches. The patient's concurrent conditions included penicillin allergy, walnut allergy, alcohol user, and non smoker. The patient experienced drug allergy when treated with sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced facial numbness. On 12-MAR-2021, the subject experienced dizziness. On 12-MAR-2021, the subject experienced aches. On 12-MAR-2021, the subject experienced joint pain. On 12-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, and joint pain on 13-MAR-2021, and headache on 14-MAR-2021, was recovering from dizziness, had not recovered from facial numbness, and the outcome of chills was not reported. This report was non-serious.
This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received SHINGRIX for prophylaxis. On 17th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced swelling arm and general body pain. On an unknown date, the outcome of the swelling arm and general body pain were unknown. It was unknown if the reporter considered the swelling arm and general body pain to be related to SHINGRIX. Additional details were provided as follows: The caller reported adverse event for herself and her husband. The age at vaccination was not reported. The patient wanted to know if her reaction was common with SHINGRIX, and how long should she wait before getting the flu shot. The patient experienced swollen arm and body pain. The caller was driving, therefore very limited data was provided. This case has been linked with US2018172540, reported by the same reporter.
there may have been patients who were administered Shingrix subcutaneously; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comments: The healthcare professional (HCP) reported that there was some confusion in their office of whether Shingrix should be administered subcutaneously or intramuscular. The reporter thought that, there might have been patients who were administered Shingrix subcutaneously but was not sure at this time until a chart review had been completed.  The reporter consented to follow up. Additional Supportive Information: The patients received Shingrix subcutaneously, which led to intramuscular formulation administered by other route.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age or gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose, frequency, route of administration, injection anatomical location, lot# and expiry date were not reported), which were improperly stored. There were no concomitant or co-suspect therapies reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
After receiving the first dose of GARDASIL, my daughter began complaining that her teeth hurt. We thought it was sensitivity, but it became so severe that she was in tears and needed pain relievers to sleep that night. They are  still very sore this morning, but according to her feel a little better. she is a trombone player and may not be able to go to a symphony clinic tomorrow. If she is still in pain she will not be able to go and I will be contacting her doctor on Monday. While I hope this is not serious and the pain will go away, it would have been nice to be made aware of this side effect. it also makes me question if she should get the next series of shots.
Three or four days after receiving last shots, had seizure, was teething, temperature 102 rectally.  Took patient to MD and neurology clinic. EEG was performed-was told had abnormal brain wave around shunt.  Was not taking medicine for fever.  Was started on Trideptal 2mL three times a day for epilepsy. 11/20/2003: Today called mother to obtain info to compete VAERS form and to inquire about how patient did with dTAP #4 given 11/11/2003.  Mother reports he had seizure 2-3 days after vaccine.  No temperature was taking Tylenol every 6 hours and Trileptal 2mL three times a day.  Tries to give medicine 9-10 am, 1:30-2:00pm and 8-9 pm but sometimes is late.  Patient acts exhausted all the time.  Local physician has recommended he go back to neurologist for medicine evaluation.  Encouraged mother to give medicine around same time each day if possible and to return for medicine evaluation.
15x10 cm area of redness,induration, warmth about injection site left deltoid.
red rash; This case was reported by a pharmacist via sales rep and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date 13th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. In August 2019, less than 6 months after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by field reporter. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The patient got a red rash from Shingrix in the last 2 days. The reporter did not consent to follow-up. This case had been linked to the case US2019AMR148399, reported by the same reporter.
Pt recvd vax 18NOV92 & pt devel swelling in rt deltoid w/inflammation of 5 cm in diameter, & very red; also devel a fever of 99.9 & nausea; No further details were provided;
Chronic headache. Some days very mild. Some days extreme migraine unable to work. Always pressure in the head. Sometimes feels like ice picks in the brain.
eczema condition continues on getting worse; eczema condition continues on getting worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional), Program ID: (005570). The reporter is the patient. A 75-year-old patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient relevant medical history included: "diabetes" (unspecified if ongoing), notes: I am a 75 year old diabetic, "Billiary cirrhosis" (unspecified if ongoing), notes: who also has Primary Billiary cirrhosis. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (I just realized that my skin condition started days after receiving my, 1st Covid vaccine., Dose 1) for COVID-19 Immunisation, reaction(s): "realized that my skin condition", Covid-19 vaccine (Dose 2) for COVID-19 Immunisation, Covid-19 vaccine (Dose 3) for COVID-19 Immunisation. The following information was reported: ECZEMA (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "eczema condition continues on getting worse".  Additional information: Patient just received my 4th shot and my eczema condition continues on getting worse. As I researched chat rooms looking for some knowledge I found a trend of others who also suffered the same fate.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
she have recorded are a low of 31.62F and a high of 47.08F.; This non-serious case was reported by a consumer via call center representative and described the occurrence of product storage error in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, Men B NVS (Bexsero) for prophylaxis and Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Boostrix, Havrix, Kinrix, Infanrix, Pediarix, Bexsero and Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Boostrix, Havrix, Kinrix, Infanrix, Pediarix, Bexsero and Rotarix lyophilized formulation, the patient experienced product storage error (Verbatim: she have recorded are a low of 31.62F and a high of 47.08F.).  The outcome of the product storage error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-SEP-2023 Office manager reported new employee did not know how to reset data logger and she has recorded the same readings on minimum and maximum long since 16Aug2023.  The readings she had recorded were a low of 31.62 degree Fahrenheit and a high of 47.08 degree Fahrenheit. He showed her how to correctly reset the thermometer and record readings, which he noted were showing a maximum of 41.29 degree Fahrenheit  and a minimum of 40.30 degree Fahrenheit at the time.  Reporter was unsure if any of the vaccines were administered after the below freezing temperature exposure, but it was a possibility. The vaccine administration facility was the same as primary reporter. The vaccine was kept under not allowable temperature, which led to Product storage error. The reporter was requested for follow up.
Patient fainted after vaccine was administered and began convulsing.  Emergency services were called immediately.  Patient regained consciousness after approximately 30 seconds.  EMS personnel monitored patient and she was able to leave without treatment
painful in the arm pit; This is a spontaneous report received from a contactable consumer, the patient. A 68-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via unspecified route of administration in left arm on 04Mar2021 at 01:30 PM as a single dose for COVID-19 immunization. Medical history included Stent in artery five and half years ago, minor kidney, heart condition (event clarification needed) at the time of reporting. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient reported he was allergic to penicillin. Concomitant medications included amlodipine, aspirin 81mg, lovastatin, metoprolol (MANUFACTURE UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. Patient experienced very sore under right arm pit on 09Mar2021, right side of chest, right arm tricep area and right shoulder blade. Patient explained that when he tried to move right arm, it was painful in the arm pit and surrounding areas. This was continued till march 16 and the area described above is still sore. Patient explained he was Not sure if from the COVID shot but he never had an issue like this. The patient did not receive any treatment for the event. The clinical outcome of the event painful in the arm pit was reported as not recovered/not resolved at the time of report. No follow-up attempts are possible. No further information is expected.
Only information known is what is in the obituary, Obituary states died suddenly on 5/1/21 after an illness.
p/vax pt exp hep b;6/5/98 lab work revealed a positive core antigen & a negative surface antigen;
Administered flu vaccine then administered GARDASIL vaccine #1, client had episode of syncope & vomiting 15-20 min. felt fine walked out.
vaccine injure 2 teenagers in the last few years; This spontaneous report was received from a consumer via newspaper article referred to 2 adolescent patients (teenagers) of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with unidentified Merck hpv vaccine (name, lot #, dose, route of administration were not provided) for prophylaxis. The reporter stated that, vaccine injured (unspecified) (adverse event) the patients in the last few years. The outcome of adverse event was unknown.  This is one of the two reports received from the same reporter.; Sender's Comments:  AU-009507513-1907AUS011276:
Patient states that after receiving the vaccine that it caused her to get a frozen shoulder on the left, where she was having a hard time moving her arm. She came in and saw my partner on a late evening visit. He started her on steroids, which helped some. We are getting an ultrasound on her in that area, and if needed, might try a longer tapering course of steroids. There were no other symptoms. No redness, swelling, warmth, or fevers - just the "locked up shoulder." She is still having trouble with the movement of her arm that I am aware of.
Vaccinated with Pfizer COVID vaccine on 12/26/2020.  On 1/6/2021 developed body aches, cough, and headache.   Positive for COVID.
Light headed and slight dizziness along with string metallic taste in mouth almost immediately following injection.  These symptoms dissipated after about 15 minutes and I was able to drive home. An hour later I started to have intense muscle and joint aches all over my body with slight dizziness. My left arm, regardless of continued movement, became increasingly sore.  The next morning only slight aches and dizziness remained and I was able to go to work.  By the end of the eight hour work day, the joint and muscle aches and fully returned accompanied with intense pain in my left arm, hand, and neck.  Today I feel no symptoms at all.
One hour after the vaccine was administered, my jaw hurt then my face went numb on both sides.  I was driving when this happened. When I arrived at home my daughter immediately told me my face had a droop on the right side  Facial numbness has continued. I notified occupational health and spoke with a Dr. He advised to monitor and no treatment at this time
Arm is itching at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Arm is itching at the site of injection) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Arm is itching at the site of injection). At the time of the report, VACCINATION SITE PRURITUS (Arm is itching at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information provided.
Redness 11/2"x2" with a knot. Itching. Hives on back. (2). Taking antihistamine.
8/26 - vaccine given on 8/23 at pharmacy,  dizzy, clammy, increased B/P, nauseous today.  Came on suddenly today at work.  History of gestational diabetes only. Feeling worse as conversation continued.  States has a history of a clotting disordered.  Advised to go to ED asap
i expected my arm to hurt for a couple of days afterwards since that's completely normal. But it didn't end there. Instead, it kept going. It's been two weeks and the pain hasn't gone away and it's spread down my arm.
Patient was given the wrong vaccine. At the time of vaccine Patient was 12yo and received 5-11 Pfizer vaccine for second dose.
on day 2 : loss of smell - continued/longstanding, permanent? unknown - #20 and 21 below - not resolved yet and unknown regarding permanency   within 1st 72 hours: loss of appetite, nausea, vomiting, diarrhea, shaking chills with teeth chattering, fever, pain in left arm and then intense body wide pain even to light touch, fatigue, mild chest tightness, loss of smell. - #20 below - resolved
Arm and Hip pain, body fatigue and sudden chronic inability to tolerate heat, chest pain, debilitating exhaustion.   Thyroid, kidney and liver functioning and levels now affected for the first time in life and daily functioning is now impaired significantly.  Daily living skills and overall functioning is now hindered severely as a result of post injection from vaccine.
Tested positive; Tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 03Mar2021 as dose 2, single (Lot number: EN6201), in left arm and on 03Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing), notes: Depression & anxiety. high blood, pressure and high cholesterol.; "Anxiety" (unspecified if ongoing), notes: Depression & anxiety. high blood, pressure and high cholesterol.; "High Cholesterol" (unspecified if ongoing), notes: Depression & anxiety. high blood, pressure and high cholesterol.; "High blood pressure" (unspecified if ongoing), notes: Depression & anxiety. high blood, pressure and high cholesterol. Concomitant medication(s) included: CYMBALTA; WELLBUTRIN; LISINOPRIL; ROSUVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant) with onset 12Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 12Apr2022, outcome "recovered" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Positive; (19Apr2022) Negative; (22Apr2022) Positive, notes: Had a positive home test on day 11 & day 13; (24Apr2022) Positive, notes: Had a positive home test on day 11 & day 13; (26Apr2022) Negative, notes: tested negative day 15, 16 & 17; (27Apr2022) Negative, notes: tested negative day 15, 16 & 17; (28Apr2022) Negative, notes: tested negative day 15, 16 & 17. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts were possible. No further information was expected.
Erythematous lesion, oval shape 3x5cm on the injection site with itching 24 hour after receiving varicella vaccine
12 Hours after getting the vaccine patient woke up with difficulty breathing. Described event as if "sucking through a pin hole" trying yo get air into lungs. She stated that her glands were swollen in her throat. Patient had an albuterol inhaler that she used and stated that she nearly emptied inhaler trying to get normal breaths in. To this day she still feels pain in her neck and throat, and feels restricted in her breathing.
Headache injection pain, fatigue, body aches, night sweats  Narrative:  employee states : "half of what the full dose did and lasted 2.5 days"
Uncontrollable itching, rash on arms, hands, neck, stomach, legs and thighs.
This spontaneous report as received from a pharmacist refers to a patient of an unknown age and gender. The patient's medical history, historical drugs and concomitant therapies were not reported. The patient's concurrent conditions included acquired immunodeficiency syndrome. On 05-JAN-2018, the patient was vaccinated with one dose of VARIVAX subcutaneously (dose, lot number and expiration date were not reported) for prophylaxis (contraindicated product administered). Other suspect therapies included sterile diluent (MERCK). On an unknown date in January 2018, the patient had a CD4 cell count which was in 48 (units not reported) (CD4 lymphocytes abnormal). The outcome of CD4 lymphocytes abnormal was unknown. The causal relationship between CD4 lymphocytes abnormal and VARIVAX was not reported.
Left upper arm w/redness, mild swelling, warm to the touch and is painful. Treatment: Observation, BENADRYL for reaction and TYLENOL if needed for pain.
Local irritation with swelling 1 day after administration, 20 cm x 10cm red swollen pruritic area, left thigh front.
This is a spontaneous report from a contactable consumer (acquaintance of patient). A female patient of an unspecified age received PREVNAR, via an unspecified route of administration on an unspecified date as single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced malaise, body pain, exhausted and feeling weak on an unspecified date. Details were as follows: the patient posted on the internet that she had a serve reaction to pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein). Her symptoms were reported as malaise, body pain, and she was exhausted. She described these symptoms as similar to influenza or pneumonia. She felt weak and "blah". The patient said that her doctor told her that she could never have the vaccine again. The outcome of malaise, body pain, exhausted and feeling weak was unknown. No follow-up attempts are possible; information about lot number cannot be obtained.
One day  following the vaccine I got redness swelling and warmth at the injection site. After 3 days this went away and my arm was back to normal. Now 8 days after the vaccine I woke up with what seems a second reaction, my arm is itching, having pains, has redness, warmth, swelling, and has a quarter size nodule.
SHINGRIX administered to a child; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received Herpes zoster (Shingrix) (batch number 75B29, expiry date 24th August 2023) for prophylaxis.   On 30th August 2022, the patient received Shingrix. On 30th August 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: The reporter reported that the child patient received Shingrix vaccine. The reporter consented to follow up. Additional supportive information: The reporter reported that the 1 year child patient received Shingrix vaccine, which led to Inappropriate age of vaccine administration.
Received flu shot (L) at lateral thigh. Noted moderate diffuse swelling over injection site area 12 cm x 7 cm. No redness, no sign of infection.
Pt was 18 months at time of administration of vaccine.  Kinrix vaccine is recommended for patients ages 4 and older