chrisvoncsefalvay/vaers-outcomes huggingface dataset:
With the itching and hives, this started within a couple hours of getting the shot. It was also with first dose but she thought it was dry skin; it also started within a few hours of first dose; With the itching and hives, this started within a couple hours of getting the shot. It was also with first dose but she thought it was dry skin; it also started within a few hours of first dose; With the itching and hives, this started within a couple hours of getting the shot. It was also with first dose but she thought it was dry skin; it also started within a few hours of first dose; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date not reported, age at the time of vaccination: 52-year-old), via an unspecified route of administration, in Hand Right (shoulder) on an unknown date in Jan2021 and was given around 14:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Jan2021, the patient experienced itching and hives, which started within a few hours of getting the first shot but she thought it was dry skin. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
MODERNA VACCINE ADMINISTERED TO 17 YEAR OLD PATIENT (3 DAYS BEFORE 18TH BIRTHDAY) (PROTOCOL FOR MODERNA IS 18 YEARS AND OVER).
Pt fainted 5 min after 3rd GARDASIL injection - Had received injection then walked on to waiting area to get father. Fainted after return to exam soon.
postural dizziness; dyspnea; paresthesia; This is a spontaneous report from a contactable Physician. This Physician reported for a 28-year-old male patient received 2nd dose of BNT162B2 Intramuscular on 10Jan2021 07:30 on Left arm for covid-19 immunization. Medical history and concomitant drug were not reported. No other-vaccine-in-four weeks. No other-medications-in-two weeks. Historical Vaccine was first dose of BNT162B2 on an unspecific date. Patient experienced Moderate reaction: postural dizziness, dyspnea, and paresthesia on 10Jan2021 09:00 AM that resolved with H1 and H2 antagonists and IV hydration. AE-resulted-in Emergency room/department or urgent care. Outcome of the event was recovered. No covid-prior-vaccination. No covid-tested-post-vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate.
PT GOT SHOT 10/22 11:30 AM AND PT'S ARM STARTED TO SWELL WITH SORNESS  STARTING AROUND 4PM. AT 8PM PT HAD NAUSEA, VOMITING, DIARRHEA, FEVER, AND CHILLS. ON 10/23 PT STILL DIDN'T FEEL WELL BUT REFUSED TO CONTACT PCP OR GOT TO ER. ON 10/24 CALLED PCP IN THE AM AND THEY INSTRUCTED PT TO GO TO ER IN THE AFTERNOON. PT'S WIFE CONTACTED PHARMACY AND PHARMACIST INSTRUCTED PT TO TAKE BENADRYL AT BEDTIME AND CALL DOC ON WED AM. WED AM PT COULD HARDLY MOVE. PT WENT TO ER ON 10/25. PT WAS PRESCRIBED BY PA AN ANTIBIOTIC, NAUSEA, AND PAIN MEDICINE ON 10/25 FROM ER. PT IS REPORTING TO BE DOING ALOT BETTER. PRESCRIBER REPORTS THAT PT WAS MILDLY DEHYDRATED AND GOT IV FLUIDS.  THEY DIDN'T SEE ANY SWELLING OF ARM. THEY DON'T BELIEVE IT WAS A REACTION TO THE IMMUNIZATIONS. PT IS DOING ALOT BETTER FROM THE ER VISIT AND IS AT HOME RESTING.
Saturday, 07/30/2022, I began to feel very lightheaded, achy, and overall, not feeling well. By Monday, I was still lightheaded, so I went to the emergency room. They said I was dehydrated and had a temperature, but they did not know why. They just advised that I go home and rest. It took a few days before I was feeling back to normal but now, I am feeling chipper.
CHEST PAIN; This spontaneous report received from a patient concerned a female of unspecified age. 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 was not reported, administered on 02-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-OCT-2021, the patient experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain. This report was non-serious.
High fever 103.8 within 24 hours of injection.  Chills, headache.  Resolved in 24 hours.
On 2/4/2022, I developed a sore throat. I also began sneezing and got a headache. I was also fatigued and had very dry, sore eyes. I was given a PCR test 2/5/2022 and tested positive for COVID-19. I received sotrovimab monoclonal antibodies on 2/9/2022. I had started to get better before receiving the antibodies, and I continued to improve afterwards. I didn't have to see a doctor. If there are any possible long-term effects from this, it's the chronic dry eye I developed. I now have to use Restasis eye drops twice a day.
Pt. is a 65 y.o. female with past medical history of asthma, diabetes, morbid obesity with BMI of 55, hypertension, who presents to the Emergency Department with chief complaint of as mentioned above.   The patient has been sick for the last 1 week with fever, cough, shortness of breath.  She went to ER a couple times and was diagnosed with COVID-19 and viral pneumonia.  The patient was sent home with Decadron.  Despite the treatment, the patient progressively became more hypoxic with oxygen saturation of 70 to 80% at her baseline of 4 L of home O2.  The patient also continues to have fever 101 F.  Onset of her condition was gradual with moderate symptom.  Exertion aggravates her condition and oxygen helps   In the ER today, the patient has fever 101.5 Fahrenheit.  Blood pressure was mildly low between 90-110.  The patient had a chest x-ray today that showed stable diffuse patchy multi lobar lung infiltrate.  The patient at this point is being admitted for COVID-19, multi lobar pneumonia, acute on chronic hypoxic respiratory failure, failure of outpatient treatment.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unspecified date, the patient was vaccinated an improperly stored dose of PEDVAXHIB (strength, dose, route of administration and anatomical location were not reported) lot # N014944 and expiration date: 06-MAR-2020, indicated for prophylaxis. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 9 degrees Celsius to 25 degrees Celsius (8.8 degrees Celsius) for 5 hours and 15 minutes on unspecified dates. There were no previous excursions reported. Medical Assistant was not sure why the refrigerator went out of range. This is one of several reports received from the same reporter (MARRS#:1808USA004064). Sender's Comments: US-009507513-1808USA004064.
Fever for several days. Swollen lymph nodes in the armpit where the booster was given. Breast hurts. Fatigue.
Patient fell and hit head about 10 minutes after injection. Fall was not witnessed so it is not clear if he had a seizure (is on seizure medication but not sure if he has a seizure disorder), fell on the ice, or fainted. 911 was called and paramedics arrived and took the patient to the local hospital. He was very confused and disoriented before and after the fall.
Patient had a reaction to PNEUMOVAX. Patient's injection was swollen similar to a bee sting and itching. Patient had an order for BENADRYL placed.
Severe headache with  intermittent sharp pains lasting 7+ hours: hypotension (88/50) : decreased pulse (56): decreased body temperature (97): epidermal contact sensitivity
A seizure that lasted about 5 seconds occured 5 to 10 minutes after the meningococcal vaccine was given.  Patient was taken back to doctor and heart rate was monitored for a half hour and everything was normal.
Hives, rash -> stomach, arms. Wheezing. Started about 630pm 10-14-14. BENADRYL 25mg 630pm -> to ER. Recieved epinephrine and BENADRYL 25 mg PO.
PATIENT REPORTS CHILLS, FEVER, BODY ACHES, SHORTNESS OF BREATH BEGINNING 12 HOURS POST VACCINE #2
This is a spontaneous report from a contactable physician, received via a Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on 15May2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced high fever, diarrhea, and pain in the arm. The outcome of the events was unknown. Information on the batch number has been requested.
No additional AE reported.; HCP reported VARIVAX was administered to patient after a temperature excursion.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 28-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, once, (valid lot number W039293 [expiration date 11-DEC-2024]) (dose, dose number, strength, vaccination scheme, and route of administration were not provided), administered for prophylaxis, after a temperature excursion of 23 degrees Fahrenheit (F) with a time frame of 2 hours, 17 minutes. No previous temperature excursion.  No additional adverse event (AE) was reported.
1 day p/vax site became red, swollen, golf-ball size & painful;
fever (1 day), extreme fatigue (7 days), fatigue (subsiding but still present, intermittent), headaches (intermittent for 3 weeks), extreme inflammation, weakness, and joint pain (SEVERE for three days, inability to walk more than a few feet (3 days), continuing and improving over the course of 4 weeks, almost completely gone, but still experiencing sx
rash appeared on the arm, itching and swelling 7 days after Moderna vaccine. For the first 2 days after vaccine  patient had had pain in the arm at the injection site and a headache but this painful rash appeared 7 days after the vaccine. It is becoming less red and more pinkish since Tuesday she is using Hydrocortisone for itching and pain.
Information has been received from a physician concerning a 63 year old female who was vaccinated with a 0.5ml dose of varicella zoster virus vaccine live. Subsequently fourteen days after vaccination, the pt developed a possible breakthrough case of shingles. Unspecified medical attention was sought. No lab studies were preformed. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a health care professional concerning a patient who on 03/28/2000 was vaccinated with one dose of varicella virus vaccine live. Subsequently, the patient missed 2 menstrual periods, however, a pregnancy has not yet been confirmed. Additional information has been requested. Follow up was received which indicated that after 2 months of amenorrhea, the first pregnancy test had been negative but they would repeat it in another month to confirm it. Since enough time had passed from LMP with the initial test, the reporter assumed another etiology for the amenorrhea and did not believe the patient was pregnant. This report is part of the pregnancy registry.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medication information was reported. Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
I had reddness, pain and a knot at the site of injection 11 days afterward.  Pain radiated up my shoulder  when  I press on the knot. I took tylenol for the pain. At day 9, I took ibuprophen and benadryl.  I still have  discoloration   but  the knot has gone down alot. It's more of a welt the length of my thumb now.
Area around the injection site, approx. 3 inches across, turned red and was warm to the touch. This started the next day after the immunization (12/01/2017) and has remained mostly unchanged since then to reporting the event  12/08/2017. Pt has been icing the area. The pt was advised to report this to there Dr. as well.
Patient's mother calls to report that about 3 hours after immunizations received client began feeling "lethargic" and then later in the evening developed "low-grade fever, headache,and chills".  Mother does not know highest temp. because said temperature was not taken with a thermometer.  Client having symptoms at time of report but are not worsened.  Instructed mother to have patient rest, push fluids, and give tylenol and/or ibuprofen as directed and to call if any additional symptoms.
DEATH; This spontaneous report received from a consumer via social media through company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. It was unspecified whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (dose number in series 1).  The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, 1 total, 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, 4 hours after taking the booster shot the patient died (dose number in series 2). The patient died from unknown cause of death. It was unspecified if an autopsy was performed. It was reported that "My friend's mom dropped dead 4 hours after taking the booster. I refuse to take it." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event death was fatal. This report was serious (Death).; Sender's Comments: V0: 20220234178-COVID-19 VACCINE AD26.COV2.S-Death. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, this event is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Soreness at injection site, erythema/warmth just distal to injection site on mid upper arm.
Patient was seen for a flu shot on 11.13.18 she was then seen again on 11.28.18 for her 9 month wellness appointment at which time the doctor ordered her 2nd Flu shot (booster). On 12.4.18 she was seen for a sick visit and diagnosed with an ear infection and pink eye. Her last dose of medication was 12.14.18 and by that afternoon I had a 2:45 appointment scheduled. It was at this time she was diagnosed with a left ear infection. On 12.18.18 was supposed to be her booster to the flu shot which was canceled due to the error in giving it at her 9 month appointment.
Redness; Rash around my neck; Itching rash above my buttocks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 12:00 (Batch/Lot number: unknown) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Known allergies: Milk products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Administration time: 06: 00 AM, Vaccine location: Right arm), administration date: 09Mar2021, when the patient was 62 years old, for COVID-19 Immunization. The following information was reported: ERYTHEMA (non-serious) with onset Aug2021, outcome "not recovered", described as "Redness"; RASH (non-serious) with onset Aug2021, outcome "not recovered", described as "Rash around my neck"; RASH PRURITIC (non-serious) with onset Aug2021, outcome "not recovered", described as "Itching rash above my buttocks". The events "redness", "rash around my neck" and "itching rash above my buttocks" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of erythema, rash, rash pruritic.  Additional Information: It was reported that facility type vaccine was at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received list of any other medications within 2 weeks of vaccination. Treatment received for the adverse event as Triamcinolone Acetonide ointment USP, 0.1%. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever throughout the night, muscle aches over entire body, moderate plus soreness in L deltoid injection site
Neck aching and headache the day after vaccination. Later that day I have had general body ache with mild headache. Dry burning sensation at the lower throat. It's been like that since 10/12/2021. Chest pains. Joint pains. Dry raspy cough. I had my flu shot 2days after the 3dos of the COVID-19 vaccine. On my right arm.
Post vax, the patient "experienced a severe reaction to the vaccine. He has over 50 pox, some the size of a dime". It was reported that the mother was told "that this could continue for the next 3-4 weeks". The mother indicated that she was told that "there would only be a mild reaction", and she stated that "this is not a mild case of the chicken pox". Additional information has been requested.
Seizure; including vomiting for an unknown amount of time. Pt also seized while admitted to the hospital. Follow-up information received March 12.  This was not the 4th vaccination.  This is the 1st.  Medical records have been requested.
Emense pain starting the from top of neck all the way to lower back on the side of injection. Felt a lot of pain on both sides where kidneys are located. On 10/15/2016 at 9:00am there was a red cicle 2 inches in diameter around injection site. Pain continued and spread to other side of body. By 5:00PM on 10/16/2016 pain continued, neck was stiff and began to run a low fever of 99.3.
3 year old that was administered Pentacel but was only given the Dtap-IPV portion and not the ActHIB; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years old patient who received only Dtap-IPV portion and not the ActHIB from the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ095AA Dtap IPV Lot UJ108AA, ActHIB: LOT: UJ095AAA (Expiry date 24-Jul-2020) via intramuscular route in the left thigh on 01-Aug-2019.  The patient's past vaccination(s) included Pentacel on 15-JUL-2016, Pentacel on 16-SEP-2016 and Pentacel on 16-NOV-2016.  Concomitant vaccination included Hep A and Prevnar.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to Inappropriate reconstitution technique.  At a time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Severe swelling, moderate pain from rt shoulder to elbow, redness, fever and very irritable/agitated. These symptoms lasted 6 days. Treated with Tylenol.
Patient experienced severe and recurring pain in the left deltoid muscle for 3 months after vaccine was administered.  Patient was referred to orthopedist after 2 months, treated with methylprednisolone, treatment ongoing. Information from medical records states pain, reduced range of motion. msv
Left neck, head, shoulder pain starting 3 days after vaccination that started suddenly. Area felt like it was on fire, sensitive to touch. Worse with movement. No swelling, redness, or warmth. Pain was constant for a couple of weeks, then started to resolve. Pt now has intermittent pain lasting 30 minutes to an hour about 3 times a week. Pain is milder and located left shoulder, clavicle, throat, posterior neck. Some radiation to right clavicle.
16 year old patient given flubok. No adverse reaction after receiving injection. She should have received fluzone for her age according to CDC guidelines.