chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient passed out/feeling that she was going to pass out, and in fact she did.; sinus pressure; lack of energy; headache; feeling lousy; had to stay in bed all day; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-AUG-2023, the patient received the 2nd dose of Shingrix (left arm). On 12-AUG-2023, 1 days after receiving Shingrix, the patient experienced passed out (Verbatim: patient passed out/feeling that she was going to pass out, and in fact she did.) (serious criteria GSK medically significant) and bedridden (Verbatim: had to stay in bed all day). In AUG-2023, the patient experienced sinus pressure (Verbatim: sinus pressure), loss of energy (Verbatim: lack of energy), headache (Verbatim: headache) and feeling bad (Verbatim: feeling lousy).  In AUG-2023, the outcome of the sinus pressure, loss of energy, headache and feeling bad were resolved (duration 2 weeks). The outcome of the passed out and bedridden were resolved (duration 2 weeks).   It was unknown if the reporter considered the passed out, sinus pressure, loss of energy, headache, feeling bad and bedridden to be related to Shingrix.     It was unknown if the company considered the passed out, sinus pressure, loss of energy, headache, feeling bad and bedridden to be related to Shingrix.   Additional Information: GSK Receipt date: 29-AUG-2023 The reporter reported about herself she received the second dose of Shingrix on 11 August 2023 and the next day the patient woke feeling that she was going to pass out, and in fact she did.  The patient passed out and had to stay in bed all day. The patient also had headache, lack of energy, sinus pressure and feeling lousy.  According to patient the symptoms persisted for about 2 weeks and yesterday 28 August 2023 she started to feeling back to normal.  Reporter states she got a Covid test 4 times with negative results.  Patient contacted her doctor to inform him about the symptoms.  The reporter consented to follow up.
Very slight chills lasting 2 hours evening after first dose.; Slightly sore arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 71-years-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Left arm on 28Jan2021 at 01:00 pm (71-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included hbp (high blood pressure), high cholesterol, hypothyroid from an unknown date and unknown if ongoing. The patient have allergies to bees and sulfa. Concomitant medications included Levothyroxine (LEVOTHYROXINE SODIUM), Sanctura (TROSPIUM CHLORIDE), Pravastatin (PRAVASTATIN), Buspar (BUSPIRONE HYDROCHLORIDE), Ateno (ATENOLOL); all for unknown indications from unknown dates and unknown if ongoing. The patient previously took tramadol (TRAMADOL), celebrex (CELEBREX) and theophylline (THEOPHYLLINE) and experienced allergies. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 28Jan2021, at 08:00 pm, the patient experienced very slight chills in the evening after first dose and slightly sore arm at. No treatment was received for the events. The outcome of the events were recovered.     Follow-up attempts are completed. No further information is expected.
Pt got the typhoid vaccine at 0800 waited in the clinic 20 mins. Pt then went back to work then around 1330 came into to the clinic with a rash on his left heel and a rash on the top side of his left foot.
Patient became pale, lethargic, unresponsive possible seizure activity within minutes of receiving vaccinations. Responded to stimulation. Blowby O2 took several minutes to recover.
This spontaneous report was received from a Licensed Practical Nurse referring to a unspecified multiple patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL lot # L039066 with expiration date of 19-MAR-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was also reported by the Licensed Practical Nurse, that the vaccine was exposed to a temperature excursion of 23.4 degree C for a time of 3842 minutes. Data logger was stated. Furthermore, no adverse events were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of pruritus in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, several hours after receiving SHINGRIX, the patient experienced pruritus and intramuscular formulation administered by other route. On an unknown date, the outcome of the pruritus was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the pruritus to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional reported that his wife received a dose of SHINGRIX subcutaneously, which led to inappropriate route of vaccination. He also reported that she experienced extreme itching that lasted up to 10 days after receipt of vaccine.
Chills, body aches, shakiness, twitching in my hands & feet, feeling of restless leg syndrome, increased seizure activity including petite mals and grand mals, migraines, raising my voice for no apparent reason (not angry, just catching myself yelling and not knowing why) involuntary crying at random, increased instances of narcoleptic episodes, hallucinations, nausea and vomiting
Headache, Myalgia, chills, neck soreness Narrative:  Pt called into work on 11-5-21 from symptoms, stated mild and did not seek outside care
Approximately 1.5 hours after injection the patient reported right sided facial tingling, mostly around her lip.
mom states site were vax given swelled to size of goose egg;took to ER on 31MAR96 (5th day form inj);thinks pt had fever but was never taken ER rx an ATB
Eyes dilated, limited vision, limited hearing then threw up. Felt better after throwing up. 12:25 pm 6/12/21
Patient reports onset weakness, intermittent dizziness with redness and warmth of injection site on 10/6/09 no fever. Rt arm (injection) sore. States area is approximately 5 1/2 " long x 2 1/2 " wide red, firm and warm to the touch. She called her MD. No treatment. Did not want to come to office. Pt has history feels better today.
Patient presented to clinic for 2nd  Covid 19 vaccination.  1st dose received was Moderna on 3/1/2021.  Patient given above vaccination, Pfizer\BioNtech, today 3/29/2021 erroneously.  At time of release patient had no s/s of problem.
Patient developed fevers and malaise within 10 hours of the vaccine and then subsequently developed progressive shortness of breath and presented to the ED locally.  Was thought to have a PE and underwent CT images which was equivocal.  Transferred to our hospital where an MRI cardiac stress indicated myocarditis.  Started on aspirin and colchicine and will require cardiology outpatient follow up.  Patient is feeling better
Started a low grade fever yesterday, but it has gone up since then.  Fever is now about 102.  Has been on Motrin, but fever went up even on the Motrin, so I am alternating between Tylenol and Motrin every 3-4 hours.
Pt recvd Hep B vax in OCT91; following vax pt ex funny feeling in head;
Patient received Pfizer booster shot earlier than 6 months since dose 2 was administered. Dose 2 was administered on 7/29/21, Dose 3 (booster) was administered on 12/8/21
pt recvd vax & devel t104, fever, chills, diarrhea requiring IV fluids on 2AUG, 3AUG assoc w/swelling/redness/tender inject site;
Patient received Pneumovax23 on 2/5/20 and experienced swelling in the same arm as vaccination (left) above and below the elbow, but not at the vaccination site, redness, and warmth on the morning of 2/7/20.  She consulted with the pharmacist on duty and the pharmacist assessed the arm and advised her to see her doctor.  She went the same day and was told it is most likely cellulitis and was prescribed SMZ/TMP ds bid for 7 days.  She was advised by her provider to go to hospital  to get ultrasound to make sure there was no blood clot.  The patient proceeded to the hospital that same day and based on ultrasound, there was no clot.  Pharmacist on duty followed up with patient 2/10/20 and patient was going back to provider for follow up.  She got an extension of her antibiotic for 3 more days.  According to the patient, over the course of the weekend, the swelling and redness significantly reduced and no longer warm to the touch.  She just has very slight redness and swelling as of today 2/10/20.  She will follow up with her provider when done with the antibiotics.  She did state that she had a history of frozen shoulder and she did fracture that same shoulder a few years ago.
Pt stated red rash, warm to touch, painful, hard to lift arm, no itching but swollen last 2 days.
Numbness, tingling, jint pain, cardio and gastro problems, eye sight problems, bone pain, headaches, rash, edema, etc, etc. Lot #'s were not recorded.
This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reaction or allergies were not reported. On an unknown date, the patients were vaccinated with MMR II (dose and lot number were not reported). Concomitant therapy was not reported. On an unknown date, the patients may have received improperly stored MMR II. No adverse event was reported. Additional information is not expected.
This spontaneous report as received from a licensed practical nurse refers to a 25 years old female patient with no pertinent medical history and no drug reactions/allergies who was not pregnant. The patient was vaccinated with the first and second dose of GARDASIL (dose, route and lot number not provided). No other co-suspects were reported. There were no concomitant medications. On an unknown date the patient tested positive for human papilloma virus (HPV) after receiving first 2 doses of GARDASIL. The patient did not get the third dose yet. The patient had sought unspecified medical attention and no treatment information was given. The patient performed Pap smear test. The outcome of the patient was reported as not recovered/not resolved. Additional information has been requested.
She got her vaccine, it hurt as soon as she put the medicine ill, as she even jumped a little.  It was like tons of pressure when she put the medicine in her arm.  She was fine, and did some shopping and went home.  Last night she knew she was itching, but didn't think any of it.  When she woke up this morning she was scratching her arm like a mosquito bite.  Later on the area went down, and then it started on her hip areas, in between her legs but in the hip area.  It looks like a lot of mosquitos bit her with the redness and swelling, and the itching.  The arm one went down, but the others kind of just started.  She is not taking anything for that reaction.
urticaria approx 2 hrs p/dose; resolved by following morning; no treatment; resolved prior to seeing MD:
This case was received from a health professional in the United States on 08 May 2008, and is one of three patients reported in a cluster. A five-year-old female patient received an intramuscular left deltoid fifth injection of DAPTACEL (lot number C2933AB) and an intramuscular left deltoid fourth injection of IPOL (lot reported as A047U) on 01 May 2008. Five days later, on 06 May 2008, she complained of a nickel-sized red bump on the left arm at the injection site, which was hard to the touch and itchy. Treatment included BENADRYL and MOTRIN, the patient recovered. The reporter in this case also reported two other patients with large local limb swelling following administration of DAPTACEL; those events are captured in case numbers 2008-01480 and 2008-01482.
Vaccine was initially stored in refrigerator on 10Oct2022 and was administered to patient on 21Nov2022; No adverse event; Received Moderna Covid 19 Bivalent Booster after 30 Day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent Booster after 30 Day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10Oct2022 and was administered to patient on 21Nov2022) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent Booster after 30 Day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10Oct2022 and was administered to patient on 21Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent Booster after 30 Day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10Oct2022 and was administered to patient on 21Nov2022) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent Booster after 30 Day use by date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10Oct2022 and was administered to patient on 21Nov2022).    No concomitant information provided. The vial did not undergo any temperature excursions. Vaccine was initially stored in refrigerator on 10-Oct-2022. No treatment information provided.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-DEC-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX injection, lot # L026410, expiry date: 15-FEB-2017 (route, dose and strength were unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX Vial 19400 PFU (lot # J000494, Exp date: 14-APR-2014) (dose and route unspecified). Patient experienced "redness that was spreading down the patient's arm and a bulge at the injection site" on an unspecified date after receiving ZOSTAVAX. The patient contact pharmacist for medical attention. The outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
11/18 onset of fever (103 or greater) 8 hours after vaccination, diarrhea, and some vomiting for 72 hours, achiness, crying, change in temperament, fussier and irritable, night waking. Red bump at injection site on right leg.
I had felt a little crummy overall the afternoon of my second shot, but nothing specific aside from a slightly sore arm. The next day my legs started to feel funky, but I had a strong 4 wheel rollator and I continued on to assist my wife with getting her first shot at . By the time we got to the  elevators, after walking about two blocks the legs were feeling worse. On the way out my wife noticed me walking poorly and after about one block my legs "gave out" completely and I collapsed.
Pt had Pfizer for her first dose of COVID vaccine but mistakenly received Moderna for her second dose.  She went home with no adverse reaction noted.
the patient experienced tonic clonic movements intermittently for about ten minutes; This spontaneous report was received from a nurse via company representative, referring to a female patient of unknown age. The patient did not have any pertinent concurrent conditions, medical history or previous drug reactions or allergies. It was unknown by the reporter if the patient took any concomitant medication.   On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and on 04-JUN-2020, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) both by intramuscular route as prophylaxis (concentration, vaccination scheme frequency and anatomical location were not reported; lot number and expiration date were unknown by the reporter).   On 04-JUN-2020, within 5 minutes of the administration of the second dose, the patient experienced tonic clonic movements intermittently for about 10 minutes. The patient received attention in the physician office because she was still there, however no laboratory diagnostic or studies were performed and no treatment was given to the patient.  At the time of this report, the outcome of tonic clonic movements was reported as recovered.   The causality assessment between therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the aforementioned event was not reported.  Upon internal review, tonic clonic movements  was determined to be medically significant event.
Vaccine was given 4:10 PM. Onset 4:45 PM, itching soles of feet. At 5:00 PM, ankles and feet were swelling. At 5:15 PM, itching over entire body and swelling feet and wrists. At 5:30 PM, face and mouth numbness with lip swelling. At 5:30 PM, next door neighbor (ER doctor) administers Epinephrine, steroid and 4 Benadryl. He felt better for a while after steroids and Epi. He admits Benadryl makes him restless and drowsy but not sleepy. At 7 PM, he had chest pains with sweating (indigestion type pain in the center of chest). Called neighbor (ER doctor), sent for rescue squad. Taken to ER, IV started, Nitroglycerin. Kept over night. Tests run. Released Saturday 09/01/01, midday.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Patient is on Diabetes medication).    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 21-Feb-2021, PYREXIA (Fever) had resolved.            This case was linked to MOD-2021-297879, MOD-2021-297903 (Patient Link).
Localized redness induration measuring 4cmx5cm, pruitic Given zyrtec, advised cool compresses, symptoms improved within 48hours
Fever 104.4. Headache with pressure behind eyes and pain shooting and radiating in neck.
Approximately 5 minutes after receiving the FLUVIRIN injection, patient started to pass out. He was fine immediately after his injection, and stood up to watch his girlfriend get the vaccine. While watching her, he passed out partially. He was still conscious so we just monitored breathing. He hit wall when fell, so was going to ER to see if his nose was broken.
eye starring, Lip smacking, rhythmic movements of upper extremity 2/8/08-records received-HX seizures previously controlled with medication. Seen for multiple seizure acitivty, patient drowsy and dazed afterward.Tonic clonic movements. 3/18/08-records received for 1/12-2/5/08-DC DX: Seizures. Gastroesphageal reflux disease.Admitted with new onset of seizure disorder. Intractable seizures with prolonged periods of somnolence. Left sided exotropia with decreased visual acuity. 1/20/2010 Patient had immunizations. Then noted seizures/behavior abnormal which later diagnosed as seizures. Has developmental delays. No longer in our practice.
booster; Fatigue; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose unknown single (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever". The lot number for bnt162b2 was not provided and will be requested during follow up.
"I felt the initial reaction 2-3 hours after I received the vaccine dose. The effects that I felt lasted 2 days after the dose and I knew my throat was swelling because I was having trouble swallowing and breathing. I have felt this before with other anaphylactic reactions from other allergies. There was some trouble for me to get a full sentence out without feeling breathless. I took Benadryl and an allergy pill wig in seemed to help a little bit"
Tiredness, headache, muscle pain, chills, fever, body aches, injection site swelling, feeling unwell.
The day after the shot, I started experiencing extreme chills, a very high fever and fatigue.  This lasted from about 4:30pm until around 10pm that evening.  The days following that I have been fine...just slight soreness in my arm.  But the day after, the fever and chills were miserable.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 26-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Narrative:  Patient is a Female to Male transgender patient who has been on testosterone therapy for several years and has had elevated Hgb/Hct throughout that time.Even with testosterone levels remaining fairly consistent and elevated for a woman but not for a man. He got the Johnson and Johnson vaccine and now has developed critical high Hgb/Hct and even with stopping testosterone the levels have not subsided. Unsure if this is reaction or not but endocrinology wanted this reported.