chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEART BEATING FAST; HEART "SKIPPING BEATS"; ACHING JOINTS/JOINTS HURTING; NAUSEATED; HURTING ALL OVER; DIZZY; COULDN'T SLEEP; STOMACH FELT "BLOWN UP"; NO APPETITE; HURTING "DOWN REAL LOW" IN ABDOMEN; HAD TO URINATE ALOT; SHAKINESS; ITCHING ARM; FATIGUE; WEAKNESS/NO ENERGY; SORE ARM; DID NOT FEEL WELL; CHILLS; BREASTS SORE; SEVERE HEADACHE/SORE SPOTS ON HEAD; UNDER ARMS SORE; SUSPECTED COVID; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dental surgery, and left arm broken. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced suspected covid. On MAY-2021, the subject experienced breasts sore. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced did not feel well. On MAY-2021, the subject experienced sore spots on head. On MAY-2021, the subject experienced under arms sore. On 11-MAY-2021, the subject experienced shakiness. On 11-MAY-2021, the subject experienced itching arm. On 11-MAY-2021, the subject experienced weakness/no energy. On 11-MAY-2021, the subject experienced sore arm. On 11-MAY-2021, the subject experienced fatigue. On 11-MAY-2021, the subject experienced severe headache. On 12-MAY-2021, the subject experienced hurting all over. On 12-MAY-2021, the subject experienced dizzy. On 12-MAY-2021, the subject experienced couldn't sleep. On 12-MAY-2021, the subject experienced stomach felt "blown up". On 12-MAY-2021, the subject experienced no appetite. On 12-MAY-2021, the subject experienced hurting "down real low" in abdomen. On 12-MAY-2021, the subject experienced had to urinate alot. On 12-MAY-2021, the subject experienced aching joints/joints hurting. On 12-MAY-2021, the subject experienced nauseated. On 18-MAY-2021, the subject experienced heart beating fast. On 18-MAY-2021, the subject experienced heart "skipping beats". Treatment medications (dates unspecified) included: ibuprofen, naproxen sodium, and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate. The action taken with covid-19 vaccine was not applicable. The outcome of the severe headache, shakiness, weakness/no energy, fatigue, sore arm, itching arm, did not feel well, hurting all over, hurting "down real low" in abdomen, nauseated, dizzy, chills, couldn't sleep, stomach felt "blown up", no appetite, had to urinate alot, heart beating fast, heart "skipping beats", breasts sore, aching joints/joints hurting, sore spots on head and suspected covid was not reported. This report was non-serious.
Vesicular rash on the back of patient's arm where the Varicella vaccine had been administered about one week ago.
Awaken from sleep at 3 am 1/17 with severe headache, chills, shaking., severe thirst. Severe fatigue and aching in back and legs. Took  200 mg Advil. Slept for entire 12 hours only getting up to bathroom. By  5p fatigue liefting. Headache remained. Additional 200mg Advil. By  1/18  fatigue 80% gone. Headache lifted.  By end of the day back to 100%
the patient experienced dizziness and nausea; the patient experienced dizziness and nausea; This spontaneous report was received from a physician concerning to a male patient of unknown age. The patient's historical conditions, concurrent condition, and concomitant medications were not provided.  On 21-NOV-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route of administration, anatomical location were not reported; lot # R017249 and expiration date 04-MAY-2021) as prophylaxis.         The physician reported the patient experienced dizziness and nausea after being administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). They gave the patient water and a dextrose electrolytes (unspecified) (Pedialyte Popsicle).  The outcome of dizziness and nausea was not reported.      The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  was reported.    Lot number was reported in the source document but the expiration date was not. But, when entering the lot number in MARRS the system automatically auto-populated the expiration date.  This Case is one of three Multiple Patient Reports.; Sender's Comments:  US-009507513-1905USA011304:
Tightness in chest; feeling light headed; This is a spontaneous report from a contactable consumer (Reporter's Husband).   A 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 24Mar2021 13:10 at the age of 81-year-old as dose 2, single for covid-19 immunisation.  The patient's medical history and concomitant medications was none. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 03Mar2021 as dose 1, single for covid-19 immunisation.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced tightness in his chest and feeling lightheaded. Both symptoms have recovered completely. They didn't know something else was going to happen 5 days after the shot. He says he feels fine and has progressively gotten better. Patient was not visit emergency room and physician office. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Swollen and enlarged left armpit 24 hours after shot was administered. Sore and tender to touch. Swelling of surrounding tissue and lymph nodes across the left upper chest, collar bone, and neck. All on the left side which is the side of the injection. Has remained swollen for 48 hours.
Expired vaccine administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Latanoprost Allergy), Drug allergy (Propylene glycol Allergy), Drug allergy (Sertraline Allergy), Hypertension, GERD, Asthma, Psoriatic arthritis and Hyperlipidemia. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for Asthma, ATORVASTATIN for Hyperlipidemia, HYDROCHLOROTHIAZIDE and CANDESARTAN for Hypertension, ETANERCEPT for Psoriatic arthritis.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022 at 8:18 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022 at 8:18 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration). On 24-Jan-2022 at 8:18 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) to be not related.    Patient weight was reported as 79.4 kilograms. No Treatment information was reported. Reporter had stated that no adverse events were associated with the event and the patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date.   Reporter did not allow further contact
I started feeling dizzy, my ears were full and though I had a sinus infection went to the Dr. and I had a sinus infection turning into an ear infection. But I didn't have any of the sinus infection symptoms. It was weird, I was just feeling dizzy and so I went to the Doctor.
No adverse effects reported; The vaccine was inappropriately stored at 25 degrees Fahrenheit for 3 hours and 49 minutes; This spontaneous report was received from a receptionist referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant medications were no reported.  On 26-JUL-2019, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot# R021370 and expiration date 07-NOV-2020) (dose, frequency and route not reported) for prophylaxis. The vaccine was inappropriately stored at 25 degrees Fahrenheit for 3 hours and 49 minutes (product storage error). It was reported that a digital data logger was involved, but no previous temperature excursion information was provided. No adverse effects were reported.  This is one of two cases received by the same reporter.; Sender's Comments:  US-009507513-1907USA016666: US-009507513-1907USA016666:
ringing in ears; nasal pressure; body ache; head ache; joint pain; slight nausea; tiredness\quite debilitating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (ringing in ears), NASAL DISCOMFORT (nasal pressure), PAIN (body ache), HEADACHE (head ache) and ARTHRALGIA (joint pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iodine allergy.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced NASAL DISCOMFORT (nasal pressure), PAIN (body ache), HEADACHE (head ache), ARTHRALGIA (joint pain), NAUSEA (slight nausea) and FATIGUE (tiredness\quite debilitating). On 04-Apr-2021, the patient experienced TINNITUS (ringing in ears). At the time of the report, TINNITUS (ringing in ears) had not resolved and NASAL DISCOMFORT (nasal pressure), PAIN (body ache), HEADACHE (head ache), ARTHRALGIA (joint pain), NAUSEA (slight nausea) and FATIGUE (tiredness\quite debilitating) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.    This case was linked to MOD-2021-089103 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Documents attached
Heart attack level adverse event, Troponin levels highly elevated, hospitalized for 5 days.  Immediate emergency room surgery to detect any heart blockages but could not find any. Another surgery to ablate accessory pathway but that failed. Woke up with complete 3rd degree heart blockage and various heart arrhythmias. Took until February 2022 until I was able to walk normally without assistance.
The patient presents with rash.  Other comments include: Pt had HPV #2 yesterday around 4:30. At about 6pm, she developed a red itchy rash. Her face became blotchy.  No fever, swollen lips/tongue, no URI sxs. Pt is on D9/10 Amoxil for strep throat. No h/o medication allergies in past.  There has been the acute onset of a rash.  It is pruritic.  It is located on the face, chest and arms .  Comments: rcvd HPV vaccine 5/28/19. Hives started last PM.
teeth are extra sensitive to cold and sugar; headache; some chill; This is a spontaneous report from a contactable consumer reporting for himself. A 41-year-old male patient received bnt162b2 (BNT162B2, Lot no: EN5318), via intramuscularly on an unspecified date at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient stated: "my teeth are extra sensitive to cold and sugar a day or two after my vaccine. Otherwise just a headache and some chill, but those went away after 12 hours. Tooth sensitivity persisted 48 hours after vaccine." No treatment was received for the events. The outcome of sensitivity of teeth was not recovered, headache and chills was recovered on an unspecified date.
Threw up close to 30 times; extreme body aches; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 25-year-old female patient received second single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported) , via an unspecified route of administration (Vaccine location: left arm) on 14Jan2021 17:45 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included factor 5. The patient was not pregnant and was not pregnant at the time of vaccination. Patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications the patient received within 2 weeks of vaccination. The patient previously took first single dose of BNT162B2 (Pfizer) on 24Dec2020 10:15, Vaccine location: left arm for COVID-19 immunization. On 15Jan2021 07:45, the patient threw up close to 30 times with extreme body aches. The events were considered as non-serious by the reporter. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021 with lasting effects.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
pt recv vax & 2 wk later pt devel chicken pox; No further details were provided;
This female subject was enrolled in the prophylactic study. On 18 November 2010, she received the 1st dose of Sanofi Pasteur's ACTHIB (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVENAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 18 November 2010, on the same day after the 1st dose of ACTHIB, on the same day after the 1st dose of PEDIARIX, on the same day after the 1st dose of ROTARIX, on the same day after the 1st dose of PREVENAR 13, this one-month-old subject developed possible seizure. The subject was hospitalised. The subject was treated with acyclovir, ampicillin trihydrate, cefotaxime and paracetamol. The event resolved on 20 November 2010. The investigator considered that there was a reasonable possibility that the possible seizure may have been caused by ACTHIB, PEDIARIX, ROTARIX and PREVENAR 13. Subject was randomized to the study on 18NOV2010. Primary physician notified the clinic that subject experienced a seizure last evening and was hospitalized. Update 22Nov2010. Medical records obtained. Had spinal tap, CBC, head CT scan, EEG, all within normal limits. Neurology consult impression felt that this was a "blue episode" related to a passage of stool. Parents feel that this episode was a seizure or event of significance. Principal investigator confirms that this should be regarded as a possible seizure and possibly related to study vaccine.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 10-OCT-2014, unspecified amount patients were vaccinated with GARDASIL lot # K001631, expiry date 06-NOV-2016 (dose and route of administration were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reproter. Additional information has been requested.
received 1st dose in July 2021, received on April 13th 2022 second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in July 2021).   On 13th April 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 13th April 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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: 13-Apr-2022 Reporter's Comments: Registered pharmacist reported that a patient received 1st dose of Twinrix in July 2021 and received on April 13th 2022 second dose. The Healthcare professional wanted to know if the patient had to start over the schedule or how to proceed in this situations. Call Notes:Patient's demographic details were asked but Healthcare professional wasn't sure if she could share that information so she didn't provide that information. Lot number and expiration date asked but Healthcare professional didn't have that information. 1st dose date of vaccination : July 2021 2nd dose date of vaccination : April 13th 2022. The reporter consented to follow up. Additional Supportive Information:  The patient received the 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Vaccine administered 10 am 12/26/20.  Post vaccine experienced headache, sore arm and fatigue.  Approximately 6 hours post injection developed  a hot feeling like she was sunburned, pruritis  and then a pepper rash/hives started to develop inferior to injection site on right arm, spreading to left arm, chest and neck.  Went to ER and treated with IV steroids, diphenhydramine, and hydroxyzine.  Discharged on a 5 day course of Famotidine, Hydroxyzine Pamoate, and Prednisone  with PRN Diphenhydramine.
Rash and itchiness all over body and hives. Treated with BENADRYL 25 mg/m and BENADRYL susp 1 tsp PO q 12 hours.
2 years out from her first dose of Shingrix? looking for the guidance as far as resuming with her last dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose about 2 years ago, prior to reporting.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details was reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received the 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter mentioned that, they were looking for the guidance as far as resuming the patient with her last dose or if they need to restart the series.
Pain at the site; Hot flashes; burning in the throat; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Jun2021 at 13:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jun2021 at 14:00, after 30 minutes of vaccination, the patient experienced burning in the throat; and on same day at 14:45, the patient experienced pain at the site and hot flashes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event pain at the site, burning in the throat and hot flashes were unknown at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Got the shots at 10:20am. Then around 1:00 the same day, starting feeling cold and chills and shivering. Then about 6:00 pm starting feeling very hot. Had difficulty sleeping, breathing, felt very nauseated through the night of 10/27. On 10/28 in arm, still felt hot and had trouble breathing. Was unable to eat until 3:00 pm 10/28/17. After eating still felt generally unwell and had occasional chills. Felt normal by 10/29 in he A.M. No injection site swelling or redness. Arm was slightly sore, but not usually so. No medical treatment was sought.
Patient was diagnosed with acute PE that required urgent transfer for thrombectomy. Patient recieved Moderna booster shot 2 days prior to sxs onset. Also of note, patient had a prolonged car trip, but this was 2 weeks prior to presentation.
Information has been received from a physician concerning a 16 year old female patient with no illness at time of vaccination who on 12-MAY-2008 was vaccinated with her third dose of GARDASIL vaccine (yeast) (therapy route, dose and Lot # unspecified). There was no concomitant medication. No lab diagnostics studies were performed for the patient. A couple of months after the vaccination, the patient experienced Bells Palsy. The patient sought medical attention in the emergency room but not admitted to the hospital. Subsequently, the patient recovered from Bells Palsy (recovered date unknown). Additional information has been requested.
Severe, stabbing pain in head near temple area.  Not sinus pressure like usual with allergies, but stabbing headache.  Very fatigued and achy.