chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in left elbow and left wrist has continued for a month. The pain seems to be getting better--I still cannot do the gutter cleaning and landscape pruning that needs to done at home.
Patient admitted with cholecystitis (recent cholecystectomy with remnant remaining) s/p remnant removal with finding of new metastatic liver cancer and advanced cirrhosis.  Hospital course further complicated by massive GIbleed from esophageal varices and aspiration pneumonia. ED visit, hospital admission, patient deceased. This visit was within 6 weeks of receiving the COVID vaccine.
3 hours after vaccination, patient lost vision and hearing. She laid down to wait for it to pass. When standing up to go to bathroom, she felt weak and ended up blacking out in bathroom. Time of loss of consciousness is unknown. When patient came to, she vomited several times. She still feels weak the following day.
Information has been received from a nurse referring to an adult patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was inadvertently vaccinated with a pediatric dose of VAQTA (lot#, expiration date, strength, dose and route were unknown). No adverse effect reported. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-DEC-2016, the patient received an improperly stored dose of M-M-R II (therapy type: recombinant human albumin, RHA) injection (lot # M015931 with expiration date at 30-MAR-2018; dose, route of administration and anatomical location were not reported). The administered dose of vaccine was exposed to a temperature of -14.4 degrees Celsius (C) for 54 minutes. Digital data logger was used to track the temperature. There was no previous temperature excursion reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113.
Hives by injection site, groin, chest and back soon after flu shot administered on 10/9/15 mom advised to give patient BENADRYL.
Event dated 1 Jan 1992. Approximately 30 min after receiving Typhoid vaccine, member developed severe headache, vomited, and notable respiratory distress. Sent to ER via ambulance. Reassessed, intubated and admitted to ICU with ARDS. Released 3 days later once resolved.  Reporting this event as a matter of record.  2/20/09 Received hospital medical records of 1/11-1/15/1992. FINAL DX: anaphylactic shock, pulmonary edema Records reveal patient intubated & admitted ICU.  Only labs are available due to age of records.
intermittent substernal chest pain 8/10 pain scale -shortness of breath      each episode lasting approximately 2 minutes   Not relieved with rest
1037 Pt c/o dyspnea, metal taste in mouth and dizziness; 50 mg Benadryl given..  1039 vs 160/112, HR 123; rr 20; spo2 98 - pt reports metal taste gone. 1044 VS 148/107; hr 94; rr 20; sp02 96; 1052 vs 162/106, 90 sp02 97 - pt said he felt fine and wanted to drive home.  no further reports of any s/s first reported.
during the first week of JAN96 pt exp achy, tender inj site & was tx w/Ibuprofen;devel coldness @ inj site;3JAN96 pt exp stiffness, numbness, & soreness around the inj site;pain was very obvious when pt arm in use;dx tendinitis;
Hives from shoulder to elbow for 6 days; Fatigue; Fever; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hives from shoulder to elbow for 6 days), FATIGUE (Fatigue) and PYREXIA (Fever) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives from shoulder to elbow for 6 days), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, URTICARIA (Hives from shoulder to elbow for 6 days), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.
Minor loss of hearing in right war accompanied by tinnitus. Following day, hearing ok but tinnitus continues. Tinnitus is not typical for me and I?m not sick wit congestion or anything.
06/07/12 Mother of client reports client woke up "not feeling so well," went to school & returned home early with a "wicked case of the flu," symptoms included chills, temp 101 degrees F, severe aches, upset stomach, headache. Mom called PCP nurse who encouraged Ibuprofen. Mom went to pharmacy & pharmacy-D thought it was a severe reaction to Hep A due to combo with MENACTRA. Mom gave Ibuprofen Q 4 hours 06/08/12 Mom reports child woke up a 8:00am & ate & seemed fine," did not report symptoms. Encouraged cont. supportive care. 06/13/12 client completely recovered.
11:45pm chills, nausea, aches. It?s now 10:04 am and I?m still feeling poorly.   This happened after my first dose in August 2019.   Lot no. May be 58160-0823-11
patient was given one additional dose  of varicella. Proquad was given instead  of MMR. No reaction @ the time of  visit
4/15/2021 Evening:  Dry mouth, sore  arm 4/16/2021 By 8am: Headache, stiff joint, temp 99.5F 4/16/2021 Throughout the day, headache and temp ranging 99.5F to 100F 4/16/2021 6:30 pm:  Took Tylenol 4/16/2021  By 7 pm, the headache is gone 4/16/2021 By 8pm, temp 97.2F, still higher than normal temp (below 96.8F) 4/17/2021 9am.  Temp 98.1F.  Sharp sting in right eye, mild sting in left eye. They went away after 5 mins or so.  Eyes felt heavy through out the day. 4/19/2021 3pm.  Tinnitus. Usually it is unnoticeable, but it's very loud.  It comes and goes, but this is the worst tinnitus I have experienced.
Patient started their bowel movements early in the morning it slowed down and then late afternoon; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Patient started their bowel movements early in the morning it slowed down and then late afternoon) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced DIARRHOEA (Patient started their bowel movements early in the morning it slowed down and then late afternoon). On 06-Aug-2021, DIARRHOEA (Patient started their bowel movements early in the morning it slowed down and then late afternoon) had not resolved.            No concomitant medication information was provided by the reporter.  The patient started their bowel movements early in the morning, then it slowed down and started again in the late afternoon.  No treatment information was provided by the reporter.
One week after vaccine administration I developed lymphadenopathy on the left side - very painful and has lasted 4 days and is ongoing.  Antibiotics were started on day 4.
My co-worker who is 32 wanted MMR and Varicella, and I gave her MMRV inadvertently. No adverse outcomes.
Swelling of the arm; Red, hot to the touch and itchy arm; Red, hot to the touch and itchy arm; Red, hot to the touch and itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of the arm), VACCINATION SITE WARMTH (Red, hot to the touch and itchy arm), PRURITUS (Red, hot to the touch and itchy arm) and VACCINATION SITE ERYTHEMA (Red, hot to the touch and itchy arm) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swelling of the arm), VACCINATION SITE WARMTH (Red, hot to the touch and itchy arm), PRURITUS (Red, hot to the touch and itchy arm) and VACCINATION SITE ERYTHEMA (Red, hot to the touch and itchy arm). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling of the arm), VACCINATION SITE WARMTH (Red, hot to the touch and itchy arm) and PRURITUS (Red, hot to the touch and itchy arm) had not resolved and VACCINATION SITE ERYTHEMA (Red, hot to the touch and itchy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Perfused diaphoresis; really anorexic again; could not eat for 2 weeks; trouble drinking; really sick; got dehydrated; really nauseous; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Perfused diaphoresis), DECREASED APPETITE (really anorexic again), FEEDING DISORDER (could not eat for 2 weeks), DYSPHAGIA (trouble drinking) and ILLNESS (really sick) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037821B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (sick for 2 weeks with a dry cough, anorexic, could not eat anything, nauseous) on 07-Feb-2021, COVID-19 pneumonia (admitted in hospital from 7-Feb-2021 to 11-Feb-2021) and Chest X-ray (showed a bit of scarring on the lower left quadrant ).  Concomitant products included METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) for Migraine, CALCIPOTRIOL (DOVONEX) for Psoriasis, CALCIUM, COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE], VALPROATE SEMISODIUM (DEPAKOTE ER), GABAPENTIN (GABAPENTIN "PCD"), CHONDROITIN SULFATE, GLUCOSAMINE SULFATE (1120 GLUCOSAMINE & CHONDROITINE), LEVOTHYROXINE, MELATONINE, METFORMIN, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (LANTUS), CARVEDILOL (COREG), CYPROHEPTADINE HYDROCHLORIDE (PERIACTIN), DULOXETINE HYDROCHLORIDE (CYMBALTA), EZETIMIBE (ZETIA), MAGNESIUM OXIDE, GINKGO BILOBA, PANAX QUINQUEFOLIUS (GINSENG AMERICANO) and ORIGANUM VULGARE (OREGANO) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced HYPERHIDROSIS (Perfused diaphoresis), DECREASED APPETITE (really anorexic again), FEEDING DISORDER (could not eat for 2 weeks), DYSPHAGIA (trouble drinking), ILLNESS (really sick), DEHYDRATION (got dehydrated), NAUSEA (really nauseous) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (Perfused diaphoresis), DECREASED APPETITE (really anorexic again), FEEDING DISORDER (could not eat for 2 weeks), DYSPHAGIA (trouble drinking), ILLNESS (really sick), DEHYDRATION (got dehydrated), NAUSEA (really nauseous) and CHILLS (chills) had resolved.      Treatment information was not provided.  The patient also took concomitant medications such as garden of life (probiotic formulated by physician) once daily and vitamin 1000 mg (200mg total daily).   This case was linked to MOD-2021-321229 (Patient Link).
Pityriasis Rosea occurred 3 weeks after 2nd vaccine.  Is still active but is now beginning to subside (June 6, 2021).
Headache dull; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache dull ) 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 HEADACHE (Headache dull ). At the time of the report, HEADACHE (Headache dull ) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       the treatment history was not reported.  the concomitant medications and medical history was not provided.
The first 24hrs  ran fever and vomiting as well as a headache, bruising and a large red circle at the sight of injection that was warm to the touch. Dr. Put me on a 7 day azithromycin course.  3 days later the area turned yellow and 7 days later the whole area burned was hot and red and swollen. Dr gave me a shot of Rocephin and told me to call of it got bigger. The next day it was much bigger and I got another shot of Rocephin and an oral course of cephalexin. The entire time I?ve had headaches and migraines that have caused some vision impairment.
pt recvd vax; w/in 24 hrs exp photophobia, red eye & itching; sxs resolved w/ out tx
This case was received on 27 November 2008 via a search of the VAERS database (VAERS Id Number: 317893). It was originally reported to VAERS by another manufacturer (Acambis, Inc)" A 23 year-old female patient, had received on 05 May 2008 a first intramuscular injection of TYPHIM VI, and a first infection of SMALLPOX. At an unspecified amount of time later, on the same day, the patient experienced swelling, pruritus, tachycardia (heart rate 117 beats/min), elevated blood pressure (160/90mmHg), and shortness of breath. The patient was hospitalized and received corrective treatment with intramuscular EPINEPHRINE times three doses, intramuscular and intravenous SOLU-MEDROL, OXYGEN and ZYRTEC. It was not reported whether the patient underwent diagnostic tests or had any laboratory data completed. The patient had positive response to the anaphylactic medications. The patient recovered; however a recovery date was not provided. Documents held by sender: None
Moderate to severe menstrual cramps; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included rivastigmine hydrogen tartrate (RIVERA), fish oil (MANUFACTURER UNKNOWN), and multivitamin; all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 08:00, the patient experienced moderate to severe menstrual cramps. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event moderate to severe menstrual cramps was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Chest pain, ST elevations on EKG, Elevated Troponin, likely myocarditis
Vaccine expired 11/5/21, given 11/8/21 no adverse events reported.
Pain in injected arm 12 hours after shot Fever of 101.2 24 hours after shot Rash on injection site, chest, back, and behind ears 40 hours after shot
pt was ghostly white when sitting in chair prior to vaccine, pt stated he was very afraid of needles and shots. Sat and talked to patient until he said he was comfortable getting vaccine. pt took several deep breaths and was vaccinated.  Had pt sit in chair for a minute or so and talked to him. instructed pt he could go over and sit in more comfortable chair or walk around for 15 minutes.  Approximately 1-2 minutes after leaving vaccination chair, pt's GF yelled she needed help that pt had passed out.  I immediately walked to pt and he was lying face down on carpet in the aisle. I touched pt and attempted to stir him while calling his name. His eyes flung open and he attempte to sit up.  I had pt remain still any lying on floor until I was comfortable that he was breathing ok and he knew his name and where he was.  I instructed my techinician to call 911 and have EMS come to store. Pt then sat up on floor and my technician brought him a bottle of water.  Pt was still ghostly white and his hands were very mildly shaking, like he was nervous.  Stayed with pt, sitting on floor until EMS arrived.  Pt was then walked to ambulance with EMS and evaluated there.
89yr old mother (former nurse) and states her mother got "a very bad outbreak of shingles; liver was swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 89 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "sinus infection".  The following information was reported: HERPES ZOSTER (non-serious), outcome "not recovered", described as "89yr old mother (former nurse) and states her mother got "a very bad outbreak of shingles"; HEPATOMEGALY (non-serious), outcome "unknown", described as "liver was swollen".  Additional information: Reporter is a consumer who is reporting on behalf of her 89year old mother (former nurse) and stated her mother got "a very bad outbreak of shingles" a "day or 2" after receiving her 3rd dose (booster dose) of Pfizer Covid19vaccine. Reporter states that her mother received the Shingles vaccines several years ago. Reporter states that the shingles have now blistered over and now in area where she broke out, she has severe swelling, and it looks like there could be "liver" involvement (they are waiting on a sonogram). She got the Pfizer COVID 19 first dose and on her second dose, she got sinus infection and when she received third dose about a month ago, she came out with shingles and liver was swollen. Shingles has been about 3-4 weeks since she developed it, which was a couple of days after getting the third vaccine dose. Shingles is in the same area of the liver.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report has been received from a nurse, via a field representative, concerning an approximately 14 year old patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The nurse stated that on an unknown date, at the age of 13 year old, the patient was vaccinated with a dose of GARDASIL (reported as GARDASIL 4) (dose, dose number, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was reported that one year later, on an unknown date, the patient was administered a dose of GARDASIL 9 (dose, dose number, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was also reported that the time frame was longer than recommended. No adverse effects were reported.
Brief episodes of chest tightening, followed by spinal pain between shoulders.; Brief episodes of chest tightening, followed by spinal pain between shoulders.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262 and expiration date not provided), via an unspecified route of administration (left arm) on Jan2021 at single dose for Covid-19 immunization. There was no medical history. The patient's concomitant medications were not reported. On 30Jan2021, the patient experienced brief episodes of chest tightening, followed by spinal pain between shoulders. The patient did not received treatment for the event. The outcome of the events was not recovered.  The reporter assesses the events as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
This case was reported by a consumer and described the occurrence of rash in a female patient who received INFANRIX (batch number AC7AG, expiry date 17th October 2016) for prophylaxis. On 14th May 2015, the patient received INFANRIX. On 14th May 2015, less than a day after receiving INFANRIX, the patient experienced rash (serious criteria hospitalization). On an unknown date, the patient experienced skin warm (serious criteria hospitalization) and skin discoloration (serious criteria hospitalization). On an unknown date, the outcome of the rash, skin warm and skin discoloration were recovered/resolved. It was unknown if the reporter considered the rash, skin warm and skin discoloration to be related to INFANRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was taken to hospital on 15th May 2015. Less than a month after vaccination, the patient experienced warm spots that became bright. It took almost a month for spots to go away and every time she was outside or got real warm spots became bright. The photos of spots were taken on the day and on the next day of vaccination were provided by the reporter.
This spontaneous report as received from a patient's mother refers to a 14 year old patient with no pertinent medical history and no drug reactions/allergies. On 09-AUG-2013 and 11-OCT-2013 the patient was vaccinated with two doses of recalled lot of GARDASIL (lot # J007354, expiration date 20-FEB-2016), dose unspecified, intramuscular for prevention of HPV respectively. No concomitant medication was reported. On 11-OCT-2013, the patient experienced headache and swelling around the injection site after receiving the recalled GARDASIL. No lab diagnostics studies performed. The patient had no sought medical attention. Ibuprofen was given for headache, cold packs and heat were provided for swelling. Headache and swelling resolved within 48 hours. Additional information has been requested.
VACCINE GIVEN NEXT DAY AFTER TEMPERATURE EXCURSION FROM 46.2-46.7F FOR ABOUT 31 MINUTES; This spontaneous report received from a health care professional concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced vaccine given next day after temperature excursion from 46.2-46.7f for about 31 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine given next day after temperature excursion from 46.2-46.7f for about 31 minutes was not reported. This report was non-serious.