chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Passed one stone that week on Saturday after shot; Fever was almost 102degF; Woke up at 5am with chills; Normally sore in my right arm/all the way down to right elbow; Extreme pain in right kidney; Extreme back pain between my shoulder blade; A spontaneous report was received from a consumer concerning a 64-years-old female patient (weight: 240 lbs.), who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore in my right arm, all the way down to right elbow/pain in extremity, chills, extreme back pain between my shoulder blade/back pain, extreme pain in right kidney/renal pain, passed one stone/nephrolithiasis, fever was almost 102degF/pyrexia.   The patient's medical history was not reported. Products that have been known to be used by the patient were not reported.   The patient received the first of planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection on an unknown date. On 04 Mar 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 010A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 04 Mar 2021, the patient experienced soreness in my right arm, next day at 5 am with chills, extreme pain in right kidney and fever was almost 102-degree F. On unknown Saturday, the patient passed one stone. The patient also experienced extreme back pain between shoulder blade and all the way down to right elbow. Treatment information was provided as ice packs, heating pads, pain killers.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events were considered as unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Strong Atrial Fibrillation/ pressure in chest (2/27/2021 at 10:00 PM) event followed by shorter intermittent for a few days, shortness of breath,  fatigue, chills, cold extremities and overall body temp feeling throughout the day for the same time-line (3-4 days following the injection).  7 days after the injection 3/4/2021 Deep pressure under left under arm and injection site inflamed into a hard mass which dissipated into a spherical rash 3 cm below the injection site.  Pain under arm dissipated within 24 hours.  Rash took a few days.
This spontaneous report was received from a registered nurse and refers to a 4 month old patient. The patient's concurrent conditions or medical history were not reported. Concomitant therapies included PREVNAR. On 07-FEB-2017, the patient inadvertently received a dose of PROQUAD subcutaneous injection (lot M029599, expiration date 12-OCT-2017) instead of PENTACEL. The nurse confirmed this event was not related to product confusion but was due to a human error. No further details were provided. Additional information has been requested.
Giving my first monkeypox vaccine to Lab staff as PEP and because the guidance stated deltoid I believed it was an intramuscular injection and gave it IM, however the next day realized dose should have been given SQ.  Incorrect administration error.  No adverse reactions reported by staff member.
ran fever around 24 hrs; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (ran fever around 24 hrs) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 1. On an unknown date, the patient experienced PYREXIA (ran fever around 24 hrs). At the time of the report, PYREXIA (ran fever around 24 hrs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Student was sitting on bench in hall of clinic and fell forward off bench onto floor hitting Left forehead and top lip of mouth on the floor.  Observed student having seizure activity with bilateral pupils dilated with fixed gaze down and to the right for approximately 30-60 seconds.  Student vital signs at 09:55 AM were BP 111/64, Pulse 57, Temp 98.5 orally with PERL with Right eye sluggish response to light and dilated 3mm.  At 10:15 AM BP 105/63 Pulse 66 Temp 98.8 orally with both eyes PEARL and pupil dilated at 2mm.  At 10:30 AM BP 100/62 Pulse 63 Temp 99.5 orally Respirations 16.  Student stated he felt much better, had normal pallor and was released to complete our new student Intake Processes.  Of Note: student had also had blood drawn approximately 20 minutes prior to receiving immunizations in which student had started to pass out, but was given juice to drink and allowed to lie on exam table for about 5-10 minutes at which time the student stated he felt much better and had normal pallor.
Report obtained from client's mother.  Mother states she received a telephone call from her sister, client's aunt, the morning of 10/24/09 stating patient had "hives on his trunk, back, face, under his eyes".  He was "scratching all over" but did not have a temperature and was playing while scratching.  The hives were raised, running together, not an individual rash, not warm to touch.  No medication was given.  He did not have any shortness of breath, and the aunt was not concerned because he continued to play.  Earlier that AM he had vomited after eating breakfast.  He continued to scratch but did not complain of pain.  Late Saturday night, he was given a bath and lotion was applied. He slept throughout the night.  Sunday morning the rash remained, but had not gotten worse, he continued to have some itching but continued to play.  The mother was home from work with him on Sunday and states by 10-11 PM the rash had disappeared.  He went to school on Monday, October 26.  Mother states following school on 10/26, he did not look well, looked "drained" but said he was OK, although other parents noticed he was not as active as usual.  Tuesday, October 27, temp. was taken, 99.4, he vomited after breakfast and was coughing.  Kept him home from school, administered Tylenol. Continued to play and eat as normal on Tuesday.  By Wednesday, 10/28 he was "OK".
FEVER; MUSCLE ACHES; NAUSEA; CHILLS; This spontaneous report received from a parent concerned a 23 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, intramuscular, batch number: Unknown) .5 ml, administered on 09-MAR-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced muscle aches. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.4 F, 102 F. On 10-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F, 100 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and chills on 10-MAR-2021, and had not recovered from fever, and muscle aches. This report was non-serious.
Extreme raised rash on torso, under arms and part of neck.  Took Benadryl first day but with minimum relief.  Went to urgent care and received prescription for prednisone.
Pt spiked a fever of 102.2.  Treated with fluids, apap, ibuprofen.  Pt received vaccine @ roughly 1100, I believe he stated fever started around 1500.  When reported the next afternoon, his fever had subsided down to 99.
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose, route, lot # and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
vomiting; Injection site redness; delirious; oral intake reduced; mobility decreased; sweating; fever; This spontaneous case was reported by a physician and describes the occurrence of DELIRIUM (delirious) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Smoker (Former cigarette smoker) from 1970 to 1996. Concurrent medical conditions included Shellfish allergy (Hives), Allergy to antibiotic (Doxycycline- skin eruption) and Rheumatoid arthritis. Concomitant products included RISEDRONATE SODIUM (RISEDRONATE) for Bone disorder NOS, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Pain.   In November 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 12-Mar-2021, the patient experienced DELIRIUM (delirious) (seriousness criterion medically significant), HYPOPHAGIA (oral intake reduced), MOBILITY DECREASED (mobility decreased), HYPERHIDROSIS (sweating), PYREXIA (fever) and INJECTION SITE ERYTHEMA (Injection site redness). On 14-Mar-2021, the patient experienced VOMITING (vomiting). On 14-Mar-2021, DELIRIUM (delirious), HYPOPHAGIA (oral intake reduced), MOBILITY DECREASED (mobility decreased), HYPERHIDROSIS (sweating), PYREXIA (fever), VOMITING (vomiting) and INJECTION SITE ERYTHEMA (Injection site redness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pain in arm that vacccine was administered immediately after injection. Pain continued for three weeks and is now being treated by PCP
Pt reports headache, vomiting for 3 hours, fever, chills, bodyaches.
On 10/13 arm and shoulder area was sore, 2 knots appeared on the neck. Took Tylenol. Visited ER; was prescribed Ibuprofen 800.
Started having pain in my spine as well as a Migraine and severe joint pain in the rest of my body. Took a home COVID-19 test and was positive. Went to doctor the next day for a PCR COVID-19 test and was positive. Advised to monitor my blood pressure and was recommended to take over the counter cold and flu medicine, and antihistamine and saline wash nasal spray. Two days later I started having PVC Heart Palpitations and blood pressure was high. Went to the Emergency Room and was given an EKG, then was sent home because I tested positive for COVID-19. Was advised to take TYLENOL.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting,  Fatigue, Chills. Flu-Like Symptoms Narrative:
patient reported low fever, nausea, fatigue and didn't  get out of bed for 3 days (til Thursday).  Her arm hurt but was not swollen
SWELLING IN UPPER ARM AND BEND OF  ARM AND A LITTLE ITCHING.
Patient did not experience adverse events. They had previously been vaccinated with the Moderna vaccine (lot 025A21A) on 3/16/21. He did receive the Pfizer vaccine on 4/13. The pharmacy and the patient did not realize the mistake until the afternoon of 4/28/21 when the patient was looking at their COVID vaccination card.
REACTION/MODERNA BOOSTER VACCINE CAUSED PLAQUES TO GET WORSE; PLAQUE PSORIASIS FLARE UP ON FEET, HANDS AND SCALP; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (REACTION/MODERNA BOOSTER VACCINE CAUSED PLAQUES TO GET WORSE) and PSORIASIS (PLAQUE PSORIASIS FLARE UP ON FEET, HANDS AND SCALP) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2022, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced VACCINATION COMPLICATION (REACTION/MODERNA BOOSTER VACCINE CAUSED PLAQUES TO GET WORSE) and PSORIASIS (PLAQUE PSORIASIS FLARE UP ON FEET, HANDS AND SCALP). At the time of the report, VACCINATION COMPLICATION (REACTION/MODERNA BOOSTER VACCINE CAUSED PLAQUES TO GET WORSE) and PSORIASIS (PLAQUE PSORIASIS FLARE UP ON FEET, HANDS AND SCALP) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   The patient had moderna booster vaccine and which caused plaques to get worse.  No treatment information was provided.  The reporter's causality for the event of reaction/moderna booster vaccine caused plaques to get worse with Skyrizi (Risankizumab) was no reasonable possibility.   The reporter's causality for the event of plaque psoriasis flare up on feet, hands and scalp with Skyrizi (Risankizumab) was a reasonable possibility.
Symptoms: tongue numbness, mild SOB, throat itching Treatment: Epi pen and EMS called Time: started about 30 min after injection lasted about 15-20 min after epi
10 MINUTES POST VACCINIATION, PT.C/O NAUSEA, CHEST PAIN, TINGLING IN ARMS. NO LOSS OF CONSCIOUSNESS. VITALS TAKEN, ICE APPLIED TO NECK, RESCUE CALLED. PATIENT TO HOSPITAL BY AMBULANCE. ALERT AND RESPONSIVE, ORIENTED X 3.
Some redness, pain and swelling at injection site. Counseled to use ibuprofen or acetaminophen for pain, BENADRYL or loratadine for any itching and hydrocortisone topically.
Information has been received from a third party claims administrator concerning a female (unknown age). On 20-DEC-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml (lot # J006831 expiration 14-SEP-2014). It was reported that the patient sustained the shingles condition and as a result of this her right leg was amputated. At the time of this report the patient's outcome is unknown. Upon internal review right leg amputated was determined to be a significant medical event. Additional information has been requested.
Guillain Barre syndrome, paralysis, extreme tingling/ pain   still present after 6 months
1.5 hours after Pneumovax vaccine, pt developed chest pain, shortness of breath, tightness in chest.  Pt is asthmatic he took 2 puffs on Albuterol inhaler and started breathing easier.  Then went to ER and was given SC Epi 1/1000 0.4cc and rest symptoms resolved.
first dose in March 2019, second dose in January 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number T29Y2, expiry date 8th April 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2019).   In January 2022, the patient received the 2nd dose of Shingrix. In January 2022, unknown after receiving Shingrix, 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.   Additional Information: GSK Receipt Date: 07-Apr-2022 Reporter's Comments: The patient received second dose of Shingrix in January 2022 and wanted to know if the patient needed a 3rd dose or how to proceed in this situation. The reporter consented to follow up via fax. Additional Supportive Information: The patient received delayed second dose of Shingrix, which led to lengthening of vaccination schedule.
Terrible chills; Abdominal pain, across the whole part, just terrible abdominal pain; Joint pain; Muscle aches all over me, I never had that bad pain before and then all my muscles hurt; I had tiredness, very tired and it lasted for about a day; Headache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6202, Expiration Date: Unknown), via an unspecified route of administration, administered in right arm on 27Feb2021 (at the age of 69 years) as dose number unknown, single for covid-19 immunisation. Medical history included ongoing blood pressure . Concomitant medications included some blood pressure medications. He does not have that information with him. Patient called to report some of the side effects for the Covid-19 vaccine Pfizer. On an unspecified date, the patient stated chills, terrible chills and abdominal pain, across the whole part, just terrible abdominal pain and then he had joint pain and muscle aches all over him. He never had that bad pain before and then all his muscles hurt. He had tiredness, very tired and it lasted for about a day. He just took a Motrin or Ibuprofen about, it was (sentence incomplete, pending for clarification), he got a little bit of a headache, the next day and he took Motrin and that was about fifteen hours later. Outcome of the events are unknown.  No follow-up attempts are possible. No further information is expected.
COPD exacerbation; This is a spontaneous report received from contactable reporter(s) (Nurse).  An 84-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 83 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1:, Time: 15:45, Anatomical site of injection: Left Arm, Route of administration: Intramuscular , Batch Lot number: EL3302), administration date: 22Jan2021, when the patient was 83-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2:, Time: 15:45, Anatomical site of injection: Left Arm, Route of administration: Intramuscular , Batch Lot number: EL9261), administration date: 12Feb2021, when the patient was 83-year-old, for Covid-19 Immunization. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious) with onset 26Sep2022, outcome "recovered" (01Nov2022), described as "COPD exacerbation". Therapeutic measures were taken as a result of chronic obstructive pulmonary disease which included oral prednisone.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026423 same patient/vaccine, different dose and event;
Was at a birthday party felt warm to touch,  Hour later in car mom noted a rolling back of eye and tonic movement of arms x < 1 minute.  Went to ER and they eval him.  Gave Tylenol and took a CXRAY and U Cx both neg.  Gen well.
Leg pain. I came home and went to bed because I wasn't feeling good. I was very lethargic for 2 days afterward. Slight nausea, but nothing major.
Received flumist as directed to each nare on 10/23/09. 2-3- hours later began to have severe itching & flushed feeling. Next day had hives.
The morning following vaccination: Fever, chills, extreme exhaustion, migraine.  Lasting two days.   Second day following vaccination: Lump at injection site and rash around it.  Still present. Five days following vaccination: Blood in urine.  Have not had a period in 11 months, and blood only shows in the toilet, none on pad.
Injection site was left shoulder high and to the back of shoulder. Patient reported discomfort immediately. The next day he complained of severe pain with inability to move/lift his are. He was given a steroid dose pack along with ibuprofen. He had already started Tylenol/Codeine for back pain. Pain diminished within a few days but then resumed once the steroid was discontinued. 11/28 he called to complain of more pain and the feeling of "locking up". He will be seen in the office on 12/1 for exam and to discuss next options.
I was woken up at 01:30am in extreme pain; Sharp pain in the left side chest wall muscle; Difficult to breathe normally without significant pain; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 10May2021 as 2ND DOSE, SINGLE for Covid-19 immunisation. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on unspecified date as first dose, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14May2021 the patient went to lay down then suddenly, the patient got sharp pain in the left side of the chest wall muscle, the patient found it difficult to breathe normally without significant pain. The patient had applied heat, balms, icy hot as corrective therapy. Last night the patient was woken up at 01:30 in extreme pain, the muscle pain was so sharp and debilitating, the patient seriously thought of calling 911. The outcome of the events was unknown.  Information about the Lot/batch number has been requested.