chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 6 months 11 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. All telephone attempts to obtain follow-up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
m.d. rpt after pt recv 2nd dose of vax pt exp a high fever of 103 to 104. pt sought unspecified medical attention
Oral temperature measured approximately 12 hours after injection was 100.6 F.  Normal temperature is about 98.0 F for patient. Experienced significant night sweating the night of the injection and the night after that. Medium headache also at that time.  First modern injection on 02/12/2021 produced no temperature elevation but produced mild headache.
got shingles after this shot; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (got shingles after this shot) 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 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (got shingles after this shot). At the time of the report, HERPES ZOSTER (got shingles after this shot) outcome was unknown.            No concomitant medications were reported.  The patient had to spend three months with a catheter and was reluctant to get the booster dose of the vaccine. The patient was concerned about having no protection and would like to know if the booster shot would still be effective if the patient got it now.
Swelling; Tender to touch; Achy when I raised my arm; Itching; delayed side effect; Rash/round rash about 3 by 4 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), TENDERNESS (Tender to touch), PAIN IN EXTREMITY (Achy when I raised my arm), RASH (Rash/round rash about 3 by 4 inches wide) and PRURITUS (Itching) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included CICLOSPORIN (RESTASIS) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling), TENDERNESS (Tender to touch), PAIN IN EXTREMITY (Achy when I raised my arm), RASH (Rash/round rash about 3 by 4 inches wide), PRURITUS (Itching) and SKIN REACTION (delayed side effect). At the time of the report, SWELLING (Swelling), TENDERNESS (Tender to touch), PAIN IN EXTREMITY (Achy when I raised my arm), RASH (Rash/round rash about 3 by 4 inches wide) and PRURITUS (Itching) had resolved and SKIN REACTION (delayed side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
FEELS LIKE A SHARD OF GLASS AT THE INJECTION SITE; DECREASED RANGE OF MOTION; CANT SLEEP ON THAT SIDE BECAUSE OF PAIN; MUSCLE WEAKNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced feels like a shard of glass at the injection site, decreased range of motion, muscle weakness, and cant sleep on that side because of pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feels like a shard of glass at the injection site, decreased range of motion, muscle weakness, and cant sleep on that side because of pain. This report was non-serious. This case, from the same reporter is linked to 20220316497.
Right arm began itching on Saturday, March 6, 2021, which is  11 days after the COVID shot.   During the night of March 6, right shoulder and upper right arm ached most of the night making it very difficult to sleep.  When I got up the morning of March 7, upper shoulder of right arm had a large red rash (about 4" in diameter) and another red rash (about 2" in diameter) was on my right arm just to the left of where the COVID shot was given.    The rash was very itchy and my upper right arm felt warm.    Applied hydrocortisone cream which slightly relieved the itching but not the redness.
A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a seven-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 25-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
General slight malaise/ Feels off; General slight malaise/ Feels off; Slight chills; Sore deltoid; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced general slight malaise, feels off, slight chills, sore deltoid on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Case number PHEH2015US016744, is a combined initial and follow-up spontaneous report from a patient (also health care professional) received on 26 Aug 2015. This report refers to a 25 years old male patient. Medical history was not reported. Concomitant medication included 5 HTP. His vaccination history included administration of first dose of RABAVERT (batch number: not reported) on 20 Aug 2015 after a bat was found in their home. The patient was inadvertently vaccinated only with the diluent as the second dose of RABAVERT (batch number: not reported) into deltoid muscle of right upper arm on 23 Aug 2015. The patient also received IG injection for the post exposure. The patient experienced immediate pain with the injection in his deltoid muscle and felt faint after the injection. The patient recovered from felt faint on the same day. On 26 Aug 2015 morning the patient noticed mild discomfort at the injection site of his right upper arm. The patient did receive the actual vaccine for the second dose but that was administered in left thigh. Outcome of the events pain and discomfort at the injection site was reported as not recovered. Seriousness and causality of the events were not reported.
Fever of 100 F and lasted about 36 hours.  Sore joints along with flu like symptoms.  No treatment taken.
Injection site pain level 7 to 8 about 6 hours after injection; Very tired and sleepy 4 hours after injection; Very tired and sleepy 4 hours after injection; This is a spontaneous report from a  contactable healthcare professional.  A 54-year-old male patient received first dose of BNT162B2 (lot number: Ek5730), intramuscularly at the right arm, on 19Dec2020 09:00 at a single dose for COVID-19 immunization at a public health clinic/veterans administration facility. Medical history included continuous positive airway pressure (CPAP), high cholesterol, and high blood pressure (BP). Patient has no known allergy. The patient was no previously diagnosed with COVID-19 not was tested for it. Also the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included atorvastatin calcium (LIPITOR). The patient was very tired and sleepy 4 hours after injection on 19Dec2020 13:00 and experienced injection site pain level 7 to 8 about 6 hours after injection on the same day of 19Dec2020, 15:00. Therapeutic measures were taken as a result of injection site pain which included acetaminophen (TYLENOL). The patient recovered from the event injection site pain by the next day of 20Dec2020 and from the event tired and sleepy after a nap on the same day of 19Dec2020.
Congestive Heart Failure Shortly After Booster 3/20 Seizure 10/20/21 AtrialFlutters 10/26/21 Died 10/28/21
No adverse event; child recived the bivalent booster dose instead of the monovalent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (child recived the bivalent booster dose instead of the monovalent dose) and NO ADVERSE EVENT (No adverse event) in a 9-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 09-Dec-2022, the patient experienced INCORRECT DOSE ADMINISTERED (child recived the bivalent booster dose instead of the monovalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (child recived the bivalent booster dose instead of the monovalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (child recived the bivalent booster dose instead of the monovalent dose).    No relevant concomitant medications were reported.  No other adverse reactions are reported. No treatment information was provided.
Extreme itching all over for a day or so. After 2 days a hive like rash broke out and was especially itchy for 4-5 days on my jawline, ears, shoulders & chest, especially my left shoulder & upper arm. I had a reaction to the flu shot in the past, so I had purchased benadryl and took 2-4 pills daily  for 7 days. As itching was getting better, I had a scaly rash where the hive like rash had been.  Today is day 8 and I am almost back to normal.
Bullous drug eruption large fluid filled blisters in 1 arm. Dr gave valcyclovir and prednisone.
the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 08-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Patient received second dose of COVID Moderna <6 vaccine on 8/10/22 at 11:00 am. Parents noticed patient started to get very fussy that evening, parent went in to check on patient around 1:00 am on 8/11/22, patient was extremely warm so they went to give tylenol and when they did the patient's head went back and his arms and legs shook for 1-2 minutes. Went to the ED and patient was diagnosed with febrile seizure.
Case number PHEH2015US022798, is an initial spontaneous report from a health care professional received on 04 Nov 2015. This report refers to a 36 years old female patient. Medical history and concomitant medications were unknown. The patient was vaccinated with FLUVIRIN (batch number: 158204) at a dose of 0.5 ml intramuscularly on 02 Nov 2015. It was reported that the patient received vaccine that had been stored at 8.2 degrees Fahrenheit overnight before administration. The case was assessed as non-serious. No adverse event was reported following this maladministration.
Patient stated about 7 days had right arm soreness, with redness and rash on arms, face and stomach. Rash subsided but had "painful walking", "bottom of feet hurt", soreness of joints in neck, knees, arms and swelling of hands. Stated joints are better now but hands sore and swollen some. Encouraged patient to see doctor. Reported no medication on date of consult.
He came home that night and had sore arm and he was flushed in the face; He came home that night and had sore arm and he was flushed in the face; This is a spontaneous report from a contactable consumer.  A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: ER2631; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 at 09:30 as 1st dose, single dose for COVID-19 immunization.Medical history included intervertebral disc protrusion (Back and neck herniated) from 2014, ligament injury (2 knees going out, 2 surgeries by scope on both knees) from 2012  , knee operation (2 knees going out, 2 surgeries by scope on both knees) in 2012 , rotator cuff syndrome (Rotator cuffs left and right) from 2016 , wrist surgery(Bicep and left wrist surgery) in 2000  , surgery (Bicep and left wrist surgery) in 2000 , ongoing blood pressure measurement (Had for 5 years). Concomitant medications received within 2 weeks of vaccination included tramadol (TRAMADOL) 50mg  taken for ligament injury, intervertebral disc protrusion, rotator cuff repair  taking from over 10 years and losartan (LOSARTAN) 100-12.5mg taken for blood pressure measurement from 5 years.It was unknown Since the vaccination, if patient has been tested for COVID-19. It was unknown if patient was diagnosed with COVID-19.Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient underwent lab tests and procedures which included on 14May2021, blood test seem to be fine ,chest x-ray,magnetic resonance imaging and electrocardiogram were negative, on 22May2021blood test seem to be fine, on 22May2021 electrocardiogram was negative and  SARS-CoV-2 antibody test was negative.  On 18Mar2021, patient experienced sore arm and flushed face. It was reported that patient came home that night and had sore arm and he was flushed in the face. The outcome of event sore arm resolved in 2021 and out of flushed face was resolving.  Information on Lot/Batch number was available. Additional information has been requested.
Chills and cold sweats the night after receiving the vaccine. Next day had fatigue and soreness in the left shoulder. Also had swollen lymph nodes under my left armpit which led to an inflamed lump there.
C/O feeling hot heart racing flushed, dry mouth, nausea vital signs monitored, condition improved and sent home
Vaccine was on Wednesday 1/27/21 at 8:30.   Felt a little off and sore arm during the day Wednesday.  Started with some body ache during night ( approximately 13:30 a.m.) at sleep.  Woke up at 5 a.m. with fatigue, significant nausea and a headache.  Unable to go into work. Headache improved by mid day.  The fatigue and nausea continued and gradually decreased, lasted until laterThursday evening.     Returned to work at 6:30 a.m. on Friday.
Vaccine administered at 2:10 pm on 1/6/2021. Patient immediately stated that she "feels warm all over", then states that "I am having an allergic reaction". Emergency protocol initiated immediately, 911/EMS called. Patient heart rate in the 140's-150's. Patient refused epipen at this time due to no SOB. EMS arrived and patient states "I feel better". Patient refused transport to hospital and instead opted for calling her husband to come and get her. EMS waited with patient for approximately 15-20 minutes to ensure improvement.  Patient monitored for next 45 minutes-60 minutes until husband arrived. Continued to improve. Left with husband.
Hot, red arm. Lethargy -> bed-ridden. Fever. E.R. visit, overnight stay. High WBC needed IV fluids, morphine.
Information has been received from a registered nurse concerning her 21 year old daughter, with no allergies and no medical history, who on 11/30/98 was vaccinated with a third dose of MMR (lot # 619344/0100E). The patient had previously been vaccinated with the first dose of MMR on 6/12/84 (lot # not reported) and with the second dose on 11/13/96 (lot # reported as FKF0619B). It was noted that the patient had no other vaccinations on any of the days when these three doses were given. There were no concomitant medications. Subsequently, five years after the third dose of vaccine, the patient had a negative titer to MMR. Laboratory evaluation on 5/27/04 revealed MMR antibody IgG was negative. Unspecified medical attention was sought. No treatment was required. Additional information is expected.
Employee stated that several hours after injection the site was reddened raised and sore. She stated that she took Ibuprofen and BENADRYL and had a face time visit with her CRNP, who told her this was a common reaction. The employee stated that the site improved over 3-4 days without treatment. No drainage or purulence reported from site.
No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 27-JUN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Fever, fogginess, swollen lymph nodes, severe headache, sharp shooting pains all through body, swollen left arm.
TRIGGER FINGER OF RIGHT MIDDLE FINGER.LEFT MIDDLE FINGER AND RIGHT POINTER FINGER; RIGHT MENISCUS WAS NOT OK; SWELLING IN THE KNEES; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: unknown) dose was not reported, 1 total, at left arm administered on OCT-2021 for prophylactic vaccination. The batch no was not reported and has been requested No concomitant medications were reported.  On an unspecified date, since he received the shot in OCT-2021, the patient experienced swelling in his knees. The patient underwent MRI and X-Ray knees and his doctor mentioned that his right meniscus was not ok, and may need surgery too. On an unspecified date in early in NOV-2021, the patient experienced his tendon getting tight, trigger on the middle finger of the right hand and started to have difficulty with the mobility of the middle finger of his right hand. His finger would get stuck in a bent position from time. He received cortisone as a treatment to help with his condition. On an unspecified date, a few months after, in MAR-2022, The patient also experienced trigger in the middle finger of the left hand. On an unspecified date, in APR-2022, he had to do surgery as cortisone treatment was not really effective. His doctor had to make an incision in both of his fingers and cut a sleeve of his tendon to help to recover the mobility of his fingers. On an unspecified date, in the beginning of May-2022, the patient experienced trigger in the pointer finger of the right hand. Laboratory data (dates unspecified) included: MRI (Magnetic resonance imaging) and X-ray shows right meniscus was not ok. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the trigger finger of right middle finger, left middle finger and right pointer finger, right meniscus was not ok and swelling in the knees was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220627447 -Covid-19 vaccine ad26.cov2.-Trigger finger of right middle finger, left middle finger and right pointer finger. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Approximately 45-50 minutes after vaccine administration, parent brought client back to clinic with compaints of itching and "bumps" present.  At 3:12pm presented with red whelps over trunk and upper arms.  Upon assessment of vital signs she began to complain of tongue tingling and inspiratory wheezing auscultated by RN.  Client also complained of throat hurting.  EMS summoned.  Treatment while awaiting for EMS to arrive:  At 3:14pm: Epi (1:1000)0.3cc SQ followed by diphendydramine (50mg) 1cc IM at 3:15pm.  Received in ER for observation.  Vs stable.  Given Prednisone 50 mg orally.  Observed for 2 hours.  Reaction resolved.  No recurrence of symptoms.  Discharged with referral to Asthma and Allergy for testing.
On 11/3/2021, Medical assistant administered incorrect vaccine type-dose.  Patient received incorrect vaccine type-dose for his age.  Patient was to receive Covid-19 Pfizer Pediatric dose (0.2ml)  and instead received the wrong dose of Covid-19 Pfizer dose for 12 years old and up. RN followed up with parents and they voiced understanding of the error during vaccine administration and reported patient was doing well.   They agreed to monitor child for any side effect and call us to report concern.