chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a 21 year old female with a penicillin allergy and no medical history who on 14-OCT-2008 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 661046/0546X), intramuscularly in the deltoid.  There was no concomitant medication.  After received the vaccine the patient experienced a rash on her back that lasted for 2.5 weeks.  There were no laboratory studies performed.  Follow up information received on 18-DEC-2008 at 13:00 stated that "the patient was actually in the office about to get the second of GARDASIL and reported that after the first dose she developed a welt in the area of the bra strap at the cup part of the bra". Follow up information received on 16_JAN-2009 stated that the patient complained of a wheal within 2 to 3 hours after her second dose of Gardisil. The rash area was only by her bra strap scan. A third dose of Gardisil was given and the patient had no reaction at all. Her problem was likely related to the garment and not Gardisil.  Additional information indicated the patient's rash had nothing to do with the vaccine. No further information is available.
A few days after shot, patient complains of tingling from shoulder down to fingers and any pressure on his hand makes it worse. This is the same arm the shot was given in (left arm only).
Information was received on 06-APR-2017 from a certified nursing assistant concerning a patient of unknown age and gender. No medical history or concomitant medications were reported. On 25-JAN-2017, the patient received a dose of ROTATEQ (lot M026315, expiry unknown)(dose not reported) orally for prophylaxis. On 05-APR-2017 the patient received a second dose of  ROTARIX (Lot 4Ra2T, expiration not reported)(dose not reported) orally for prophylaxis. No other information was provided. No adverse effects were reported. Additional information has been requested.
SLIGHT SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown 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 subject experienced slight sore arm. The action taken with covid-19 vaccine  was not applicable. The patient recovered from slight sore arm. This report was non-serious.
Child ran a low grade temp T max 101 degrees the day after given the shot. Baseball sized noticed bump.
Headache; Chest tightness; Cough; Difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 11:30 (Batch/Lot Number: EL8982) (at the age of 79-year-old) as 1st dose, single for covid-19 immunization. Medical history included latex allergy and A-Fib. Concomitant medication(s) included apixaban (ELIQUIS) and metoprolol (MANUFACTURER UNKNOWN) both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Jan2021 08:00, the patient experienced headache, chest tightness, cough and difficulty breathing within 24-36 hours. No treatment was given for the events. The outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 16Apr2021 as dose 2, single (Lot number: ER8731), in left arm and on 17Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". Therapeutic measures Paxlovid were taken as a result of vaccination failure, covid-19. Patient started Paxlovid on 01Aug2022.
Pt called clinic to report that she had a hard raised area around where needle was inserted in her arm with red streaks extending to her elbow.  Pt was advised to take Benadryl and put ice packs on the area and if not better in a couple of days to return to the clinic for revaluation.  Advised to go to the ER if she has trouble breathing or if rash develops.
flu like symptoms; fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms and fatigue. On an unknown date, the outcome of the influenza-like symptoms and fatigue were unknown.   It was unknown if the reporter considered the influenza-like symptoms and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The pharmacist noted the patient had flu like symptoms consisting of fatigue. The pharmacist did not wish to provide greater detail for patient number as she was busy and in a hurry.  I am reporting what she said with no elaboration. The pharmacist did not wish to provide greater detail for patient number as she was busy and in a hurry.  The reporter gave consent to follow up. This case is linked to case US2019111392, reported by same reporter.
Macular papular rash on torso, face and extremities that evolved to plaques and patches, erythematous but not pruritic. No other symptoms. Mostly residual rash after prednisolone.
-Recurrence of IBS symptoms. Had not had in over 20 years. Lasted about three weeks. -Severe body pains.  Have lessened -Migraines.  Ongoing; periodic. -Dizziness.  Has lessened. -Joint pain.   Has lessened. -Heart Palpitations.  Ongoing.  Periodic. -Mood affected.  Ongoing. Periodic. -Ovary pain.  Ongoing.  Periodic. -Breast pain.  Ongoing.  Periodic. -Muscle spasms.  Have lessened. -Worsened tinnitus.  Ongoing. -Chest wall soreness.  Has lessened.
Starting on July 1, 2021 I had my period about 20 days after my last period then another period starting 12days after this one. I had 3 months of having my period every 2 weeks. I had a normal period in September and then in October I started having periods again every 2 weeks. Then I missed a period in November. Normal period in December. Then I had a period that lasted a month a half straight. So then I started taking birth control in mid February and since then it has been more controlled. On April 10, 2022 I passed decidual cast.
patient had received Johnson & Johnson Covid Vaccine on 4/2/21. Patient thought she needed to return for 2nd vaccine. When she returned on 4/26 and was asked if she had received a previous covid vaccine she replied "NO" and was vaccinated a 2nd time with Moderna Covid vaccine. No sypmtoms were reported after she received the Moderna vaccine. Patient's PCP noted the error and confirmed patient does get confused and is dx with schizophrenia
pt devel acute loss of vision 2wk p/vax;on exam had bilat disk edema & could only perceive light in rt eye;could count fingers @ one foot w/lt eye;MRI negative, bloo cell count & chem unremarkable;dx bilat optic neuritis;optic disk pallor;
Was monitored for 15 minutes with no symptoms. On my way home around 810 my left arm felt numb with some tingling to my left hand. By the time I got home it was about 830 and my left lower face and jaw felt numb and a little off. My face was still symmetrical and it was just in the lower left area of my mouth and jaw region. I took Tylenol and when I woke up my face felt normal. Since then occasionally I still feel tingling in my left hand.
Fever, nausea, body aches, myalgia, shaking x 12 hours
The patient's wife called the pharmacy and said that the patient was cold and sweaty then his erectile dysfunction became worse about 10 hours after being vaccinated.  She was concerned about these effects due to reading something on the Internet and was adamant about the Pharmacist reporting this to VAERS.
presumptive Cellulitis; Initial information received on 08-Aug-2022 regarding an unsolicited valid  serious case received from a physician.  This case is linked to 2022SA318109.  This case involves a 2 years old patient of an unknown gender who had presumptive cellulitis after receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.25 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE , with an unknown formulation and strength, (frequency: once) (lot : C5816AA ; expiry date: not reported) in an unknown administration site for immunization. or TB skin test (tuberculin test).  On an unknown date the patient had presumptive cellulitis (cellulitis) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  It was reported that 3 kids received the suspect vaccine and 2 out of the 3 were started on antibiotics for presumptive cellulitis. All three kids were doing better.   Action taken : not applicable.  Corrective treatment: antibiotics for cellulitis  At time of reporting, the outcome was Recovering for the event presumptive cellulitis.; Sender's Comments: Sanofi company comment date 09-Aug-2022: This case involves a 2 year old patient of an unknown gender who had presumptive cellulitis after receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. Other medication, current illness, preexisting conditions and allergies were not reported. Also,  the time to onset of event and latency is not provided to assess the role of the vaccine. Further information such as circumstances leading to and patient's health status directly preceding the reported event and the results of investigations to research an alternative etiology such as infectious check-up is missing to fully assess the case
Next day post vax, the pt woke up with a severe headache; went to school and got chills. Her temperature was normal, but later at 3:00 pm it was rechecked and it was 101. She took Advil and three hours later took Tylenol and three hour after that took Advil again. She woke up the next day feeling fine.
Initially had soreness around site of injection, but as that wore off I continued to have considerable shoulder pain, especially related to lateral movement. Have now participated in PT for approximately 2 months without improvement. Have been given a dx of rotator cuff syndrome.
Heart racing, jittery, odd tasting post nasal drip, teeth feel tingly, fatigue.
Started to feel feverish and had chills, severe headache, neck pain and generalized joint pain.  Symptoms partially subsided at 48hours post-vaccine, but feverish spells and headaches continued to occur randomly over next several weeks.  Wrist and hand pain did not subside and seemed to worsen over several months until hand pain(throbbing, aching, burning)  was waking me up at night. Saw primary doctor who referred me to rheumatologist.  Received diagnosis of post-vaccine arthritis and Sjogren's syndrome. Started taking hydroxychloroquine today and more tests to be done in January to rule out other autoimmune issues.
I have been experiencing vertigo, dizziness, pressure in head, headaches, nausea, pressure, ringing, popping, cracking in ears post Covid vaccine and booster.
Lousy feeling; Lethargic; Sore arm; Sensitive scalp; Sharp tingling; Raised blisters / Scalp blisters; Shingles; Jaw pain; Head pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 23rd September 2019, the patient received the 1st dose of Shingrix. On 2nd October 2019, 9 days after receiving Shingrix, the patient experienced jaw pain and headache. On 8th October 2019, the patient experienced shingles, increased skin sensitivity, tingling and scalp blister. On an unknown date, the patient experienced feeling bad, lethargy and pain in arm. On an unknown date, the outcome of the shingles, feeling bad, lethargy, pain in arm, jaw pain, headache, increased skin sensitivity, tingling and scalp blister were unknown.   It was unknown if the reporter considered the shingles, feeling bad, lethargy, pain in arm, jaw pain, headache, increased skin sensitivity, tingling and scalp blister to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine in left arm. The patient had shingles before. Less than 3 weeks after vaccination, the patient had feeling lousy the first few days, reporting lethargic, and sore arm.  The patient doing better but then he began to experienced head and jaw pain last wednesday from day of reporting.  His scalp was sensitive and he had a sharp tingling with raised blisters on day of reporting on his head. 15 days after vaccination, the patient was diagnosed with shingles at the immediate care facility. The emergency room visit was required. The reporter consent to follow up. This case is 1 of the 2 linked cases, reported by the same reporter.
Stomach ache around 11pm and projectile vomiting multiple times around 3am. Heavy breathing.
Patient was given booster dose of Moderna Bivalent when they supposed to receive the initial dose of Moderna. No adverse reaction. Patient is going to start the Moderna series  per CDC ASAP. Patient was observed in the office for 15 minutes. patient is notified of the error, according to CDC guidlines, she was advised to start primary series with either Moderna or Pfizer immediately but she can wait a few weeks if she prefers. Patient voiced understanding
blisters on her thigh which spread out to her arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (blisters on her thigh which spread out to her arms and legs) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced BLISTER (blisters on her thigh which spread out to her arms and legs). At the time of the report, BLISTER (blisters on her thigh which spread out to her arms and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received Janssen vaccine on 4/7/21. Started having symptoms approx Labor Day weekend (9/4/21). Started with chills and malaise and progressed over the next few days with cough, runny nose, mild SOB, and fatigue. Presented to ED 9/7, COVID PCR via NP was sampled 9/7 and positive 9/8, transferred to Hospital for admit to IMC unit on 9/8/21. Remains in hospital at time of submission with primary diagnosis of acute hypoxic respiratory failure secondary to COVID pneumonia.
Headache, Arthralgia, NauseaVomiting, chills, fatigue, injection site pain/arm pain Narrative:  Other Relevant History:
Swelling and redness at site of injection 9" long x 7" (around arm).
Sick; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Nov-2021 and was forwarded to Moderna on 29-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Sick) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MYCOPHENOLATE MOFETIL for Heart transplant.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Sick). At the time of the report, VACCINATION COMPLICATION (Sick) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment drugs were reported.
Pt.'s Wife states that after Pt. received the 2nd dose of Moderna 02/18/2021, started experiencing symptoms 03/2021 of Fluid on the Brain, 05/2021 Hematoma (Left Side). * Resulting in 3 Brain Surgeries.
administered the second dose of Moderna COVID-19 vaccine from a vial that have been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the second dose of Moderna COVID-19 vaccine from a vial that have been punctured for more than 12 hours) in a 36-year-old female patient who received mRNA-1273 (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the second dose of Moderna COVID-19 vaccine from a vial that have been punctured for more than 12 hours). On 30-Apr-2021, EXPIRED PRODUCT ADMINISTERED (administered the second dose of Moderna COVID-19 vaccine from a vial that have been punctured for more than 12 hours) had resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs and treatment medications were reported.
"Covid arm". Developed a red irritated lesion around the injection site about 6 days after vaccination. Approx. 1" x 2"
No adverse events reported at this time. Patient will receive bivalent vaccine in 2 months.
Pt vaccinated with DTP 65-70% of pt immunized with this lot # 259958 developed lumps in the thigh. Vaccine will not mix properly.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 12-JAN-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K006682 with expiration date 17-DEC-2015; dosage and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
asymptomatic, tested positive on binax rapid antigen test done as follow up to known covid exposure- is up to date with covid vax-  has had 4 doses of pfizer (completed initial series plus 2 boosters) and pfizer bivalent booster listed above
flu like  reaction hot fever/temp- 2 days hands and soles of feet, red, flushed, hot loss of appetite- 1 day drained feeling, tired and sleepy- 2 days coughing-2 days night sweats-1 day
Approximately 38 hours after injection, I woke up with severe pain in my left shoulder and up the neck.  Pain is mostly at night in the neck, shoulder, and upper arm.  I also have weakness in my arm and some loss of range of motion.  I am currently working with facility to schedule an evaluation with a physician.
Moderate to severe pain and feeling of blacking out/fainting with nausea morning after. Fever the night of. Stayed in bed and rested.Fell good today just a little sore so do not have full use of arm without.
9AUG98 pt awoke w/a blind spot in lt eye;saw flashing lights in lt eye but blind spot remained;swelling of optic nerve w/white spots & light cell dots on retina;dx mult evanescent white dot synd;depressed & distressed;legally blind;
This is a spontaneous report from a contactable consumer or other non healthcare professional (HCP). The patient reported for self.  A 41-years-old (non-pregnant) female patient received BNT162b2 (Formulation: Solution for injection; Lot Number and Expiration date: UNKNOWN) , via intramuscular route of administration on, Solution for injection) (reason for unknown Lot number: Unable to locate or read the details), via an unspecified route of administration on 30Apr2021 (at 41-years-old) as single dose for COVID-19 immunisation. Patient medical history included known allergies to Penicillin, Sulfa from an unknown date and unknown if ongoing. Concomitant medication (other medications the patient received within 2 weeks of vaccination) included estradiol (.025mg patch) taken for an unspecified indication, start and stop date were not reported. No other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  On 02-May2021 the patient experienced Bruising of legs, calf area. Severe throbbing in both legs, numbness and tingling in both feet and toes. No distal pulse in right foot. Anxiety, due to worry of health after the vaccine. The patient had been tested for COVID-19, underwent lab tests and procedures which included Nasal Swab test (sars-cov-2 test) result was negative on 06May2021. Patient underwent venous and arterial ultrasounds of unknown results. Therapeutic measures were taken for the events occurred. Events were reported as non-serious. The outcome of the events was reported as recovered on an unspecified date.  Information on the lot/batch number has been requested.
Slight headache; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A patient in their 50's received BNT162B2 (Batch/Lot number: unknown, Expiration Date: Unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Slight headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
injection site redness; injection site pain; Injection was administered Subquetanious; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: injection site redness), injection site pain (Verbatim: injection site pain) and intramuscular formulation administered by other route (Verbatim: Injection was administered Subquetanious). The outcome of the injection site erythema and injection site pain were not reported and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site erythema and injection site pain to be related to Shingrix.   Additional Information: GSK receipt date: 17-AUG-2023 The reporter stated that injection was administered Subquetanious, causing injection site redness and pain. The patient received Shingrix via subquetanously, which led to intramuscular formulation administered by other route. The reporter agree to follow up to GlaxoSmithKline (GSK).