chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Directly after receiving the last vaccination (HPV-9) the patient became pale with complaint of dizziness. Patient was place in supine position with legs raised on exam table. At this time I observed slight left leg spasms. Patient remained A&O x4, conversing appropriately,  dizziness resolved, denied nausea & s.o.b.  No other complaints noted by patient. Patient self noticed left leg spasms asked when it will go away, mom was asked if the leg spasms have happened with previous vaccinations. Mom stated no.  Patient remained supine with cold packs to forehead, and bilateral armpits.  Patient left facility with slight muscle spasms to left leg remaining. Patient was escorted to vehicle. Mom advised that if condition remains or worsens seek medical attention at local ER. Mom stated understanding.
when he blows his nose it is bloody; runny nose; nose bleeding slightly; feels awful; felt like he was hit by a freight truck; felt bad all over; felt feverish but did not have a fever; arm was sore; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore), FEELING ABNORMAL (felt like he was hit by a freight truck), FEELING ABNORMAL (felt bad all over), PYREXIA (felt feverish but did not have a fever) and FEELING ABNORMAL (feels awful) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040a21a and d13m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (pituitary(surgery through sinus).) in February 2020 and Surgery. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm was sore). In February 2021, the patient experienced HEADACHE (headache). On 20-Mar-2021, the patient experienced FEELING ABNORMAL (felt like he was hit by a freight truck), FEELING ABNORMAL (felt bad all over) and PYREXIA (felt feverish but did not have a fever). On 22-Mar-2021, the patient experienced FEELING ABNORMAL (feels awful), RHINORRHOEA (runny nose) and EPISTAXIS (nose bleeding slightly). On 23-Mar-2021, the patient experienced EPISTAXIS (when he blows his nose it is bloody). On 15-Feb-2021, VACCINATION SITE PAIN (arm was sore) had resolved. At the time of the report, FEELING ABNORMAL (felt like he was hit by a freight truck), FEELING ABNORMAL (felt bad all over), PYREXIA (felt feverish but did not have a fever), FEELING ABNORMAL (feels awful), HEADACHE (headache), RHINORRHOEA (runny nose), EPISTAXIS (nose bleeding slightly) and EPISTAXIS (when he blows his nose it is bloody) outcome was unknown. Not Provided
Patient's parent called to report the patient has a red area the size of a nickle where the vaccine was given. The patient is being treated with cold compresses. The next day the rea area is about the size of a quarter, but not quite as red. The following day the area is no longer raised and is about the size of a dime, The patient has been treated wtih Ibuprofen and cool compresses.
So a couple of weeks after the vaccine, I felt feverish and had a fever and it came out of no where and I had no other symptoms. I had no aches or pains. I took a home test that came out negative, but the next day I did a drive up test and came out positive. I never had any symptoms. I had a fever and some sniffles, it was not even as bad as a flu.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an eight years old male patient and reported that Flublok was inadvertently given to an 8 years old patient, while he received vaccineFLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. No other vaccines given at the time. On 20-Oct-2018, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1820 and expiry date: 30-Jun-2019) via intramuscular route in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Persistent shoulder pain.  Not painful to touch but rather more like. Deep  tissue or nerve injury.  Range of motion limited above location of injury.  Ex: opening a standard window is rather painful due to the positioning and strain on muscles in this particular area.
1/1/2022 - Presents to ED for Covid screening/cough. Went for dialysis but they refused without Covid screening.  Covid + in ED. Vitals WNL. Admitted for observation due to Covid + status and emergent dialysis. Treatment plan for oral Doxycycline, IV Rocephin and tapering Decadron for completion at home.  1/2/2022 - Minimal symptoms, Discharged to home.
One week after shot there was a consistent low faint buzzing in left ear. Ear felt a bit clogged. Buzzing is constant and has not yet resolved.
This spontaneous report was received from a pharmacist refers to a 65 year old male patient. Pertinent Medical History: unspecified chronic pain issue. Drug reactions/Allergies: None. On 07-MAR-2016 the patient was vaccinated with the right arm with ZOSTAVAX lot # L035285/expiry: 15-DEC-2016, dose: 0.65ml, once, subcutaneous for prevention of shingles. Concomitant therapies included gabapentin, acetaminophen, PERCOCEET, ibuprofen (+) acetaminophen (manufacturer unknown) and lisinopril (manufacturer unknown). On 08-MAR-2016 the patient developed an area of redness, swelling, and soreness in a 3-inch diameter around the injection site. Patient's wife reported to pharmacist on 11-MAR-2016 that the redness was spreading down the patient's arm, and that "little white spots" have also developed around the injection site. Patient sought medical attention and visited pharmacist. No treatment given for the events. No additional information provided. The outcome of all the events was reported as not resolved. Causality assessment was not reported. Additional information has been requested.
Diarrhea; vomiting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 14:25 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, Batch/Lot No: Unknown. Misplaced/discarded), for COVID-19 immunization; Bnt162b2 (DOSE 1, Batch/Lot No: Unknown. Misplaced/discarded), for COVID-19 immunization; Flu. The following information was reported: DIARRHOEA (non-serious) with onset 10Nov2021 16:15, outcome "recovering", described as "Diarrhea"; VOMITING (non-serious) with onset 10Nov2021 16:15, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of diarrhoea, vomiting.  Additional information: Facility type vaccine: Pharmacy or Drug Store. No Covid prior vaccination. Covid not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
48+ Miserable hours of chills/sweating No appetite- threw up the two apple slices I got down Headache
Pt developed red, goose egg at injection site. Itching at site. Pt did have pain when injection occurred. On 7/27/18 redness measured 11x12cm.
She had  little rash on her neck but more on her lower back and it just kept getting worse. It wasn't on her face at all around 10:30 that night but then it spread to her face and ears by 7:00 AM. We have been fighting fevers of over 102 for over 3 days now and it is still continuing so we are taking her in again today.
The patient noticed hematuria the next day (5/5/18), which was confirmed by her PCP on 5/9/18.
Little bit face swelling, now her face is really swollen/swelling of her face; swelling of neck; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Little bit face swelling, now her face is really swollen/swelling of her face) and SWELLING (swelling of neck) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Little bit face swelling, now her face is really swollen/swelling of her face) and SWELLING (swelling of neck). At the time of the report, SWELLING FACE (Little bit face swelling, now her face is really swollen/swelling of her face) had not resolved and SWELLING (swelling of neck) outcome was unknown.            No concomitant medication were reported. No treatment information was provided by the reporter.  Patient took the first 2 doses of the Moderna COVID-19 vaccine and had no reaction to these doses. Patient got the booster dose and was experiencing swelling of neck and face. The reaction was not immediately after the shot. When it started it was a little bit and patient did not pay much attention to it, by now face was really swollen.
Patient has 1 1/2 in L x 2 in W red circle with a 1/2 in W x 1/2 in L blister in the center. Oddly this red whelp (not raised) with blister is about an inch above the actual injection site itself  (almost to the point of the shoulder). The patient noticed whelp and blister this morning and reports that the current pain is different than the soreness felt the 2 days after the injection. It now is more of a burning sensation.  Patient has not treated the area at all and had not directly washed the area before arriving to the pharmacy.  We have marked the margins of the whelp at 4 different point to monitor the progression.
July 12, 2006  At 1:20pm received 2 vaccines (MCV4 and Tdap) and fainted after receiving the 2nd one. While her Mother and I were assisting her to the reclining chair, she arched her body and became stiff, lasting about 15 seconds then she went limp. We placed her in the reclining chair and elevated her feet, placed ice pack behind her neck, cool cloth on  forehead and wrists. BP 104/61 pulse-64. She started to waken and verbalized she was hot. At 1:55pm BP 122/69 pulse-77. Questioned mother about history of seizures and she denies any history, but that she has always had anxiety with immunizations. Was becoming more coherent and ate one cracker and drank some water. Encourage  mother to have her seen by doctor. Mother called the doctor and spoke with the NP.  While she was doing that I slowly raised the chair to an upright position. Right after sitting up she started to faint again and her BP dropped to 90/70. Laid her back down and spoke with the NP, made her aware of inability to maintain BP. Called 911. Called Immunization Program Manager, and made her aware of situation. After phone calls and her lying down her BP 107/68 pulse-61. Ambulance arrived and transported her to hospital. She was alert on transport.  July 13,2006  Telephoned mother. She said that she is doing much  better. Had head CT and EKG. Reports all were normal. She will have follow up with her doctor.
Pt came in for walk in vaccine. No medical hx or meds on file. 15 days later pt hospitalized for RA. Unbeknownst to our staff pt had RA and was on REMICADE. Receipt of vaccine delayed infusion and as result pt was hospitalized.
I just realized that my menstrual cycle was missed last month, not sure if this is related but wanted to report just in case
VACCINE EXPIRED ON 02/2022  AND WAS ACCIDENTLY GIVEN ON 03/02/2022  ,  MD NOTIFIED  , supervisor notified patient notified.  Pharmacist notified and was asked about any complications from error.
Client reports developing shingles - has not returned call to supply remaining info for this report. States she is leaving for vacation 3:00am
12-24 hours after immunizations given, had bilateral eye swelling.  Resolved after 24 hours.
REDNESS/PAIN/SWELLING/WARMTH AT INJECTION SITE --> PHARMACIST RECOMMENDED ICE PACK & ANTI-INFLAMMATORY (IBU).
Swelling and redness around left shoulder into upper biceps, lymph node and right breast.
Vaccinated with Tdap in left deltoid. Allergic reaction: swelling of left deltoid (where the vaccination was administered); redness; heat; itchiness. Next day, all adverse reactions spread down to include tricep and bicep. Treatment: ibuprofen and ice packs.
Pt received second dose of Pfizer vaccine on 03/27/21. On 06/05/21, pt presented to the ED with complaints of SOB. Pt was found to be COVID positive on 06/05/21 requiring supplemental oxygenation.
This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 14-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (Lot No. J006850 Expiration date: 31-MAR-2016 this lot was not improperly stored). Then, on 16-OCT-2014, the patient received the second dose of an improperly stored GARDASIL (Lot No. 010668 Expiration date: 29-APR-2016) and on 27-FEB-2015, received the third dose of an improperly stored GARDASIL (Lot No. J010668 Expiration date: 29-APR-2016) (doses, routes and anatomical locations of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Felt bad like I was coming down with something. Got cold just wanted to lay down and cover up. At 11:30 P.M. I got very cold and I began to shake. I had a fever of 100.1 so I took 2 tylenol and went to bed. I dont know if my fever would have gone higher but didnt want to find out so I took the tylenol.  I felt bad all day April 1, 2021. I didnt go to work and slept off and on all day. I felt a little sick to my stomach but no throwing up . I finally felt myself late the evening of April 1. What was strange to me was the sudden shaking.
DIAG: COVID; DIAG: COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient.  An 84-year-old patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "DIAG: COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: DIAG: C0VID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient was prescribed Paxlovid on 01Sep2022 after experiencing slight sore throat, cough, nose drizzles. Diag: Covid. According to the patient, "4th day, I experienced (while standing) a situation in which I had a dry feeling up and down my airway and I had to breathe and choke for breath for several seconds. My airway felt completely dried out is how I can explain it. It is a sensation of gasping I have never had before. It then cleared after several seconds of gasping. I am fully vaccinated and double-boosted. Age 84".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine given to somebody who is underage; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to somebody who is underage) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to somebody who is underage). On 01-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to somebody who is underage) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment was reported.
GIVEN HALF-DOSE; MEDICATION ERROR; This spontaneous report received from a parent concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic to all nuts, and allergic to animal dander. The patient was previously treated with bnt 162 (Dose number in series 1) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on an unspecified date for prophylactic vaccination. On an unspecified date following vaccination with bnt 162, the patient had her throat closed up and experienced allergy. (Dose number in series 1). The outcome of throat closed up and allergy was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) half of the dose administered by mistake by the pharmacy which was vaccine underdose and a medication error, 1 total administered on FEB-2022 for prophylactic vaccination. (Dose number in series 2) The batch number was not reported and has been requested. Concomitant medications included epinephrine (epipen) which the patient carried with her.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the given half-dose and medication error was not reported. This report was non-serious.
Arm/muscle soreness; Tired; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 02Apr2021 at 16:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications 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 02Apr2021 at 19:00, the patient experienced arm/muscle soreness and tired. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events arm/muscle soreness and tired was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of urinary incontinence in a 71-year-old female patient who received Shingrix (batch number 4FS5N, expiry date 8th March 2021) for prophylaxis. On 16th September 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2018, 19 hrs after receiving Shingrix, the patient experienced urinary incontinence. On an unknown date, the outcome of the urinary incontinence was unknown. It was unknown if the reporter considered the urinary incontinence to be related to Shingrix. Additional information received as follows: At 17:00, the patient received Shingrix. On 17th September 2018, at 12 noon, the patient experienced urinary incontinence. The patient experienced total three episodes of urinary incontinence between 12 noon and 3 pm. The healthcare professional reported that the patient had no prior history of urinary incontinence and had no obvious signs of urinary tract infection. The healthcare professional recommended that the patient consult her licensed medical doctor (LMD).
2 3/4 width 1/2 length, hot to the touch, slight swelling, hard nodule center, still has full range of motion.
Pt mouth was twitching, difficulty speaking, anxiety.  Negative on stoke scale, no facial drooping, no arm drift or weakness. Vitals:  HR 80, BP 105/160, O2 99%.  This has occurred previously due to unknown brain condition idiopathic.  Pt was observed for additional 15 minutes and was cleared.
Chills; Body aches; This is a spontaneous report from a contactable consumer (patient). This 23-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiry date unknown), via an unspecified route of administration on the left arm on an unspecified date (09:15) at a single dose for COVID-19 immunization. Medical history included COVID-19 diagnosed prior to vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin;clavulanic acid (AUGMENTIN) and experienced allergies. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 03:00, the patient experienced chills and body aches. No treatment was received. Outcome of the events was recovering. Events were reported as non-serious.