chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called this AM to report red patches underneath both armpits that were present this AM. There is no itching or burning.
Pt's daughter recv vax on 3/26/99; on 4/4/99 pt exp varicella rash, fever, cough, rhinitis; tx=6-mercaptopurine, steroids, acyclovir, at present, has over 100 lesions, was hosp as a precaution,   vaccinee did not exp a rash post vax.
Initial report received from a health care professional on 16 Jun 2010: This patient was vaccinated with expired S-OIV FLUVIRIN (batch number: 105051P1m), (with an expiration date of May 2010), (dose unknown) intramuscularly on an unspecified date in Jun 2010. No adverse reaction had occurred following this administration.
This spontaneous report as received from a Registered Nurse (R.N.) refers to a male patient of unknown age. The R.N. reported on 04-DEC-2014, the patient was vaccinated with MMR II. On 12-DEC-2014, the nurse reported the patient was inadvertently vaccinated with PROQUAD instead of VARIVAX (Merck). No adverse effects reported. No additional information. Additional information has been requested.
Information has been received from a medical assistant (MA) concerning a 14-15 week old patient who was vaccinated with the first dose of rotavirus vaccine (human-bovine). It was unknown if medical attention was sought. Additional information has been requested.
Initial unsolicited report received from a healthcare professional (trained Medic) via social media on 12 October 2015. "That report is from social media and contact information in based upon the location of our trading partner". This case involves a female patient (age at onset not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DPT) (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date following the vaccination, the patient experienced bad leg muscle spasms and her legs were locked with severe pain. Laboratory investigations and corrective treatments were not reported. The outcome of the events was not reported. List of documents held by sender: none.
Patient came in for a flu vaccine, and received a covid-19 vaccine. Patient had 2 doses in series and this would be the third given.
2 days from Menactra immunization, local swelling at site and on (L) deltoid; + erythema, + warmth (hot), pain at injection site. Skin tight - taunt - resembling cellulitis. Erythema from top deltoid to 1 inch above antecubital region. - abscess, - resp distress. Pt was sent to school.
Patient woke up this morning with a temperature of 103.5 whereas her mother gave her daughter a dose of tylenol and a dose of motrin.  At 1030hrs her temperature was 98.8 and the injection sites where not inflammed and patient was feeling better.
2 days after vaccine bad stuttering began. It lasted for 3 weeks. It is now resolving.
minor GI issues; diarrhea; nausea; constipation; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program. A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization.  The following information was reported: GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "minor GI issues"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; CONSTIPATION (non-serious), outcome "unknown", described as "constipation".  Additional information: Patient took an extra 4 days off of her week break of Ibrance (Tab 100mg, start date: 15May2020) due to getting Covid booster shot. Patient reports having minor GI issues (diarrhea, nausea, constipation).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated that his arm was extremely swollen the next day (size of a baseball in deltoid muscle that immunization was administered in). He also stated that every muscle in his body hurt the following day. Patient did not endorse any fever or other symptoms. Symptoms resolved within 24 hours.
Extreme dizziness, vertigo, soreness and fatigue. Patient was in tears, unable to stay awake or do homework. Onset 5-6 hours post injection. Minor fever (99?).
All of the following symptoms hit almost at once  at around 1:00 AM  * Fever (I checked my temperature around 4:00 AM and it was 100.8º, and hit 101.1º around 8:30 AM) * Chills * Shaking * Body aches (entire body) * Intense headache (still present at 2:35 PM on Nov. 1 after taking 800 mg ibuprofen) * Nausea * Fatigue, but unable to fall asleep
Suspected vaccination failure; Shingles breakout now, disconcerting; This serious case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient have had shingles before).   On an unknown date, the patient received the 2nd dose of Shingrix. In JUN-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles breakout now, disconcerting). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 27-Apr-2023 The patient has had shingles before. The patient received the Shingrix vaccine last year first dose in June 2020 and second in August or September 2020. The patient has developed a shingles break out now. As we get ready for vacation travel, this was most disconcerting. The patient was asking for advise. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Dizziness, fainting 2 times, once in school 1/19, again 2/1.  headache, extreme fatigue
Severe back pain in lower back muscle next to spine.   Difficulty to get out of bed and move. 24 hours of pain severe back pain, 24 hours of more manageable back pain and now the back pain is subsiding.
This case was reported by a pharmacist via call center representative and described the occurrence of welts in a 63-year-old female patient who received SHINGRIX (batch number 3NY5G, expiry date 7th March 2021) for prophylaxis. Concomitant products included FLUCONAZOLE (FLUZONE (FLUCONAZOLE)). On 8th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 9th September 2018, 1 days after receiving SHINGRIX, the patient experienced welts and fever. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the welts and fever were unchanged. It was unknown if the reporter considered the welts and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of FLUZONE vaccine on 8th September 2018 on left deltoid intramuscularly. The patient reported 5 welts all down her right arm as well as fever. The patient visited her physician for these symptoms, who referred her to the pharmacy where the vaccine was administered. The pharmacist recommended managing symptoms with Benadryl. The patient stated that she did not have a thermometer, so did not actually know her body temperature, but felt certain she had a fever.
Nausea, vomiting, diarrhea, fever, stomach pain, dizziness, eyes going sideways, weak legs
Seen @ 48 hours ago - got 3 shots GARDASIL, VARICELLA, MENACTRA.
This spontaneous report was received from a physician refers to a  78 year old female patient. On an unknown date in May 2014 the patient was vaccinated with ZOSTAVAX dose 2, and dose 1 in July 2013, subcutaneously . No other concomitant therapy reported. No adverse effect reported. The outcome of the events was unknown. There was no PQC reported. Additional information has been requested.
Chills, aches, 100.3 fever. Tired. lasted 24 hours.
This spontaneous report was received from a medical assistant refers to unknown number of patients of unknown age and gender. On unknown date (between November 2013 and July 2013), the patents were vaccinated with RECOMBIVAX HB (dose, route and lot # were not reported) that had been improperly stored. No adverse effects reported. This is one of 6 reports received from the same reporter. Additional information has been requested.
Welt symptoms; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welt symptoms) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Welt symptoms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Welt symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication includes VITAMIN PILLS.    This case was linked to MOD-2021-044118 (Patient Link).
Area of swelling and erythema appeared on right thigh the evening of vaccination.  Area continues to spread.  Seen once already on 3/6, returning 3/8 due to spreading of site.  Site - right lateral thigh.
First of all, I am rarely sick.  I had 4 days of total exhaustion which I expected.  On the thirteenth day, I had severe lower abdominal pain. the pain diminished over 5 days, then I had a migraine headache which lasted about 8 hours.    Did not see a doctor.
watery bowel movements; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (watery bowel movements) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced DIARRHOEA (watery bowel movements). At the time of the report, DIARRHOEA (watery bowel movements) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  The action taken with mRNA (Moderna COVID-19 Vaccine)(unknown) was Not Applicable.   Reporter did not allow further contact
Fever, aching, (severe) chills, (a little) nausea, unable to get out of bed for 30 hrs, symptoms continued for 48 hrs toatal.
inflammatory response; sore arm; redness; rash; A spontaneous report was received from a  health care professional  concerning about a 60 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash, redness/erythema, pain in arm/pain in extremity and inflammatory reaction/inflammation.  The patient's medical history was reported as have hypothyroidism.  Concomitant medications were reported as having medication levothyroxine sodium.  On 05 Jan 2021, prior to the onset of the events, the patient received their first planned doses of mRNA-1273 (Batch number: 026L20A) via intramuscular in left deltoid for the prophylaxis of COVID-19 infection.  On 05 Jan 2021, same day of vaccination the patient experienced events sore arm, redness and rash.  On 15 Jan 2021, the rashes came back.  On 17 Jan 2021, patient seeks medical consult and advised that rash might be an inflammatory response and a beginning of cellulitis (not certain).  Laboratory details was not provided.  Treatment information was provided as patient prescribed to take hydrocortisone steroid cream, anti-bacterial cream and benadryl.  On 06 Jan 2021, the events sore arm, redness and rash resolved.  Action taken with mRNA-1273 in response to the events are unknown.  The outcomes of the event which reappeared remain unknown.
Patient receive 2 vaccines ADACEL (Tdap) & MENACTRA (MCV) and stood up. Was talking to a provider and suddenly fainted and fell to the floor and bumped her head. Per nurse practitioner, pt appeared to have a "seizure". Pt woke up within 1-2 minutes and was alert and oriented. 911 was called.
Patient hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was multiple subsegmental pulmonary embolism.
Approximately 36 hours post 2nd dose of vaccine I experienced intermittent  fever and severe chills (rigors)  over a 6 hour period not relieved by ibuprofen; tmax 103. All symptoms resolved by the 48 hour post vaccine mark
On 5-25-04, child woke up with fever of greater than 104 degrees and spots on her stomach, and then the next day was covered with spots. She was seen in ER on the 1st day (no treatment) and then at medical center on the 2nd day and started on Zithromax also Tylenol as needed.
Information has been received from a physician concerning a 66 year old male with no allergies and a history of hernia surgery who on 30-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot # 656606/0033U).  There was no concomitant medication.  On 31-MAY-2007, the area under his eyes was puffy and swollen and his face was very flushed.  Unspecified medical attention was sought and he was treated with antihistamines.  At the time of the report, the patient was recovering.  A product quality complaint was not involved.  Additional information has been requested.
Clinic nurse administered PROQUAD and VARIVAX. Child was due for MMR and Varicella and DTAP/POLIO vaccines.
Patient has signs and symptoms of an infection. Patient had experienced pain, redness that radiated up to her neck. Patient currently has a bruise and is still experiencing pain in her neck. She has just seen a doctor to manage the symptoms and received keflex and ibuprofen.
LOCAL REACTION R ARM W/REDNESS, ITCHINESS, ERYTHEMA/EDEMA AROUND SITE PATIENT LOOKS WELL NO FEVER NO CHILLS, DYSPIRGIA.
Moderna vaccine was out of the freezer for more than 30 days when administered.  Receipt of vaccine was 09/20/2022, administration was 11/15/2022
Vaccine was administered at 10:29 AM, patient began experiencing pain, numbness, and tingling sensation at 10:39AM. Provider Fenny Lin, FNP was notified and assessed patient monitored patient for another (30) Minutes. Symptoms subsided and patient was release home. patient advised if symptoms persist she may go to the nearest emergency room  to further assess or she may follow up with her PCP and/or contact our office for further assistance.
Redness, swelling, warm to touch, fatigue, malaise, low grade fever. Dr diagnosed as cellulitis, gave antibiotic rx.
This spontaneous report as received from a registered nurse regards an unspecified number of patients of unknown age and gender. On an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ (dose, route, lot number and expiration date were not reported) and GARDASIL (dose, route, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint was filled. Additional information has been requested.
Patient states 8-10 hours after receiving vaccination she began developing rash on arms which progressed to most of body.    Pt currently monitoring for worsening of rash or anaphylactic event.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4443272-00.  An elderly female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular 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; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The action taken for adalimumab was unknown. Clinical course: It was unknown if the patient was enrolled in a COVID-19 Vaccine trial. On unknown dates, the patient experienced covid-19. The reporter's causality for the event of covid-19 with HUMIRA (Adalimumab) was no reasonable possibility and the causality as per report for the event of covid-19 was not related. The causality as per report for the event of covid-19 with BNT162b2 was possible.  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out.
Vaccine was given to 11 yr old pt, this vaccine is approved only for 12 yrs and up.  pt was observed in the public vaccine facility and was counseled on se.
A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving nasal FLUMIST started on an unknown date. The patient reported that Two doses of FLUMIST incorrectly administered to one patient. The outcome of the event of TWO DOSES OF FLUMIST INCORRECTLY ADMINISTERED TO ONE PATIENT is unknown. The report was considered to be non-serious. The reporter and company physician considered that there was no casual relationship between TWO DOSES OF FLUMIST INCORRECTLY ADMINISTERED TO ONE PATIENT and FLUMIST.
rash inside her mouth; scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL ERUPTION (rash inside her mouth) and THROAT IRRITATION (scratchy throat) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ORAL MUCOSAL ERUPTION (rash inside her mouth) and THROAT IRRITATION (scratchy throat). At the time of the report, ORAL MUCOSAL ERUPTION (rash inside her mouth) and THROAT IRRITATION (scratchy throat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not provided. No relevant concomitant medications were reported.
Severe headache, fevers, Tmax of 103, vomiting 15 minutes post ibuprofen administration.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 31-JAN-2014 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # J011272, expiration date 21-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
On 11/28/99, the pt experienced breakthrough varicella. Subsequently, the pt recovered. It was noted the vaccine was given 3 days after exposure to chickenpox.
-BY 11PM ON EVENING POST INJECTION - FEVER, BODY ACHES, CHILLS (SUBSIDED AFTER 2 DAYS) AND FATIGUE (ONGOING, BUT SUBSIDING) -1-2 DAYS POST INJECTION - SMALL, RAISED, BLISTERY HIVE TYPE RASH - ITCHY SPOTS ON ARMS, TRUNK, AND FACE (ONGOING 3 DAYS POST INJECTION)
Pt received dose on 5/6/23.  Presented back to pharmacy 5/24/23, complaining of swelling and tenderness in arm below immunization site as well as redness and rash that has persisted since immunization occurred.
Initial report received from a physician in the USA on 04 January 2007. A 2 1/2 year old, male patient (with a history of mild respiratory distress) received 4 doses of Daptacel up to date. He had recurrent sinusitis and otitis media. An ENT physician drew a tetanus antitoxoid IGG titer which was less than 0.1 IU/mL (protective level according to the laboratory is 0.4 IU/mL). Additionally, the diphtheria level was 1.67 IU/mL, which the doctor stated was consistent with a protective level.  The patient's recovery status was not reported.
4.5-5 in cellulitis to L upper arm plus warmth. Maybe mild swelling to one area plus erythema marked with pen. Able to freely move extremity. Mildly TTP. No puncture site visualized.
DEVELOPED RASH WITH PUSTULES WITH NUMBNESS AND MINIMAL PAIN, ON RT THIGH AND RT BUTTOCKS AREA INTO THE GROIN AREA.  STARTED THE AM OF 4/3/08. DX BY DERMATOLOGY AT THE HOSPITAL ON 4/12/08 AS SHINGLES.
Employee received a flu shot there on 10/22, she went to her doctor on 11/11 with increasing left shoulder pain since the shot. I'm on weight lifting restriction and I'm now being sent for an ultrasound and to an orthopedic surgeon for a possible shoulder injury.  This was copied directly from an email from the employee.
his spontaneous report was received from a registered nurse and refers to four patients ages 18-22 years old of an unknown gender. The patients' pertinent medical histories, drug reactions, allergies, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of hepatitis b vaccine (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported). On unspecified dates, lab diagnostic studies were performed and all of the patients had negative titers after the vaccination. Product quality complaint (PQC) was not involved. The outcome of the event of negative titers was not reported. The relatedness between the event and hepatitis b vaccine (manufacturer unknown) was not provided. Additional information has been requested.
Day after vaccines given, patient developed a rash from her bottom rib cage to her ankles.
Patient reports feeling strange sensation soon after shot. By 6pm she had cold chills, a fever of 102.5 degrees F. Threw up had diarrhea and had weakness.