chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist refers to a 554 year old female patient. The patient's pertinent medical history includes sinus infection (Chronic). She had an unspecified drug reaction with Penicillin. On 05-DEC-2015, the patient was vaccinated with ZOSTAVAX (lot # L027322, expiry date 21-DEC-2016) 0.65 ml, subcutaneous for prevention of shingles. Concomitant therapies included Z-PAK. On an unknown date, the patient was seen by an unspecified physician, after receiving ZOSTAVAX and was prescribed prednisolone 20 mg for 5 days and BACTRIM DS for sinus infection. The outcome of sinus infection (sinusitis) was unknown. The reporter did not provide the relatedness of the event with ZOSTAVAX. Additional information has been requested.
1 year old was given Ipol twice/has already received the 3 doses as scheduled for his age/dose was too early because the next dose was due at age 4 with no reported adverse event; Initial information received on 09-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 months old patient who was given ipv (vero) [ipol] twice/has already received the 3 doses as scheduled for his age/dose was too early because the next dose was due at age 4 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (prevnar) for immunisation; and hib vaccine (hib vaccine) for Immunisation.  On 09-Jan-2023, the patient received a dose of 0.5 ml (dose 4) once of suspect ipv (vero) (Suspension for injection) (strength: standard; lot: V1B891M; expiry date: 01-Jun-2024) via intramuscular route in the left thigh for immunisation.  On 09-Jan-2023 the patient of 1 year old was given ipv (vero) [ipol] twice/has already received the 3 doses as scheduled for his age/dose was too early because the next dose was due at age 4 with no reported adverse event (Inappropriate schedule of product administration) (latency: same day).  It was reported that the wrong child's name was clicked on which indicated that the child need vaccine, but the child had already had vaccine, and was administered again.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
Itching, soreness and warm red circle around injection site. Itching comes and goes. Ice application provides relief
More than 35 days since the first shot; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot) had resolved.        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.   Concomitant medications included unspecified  blood pressure medication. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up included no new information.
HYPERSENSITIVITY TO THE SUN; LIGHT RASHES ON ARM BILATERALLY; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcohol user, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient did not have pertinent medical history. The patient experienced hypersensitivity when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced hypersensitivity to the sun. On JUN-2021, the subject experienced light rashes on arm bilaterally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from light rashes on arm bilaterally, and hypersensitivity to the sun. This report was non-serious.
Patient was ordered to receive DTap Pediatric and instead received DTap-Hep B-IPV (Pediarix).  Patient had already finished both Hep B and Polio series prior to the visit.
Information has been received from a certified medical assistant concerning an approximately 31 year old female, who on 28-SEP-2006 was vaccinated with the first 0.5ml dose of GARDASIL.  In October 2006, the patient was vaccinated with the second 0.5 ml dose of GARDASIL.  In March 2007, the patient was vaccinated with the third 0.5ml dose of GARDASIL.  On an unspecified date, the papanicolaou test was done and the result revealed abnormal.  At the time of this report, the outcome was unknown.  The patient was see by the physician and sought unspecified medical attention.  Additional information has been requested.
the vaccine may have cleared up something in my MS; bloat all the time so, I have gas constantly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Jun2021 (Lot number: EW0180) as dose 2, single for covid-19 immunisation. Relevant medical history included: "multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: EW0186), administration date: 24May2021, for covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "the vaccine may have cleared up something in my MS"; ABDOMINAL DISTENSION (non-serious) with onset 2021, outcome "unknown", described as "bloat all the time so, I have gas constantly".  No follow-up attempts are possible. No further information is expected.  Follow-up (02Nov2021): Follow-up attempts completed. No further information expected.
Dizzy; Weak after the 2nd dose; Nausea that is slowly getting stronger and stronger after the 2nd dose / Nauseated upon standing after the 2nd dose / Nauseated after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weak after the 2nd dose) and NAUSEA (Nausea that is slowly getting stronger and stronger after the 2nd dose / Nauseated upon standing after the 2nd dose / Nauseated after the 2nd dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 021b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received 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 DIZZINESS (Dizzy), ASTHENIA (Weak after the 2nd dose) and NAUSEA (Nausea that is slowly getting stronger and stronger after the 2nd dose / Nauseated upon standing after the 2nd dose / Nauseated after the 2nd dose). At the time of the report, DIZZINESS (Dizzy), ASTHENIA (Weak after the 2nd dose) and NAUSEA (Nausea that is slowly getting stronger and stronger after the 2nd dose / Nauseated upon standing after the 2nd dose / Nauseated after the 2nd dose) outcome was unknown. Not Provided
Pt. reported headache, upper torso myalgia approx. 6 hours after vaccine. Symptoms lasted approx 48 hours.
Information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The nurse stated that an improperly stored dose of PROQUAD (Merck) Lot# L031600, an expiry date 18-FEB-2017 (dose and frequency were not reported) was administered to an unspecified patient on an unspecified date. No adverse effects were reported. No further information was provided. Additional information has been requested.
Patient's face was tingling and red underneath her mask.  She was not having SOB, swelling of the tongue, closing of the throat or itch/rash.  She was observed and given 2 Benadryl 25mg and a bottle of water.  Called her later in the evening and she was doing well.
no additional adverse event; Patient was administered an expired dose of MMR II on 07-JUL-2022; This spontaneous report was received from a pharmacy intern and refers to a female patient of unknown age. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 07-JUL-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) lot # T020655 confirmed to be valid with expiration date:16-JUN-2022 (exact dose, route of administration and injection site were not reported) for prophylaxis (expired product administered). No additional adverse event was reported.
I have a rash in my right arm and both of my left and right foot; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient) reported that 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 dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had rash in right arm and both of left and right foot on an unspecified date with outcome of unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Only one abnormal menstrual cycle in the last 5+ months. Extremely reliable and predictable prior to vaccinations.
Patient stated that when she woke up the day after receiving the vaccine her left ear was swollen. She is also having trouble hearing out of that ear.
Clinical failure of vaccine. Pt received ZOSTAVAX on 08/29/2008 and presented today with uncomplicated truncal Herpes zoster.
I had a persistent headache on day 1 after the vaccination. Also, had severe fatigue and later that day I had chills with severe myalgia that lasted 48 hours requiring to take Ibuprofen for 2 days. The sourness in my left arm was more pronounced that with any other vaccine.
Proquad administration was administered to a 4 month old baby. After a week of administration patient developed a rash,
Pt was shaking shortly after immunization administered.  No Vomiting, No Fever, Alert and active.
she called her employee health and they set her up for a rapid test, which came back positive; she called her employee health and they set her up for a rapid test, which came back positive; Fighting cold; congested on left side of her nose; Mild chills; achy feeling on and off; Fatigue; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 26Dec2020 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 16Jan2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The Patient's 2 sons and husband (her husband had received his first Pfizer COVID vaccine dose on 13Mar) all tested positive for COVID week of 22Mar2021. Patient family member was taking care of all of them at home and was not wearing a mask or taking precautions because she assumed that the vaccination would prevent her from contracting it. But on 28Mar2021 she started to feel like she was fighting a cold or having allergies -somewhat congested on left side of her nose. She then started to have mild chills, achy feeling on and off, and fatigue. Symptoms were very mild by her definition but like the more severe version that the rest of her family was experiencing. She went to work on Monday through Wednesday of this week but on Wednesday 31Mar2021 she called her employee health and they set her up for a rapid test, which came back positive. She is quarantining at home now with the rest of her family. I have no further information regarding whether anyone else in her office who had the Pfizer vaccine contracted COVID. The outcome of all the events was unknown.
Cellulitis R shoulder 11cm x 8cm lesion and spreading. Motrin 800mg TID, Diciox 750mg QID x 70mg
Increased Pulse rate - as high as 130bpm on occasion for 3 days.  Doctor prescribed benadryl every 4 hours..  By the time I spoke with the doctor the occasional increase in pulse rate had stopped.  She explained that this was not a common listed side effect for Moderna.  I have since spoken to 3 other individuals who have had a similar reaction in a similar time span as well as one more person anectodately.
Headache and warmth in the upper body. No treatment perform, employee already left center and did not perform any treatment at home. Headache and warmth lasted a couple hours.
11/23/21  Reported fever, seen by PCP 11/23/21  Regeneron infusion given
pt had nausea & diarrhea & cold sweats on days following the vax;
PATIENT WAS NOT IN SYSTEM. PATIENT HAD A IMMUNIZATION CARD THAT INDICATED THAT HIS SECOND PFIZER DOSE WAS ADMINISTERED ON 6/15/2021. HE REQUESTED HIS BOOSTER TODAY AND IT WAS ADMINISTERED BUT DISCOVERED IT WAS 1 WEEK TOO EARLY.
Persistent pain in upper right arm where injection was, burning, numbness sensation in upper arm, some tingling in fingers.  Also has spread in other arm, similar sensation - this occurred 1 week after vaccination first shot, and has now persisted now on week 3.   Initially told to put warm compress or cold with ibruprofen - that has not helped.    The sensations are getting more pronounced, all day long, nothing helps.   Also now getting shooting pains in my head, bad headaches.
1-2 min after vaccination of HAVRIX #1 c/o dizziness, weakness - GI distress - cold, clammy, B/P 80/60 P. 60 R. 28, administered epi 0.5 ml + 50 mg BENADRYL, monitored symptoms - No respiratory distress - Continued to deconp 911 to ER for evaluation - No resp distress evaluated at ER and released at 4PM 7/31/09.
Pt vax /w DTP/OPV developed flaccid tone w/eye rolling. Probably afebrile (3-4 min) +post-ictal state; 2 days post injection diarrhea that night, temp 99.9.
Patient reported ocular migraines on 04/07/21 and 04/10/21. Patient also reported consistent headaches since vaccination on 04/02/21. Patient has had previous migraine with pregnancy but hasn't had a migraine in the years since.
The patient's mother called on 08/23/2001. The patient developed crying since receiving the vaccine, throwing up, a headache, weakness, and feels feverish. The patient has been treated with Tylenol and Motrin but does not get relief. The patient went to a physician who feels her symptoms may be due to the vaccine. The physician gave the patient some medicine for a cold and runny nose.
Polyhydramnios at 32 weeks; Pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of POLYHYDRAMNIOS (Polyhydramnios at 32 weeks) in a 30-year-old female patient (gravida 4) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Miscarriage. Concurrent medical conditions included Latex allergy. Concomitant products included SERTRALINE from 04-Jan-2020 to an unknown date for Anxiety, FAMOTIDINE (PEPCID AC) from 02-Jan-2020 to 19-Mar-2021 for GERD, VITAMIN B6 from 08-Jan-2020 to 24-Sep-2020 and DOXYLAMINE SUCCINATE (UNISOM ) from 08-Jan-2020 to 24-Sep-2020 for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 02-Jul-2020 and the estimated date of delivery was 08-Apr-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 11-Feb-2021, the patient experienced POLYHYDRAMNIOS (Polyhydramnios at 32 weeks) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy. The cesarean delivery occurred on 19-Mar-2021, which was reported as Full-term. For neonate 1, the birth weight was 4252 grams (9lbs 6oz) with an APGAR score of 7 at 1 minute. The outcome was reported as Term Birth w Complications. Infant's birth weigh was 9lb 6oz and length was 21 inches. Perinatal complications for infant: retained fetal lung fluid. APGAR Score at 5 min - 7. On 19-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, POLYHYDRAMNIOS (Polyhydramnios at 32 weeks) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2020, Pregnancy test: positive (Positive) Positive. On 22-Nov-2020, Ultrasound foetal: normal (normal) Normal findings.. On 11-Feb-2021, Ultrasound foetal: abnormal (abnormal) Polyhydramnios at 32 weeks.     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.   This case was linked to MOD-2021-095848 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Internal review on 21 JUL 2021 , resulting updates of fetal outcome; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
This spontaneous report as received from a pharmacist refers to a 58 year old male patient. The patient's concurrent conditions and medical history were not reported. On 18-AUG-2016,reported as yesterday, the patient was vaccinated with ZOSTAVAX (strength, dose, route of administration, lot number and expiration were unknown). There were no concomitant therapies reported. The reporter stated that then, the patient experienced joint pain and tingling in his fingers. The patient did not seek medical attention nor treatment was given for the adverse events. No product quality complaint was involved. The outcome of parasthesia and arthralgia was unknown. The causality between parasthesia and arthralgia and ZOSTAVAX was not provided. Additional information has been requested.
Received ROTATEQ 5/5/10, vomiting and diarrhea started 24 hours later patient seen in ER for IVFP for dehydration. Attended daycare 1 day at the start of illness. Vomiting has stopped. Still with very loose stool. All blood work done in ER was normal.
Nurse gave dose from the Moderna 6 year to 11 year old COVID vaccine vial instead of the correct vial for Moderna 6 months -5 years old. Dose given was correct at 0.25 mL. Parent does not answer the phone and has a voicemail box which is full and cannot accept any messages.
Patient was given his 2nd Moderna vaccine 7 days before the recommended time between the 1st and 2nd dose. No adverse symptoms as a result of early vaccination in series.
Information has been received from a nurse practitioner concerning a 14 year old female patient who on 17-JAN-2007 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (Lot# was unknown). On 16-MAR-2007 the patient was vaccinated intramuscularly with the second 0.5 mL dose of GARDASIL (Lot# was unknown) and on 11-JUL-2007 the patient was vaccinated intramuscularly with the third 0.5 mL dose of GARDASIL (Lot# was unknown). In February 2009, the patient started developing a seizure disorder. The patient sought medical attention by specialist visit. At the time of the report, the patient's seizure disorder persisted. Upon internal review, seizure disorder was determined to be an other important medical event. Additional information has been requested.
A little tired/I was tired; Headache/I had a continuous dull, throbbing headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (A little tired/I was tired) and HEADACHE (Headache/I had a continuous dull, throbbing headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Hand operation. Concurrent medical conditions included Osteoarthritis and Writing impaired.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (A little tired/I was tired) and HEADACHE (Headache/I had a continuous dull, throbbing headache). On 18-Mar-2021, FATIGUE (A little tired/I was tired) and HEADACHE (Headache/I had a continuous dull, throbbing headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant follow-up included: updated email address of the primary reporter, updated other relevant history, Event verbatim and event outcome updated.
red whelps on arms, legs & body started on 3AUG98;tx pred x 5 days;1% cream atarax elixir;
This spontaneous report was received from a medical assistant who refers to a female victim of unknown demography, who is also a medical assistant. On an unknown date the medical assistant was administering a vaccine to a patient with RECOMBIVAX HB (therapy type, dosage and lot # were not reported). The reporter stated that the finger flange broke off the syringe and sliced the victim's thumb and she needed stitches in her thumb. The reporter also stated that no other adverse experience did occur with the victim. Product quality complaint (PQC) was filed for the RECOMBIVAX HB syringe issue. The reporter did not provide the relatedness towards the event and the vaccine. Additional information has been requested.