chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 29-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included PYRIDOXINE HYDROCHLORIDE (VITAMINE).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Jun-2020 and the estimated date of delivery was 28-Mar-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 27-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2020, Pregnancy test: positive (Positive) Positive.         Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Headache injection site reaction Narrative:  Pt received 2nd dose of Moderna vaccine on 09/30/21 @ 1450. Reports by the following morning, was experiencing injection site pain/discomfort ("cannot lift left arm to full range of motion"), injection site redness/"rash", headaches ("self-diagnosed migraine", no history of migraines prior), "feels hot", "sweats", fatigue. Did not take any meds for reaction. Did not present to PCP as suggested by RN taking report. Pt also reported "blurry vision-haziness", elevated BP "140/90, usually 117 SBP." No further information provided in report.
Patient came into store and reported soreness/pain with difficulty moving left arm in full range of motion; 3 weeks after shot was given Patient said she has soreness the following day after injection which was the peak pain/soreness but it slowly started to disappear but is still present 3 weeks later.
Pt called 12/12/18 around 11:30 am and reported since she got the vaccine, right the next day she experienced high fever, body ache, lasted a few days, the symptoms got better when she called pharmacy however, she reported that the night before (12/11/18), at the injection site, the area (about the size of the palm of hand) turned red and raised and blotchy. The area is hot to touch and she's got an achy arm. She has been taking Tylenol. Advised pt to see her md so she could be monitored.
Tired; Achy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced tiredness (Verbatim: Tired) and pain (Verbatim: Achy). The outcome of the tiredness and pain were resolved (duration 1 day).   It was unknown if the reporter considered the tiredness and pain to be related to RSV vaccine.     It was unknown if the company considered the tiredness and pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 27-SEP-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received RSV vaccine and experienced tired and achy for a day so receive it now. Follow-up would not possible as no contact details were available.
Pt received vaccine in left arm and instantly felt dizzy. Lowered to floor and legs were elevated. Pt brought to med observation given crackers and apple juice.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 28-OCT-2013 the patients were vaccinated with ROTATEQ lot number J002505. Dose, route and frequency were not provided. On 28-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007697, 1311USA007057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Pt stated has stomach cramps, was sweaty, became very pale, lethargic; Use of NH3 ampule; Exposed to fresh air; Improved w/in 10-15min;
Vaccine was administered and 10 minutes later patient indicated he was getting dizzy with some vision changes and was sweating profusely.  He was administered water and a snack and 20 minutes later was feeling better.
Headache, Myalgia, Arthralgia & Fever Narrative: OTC Tylenol as needed
Swelling around facial fillers under eyes - noticed next morning. Dissipated somewhat but still present as of day 3
This spontaneous report was received from a registered nurse and refers to a 4 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-DEC-2018, the patient was vaccinated with an improperly stored ROTATEQ, orally, lot # R002516,  expiration date 13-SEP-2019 (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 1 degrees Celsius (also reported as from 0 to 1 degrees Celsius) for 15 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved.
Tingling feeling in head and mouth, lasted about 2-3 hours, felt better the next day.
Very sick from it; arm soreness; headache; fever; rash; chills; tired; swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick from it), PAIN IN EXTREMITY (arm soreness), HEADACHE (headache), PYREXIA (fever) and RASH (rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ILLNESS (Very sick from it), PAIN IN EXTREMITY (arm soreness), HEADACHE (headache), PYREXIA (fever), RASH (rash), CHILLS (chills), FATIGUE (tired) and INJECTION SITE SWELLING (swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, PYREXIA (fever) and RASH (rash) had resolved. At the time of the report, ILLNESS (Very sick from it), PAIN IN EXTREMITY (arm soreness), HEADACHE (headache), CHILLS (chills), FATIGUE (tired) and INJECTION SITE SWELLING (swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter  treatment information was not provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Bullous Pemphigoid, eye redness (serious),  swollen stomach, death
SEVERE CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 19-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 20-MAR-2021, the subject experienced severe chills. On 20-MAR-2021, the subject experienced fever. On 20-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills, fever, and nausea on 21-MAR-2021. This report was non-serious.
Client noticed a round red circle on her right arm at the site of injection of her vaccine while she was showering on the morning on 01/19/21. There was no pain, itching, or swelling at the site and no alterations to the skin besides the red circle. The red circle is warm to the touch. It is not painful to touch per the client. It is about 3 inches across. Since noticing the red circle this morning, there have been no changes to the circle.
given a pediatric dose of VAQTA instead of the intended adult dose; No adverse effects; This spontaneous report was received from a nurse regarding an adult patient of unknown age and gender. Information on patient's medical history, concurrent conditions and concomitant therapies was not provided. On an unknown date unspecified patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) strength 50 dose/frequency (dosage form) (dose, frequency were not reported, lot # R034339, expiration date  23-NOV-2019) via unknown route for prophylaxis. On an unknown date the patient was given a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) instead of the intended adult dose (incorrect dose administered). No adverse effects were reported (no adverse event). There was no involvement of product quality complaint (PQC).
5-10  minutes after the injection  I noticed my heart  was beating fast, the EMS  immediately monitored me . My heart rate went up to 160  , O2 sat 98% and blood pressure 160/110. I did not have any itchiness, rashes or difficulty breathing.  the palpitations  lasted for about  10 minutes then it came down to 80.   8 days after the  vaccine injection, my Left arm (injection site) was very red, hot to touch and painful lymphnodes in my armpit.
ringing in ears (high pitched screech)  within 1 hr of vaccine,( getting louder 1 day later), sneezing, fatigue started next day,
had flare of RA; This is a spontaneous report based on information received by Pfizer from the Regulatory Authority (Manufacturer control number US-AMGEN-USASP2021072400) from a contactable consumer (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 2021 as DOSE 3 (BOOSTER), SINGLE for Covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medication(s) included etanercept (ENBREL) taken 50 mg weekly for rheumatoid arthritis on unspecified date on 2021. On an unknown date in 2021, the patient received the "COVID booster" and had flare of RA (rheumatoid arthritis). The outcome of the event was not recovered.   No follow-up attempts possible. No further information expected.
got her second dose about a year or a lil bit more after the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date, about one or more than 1 year prior to the 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, more than recommended interval, which led to lengthening of vaccination schedule. The reporter mentioned that, patient received 2nd dose about a year or little bit more after the 1st dose. The reporter consented to follow up.
Full body skin sensitivity,    less tolerance for heat on skin,    itchy skin around mid section of body.    These symptoms are slowly reducing.
Pain in arm has not dissipated since receiving vaccine. Unable to lift using (R) arm. Experienced pain in every day activities and pain wakes me up at night.
Pt became dizzy, diaphoretic, and warm. Pt was rehydrated by PO fluids and felt better, and wanted to go home. Pt was stable when he left
my sde affect is very sore/is very painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (my sde affect is very sore/is very painful) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (my sde affect is very sore/is very painful). At the time of the report, PAIN (my sde affect is very sore/is very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   Reporter did not allow further contact
Breakthrough. I was at a wedding with others who had COVID. About a week later I started coughing and had nasal congestion that led me to take a Home COVID-19 test that was positive. Went to Urgent Care and tested positive as well then. Was offered Paxlovid, but decided not to take it.
Pt had injection site reaction after getting FLUZONE High Dose 2015 vaccination. Pt right upper hand was looking little bit red, slight swollen. No chill, no fever, breathing ok.
pt recv vax 6FEB94 & 10min p/vax pt began to exp joint pain, fatigue, & skin rxn;pt is under a MD care;sx cont;
First 2 days has muscle aches , chill and fever 101,  Took Tylenol.  third day to now fifth day continued having fever 101 and pain switch to oral . From the third day after shot to now I have had painful swollen gums ( red and puffy),  My tongue  color is white,  its two sides has blisters and middle of the tongue has cracks.  I can't eat the solid food because the pain. lymph nodes under jaws are tender and feel pain when you touch the place,  Consistant have fever 101.
Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves an 18 months old male patient received PENTACEL instead of HEPATITIS B. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE. On 04-Feb-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number, expiry date and dose in series was not reported) via intramuscular route in left leg. It was a case of actual medication error due to extra dose administered and wrong vaccine administered. It was also reported that a 18 month old patient received a 5th PENTATCEL injection instead of receiving the Hep B vaccine. No adverse event was reported. 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.
H1N1 injection, got on November 2. Symptoms started on Nov 8-dizzy, lightheaded, weak, legs feel heavy (fatigued). Felt jittery-still feels this way. Saw Family Dr-12-14-09.
Pt has known hx of febrile seizures.  She developed fever and seizure.  Pt was intubated and admitted in ICU.  Pt was hospitalized for 5 days.
Manufacturer= Merck Sharp & D. Innoculation was given in October, 2017. On 6/6/19 Sudden vomiting and collapse at work from extreme vertigo, was hospitalized for 6 days. Lost 2 weeks of work before returning to work, part time. I was not sick from anything for an entire year and a half prior to this incident. Vertigo is persistent 6 weeks later. (Today is 7/21/18.) I am still fighting vertigo and am going to PT sessions for the symptoms. I believe that such an extreme condition is because of the ZOSTAVAX inoculation causing nerve damage in my vestibular passages.
DID NOT COMPLETE THE COURSE OF VIVOTIF ONE WEEK BEFORE TRAVEL; This spontaneous case report was received from a pharmacist (PVX2019-206) on 22-Jan-2019. The report describes a 49-year-old adult female consumer who "did not complete the course of Vivotif one week before travel". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer started Vivotif today and would be travelling during her last dose.  The action taken with Vivotif with respect to the event "did not complete the course of Vivotif one week before travel" was not applicable.  The clinical outcome of the event "did not complete the course of Vivotif one week before travel" was unknown.  Company's Comment: The causality of the event "did not complete the course of Vivotif one week before travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete the course of Vivotif one week before travel" was considered as not applicable.
PATIENT WAS GIVEN .5ML OF VACCINE (IN TWO .25 SHOTS) AND SHOULD HAVE RECEIVED .25ML
Went to PCP on 12/1/21.  Pain at injection site area..   Treatment:  Naprosyn, 2 week course; twice a day with no relief.  Blood work ordered due to no relief.  Referral to rheumatologist after blood work results.  Rheumatologist appointment date 3/29/22.
Pt recvd 2nd dose of MMR IM & @ time of report there were no noted problems;
10/13/23 Friday, Approx 7:00 pm, about 5 hours after Moderna COVID19 vaccine injection: shaking chills, headache, fatigue, which continued all night and through Saturday, 10/14/23. On 10/14/23, I had bad diarrhea 3x, splitting headache, nausea, shaking chills, body aches, left arm soreness, I also had some weird heartbeats similar to fast heartbeats and skipped heartbeats.
This spontaneous report was received from a pharmacy technician refers to unspecified patients of unknown age and gender. On an unknown dates in 2017 (reported as from 25-OCT-2017 to 01-NOV-2017), the patients were vaccinated with an improperly stored doses of PNEUMOVAX 23, GARDASIL 9 for which was used improperly stored sterile diluent (MERCK). The improperly stored sterile diluent (MERCK) was used to reconstitute properly stored VARIVAX and ZOSTAVAX (for all vaccines dose, route of administration, lot # and expiration date were not reported). Administered doses of vaccines experienced the temperature excursion of -1°C or colder to -9. 7 degrees Celsius for 5 days. Data logger was not involved. There were no previous excursions reported.
24 hours after vaccine was given pt developed redness at injection site 72 hours after vaccine was given patient develop large, red, popular rash on the shoulders, arms, face and neck. Reports rash  felt very warm. No itching, no throat swelling.
Very sore from shoulder to elbow, hard to the touch, redness from injection site to elbow. Headache started about 4 pm, front temples, contact sharp pain
Visited County on 3/21/07 and was given Rx for Ty21a (Live oral typhoid vaccine). Client took Rx to local pharmacy to have it filled. Client did not have Rx filled until 5-2-07. Approximately on 5-9-07, she began experiencing "heart racing" which she reported increasingly severe over the next few days. She sought treatment at her internist's office. She was to wear a holter monitor and several medications.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. medical history was not reported.  The reporter stated that M-M-R II underwent a temperature excursion. It was reported that on 13-NOV-2014 the patient was vaccinated with the improperly stored M-M-R II, 0.5 ml, subcutaneous injection, lot number reported K007107, expiration date 16-MAY-2016. Concomitant medication was not reported. No adverse effect was reported at the time of the report. The outcome of improperly stored M-M-R II was administered was unknown. This is one of several reports received from the same source. Additional information has been requested.
Headache (1 hour after treatment - applied motrin) Fatigue (gone after good night's sleep 25 hours)  Soar arm at injection site (went away in 3 days)
A Pfizer-Biontech Covid-19 bivalent booster  for use in individuals 12 years of age and older was administered by error  to an 8 year old patient. The patient did not develop any adverse side effects.
Right deltoid. Knot at the site of injection, warm to touch, with redness going in to the underarm, started on Thursday 11/30/06 AM. RN spoke with doctor and instructed the client to put either cool compress or warm moist compress, Ibuprofen for pain and elevate arm. Contact medical doctor if symptoms would become worse.
Flu-like symptoms; cold, fever, joints ache, nausea, insomnia, headache and loss of appetite. Started a day after immunizations and lasted 2+ days.
brought to ER w/swelling lt eye 24 hrs p/vax; rash morbilliform anterior trunk & face; swelling went down by the time ER visit; cool compresses to eyelid
This spontaneous report as received from a physician refers to a 13 year old female patient with no pertinent medical history and no drug reaction or allergies who on 23-JUL-2013, was vaccinated with the first dose of GARDASIL (lot # H021861, Exp. Date: 09-OCT-2015) in the left arm. Other suspect therapies included VAQTA administered in the right arm. The physician reported that the patient developed nausea, shivering, sweating, blurry vision with black spots in her vision field and was pale with-in 5 minutes of receiving the dose of GARDASIL on 23-JUL-2013. The patient started to feel better after about 15 minutes (from receiving the vaccine), but then on the same day developed a headache. The patient's symptoms (nausea, shivering, sweating, blurry vision with black spots in her vision and was pale) resolved with-in another 10 minutes (25 minutes from receiving the vaccine), but the headache persisted. The patient was sent to home with the headache. The physician recorded the patient's blood pressure during the adverse event as 90 over 60 and right before the patient was sent to home the patient's blood pressure was 100 over 65. Unspecified treatment was given for the experience. At the time of the report, the patient's outcome was reported as recovering. The patient sought medical attention through office contact. The relatedness for nausea, shivering, sweating, blurry vision with black spots in her vision field, headache and was pale and GARDASIL was unknown. Additional information has been requested.
Our new medical assistant gave a DTAP-IPV combo shot that expired on XX/XX/2022. Kinrix was the manufacturer and 0.5ml was the injection dose. She gave the shots to two siblings on XX/XX/2022. We will be checking our vaccine inventory daily to make sure we do not have any expired vaccine in the fridge. We will be double checking expirations date as we are preparing injections. If we have ant doubt or questions, we will be sure to speak up immediately.