chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness and swelling right after injection (Hib) administered on RV IM at 8:50 am 6/19/2014. Ice pack applied on affected area per RN instruction. Patient was observed in office 30 min after swelling noted. Patient in no acute distress. Pt discharged. Site was warm to touch.
Itchy; Hard; Very painful; Redness/big red; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Redness/big red), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PAIN (Very painful) and VACCINATION SITE INDURATION (Hard) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concomitant products included LITHIUM, CITALOPRAM and FREMANEZUMAB (AJOVY [FREMANEZUMAB]) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness/big red) and VACCINATION SITE SWELLING (Swelling). On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Very painful). On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE INDURATION (Hard). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Redness/big red), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PAIN (Very painful) and VACCINATION SITE INDURATION (Hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included unspecified lotion.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, and excluding any other etiology, a causal relationship with the event cannot be excluded. The reported events are consistent with the known safety profile of the vaccine.
Rash on left  arm seven days post vaccine, then rash on right arm 11 days post vaccine then rash on abdomen 14 days post vaccine. Wide spread itching still 19 days post vaccine
Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
My first vaccine dose was Moderna and two weeks later I had a localized rash and giant lump on my arm. For my second dose I did Pfizer and had a grand mal seizure in my sleep at 4 am 6 months later.
Fever 104F, high fever lasting 48-72 hours (Tylenol dropped it to 101F. Eczema along both arms (Dorsal surface). Baby's demeanor changed with inability to sleep only 10-20 min at a time with screaming agitation and increased startling lasting 3 weeks. Prior to shots baby was happy, mild mannered slept through pm except waking once to nurse after 6 hours. Mother does not drink caffeine, smoke or drink alcohol. As of 08/12/2005 seems to be improving. Eczema healed. Still no sleeping > 20 mins.
Expired vaccine was given to pt.  Unware of that the vaccine was expired when it was given due to see other co-worker drawing up the vial I also drew up the remaining dose in the vial passed it on to supervisor who stated to draw up vaccine and see how many are left and give. When found out that vaccine was expired patient was notified. The patient was aware of the error.
Patient began with new onset headache (no hx headache) within a few days of receiving vaccine (2nd). Self medicated and eventually headaches went away within 1 week. About 1 month later, headache returned with severe intensity. Presented to er. Had lumbar puncture. Elevated monocytes in fluid analysis.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: RAISED RASH AT INJECTION SITE-Medium
soreness; This is a spontaneous report received from a contactable consumer or other non hcp. A patient of unspecified age and gender received 1st dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine,Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 1, single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced soreness on an unspecified date.Caller was asking if the of use CVD Topical Ointment, the medical marijuana ointment for soreness is excluded from the medications you're not supposed to use before or after getting vaccinated.The outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Information has been received from a nurse concerning a 20 year old female with pertinent medical history, allergies and concomitant medications reported as none, who on 06-MAY-2008 was vaccinated with the first dose of GARDASIL, 0.5ml, IM, (lot# 659964/1978U).  On 07-MAY-2008, one day after receiving GARDASIL, the patient developed red, blotchy areas on both arms.  The areas of redness were intermittent, reappearing at night.  Unspecified medical attention was sought via the telephone and and resolved completely on 09-MAY-2008 without treatment.  Additional information has been requested.
One day post vax the pt noticed redness, warmth and swelling on left arm (area approximately 4 X 4 inches), with chills and generalized fatigue.
shingles rash from breast to armpit around to back in a line on right side; muscle knot in back; shingles rash/ rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles rash from breast to armpit around to back in a line on right side), myofascial spasm (Verbatim: muscle knot in back) and rash (Verbatim: shingles rash/ rash).  The outcome of the shingles, myofascial spasm and rash were resolved.   It was unknown if the reporter considered the shingles, myofascial spasm and rash to be related to Shingrix.     It was unknown if the company considered the shingles, myofascial spasm and rash to be related to Shingrix.   Additional Information: GSK Receipt date: 26-SEP-2023 The patient self-reported this case. The reporter stated that she received Shingrix dose 1 about a year ago from reporting and within 3 days, she experienced shingles rash from breast to armpit around to back in a line on right side.  The patient stated the rash went away within a week-10 days and the muscle knot took about a month to resolve.  The reporter did not consent to follow-up.
Patient came into office crying in waiting room while waiting for immunizations. Once she got back to room she was very upset and stated she felt like throwing up. I let her sit for a few minutes to calm down. I gave immunization and immediately she felt dizzy. I had her lie down on the exam table. She laid there for about 10 minutes. She drank water and ate some crackers because she had not eaten. She was able to sit up and walk without dizziness. I instructed her to eat something and if she is not feeling well to lie down. Also if it gets any worse go to the emergency room. Walked patient to car. BP lying down 108/49 and sitting up 106/65.
NAUSEA VOMITTING DIARRHEA CHILLS MUSCLE JOINT PAIN GENERAL MALAISE LIKE HAVING A HEAVY  FLU NO FEVER SLEEPY STAYED IN BED UNTIL 02/12/2021 SLOWLY RECOVERING
Fever 102.9, fatigue, headache, ache, cough, nasal drip, sneezing
warm; raised lump size of coke can; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm) and VACCINATION SITE SWELLING (raised lump size of coke can) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm) and VACCINATION SITE SWELLING (raised lump size of coke can). At the time of the report, VACCINATION SITE WARMTH (warm) and VACCINATION SITE SWELLING (raised lump size of coke can) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medication was not reported.
Almost killed me never again; Initial information was received on 01-Feb-2021 regarding an unsolicited non-valid non-serious case from a consumer/non-health care professional via social media.  This is a non valid case as event is unevaluable.  This case involves a patient (unspecified age and gender) who had almost killed me never again(unevaluable event), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Cardiac disorder and Chronic obstructive pulmonary disease.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious almost killed me never again (unevaluable event) unknown latency following the administration of INFLUENZA VACCINE.   No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
08/26/22 presents to ED for "chest pain" "nausea and vomiting". PMHx of "GERD and HTN"
A sales representative reported that a 12 month old received Prevnar, Varivax and Hep-B on 10/4/00 and the next day, developed "swollen eyes which were almost shut for a couple of hours". The reporter indicated that the child's mother has a history of allergies. Additional information received on 10/16/00, from the sales representative, included the Prevnar lot #. Additional information received on 10/23/00, indicated that the pt developed an injection site reaction, the evening of immunization characterized by a raised area of redness and warmth at the Prevnar injection site. The pt recovered.
Swelling; Itching; Hot fever in her arm; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 69-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced swelling, pruritus and feeling hot. On an unknown date, the outcome of the swelling was recovered/resolved and the outcome of the pruritus and feeling hot were unknown.   It was unknown if the reporter considered the swelling, pruritus and feeling hot to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles vaccine and experienced swelling, itching and hot fever in her arm. The patient experienced same event when she received Shingles vaccine (refer case US2019074965) The reporter consented for follow up. This case has been linked to case US2019074965, reported by the same reporter for the same patient.
SORE ARM AFTER 1 WEEK. BLACK AND BLUE ARM . RAISED UP, SWOLLEN, ITCHING, WENT AWAY 3 DAYS LATER. TOOK TYLENOL
Same day of injection: general malaise and tiredness within 2 hours of shot Day 2: malaise and tiredness lessened, but incredible soreness to injection site (left deltoid) Day 3: moderate diarrhea
Began on 4/3/00, had 10 lesions scattered on body and chest. Sibling had varicella on 3/22/00. Mother had shingles a few weeks ago.
Patient received first dose of Moderna vaccine  About 30 minutes later had bradycardia, diaphoresis, N/V and malaise
I was feeling like I had the flu and I couldn't stop blowing my nose and sneezing. I was very weak, and I couldn't hold my urine, I had no strength. I kept coughing and my chest hurt, and my daughter gave me a COVID-19 test and it was positive. So I want to a urgent care for another test and they confirmed that I did have COVID-19. They prescribed me a dual antibiotic that was supposed to make me feel better. It wasn't approved by the FDA but it was supposed to lessen the episode. The antibiotic was really strong and made me feel nauseous. I had severe coughing for a while but it finally tapered off after a month. Ever since I've had COVID-19 I just don't feel well. I still have fatigue, and my nose is sore, and general weakness. I just don't feel the same.
Dizziness.  I can't sit up in bed or stand up.  I was fine earlier in the day   I laid down to rest and the dizziness started when I tried to get up.  I have been diagnosed with Meniere's disease but haven't had problems for 4 years.
Intense arm pain near injection site starting 2 hours after shot. About 12-17 hours after shot, started to feel moderate cold symptoms: headache, congestion, sore throat, body fatigue. Still feeling these symptoms about 36 hours later. Don't seem to be improving. Arm pain has also not improved in 36 hours.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patient details. This report refers to a 6 months old infant patient of unkown gender. On 12-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date: 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reported. Additional information is not expected.
On 11/5/00, complained of sore throat with no temperature or chest discomfort. On 11/6/00, complained of hip discomfort, unable to place weight on leg (1998 had a hip replacement). Had generalized aches and discomfort x 7 days. MD dx-flu disease on 11/7/00.
Presented to COVID Vaccine clinic to receive 3rd Vaccine (immunocompromised); verbalized prior history of mild-mod reaction to 1st Moderna that she self-treated with Benadryl, no Epi or ED evaluation; second vaccination, similiar sx's slightly worse but still no Epi/ED visit;  Received 3rd vaccine, being observed x 30 minutes; after 15 minutes described sx's similar to previous moderna vaccinations--tingling feeling in mouth/tongue, throat clearing, tingling right side of face (all experienced with first dose) but she indicated they were 'worse"; 1102 indicated sx's were worsening--airway clear/good trach sounds/sats good - administered Benadryl--some improvement of sx's within 15 min; continued to improve x 10 minutes then described return of sx's (mouth tingling/tongue feeling swollen, difficulty swallowing although able to take po water); VSS--at this point 911 was called so she could be brought to the hospital for further evaluation and monitoring; No EpiPen was administered
This spontaneous report as received from a male patient with type II diabetes and cirrhosis of the liver refers to himself. On 12-FEB-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, indication not reported, subcutaneously). Concomitant medication included unspecified diabetes medication. There were not drug reactions/allergies. The patient had a rash before he received ZOSTAVAX and after he received the shot the rash became worse in 2013. There was no treatment given for the event. No lab diagnostics studies performed. The patient sought medical attention via saw an unspecified physician. The outcome of the event was reported as not recovered. Additional information is not expected.
Pt found negative Anti HBs 1 1/2 yrs p/vax initial series completed; Given 5 doses 2NOV88, 6DEC88, 24MAY89, 14DEC90, 22MAR91; lot #s 1893P, 0302S, 1238S, 1st, & 2nd dose lot# not recorded;
VACCINE WAS ADMINISTERED 1.5 HOUR AFTER BEYOND THE USE TIME; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-SEP-2021, the patient experienced vaccine was administered 1.5 hour after beyond the use time. On 09-SEP-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was administered 1.5 hour after beyond the use time and incorrect product storage was not reported. This report was non-serious.
This literature marketed report was received from the authors of the literature article. The authors conducted a retrospective cohort study among the patients of unknown age (reported as "older"), with autoimmune or inflammatory (AI) diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), inflammatory bowel disease (IBD), psoriasis, and psoriatic arthritis (PsA), using 20062013 insurance data. The aim of the study was to evaluate the duration of herpes zoster (HZ) vaccine (manufacturer unknown) effectiveness. The vaccinated cohort consisted of 59627 patients. 53.1% of the patients had RA, 1.4% had AS, 20.9% had IBD, 31.6% had psoriasis and 4.7% had PsA. 11.0% of the patients used biological drugs prior to index date, 46.1% used disease-modifying antirheumatic drugs (DMARD). 14.0% used unspecified glucocorticoids at the dose lower than 7.5 mg/day, 2.5% used them at the dose higher or equal to 7.5 mg/day and 83.5% of the patients did not use them at all. Upon evaluation of potential confounders, 26.7% of the patients had diabetes, 24.9% had chronic obstructive pulmonary disease (COPD), 10.4% had renal disease, 11.3% and heart failure, 44.8% had outpatient infection during baseline, 50.7% used narcotics, 27.7% used unspecified antidepressants and 21.8% used unspecified nonsteroidal antiinflammatory drugs (NSAID). On unknown dates, the patients were vaccinated with a dose of  zoster vaccine live (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. To understand long term effectiveness and avoid misclassification related to healthcare associated with vaccine administration, follow-up started from 30 days after the vaccination date or corresponding calendar date in the matched cohort, and ended at the earliest of first HZ, death, loss of coverage, or 31-DEC-2013. Matched patients were censored if they were subsequently vaccinated, and then included in the vaccination group and re-matched. The maximum follow up time was 7 years post-vaccination. HZ was diagnosed using an International Classification of Diseases, 9th (ICD-9) inpatient diagnosis code alone or an outpatient diagnosis code plus antiviral medication (famciclovir, acyclovir, valacyclovir) within 7 days of HZ diagnosis. This report refers to 315 patients who, on unknown date, developed HZ in the 2nd year after the vaccination (considered as lack of efficacy). The authors concluded that the duration of HZ vaccine (manufacturer unknown) effectiveness waned over about 5 years among older patients with AI conditions, many of whom were treated with immunosuppressive and immunomodulatory agents. This is one of several reports from the same literature article (cross-referenced with MARRS # 1703USA010321, 1703USA010593, 1703USA010594, 1703USA010595, 1703USA010596, 1703USA010597). A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010321:
Bivalent booster when patient was breastfeeding; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Bivalent booster when patient was breastfeeding) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Bivalent booster when patient was breastfeeding) and NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Bivalent booster when patient was breastfeeding) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant and treatment medications were reported   This case was linked to MOD-2022-656355 (Patient Link).
The patient developed numbness to left cheek and tightness in her chest 30 minutes after she received the vaccine. The patient was seen in the ED and given Benadryl and Pepcid. She never developed a rash or difficulty breathing. He O2 sat was 98% and ED provider told patient she more than likely had a panic attack.
At 8:00am on 8/12/21 I woke up with body aches, headache and a terrible upset stomach. The upset stomach is persisting to date. My stomach is still quezy and my back hurts also behind my stomach. I contacted my doctor's office and they instructed me to get another COVID test, which I did and it came back negative.. It has been over a month since the shingrex shot and I'm still not feeling 100%. I did not get the second dose of the shingrex shot.