chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Given expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. No concomitant medications were provided. No treatment information was reported.
No additional AE reported; 12 doses of PNEUMOVAX 23 were administered to 12 different patient's instead of Prevnar 13; She reports out of those 12 patients, 6 were under the age of 2; This spontaneous report was received from a physician referring to 11 patients, 5 were under the age of 2 years old, (one youngest patient was 6 months old was captured in case# 2107USA007992). Information regarding the patients' pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date in June 2021, these patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (0.5 ml, lot # T021485, expiration date 15-MAR-2022, strength and route were not provided) for prophylaxis instead of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (wrong product administered and product administered to patient of inappropriate age). No additional adverse event reported.  This is one of two reports received from the same reporter. This is a non-valid case due to no patients' identifiers. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T021485; expirationdate: 15-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA007992:
Approximately 20 minutes after receiving the influenza injection on 11/06/2001, client reported that her hands, especially the palms, and her feet were itchy and that her hands seemed to be somewhat swollen, requiring her to remove her rings. RN informed her supervisor and telephoned the HD MD, who advised that this was a "normal variation" and that client should take 25mg of Benadryl when she gets home. About an hour later, around 4:05 PM, client reported to another nurse in Clinic that her bottom lip was itchy, slightly swollen and her tongue was tingling. This nurse consulted with the supervisor, who instructed her to promptly call MD for further guidance. MD advised client to take two 25 mg Benadryl immediately and go home, which client did. By the time the client arrived home, she was experiencing some difficulty swallowing along with some soreness in her throat and was beginning to have some difficulty breathing. Her husband accompanied her to the ER, where she received epinephrine with IV fluids, an injection of Benadryl and an oral dose of Prednisone. She was observed for an hour, her symptoms improved and she was discharged with a Prescription of Zantac and Claritin, as well as continued Prednisone. Client also reports that she has had some local redness, swelling and discomfort in the left deltoid area around the injection site.
Mom reported pt had redness, hard bump at injection site that traveled down his arm. It lasted a week and then went away.  During the week, pt was given ibuprofen OTC.
The pt experienced significant local swelling (twice as big), hot to the touch, redness, pain and tenderness at the injection site. Additionally there was a hard area around the injection site. The pt returned to the office on 2/16/00 and was treated with Keflex for possible cellulitis. The pt recovered on 2/17/00. The most recent information received on 2/18/00 reports the outcome of the pt as resolved.
She's been so sick , sick as a dog; headache that doesn't go away ,It's like a burning headache; She has fevers going up and down - not extremely high, but 99 or 100; She has chills; She's trembling; body pain; body is burning; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (She's trembling), PAIN (body pain), BURNING SENSATION (body is burning), ILLNESS (She's been so sick , sick as a dog) and HEADACHE (headache that doesn't go away ,It's like a burning headache) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Nov-2022, 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 12-Nov-2022, the patient experienced ILLNESS (She's been so sick , sick as a dog). In November 2022, the patient experienced TREMOR (She's trembling), PAIN (body pain), BURNING SENSATION (body is burning), HEADACHE (headache that doesn't go away ,It's like a burning headache), PYREXIA (She has fevers going up and down - not extremely high, but 99 or 100) and CHILLS (She has chills). On 13-Nov-2022, ILLNESS (She's been so sick , sick as a dog) had resolved. At the time of the report, TREMOR (She's trembling), PAIN (body pain), BURNING SENSATION (body is burning), HEADACHE (headache that doesn't go away ,It's like a burning headache), PYREXIA (She has fevers going up and down - not extremely high, but 99 or 100) and CHILLS (She has chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2022, Body temperature: not extremely high, but 99 or 100.         No concomitant medications were reported.  The patient took 4 shots of Moderna. The patient states that she got very sick from the last one that she took in Dec-2021.  No treatment medications were reported.   This case was linked to MOD-2022-674590.
This spontaneous report as received from a health department nurse refers to unspecified number of patients. On an unknown date the patients ws vaccinated with improperly stored LIQUID PEDVAXHIB (lot no. and dose no. not reported). No concomitant medication was reported. No adverse effect were reported. Product quality complaint was not reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Immediately after injection i had extreme fatigue and muscle soreness around the injection site with firm red swelling that lasted for 2 days.  Then on the evening of 2/8/2021 the muscle below the injection site became red,swollen, firm,  warm to touch and itching.  The fatigue also came back. It is 6:38 pm on 2/9/2021 and I am still suffering the above symptoms.
36 HOURS OF HIGH TEMP -102 3 DAYS OF SORE MUSCLES
p/vax pt awoke the next morning & noted pain & red streaking from the inj site to the axilla w/axillary lymph node tenderness;pt seen by MD who dx lymphangitis;
Pt. being monitored after receiving vaccine.  Approximately 10 minutes after dose given left side of face became red, left ear tingling, tingling under left eye.  25 mg oral Benadryl given.  Continued to monitor patient for another 30 minutes.  No further reaction noted.
Complete loss of motion in body. Could not sit without assistance.  Extremely confused. Did not want to eat or drink. Felt terrible.
I received my first dose on 01/19/21, one week later on 1/26/21 the site of injection began to turn red along with soreness and itching.   On 1/28/21 the redness expanded and soreness persisted. I saw my primary doctor who placed me on an antibiotic in case of infection.
Fever that peaked at 105.9F, not eating or drinking beginning am of 6/28/08.  Pt. seen at 2 ERs on 6/28/08.  Given Motrin & IV.  6/30/08:  Mom states child is better; 7/1/08: much better per mom.
The patient received Moderna Bivalent booster dose on this date 1/17/23 instead of the Moderna Monovalent dose for dose #2 in the series. Patient returned back on 3/17/2023 and received Moderna Bivalent Booster.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "recovered" and all described as "tested positive for Covid-19 after receiving 3 doses of PBCV". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive, notes: tested positive for Covid-19 after receiving 3 doses of PBCV; (2022) Negative. Clinical course: Reporter declined to be transferred during call. Reporter providing her age also. (Tested positive for Covid-19 after receiving 3 doses of PBCV) Calling regarding the PBCV and her 2nd booster dose. Patient initial 2 dose series was Pfizer and her 1st booster dose was Nov2021. The patient states patient had COVID 19 disease 01Jun2022 and now tests negative. Reporter wanted to know how long should she wait to get her 2nd booster dose? The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown ages and genders whom since 01-JUL-2015, had been administered doses of  ROTATEQ (lot # K023534, expiration date: 15-APR-2016)(doses and routes not reported) that were improperly stored. No adverse effects reported. Additional information has been requested (correspondence containing a request for additional information is scheduled).
95 cm x 65 cm right arm redness, swelling, full range of motion, cold compress.
This child woke up on 8/29/01 with a rash or hives on his left trunk. Skin was cool to touch. No vomiting or other symptoms. Reported to PMD for evaluation and he recommended Tylenol and Benadryl if hives persist. On 8/31/01, telephone call to mother and she reported that hives had increased to full body but now are resolving. Temperature went to 101F (axillary) but now resolved.
Right side of tongue was swollen making it difficult to eat, drink or talk.Swelling in right side jaw, same side as injection. Dry mouth. Symptoms have subsided slightly after 10 days. Family doctor told me to go to ER if symptoms got worse.
TOOK SECOND DOSE ON DAY 4; This spontaneous case report was received from a consumer (PVX2019-341) on 07-Feb-2019. The report describes a 33-year-old adult female consumer who "took second dose on day 4". The consumer was receiving oral Vivotif (one capsule every other day) for typhoid prophylaxis  It was reported that the consumer took her second dose of Vivotif on day 4. The doses were taken on 04-Feb-2019 and 07-Feb-2019, respectively.   The action taken with Vivotif with respect to the event "took second dose on day 4" was not applicable.  The clinical outcome of the event "took second dose on day 4" was unknown.  Company's Comment: The causality of the event "took second dose on day 4" was considered as not applicable; Sender's Comments: Company's Comment: The causality of the event "took second dose on day 4" was considered as not applicable
0/24/2021: vaccination site a little itchy. Had a migraine at 6pm advil didn?t help. Threw up. Exceeding migraine helped. (Not 100% sure if this is related to the covid vaccine as I have had migraines in the past) 01/25/2021, a week after the vaccination, woke up with vaccination site red, hot, swollen and itchy. Was itchy the previous day but not as severe. Swelling and redness not going down with  ice pack. The red circle around the vaccine site is about 2 inches. I am monitoring if it gets bigger.
hot to touch; pain; A spontaneous report was received from a consumer concerning a 83-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain, hot to touch.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 1900, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the event(s) pain at the injection site (pain scale level 5 -1 being no pain and 10 with, worst pain), hot to touch.  No treatments was taken.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain, hot to touch was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 23-NOV-2015, the patient was vaccinated VARIVAX dose 1, lot # L015045 (dose, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
On June 4th she felt first jerk. Had a seizure on June 29th. After waking up from nap. Jerks are worse during menstrual cycle. Never any health problems before. Now has Juvenile myoclonic epilepsy.
Patient received first dose in right arm. Several days later developed pain in the region of the injection without weakness or numbness. Pain has been persistent. Second dose was given in left arm. At time of physician evaluation (approximately 2 months after first dose), patient reports pain is persistent and unchanged.
PT COMPLAINED OF SEVERE SWELLING. PT  WAS ADVISED BEFORE IMZ ADMINISTERED COMMON SIDE EFFECTS, ADVISED TO TREAT WITH TYLENOL, IBUPROFEN, OR AND ANTIHISTAMINE IF ANY SHOULD OCCUR. IF SYMPTOMS CONTINUED I ADVISED PT TO GO TO EMERGENCY ROOM.  PT DAUGHTER SAID SHE COULDN'T B/C MOTHER HAD COPD
RESIDENT WAS GIVEN ONE COVID VACCINATION BY THE NURSE ASSIGNED TO HALL. RESIDENT TOOK TIME STICKER OFF AFTER RECEIVING VACCINE. THE NURSE ON THE HALL WAS REPLACED BY ANOTHER NURSE. RESIDENT ASKED WHEN SHE WAS GOING TO GET HER SHOT. THE NEW NURSE GAVE RESIDENT A SECOND VACCINATION IN THE OPPOSITE ARM.
p/vax pt exp a high temp lasting days;3/89 pt becam distant;showed no interest in interaction & began making strange hand movements & mannerisms;6/89 pt sleep patterns had been disrupted;became hyperactive & required little sleep;dx autism; Follow-up information received states the pt had been found to have "glue ears." His hearing fluctuates. Grommets were inserted in ears in 12/89, further testing was normal. Pt was retested 7/24/91 and was found to have reduced hearing again. At this same time the pt was not eating very well. He has a language delay. Mental examination revealed a 4-year old boy who appeared to be functioning at an 8-month-old level in all areas except locomotion. He did not appear to have a social deficit which is described in autism, eye contact was good and he would smile and play some baby games. No evidence of avoidance behavior. A child psychiatrist summarized his finding and felt the pt had a general developmental delay in all areas except locomotion. He didn't feel the child fit the category of childhood autism, but thinks th pt could be classified as having atypical autism which is the other term used for children with mental retardation with autistic features. Additional follow-up information from a foreign legal firm reported that the pt's parents completed an annual educational review of their son's progress for 1999. The parents note that there has not been change in their son's general health such as fitness, eating and sleeping habits, diet or medication. They felt that their son is generally happy and is able to cope better in crown situations and that his moods are more settled. The child uses photographs of places while their family is out and about. He seems more reassured to know what is going on.60 day follow-up / provided no additional data.
8/22/21 headache, nausea, body aches, cough, sore throat, fever presented itself.  8/24 cough and tightness of chest started.  Fever was gone.  8/26 rash at injection site was present, 8/28 realized had no sense of taste and no smell.  By 9/1 symptoms other than cough, tightness of chest, taste and smell had gone away.  9/2 Smell and taste were back but still had cough and chest tightness.   Claimed as if she felt like she had pneumonia.  9/7 cough remains.  9/20 cough remains, O2 level drops, high heart rate (per pulse ox), confusion.   9/27 Seizures started.
left cheek is slightly swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (left cheek is slightly swollen) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027620A) for COVID-19 vaccination.     The patient's past medical history included No adverse drug reaction (no reports of individual history).    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 14-Jan-2021, the patient experienced SWELLING (left cheek is slightly swollen). On 14-Jan-2021, SWELLING (left cheek is slightly swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event include antihistamine.   Reporter did not allow further contact; Reporter's Comments: patient is asking wheather she can go with the  second shot or not?because she is not sure if she had an allergic reaction?
Hot rash below the injection site; swelling spread down to the elbow; Both shots still itch and and feels scratchy at the injection sites; Pain at the injection site; Red huge swelling at the injection site; Chills; Headache; Red hot rash below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot rash below the injection site), VACCINATION SITE SWELLING (swelling spread down to the elbow), VACCINATION SITE PRURITUS (Both shots still itch and and feels scratchy at the injection sites), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Red huge swelling at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Neuropathy and Blood pressure. Concomitant products included BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (BISOPROLOL /HCTZ) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot rash below the injection site), VACCINATION SITE SWELLING (swelling spread down to the elbow), VACCINATION SITE PRURITUS (Both shots still itch and and feels scratchy at the injection sites), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Red huge swelling at the injection site), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE RASH (Red hot rash below the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at a dose of 1 dosage form once a day; PARACETAMOL (TYLENOL) at a dose of 1 dosage form once a day and NAPROXEN SODIUM (ALEVE) for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot rash below the injection site), VACCINATION SITE SWELLING (swelling spread down to the elbow), VACCINATION SITE PRURITUS (Both shots still itch and and feels scratchy at the injection sites), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Red huge swelling at the injection site), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE RASH (Red hot rash below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant products also included medication for diabetes, blood pressure and neuropathy.   This case was linked to MOD-2021-274013 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received and Event- vaccination site pruritus and concomitant medications were added.
About six hours the vaccine I got a fever with flu-like symptoms and my arm hurt really bad. My fever was 103-104 degrees. I had a fever for two or three days. I still felt very achy and tired. I could not lay on my arm for two days.. I took some Tylenol and I was given Zithromax after consulting my doctor. After four days I felt better but it was a week before I felt normal.  I got the second dose of the vaccine and the fever was lower at 101 and it only lasted for two days.
shingles; reported it as adverse reaction. It was awful; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles and feels awful. On an unknown date, the outcome of the shingles and feels awful were recovered/resolved.   It was unknown if the reporter considered the shingles and feels awful to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient had the first vaccine and got shingles from it which was lasted several months. The PCP (primary care provider) reported it as adverse reaction and it was awful. The reporter mentioned that, she would never get this vaccine. The follow-up would not possible, as no contact details were available.
MY UNDER ARM IS SORE AND SWOLLEN, I FEEL LIKE THE NERVE OR GLAND THAT GOES UNDER THERE IS SWOLLEN AND IS UNCONFORTABLE AND PAINFULL.
Patient felt faint briefly after receiving the vaccine. Mother assisted patient to floor. Mother believes this was a panic episode induced by the injection as patient has a history of anxiety-related effects following vaccinations. Patient's feet were elevated. Less than ten minutes later the patient was able to stand and left the pharmacy without assistance.
I had a seasonal flue vaccine But I DON?T KNOW WHICH ONE.  At the beginning of October I began having symptoms of Giant Cell Arteritis.  I wasn?t diagnosed immediately, but shortly thereafter I was admitted to the emergency room.