chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my husband had both vaccines, but he came down with the shingles/suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the wife for his husband. The age at vaccination was not reported. The reporter stated that her husband had both shingles vaccine, but he came down with the shingles. The reporter also stated that the doctor said the vaccine keeps you from getting a bad case of the shingles so beware. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting
Information has been received from a medical assistant concerning a 10 year old female patient with no pertinent medical history and no known drug reactions/allergies who in 2001 was vaccinated with a first dose of VARIVAX (Merck) (lot# 632719/1241K). On 30-APR-2010 the patient was vaccinated SC with a second 0.5 ml second dose of VARIVAX (Merck) (lot# 665887/1591Y) in her left arm. Concomitant vaccination administered in the patient's right arm included GARDASIL and VAQTA. Subsequently, the patient was back in the office for cellulitis. On 02-MAY-2010 the patient was seen at an after hours pediatric acute care for a left swollen arm. The patient was being treated with KEFLEX and BENADRYL. At the time of the report, the patient was recovering. No laboratory or diagnostic studies were performed. Additional information has been requested.
Case number PHEH2014US024286, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 22 Jan 2015. This report refers to a 19 years old female patient. Medical history and concomitant medications were not reported. She had tolerated vaccines (no further details provided) well in the past. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) left deltoid intramuscularly at a dose of 0.5 ml on 05 Nov 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour 15 minutes. No adverse event was reported following this maladministration. Follow-up from a nurse received on 22 Jan 2015: Site of vaccination (left deltoid) and other clinical relevant information on previous vaccinations in the narrative was updated.
Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old patient who received Hepatitis A vaccine (batch number LY35X) for prophylaxis.   On 09-JAN-2023, the patient received the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Only received the Rotarix diluent; Only received the Rotarix diluent; This case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a 6-week-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received only the Rotarix diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient was receiving multiple vaccines at the same visit. It was realized after the fact that the patient only received the Rotarix diluent. No further information was reported. The follow-up would not possible as no contact details were available.
After receiving the vaccine I had the occasional sore arm and was experiencing chills for the first 3 days. Later on throughout the month I started to experience heart palpitations. I mentioned them to my PCP and he advised me to use a heart monitoring system until they could find out the reason why I was experiencing them out of nowhere.  Also I have an appointment coming up to check out what is going on with my hip. I have been experiencing hip pain ever since receiving my 2nd dose of the vaccine. They are sending me to an orthopedic after they did an xray and seen how it was slowly deteriorating.
10 minutes post vaccination pt reported tingling in right arm that spread to the fingertips. V/S were taken, HR 80, T97.9, SpO2 98%. BP monitored BP 137/93. Pt observed for additional 15 minutes. Electrolytes given for rehydration. Discharged at 1712. Pt reported feeling better.
Received DTAP, swelling, hot skin, lump developed about 48 hours later. I don't know the outcome yet.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment medication  was not provided .
mild  left upper arm soreness; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EL3247; Expiration Date: May2021), via an unspecified route of administration, administered in Left arm on an unspecified date as single dose for covid-19 immunisation. Medical history included cardiac valve disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, 9 hours after receiving the vaccine, the patient experienced mild left upper arm soreness. No other symptoms. Event took place after use of product. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected
One week after first dose of vaccine, I noticed excessive fatigue and a swollen lymph node in my neck. I did have the normal reaction of fatigue and arm soreness in the immediate days after, but that went away, and the next week I started feeling too tired to do typical daily activities. I am usually a very early riser and I worked out 5 days a week, but suddenly it felt impossible to get out of bed. These same symptoms have continued since January and are not improving. It's a very mild fatigue, but it is still bothersome and it's impacting my functioning.
Presented to office 9/17/03, left thigh red, swollen, c/o "heart racing," slept alot 6/16, had DTaP and IPV on Monday 9/15/03.
patient called following morning, stating the night following her shot she started getting freezing chills, body aches, and had a 102 temperature.  it started a few hours after the shot when she felt warmer than usual at work. also some pain at the injection site
On 6/207 pt. state she developed ringing in her L. ear accompanied by pain. It continued for the next two days without relief. On 6/5/07 she contacted her primary MD to ask for pain medication. She states she then developed numbness on the L/ side of her face and had difficulty sipping/drinking liquids(but not difficulty swallowing).  No fever, rashes or swelling was noted by the patient. She saw her primary MD who began tests. Pt. states she had bloodwork and an MRI of her head.  She states now has difficulty with her L. eye closely simultaneously as her R. eye.  She was told to take ibuprofin for pain and states she has relief from the medication.  She was advised to wear a patch on L. eye at night when sleeping as it is not closing completely. She states that the L. side of her face is "twisted" and not symmetrical.   She is under MD care for the above and no diagnosis has been made yet.
This spontaneous report as received from a physician refers to a 34 year old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 11-JUL-2017 the patient was vaccinated with PROQUAD, subcutaneous for prophylaxis. No adverse event reported. Additional information has been requested.
sleepy; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 22Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Feb2021 09:00 (Lot number: EL9261) at the age of 79 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SOMNOLENCE (non-serious) with onset 12Feb2021 15:00, outcome "unknown", described as "sleepy". Therapeutic measures were not taken as a result of somnolence. No follow-up attempts are possible. No further information is expected.
Pt reports onset of flat, pink rash on trunk, front and back. 1st noticed on 9/17/03, rash is occasionally itchy. Pt states she feels fine, but is concerned and questions if contagious. Phone call 9/17/03 to CDC for verification of non-communicable status after MMR vaccine. Also felt exhausted on 9/18 and 9/19/03. 9/23/03-feels fine.
8 days after administration, developed red rash starting on hands and feet. Rash was painful. Also had slight nausea and muscle pain. Rash eventually spread up arms, back, and neck. Did not have fever, shortness of breath. Was seen by dermatologist and was diagnosed with erythema multiforme. Tested negative for herpes, strep, and other viral infections. Patient did not start any new medications or have any other major life changes. Denies new detergents, soaps, bedding, clothes, etc. Introduced no new foods. This has not happened to the patient in the past.
headache; had a little migraine; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number EW0IS) via an unspecified route of administration, administered in left arm on 08Apr2021 as single dose for COVID -19 immunisation. The patient medical history and concomitant medications were not reported. On 08Apr2021 the patient experienced headache, had a little migraine. Caller stated he had the first dose of the Pfizer COVID vaccine today and had a little migraine; stated he did not eat a lot today and had a headache that occurred after the vaccine; caller stated he was calling to see if he could take Aspirin BC powder or Tylenol or something and known once he taken something like Tylenol, he will feel better. Caller aware that we could not provide treatment recommendations or medical advice and was referred to his HCP. Caller stated he did not think the headache had to do with the vaccine, but he did not eat and did not know but the headache just up and started. HCP information: Caller declined HCP information and stated he did not have HCP. Caller stated he had the Pfizer COVID Vaccine about 10:25 am and the headache began after that. Stated the headache was not like it was earlier and he got something to eat so he was 80 percent feeling a little better. Caller stated he had not required treatment for the reported event at this time. No follow-up attempts are possible; information about lot/batch number cannot be obtained. The outcome of all events was recovering.  Communication: Caller stated the lot number for the Pfizer COVID vaccine was handwritten on his patient card and he thought it was EW0IS; captured as stated by the caller; stated his card did not have the NDC or expiry date written on it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severely sore arm, lethargy. Minor seemingly mostly healed nick on knuckle on same arm as injection became very swollen and painful within a few hours. Increasing malaise and edema required treatment with antibiotic injection and oral antibiotics. Slow to respond.
Per pt, had body aches and flu like symptoms on the 2nd day and by the 3rd day there was an acute change in the mental status and became oriented by the 5th day at 1 pm.
Information has been received from a consumer concerning her 16 year old daughter who on 31-JUL-2008 was vaccinated with a dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). On 01-AUG-2008, the patient "woke up feeling fine, but after riding her bike to work, she was dizzy and pale, her hands were shaking, and she felt her knees not going to hold her up". The consumer took her daughter home from work and the patient "fell right asleep". The reporter was concerned she would have to take the patient to the hospital to seek medical attention. No further information is available.
He got his vaccine, the next morning when he woke up and he had some body aches, had some night sweats, and was incredibly congested and still is.  He was real irritable as well.  He also had some fatigue.  He took some Tylenol as he had a headache as well, and took some nasal spray to help with the congestion.  He is othewise improving.
Patient came in to show the injection site which was circular, large in diameter beyond site and hot to the touch. Very little swelling. Asked her to use ice, Ibuprofen, BENADRYL and hydrocortisone cream. Asked her to return if symptoms persist. Contacted pt but no response.
achy; feeling tired; febrile; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 65 years old female patient who experienced tiredness (Fatigue), febrile (Pyrexia) and achy (Pain), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history included underweight. The patient's past vaccinations included Influenza Vaccine. Medical treatments and family history were not provided.   On 01-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number and expiry date were not reported] via intramuscular route in unknown administration site.  On unknown date, the patient developed a non-serious feeling tired (fatigue), febrile (pyrexia) and achy (pain), 2 weeks following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests included no lab data.  Final diagnosis was achy, febrile and tiredness.   It was not reported if the patient received a corrective treatment.  The patient was recovered from all events.  Information on the batch number was requested.
22SEP91 bruising began on the stomach, progressed to the entire body; 24SEP91 petechiae & bruising over entire body; roof of mouth purple; 25SEP91 bruising more prominent; Drooling reddish & brown liquid from mouth;
LUE erythema, warmth, within hours of vaccine. In 24 hours c/o pruritus, local.
Headache  Nausea  Arm pain into lymph nodes  Low grade fever  Body aches / chills  Tired  Started evening of vaccine. Currently two days later and still unwell although not as bad as the next day.   Advil, promethazine, Tylenol, were taken.
Narrative: 82yoM admitted due to COVID. Presented to ED with complaints of generalized weakness, fever Tmax 102, chills, cough, and slow onset SOB with wheezing. Patient has received 3 COVID vaccinations. Treated with IV methylprednisolone 125mg x1 dose and continuing on dexamethasone 6mg IV daily.
No Reaction to the vaccine itself. Tested positive on June 22, 2022. Symptoms were cough, nasal congestion, slight fatigue.
Burning in her mouth; Terrible mouth sores on my tongue, inner lips, and gums.; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Terrible mouth sores on my tongue, inner lips, and gums.) and ORAL DISCOMFORT (Burning in her mouth) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced ORAL PAIN (Terrible mouth sores on my tongue, inner lips, and gums.). On 02-Feb-2021, the patient experienced ORAL DISCOMFORT (Burning in her mouth). The patient was treated with ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (MAALOX ADVANCED [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE;SIMETICONE]) ongoing since an unknown date at a dose of 1 dosage form; HYDROGEN PEROXIDE ongoing since an unknown date at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, ORAL PAIN (Terrible mouth sores on my tongue, inner lips, and gums.) and ORAL DISCOMFORT (Burning in her mouth) was resolving.            No relevant concomitant medications were reported.   This case was linked to MOD-2021-256827 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up document contains No New Information.
RECEIVED DTaP &IPV ON 6/9/08.DEVELOPED SWELLING & REDNESS ON LEFT ARM.WAS PLACED ON AUGMENTIN FOR POSSIBLE CELLULITIS OR ADVERSE REACTION. WAS SEEN AGAIN ON 6/11/08. THOUGH SWELLING INCREASED, INDURATION HAD RESOLVED & LOOKED BETTER. ADVISED TO CONT AUGMENTIN, & FU PRN .WE CALLED & LEFT MESSAGE TO CALL US HOW CHILD WAS.
Newborn received Hep B vax and fifteen minutes later the baby was cyanotic and not breathing. The child was stimulated and given O2 via face mask, then the baby turned pink and was transferred to NICU and discharged the following day.
10/10/11 was seen with rash that started 10/8/11 as well as fever 102, decreased appetite and no energy. Rash started as few dots on face then covered face, arms, abd.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was inadvertently administered an expired single dose of VARIVAX injection (lot # L006384 with expiration date at 25-FEB-2017; exact dose, route of administration and anatomical location were not reported), for prophylaxis, which was reconstituted with sterile diluent (STERILE DILUENT) single dose (lot # M024782 with expiration date at 23-FEB-2019; strength and exact dose were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.