chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the registered nurse. It was reported that GARDASIL were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 30-JAN-2013 was administered a dose of GARDASIL (lot # and expiration date were not reported) that was exposed to temperature of 11 Celsius degree. No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected.
Patient received a fourth dose of HepB at her six month appointment. She received doses at birth, 2 months, 4 months, and 6 months. I don't have a specific onset of symptoms but she was noted to have unexplained increased irritability. In the weeks after she was sent home from daycare with a fever of unknown origin.
Received his 2nd covid 19 vaccination on 3/19 and the following day was walking to the dining room of his facility and became weak and slumped to the floor with inability to get up. he presented to the ER with malaise, body aches, fever 101.4 and inability to ambulate and was admitted to the hospital with new leukopenia and thrombocytopenia
This spontaneous report as received from a physician refers to unknown patients of unknown age or gender. On an unknown date the patients might have been vaccinated with ROTATEQ (dose, route and lot# not reported) with an unsupported temperature excursion. No adverse effects reported. This is one of several cases from the same source. Additional information has been requested.
Information has been received from a nurse referring to a 12 month old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 28-JUN-2016, the patient was vaccinated with a dose of PROQUAD and a dose of VARIVAX (overdose). The lot #, expiry date, dose, frequency and route was not reported for the two vaccines. No adverse effects were reported. Additional information has been requested.
Patient >6 years received Dtap in form of Pediarix vaccine. No adverse outcomes known to patient
Eight days after her injection, Raised bump  that looked like two mosquito bites about the size of two nickels  pushed next to each other; brief 99-101 F fever that lasted only an hour or two for two consecutive nights. Bump turned flat and area got to be more of a red spot in similar size. Resolved itself in 24 hours after redness.  Not serious but worth mentioning because I have read about this fairly uncommon side effect from recent NEJM article, but ghe article stated the effects were coming from folks who had the Moderna shot, and not the Pfizer.
pt recv vax; 3 hr of unconsolable crying beginning about 3 hr p/ vax;
Approximately one hour after the shot, I felt a little weird. About 3 hours after shot, having just walked up stairs, I felt dizzy. I had to hold a table to prevent falling. I felt so dizzy I couldn?t see. Since then I have walked up stairs, slowly, and have not felt dizzy. Also my left arm is sore.
This case was reported by a other health professional via sales rep and described the occurrence of localized erythema in an unspecified number of patients who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was unknown. It was unknown if the reporter considered the localized erythema to be related to BEXSERO. Additional details were provided as follows: The reporter was a Certified Medical Assistant (CMA) or an office manager. The age at vaccination was not applicable for this report. The reporter stated that few patients develop a large circular red ring on their arm after vaccination with BEXSERO. The reporter requested to let her know if GSK had heard anything or if there was a recall on a lot numbers that they might have purchased. The reporter said it was about an average of 2 to 3 patients per box of BEXSERO. The reporter agreed for follow up contact.
Tenderness in left shoulder after first dose; This is a spontaneous report received from a contactable consumer (patient, self -reported). This 62-years-old male patient received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8727 and expiry date: Jul2021) via Intramuscular route, into left upper arm in the muscle, on 22Mar2021, at 13: 15 (at the age of 62-year-old), as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 23Mar2021 at 02:00, the patient experienced tenderness in left shoulder after first dose. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Myalgia fatigue Narrative:  fatigue evening after injection. sore arm  for 2 days.
Patient reports soreness the day after vaccinations.   On 3/5, 7 days after vaccination, patient has complaints of red, hot skin and a welt where the vaccine was administered.  Symptoms have improved with benadryl cream.  She reports continued redness as of 3/8/2021
Patient was seen in our office on 11/21/2007 with recurrent rash on his left thigh at the sitre of his injections.  He experienced a slightly raised red area of about 1-2 inch diameter around the injection site on the day of vaccination.  Otherwise he did well and had no obvious pain or fever. Initial redness faded, then rash returned 11/21/07.  On exam he was noted to be alert and generally well appearing.  He was active, playful, and afebrile.  Focused exam revealed 3 pinpoint erythematous papules on the anterior chest and in addition a coalescent area of erythema, slightly dry papular testured skin of the left upper outer thigh.  It is 3 x 3 cm in size.  It is nontender.  No drainage.  It has been excoriated and there are a couple of scratch marks near this that have a slightly raised welted appearance. 12/14/2007:  spoke to patient's grandmother who reports that he now has bruising at the injection sight and a "half dollar size lump".  Patient is afebrile, cranky.  Injection site area does not appear tender nor is it hot to touch.
Mom called with report of redness, heat, itching, and swelling left deltoid. Asked mom to come in to measure area. Left deltoid hot, red, indurated, swollen measuring 15cm long by 9cm wide. Suggested ice and Motrin PRN.
pt got vaccine at 12:40pm on 11/7/22 and she reported fainting or passing ou at 4 am on 11/8/22. treatment and outcome are unknow as were unable to reach pt and we left her a msg to call us back. she reported it using the survey for the pharmacy
15 hours after administering the vaccine I had an event of severe pain in my left arm (where the vaccine was administered) and consequently severe dizziness and I fainted, I was unconscious for 5 minutes. During this time I was gasping for air, I was twisting making involuntary movements and my eyes rolled. They manage to wake me up with alcohol and syrup. After fainting, I felt tingling all over my body, dizziness and nausea. I fainted and collapsed 3 times total.
Patient received a dose of Pfizer vaccine.  It was noted that the vaccine 5 day expiration date/time was 5/12/2021 @ 930 am.  Vaccine was administered to patient at 10:00 am on 5/12/2021.  No adverse reactions noted during observation period.  MD and management team aware.
The intern administering the vaccines did not add the diluent prior to injecting the patient with the vaccine. The patient was given an injection of the covid vaccine without diluent. Patient was spoken to, and no adverse reaction or events have been reported at this time.
Starting at 0300 on 4/7 and lasting until 1200 pm on 4/11, significant and at times, severe vertigo
Minor itching; some minor rash, mostly on back of arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 15:00 (Lot number: fl9262) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: en6201, prev dose lot unknown: False, prev dose administration date: 24Feb2021, prev dose administration time: 02:00 PM, prev dose number: 1, prev dose vaccine location: Left arm), administration date: 24Feb2021, when the patient was 74 years old, for Covid-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "Minor itching"; RASH (non-serious) with onset Mar2021, outcome "not recovered", described as "some minor rash, mostly on back of arms". The events "minor itching" and "some minor rash, mostly on back of arms" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus, rash.  Additional information: The patient had no known allergies. The patient did not receive any other vaccine in four weeks. Covid prior vaccination and Covid tested post vaccination was reported as no. After 2nd shot got minor itching and some minor rash, mostly on back of arms. Using anti itching creams. seems to help, but problem was still intermittent. Ae treatment was reported as anti itching cream.  No follow-up attempts are possible. No further information is expected.
Initial report was received 27 June 2011 from a health care professional. An unidentified patient had received PENTACEL (lot number, route, site and date of administration were unknown) and an unspecified amount of time later, developed neutropenia and anemia. It was unknown if the patient received any other vaccines within four weeks of PENTACEL. Past medical history, concomitant medications, and laboratory/diagnostic testing were reported as unknown. Outcome was not reported. Documents held by sender: None.
Couldn't breathe or difficulty, took MUCINEX didn't help. Felt the exact same symptoms as if she got the flu. Went to the doctor and talked with him he gave her a MEDROL dose pack to fill if didn't start feeling better.
Pt recvd vax & devel 78x 38mm area of erythema & local tenderness @ the inject site; poss hypersensitivity reaction & poss cellulitis;
soreness @ inj 6-8cm;rt deltoid pink, warm, sl swollen region;cellulitis inj site;3 axillary nodes;1cm in area;
Rash Red rash on scalp Scaling rash in interdigital areas of bilateral hands
I was administering the Pfizer vaccine for the patient's daughter. The patient asked if she could also receive her second dose, I mistakenly administered the Pfizer vaccine instead of the Moderna vaccine. Patient and I were unaware of the mistake until I was documenting the administration of the vaccine. At that time I realized that the patient had received Moderna instead of Pfizer as her first dose.
per pt she felt warm . she was given ice pack and her bp was measured twice. after 30 minutes she felt better and back to herslef
Suprascapular lymphadenopathy noted 3 days after vaccination, unilaterally on the same side as the administration; This is a spontaneous report from a contactable nurse (patient himself). A 24-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), intramuscular in the left arm on 21Dec2020 18:45 at single dose, and then second dose (lot number: EL0142, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 at single dose for COVID-19 immunisation. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported.  The patient experienced suprascapular lymphadenopathy noted 3 days after vaccination, unilaterally on the same side as the administration on 24Dec2020 09:00. No treatment was received for the adverse event. Clinical outcome of the event was not recovered.
No adverse event; HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL); This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. Patient didn't receive any other vaccine in the 4 weeks prior to COVID-19 vaccine.    On 29-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 27-Jul-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)).    No concomitant medication was reported.  It was reported that patient 10 didn't report any adverse events. No treatment medication was reported. This case is reported for patient 10 out of 12 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-737216 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737216:master case
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193;.  This case involves (an elderly) male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  It was a case of actual medication error due to incorrect product storage.  At the time of report 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 holders 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.  Documents held by sender: none.
Per mom child seemed in pain, gradually guarded her walking, avoided walking at times. Child refuses to bear weight or both legs. Able to crawl and move lower extremities normally. No fever, redness and swelling from IZ sites. Per mom stated better now than 3 days ago.
screaming assoc w/jerking of muscles @ 4AM on 1JUL92; fever 101 29JUN92; appeared to have a brief convuls along w/fever; pt seemed to have soreness around shoulders & very cranky most of day;
STOOLS BECAME LOOSER NOW MUSHY TIMES 3-4 DAYS (PATIENTS STOOLS ARE NORMALLY FORMED, IRRITABLITY TIMES 8 DAYS(20 MINUTES AT A TIME)DR. DIAGNOSED PATIENT WITH ACTIVE ROTOVIRUS.
Extremely stiff arm with pain. Whelps across arm. Bad headache ,little fever. Also had pneumonia shot in the same arm.
While in post vaccination observation, alerted staff that she was feeling lightheaded. VS: BP105/52  P60 R18. Alert and oriented x3.  Offer powerade to patient, she agreed. 1003 VS: BP110/78 P60 R18 Patient reports to feeling the same. 1012 VS BP110/76 P64 R18 Patient reports to "feeling a little better," but not quite back to baseline. Agreed to stay a bit longer. 1020 VS: BP110/62 P60 R18 Patient states that she is unsure if what she is feeling now is now more anxiety related. Discussed if her current feeling is any different from any anxiety that shes experienced in the past. She says there is no difference. Agreed to stay for monitoring a little longer. 1043 VS:110/68 P74 R18. Patient states she is feeling okay and is ready to leave. Lightheadedness has resolved.
had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (had a reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 ADVERSE EVENT (had a reaction). At the time of the report, ADVERSE EVENT (had a reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Pain on the left armpit.  Also still feeling pain on the left arm at the site of the shot.
Pt has experienced a numb and tingling sensation to his left index finger and part of his thumb extending up into his forearm. This started a couple days after his second covid-19 vaccine and has not resolved.
He tested positive for COVID-19 on 8/22/2022. He had a fever, cough, stuffy nose, stomach pain, and vomiting. I had to take him back to the doctor yesterday 8/29/22, because he was vomiting again and he had a terrible headache. He is about to be looked at by his doctor to see if he has migraines. When he was diagnosed with COVID-19 the just had him taking TYLENOL, MOTRIN, and MUCINEX. Then, when we went to the doctor on 8/29/22, he was prescribed amoxicillin, MOTRIN, and a compound of PHENERGAN.
expired vaccine used; No addittional adverse events reported; This spontaneous report was received from a nurse supervisor (conflicting information also reported as office manager) referring to a 38-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 02-SEP-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, 0.5 milliliters (ml) as prophylaxis (lot number T014145, expiration date reported as 31-AUG-2021) (route of administration and anatomical site of injection were not reported) (expired product administered). In addition, the reporter mentioned that the administered dose of the vaccine was found to be supported by a memo with no temperature excursions. No additional adverse events were reported in the patient.
Normal mild pain at injection site beginning night of vaccine and extending to a swollen, hot upper arm that lasted four days. Woke day after injection with strong flu-like symptoms that lasted about 54 hours. Symptoms included muscular aches and pains, lethargy, a feeling that I had been hit by a truck as well as feeling very swollen and bloated. It resulted in doing nothing other than watching TV for two days. I am a runner, healthy eater and very active so this behavior is very unusual. I felt a mild fever during this time and had a severe headache. The headache continued for 5 days following the vaccine. In addition, I had GI distress consisting of loose, frequent stools for about 5 days. I have never had a reaction to a vaccine nor but felt compelled as the pharmacy people seemed to think this must be something else since it never happens but it was not. My sister manages pharmacies and asked her pharmacist to speak to the drug rep. Again, it was portrayed that this must not be true. Your website indicating my reactions and that younger people may have more response is what saved my sanity. I will get the follow-up part two vaccine as this is certainly better than getting shingles, I just believe the side-effects need to be more accurately portrayed by the company and its reps so that the pharmacy dispensing can alert people (as well as websites). My husband had the vaccine at the same time and had almost identical symptoms; therefore he is reporting as well.
Convulsions late evening, following morning 6/23/07 more intense clenching and splitting  of eyes.  Seizures. 7/14/08-records received for DOS 6/23-6/29/07-DC DX:Seizure disorder. presented with 1 day history of sudden jerking twitching episodes, eyes roll back and to side. Did not respond to stimuli by tracking. 10-15 episodes during the night. Fussy, less active, decreased oral intake. Emesis. Decrease in amount of wet diapers. One bowel movement today. 1/25/2010 Nonstop seizure that led to epilepsy, intubated due to seizures, that unfortunately resulted to brain injury. Currently has trachey j tube.
Left arm is still feeling pain and numbness causing me to feel horrible when touching certain material with my left hand or feet
1-22-08 Fever, shakes, no wt. bearing, poor appetite. 1-24-08 Unable to bear wt, decreased appetite - ER. 1-25-08 Decreased appetite, still not walking. 1-30 No walking, fever and blotchy rash.
anaphylaxis, hives, itching, lip swelling resolved after 0.2m IM epinephrine  120mg, solumedrol, and 1L NS given.