chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Merck employee concerning a 6 year old female who last week (between 23-JUN-2008 to 29-JUN-2008) was vaccinated with the second dose of VARIVAX (Merck). Subsequently, the patient developed swelling, redness and a poc mark at the site. The patient went to the emergency room and was treated with antibiotics. The outcome of the adverse events was not reported. No further information is available.
Booster given 12 hours past vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours past vial puncture) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours past vial puncture). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours past vial puncture) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment details were reported.   This case was linked to MOD-2021-416295 (Patient Link).
Case received from a Healthcare Professional on 11 October 2010 under the local number 10-0700. Two patients (not identified), with no reported medical history and concomitant therapies, had received a dose of ADACEL (batch number C14B091AA was a not valid lot number for Sanofi Pasteur, route and site of administration not reported) on an unspecified date. Patients experienced lesion, swelling and redness at injection site on an unspecified date. Outcomes were not reported. Documents held by sender: none.
Information has been received from a pharmacist regarding to a patient of unknown age and gender. On 16-OCT-2012, the patient was vaccinated with an expired dose of PNEUMOVAX 23 INJ, (dose and route were not provided) (lot number 669579/0595AA, expiration date 30-AUG-2012). No symptoms reported. Additional information has been requested.
Rash on 75% body (small, raised, red bumps), dizziness, mild light-headedness. Lasted 1 day.
SEVERE VACCINE INJURIES; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe vaccine injuries. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe vaccine injuries was not reported. This report was non-serious. This case, from the same reporter is linked to 20221222509. Sender's Comments: This report is for multiple patient. Number of patients- numerous (not known exact number of patients).
Fever; Arm pain came back like a nerve pain, it felt like its stabbing in middle of the arm; Arm pain on site of injected; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Arm pain came back like a nerve pain, it felt like its stabbing in middle of the arm), VACCINATION SITE PAIN (Arm pain on site of injected) and PYREXIA (Fever) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), LOSARTAN and PANTOPRAZOLE for an unknown indication.    On 11-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced VACCINATION SITE PAIN (Arm pain on site of injected). On 22-Aug-2021, the patient experienced NEURALGIA (Arm pain came back like a nerve pain, it felt like its stabbing in middle of the arm). On an unknown date, the patient experienced PYREXIA (Fever). On 15-Aug-2021, VACCINATION SITE PAIN (Arm pain on site of injected) had resolved. At the time of the report, NEURALGIA (Arm pain came back like a nerve pain, it felt like its stabbing in middle of the arm) and PYREXIA (Fever) outcome was unknown.            Treatment information not provided.   This case was linked to MOD-2021-317898, MOD-2021-317908 (Patient Link).
Sudden onset of a Burning Hot Red Rash from head to toe with itching & tingling  that lasted about 1 &1/2 hours than slowly cleared up after taking a cool shower
neck pain; A mild reaction; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain) and UNEVALUABLE EVENT (A mild reaction) in a 91-year-old male patient 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 NECK PAIN (neck pain) and UNEVALUABLE EVENT (A mild reaction). At the time of the report, NECK PAIN (neck pain) and UNEVALUABLE EVENT (A mild reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was reported. Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-062327, US-MODERNATX, INC.-MOD-2021-062604.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up document was received. It contains an additional event mild reaction. It contains significant information.; Sender'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. US-MODERNATX, INC.-MOD-2021-062327: US-MODERNATX, INC.-MOD-2021-062604:
Local reaction, swelling throughout the day, then 6/25/2017 pt complained of difficulty swallowing, swollen tongue, racing heart rate.
Patient passed out shortly after vaccination. 911 was called. EMT came and did EKG and asked questions if patient is allergic to anything, has any illness, currently taking any medication? His mother answered no to all theses question. Mom reported that patient was anxious about the vaccines. Patient lost consciousness for a couple of seconds. He regained consciousness 911 was called immediately and patient was fine. Mother proceed to have her two other children 5 and 12 get Pfizer vaccines as well. The other two children did not suffer any adverse event.  EKG was perform, blood pressure was checked, oral question were asked. He was found to be normal
Patient was given 0.5ml instead of 0.25ml booster vaccine, patient was called on 1/19/2022 and denies any problems since vaccination. Letter sent to patient informing of dosage given.
12-12-10 Vomited x6, diarrhea x1 - looked "grey" while vomiting, "pasty" looking after vomiting.
Information has been received from a health professional concerning a patient (demographics unknown) who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 641115/1159L). Subsequently the patient developed a swollen, red and hot arm. Unspecified medical attention was sought. Additional information has been requested.
Needle malfunctioned and vaccine leaked out of seam between needle and syringe instead of being administered intramuscularly.
patient was given the liquid part of Pentacel and not the powder part, the ActHib, no Ae; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 10 months old female patient who was given 0.5 ml the only the liquid part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Batch numbers UJ349AAA, U6841AA ,UJ349AA and expiration date: 22-Jun-2021) and not the powder part, the Act-Hib, via intramuscular route in the left thigh for prophylactic vaccination on an unspecified date (PT: product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique (same day latency).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Client stated the site of the injection was sore like a knot the evening he got the shot and his joints were all achey also had generalized maliase. He took tylenol. Today 11/05/03 there  is erythema to under aspect of the right upper arm which is warm to the touch. Doctor looked at the area as well as the injection site where there was no erythema. He feels he may have had a reaction to an insect bite. He referred him to his private provider for follow-up.
Reconstituted with sterile diluent; Reconstituted with sterile diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 3FE44, expiry date 17-JUN-2024) for prophylaxis.   On 13-MAR-2023, the patient received Shingrix. On 13-MAR-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted with sterile diluent) and inappropriate dose of vaccine administered (Verbatim: Reconstituted with sterile diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-MAR-2023 The Licensed Practical Nurse (LPN) enquired that was the vaccine invalid and how long to wait? The reporter reported that they inadvertently administered a patient with Shingrix lyophilized powder reconstituted with a sterile diluent.  The reporter confirmed that this was an attempt at the second dose of Shingrix series for the patient. The reporter did not consent to follow-up. At the time of reporting, the patient was inadvertently administered with Shingrix lyophilized powder reconstituted with a sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was linked with US2023042731 reported by the same reporter.; Sender's Comments:  US-GSK-US2023042731:Same reporter
May 14th 2021, patient started to show signs of left side of mouth pulling upward, left arm shaking/twitching and eye twitch. After a month of continuous symptoms, patient started to have difficulty speaking, speech slurred and felt like her tongue felt swollen. 5 months later still no difference. One a medication (for tartive dyskinesia though not on mental health medications) that is currently helping ease symptoms as long as taking it.   Had about three days of hallucinations even though mental clarity was intact, no reason as to why, went away after a few days.
Vaccine was administered to the left upper arm. Having limited mobility, soreness, pain, difficulty lifting-pulling. Weakness, dizziness. Left side warmness. Upset stomach.
No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 29-MAR-2020 (as reported), the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes; Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
3 days later Felt bloated and itchy. Rash, raised bumps on Forehead and cheeks.
Redness, went to md, md diagnosed cellulitis, prescribed prednisone, amoxicillin, and zofran
I have been experiencing testicular pain and kidney pain. Throbbing and to a 6/10 scale.
A nurse reported that a female "over 60" tested positive for hepatitis B surface antigen after being vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history included renal failure (cause not reported) treated with hemodialysis. Concurrent medications were not reported. On 02/26/2003, the pt received a 40-mcg injection of Engerix-B. Seven days later, on 03/05/2003, testing for hepatitis B surface antigen was "positive", this test had "previously" been "negative". A healthcare professional was consulted regarding the positive test. The reporting nurse considered the event to be possible related to Engerix-B administration.
Bilateral redness and swelling at vaccine injection site. Patient prescribed cephalexin for treatment of possible cellulitis.
Patient is still 1 week later experiencing pain radiating from shot arm (left) over to right arm and puffiness at injection site.
Unspecific AE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Unspecific AE) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 VACCINATION COMPLICATION (Unspecific AE). At the time of the report, VACCINATION COMPLICATION (Unspecific AE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not  provided.
Flu-like symptoms began Thursday, April 15, 2021 around 12 noon.  Symptoms included very aching joints/bones, fatigue and fever of 100 degrees Fahrenheit.  Right Arm was sore at injection site but I thought nothing of it.   Very sore arm continued overnight Thursday into Friday morning and was so sore it kept me awake.  Woke Friday AM to extreme soreness in upper arm, armpit and shoulder blade on right side.  Area between armpit and right breast was tender to the touch.   Friday evening, right upper arm was extremely sore, and hard to the touch.  Redness on arm looked more it had been slapped...it was not just near injection site.  Took ibuprofen to help with soreness.  Sore armpit area continued through Sunday but get better Monday.  However, lymph nodes near collar bone became hard and swollen and continue to be hard swollen today, Friday April 23rd.  In addition I have been much more tired than usual for the past week despite getting normal, if not more,  sleep than usual.
Patient received first dose of her covid vaccine. She was waiting in a chair where I could see her after her vaccine. About 6 minutes later she said she was feeling dizzy. As I was walking to get her water she passed out. I grabbed the emergency kit and ran out to her, she was conscious and I sat her up and she was able to say her name and birthday. She then began throwing up. I tried to then take her blood pressure because she looked very pale, but she began throwing up again. She then wanted to drink something, provided patient with orange juice and stayed with her until EMS arrived.
This is a spontaneous report from a contactable consumer. A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot: unknown, brand: Pfizer), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Pfizer product) at single dose for COVID-19 immunisation. It was unknown whether the patient diagnosed with COVID-19 prior to vaccination or not. It was unknown whether the patient been tested for COVID-19 since the vaccination or not. It was reported that this was the second shot. The patient described muscle aches and a fever the night of the shot (on an unspecified date in Jan2021) and into the next day. It was unknown whether the patient received treatment for the adverse event or not. No seriousness criteria were reported for events. The outcome of the events was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
One hour post vax, the pt complained of headache. The next day she developed fever with nausea, vomiting, diarrhea, and severe abdominal cramps. States "just feels bad". She also complains of itching at the injection site. No swelling or redness noted at injection site.
The patient reports that after the administration of the vaccine she felt palpitations. Patient with 21 weeks of gestation. The Doctor recommends observing her for 30 minutes which she refers to feeling well and Doctor discharges her.
Blood pressure rise; heart rate went up; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure rise) and TACHYCARDIA (heart rate went up) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (Blood pressure rise) and TACHYCARDIA (heart rate went up). At the time of the report, HYPERTENSION (Blood pressure rise) and TACHYCARDIA (heart rate went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Heart rate: high (High) High.         No concomitant medications were provided.   No treatment medications were provided.  Action taken in response to mRNA-1273 was considered to be not applicable.
Case number PHEH2016US023430, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 30 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in left arm on 18 Feb 2016. On 18 Feb 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error (incorrect product storage).
aches all over body from head to toe Headache fever around 101 some nausea exhaustion  Took Tylenol and seemed to help a little.  All symptoms gone within 24 hours except for exhaustion.  I'm on day 3 and I am still exhausted.
6/10/2021 - ER - Unstable angina  Chest Pain      PT C/O CP - SEVERAL WEEKS, WORSE TODAY, WOKE WITH PAIN - WENT INTO SHOULDERS, TOOK HOME NTG , WITH NAUSEA AND SWEATING,   5/11/2021  - ER- chest pain with high risk for cardiac etiology
Dyspnea, Fever, decreased appetite. Patient fully Covid-19 vaccinated with Moderna with Covid-19 positive
Noticed slight induration (redness/mild swelling) at injection site after 24 hours of administration. Induration disappeared within 3-4 days without any type of treatment.
Patient came to clinic 12/28/22 to get first dose of primary covid vaccine series. The patient was given the Pfizer Bivalent vaccine instead. The covid vaccines were stored in the same container. Now they are stored separately and marked clearly. No s/s of adverse reactions
Chills, fever - 101.5. Dizziness, weakness, nausea, aching. Passed out and hit head - result was a concussion and vertigo! I also reacted to the 1st vaccine. 1st SHINGRIX was Sept 24 - 2018. I did develop fever - 102 chills aching that slowly improved over 3 days. The second vaccine was worse. I have had vaccines my whole life and have never had such a profound adverse effect. I feel there is a problem with the vaccine.
Soreness in arm 4 days Temperature over 100 for 48 hours Intense fatigue for 48 hours Mild fatigue from 48 hour to 4 days
devel shingles on rt buttocks on 9/4/99 dx today by dermatologist;
positive Covid test; positive Covid test; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Nov2021 (Lot number: FF3389) at the age of 56 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jan2022, outcome "recovered" and all described as "positive Covid test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient did not take any other vaccine in four weeks. The patient did not have covid prior vaccination. No known allergies were reported. No other medical history.
06/07/05 Mother describes child with generalized rash 30 or more lesions; red with dark spots in the middle.  Referred to physician.  06/10/05 Reported varicella disease post vaccination, doctor told mom not contagious.
Vaccine frozen instead of refrigerated. Dose administered. Offered revax. will consider revax