chrisvoncsefalvay/vaers-outcomes huggingface dataset:
booster shot to a patient before the 6-month mark; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster shot to a patient before the 6-month mark) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster shot to a patient before the 6-month mark). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster shot to a patient before the 6-month mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was not sure if she was immunocompromised.  Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
From the time I woke up, on the day after receiving the vaccine I was extremely dizzy. It was so bad all of Sat I could barely move. It is fourvdays later and I am still dizzy, but can function, just slower than normal.
Initial unsolicited report received from a consumer on 18-May-2017. This case involves 22 year-old male patient who was vaccinated with dose of TETANUS TOXOID (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 17-May-2017. Medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify)allergies were not known as per reporter. Illness at the time of vaccination was none. Any other vaccinations within four weeks of vaccinations were not reported. On 17-May-2017, same day following vaccination patient developed fever, headache and soreness of arm at injection site. Laboratory investigations and corrective treatment were not reported. Outcome of the event was unknown. Documents held by sender: none.
COVID arm; Arm only slightly sore; Red spot at injection site/Spots going half way down to elbow; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), MYALGIA (Arm only slightly sore), VACCINATION SITE ERYTHEMA (Red spot at injection site/Spots going half way down to elbow) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Patient had infiltrating lobular breast cancer in one breast and ductal cancer in the other.) and Vasculitis (Patient had vasculitis secondary to an allergic reaction 5-6 years ago to Reclast which patient was taking for osteoporosis.). Previously administered products included for an unreported indication: METHOTREXATE (Patient has been off the methotrexate for 2-3 weeks now.). Concurrent medical conditions included Drug allergy (Allergy to reclast.) and Immunocompromised.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 25-Aug-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), MYALGIA (Arm only slightly sore) and VACCINATION SITE ERYTHEMA (Red spot at injection site/Spots going half way down to elbow). On 23-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, VACCINATION SITE REACTION (COVID arm), MYALGIA (Arm only slightly sore) and VACCINATION SITE ERYTHEMA (Red spot at injection site/Spots going half way down to elbow) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  Patient states that she is feeling fine. Patient also states that with the first two shots she couldn't tell anything and relates the symptoms having now to body producing antibodies.
I was infected with COVID-19; I was infected with COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: en6206), on 01Apr2021 as dose 2, single (Lot number: er8733) and on 09Dec2021 as dose 3 (booster), single (Lot number: ew0196) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29May2022, outcome "recovering" and all described as "I was infected with COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Joint pain, starting in feet, knees, then hands and elbows at time of visit 11/21/19
patient received expired dose of ACT-HIB/no AE; Initial information was received on 27-Jul-2021 regarding an unsolicited valid non-serious case received from a pharmacist via global medical information (GMI) (Reference number- 00699546).  This case involves a child patient of unknown age and gender who was vaccinated with expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received first dose of suspect HIB (PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported that "If a child receives an expired 1st dose of your HIB vaccine, do you recommend giving a replacement 1st dose? Would they receive any protection at all despite being expired? Would this change timing of the next dose? Lastly, Do you have any studies showing extended stability data beyond the expiration date? If about 20 days expired, can it be used?".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   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 the 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.  There will be no information available on batch number for this case.
Staff did not dilute the vial of pediatric Pfizer COVID-19 vaccine and administered 0.2 mL of undiluted drug.  Pediatric patient received 30 mcg instead of prescribed 10 mcg dose.
This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received 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 fever and muscle pain. On an unknown date, the outcome of the fever and muscle pain were recovered/resolved. It was unknown if the reporter considered the fever and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The reporter gave consent to follow up. This case was 2 of the 2 cases, reported by the same reporter.
Hives started to appear 2h after second dose fist on lover torso,  these disappeared overnight, the next day  more hives appear around neck, chin, hair line.
itching; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and RASH (Rash) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) from 31-Oct-2023 to an unknown date for an unknown indication.    On 31-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 31-Oct-2023, the patient experienced PRURITUS (itching) and RASH (Rash). At the time of the report, PRURITUS (itching) and RASH (Rash) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The patient got Spikevax at noon time, she just broken out into a rash under her waist and on her back. The patient received 3 original shots and 2 or 3 boosters after, and she reported all the doses were Moderna, the patient drank a ton of water concomitant supplements and vitamins.
Diagnosed with pericarditis on 11/15/2021 at ER Prior to this date, joint pain was experienced.
Anaphylaxis - swollen tongue, swollen lips, difficulty breathing, body numbness and tingling
Patient showed picture of arm with bandage still applied. Erythema, pain and redness over lower portion of deltoid beginning at lower portion of bandage and extending in direction of elbow. Estimate about 2.5 in. by 3 in. area. No anaphylaxis or pruritus. No hives. Limited to local area. Full recovery in 2 days.
her arm became swollen; red and itchy; red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (her arm became swollen), ERYTHEMA (red and itchy) and PRURITUS (red and itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001652) for COVID-19 vaccination.     Concomitant products included CLOZAPINE for Sleep disorder.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PERIPHERAL SWELLING (her arm became swollen), ERYTHEMA (red and itchy) and PRURITUS (red and itchy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (her arm became swollen), ERYTHEMA (red and itchy) and PRURITUS (red and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 20-Apr-2021, the patient developed a rash which she describes as white on the inside and red on the outside, similar to a bull's eye and the rash 2.5 inches in diameter.  The patient mentioned she gently cleans her arm everyday with Isopropyl alcohol.
Same day of vaccine, the pt became irritable and began screaming at 4:00 PM lasting until 2:00 PM the following day. Pt was taken to the hospital at 12:45 and the pt stopped screaming at 2:00 PM. Left the hospital at 3:00 PM.
Prescribed me Paxlovid and started I taking it; Prescribed me Paxlovid and started I taking it; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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), outcome "unknown" and all described as "Prescribed me Paxlovid and started I taking it". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a pharmacist concerning her son who was vaccinated with VARIVAX (Oka/Merck) a while ago.  The patient developed a circular rash around injection site.  The pharmacist stated the she does not remember where the injection site was, and can not be sure the reaction was caused by VARIVAX (Oka/Merck) or another vaccine.  Unspecified medical attention was sought.  The patient recovered.  No further information is available.
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and unknown gender. Concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On an unspecified dates the patients were vaccinated with exposed to 44F doses of PROQUAD (Merck), (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. No adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
On May 18 woke up with a gray field in upper part of vision field. Have lost 80% of vision in the right eye. Dx with NAAION. Damage to optic nerve.
A non serious spontaneous report of fever, runny nose and sore all over has been received from a consumer/non health professional concerning a 29-month-old female, subsequent to H1N1, Intranasal. Neither the patient's past medical history nor the concomitant medications have been reported. The patient received H1N1, Intranasal on 20-Nov-2009 for an unknown indication. The reporter stated that three days after receiving the vaccine, on 23-Nov-2009, the patient developed the symptoms of fever, runny nose and sore all over. The outcome of all these events was unknown.
Patient received first COVID-19 Moderna vaccine on 1/30/21 at Hospital. Three weeks later he received a COVID-19 Pfizer vaccine at another Hospital. Today (4/16/21) patient presented to receive his second  COVID-19 Moderna vaccine. Per CDC recommendation, no additional doses are recommended. This was explained to the patient and he was sent home.
On 01/28/2023, as soon as I woke up, I had a scratchy throat. I had full body aches, fever, respiratory issues, trouble breathing, coughing.   I took it easy and rested for a week. I took Ibuprofen and Robitussin. I have recovered, but still have a lingering cough.
swelling in lt arm w/rash; pt is limited to mobility; red blotches; cellulitis of lt arm devel;
pt recv vax 19MAY98 & 4 days later pt exp diarrhea, confusion & abd pains;some time later the pt exp resp distress, renal failure, myocarditis & septic shock;pt seen by MD & sent to ER:pt adm to ICU;1JUN98 pt still on ventilator-stable;
received only the HIB powder portion of PENTACEL, with no reported adverse event; PENTACEL that was diluted with normal saline, with no reported adverse event; Initial information received on 17-Nov-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and non-healthcare professional via phone via Global Medical Information (GMI) (Reference number- 00862514).  This case is linked to case 2021SA388584 (CLUSTER).  This case involves a 1 years old male patient (date of birth: 15-AUG-2020) who received only the haemophilus influenzae type b (HIB) powder portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product preparation issue) and that was diluted with normal saline (product preparation error).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination.  On 16-Nov-2021, the patient received a (fourth, 0.7 ml) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (once, total, lot number: UJ580AAA and expiry date: 10-SEP-2022) via an intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique and wrong solution used in drug reconstitution (same day).  It was reported "Caller states that after checking the refrigerator to see how many doses of the DTAP-IPV liquid portion of PENTACEL and HIB powder portion of PENTACEL were remaining, it was determined that two patients on 16NOV2021 received only the HIB powder portion of PENTACEL that was diluted with normal saline by a nurse in the facility. Caller asked if this would count as a valid ACTHIB dose for these patients or if they required re-vaccination with PENTACEL. Caller asked if the Safety department would attempt to contact the patients prior to the doctors in the practice having the opportunity to address the situation with the patients' families. Caller asked for information regarding the HIB portion of PENTACEL not counting as a valid dose if administered with any diluent other than 0.4 percent NaCl saline solution."  At the time of reporting, no adverse event reported.   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 by the regulatory authority. 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.
Patient received PENTACEL injection by itself (IM) in right lateral thigh.  5 hours later mom called stating his right leg was swollen and warm to touch.  Also that he was crying.
Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female patient with no pertinent medical history and no known drug reactions/allergies who on 18-AUG-2009 was vaccinated with the first dose of GARDASIL (lot no. 661953/1130X). There was no concomitant medication. The nurse reported that after vaccination the patient started vomiting that evening and her mother called the emergency room that evening and they recommended calling the nurse. The mother called the office next morning to report that the patient had been vomiting on 18-AUG-2009 and 19-AUG-2009. A home pregnancy test was positive. The patient had denied being pregnant on 18-AUG-2009 prior to being vaccinated. It was not known if the patient will be followed at the health professional department or by a physician. The patient's LMP was unknown. Follow-up information has been received from a registered nurse who indicated that on 18-AUG-2009 the student with no illness at the time of vaccination was vaccinated with her first IM dose of GARDASIL (lot # 661953/1130X) in her left arm. Concomitant vaccination administered on 18-AUG-2009 included a first IM dose of BOOSTRIX (lot# AC52B031AB) in her right arm. The registered nurse stated that the patient's mother called the next day after vaccination and mentioned that the patient had vomited the night of 18-AUG-2009, went to the ER (Emergency Room) and had a positive pregnancy test. At the time of the report, the outcome of the patient was unknown. Additional information is not expected.
3/3/2010 Pt. came in for lab results and mentioned he had experienced a worsening of agitation, decreased hearing, dizziness similar to symptoms he had when he was diagnosed with viral meningitis.  No treatment was rendered.  Pt. stated he asked his chiropractor and he mentioned concern about mercury component in vaccine.  Vaccine given to patient was thimersol free, single dose vial.  Client wondered if vaccination could possibly caused minor flare up of symptoms.
The patient developed hives on both arms and behind his knees and near the joints. The patient's lip was swollen in the A.M., but the shot may not be related.
received a YF-VAX intramuscularly rather than subcutaneously with no reported adverse event; Initial information was received on 21-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 48 years old female patient who received a yellow fever vaccine [Yf-Vax] intramuscularly rather than subcutaneously with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine and polio vaccine for Prophylactic vaccination.  On 21-Jun-2023, the patient received a 0.5 ml, total dose of suspect yellow fever vaccine  Solution for injection (lot: UJH20AB, expiry date: 28-May-2024, strength: Standard) via intramuscular route in  Left deltoid for Immunization.  On 21-Jun-2023 the patient received a yf-vax intramuscularly rather than subcutaneously with no reported adverse event (incorrect route of product administration) (Latency: same day) following the administration of yellow fever vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
MY HUSBAND RECEIVED HIS SECOND COVID SHOT AT 1:30 PM AND WHEN I CAME HOME AT 5:30ISH HE WAS BEET RED ON HIS FACE ARMS AND UPPER BODY. HIS LEGS LOOKED FINE.  HIS COLORING  LOOKED LIKE HE WAS HOLDING HIS BREATH. HE FELT FINE AND HIS BLOOD PRESSURE WAS FINE. MY SON WAS ALSO CONCERNED WHEN HE SAW HIS COLORING. IT ENDED UP GOING AWAY AND THEN AGAIN IN THE MORNING IT WAS BACK AFTER HE WAS UP FOR A WHILE. THE REDNESS HAS SUBSIDED BUT HE IS STILL A LITTLE PINK . NO OTHER SYMPTOMS
12 hours after receiving the vaccine I experienced: -Chills -Headache -Body Ache -Fatigue  Headache and Fatigue lasted for 24 hours