chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got the shot, hurt like hell; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The patient's husband reported this case via interactive digital media. The reporter stated that he and his wife got the Shingles shot and it hurt like hell but worth it. The reporter stated that his brother had shingles for a year, suffered daily. Additional supportive information: The follow-up would not possible, as no contact, details were available. This case had been linked with case US2022AMR140127, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR140127:Same reporter
Information has been received from a physician, for the Pregnancy Registry for GARDASIL concerning a 19 year old female patient who in November 2008, was vaccinated with her first dose of GARDASIL. The patient was vaccinated with her second dose of GARDASIL in January 2009. The patient became pregnant on an unspecified date after receiving GARDASIL doses. The patient had not yet received her third dose. No adverse effect was reported. The patient had called the physician for medical attention. Follow-up information received from the doctor's assistant indicating that originally the patient transferred to another Health Center. At some point during her pregnancy she then transferred to an obstetrician. The obstetrician delivered the patient who had a Cesarean Section (indication not known, date and outcome unknown). The reporter added that after the patient delivered, she then went back to the Health Center for care. The reporter thought the baby was fine "because she kept the baby and seems happy." Upon internal review, Cesarean section was considered to be an other important medical event. Additional information has been requested.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about concomitant medications, concurrent conditions and medical history provided. On 26-MAY-2015, the patient received an expired dose of PNEUMOVAX 23 0.5 ml (lot # J013555, expiration date 02-MAY-2015) intramuscular. No adverse effects were reported. Additional information has been requested.
Prevnar given to right thigh on 02/05/2002. 2cm sterile abscess 1 day later.
Fever of 105 R started 3-4 hrs p/DTP also continuous crying lasted over 3 hrs; Pt taken to hosp;
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (doses, routes of administration, injection sites, lot numbers and expiration dates were not reported). Administered doses of (Merck) VARIVAX underwent temperature excursion at 7 Fahrenheit degrees. At the time of reporting, the time frame of temperature excursion and information about the previous temperature excursions were unknown. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patients mother stated and wrote incorrect birthday on vaccine admin record. Stated they were not in the registry because they had just moved. When pharmacist later tried to add a patient a near match was found - RPH called primary physician (mother also stated they didn't have a physician) and informed them of the situation. They said no second dose was authorized to be given. RPH called mother to clarify details- mother again stated child was five years old and registry must be incorrect but failed to provide any documentation proving date of birth. No adverse events were reported
Red eyes, congestion, dizziness, fatigue. Treatment was Mucinex, Flonase, and Ofloxacin eye drops. After a week of treatment, eyes are normal, no more congestion, fatigue, or dizziness.
This spontaneous report as received from a physician refers to a 71 year old female patient with heartburn, allergic to amoxicillin and allergic to tetanus vaccine. On 30-JUL-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Lot number and expiration date were not reported. Concomitant therapies included PEPCID. The physician reported that a patient developed "burning and tingling" around her eye, on both sides of her face, tongue and the base of her neck the day after receiving ZOOSTAVAX (on 31-JUL-2014). The patient reported to the physician that she felt like she had a rash. The physician reported that a pink area was noted at the base of the neck. The outcome of adverse events was reported as not recovered/not resolved. The patient did seek medical attention. The physician had started the patient on hydroxyzine. Additional information has been requested.
Patient received Hep B vaccine #3/3 in my office on 12/7/01.  From there went to a local market (with parent) where he experienced light headedness and near syncope.  EMS was called.  He was evaluated and released from the site.  The family did not report this to me until recently (2003) at another visit.
I was diagnosed with shingles on my left side on 12/31/2020, with symptoms (burning/skin sensitivity on my back (probably on 12/27, definitely by 12/28 progressing to waves of pain in my back to abdomen).  On 12/30, a rash appeared on my abdomen starting below my navel and going around my left side to about an inch before my spine.   I submitted a picture and it was diagnosed as shingles via a virtual visit.  It is  responding to antiviral therapy, although I still have a rash and pain (but improving). I did not go through the COVID vaccine side effect virtual visit route because I did not really think it was a side effect and knew I had a history of chicken pox and have been experiencing ongoing stress.  The provider for the virtual visit told me to still report it for it to be investigated, but she too, thought it was likely unrelated, but still should be investigated.
heart palpitations, abdominal pain, digestive problems, constipation, exercise intolerance.  This felt like a flare up of my Hashimoto's thyroiditis.
Vaccine was given at 8 pm PT on 2/11/2021.  Painful red rash appeared on 2/13/2021 on same arm as injection site (left arm), just below injection site.  Rash is on left arm only, appears to be growing, but has not spread beyond that arm.
Information has been received from a physician and the office manager concerning a 9 week old female patient who on 25-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is on of several reports from the same source. Additional information is not expected.
No adverse event; The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023. This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.) 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 EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.).    No concomitant medications was reported.  It was reported that the reporter asked for a stability letter from Moderna for the 6 doses of bivalent vaccine that had been administered beyond the published expiration date. No patients had reported adverse event.  No treatment details were reported.  This case was reported for Patient 6 out of 6 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719555 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719555:Master case
Chills; Flu like symptoms; Insomnia; losing appetite; aching; Fever (highest 102.9); Joint pain; Muscle aches; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), INSOMNIA (Insomnia), DECREASED APPETITE (losing appetite), PAIN (aching) and PYREXIA (Fever (highest 102.9)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Hyperthyroidism, Menopause, Neck pain, Neck tightness and Sleep disorder. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hyperthyroidism, ESTRADIOL for Menopause, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Neck pain and Neck tightness, MELATONIN for Sleep disorder.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), INSOMNIA (Insomnia), DECREASED APPETITE (losing appetite), PAIN (aching), PYREXIA (Fever (highest 102.9)), ARTHRALGIA (Joint pain) and MYALGIA (Muscle aches). On 05-Mar-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 05-Mar-2021, INSOMNIA (Insomnia) had resolved. On 06-Mar-2021, PYREXIA (Fever (highest 102.9)) and CHILLS (Chills) had resolved. On 07-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (losing appetite), PAIN (aching), ARTHRALGIA (Joint pain) and MYALGIA (Muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received second dose on 01Apr2021 Intramuscular at right arm (Lot no: 017B21A)   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Reporter details updated, Dose details updated, concomitant medication, lab data and medical history added.
In April 2023 I had extreme dizziness and was able to walk well.  I have also had odd headaches with intense sharp feelings that don't last very long, and this began in January 2023.  I have also had facial tingling that started in about February 2023.  I saw my doctor on April 10, 2023.  The doctor referred me to a hospital.  However, I ended up going to the emergency room on April 18, 2023.  They ran tests and determined I did not have a stroke, clots or brain tumor.  I will see my doctor again tomorrow.  I see another doctor today, physical therapist, that specializes in vertigo.  In addition, I have been experiencing growing confusion.
After receiving the first dose, he has not been able to open and close his hand/it is very stiff in the same arm of the injection; pain; swelling; has a slight fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (After receiving the first dose, he has not been able to open and close his hand/it is very stiff in the same arm of the injection), PAIN (pain), SWELLING (swelling) and PYREXIA (has a slight fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (After receiving the first dose, he has not been able to open and close his hand/it is very stiff in the same arm of the injection), PAIN (pain), SWELLING (swelling) and PYREXIA (has a slight fever). At the time of the report, MUSCULOSKELETAL STIFFNESS (After receiving the first dose, he has not been able to open and close his hand/it is very stiff in the same arm of the injection), PAIN (pain), SWELLING (swelling) and PYREXIA (has a slight fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Patient gender updated, onset date of event provided, outcome updated.
Patient was administered only 1 vial of pentacel/Nurse did not reconstitute (with no reported adverse event); Initial information received on 24-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender who was administered only 1 vial of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)]/nurse did not reconstitute (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Aug-2023, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (with an unknown strength, expiry date and lot number) via intramuscular route in unknown administration site for Routine vaccination (Immunisation).  On 23-Aug-2023, the patient was administered only 1 vial of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine/nurse did not reconstitute (with no reported adverse event) (product preparation error) (Latency: same day).  Action taken: not applicable.  Outcome: 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 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.
Patient experienced abdominal pain on January 12th. She reported having a headache and joint pain as well. Her temperature was 103.5. On January 14th the patient was admitted for acute appendicitis with perforation, localized peritonitis, and gangrene. Patient was discharged on January 16th post appendectomy.
Headache, Myalgia, Fever, polyarthralgias, injection site tenderness, left axillary lymphadenopathy Narrative:  employee states: He began to experience the following symptoms around 5pm on the day of second injection: headache (still present) myalgias low grade fever currently 100.2 F at 10:40 (1/21/21) also has chills polyarthralgias injection site tenderness with left lymphadenopathy with tenderness (injection received on left arm)
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a adult male patient who received Shingrix for prophylaxis. In May 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient had only sore arm which was normal. This case has been linked with US2018GSK101943, reported by the same reporter.
hard lumps; redness blotches; papules; itchiness; redness all over arm; This spontaneous case was reported by a consumer and describes the occurrence of PAPULE (papules), PRURITUS (itchiness), ERYTHEMA (redness all over arm), MASS (hard lumps) and RASH MACULAR (redness blotches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESYLATE and ACEBUTOLOL for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAPULE (papules), PRURITUS (itchiness), ERYTHEMA (redness all over arm) and RASH MACULAR (redness blotches). On 07-Mar-2021, the patient experienced MASS (hard lumps). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAPULE (papules), PRURITUS (itchiness), ERYTHEMA (redness all over arm), MASS (hard lumps) and RASH MACULAR (redness blotches) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were Provided.  No treatment medications were provided.
PT. presented feeling lightheaded and dizzy. PT. moved To TreaTment area where hisTory and viTals obTained. After 10-15 mins. PT. sTaTed he was no longer dizzy or lighTheaded. Final seT of viTals obTained with PT. sTanding up. PT. released and advised To call 911 w/any further issues.
-Onset of symptoms began at 2:00 am on Friday, March 26 -Sweating, fever, and chills -Muscle and joint aches -Abdominal cramping -Pain at the injection site -Malaise/fatigue -As of 8:00 am on Saturday, March 27, symptoms are still present
Immediately after the vaccine administration, she felt tingling around her lips, swelling of the lips, slight facial and chest flushing. She was given Benadryl 25 mg PO and sent to the ED for further evaluation. In the ED she was given famotidine 20 mg IV push once, methylprednisolone 125 mg IV push once, and a bolus of NaCl 0.9% 1000 mL over 65 minutes. Patient was asymptomatic 3 hours after vaccination.
Narrative:  Pt was an 88 YO Male with PMH of PVD, neuropathy, afib, DM, HTN, CAD, COPD, hypothyroidism, and HLD. Agency was informed of patient's passing by patient's daughter. No additional details available.
Within 15 minutes of my 16 year old daughter receiving the gardasil vaccine she passed out and fell. Hit her head resulting in a minor concussion
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 03-OCT-2018, the patient was vaccinated with improperly stored M-M-R II (lot # N025895, expiration date 19-SEP-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). The sterile diluent used to reconstitute M-M-R II was properly stored. No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
PCR testing which was positive for strain found in MMR II; had fever; rash; This spontaneous report was received from the employee from the office and refers to a 1-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(dose, frequency, route of administration, lot# and expiry date were not specified) for prophylaxis. Other suspect therapies included sterile diluent (Merck Sharp & Dohme). On an unknown date (also reported as "two of the patients were female and one of the patients was male", "4, 6 and 12 days respectively, after measles, mumps, and rubella (wistar ra 27-3; virus vaccine, live (M-M-R II) was administered"), the patient experienced fever and rash. Additionally, on an unknown date, the patient had polymerase chain reaction (PCR) testing which was positive for strain found in measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA005218:
Patient presented to the ER on 5/23/21 at 0944. Per the ER physician report: Patient is here with complaints of nausea, vomiting, diarrhea, fever, chills, muscle aches, dyspnea, and her left upper extremity tingling.  Patient had her second ModeRNA Covid vaccine yesterday, has been feeling ill since then.  Patient was unable to sleep all night due to vomiting chills and muscle aches.  She had a Covid 19 in December of last year. Room air pulse oximetry is 95%.  Blood pressure on presentation 152/101, heart rate 134, respirations 24, temperature 102.2
SVT rapid heart beats over 200. Hospitalized.; SVT rapid heart beats over 200. Hospitalized.; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number FA7485 and expiry date not reported), via an unspecified route of administration, on 19Aug2021 (at the age of 40-year-old), as dose 1, single, for COVID-19 immunisation in Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Aug2021, the patient experienced SVT rapid heartbeats over 200. Paint went to emergency room visit and was hospitalized. Patient was treated by cardiologist due to the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.