chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got the 2nd dose at 5:15pm June 1st. Woke up at 2:30am with a splitting headache and moderate nausea. Both symptoms last all day. Around 6pm, I start violently vomiting regularly (about 20-30 minutes in between) until around 11pm. Couldn?t keep anything down, including water, Tylenol, and pepto to try to ease the nausea, so there was really nothing to throw up but stomach acid. Otherwise it was dry retching for hours on end. Finally fell asleep after 11pm with mild discomfort in my stomach. Woke up the following morning (today) with just some mild stomach aches and soreness with a slight headache. I could keep down water this morning for the first time in 24 hours.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 15-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed acyclovir and prednisone for management of her painful symptoms and chronic pain. On or about 29-AUG-2016, the patient sought subsequent treatment from another physician for a blistering vesicular outbreak which was diagnosed as chronic post herpetic neuralgia. The patient was prescribed gabapentin for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Information has been received from a registered nurse concerning a child who "last week" (on approximately 17-JUN-2009) was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not reported). Secondary suspect vaccination included a dose of MMR II (MSD) (dose, route and lot number not reported). Other concomitant vaccination included polio vaccinination (manufacturer unknown). The registered nurse reported that the patient developed a fever as high as 103 degrees F. It was not known where in the series the patient was. The patient sought medical attention by making a phone call. Follow-up information was received from the registered nurse via a vaccine adverse experience report. It was reported that the child is 12 months old, female. Birth weight 3.7 kg, no siblings. Patient has a history of excessive crying and fever at 6 months of age, after being vaccinated with DTAP/HEP B/RV/HIB/PCV. On 09-JUN-2009 at 2:00 pm the patient received the fourth dose of PREVNAR intramuscularly on the left arm, and first dose of HAVRIX (AHAVB246AA) intramuscularly on the right arm. On 18-JUN-2009 at 5:00 pm patient was vaccinated with the first dose of VARIVAX (Merck) (lot# 657720/0358Y) subcutaneously, on the left thigh. That same date and time patient received the first dose of MMR II (MSD) (lot# 662862/1469X) (RHA) subcutaneously, on the right thigh and the third dose of IMOVAX POLIO (lot# B04752) intramuscularly on the left thigh. On 22-JUN-2009 patient developed a fever during 2 days. Highest temperature was 104.6 degrees Fahrenheit. On an unspecified date the patient completely recovered. No further information is expected.
Improperly stored product administered / temperature - 14C; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 05-MAY-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # T021828, expiration date 25-JUN-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose of the vaccine was stored in a temperature of -14 degrees Celsius (C) for 35 hours and 43 minutes. There was no previous temperature excursion reported. Digital data logger was involved.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2106USA001746: US-009507513-2106USA001739: US-009507513-2106USA001959: US-009507513-2106USA001941: US-009507513-2106USA001761:
Experienced headache, fever, chills, nausea starting the morning after I received the second shot.  The side effects lasted the entire day.  The second day only the headache remained.
pt recvd vax 27SEP93 & states had fever during noc arm was swollen, painful w/red whelps; called MD & was given DPH; had pain in arms x 1 wk;
Patient had received 0.25 ml when they should have received 0.5 ml; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient had received 0.25 ml when they should have received 0.5 ml) 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)) (batch no. 022H22A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient had received 0.25 ml when they should have received 0.5 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient had received 0.25 ml when they should have received 0.5 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 UNDERDOSE (Patient had received 0.25 ml when they should have received 0.5 ml).    No concomitant medications were provided. Dosage text for suspect drug was unknown.  The date of administration was unknown, but this was last week.  Patients did not experience adverse reaction. The pharmacist did not know the COVID-19 vaccination history of patient. No treatment medication was provided. This case contains information for the 2nd of 4 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727606 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727606:Patient 1 out of 4 patients
Mild to moderate stomach ache, excess burping and flatulence  Increased mucoid secretions, mild asthma symptoms: some wheezing and tight cough  Started at 10 pm day of injection and continued through the next day.
Numbness lower face; swelling lower face and tongue; lump in throat (throat closing); extreme thirst
More than 35 days after the first dose without receiving the second dose; This case was received via Regulatory Authority (Reference number: 119152) on 09-Jul-2021 and was forwarded to Moderna on 09-Jul-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved.        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.   No concomitant medication was reported. Treatment information was not provided.
Life Threateningly Low Vital Signs, Kidney Failure, Dehydration, Diarrhea Extreme Weakness, Vertigo, Extreme Pain at Arm for 5-days, Swollen Arm, Redness...Pulse - 38 BP - 48/30.
Dizziness 12 - 14 hrs following administration of seasonal flu injection. Influenza (AFLURIA) 0.5 mL given IM (R) deltoid, 25 OCT 2013 at 10:00 tx'd at local urgent care clinic w/meclizine 25 mg.
Was administered the first dose / subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 74359, expiry date 15th November 2022) for prophylaxis.   On 31st July 2021, the patient received the 1st dose of Shingrix (subcutaneous). On 31st July 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The pharmacist reported that the patient was administered with the 1st dose Shingrix vaccine in left arm subcutaneously, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
Fever Dry cough Aches Headache Unable to take a deep breath Throat sore Diarrhea Swollen lymph nodes
Paresthesias Bilateral Feet, Muscle Spasms in back, Back Pain, Leg Weakness, "Brain Fog," "weird sensation in arms," Nausea, Abdominal Spasms, Palpitations, Vision Changes (wears glasses)
This spontaneous consumer report (initial receipt: 23-Feb-2012) concerns a 56-year-old male patient, who had a medical history of hypertension and diabetes. Concomitant medications included lisinopril and glimepiride. On 04-Nov-2011 the patient received one dose of AFLURIA injection. It was the first influenza vaccine he ever received. Following vaccination with AFLURIA the patient's left arm and hand were numb and felt as if they were exposed to the cold for too long. The patient stated that his arm and hand hurt, as well as felt numb. Shortly after the vaccination the patient was hoarse, then he experienced neck stiffness, which transitioned to shoulder pain, and then resulted in numbness and pain in his arm and hand. An x-ray performed on the arm showed the joints appeared to be intact and undamaged. He had been scheduled to undergo an MRI (magnetic resonance imaging) to assess the muscles in his arm. The patient was treated with unspecified anti-inflammatories. The events persisted to the time of the report on 23-Feb-2012. The event outcome was not recovered.
migraine; fatigue; light headed; chills; fever; constant itch below my ankle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. This case is for her 2nd dose.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Sep2021 (Lot number: FC3184) at the age of 36 years as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: FF2589, first dose, Left arm), for COVID-19 immunization, reaction(s): "bad nightmares". The following information was reported: MIGRAINE (non-serious) with onset Sep2021, outcome "recovering", described as "migraine"; FATIGUE (non-serious) with onset Sep2021, outcome "recovering", described as "fatigue"; DIZZINESS (non-serious) with onset Sep2021, outcome "recovering", described as "light headed"; CHILLS (non-serious) with onset Sep2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset Sep2021, outcome "recovering", described as "fever"; PRURITUS (non-serious) with onset Sep2021, outcome "recovering", described as "constant itch below my ankle". Therapeutic measures were not taken as a result of migraine, fatigue, dizziness, chills, pyrexia, pruritus.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications the patient received within 2 weeks of vaccination. The patient neither diagnosed with COVID-19 Prior to vaccination, nor been tested for COVID-19 Since the vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Pt described that left side of nose from bridge to nose became itching, turn red, then numb on Wed 2/11. Had had cold 1 1/2 wks before. No redness or itching after 1 day. Nose still numb. Saw doctor 2/12. Asked to call district health.
Patient presented with symptoms of acutely worsened shortness of breath and was diagnosed with COVID-19 positive acute hypoxemic respiratory failure. In addition to usual maintenance medicines he received dexamethasone, remdesivir, and anticoagulation. He was discharged in medically stable condition with follow-up care plans in place.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive, notes: Tested positive and was symptomatic again on Friday, 08Jul. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Addition information: Start date of treatment of COVID-19 was 27Jun2022. Stop date of treatment of COVID-19 was 01Jul2022. Full relapse of COVID illness one week after completing Paxlovid regimen. Tested positive and was symptomatic again on Friday, 08Jul. Known allergies was none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had vaccination on 09/09/2021. I had sore arm fatigue axillary tenderness under right arm and chest pain that lasted intermittingly for twelve hours that radiated to shoulder blades. I did take some Ibuprofen. On 01/30/2022 I tested COVID-19 Positive. The chest pain returned with a cough and lasted about 7 days. I saw my PCP on 02/01/2022 due to my chest pain. He prescribed Plaxovid which I did not take due to having some improvement with the exception of the chest pain. It was intermittingly non exertion chest pain. On 03/17/2022 I woke up at 4am and the chest pain woke me up out of sleep and it was intense and constant. I went to PCP who did a cardiac work up. I was diagnosed with Pericarditis on 03/19/2022 and treated by cardiologist.  They prescribed me 04/05/2022 Ibuprofen which was tapered down over time. We did have to extend it at follow up as the chest pain was still present in which we repeated the Ibuprofen and tapered again with Colchicine. It was advised by Cardiologist to hold off on second COVID-19 booster. We will revisit this discussion if there is an uptick in COVID-19 cases and possibly changing to Pfizer.
Caller reporting temperature excursion. Vaccine has been administered. No PQC. No additional information.; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 13-OCT-2023, the patient was vaccinated with improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 milliliters as prophylaxis (lot number: X006982, which was determined to be valid, with an expiration date on 07-MAR-2025) (strengths, scheme, route and anatomical location of administration were not reported).  The administered dose underwent a temperature excursion of unreported temperature during an unspecified period time. Previous temperature excursion was not reported.    No additional adverse event was provided.
Information has been received from a health professional concerning a 11 yr old male with cashew and walnut allergies and no other medical history who on 24May96 was vaccinated  SC with a 0.5ml dose of varicella virus vaccine live (lot609287/0393B). There was no concomitant medication. On 28Feb06 the pt presented with 28-35 insect bite like lesions on his chest and back. The child also had a low fever and congestion. He was treated with acetaminophen (Tylenol) and household spray starch and applied to the rash. No labs were done. At the time of this report the pt was recovering. No product quality complaint was involved. Additional information has been requested.
full body rash/the rash on all over their body; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 4 patients (resident of a long term facility and are above 65 years of age). This is 1st of 4 reports.   A elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The Pharmacist reported 4 patients who experienced Full body rash/the rash on all over their body after getting pfizer covid vaccine on an unspecified date, It happened 2-3 days after the vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021113120 Same reporter/ drug/ event for different patients.;US-PFIZER INC-2021113121 Same reporter/ drug/ event for different patients.;US-PFIZER INC-2021113122 Same reporter/ drug/ event for different patients.
This spontaneous case was initially received on 05-OCT-2015. The case report was received from a(n) Health Professional and concerns a(n) 65 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s):The patient received AFLURIA on 05-OCT-2015 - unknown stop date, Batch no: U54606, Route of administration: not provided, Dose: no information provided. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 05-OCT-2015, after starting / treatment with AFLURIA the patient experienced Temperature excursioned AFLURIA administration/medication error (non serious, outcome: Recovered / Resolved). On an unknown date, after starting / treatment with AFLURIA the patient experienced Temperature excursion occurred due to power outage (non serious, outcome: Recovered / Resolved). Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: Not provided.
A week after my second Moderna vaccine shot, I started to experience pain in my abdomen area  under the skin surface.  The pain became progressively worse. I thought I had shingles but no rash or blisters.  I took a blood test on 3/30/21 and it was negative on shingles.   I was examined by a doctor on 3/31/21 and she is scheduling  an appointment with a neurologist at the local hospital, due to inflammation of my spinal chord.  She said she wants to rule out transverse myelitis.
Arm inflamed and red the following morning and doctor told her she had phlebitis. Got a prescription for bactrim ds on wednesday morning. Big red blotch on arm and heading to axilla.
Information has been received from a female patient who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently, the patient "broke out in small bumps." No further information is available. No product quality complaint was involved. Additional information has been requested.
15-30 seconds after administration of GARDASIL the patient had a syncopal episode lasting approximately 15 seconds, during this time noted rigid extremities and pale in color. Patient monitored for one hour post reaction and normal procedures were followed.
After / dose 2  / experienced fatigue; After / dose 2  / experienced / muscle aches; After / dose 2  / experienced / pain in joints; This case was reported by a physician via call center representative and described the occurrence of fatigue in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date). Concomitant products included COVID-19 VACCINE MRNA (MRNA 1273) (COVID 19 VACCINE MODERNA) and COVID-19 VACCINE MRNA (MRNA 1273) (COVID 19 VACCINE MODERNA).   On 9th June 2021, the patient received the 2nd dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced fatigue, muscle pain and joint pain. On an unknown date, the outcome of the fatigue was unknown and the outcome of the muscle pain and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, muscle pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and experienced fatigue, muscle aches and pain in joints few days after the vaccination. The patient was still experiencing pain in joints and muscles. The physician wanted to mention that the patient received the Covid Moderna vaccine in between dose 1 and 2 of shingrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.