chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a patient (age and gender unknown) was inoculated with ZOSTAVAX on or about 01-OCT-2012, at a clinic, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-JAN-2015, patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. On or about 03-SEP-2015, patient was treated for ongoing and worsening symptoms which was diagnosed by physician as post herpetic neuralgia, a chronic condition on nerve pain and residual to shingles. Patient was prescribed pregabalin (LYRICA) for management of her painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
This spontaneous report was received from a consumer, who received the information from her 14 year old daughter, referring to a 14 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On 29-NOV-2013, the patient was vaccinated with the 1st dose of GARDASIL (anatomical route of vaccination, lot number and expiration date were not provided). The patient's concomitant medications were not reported. It was stated by the reporter, that immediately after being administered the dose of GARDASIL, the patient fainted. Furthermore, she experienced shaking through the episode. The patient was "out" for a brief period of time. Due to it, she was attended by her mother, a nurse and her pediatrician. At the time of the report, the outcome of tremor and syncope were unknown. The causality between the adverse events and vaccination with GARDASIL was not provided. Additional information has been requested.
BODY ACHES; SWEATS; DIZZINESS; NECK PAIN; WRIST PAIN; ANKLE PAIN; FEVER; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 02:00, the subject experienced body aches. On 08-APR-2021 02:00, the subject experienced sweats. On 08-APR-2021 02:00, the subject experienced dizziness. On 08-APR-2021 02:00, the subject experienced neck pain. On 08-APR-2021 02:00, the subject experienced wrist pain. On 08-APR-2021 02:00, the subject experienced ankle pain. On 08-APR-2021 02:00, the subject experienced fever. On 08-APR-2021 02:00, the subject experienced fatigue. On 08-APR-2021 02:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain on APR-2021, and had not recovered from fever, body aches, sweats, dizziness, wrist pain, ankle pain, fatigue, and headache. This report was non-serious.
nausea; headache; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 22nd December 2020, the patient received the 1st dose of Shingrix (intramuscular), Influenza vaccine Quadrivalent 2020-2021 season and PNEUMONIA VACCINE. On an unknown date, less than 4 months after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced nausea and headache. On an unknown date, the outcome of the nausea and headache were recovered/resolved.   It was unknown if the reporter considered the nausea and headache to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional information was provided as follows: The age at vaccination was not reported. The reporter declined to provide demographics or additional information. The patient received 1st Shingrix shot on an unknown arm and on the same day received flu and pneumonia shot in different arm. The patient developed nausea and headache. At the end of March 2021, the patient got moderna covid vaccine and felt dizzy, had joint pain and sluggish.  The reporter did not consent to follow up. It was unknown if the reporter considered the nausea and headache to be related to Pneumonia Vaccine.
Excessive crying, unconsolable for many hours, decreased PO intake, tactile temp at home symptoms began approxmately 4am 1/26/03. Vaccines were given 1/25/03 at 10:40am. At home pt was given Tylenol, Mylican, some water but no allenation of symptom. Pt brought to ER ?picillin and cefatexime started IVF given.
Hospitalization: ADMITTED 9/5/22, DISCHARGED 9/9/22. Presentation to the ED: general weakness and shortness of breath.    COVID-19 + date: 9/5/22. Treatment: Remdesivir. Discharge to: HOME.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
chills; shakes ten blankets blankets and setting next to heaters; took one that same night I about died; Initial information received on 23-Oct-2020 regarding an unsolicited non-valid non-serious social media case received from a consumer (Patient).  This case is linked to case 2020SA300682.  This case involved a patient who experienced chills and shakes ten blankets and setting next to heaters (Tremor) and felt about died (Unevaluable event), while patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s)and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced a feeling of about died (Unevaluable event), had chills and shakes ten blankets and setting next to heaters (Tremor), (unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.    It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all the events at the time of reporting.  There will be no information available on the batch number for this case.
Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an elderly 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 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 ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    Concomitant medications were not reported.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults. No AEs were reported.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  Treatment medications were not reported.
REPORTED HEADACHE AND LETHARGY STARTING  09/24/2014 AND RESOLVING 0N 09/27/2014. NO REPORTED TREATMENT.
I had the vaccination on May 5th my arm was more sore than normal. I began to experience gastrointestinal issues. I had lot of congestion, nausea and a lot of coughing. I called the doctor and they did blood test and it seemed like I was low in sodium and my blood levels were funny. She ordered some test and one of them was scheduled for Wednesday. On Wednesday I woke up and felt sicker. My husband toke me to the Hospital they admitted me and my blood cell count was quite low. I have been here ever since on the hematology floor. While there I tested positive for COVID-19. The hematology people did a blood scan and it was determined that the COVID-19 virus stirred up some sort of infection. I am due to get some treatment for pre leukemia symptoms which will take place at another hospital
Per patient's spouse, patient had a skin reaction to the vaccines administered including a skin infection at site or nearby site - vague description.
Patient has a 3 inch red spot on arm where vaccine was given. It is warm to the touch and hurts. Instructed patient to try TYLENOL and if that doesn't help she can also try BENADRYL.
Started as a knot under armpit, knot got itchy, then rest of body got very hypersensitive. My skin breaks out in hives when touched.
Hives all over body beginning on 11/11. Hives still present today. Took Zyrtec 10mg for two weeks which helped, but have stopped taking Zyrtec since day as I do not want to become dependent on it.
patient was leaving  and fainted in chair while waiting 15 minutes, no fall reported,  checked pulse and pupils, regained consciousness within 1-2 minutes. left under own power.
Caller confirmed that she tested positive for COVID-19 yesterday; Caller confirmed that she tested positive for COVID-19 yesterday; 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 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (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) all with onset 09Aug2022, outcome "unknown" and all described as "Caller confirmed that she tested positive for COVID-19 yesterday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Aug2022) Positive.  Clinical information: Caller asked about Paxlovid. Caller confirmed she has not started it yet, and is concerned if there is any recommendation or contraindication for those with a history "C Diff" [Clostridioides difficile infection]? Caller confirmed she can't get just any antibiotic and that she sees diarrhea as a possible side effect. Caller confirmed that she tested positive for COVID-19 yesterday, and that she got both the Pfizer-BioNTech COVID-19 Vaccine and boosters. Caller also added that she is has "underlying issues with health" and was also prescribed Paxlovid yesterday. Caller also reported that her daughter had a terrible bitter metal taste that won't go away and made her throw up; "the side effects are scary". Caller mentioned, she expected to be transferred to someone who knows the product and the benefits, as you are the ones who made the product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax & pt exp redness, swelling, tenderness @ the inject site; It is uncertain if the pt had an allerg react;
the patient experienced tiredness, itching and little rashes after receiving ZOSTAVAX; the patient experienced tiredness, itching and little rashes after receiving ZOSTAVAX; the patient experienced tiredness, itching and little rashes after receiving ZOSTAVAX; This spontaneous report has been received from a consumer referring to herself, a female patient of unknown age and ethnicity.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On an unknown date (also reported as "9 days ago"), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency, anatomical location, lot and expiration date were not provided) for prophylaxis.  Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) (dose, frequency, indication, anatomical location, lot and expiration date were not provided)  On an unknown date, the patient experienced tiredness (fatigue), itching (pruritus) and little rashes (rash) after receiving zoster vaccine live (ZOSTAVAX). The outcome of fatigue, rash and pruritus was unknown. In addition, the patient refused to provided any additional information.   The causal relationship between fatigue, rash and pruritus and both suspect therapies was not reported.
the patient was currently six monfus pregnant and was administered "catch up" vaccinations with MMRII and VARIVAX; No additional AE information provided; Patient was vaccinated with MMRII on 07-OCT-2019 and 11-NOV-2019; This spontaneous report was received from a physician concerning a 15 year old female patient.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  At the time of reporting the patient was pregnant with 6 months of gestational age.   On On 07-OCT-2019 (1 trimester of gestational age), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously (lot # and expiration date were not reported), and varicella virus vaccine live (oka/merck) (VARIVAX) (route, lot # and expiration date were not reported), for prophylaxis; the vaccines were diluted with sterile diluent (STERILE DILUENT) (lot # and expiration date were not provided). On 11-NOV-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHa) (M-M-R II) lot # S004118 and expiration date 11-FEB-2021, subcutaneously, and varicella virus vaccine live (oka/merck) (VARIVAX) (route, lot # and expiration date were not reported); the vaccines were diluted with sterile diluent (STERILE DILUENT) (lot # and expiration date were not provided). No additional adverse event information was provided.
severe stomache pain 22OCT93 PM; sl fever 22OCT93-27OCT93; uncontrollable & shakes 23OCT93;
Nauseousness Intense headache Shaking chills Fever Severe muscle pain Loss of flavor Huge weakness
Left deltoid swelled about 40% greater than right deltoid. Erythema of entire area of deltoid muscle. Positive blanching; positive pain to touch; positive warm to touch. No line of lymphatic extention.
No reaction to vaccine.  However, I came down with Covid symptoms on 8/5/2022 and was diagnosed with it (PCR Test) on 8/7/2022
Over 24 hrs after my 2nd vaccine I have a very unwell feeling and temp of 100. Also lump and severe pain at injection site.
Information has been received from a female nurse who was vaccinated with a second dose of varicella vaccine. Subsequently the pt did not have any detectable antibody levels to varicella  one month after her second dose.
slight sore arm after her 2nd Moderna dose; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (slight sore arm after her 2nd Moderna 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.    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, the patient experienced VACCINATION SITE PAIN (slight sore arm after her 2nd Moderna dose). At the time of the report, VACCINATION SITE PAIN (slight sore arm after her 2nd Moderna dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-319756 (Patient Link).
First / vaccine September 2020 / had arm pain; First / vaccine September 2020 / has not gotten the second; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follow: The age at vaccination was not applicable for 2nd dose of Shingrix.. The patient received first dose of shingrix and experienced arm pain. Till the time of reporting, the patient did not receive her second dose of Shingrix, which led to incomplete course of vaccination. The patient did not consent to follow-up
At 10:00 pm on 02/25/21), I began to experience body aches, chills, and a low grade fever.  I took 400 mg of Tylenol.  During the night, I experienced chills and excessive sweating.    The next day (02/26/21), I experienced body aches, joint aches (especially in my fingers), headache, chills, and a fever (highest 101.7).  Drank lots of fluids and took 400 mg of Tylenol every 6 hours.  Noticed around noon that I my taste buds were off, meaning I had a loss of taste even when consuming salty food.  Fever rose to 101.7 and experiences chills and excessive sweating during the night.    Today (02/27/21), I woke up with no fever and little body aches.  Joint pains and headache are gone.  Left arm (near injection site) is still tender.  Around 11:00 am, I had a low grade fever (99.9) but no other symptoms bu continue to experience a loss of taste.  It is now 3:45 pm, and I still have a low grade fever and a loss of taste.
Sore arm for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for 24 hours) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm for 24 hours). At the time of the report, PAIN IN EXTREMITY (Sore arm for 24 hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 07-JUN-2021 contains non-significant information.
Transaminitis - 200's. Abdominal pain. Jaundice (Tbili 2.0).
This spontaneous report was received from a nurse practitioner via medical records and refers to a 16 year old male patient. On 25-AUG-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M011117, expiration date: 07-DEC-2017; dose and route were not provided). The vaccine underwent a temperature excursion of 29.7 degrees Fahrenheit for 5 hours, which was detected by a data logger. There was also previous temperature excursion, but more details were not available. No adverse effects were reported. All available medical records will be provided upon request. This is one of several reports received from the same source. Additional information is not expected as all follow up information was received. Sender's Comments: US-009507513-1609USA007391: US-009507513-1610USA002333: US-009507513-1612USA003506: US-009507513-1612USA003507: US-009507513-1612USA003509: US-009507513-1610USA002334.
Shot at about 10:30am. Sore arm by 4:30pm. By 9:30pm, could not lift arm - extremely store. Overnight woke up multiple times - achy, nauseas, headache, chills/sweats. By 10:30am, I was ready to get up and was very thirsty. I made it about 10 steps before collapsing to the floor, almost fainting. I was extremely lightheaded and sweating. Couldn't move, couldn't speak. I assume my blood pressure was very low. I eventually crawled back to bed, drank some water and some gatorade, and slept for another 3-4 hours. I was tired and had low energy for another 5-6 days. It took a week for me to feel back to normal energy, normal appetite, normal physical health.
BLOOD CLOT NARRATIVE: SUSPECTED POTENTIAL BLOOD CLOT - WAS SENT TO ER AFTER REPORTS. NO RESULTS AVAILABLE.
A non-serious spontaneous report of gave full dose of H1N1 LAIV in one nostril was received from a registered nurse concerning a 13-year-old male. No relevant medical history was reported for this patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Pt presented on Feb. 6, 2006 at Emergency Room with 1 week history of seizures. Pt was subsequently diagnosed with tuberous sclerosis, a genetic neurological disease. Parents feel seizures and tuberous sclerosis are related to vaccines given on 12/29/05.