chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; shaking; fever; dizziness; fast heart rate; headache; almost passed out; This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a day after receiving Shingrix, the patient experienced chills, tremor, fever, dizziness, heart rate increased, headache and presyncope. On an unknown date, the outcome of the chills, tremor, fever, dizziness, heart rate increased, headache and presyncope were recovered/resolved.   It was unknown if the reporter considered the chills, tremor, fever, dizziness, heart rate increased, headache and presyncope to be related to Shingrix.  Additional case details were reported as follows: When the patient went to bed on 12th April 2019, evening she noticed that her heart rate was elevated.  At 2:30 AM on 13th April 2019, 1 day after vaccination she was woken from sleep by shaking because she was so cold. The patient had chills, fever of 101 degree Fahrenheit, dizziness such that she almost passed out, her heart rate was 115 and had headache.  The patient visited the clinic where she got the vaccine and was told the symptoms would resolve.  The symptoms resolved after 24 hours. Emergency room visit required. The reporter did not consent to follow up.
Redness & warmth surrounding the injection site involving front of thigh, c/o itching, no pain, walking without difficulty, no fever, warmth on touch. Plan: Start CEPHALEXIN 250/5ud 3/4 by po Tid x10 day. BENADRYL ELIXIR 1 1/2 Po Tid-QD.
slight discoloration around the injection site; itching near the injections site; 8 cm erythematous circle around the site of injection. It got worse; fatigue; chills; headache; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In July 2022, 24 hrs after receiving Shingrix, the patient experienced injection site erythema, fatigue, chills and headache. On an unknown date, the patient experienced injection site discoloration and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site itching, fatigue, chills and headache were recovered/resolved and the outcome of the injection site discoloration was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site discoloration, injection site itching, fatigue, chills and headache to be related to Shingrix.  Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's Comment: The reporter was stating that, she had a patient that got their Shingrix vaccine at the end of July 2022.She stated that, about 24 hours post vaccine, the patient had fatigue, chills, and a headache that lasted for about one day. She also stated that, about 24 hours later the patient developed an 8 cm erythematous circle around the site of injection. The patient stated that, she received her Shingrix about two and one-half months ago.  She experienced redness and itching near the injections site.  The size of the area was 4 inches x 2 inches.  It was bothersome and lasted a long time. She stated that, it got worse over the next few weeks and then started to fade. She reported the patient still had slight discoloration around the injection site. She had been left with a discoloration in her arm.  The reporter stated that, she had a picture of the redness which was taken a day after the vaccine which she would be happy to share reporter gave consent to follow up with healthcare professional (pharmacy). The reporter did not consent to follow-up.
Fever, nausea, headache, dizziness, sore throat, pale, eye bothering her, light rash within 48 hrs of vaccination per parent. Seizure noted on 9/9/15.
Bad headache started middle of the night, body aches, unable to sleep, nausea 14 hours after vaccine.
Case number PHEH2015US0225122, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 92-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
vomiting, diarrhea, nausea, muscle ache few hrs p/vax;
HOT CHILLS; EVERYTHING HURT JUST LIKE FLU; FREEZING COLD; NAUSEOUS; VERY TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced hot chills, everything hurt just like flu, freezing cold, nauseous, and very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot chills, everything hurt just like flu, freezing cold, nauseous, and very tired. This report was non-serious.
I had a huge lump where the vaccine was administered. The site was red, burning hot, itchy and swelled for 1.5 weeks. It is now a couple weeks later and I still have a bruise
First the usual head ache, fever and achy body.  I also had disturbing dreams for 2 nights and woke up with intense anxiety the morning after, and some the second morning.
heart stopped and was resuscitated by neighbors until ambulance came; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 84-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) other for covid-19 immunisation.The patient's relevant medical history included: "Muscular dystrophy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Unknown, reaction(s): "Allergy". Vaccination history included: Covid 19 vaccine (Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: CARDIAC DISORDER (hospitalization), outcome "recovered", described as "heart stopped and was resuscitated by neighbors until ambulance came". It was unknown if therapeutic measures were taken as a result of cardiac disorder.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Very itchy rash at injection site.  Showed up 6 days after vaccine was administered.  Somewhat improved three days later.
arm pain; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in an unspecified number of patients who received Herpes zoster (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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   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 the vaccination was not reported. The patient received Shingrix and had arm pain and she knew she was not alone because others have too.  The pain lasted for a couple weeks and was significant. She had no reactions after the second dose. The reporter did not consent to follow up. The HCP did not wish to provide any further information regarding this.  She declined to provide any further information since she knows this was an expected adverse event following Shingrix administration. This case linked with US2020078036 and US2020078030, reported by same reporter.
Felt a little off; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt a little off) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder (Thyroid medication) and Back pain. Concomitant products included GABAPENTIN for Back pain, LEVOTHYROXINE for Thyroid disorder, METOPROLOL, ATORVASTATIN, TIMOLOL MALEATE and LATANOPROST for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION COMPLICATION (Felt a little off). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; VITAMIN D3 for Adverse event, at a dose of 2000 IU; PROBIOTIC 10 for Adverse event, at an unspecified dose and frequency; CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D3) for Adverse event, at an unspecified dose and frequency; COD-LIVER OIL (FISH OIL [COD-LIVER OIL]) for Adverse event, at a dose of 1200 mg; VITAMIN B12 (VITAMIN B12 (CYANOCOBALAMIN AND ANALOGUES)) for Adverse event, at a dose of 1200 mcg and UBIDECARENONE (COQ) for Adverse event, at a dose of Coq10  300 mg. At the time of the report, VACCINATION COMPLICATION (Felt a little off) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications used metoprolol for beta-blockers.   This case was linked to MOD-2021-350420 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Follow-up received contain significant information concomitant and treatment drug updated, On 15-Oct-2021: Follow up contains no new information.
Pt vaccinated w/FLUOGEN developed thrombocytopenia & petechiae, sore mouth, CBC & platelet count revealed a platelet count of 2000 per cubic mm. Diffuse petechial hemorrhages. MD feel prob unrelated to the FLUOGEN to do bone marrow analysis
Approx 25 hours after flu shot was received, developed itchy rash over all body. As time went on, it worsened to bumps and redness (11/1/06 about 2am). Went to ER at 0230am 11/1/06. Treated with meds with symptoms resolved almost immediately.
achy; feeling feverish; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (achy), PYREXIA (feeling feverish) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PAIN (achy), PYREXIA (feeling feverish) and CHILLS (chills). At the time of the report, PAIN (achy), PYREXIA (feeling feverish) and CHILLS (chills) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
5 days post vax pt noticed a rash, redness and swelling around the left arm - injection site. The area was itching and warm to touch.
About 3 hours post injection, patient developed anaphylactic reaction. She had difficulty swallowing and felt lump in throat that progressed to difficulty breathing. Patient called ambulance and was given 50mg BENADRYL IM and oxygen. At emergency department, patient received further BENADRYL and steroids, which resolved symptoms. Unable to receive epinephrine due to allergy.
Less than 12 hours, post vax, the pt developed a local left arm pain, redness and tenderness that progressed over 36 hours, then began to improve. At 48 hours, she had chest tightness that began without wheezing. At 72 hours, local arm symptoms responding nicely to ice/heat. Lungs clear on exam.
Patient came back to clinic 10:36 am after a meal outside the clinic and c/o generalized itching. The patient had some rash in her right cheek and lateral left thigh where she was scratching. There was no rash and itching at the injection site on both arms noted. Patient denied any difficulty breathing. MD was informed and an order was carried out of BENADRYL 25 mg. IM. given at 10:36am to left deltoid. Patient observed until 11:30am. Patient's mother advised that patient is going to be drowsy and not to be allow to drive or operate machinery and advised to obtain OTC diphenhydramine 12.5 mg p.o. tid x 2 days and 0.5% hydrocortisone cream to the affected skin TID. Mother of patient said that patient already has an existing topical medication for rash because she has eczema. List of ED, Pediatricians, and clinics given to patient. Advised patient to report to ED if symptoms worsen. And given an appointment for patient to RTC 07/26/2018 for reassessment of symptoms.
Patient said started feeling symptoms on Saturday evening after receiving vaccine. Shingles outbreak on nose and left side of face (when facing patient.) Patient started on Valacyclovir 1g TID and Gabapentin 300mg HS on 10/9/20
1st dose of Shingrix on 04Aug2020 and is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 4th August 2020) and Zostavax (received in 2015).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The Healthcare professional did not have the lot number and expiration date. The reporter consented to follow up.
very minor However, I am unable to get a schedule for the second shot. The web site shows no slots available on 21 days after first shot. What should I do?
This case was reported by a nurse to a sales representative and described the occurrence of injection site hives in a 21 year old female subject who was vaccinated with combined hepatitis A, hepatitis B for prophylaxis.  The subject had no known allergies.  Concurrent medications included Ibuprofen, Paracetamol and Guaiphensin for unspecified drug indications.  On an unspecified date in 2005, on or after 01/18/2005 and on or before 05/03/2005, the subject received 3 dose of Twinrix.  The site of the Twinrix administration was not provided.  The same day that she received the Twinrix, on an unspecified date or after 01/18/2005 an on or before 05/03/2005, the subject experienced a hive like rash at the injection site.  The injection site hives resolved on an unspecified date in 2005, on or after 01/18/2005 and on or before 05/03/2005.
Not feeling well. The patient had his prescription for Lymerix filled on 05/06/200 which was kept unrefrigerated for approximately one week.  In March 2000, the patient received the first injection of Lymerix for prophylaxis. Sometime thereafter, he experienced not feeling well. No treatment was given. The information received on 4/11/2000 reported the patient received the second Lymerix dose. No further information was provided.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about September 2016, the patient was inoculated with ZOSTAVAX at a medical center for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient broke out with a rash on her arm that then spread throughout her entire body. In or about November 2016, she presented to her primary care physician who referred her to a Dermatologist. In or about December 2016, the patient was diagnosed with shingles by the Dermatologist. She was evaluated and diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events were unknown. Causality assessment was related. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of bursitis in a 67-year-old female patient who received FLUARIX QUADRIVALENT (batch number CS979, expiry date 14th June 2017). Concomitant products included LEVAQUIN. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced bursitis, contusion and numbness of upper extremities. On an unknown date, the outcome of the bursitis, contusion and numbness of upper extremities were unknown. It was unknown if the reporter considered the bursitis, contusion and numbness of upper extremities to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age of vaccination was not reported. The patient received the vaccine in her right deltoid. The patient had numbness on the same arm where the injection was given. It was not known in which arm the vaccine was received. The patient had bruising near elbow on the right side and numbness on the right arm. The nurse believed it could be deltoid bursitis. The nurse practitioner reported minimal details for 3 different patients. All had the shot administered somewhere else within the hospital system but mentioned the events to this healthcare provider. She did not administer the vaccine. It is not known if CS979 is the exact lot number of the administered vaccine but she assumed it might be since it was the lot she had. She was also in a hurry to speak with Medical Information (MI) and was quickly providing information and not allowing all questions to be asked. No additional details were known. This case was 1 of the 3 cases reported by the same reporter.
pt recvd vax 25AUG95 & 5SEP95 pt devel a rash;7SEP95 pt devel a fever;pt's MD indicated that the rash was chicken pox; No further details were provided;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 at 09:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: bananas" (unspecified if ongoing), notes: known allergies: bananas. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; ADVIL [IBUPROFEN]. Past drug history included: Codeine, reaction(s): "Allergy: Codeine", notes: known allergies: Codeine; Zythromax, reaction(s): "Allergy: zythromax", notes: known allergies: zythromax. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (01Jun2022) Positive, notes: Tested positive after testing negative the last 2 days. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid, treatment start date: 24May2022, treatment stop date: 29May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
who can no longer drive/unable to drive; Muscle weakness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (who can no longer drive/unable to drive), MUSCULAR WEAKNESS (Muscle weakness) and FATIGUE (fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (who can no longer drive/unable to drive), MUSCULAR WEAKNESS (Muscle weakness) and FATIGUE (fatigue). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (who can no longer drive/unable to drive), MUSCULAR WEAKNESS (Muscle weakness) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant FUP: event verbatim updated, additional events added
very sore arm (redness, swelling, heat, pain--couldn't sleep on L side).  Fatigue.  Soreness in neck/shoulder on L side.  Achiness.  Headache.  Balance affected adversely.  "Stupid" feeling.  Completely resolved in 72 hours.
This spontaneous report as received from a healthcare worker refers to a 23 year old female patient. The patient's medical history included hay fever. On 28-JAN-2015, the patient was vaccinated with first dose of GARDASIL (intramuscular, dose/frequency: 1 shot, lot # K006191, expiry date: 02-FEB-2017). Concomitant therapies included SINGULAIR (dose and frequency unknown) and ALLEGRA (dose and frequency unknown). On 28-JAN-2015, the patient became lightheaded immediately after receiving the vaccine. On 06-FEB-2015, the patient experienced weakness and soreness in both of her arms which had caused difficulty in lifting and moving objects with her arms. The patient had visited an unspecified primary care physician. No hospitalization or prolongation and significant disability or incapacity was reported. The outcome of the events was unknown. The Causal relationship between the events and GARDASIL was not reported. Additional information has been requested.
Within 3hrs developed facial and lip swelling then facial rash that progressed slowly over 2-3 more days. Family called that evening and told to give Benadryl, symptoms slowly progressed and spoke gain 3/23 and started course of oral steroids.