chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered Havrix after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received HAV (Havrix) (batch number 2K57N, expiry date 11th December 2022) for prophylaxis.   On 17th March 2022, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Linked case(s) involving the same patient:  US2022093644   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's comment: The medical assistant reported a patient was administered the Havrix on left arm after a temperature excursion. The reporter consented to follow up. Additional supportive information: Havrix was administered after a temperature excursion, which led to incorrect storage of vaccine. This case is one of 12 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093597:Same reporter. US-GLAXOSMITHKLINE-US2022093643:Same reporter. US-GLAXOSMITHKLINE-US2022093602:Same reporter. US-GLAXOSMITHKLINE-US2022093637:Same reporter. US-GLAXOSMITHKLINE-US2022093638:Same reporter. US-GLAXOSMITHKLINE-US2022093640:Same reporter. US-GLAXOSMITHKLINE-US2022093642:Same reporter. US-GLAXOSMITHKLINE-US2022093644:Same reporter. US-GLAXOSMITHKLINE-US2022093645:Same reporter US-GLAXOSMITHKLINE-US2022093646:Same reporter US-GLAXOSMITHKLINE-US2022093647:Same reporter US-GLAXOSMITHKLINE-US2022093648:Same reporter
Arthritis flared up very strongly after vaccination, to a disabling extent. Both my primary and I think this was coincidence.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 20-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    This case was linked to MOD-2022-690924 (Patient Link).
The 4th day I tested positive again; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-May-2022 and was forwarded to Moderna on 24-May-2022.    This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The 4th day I tested positive again) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Migraine and Drug allergy.   On 15-Apr-2022 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 21-May-2022, the patient experienced COVID-19 (The 4th day I tested positive again). At the time of the report, COVID-19 (The 4th day I tested positive again) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 21-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. The patient took other medications/products within 2 weeks of starting COVID-19 treatment.  After completing the 5 day treatment the patient tested negative the following day. 3 days later the patient had a runny nose and sore throat again. The 4th day I tested positive again.  Device date: 22-MAY-2022 COMPANY COMMENT: This is an spontaneous case concerning a 63-years-old female patient with medical history of Co-suspect product PAXLOVID for COVID-19 treatment, concurrent medical conditions included Migraine and Drug allergy who experienced the unexpected  event of COVID-19 36 days after  receiving a  dose of  mRNA-1273 vaccine. On 17-May-2022, SARS-CoV-2 test: negative; On 21-May-2022, SARS-CoV-2 test: positive  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 63-years-old female patient with medical history of Co-suspect product PAXLOVID for COVID-19 treatment, concurrent medical conditions included Migraine and Drug allergy who experienced the unexpected  event of COVID-19 36 days after  receiving a  dose of  mRNA-1273 vaccine. On 17-May-2022, SARS-CoV-2 test: negative; On 21-May-2022, SARS-CoV-2 test: positive  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Moderna vaccine was administered outside of our facility- reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------ J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/6/2022 ABDOMINAL AORTIC ANEURYSM 4.0-4.4 CM J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/11/2022 ABDOMINAL AORTIC ANEURYSM 4.0-4.4 CM
severe arthric conditions.  Trigger finger on left index finger and right middle finger.  Immune system has deteriated.  Sick every other month.
Acutely: fever, reactive arthritis/joint pain chronic following injection developed muscle fatigability, muscle spasms, fasciculations and since then asymmetric muscle atrophy, extensive neurologic workup/testing since 2011 has led to diagnosis of CDIP and we are attributing it to the flu vaccine.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 02-JAN-2008 the patient was vaccinated with ZOSTAVAX, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-AUG-2015, the patient was treated by a Physician Assistant for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles accompanied by trigeminal neuralgia. On or about 12-AUG-2015, the patient received subsequent treatment from another physician at an Urgent Care facility for continued and worsening symptoms or shingles and progressive trigeminal neuralgia. On or about 13-AUG-2015 the patient was treated by another physician for worsening outbreaks of shingles and complications. Shingles has spread to the patient's back, neck, scalp and eyes, resulting in ocular adnexa, herpes zoster conjunctivitis, and keratitis. Because of the serious complications of zoster infections throughout the body and in the eye and trigeminal neuralgia, the patient has been prescribed acyclovir, baclofen, NORCO, ARTIFICIAL TEARS, lid care therapy, VALTREX, EMYCIN and other medications for management of her painful symptoms. 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. Upon internal review herpes zoster conjunctivitis was considered a medically significant event. Additional information has been requested.
I walked down a very short flight of stairs to take laundry out of the dryer. My heart started racing and I began to sweat uncontrollably. My hands and feet became clammy.  I became very hot and thirsty and distressed. My hands and feet were very clammy and I had to sit down and take deep breaths. I drank two water bottles of water and poured some on me to cool off. My breathing was compromised and I was taking gulps of air. I became  slower in movement and responses and too disoriented to drive. I asked my boyfriend to give me a ride to the ER. I went through intake and was later given an EKG, IV for  bloodwork and Chest X-ray. Symptoms:  Nausea, palpitations, heart racing, muscle aches, chills, sudden sweating, clammy hands and feet, extreme thirst, difficulty breathing, slowed responses, slowed speech, burning tingling from top of neck down to left arm.
About 2 hours after injection patient started getting a severely sore arm, headache, and later in the evening heard voices. He went to his primary care doctor today, and his doctor told him he was likely having a reaction to the vaccine.  He is taking ibuprofen for the headache and soreness.  The arm is slightly red at injection site, but the voices are gone.  He has a follow up appointment in 3 weeks.
This spontaneous report as received from a registered nurse refers to unspecified patients. The nurse reported that VARIVAX (Merck) vaccines were exposed to 25 F for 420 hours, but did not have lot numbers and expiration dates available for evaluation. The nurse stated that she believed that patients may have received 0.5 ml dose of VARIVAX (Merck) (Lot# not reported) subcutaneously in the month of July 2013. No adverse effects were reported. This is one of several reports from a same reporter. Additional information has been requested.
Pt c/o being nervours and shaky. Vital signs 106/76 HR 76 RR 12 O2Sat 99%.  Skin warm and dry.  Cap refil <2sec. Breath sound clear bilaterally. Red flushing across upper chest and forehead.  Faded within 10 min.  Observerd for 30 min, no progression of symptoms.   Repeat vital signs:  118/78 HR 79 RR 12 Os Sat 99% Skin warm and dry.  Breath sound clear.  Reddness resolved.  Patient discharge home by self.
Case number PHEH2014US025092, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 63-year-old male 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 in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
On August 19, 2021 patient had a intractable migraine. Pain level has been an 8 or higher. Very light sensitive. Vertigo has gotten really bad; participant can not drive. Extremely, dizzy, vomiting. Physical therapy started on October 18, 2021.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. The nurse reported that on an unknown dates, an unknown number of doses of (Oka/Merck) VARIVAX 1350U (dose, route and lot numbers were not reported) that have been exposed to temperature fluctuations of 10 degrees F to 15 degrees F for unspecified times, during defrost cycles, have been administered. No adverse effect reported. Additional information has been requested.
low grade fever and achy joints; Achy joint; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK5730) via an unspecified route of administration in left arm on 25Mar2021 at 08:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient' did not take any concomitant medication. The patient had no known allergies to medications, food, or other products. 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 26Mar2021 at 18:00, the patient experienced low grade fever and achy joints. The patient did not receive any treatment for events reported. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events, low grade fever and achy joints was recovered.   No follow-up attempts are needed. No further information is expected.
Body irritation/itching, especially back and scalp; Body irritation/itching, especially back and scalp; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Minor Afib" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3, manufacturer unknown), for COVID-19 immunization. The following information was reported: SKIN IRRITATION (non-serious), PRURITUS (non-serious) all with onset Sep2023, outcome "not recovered" and all described as "Body irritation/itching, especially back and scalp". Therapeutic measures were not taken as a result of skin irritation, pruritus. Additional information: The current dose is patient's 4th COVID-19 vaccine. Patient has no drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Pfizer Bivalent was given instead of second dose of primary series. No adverse reactions. Patient was told to not repeat the series
This spontaneous report was received from a pharmacist and refers to a 76 year old female patient. The patient did not have any pertinent medical history and drug allergies or reactions. The patient's concomitant therapies included apixaban (ELIQUIS), atenolol, rosuvastatin calcium (CRESTOR) and amlodipine. On 30-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, lot # N013521 and expiration date: 23-JAN-2019 (dose was not reported) as "routine vaccine" and a dose of unspecified flu vaccine. In August 2017, within 12 hours of receiving the vaccines, the patient developed a severe headache and vomiting and 14 hours after receiving the vaccines she developed erythema at the PNEUMOVAX 23 injection site that was 4 inches. The outcome of headache and vomiting was reported as resolved on an unknown date in 2017. The outcome of the erythema was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported.
3 mo old with no prior vaccines. Developed colic @ 2 mo of age. Suspected GERD and started ZANTAC at 2 mo and 1 wk of age. At 3 mo got DTaP and Hib -> 1 day later developed oral aversion and has refused to nurse at 75% of feeding times. This has persisted for 1 mo so far without improvement. Stopped ZANTAC - no improvement.
Information has been received from a consumer concerning her 16 year old daughter with allergy to AMOXICILLIN who in August 2008, was vaccinated with the first dose of GARDASIL (Lot # not provided), in OCT-2008, was vaccinated with the second dose of GARDASIL (Lot# not provided).  Concomitant therapy included MENACTRA which she received with the first dose of GARDASIL.  Then in the first week of November 2008, the patient started to have severe lower back pain.  Then the back pain progressed over the week with some tingling in her legs.  The patient then saw a physician who recommended physical therapy and to see a chiropractor.  The patient had a MRI which showed everything was fine.  The patient had been doing better with the physical therapy, but then two weeks ago the back pain started to bother her again.  The reporter was not sure if the back pain and tingling in the legs was related to GARDASIL, but she decided not to give the third GARDASIL at this point in time.  The patient was not recovered from back pain and tingling in her legs.  She went to the doctor, chiropractor, physical therapy, MRI.  This was one of several reports from the same source.  Additional information has been requested.
Headache, body aches, joint aches, fatigue .  Majority of pain  subsided within 24 hours, fatigue and a mild headache with mild sinus congestion persisted for about 48 hours.  Fully subsided within 3 days.
inadvertently administered to infant who will not be turning 6 weeks old until 2 more days; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number AB3BR, expiry date 29th June 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 23rd November 2021, the patient received the 1st dose of Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 23rd November 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The rotarix was inadvertently administered to infant who would not be turning 6 weeks old until 2 more days, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
After the injection about 1-2 minutes, my son fell in faint for 1-2 minutes. His face turned to very pale for about ten minutes, his lips also turned to very pale.
Hives all over from scalp to toes for over six days; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9262), via an unspecified route of administration in left arm on 22Jan2021 14:30 at a single dose for COVID-19 immunisation. Medical history included allergies to Sulfa. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19  Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and ethinylestradiol, etonogestrel (NUVARING).  The patient experienced hives all over from scalp to toes for over six days on 22Jan2021 22:30. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the event was not recovered.
Local rxn - lt deltoid- temp 98.6 pain, induration @ inject site; No abcess; mom called MD & he recommended giving periactin until swelling disappears;
tired, body aches, feverish-she was sent home from work 4 days later, she is still tired, arm is sore, red and hot
worsening acid reflux; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (worsening acid reflux) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (esophageal). Concomitant products included FAMOTIDINE (PEPCID AC) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Acid reflux (esophageal).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (worsening acid reflux). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (worsening acid reflux) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a physician concerning a 9 year old boy with no history of drug reactions or allergies who on 30-MAR-2000 was vaccinated with the first dose of VARIVAX  0.5 ml subcutaneous (Oka/Merck) (lot # 632371/1464J), and on 06-Dec-2006 with the second dose of VARIVAX 0.5 ml subcutaneous (Oka/Merck) (lot # 655065/1142F). On 13-APR-2008 the patient was diagnosed with shingles after he had received the two doses of VARIVAX (Oka/Merck). The patient's outcome was not reported. No further information is available.
On 06/13/2022 I had a headache, runny nose, sneezing, chills and severe fatigue. I had a home test, which was positive on 06/15/2022. My primary care physician prescribed Paxlovid. I had a recurrence after completing Paxlovid on 06/24/2022 that lasted 24 hours.
about 10 minutes after injection patient experienced throat tightening and gagging with slight decrease in O2 (95%), given epi 0.3mg IM and 50mg benadryl IM with improvement  ~1min after, improved O2 to 97%, transported via 911 to ED for further management
One week after vaccine upper arm below injection site turned red and itchy, some rash feel somewhat warm  site of redness 2 inches wide about 5 inches long
16 hours after receiving the vaccine, I started feeling welts on various part of my body and intense itching.  I proceeded to take a dose of Benadryl 25 mg and went back to bed.  I was also feeling achy which I knew to expect.  The itching improved until it wore off 4 hours later.  I continued to take Benadryl every 4 hours throughout the day to keep the welts and itching under control.  I decided to try stoping the Benadryl before bed and it seemed to be ok.  The reaction subsided about 18 hours after it had started.   I contacted my physician the next day and they told me to report what had happened.
Hives lasted off and on for about 3 days. Located on face, torso, and legs. Gave BENADRYL.
"Pt w/ allergies to Latex (rash) and Amoxicillin (rash). Pt also has intolerance to Norco (N/V/Dizziness).  Pt PMH notable for Asthma, Lupus, unspecified neurological abnormality, clotting disorder (clotted post knee surgery in 2015), Depression. 16mins post vaccination pt c/o itchy ears and throat and slight swelling of the throat. Pt c/o trouble swallowing. Pt administered 0.3mg Epi @16:24.  Vitals @16:23 BP 125/78, HR 78, RR 16, SpO2 100% RA -- >111/62, 60, 16, 100% RA -- > 118/65, 64, 16, 100% RA.  Pt stable and released from the vaccination site.  Pt was notified that second dose Pfizer appt was cancelled and appt for J&J made in 28days.  Pt may decline J&J.  Current Medications: ergocalciferol 50000Units PO Q7days cholecalciferol 1000Units PO daily Ca-Vit D3 500mg-200unit PO BID"
Fever, chills, body aches, sore throat, cough, somewhat constricted throat, swollen upper and lower eye area, red eyes.