chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients received Moderna bivalent booster doses that had undergone a temperature excursion.; Patients received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Patients received Moderna bivalent booster doses that had undergone a temperature excursion.) 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. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Patients received Moderna bivalent booster doses that had undergone a temperature excursion.) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (Patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    The case was reported for 66th out of 77 adult patients who had received the vaccine as reported by the reporter.  No concomitant drug information was provided.  It was reported that the vaccine was administered to 77 patients before it was known if the vaccine was ok to use after the excursion.  Treatment drug information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Information has been received from a nurse concerning a female patient (age unknown) who, on an unspecified date, was vaccinated with a 0.5 ml dose of Gardasil vaccine (yeast). The day after vaccination, the patient felt dizzy and lightheaded and experienced nausea. The patient was admitted to the hospital for 2 days. A CT scan performed at the hospital revealed vertigo. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Aches; Cough; Rash; shakes/ "almost rigors"; Fever (102F); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Aches), COUGH (Cough), RASH (Rash), CHILLS (shakes/ "almost rigors") and PYREXIA (Fever (102F)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 23-Dec-2020, 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 (Aches), COUGH (Cough), RASH (Rash), CHILLS (shakes/ "almost rigors") and PYREXIA (Fever (102F)). At the time of the report, PAIN (Aches), COUGH (Cough), RASH (Rash), CHILLS (shakes/ "almost rigors") and PYREXIA (Fever (102F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 °F (High) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.
Patient passed out after having the Johnson and Johnson vaccine. It occurred about 20 minute after the vaccine. Causing him to crash into another car. The patient loss consciousness and the EMT came to the site.
1st vax, fatigue, nausea ,June 26 after 2nd Vax she was sleeping , woke up and bed began spinning she was unable to regain balance  Headache and hard time walking. Still going on today. Balance is still affected and pt feels off.  Energy level is down
Became quite sleepy around 7pm same day. Went to sleep and woke up around 4 am the next morning. Felt feverish, headache, muscles pain. Just like typical influensa. Stomach symptoms gradually worse, with diarrea and slight vomitting.. This is precisely the same reaction I got formy first shot, which I believe was in August 2019.   I was gradually  feeling less bad, but spent most of the day in bed .  Even in the evening yesterday , I had a slight fever and muscle pain.  Much better today, but still lingering symtoms and will not leave the house.
Approx. 1 wk after injection, developed pink-colored circular and elongated dry lesions, no weeping, no erythema, no swelling. Located arms and legs. States sleeps with dogs which play in yard during day. Also stopped taking PREMPRO on 10/20/10.
Walking out of office after administration of Hep A/ TD. Fainted at receptionist desk, falling to floor, hitting the back of head on carpeted floor. Unresponsive x 3-4 minutes. Color good. Breathing OK. Began posturing- upper extremities. Eyes twitching. O2 started Sat 97% BP 140/80 P 53 911 called. Left for ER. Alert to DTP- groggy. O2 BNC
Per vaccinator administered 1.5 mL of Pedi pfizer Bivalent vaccine. Per vaccinator administered incorrect dose of Pedi pfizer Bivalent.  According to the manufacture the Pedi Pfizer Bivalent dose is 0.2ml after diluent reconstitution. No adverse reaction noted while in postvaccination.
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.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: It was reported that, Anti-viral Paxlovid for COVID 19 Treatment started on 15Jul2022 and stopped on 20Jul2022. No known allergies were reported. Patient received vaccine and other medications in two weeks. The adverse event reported Paxlovid rebound on 25Jul2022. The event was recovering. Therapeutic measure was not taken for the event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 27-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Narrative:  80yo male died of CoVid related complications at outside hospital. Pt with hx of: T2DM CKD OSA COPD HLD HTN hypothyroidism Afib Since pt died outside hospital, no further further information is available, however pt did receive 2 moderna vaccines on 1/28/21 & 2/25/21. Pt was fully vaccinated but developed covid infection contributing to his death.
This spontaneous report as received from a health professional refers to a 15 month old patient. On 27-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J012377, expiration date 13-OCT-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Information has been received from a 35 year old female consumer who on 28-JAN-2008 was vaccinated subcutaneously with 0.5 ml of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), which had expired in April 2007. Concomitant vaccine therapy that day included tetanus toxoid (manufacturer unknown). There was no concomitant medication. The patient reported developing pain at the injection site, on 28-JANA-2008, after receiving measles virus vaccine live (enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and a tetanus shot (manufacturer) concomitantly. Unspecified medical attention was sought. At the time of reporting the patient was recovering. No lab diagnostic studies were performed. There was no product quality complaint. Additional information has been requested.
This spontaneous report as received from a Medical Assistant, refers to an unspecified number of patient of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # K015827, expiration date: 11-MAR-2016, (administration routes were not provided). No concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Headache, sore arm, nauseated, body aches, chilled, sweating, fatigue.
Case number PHEH2014US021205 is an initial spontaneous report received from a healthcare professional on 21 Oct 2014, and with a follow-up received from a healthcare professional on 01 Dec 2014. This case refers to an 11 year old male patient. Past medical history and concomitant medication were not reported. Concurrent condition included penicillin allergy. He was vaccinated with an expired dose of MENVEO (batch number: A13017 and expiry date: not reported), at a dose of 0.5 ml intramuscularly into left arm on 18 Oct 2013 at 09:45 AM. It was reported that the patient received MENVEO 18 days after expiry date. No adverse event was reported following this administration error (expired vaccine used). Follow-up received from a healthcare professional on 01 Dec 2014: Patient's demographics (weight and height), vaccination details (site and time) and concurrent condition were updated.
It was left shoulder pain, extreme. Not heart related. It was so severe she couldn't move. My sister took her to her PCP Dr. and they did an x-ray and everything was fine. Her BP was high just because of the pain. 2 days later my sister took her to the ER because of high blood pressure. Hospital. Mon April 26th x-ray showed calcification, arthritis and a pinched nerve.
Relates that around 1700 09/17/14 her L arm began to ache from the injection site all the way down her L arm to the L wrist. Them related that was awoke at midnight on 09/18/14 running a fever of 100.9 and arthralgia in all joints. Relates that all symptoms had resolved by the time she woke up the morning of 09/18/14.
Patient stated tongue and arm were tingly about 10 minutes after vaccine administration. He was feeling like he was having an allergic reaction to vaccination. Patient said allergic reactions to foods normally clear up with Benadryl. Patient carried Benadryl in car with him, took 50 mg. We waited to EMS to arrive to further evaluate. Patient went to the hospital for further evaluation.
Patient reported dizziness after vaccine and was hypertensive into the 190's. She felt like she was going to faint but did not faint. The RN gave her some juice and crackers but since she still felt dizzy, she was sent to the ED for monitoring. Once in the ED, she was seen by a provider but reported feeling better and left before further workup.
Received zoster vaccine 06/22/22 in L deltoid Woke up this morning with dizziness, fevers/ chills  She believes this is related to the Shingles vaccine States she has always been sensitive to vaccines  Flu shot she felt terrible  Covid shot she felt ok  1st shingles shot she felt ok  Able to keep fluids down, able to drink water  Was not hungry for her breakfast this morning  States she vomiting a few times  Feels 'hot and cold'    No chest pain, pressure, SOB, syncope, falls.   1. Immunization reaction, initial encounter - ICD9: E949.9, ICD10: T50.Z95A - see HPI, received Shingles vaccine 06/22/22  - vitals stable, temp 98.9  - reviewed potential Shingles adverse effects with patient  - provided work excuse for today and tomorrow  - encouraged supportive therapies, rest, fluids and Tylenol as needed  - Discussed red flag symptoms and when to seek emergency care  - will fill out VAERS report
Case number PHEH2015US017922, is an initial spontaneous report from a pharmacist received on 10 Sep 2015. This report refers to a 55 year old female patient. Historical conditions were not reported. No concomitant medication was reported. Pharmacist reported that the patient received FLUVIRIN (batch number: 15722P) IM and FLUARIX (other manufacturer, influenza vaccine, batch number: unknown)) within a month apart on 10 Sep 2015. No adverse event was reported following the inappropriate schedule of vaccine administration. No further information was provided.
rt upper arm deltoid region is sl red, swollen & warm to touch; inj given 26JUN95 rxn started 27JUN95; c/o aching, flu-like sx, pain in arm & stomach
Shaking more than usual; A spontaneous report was received from a consumer concerning a 78-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed Tremor.   The patient's medical history included Parkinson's disease.. Products known to have been used by the patient, within two weeks prior to the event, not reported.  On 27 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot 007ML0A) intramuscularly in the right  arm for prophylaxis of COVID-19 infection.   On 27 Feb 2021, the patient developed Tremor.  Treatment for the event, was not reported.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, tremor was considered unknown.
Patient received influenza vaccination on Monday, 10/15/2007.  On Wednesday, 10/17/2007, patient broke out in hives on legs, back, groin and triceps.  Patient treated with calamine lotion and called his primary care physician on Friday.  He called pharmacy after talking to his PCP and informed us of his reaction.  He said the hives are improving and foresees no further treatment necessary.
On 08 NOV 2005 around noon, swollen lips and wheals under eyes.  Took Claritin and wheals resolved, but lips swollen, so instructed to take Benadryl.  Overnight urticaria involving thighs developed, and physician added oral steroid burst for about 5 days.  Urticaria on thighs would wane during the day, but recur at night for more than 7 days. On 06 FEB 2006 around noon, pt again noted lip swelling and took Claritin, then Benadryl.  That night, spouse said her forehead was warm to touch and gave Motrin.  Overnight, diffuse urticaria of thighs developed along with angioedema of face, throat, arms, legs, and feet.  Pt awoke feeling thirsty and had syncope on rising from bed. In ER on 07 FEB 2006, labs were drawn and IV treatment included Zantac, Zyrtec, steroids, and fluids for hypotension (BP 50s/palp with orthostatic changes).  Swollen areas were tender to touch/weight-bearing but resolved over about 4 days of missed duty, with 5-day course of oral steroids and several weeks of oral Zyrtec and Zantac.  Urticaria continued to recur overnight for more than a week after angioedema resolved.  Pt evaluated by Allergy Extender in 2006: labs repeated and pt advised to stop hormonal birth control. Evaluated by Allergist 12 JUN 2008: labs sent, EpiPen Rx renewed, and hormonal birth control discouraged.  Neither work-up identified an etiology for the illness (labs were normal) or a reproducible trigger for the 2 events (no new food or environmental exposures). For the past 3 years, pt has not had angioedema or urticaria.
very itchy rash started on 10th day and was over 6 inches long,  It is fading on third day, after applying benadryl cream.  But it's steill itchy and can still be seen.
Significant left axillary adenopathy with swelling and clear drainage with tingling/erythema down the arm. Started day after vaccination, still mildly present on evaluation 11/19/21
Developed symptoms of Covid-19 and tested positive on PCR test on 10/4/21
ALLERGIC REACTION, INIT  10/24/2022 -- RECURRENCE OF SAME SYMPTOMS
Normal reaction the following day, strong fatigue, headache, nausea, arm soreness. Disappeared 36 hours later. 3 days later experienced heavy nausea, anxiety, gastrointestinal discomfort. Heavy bloating, inability to pass gas, loose stool/diarrhea all week. 7 days post vaccination symptoms came back, feeling of wanting to vomit, strong nausea, loss of appetite. 7-14 days later lost majority of appetite, eating aversion, heavy bloating, nausea and continuing diarrhea. Weakness, fatigue and shaking. Received Stool sample and blood test April 13. Elevated levels of albumin and red blood cell count. Doctor said it was most likely from dehydration. Zofran prescribed April 13 and only taken 2 days. Nausea subsided and ability to eat came back slowly. Since April 15th have been eating more food, but still have to force myself to eat. Hunger pangs rarely felt, only know when hungry when stomach churns and fatigue sets in. Today, April 28, still experiencing slight anxiety, loose stools once every other day, brain fog and depression. Lack of emotion, irritability and  periodic upset stomach still persist, along with appetite loss. Am able to eat filling meals again, but no appetite makes food less appealing. Failure to thrive still evident and feeling like I won't get better evident. Treatment during illness was minimal, urgent care did nothing other than prescribe zofran. Gastroenterologist and GP cannot see me for another 2 weeks.
Information has been received from a licensed practical nurse referring to an 18 year old male patient. The patient had no pertinent medical history or drug allergies. On 14-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9 (dose, route, lot # and expiration date were unknown) (product use in unapproved population). Other suspect therapies included VAQTA (dose and route were not reported) during the same office visit. Concomitant therapies included MENACTRA. The patient passed out for a half of a second after being vaccinated. No treatment was given to the event. No lab was performed. The outcome of the event was reported as recovered on 14-JUL-2016. The causality was not provided. Additional information had been requested.
Seizure within 24 hours - (about 12 hrs) post vaccination on acellular DPT & IPV.  With 104-105 fever.
PATIENT WAS NERVOUS ABOUT THE SHOT. AFTER THE VACCINE WAS ADMINISTERED, SHE WAS TOLD TO WAIT AROUND FOR 15 MINUTES. APPROXIMATELY 2-5 MINUTES AFTER, THE PHARMACY STAFF HEARD A THUD AND SAW SHE SLUMPED DOWN ON OUR CHAIR. THE PATIENT CLAIMED SHE IS DIZZY, NAUSEOUS, BLURRY VISION, AND MUFFLED SOUNDS. PARAMEDICS WERE CALLED AND CAME TO CHECK HER VITALS. THE PARAMEDICS CONCLUDE THAT SHE IS FINE TO GO HOME AND REST. PHARMACIST FOLLOW UP WITH THE PATIENT'S MOTHER 4 HOURS LATER AND WAS TOLD PATIENT IS FINE.
Just smelling things that are not there/smelling unusual odors; Chills; Aches all over the body; Pains all over the body; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Pains all over the body), PAROSMIA (Just smelling things that are not there/smelling unusual odors), CHILLS (Chills) and MYALGIA (Aches all over the body) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN (Pains all over the body), CHILLS (Chills) and MYALGIA (Aches all over the body). In March 2021, the patient experienced PAROSMIA (Just smelling things that are not there/smelling unusual odors). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain and Chills, at a dose of 1 dosage form. At the time of the report, PAIN (Pains all over the body), CHILLS (Chills) and MYALGIA (Aches all over the body) outcome was unknown and PAROSMIA (Just smelling things that are not there/smelling unusual odors) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.   This case was linked to MOD-2021-079425 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Updated Patient Demographics, Suspect product details, and Event outcome as Not recovered / Ongoing.
Case number PHEH2013US008690, is an initial spontaneous report received from a medical assistant on 12 Apr 2013. This report refers to a patient of unspecified age and gender. The patient medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: M11082) intramuscularly on an unspecified date. Caller reported that they found MenA lyophilized conjugate vaccine component of MENVEO vial and was not sure if a patient received partial dose of MENVEO. Caller stated that a patient may had received only the MenCYW-135 liquid conjugate vaccine without the MenA lyophilized conjugate vaccine component of MENVEO. No adverse reaction was reported following this administration error.