chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5/3 vaccination By 10pm I had a HA and thought going to sleep it would go away. I woke up at 12AM and it had turned into a migraine. After that, I couldn't sleep and then in the morning, I went to the daycare with my son. I waited for it to go away, rested (no medication; painful but bearable).  Applied cold compress to forehead and it felt like it was easing, the pain. I did that all day long. The next day, when I woke up, the migraine was still there and decided to go to dr for medical advice. I have never had a migraine like that, not just a HA. Dr. and I didn't know what caused it. If wasn't gone by Friday, to call her back. On Wed, same symptoms. On Thursday, it was there but less intense. I felt like my left numb was slightly numb and the upper part of my arm, if felt like I had a tourniquet on it.  I called my Dr and informed her of new symptom and didn't know if linked to migraine. Advised to go to the ER and order some imaging. I went at 9:30, the Dr. told me she was going to order MRI, urine sample, blood panel, EKG. Everything was normal.  *3 weeks prior, I had been having pain in my legs. Eco doppler on my legs.  Localized pain. Appt scheduled 5/19/2021 *2nd pregnancy ('new things didnt have in first pregnancy like the pain in my legs'), EDD 09/14/2021
Patient received a booster vaccination for pfizer, and the guidelines are approved for 18 years older and above. The patient was currently 17 at the time of vaccination.
This spontaneous report as received from the patient's wife refers to an unknown age male patient. Medical history or current conditions were not reported. On 22-SEP-2012, the patient was vaccinated with ZOSTAVAX (concentration, dose, indication and lot number were not reported). Concomitant therapies were not reported. On an unknown date, the patient had suffered from hives. The outcome of suffering from hives was unknown. Causality was not reported. This is one of two cases reported by the same source (MARRS#1309USA013495). Additional information is not expected.
frozen shoulder. extremely painful at onset. improvement in pain day 2 with Motrin. Started physical therapy for frozen shoulder
On Tuesday she woke up with a headache that gradually worsened. The headache was behind the right eye, the right ear, and the teeth on the right side also hurt.  Nothing helped taking Acetaminophen; Ibuprofen.  She went to sleep around 4:00 am finally, and then woke up 6 hours and the headache was gone.  Then you had hives located behind the right ear and down the neck, into the right shoulder.  They are also in her scalp.  They have now down to the tops of her legs, hips, and back and are spreading.   She called her doctor who called her in some prescriptions.
vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023; No adverse event; Patients administered doses after the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients administered doses after the BUD), PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients administered doses after the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients administered doses after the BUD), PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients administered doses after the BUD) and PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023).    No concomitant drug information was provided.  It was reported that the 6 patients had received the vaccine beyond BUD.  No treatment medication information was provided.  The case belongs to the first out of 6 patients who had received the vaccine as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713881, US-MODERNATX, INC.-MOD-2023-713883, US-MODERNATX, INC.-MOD-2023-713884, US-MODERNATX, INC.-MOD-2023-713885, US-MODERNATX, INC.-MOD-2023-713888 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2023: Follow-up received, updated suspect drug batch number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713881:(pt 2 of 6) US-MODERNATX, INC.-MOD-2023-713885:(pt 3 of 6) US-MODERNATX, INC.-MOD-2023-713883:(pt 4 of 6) US-MODERNATX, INC.-MOD-2023-713888:(pt 5 of 6) US-MODERNATX, INC.-MOD-2023-713884:(pt 6 of 6)
pt recv APAP w/vax;from approx 5-9PM screamed for hr w/different cry;able to console only for short periods;later devel low grade fever;mom called x-change & gave APAP per MD advice & pt improved
This non-serious initial spontaneous case was received from other Non-health professional on 13-Nov-2017, concerning a 35-year-old, adult, female patient. On an unspecified date in Oct-2017, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). On 15-Oct-2017, the patient experienced pain in whole arms down to her wrists. It was reported that the pain lasted for 20 minutes. On the following day, her arms were little bit itchy. The outcome of the events was not reported.
Severe  total body muscle ache, fatigue,chills lasting about 40 hours after vaccine. Inabilty to lift left arm more than 45 degrees due to severity of arm pain. Improving
Developed singles 2 days after first dose; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 14:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to nuts and shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 12:00, 2 days after first dose the patient developed shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was recovered with sequelae on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse 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. 023H22A) 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) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse 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 aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 34th of 43 adult patients described by the reporter.   This case was linked to (E2B Linked Report).; Sender's Comments:
Pt given Pfizer COVID-19 Vaccine (first dose) around 1100. Waited 30 minutes post-vaccination observation period and left vaccine clinic. Pt reports she noted SOB going up the stairs to leave the building. Reports she waited upstairs for a while and symptoms did not resolve.. Pt reported back to healthcare facility to report symptoms at 11:45. Brought to observation area, vital signs checked (125/76, HR 60, O2- 99%). Reports SOB/tightness in chest continues at rest- Emergency Response Team is called. 1152- develops thickness in throat and coughing that becomes progressively worsening. Emergency Response Team arrives, Provider advises Epi-Pen. Administered Epinephrine Auto-Injector  at 1155. Pt is transported to ER by Emergency Response Team.
The patient should have gotten moderna dose 2 but received pfizer dose 2 in their primary series
Pt called and said she developed a rash on her stomach and back the day after receiving vaccine. The pharmacist she spoke recommended she take benadryl.  Tried calling, patient, left message,  to see how she is doing today but she hasn't called back.
Injection site pain/swelling/redness, fever, headache, fatigue, muscle pain, joint pain.
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: unsteady on her feet - waitied an hour before walking around-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Medium, Additional Details: clammy and pale in color , tingling in extremeties and  around mouth. 2 bp readings done 1st 106/65 HR 76 and 2nd 119/79 HR 85
This spontaneous report was received from a 81 year old female patient reporting on herself with none drug reaction or allergies. Patient's pertinent medical history included high blood pressure. In July 2011, the patient was vaccinated once, with a dose of ZOSTAVAX subcutaneous (Lot number, expiration date and dose were not provided) for shingles. Concomitant therapies included lovastatin (manufacturer unknown), diltiazem and KLONOPIN. The patient was diagnosed with herpes zoster reported as "shingles" on 28-NOV-2015. The same day, the patient went to an unspecified urgent care facility and was treated with VALACICLOVIR. On 30-NOV-2015, the patient saw the provider, who was the physician. No laboratory diagnostic studies were performed. The outcome of herpes zoster was reported as recovering. The reporter did not assess the relatedness of ZOSTAVAX to herpes zoster. Additional information has been requested.
48 hours after the vaccine my mouth began itching after eating. It happened during breakfast and lunch this day, and then the next morning at breakfast, which is when I became worried. My throat began feeling tight, felt like it had mucus in it and I needed to clear it. My mouth was itching and my tongue felt tingly. Four days after the vaccine my tongue started to swell so I called my doctor.   I saw him the Tuesday, 3/2 after the vaccine and he said my thyroid was swollen and felt I was having an allergic reaction to the vaccine. He did an allergy panel and lab work for my thyroid, all tests came back within normal limits. He referred me to an allergist and said to take benadryl every six hours. A few days later my  bottom lip started to swell and my tongue ached. I was also having intermittent chest pains for about five weeks. Then my lymph nodes in my throat started throbbing.   I saw the allergist on 4/6 and he advised to cancel the second dose. He did lab work to check for autoimmune disorders and inflammation but tests came back normal. He advised on 4/19 to take allegra two times a day for three weeks and we will follow up.   Ongoing symptoms are mouth itching after eating, tingling in throat, and itching on throat and neck, and on and off swelling of my bottom lip. I have also experienced lightheadedness and ocular migraines.
no additional AE; an expired VAQTA was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not reported.  On 27-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscularly (lot# S018419, expiration date was reported as 14-JUL-2020, but upon internal validation established as 12-JUL-2020; site of administration was not reported) for prophylaxis. No additional adverse event was reported.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately 2016 (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of M-M-R II lot # L020189, expiration date 03-JUN-2017; lot # L026551, expiration date 16-JUL-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 9 degrees Celsius for 9 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Follow up has been received on 14-SEP-2016, reporting the administered vaccine doses that have experienced multiple temperature excursions. It was reported that the patients were vaccinated with M-M-R II (lot # L027591, expiration date: 23-JUL-2017) on 12-APR-2016, 18-APR-2016, 19-APR-2016, 22-APR-2016, 26-APR-2016 and 27-APR-2016. The longest duration of temperature excursion with M-M-R II was 18 hours at 33.2 Fahrenheit degrees. The temperature excursions were detected by a data logger. Additional information has been requested. General, product, event information and narrative were updated.
Fever 102F for 24 hours, sweats, chills, bodyache, headache, malaise.
Vaccines were kept at elevated temperature excursions, no AE; Initial information regarding an unsolicited valid non-serious case was received from consumer/non-healthcare professional via Medical Information (Reference number- 00599790) and transmitted to Sanofi on 13-May-2021.  This case involves a patient (unknown demographics) who received IPV (VERO) [IPOL] (lot number and expiry date not reported) and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] ((lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination which were kept at temperature excursions for unknown periods of time on an unknown date (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   The reason for the elevated temperature excursions of unknown duration was that the person who was trained to properly use the data loggers stopped showing up to work so that the people who took over did not know that the data loggers had to be periodically cleared, but in addition to that, something is wrong with the data loggers so that they will not download the historical data for the temperature excursions. Practice manager asked for any extended stability information, and information on whether and when to revaccinate. The practice manager reports their data logger was not cleared so it was showing high temps for unknown periods of time. On April 22 it read 9.2 degree Celsius, through the end of the month and then 11.2 degree Celsius and then on May 7 12.6 degree Celsius.   This was a case of actual medication error case due to incorrect product storage (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
CHILLS; ARM HURTS; HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-AUG-2021 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 25-AUG-2021, the patient experienced chills. On 25-AUG-2021, the patient experienced arm hurts. On 25-AUG-2021, the patient experienced headache. On 25-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from arm hurts, headache, and fever on 25-AUG-2021, and had not recovered from chills. This report was non-serious.
One day after the second dose I felt tired, weak, cold, and with a sore arm. After, I took 3 Tylenol capsules  to feel better. Today my left arm which I got the vaccine in, feels itchy and my hand is swollen and red. Now my left feet is starting to feel itchy and swollen-red.
Patient began to have fever, headache, arm swelling on 5/4/22. Then presented with deep tissue injury and arm pain that began on 5/6/22 .
A non-serious spontaneous report of influenza A with symptoms of nasal drainage, cough, sore throat and fever up to 103 has been received from a health professional concerning a six-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received 0.2 ml FLUMIST, nasally, on 01-Dec-2010 for protection against Influenza. On 04-Feb-2011, the patient presented to the doctor's office with reports of nasal drainage, cough, sore throat and fever up to 103 which started in the evening on 03-Feb-2011. She tested positive for influenza at the office. The sample was sent to the State lab. The patient was treated with oseltamivir 45 mg twice a day for five days, acetaminophen+chlorpheniramine+dextromethorphan+pseudoephedrine and ibuprofen+pseudoephedrine+chlorpheniramine. The event resolved on 06-Feb-2011.
Information has been received from a registered nurse concerning a female patient who on 23 Feb 2007 was vaccinated with the first dose of Gardasil. On 23 Feb 2007, after the vaccination, the patient passed out and experienced a tingling sensation in her extremities. The patient's outcome was unknown.  Additional information has been requested.
Given Rotateq vaccine on May 1, 2007, developed symptoms of intussusception on May 14, 2007 and then officially diagnosed, treated, and hospitalized for intussusception on May 17, 2007.  0924/2007 Hospital record received for DOS 5/17-18/2007 for DX of Ileocolic Intussusception.  Child presented to ER on 5/17/07 with 3 day hx of abdominal pain, vomiting and bloody stool.  IS reduced by air contrast enema.  PE (+) systolic ejection murmur prior to D/C.
Patient complained of tightness in chest, red flushing in face.  Epipen 0.3 mg adminstered in left outer thigh.  Within 2 minutes patient stated no difficulty breathing, flushing subsided.
pregnant patient in the 3nd trimester was administered Arexvy; pregnant patient in the 3nd trimester was administered Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 31-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In OCT-2023, the patient received Arexvy. In OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: pregnant patient in the 3nd trimester was administered Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient in the 3nd trimester was administered Arexvy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date-13-NOV-2023 The pharmacist reported that the pregnant patient who was in the third trimester was administered Arexvy vaccine two weeks ago at an inappropriate age, which led to vaccine exposure during pregnancy and inappropriate age at vaccine administration. The reporter consented to follow up
Information has been received from a Registered Nurse concerning a 17 year old female who on 21-MAY-2008 was vaccinated "subcutaneously below the deltoid but above the elbow (arm unspecified)" with a first dose of GARDASIL (lot # 0152X). There was no concomitant medication. It was reported that "the patient was walking out of the clinic and the nurse noticed the patient had a large knot at the injection site in which there was redness, swelling, and irritation. The patient had this reaction within 15 minutes of receiving GARDASIL. The patient was given TYLENOL and warm heat. The nurse spoke to the patient this morning and the redness was getting better." Patient outcome was reported as recovering. Additional information has been requested.