chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had history of episodic migraines- she started to have progressively worsening migraines--after first injection (March 11, 2021), and then more severe after second injection which was April 7th, 2021.  There is documentation of her notifying primary care provider about side effect 4/23/21--however, suspect this was not recognized as adverse reaction.  According to AHS, post-COVID vaccination HA presents both in patients with and w/o history of migraine.  Do not have exact time-line, but with  weeks of this second injection, patient describes "The recent second COVID injection triggered my dormant chronic migraine headaches which feels like I'm being stabbed in the head, once again vomiting, blurry vision, and excruciating head and neck pain"  Patient reports she was not prescribed anything and she was only taking motrin for the pain. migraines have progressively worsened over past several months and now she has severe migraines 4 days a week, with headaches on most days of the week, <5 "clear days" in 30 day period. Pain is described as stabbing pain--bilateral, associated with photophobia, phonophobia, osphophia. She is having visual aura sx as well as sensory aura/vertigo that persists into interactal period--feels like "brain fog" and many characteristics of "long covid" type neurological.  This has led to relapse of both depression/PTSD, and she struggles to concentrate most days, doesn't want to get out of bed, often due to severe head pain.
At about 2:54 after shot at 2:50 I got a headache around my temples didnt last long maybe 5 mins. Just felt weird like a heaviness all over my body.  About 3:10 I started getting a metal taste in my mouth and throat  it was gone by 3:30, but kept coming back through the rest of the day and next morning.  By evening 8:45 PM  my arm where shot was given started to hurt and bothered me through the night could not lay on it. Next morning my arm was hurting really bad at injection site and was warm to touch. I had some errands to do so I did use the arm sometimes the pain was not as bad other times just my coat touching my arm hurt. Around 4pm I took a tylenol and slept a little not better. Sunday morning March 7 it was still sore not as bad, but after using while doing some chores it is now burning and hurting again at 2pm. I feel nauseous and really dont have a appetite.
swollen red, hard, warm & itchy lesion near vaccination site consistent with "COVID arm" vaccine was given mid upper arm. lesion appeared lateral to injection site. vaccine not given in Deltoid
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    ] No concomitant medications were reported. It was reported a temperature excursion that occurred several days ago in the Freezer. It was found that vaccines were viable. The patient received the booster dose. No treatment medications were reported.
COVID19 Moderna Vaccine given to 12yrs old patient. No adverse reaction/symtoms noted after vaccine given.
onset of a headache and myalgias. On day 3 she didn't document a fever with highest temp of 102. she was still running a temperature this morning. She has tenderness and sinus congestion/ nasal congestion over the maxillary sinuses with production of some mucus..starting 1 0/28/21
Several small areas of pruritus on chest, under (R) arm on back and (L) side of forehand. Followed up 3/25 and pt reported symptoms were "getting better."
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patients concurrent conditions, medical history and concomitant medications were not reported. On 03-JUN-2016, the patient was vaccinated with improperly stored (wistar ra 27-3) M-M-R II (lot # L003855 and expiration date 05-FEB-2017; lot # L026553 and expiration date 16-JUL-2017, albumin status therapy type, dose and route of administration were not reported) and (Oka/Merck) VARIVAX (lot # L039092 and expiration date 06-OCT-2017; lot # L043622 and expiration date 03-NOV-2017; lot # M004326 and expiration date 25-JAN-2018, dose and route of administration were not reported). The maximum temperature of excursion of (wistar ra 27-3) M-M-R II was 22.7 Celsius degrees with the time frame of 3 hours and 48 minutes and the minimum temperature of excursion was 0.2 Celsius degrees with the time frame of 31 hours and 1 minute. The maximum temperature of excursion of (Oka/Merck) VARIVAX was minus 5.2 Celsius degrees with the time frame of 50 hours and 17 minutes. There were no known adverse effects. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Body Aches from head to toe. Violent nausea and vomiting and diarrhea, severe weakness, rapid heart rate, chills and low grade fever (99*) which lasted 6 days before eventually going to ER.
did not receive both vials mixed with no reported adverse event; more than likely got the incorrect dose of PENTACEL, with no reported adverse event; Initial information was received on 16-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA254827 (CLUSTER).  This case involves an unknown age and gender patient who did not receive both vials mixed and more likely got the incorrect dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [PENTACEL (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Aug-2023, the patient received 0.5 mL, total (once) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (batch number: UJ876AA; expiry date: 19-Mar-2024, unknown strength) via intramuscular route in unknown administration site for Immunization, more than likely got the incorrect dose and did not receive both vials mixed with no reported adverse event (incorrect dose administered) (single component of a two-component product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
Patient developed 101 degree fever about 2 hours after injection. The developed a 107 degree fever 3 days later. Guardian administered MOTRIN and went to ED. Fever was down to 104 degree F after MORTRIN. Came in 10/16/18 for ER follow up. Patient continues to have fever.
Hard of hearing; still feel dizzy when getting up; fell; dizzy spells; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell), DIZZINESS (dizzy spells), DIZZINESS POSTURAL (still feel dizzy when getting up), HYPOACUSIS (Hard of hearing) and NAUSEA (nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced NAUSEA (nausea) and HEADACHE (headache). On 13-Mar-2021, the patient experienced FALL (fell) and DIZZINESS (dizzy spells). On 23-Mar-2021, the patient experienced DIZZINESS POSTURAL (still feel dizzy when getting up). On an unknown date, the patient experienced HYPOACUSIS (Hard of hearing). At the time of the report, FALL (fell), DIZZINESS (dizzy spells), DIZZINESS POSTURAL (still feel dizzy when getting up), NAUSEA (nausea) and HEADACHE (headache) had resolved and HYPOACUSIS (Hard of hearing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood thinner, blood pressure medicine, cholesterol medicine, diabetes medicine, heart problems and anxiety medication.  The patient did not receive any treatment.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up information received on 06-AUG-2021. Event details was added.
Diziness and vertigo transiently Itchiness of feet and then Lower Extremities with no rash, hives
Administration of an expired dose of Shingrix; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number c9gm4, expiry date 15th November 2021) for prophylaxis.   On 4th January 2022, the patient received Shingrix. On 4th January 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported but it could be 72 or 73 years. The patient was given an expired dose of Shingrix. No further events were reported . The reporter consented to follow-up. This is one of the three cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002054:same reporter US-GLAXOSMITHKLINE-US2022002050:same reporter
mom recv vax & became pregnant;11JAN96 ultrasound was nl (20.5 wk);a nl child was delivered;no congenital anomalies, no signs of congenital varicella synd, & no chickenpox or shingles;pt did have a skin rash poss staph infect;
Pt was supposed to receive a flu shot but received a tdap shot instead.  The student pharmacist who administered the vaccine filled out the paperwork and documentation for a flu shot but realized later on she had taken a vaccine out of the Boostrix box.
Sore left arm after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm after second dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 030L20A) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (Yearly IM Flu vaccine fall) in 2021. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Penicillin allergy, Drug allergy (Unknown blood pressure medication) and Blood pressure high (No change reported).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. In 2021, the patient experienced VACCINATION SITE PAIN (Sore left arm after second dose). At the time of the report, VACCINATION SITE PAIN (Sore left arm after second dose) had resolved.            Concomitant medications included unspecified high blood pressure medication. It was reported that the event did not cause patient to seek medical care. No treatment information was reported.   This case was linked to MOD-2022-547050, MOD-2022-547043, MOD-2022-547040, MOD-2022-548215 (Patient Link).
COVID-19/Headache, fever, cough, congestion, aches, diarrhea; COVID-19/Headache, fever, cough, congestion, aches, diarrhea; Moderna: dose#1-4 and Pfizer / BioNTech: dose#5-6; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9693), in left arm and on 20Apr2023 as dose 6 (booster), single (Lot number: GI3268) at the age of 76 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Jan2021 as dose 1, single (Lot number: 013L20A), in left arm, on 14Feb2021 as dose 2, single (Lot number: 0016M20A), in left arm, on 27Oct2021 as dose 3 (booster), single (Lot number: 012F21A), in left arm and on 30Mar2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. Concomitant medication(s) in 2weeks included: AMITRIPTYLINE; CHLORTHALIDONE; OLMESARTAN; ATORVASTATIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "unknown", described as "Moderna: dose#1-4 and Pfizer / BioNTech: dose#5-6"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Sep2023 at 17:00, outcome "recovering" and all described as "COVID-19/Headache, fever, cough, congestion, aches, diarrhea". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 07Sep2023 to 11Sep2023 for treatment of COVID-19.   No follow-up attempts are possible. No further information is expected.
The patient was 17 years of age at time of vaccination, which is not indicated for use of Moderna COVID-19 vaccine.  No adverse events took place after vaccination.
REPROTED BY PATIENT: I have a blister where I received the Covid booster and Pneumonia shot on Thursday 10/27.  There is a red ring around it. My arm feels better today as it was very sore and swollen the last 3days. The blister started Saturday.  Just checking if I should do anything special. I am being careful no to break it
10/7/10 Mother called to report patient's (R) arm swollen, red, war, down to med forearm. Mother took patient to family doctor that evening who stated he felt it was an allergic reaction and recommended mother give the patient BENADRYL. 10/6/10 mother reports patient is better.
Light-headedness; onset 30 minutes, post vax. Hives, onset 1-2 hours, post vax. Both lasted 24 hours.
patient started to get chills the next day, muscle and joint pain, as well left are swollen and in pain with a swollen red site below injection site Patient tried warm compresses on  site was told to contact her MD
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine (received in October 2018) and SHINGRIX (received 1st dose on an unknown date). On 3rd January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced tiredness, fever and feeling abnormal. The patient was treated with paracetamol (Tylenol) and medication unknown (Fluids). In January 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the tiredness and feeling abnormal were unknown. It was unknown if the reporter considered the tiredness, fever and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: In December 2018, the patient had complete physical examination  which was normal. The patient was fine after receiving 1st dose of SHINGRIX. After receiving 2nd dose of SHINGRIX, the patient experienced fever of 100.5 degree F for about a week and felt tired. The patient reported that she had excessive energy prior to vaccine and now felt like a truck ran over her. The patient reported that her normal temperature was 97.6 degree F. The patient did follow up with her physician and he advised her to take fluids and Tylenol. The patient asked was this within normal limits of side effects, was this a typical reaction and anything to do so that she could return to normal.
PATIENT STATES THAT HER VACCINE LOCATION BECAME RED, SWOLLEN, AND PAINFUL BEGINNING THE NIGHT OF THE INJECTION. BY MORNING, HER ENTIRE UPPER ARM SWELLED TO THE SIZE OF AN EXTRA LARGE EGG. THREE DAYS LATER, HER ARM HAS DECREASED IN SWELLING, BUT IS STILL RED AND A BIT SWOLLEN. IMMUNIZATION SITE IS NOT VISIBLE, BUT LOOKS LIKE IT MAY HAVE BEEN A LITTLE HIGH. NO SIGNIFICANT LIFE-THREATENING EVENT HAS OCCURRED, AND THE PATIENT HAS NEVER HAD ANY REACTIONS IN THE PREVIOUS YEARS.
Large erythematous swollen area at the  injection site the day after her shot. Resolved over 3 days w/ antihistamine
Immediate (before needle even withdrawn) syncope with short seizure (less than 30 seconds.)  Alert within 60 seconds, completely recovered within 15 minutes.
POSSIBLE BLEEDING ULCER; SUSPECTED LIVER DAMAGE; STROKE; UNABLE TO COMMUNICATE; SEVERE CONFUSION; This spontaneous report received from a consumer concerned a 34 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no prior history of any of the events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient's parent reported that the last week, he was hospitalized because the patient was unable to communicate and had severe confusion. The blood work showed very high ammonia levels, low hemoglobin and iron. There might have been other results that she did not know about. A brain MRI (magnetic resonance imaging) showed two small infarctions which was mentioned as strokes that was unusual for someone his age. It was believed that the patient had liver damage, a possible bleeding ulcer where he required a blood transfusion. The patient had no prior history of any of these and seems unusual that three unrelated events happened at the same time. The patient had been discharged from the hospital and were awaiting for follow-up visits from the neurologist and GI (gastrointestinal). The number of days of hospitalization was not reported. Laboratory data (dates unspecified) included: Ammonia (NR: not provided) Very high, Hemoglobin (NR: not provided) Low, Iron (NR: not provided) Low, Lab test (NR: not provided) Not reported, and MRI brain (NR: not provided) 2 small infarctions (strokes). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unable to communicate, severe confusion, suspected liver damage, stroke and possible bleeding ulcer was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220217887-COVID-19 VACCINE AD26.COV2.S-Possible bleeding ulcer,Suspected liver damage,Stroke,Unable to communicate,Severe confusion. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt recv vax & 4wks post vax could not urinate & c/o muscle weakness & tingling in the legs;pt hosp for urinary problems & to r/o GBS;exp optic neuritis;dx viral encephalomyelitis;paraplegia both legs-no sensation to pin or vibration;
Patient received a PNEUMOVAX vaccine administered subcutaneously and has now developed cellulitis, was taken to ER and now on antibiotic txt.
SORE; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore and tired was not reported. This report was non-serious.
Developed a red rash around injection site. Mild redness for the first few days after administration which appeared to be resolving if not already resolved when it began to worsen about one week after administration. Now warm to touch, skin is tense and itchy.
This previously healthy 7-year-old male received influenza vaccine IM in the right upper arm on 10/29. The next day, he developed localized erythema that worsened and progressed to edema and tenderness to palpation. On 10/31, he presented to the ED with a 10 cm x 14 cm area of erythema surrounding the injection site along with induration, mild edema, and warmth. He was diagnosed with possible cellulitis and started on clindamycin. I telephoned the mother to discuss the reaction to the influenza vaccination. The area of erythema eventually covered about 75% of the patient's upper arm from the shoulder to the elbow. The upper arm returned to normal on 11/6.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056:
8SPE93 1AM pt woke up w/a rash on feet, hands, wrists, around joints, swelling, itching especially bottom of feet & palms hands & joints; 10SEP93 vomited x1;
Patient presented to the ER at 630 am with acute onset of generalized hives , itching and vomiting x 2 and was treated for anaphylaxis . SHe was given OM epinephrine and Benadryl with improvement .