chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  He states experiencing mild disorientation/fog and mild dizziness ~ 20 minutes at the initial vaccination. While he was still oriented to person/place/time, he states having difficulty in trying to find his car (no issues reported during the 15 minute waiting period). Both concerns resolved w/in 5 minutes spontaneously. He had not had a prior similar reaction to a past vaccination. Denied pruritus (other than over injection area), urticaria/hives, flushing, swelling/angioedema, lightheadedness, weakness/difficulty ambulating, syncope/LOC, SOB/dyspnea, tachycardia/palpitations, nausea/vomiting/diarrhea, abdominal cramping. He has no allergies that he is aware of and was able to work afterwards. RN reviewed common adverse effects and when to seek care. Advised 30 minutes of supervised post-vaccination wait time. Reinforced to alert staff if he experiences any of the adverse effects we discussed related to concerns for immediate allergic reaction. Patients intention is to return to work today (works with health care professional). He was checked on during/at the end of the observation period and reported no issues.
PATEINT WAS GIVEN PFIZER VACCINE ON 08/13/21 AND PASSDED OUT WHILE IN WAITING AREA FOR 15 MINUTES OBSERVATION. PER HIS FATHER , CHILD IS TEND TO PASS OUT AFTER GETTING SHOTS .. FOLLOW CALL WAS MADE ON 8/13/21 AT 4 PM TO MAKE SURE THE CHILD WAS OK.. PER DAD HE WAS DOING OK WITH NO ISSUES.
Pt emerged from exam room following vaccines and passed out, hitting head against wall as she fell. Head CT confirmed linear, non-depressed occipital skull fracture. Has had ongoing post-concussive symptoms - causing multiple follow-ups & school difficulty.
Right lateral upper arm hot to touch, swollen, and surrounded by a 10" erythema area.  Patient states that it burns and hurts.
Arm was red after they got the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The pharmacist stated that the patient arm was red after they got the vaccine.  The reporter did not consent to follow up. The pharmacist stated that she has no further details and declines follow up. This case linked with US2019189773, reported by same reporter.
Given Varicella vaccine on 3-25-11, advised by PCP following titer showing no immunity - never had illness or vaccine. On 4-11-11, 2 weeks following vaccine developed headache, urticaria (hive) at injection site and several vesicles/papules scattered to scalp, face, back, chest, arms.
Pt was given Fluzone High Dose and was suposed to recieve Standard fluzone. Was monitored by assigned nurse for any adverse reactions. No adverse reations reported.
Part of the left side of my face and neck is numb. Feeling is very similar to when they numb your mouth at a dentist office.
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Dizziness, Headache & CoughWheeze Employee with history of asthma. 5 minute after 2nd vaccine, c/o tickling throat, wheezing, dry cough. Headaches soon after. Went to ER for care. Was treated with medication, and later sent home.
Vaccine Dose given was expired.  Dose Drawn up 5/2/22 @8:30AM Dose Expired 5/2/22 @8:30PM Does administered 5/3/22 @8:10AM
overall joint pain increased/Sacroiliac became very inflamed; left arm got worse; Then right deltoid pain (feels like bursitis; Some daily vertigo moments, but dissipating.; Sacroiliac became very inflamed; This is a spontaneous report from a contactable consumer. This 59-year-old male consumer (patient) reported for himself that he received bnt162b2 (BNT162B2 solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included arthralgia and fibromyalgia and diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The historical include vaccine include BNT162B2 (dose number: 1, lot number:  #R8727, administration time: 09:00 AM, vaccine location: Left arm) at 59 years for COVID-19 immunisation and experienced General joint pain, weak, and bursitis on 08Apr2021. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was no, and patient received within 2 weeks of vaccination was No. Prior to vaccination, was the patient diagnosed with COVID-19 and Since the vaccination, has the patient been tested for COVID-19 was no. known allergies was no. The patient experienced overall joint pain increased/sacroiliac became very inflamed, left arm got worse, then right deltoid pain, some daily vertigo moments, but dissipating and sacroiliac became very inflamed on 10Apr2021. General joint pain and a few days later in left arm (shot arm) at deltoid feels like bursitis) became painful and weak. Had a previous injury there decades ago. After second shot overall joint pain increased and left arm got worse (second shot in right arm) Sacroiliac became very inflamed and painful (site of other old injury) Then right deltoid pain (feels like bursitis) Still battling mild to severe pain over a month after second shot. Some daily vertigo moments, but dissipating. The outcome of the events was unknown.
The patient was found lying on the floor face down at 2:40am.  He was responsive and able to sit up.  Reported dizziness and chills.  Was visibly shaking while staff were talking with him.  Was sent to the ER for evaluation.
Pt. developed redness & swelling at injection site, after the injection. Since then a rough patch(scarring) has developed with associated tingling sensation.
Pt fainted almost 15 minutes after vaccines given. When received, she complained of her ears ringing. No reported pt dieting, having nothing to eat day of vaccination. Peanut butter crackers given. Pt left with mother. 3pm , same day, mom called to report pt had slept 2 hours and still sleeping, c/o dizziness and ringing in her ears. She also complained of hoarseness and was starting to cough. Mom advised to contact PMD if symptoms persists or worsen. 8:45pm: Pt to ER: feeling worse, more dizzy, holding onto things to walk. Ears still ringing. Kept in ER x 5 hours. Blood work drawn. Doctor feels CP x cause. Advises against second CPX. 7/28/04 11AM. PC. Pt lightheaded and off-balanced, but not as bad as yesterday.
no adverse event; an improperly stored vaccine was administered; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 25-JAN-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot number 1688504, expiration date reported as 18-NOV-2021, but upon internal validation was determined as 19-NOV-2021, 1 dosage form, oral for prophylaxis. No other adverse event was reported.  The vaccines underwent a temperature excursion above 9 degrees Celsius (°C) (13.4°C) for 2 hours and 9 minutes. There were not previous temperature excursion. The call was due to digital data logger.; Sender's Comments:  US-009507513-2101USA013457:
The shot didn't hurt. I sat for about 25 minutes, but when I got up and walking I started feeling a lot of pain.  I didn't say anything I just kept on going to see if it went away. I went home and was in a lot of pain while driving. I went home took my medication and went to sleep. Woke up in the morning and pain went away, the medication worked. I went to my Dr., went I left I started feeling nausea, dizzy and weak. I went to my sister's house and was in pain and laid down. I was cold and freezing and felt like I have Covid. I asked my sister to get me a trash bag a nd wash the blankets because I thought I had Coivd. I drove home and called my boss and told him I can't walk, I feel so bad, sweating and I was burning up, cold and hot.  I cant move I cant move. I stayed in my car until I can move. I made it inside my house and laid there and was burning up, cold hot, in pain, dizzy, everything was going on. I felt like a Mac truck hit me hard, like when I had Covid. I took Medicine and went to sleep. I woke up the next morning (Saturday) and my temp. was 101-102, I stayed in bed and later in the evening went away like it never happened. The same thing happened when I had the Covid.  I had Covid July 31, 2020 and lasted for 5 weeks.  It felt like the worst days like when I had Covid, I was going to call out to my job but it went away and I went to work.
Patient received first dose of vaccine and felt dizzy about 15 minutes after administration. She felt like she was going to "pass out." She did not lose consciousness and her vital signs remained stable.
itching, redness and swelling at injection sight.  Took Benadryl on 12/31.  Reappeared on 1/1, visited Er, got dexamethasone, Pepcid po and bendaryl
Sudden onset of aches, fever and chills at indicated time resulting in sleeplessness. Moderate to high amount of fatigue and some loss of appetite. Symptoms subsided Sunday evening (9/21/2014). Took Ibuprofen to control the fever and body aches.
Yes, I did have tetanus booster shot, but I do not know any details. Headache, lethargy, no appetite, dizziness, lightheadedness, discomfort from head to toe, fever, general weakness, sleepiness (24 hours a day), some confusion.
Narrative:  Pfizer covid vaccine 3/20 and 4/9. Covid+, SOB, fever, lightheaded, tachycardic, discharged to home on oxygen
Re-activation Oka strain disseminated zoster with vesicular rash in L4 dermatome, with left leg weakness, aseptic meningitis, fever and hepatitis.
Hives-Generalized urticarial rash. Benadryl 1/2 tsp po (q4h) at 16:00.
Pt complained of redness, swelling, warm to touch left deltoid 12 hours after injection.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # N003698 with expiration date on 31-OCT-2019 or lot # M046140 with expiration date on 27-SEP-2019. Administered doses of vaccines underwent following temperature excursions: twice an excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit, which each lasted for 12 hours and ten excursions from 32 degrees Fahrenheit to 35 degrees Fahrenheit, which each lasted for 12 hours (total timeframe of excursions was 144 hours). A digital data logger was involved in recording the excursions. No adverse effects were reported. Product quality complaint was not involved. This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA008052: US-009507513-1708USA011555:
Pt developed hives and itching the day after vaccine was administered. Began taking Benadryl OTC x 3 days with no relief. On 04/30/07 went to ER. She was prescribed Atarax x 14 days. By May 6, 2007 all symptoms had been resolved.
approx 34 hours after vaccine awoke unable to breath. symptoms consistent with laryngospasm. symptoms lasted approx 2 minutes; approx 34 hours after vaccine awoke unable to breath. symptoms consistent with laryngospasm. symptoms lasted approx 2 minutes; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot ek9231) on 08Jan2021 03.00 pm intramuscular in the left arm for COVID-19 immunization. Medical history included RA, spondylitis, GERD, known allergies to sulfa, penicillin, cefalexin monohydrate (KEFLEX), sulfamethoxazole, trimethoprim (BACTRIM), adalimumab (HUMIRA), ankylosis. Concomitant medications included acetylsalicylic acid (ASPIRIN), omeprazole, loratadine (CLARITIN) and infliximab (RENFLEXIS). First dose of BNT162B2 was administered on 21Dec2020 11:00 am (lot ek5730) intramuscular in the left arm for COVID-19 immunization. Approx 34 hours after vaccine (also reported as 03Jan2021) awoke unable to breath. Symptoms consistent with laryngospasm, symptoms lasted approx 2 minutes. No treatment provided. No COVID test performed prior or after vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of unable to breath/ Laryngospasm cannot be excluded, considering the plausible temporal relationship.  Severe allergic reaction is the known risk for the product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of allergic reaction to vaccine.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report was received from a nurse practitioner referring to an unknown number of patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of PNEUMOVAX 23 (indication, dose, frequency and dose number were not provided) (Lot # L014458 with an expiration date in 11-FEB-2017 and Lot # reported as M029681 with an expiration date in 22-JAN-2018). No adverse effects were reported. The vaccines were exposed to a temperature excursion of 15.6 Celsius degrees for 1 hour and 59 minutes. Concomitant medication information was not provided. This is one of two reports from the same reporter. Additional information is not expected as no consent for follow up was provided.
Large red patch on left arm and pain on left side of body continuing on day 3 post vaccine
Started to feel unwell within hours of receipt of the vaccine (fever, chills, body aches, sweats, fatigue).  This lasted 2 days, then symptoms improved.  Developed shortness of breath about 1 week after receiving vaccine, along with persistent fatigue.  Was seen about 2 weeks later (2/10/22) and found to have bilateral PEs.
LARGE red area around the injection site that started right away.  It is covering most of my upper arm.  It also happened with the first Covid 19 shot but was smaller.  The first shot was lot #026L20A and was received on 1/17/21.  The spot is hard, raised and hot.  The original spot from the first shot started to get smaller by about day 4 so I'm hoping this one does the same thing.  I would love to be able to send pictures.
Child was very engaged and vocal, after he started to zone out and didn't make noise for 3 weeks.
had a rash; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of rash in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced rash (Verbatim: had a rash).  The patient was treated with benadryl (nos) (Benadryl). The outcome of the rash was not reported.   It was unknown if the reporter considered the rash to be related to Arexvy.     It was unknown if the company considered the rash to be related to Arexvy.   Additional Information: GSK Receipt date: 11-SEP-2023 The reporter reported that the patient had a rash after receiving Arexvy and had to take a Benadryl. The reporter consented to follow up. The case had been link to the US2023AMR124853 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR124853:same vaccine, same reporter
Second Vaccine given on 03/20/21.  The day after (03/21) I experienced extreme all-over body aches, especially lower back and glutes.  Also experienced major fatigue.  Left arm extremely sore at injection site.  Treatment was basically rest and later in the day two prescription Tylenol.  On 03/22, in the morning I still felt all-over body ache, especially lower back.  By 11 am, I started to feel much better.  So I would say that the adverse effects lasted only a day and a half.
Did not sleep much; Slept all day; sleepiness for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepiness for 3 days), SOMNOLENCE (Slept all day) and INSOMNIA (Did not sleep much) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced SOMNOLENCE (sleepiness for 3 days). On 15-Jan-2021, the patient experienced SOMNOLENCE (Slept all day). On 11-Feb-2021, the patient experienced INSOMNIA (Did not sleep much). On 15-Jan-2021, SOMNOLENCE (Slept all day) had resolved. On 17-Jan-2021, SOMNOLENCE (sleepiness for 3 days) had resolved. On 11-Feb-2021, INSOMNIA (Did not sleep much) had resolved.            Treatment includes Tylenol and the patient had hurt all over the body and was resolved.   This case was linked to MOD21-042637, MOD-2021-031653 (Patient Link).
In bed for seven days. Severe sweating, muscle weakness, could not eat, loose stools,
Pt recvd Td vax & devel fever, chills, malaise, & sore arm w/sl redness, swelling;
Patient presented to the pharmacy on 6/4/21 to inform pharmacist that she did go to the emergency room on 5/29/21 due to severe shortness of breath and flu-like symptoms. She stated they did complete an EKG and did check for blood clots. She stated that they did not find anything significant and ruled out a blood clot at that time. She still states she feels tired, however the shortness of breath did resolve and she was discharged home without any further treatment necessary.
Patient complained of increased pain - both shoulder, back, shoulder blades, muscles in legs and hops are sore and tight, groin pain. Increased fatigue, difficulty sleeping, muscle fatigue and achiness.
Pt received TD booster, post vaccine pt stood to leave, became dizzy, diaphoretic and pale. Afebrile, heart rat/BP, pulse ok and blood sugar stable. After 10-15 minutes child recovered completely visual signs remained stable. Pt received PO fluids and tylenol for headache. 24 hour phone follow-up no repeat episodes.
Pain in left shoulder and difficulty raising left arm. Pain is not at injection site but up near the collar bone.
pt recv vax 25JAN96 & 1wk p/vax pt exp an elevated ALT (SGPT);MD will cont to monitor pt status periodically;
The patient sat down for few min before he and his sister and mom decided they will walk around the pharmacy  and rechecked that everything is fine, few minutes later, The patient felt  he has dizziness and light headed and fell in the ground with support of his mom . I went to check on him and he was sitting on the ground with pale face , I gave him water and crackers and he started to feel normal, took him back to the pharmacy , get his blood pressure and it was within the normal range 120/80. he sat for 20 min and I got the  managers who offered him calling the ambulance but he assured that he is feeling normal.  and advised his mom to go to ED to double check and to keep a close eye on him and she stated she understand and will go to the hospital if needs to after they will call the dad.
Patient given covid vaccine #2 and advised to be observed for 30 minutes due to multiple allergies. At about 25 minutes after vaccination, patient began feeling chest pressure and lightheaded and warm. No issues with first vaccination. She had eaten breakfast. Has h/o asthma. Given water to drink and advised to use her inhaler. She gave herself 2 puffs. O2 Sat prior to albuterol was 98% and pulse in mid 80s. BP checked on L arm and systolic was 140. Patient felt slightly better after albuterol, but then started having throat tightness. No itching or rash. No n/v or arm pain or sweating. Sitting in chair and appeared fine. O2 Sat 100% and BP on R arm 100/60. Stated her asthma has been 'acting up' lately with season change. Also takes singulair. Given benadryl 50 mg IM and throat tightness improved. Chest pressure remained the same (only minimally improved). Lightheadedness did not improve at all. 911 was called when benadryl was given. She opted to go to the hospital when they arrived.
11-year-old male patient inadvertently received Quadracel vaccination instead of Adacel; 11-year-old male patient inadvertently received Quadracel vaccination instead of Adacel; Initial information received on 06-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 years old male patient who inadvertently received 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number: C5325BA and expiry date: 14-Nov-2019) via intramuscular route in left upper arm, for school requirements instead DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENACTRA) for Immunisation in right arm.  It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  It was unknown whether the patient had any adverse 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 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.  List of document held by sender: none.