chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a third dose of Shingrix, a 2 dose series. Pt experienced no unusual adverse effects or injuries
Patient reported pain in left arm immediately following vaccination with difficulty moving her arm in an outward motion from her side. She had no difficulty moving lifting the arm in a forward motion. There were no signs of inflammation at the injection site. Ice pack was applied for 15 minutes. Patient had already taken ibuprofen before injection. I recommended ice packs, on for 15 minutes, off and on in intervals. Repeat dose of ibuprofen at appropriate interval.
Patient became hot and sweaty and dizzy several minutes after injection. Laid on cot. vitals monitored. Oral fluids given. Normal pulse ox.  Monitored over about 40minutes and in house rapid response team called when not feeling better. As it typical with her POTS, she felt tired, hands  cold, trouble speaking  and so was transferred to ER for further care and monitoring.
child presented for first dose of COVID pfizer manovalent and was given Pfizer bivalent in error
is a 57 y.o. male who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER8734 on 3/30/2021.  The patient experienced the following reaction(s) during the immediate   of observation:  PT reports feeling "warm"    Patient was treated/managed as follows:   Vitals were taken and are as follows:  1249: BP- 132/84 HR: 54 RR 18 O2 sat- 97% RA Pt reports symptoms are the same. Water offered. VS retaken 1300: BP- 128/82 HR: 54 RR: 18 O2: 98%  Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.  Pt escorted to car at 1308 by wife.
Patient received a refrozen dose of the vaccine; Patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a refrozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a refrozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a refrozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2021-381132 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 72 year-old, unknown gender patient with no relevant history, who experienced the unexpected events of .EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR  The event occurred with the booster dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Headache, fever, body aches, tiredness the day after the vaccine. An allergic reaction (rash) in the arm on opposite side of the vaccine evident on the second day after the vaccine.
On 03/23/2002 starting breaking out in rash all over body even in her mouth, unable to eat or drink, fever 101 deg. F. Taken to ER.
Heart burn (severe) unrelieved by tums or pepcid x 3 nights and 3 days  Fatigue Malaise Generalized muscle pain and fatigue Mild nausea
At the time of vaccine, I was on my last day of my period 4/8/2021. My period stopped on 4/9/2021-4/10/2021. Then on 4/11/2021, I started having heavy spotting which quickly turned into a very heavy bleeding and has not stopped since. I have been bleeding heavily since 4/12/21 and it is now 5/5/21.
Less than 48 hours after injection, I experienced a sudden onset of a urinary tract infection.
Patient has anxiety over needles. He felt woozy after receiveing the vaccination so sat for quite awhile with a cold compress. He felt better after awhile and felt ready to leave. I called him an hour later to see how he was feeling and he said he felt completely fine.
Itching , started, 9 days post shot, continues, but milder still on current date 2/17
Pt c/o redness, tenderness, hardness and blisters at injection site since 05/11/01. This occurred 24 hours post vax. Pt also c/o arm weakness. Instructed pt to apply warm compresses 1 hr 3x/day. Instructed pt to rest arm as necessary and if not resolved to see MD by 5/18/01. Pt agreed to plan of action.
No further AE/PQC reported.; The patient received PREVNAR 13 a little over a year ago and then again last week. Caller reports that patient should have gotten a dose of PNEUMOV AX 23 last week.; This spontaneous report was received from a pharmacist referring to a 91 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.     In approximately September 2019 (reported as a little over a year ago), the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. On 21-SEP-2020 (also reported as last week, conflict information), the patient received pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) again. It was reported that the patient should have gotten a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) last week. No further adverse event (AE)/product quality complaint (PQC) reported. The outcome of the events was unknown.
5 x 7 erythematous, mildly indurated area at injection site.
A few hours after receiving her immunizations my daughter began crying inconsolably for 5+ hours non stop, had a large painful bump at injection site, and a mild fever. It was also clear that it was painful for her to move because every time she shifted she would scream from the pain. The bump on her leg was about the size of a large marble and lasted over a week. I gave her infant Tylenol and paced with her but it didn't help much. It was clearly a reaction to the vaccine because this type of behavior is a complete departure from her usual.
Flu A: Initial information was received on 25-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional via Regulatory Authority (under reference number: US-SA-SAC20211101000706).  This case is linked to cluster cases 2021SA355175 and 2021SA361705.  This case involves an adult male patient who had flu A (influenza) after receiving INFLUENZA VACCINE.  The patient's past vaccination included INFLUENZA VACCINE every year in October for the past five years.  The patient's medical history, past medical treatments and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  In Feb-2019, the patient developed a non-serious flu A (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome of event was reported as unknown.  There will be no information on lot number for this case.
Rapid heart rate; Dizziness; Extreme thirst; Chills; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 00:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy, sulfa allergy and latex allergy. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Mar2021 at 00:00, the patient experienced rapid heart rate, dizziness, extreme thirst and chills. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included treatment with fluids and testing. On 26Mar2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events rapid heart rate, dizziness, extreme thirst and chills was resolved with sequelae. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 (at the age of 27-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Two weeks post vax, the pt found out she was pregnant. The pt terminated the pregnancy during the first trimester.
No adverse reaction, wrong vaccine was given. Two hep b's were given at the time of the visit instead of a hep b and a hib.
Severe vertigo on left side; Severe vomiting,Had to lay down because at upright position she was vomiting;; This spontaneous case was reported by a physician and describes the occurrence of VERTIGO (Severe vertigo on left side) and VOMITING (Severe vomiting,Had to lay down because at upright position she was vomiting;) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 026L20A and 026L20A) for COVID-19 vaccination.     No medical history was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced VERTIGO (Severe vertigo on left side) and VOMITING (Severe vomiting,Had to lay down because at upright position she was vomiting;). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at an unspecified dose and frequency. On 04-Nov-2021, VOMITING (Severe vomiting,Had to lay down because at upright position she was vomiting;) had resolved. At the time of the report, VERTIGO (Severe vertigo on left side) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.
throat sore & tight, bronchial spasm flushed cheeks; rx ventilator & Decadron
Large hives about body, especially to legs with itching. Client had symptoms prior to vaccines and she felt it got worst. No difficulty breathing. No wheezing.
A physician reported that a child received the 1st dose of Prevnar on 6/27/00. The child subsequently, developed swelling at the injection site, the swelling extended to involve the entire arm into which the vaccinee was administered. The child was treated with diphenhydramine.
painful; fever; Had long time ago. Had one shot but never again; was in bed for four days; This case was reported by a consumer and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced pain, fever, activities of daily living impaired and incomplete course of vaccination. On an unknown date, the outcome of the pain, fever, activities of daily living impaired and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain, fever and activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 1st dose long time ago and was painful, he/she got sick had fever and was in bed for 4 days. Till the time of reporting, the patient did not received 2nd dose, which led to incomplete course of vaccination.
Extreme fatigue, absolutely no energy, taking extended naps and change in personality with increased irritability.
PT BEGAN FEELING LIGHTHEADED AND NAUSEATED, PT WAS VERY FLUSHED FROM 0907 TO 0920.
This spontaneous report as received from a pharmacist refers to a 60 years old female patient with uncontrolled diabetes and no known allergies. The patient was vaccinated subcutaneously into the right arm with 0.65 ml ZOSTAVAX (reported lot number: 0567AE, expiration date: 04-APR-2013) on 20-OCT-2012. Concomitant medications included: influenza virus vaccine (unspecified) in left arm. The patient experienced an injection site reaction. The spouse/husband of the patient came into pharmacy on 22-OCT-2012. The patient experienced patchy redness at the site of injection of the right arm, swollen, tenderness and warm to touch. The husband stated that he thought that Aseptic technique was not used when administering ZOSTAVAX. He also mentioned that his wife had "uncontrolled diabetes" and Aseptic technique should have been used. The husband said he was a doctor, which had not been confirmed, and he placed his wife on AUGMENTIN for treatment. The outcome of the events was unknown. The pharmacist stated she was calling the patient on 25-OCT-2012 to check on her present status. Additional information has been requested.
Ill feeling, heart racing, eyes burning and chills. About 2a.m. Hot and tightness in the chest. No treatment. Just rested.
Five days post vax pt scratched leg in bed and noticed a huge bruise the next morning. Pt also experienced ankle and knee aching; ankle swelling; and scant bleeding while brushing teeth.
Initial report received from a patient (with a history of allergies to latex, SMZ-TMP, Nubain, Darvocet and asthma) developed mild itching on the back, trunk and arms at 0900 after she received an injection of Fluzone (lot number u2195aa) intramuscularly in the right deltoid on 26 October 2006 at 0745.  She had generalized itching by 1100, felt flushed at 1200 and noted her face, neck and ears were very red. The injection site was red and had chills, her neck,face and ears were red and she had generalized rash. From 1600-1900 hours, she was sleeping. At 1900 she had itching and took Benadryl 50 mg. At 2045, she had a low grade fever and at 2300, she had chills and took Benadryl 50 mg and Advair puffs. On 27 October 2006, her rash was gone and itching was gone, however her neck and ears remained red and hot. She did not have any illness at the time of vaccination. It was reported the patient.  Follow-up information received on 23 January 2007 from the patient. A diagnosis was not determined, and no diagnostic testing was performed. There was no illness at the time of vaccination.
A report was received from a health care professional on 11/07/2003, concerning a vaccinee of unspecified demography who received Fluvirin on 11/06/03. After receiving the influenza vaccine (brand unspecified) approximately two weeks earlier on an unknown date. No adverse effects were reported from the initial vaccination. There was insufficient information to determine the reporter's causality assessment. Update 1, 01/26/04: A follow up report was received from a health care professional who confirmed that the vaccinee was 62 year old female who did not experience any adverse event. Update 2, 04/06/04: Further information was received from a health care professional providing the batch of the Fluvirin administered. No follow up pending, all information received.
Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients; Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
The hypodermic needle separated from the syringe during vaccination, and about half of the vaccine was lost dripping down the arm.  It was a McKesson Syringe with needle (Luer lock tip) 3cc 25gX1"
I am unsure of exact time course above. Likely will have to contact patient. He has been working here since April. Today, his sister-in-law found him and he appeared confused. He said he tried to use his phone but was unable to work it because he was weak. Patient is a poor historian during my exam. He says he feels "Relaxed" and much  better than when he came in but is very sleepy. He initially reports to me that he has had shoulder pain for 2 weeks. Then when clarified with his sister in law, reports that shoulder pain started recently after his Hep B vaccination. He received a hep B immunization approx 1 week ago. Since that time, he reports HA, body ache. Was seen on May 30th (two days ago) and treated for migraine headache and muscle aches. Given fluids, diphenhydramine, metoclopramide, and ketorolac with some immediate relief of his headache. Today he reports that symptoms are worse. Feels like his body "won't work." + Cough productive of black sputum. Fevers and chills for 2 days. Coughing makes his HA worse. Decreased appetite. + Hives starting today. No N/V/D/abdominal pain. Worst pain is in his shoulders bilaterally. He denies new sexual partner. No pain with urination, but develops a HA when he urinates. No discharge from his penis. No new sexual partners. Patient was treated with IV fluids and IV Benadryl in ER on 6/1/15. Given IV Solumedrol 125mg IV on admission. Sx much improved on day of dischrage (6/2/15.)
Severe pain in the right side of his head, chin, right ear and right cheek associated with red rash consistent with shingles.
This spontaneous report as received from a pharmacist refers to a 23 year old female patient. In approximately 2004 (reported as over 7 to 10 years ago) the patient was vaccinated with the first and second dose of GARDASIL (lot#, dose and route not reported). According to pharmacist, as per patient's physician (name unspecified) report, the patient had the first two doses as per prescribing information schedule, but office was not able to provide any specific vaccine information, including dates of administration. The pharmacist was asking for alternate dosing schedule for GARDASIL for the patient, who presented at pharmacy asking for third dose of GARDASIL. The patient was not receiving her third dose on 16-MAY-2014, but pharmacist was providing professional information processed in this case to patient's physician (name unspecified), for their use. The patient did not seek medical attention. Additional information has been requested.
Patient developed multiple areas of alopecia on her scalp within 48 hours of receiving COVID vaccine
patient was given Pentacel instead of Quadracel, with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Medical Information (Reference number- 00766758) and transmitted to Sanofi on 13-Sep-2021.  This case involves a 4 years old and unknown gender patient who was given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] instead of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 13-Sep-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE instead of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number and expiry dates were not reported) via unknown route at an unknown administration site for prophylactic vaccination (wrong product administered).  It was reported "do they need to re-boost with Quadracel or is the patient ok with just the Pentacel?"  It was an actual medication error case due to wrong vaccine administered (latency: same day).  At the time of reporting, the patient experienced no 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 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 on the batch number for this case.