chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injected Daptacel that expired on 16May2019 to an 18 month old male patient; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old male patient who was vaccinated with expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] vaccine (lot C5202AA, Exp date- 5/16/2019).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error due to Expired vaccine used.  It was reported that injected Daptacel that expired on 16 May 2019 to an 18 month old patient.  It was not reported if the patient experienced any adverse event following vaccination.  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 documents held by sender: none.  Based on information previously received, the following information [corrections] has/have been amended.  The reporter state has been modified.
Approx @ 5PM on 20FEB91 pt had high pitched cry, prolonged continuous crying for 4hrs; DTP given @ approx 215PM same day; No fever; parents reported child calmed down later in evening;
ringing is severe enough that it affects her daily activity; Did not go for the second dose of the vaccine because of the tinnitus; Developed tinnitus (ringing in her ears); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Developed tinnitus (ringing in her ears)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Thyroiditis. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced TINNITUS (Developed tinnitus (ringing in her ears)) (seriousness criterion medically significant). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (ringing is severe enough that it affects her daily activity) and INTENTIONAL DOSE OMISSION (Did not go for the second dose of the vaccine because of the tinnitus). At the time of the report, TINNITUS (Developed tinnitus (ringing in her ears)) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (ringing is severe enough that it affects her daily activity) had not resolved and INTENTIONAL DOSE OMISSION (Did not go for the second dose of the vaccine because of the tinnitus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Upon internal review on 16-SEP-2022 non significant corrections performed to update case received from field On 06-Apr-2021: The current conditions were added: asthma, thyroiditis; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
I could not breath after the shot later next day got better; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I could not breath after the shot later next day got better) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for COVID-19 vaccination.     The patient's past medical history included Surgery. Concurrent medical conditions included Cancer. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), VITAMIN B COMPLEX, PANTOPRAZOLE, HCTZ, METOPROLOL, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ZINC and MAGNESIUM for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DYSPNOEA (I could not breath after the shot later next day got better). At the time of the report, DYSPNOEA (I could not breath after the shot later next day got better) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Tested NAAT positive for COVID on 9/20/21 after being fully vaccinated.
Seizure x2 in 12 hours. First seizure lasted 30 sec to 1 minute at 8:30 am second seizure lasted 1 minute at 4:30 pm on the same day. Took patient to the ER after both events.
no additional AE/PQC; HCP called to report that a dose of MMR II was inadvertently administered after undergoing a TE.; This spontaneous report was received from a nurse referring to an 8-years-old female patient. The patient's pertinent medical history, concomitant therapies, and drug reactions or allergies were not reported.  On 12-OCT-2023, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHa) (M-M-R II) injection 0.5 mL, lot number: U038863 was verified to be a valid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live rHa (M-M-R II), expiration date was provided and upon internal validation was confirmed to be: 20-JUN-2024 as prophylaxis (route of administration, frequency, anatomical location, lot number, and expiration date were not reported), was inadvertently administered after undergoing a temperature excursion (Product storage error) with a temperature of 53.9 F for 1 hour (no previous excursions). No additional adverse event (AE).
Developed a 10 mm local reaction at the injection site that was first pruritic ,  then warm and mildly tender increasing to the size of a tennis ball over 24 hours. At that point , subcutaneous reaction was hard, indurrated , mildly painful to touch  to touch and covered by erythema  like a giant local reaction to an allergy shot. Skin over the site remained erythematous and pruritic. I treated with high potency topical steroids as there was was limited pain, no fluctuance or pointing and no fever by thermometer. The reaction decresed in size over 5  dayof topical steroid use.
Covid monitoring documentation. PT admitted 12/17/21 documented to have positive covid. PT received Moderna 2/9/21 Lot 031M20A for dose 1. Dose 2 was Moderna given on 3/9/21 Lot 030A21A.
sore arm; This is a spontaneous report from a contactable consumer. This consumer reported same event for different patients. This is the second of two reports.  A 78-year-old female patient received COVID vaccine (trade name unspecified), via an unspecified route of administration at left arm on 19Jan2021 17:45 at single dose for COVID-19 immunization. The patient medical history was no, no other products, no investigation assessment. Family medical history relevant to event was none. No prior vaccinations within 4 weeks. Vaccination facility type was clinic. Vaccine was not administered at military facility. The patient's concomitant medications were none.  The patient experienced sore arm after getting the shot on 19Jan2021. No visit to emergency room or physician office. Her husband asked about this being related to the change of life but she didn't think so. The outcome of the event was recovered on Jan2021 (Duration of reaction was also reported as -18 days).   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021102026 same drug, same event and different patient
Could feel the heat coming of my arm; injection site muscle constricting; Injection site nerve pain; Throat also starting to swell; Arm swelling which progressed over the week,Arm doubled in size; Arm welted and itchy; Allergic reaction; fever; lymph node swell; redness at injection site; nausea; visual disturbance and distortions; seems like room was spinning; hardness near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (visual disturbance and distortions), VERTIGO (seems like room was spinning), HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE INDURATION (hardness near injection site) and LYMPHADENOPATHY (lymph node swell) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced VISUAL IMPAIRMENT (visual disturbance and distortions), VERTIGO (seems like room was spinning), VACCINATION SITE INDURATION (hardness near injection site), LYMPHADENOPATHY (lymph node swell), VACCINATION SITE ERYTHEMA (redness at injection site) and NAUSEA (nausea). On 24-Dec-2020, the patient experienced HYPERSENSITIVITY (Allergic reaction). On 23-Dec-2020, VISUAL IMPAIRMENT (visual disturbance and distortions), VERTIGO (seems like room was spinning), VACCINATION SITE INDURATION (hardness near injection site), LYMPHADENOPATHY (lymph node swell) and VACCINATION SITE ERYTHEMA (redness at injection site) had resolved. At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown and NAUSEA (nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case concerns a 27-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 025J20-2A), and who experienced the listed events of lymphadenopathy, nausea, injection site erythema, and injection site swelling, and the  unlisted events of visual impairment, motion sickness, and seems like room was spinning.  The events were considered possibly related to the vaccine due to the temporal relationship and the known safety profile.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2021: No specific follow-up information recorded. On 31-Mar-2021: HCP information added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
6 year old patient rec'd Fluzone High Dose, no treatment necessary, no adverse reaction.
PATIENT REPORTING SHARP PAIN, AND SORENESS FROM UPPER SHOULDER TO HER FINGER.
Patient had severe pain behind his eye.  It started around 3am today and continued until about 2pm today.  He instilled tobradex ophth solution in his eye this morning around noon and he said it is much better now.  He was sensitive to light, eye was red and tearing.  He said he was having difficulty seeing out of the eye.
This case was reported by a physician and described the occurrence of injection site reaction in a female subject of unspecified age who was vaccinated with FLUARIX (trivalent or quadrivalent unspecified) (GlaxoSmithKline). In 2013 the subject received a dose of FLUARIX (unknown details). On an unknown date, within months of vaccination with FLUARIX, the subject experienced injection site reaction, body temperature increased (described as "heightened body temperature") and erythema of cheek (described as "red cheeks"). No additional details were provided at the time of reporting. At the time of reporting the outcome of the events were unspecified.
I didn't feel anything more than a mosquito bite sensation when I got the second shot.; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced I didn't feel anything more than a mosquito bite sensation when I got the second shot on an unspecified date. The outcome of the event injection site discomfort was unknown.  Information on batch/lot number was requested.  Follow-up attempts are completed. No further information is expected.
A bruise on the left side of her mouth; Pain when swallowing and drinking water; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 23Mar2021 (at the age of 48-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced joint pain on 24Mar2021 with outcome of recovered, on an unspecified date he had a bruise on the left side of her mouth and pain when swallowing and drinking water. Reporter mentioned that he got the first dose of the Pfizer covid vaccine on 23Mar2021. The next two days he suffered from joint pain that went away on the third day. But one week after getting the vaccine, while he was eating, he felt that something under her tongue burst up and after a while that he checked this up, he said a bruise on the left side of her mouth. This got him pain when swallowing and drinking water. This has disappeared also. He mentioned that he should have received the second dose but when he went to the vaccination post and described his experienced, they changed his appointment and sent him to his doctor. He just wanted to know if he should get the second dose or not. He reported that, he read that there might be swelling on the lymph nodes after the vaccine, and he thinks that this is what happened to him. Case was reported as non-serious. PQC was not present. Outcome of the joint pain was resolved on 26Mar2021 whereas, rest of the events were resolved on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
MMR, Varivax and IPV given 10/08/2001. Pt developed urticaria, facial swelling and trouble breathing at home several hours later. EMS called. EMS brought Pt to ER. Pt give epinephrine, prednisone and Benadryl. In ER pt breathing "fine", still had periorbital swelling and urticaria.
8 & 9JAN painful stiffness in the joints, neck spasms, pins & needles feeling in the hand lasting 15 to 20 mins; 10JAN missed work; pain too intense;
Blood clot; Swelling at the injection site; Redness at the injection site; A spontaneous report was received from a consumer concerning a 85-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced swelling at the injection site, redness at the injection site and blood clot.  The patient's medical history was not reported. The patient current condition included chronic obstructive pulmonary disease (COPD). No relevant concomitant medications were reported.   On 11 Jan 2021, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient's wife called his doctor as he was experiencing swelling and redness. They were referred to the emergency room (ER) by their doctor for a suspected infection. In the ER they were told it may be a blood clot and the patient was given prednisone. Treatment for the events included prednisone.   Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events swelling at the injection site, redness at the injection site and blood clot were unknown.; Reporter's Comments: This case concerns a 85 year-old, male patient, who experienced events of swelling at the injection site, redness at the injection site and blood clot. The events occurred the same day after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
second day after vaccine i felt extremely tired, body aches, some congestion , couldn't get out of bed , chills and some dizziness, my head felt fluey., dizzy and chills. from third day on I felt  body aches , tired and groggy, , felt just not right , not 100% good, now I had a runny nose too.  up until that day , i still feel not completely well, body aches, run down , tired, able to hold concentration, runny nose and some chest congestion, tired and groggy.
Case number PHEH2013US006982 is an initial spontaneous report received from a consumer on 25 Mar 2013 with a follow up information received from a nurse on 16 Apr 2013. This report refers to male adult patient of unspecified age. He was vaccinated with MENVEO (batch number: not reported) on unspecified date. Reporter stated that, the vaccine had a temperature excursion. The nurse confirmed that the patient did not experience any adverse events as a result of the temperature excursion. It was stated that they were repeating the dose of MENVEO due to the temperature excursion to the vaccine. No further information was reported. Follow up information received from a nurse on 16 Apr 2013: Reporter details updated: Nurse confirmed that there were no adverse event and revaccination details updated.
COVID MONTHS AFTER THE VACCINE; This spontaneous report received from a patient via social media, 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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 an unspecified date, the patient experienced covid months after the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid months after the vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000208881.
I had congestive, sore throat, headache, serve fatigue and mild fever that lasted for about 9 days. On Jan 4th, I tested positive for Covid-19. Then again I tested positive on Jan 7th.
temp increased to 103, vomiting, severe weakness, tiredness, ache/pain (sharp) arms, shoulders, neck, back upper & lower, & leg muscles;ER significant IV fluids, x-rays, liquids & no finding;poss severe allerg rxn;
Headache. That was sharp shooting pains, like knives stabbing. Unable to sleep for long while. Slept maybe 6 hours. Woke with headache that continued for 3 days. However was more like a severe migraine headache.  I honestly thought I was going to die with the initial headache. I will never consider a booster for fear of actually dying. It was awful
Swelling of the tongue, rapid heartbeat, shortness of breath, blotchy face, high blood pressure.  Symptoms lasted about a week and gradually resolved.
Patient contacted pharmacy and reported severe back pain of the waist and hip area. He said it started about 8 hours after vaccination. He said got worse through out the night and it was hard to walk the next morning. Patient received 2 shots. He received a fluad in the right arm and a moderna booster in the left arm. Patient has used heating pads and pain meds which has helped. Symptoms are still on going.
Day 1 = Arm where given shot hurt more as the night went on.  Did not sleep well all night because of discomfort.  Also, both arms and both legs ached all night.  Head started to hurt.   Day 2 = Alarm clock went off at 6:45 a.m.  Got up and immediately realized had headache, light-headed, dizzy, nauseous, stomach upset.  Felt like was going to pass out, so had to lie down for approx 3 hours.  All day felt miserable all over due to these symptoms and both arms and both legs ached, stomach actually hurt at times.  Head hurt all day but different than a normal headache.  Slight low-grade 99-100 fever around 1:00 p.m. but lasted only approx 1 hour.  Had to lie down all evening.  No energy. Day 3 = Very Fatigued.  Intense head pain if bent over or if head went below heart.  Also more intense head pain if laugh or move head quickly.  Stomach pain.  Noticed left arm (where recvd shot) very slightly swollen with big, red oval spot around upper arm.   Day 4 = Most symptoms gone when got out of bed EXCEPT still had red oval spot on arm (not swollen).  Arm never itched.  Felt normal. Day 5 = By late evening the bright red, oval spot was barely visible.
PATIENT HAD STATE SUPPLIED VACCINE (Td AND VARICELLA) ADMINISTRATERED ON 8/6/07 AND PASSED OUT/FAINTED AFTER THE INJECTION.  PATIENT WAS STARING, PUPILS DILATED, NOT REMEMBERING ANYTHING, HAD RINGING IN THE EARS AND BLURRY VISION, NO CONSCIOUSNESS AND BECAME RESPONSIVE THEN WENT OUT AGAIN IN THE OFFICE.  LEFT OFFICE IN WHEELCHAIR BUT WAS RESPONSING.   AT HOME THAT EVENING 8/6/07- PATIENT REMAINED DIZZY, ABLE TO WALK, SLEEPY, EARS BOTHERING HER BUT NOT RINGING AND VISION WAS ok.  ON TUESDAY 8/7/07- IN THE EVENING SHE WAS DIZZY AT DANCE CLASS, NYSTAGMUS, PUPILS DILATED, TIRED, HAD EAR TROUBLE AND WAS SEEING DOULBLE WITH IMAGES APPEARING TO WIGGLE AND SLEPT FOR 11 HOURS.  ON WEDNESDAY 8/8/07- DURING THE EVENING PATIENT WAS TIRED AND LAZY. ON THURSDAY 8/9/07- BECAME DIZZY AGAIN AT DANCE CLASS, NO VISION CHANGES OR EAR INVOVLEMENT.  SEEN IN OFFICE 8/10/07 BY DR.
Student broke out in a cold sweat, stated he fainted and was to weak to walk. b/p 82/60, P74, R24 and ? O2 at 6L face mask was initiated & legs elevated and juice given. After 10min b/p 110/70. Light headness subsided & students color returned. He was always oriented x 3 & PERRLA episode lasted 10-15 minutes & slowly subsided with 02, juice, crackers & elevated legs.
Allergic reaction; Breaking out rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 13May2021 (batch/lot number was not reported) as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported had the shot on 13May2021 and the patient was breaking out rash on 14May2021. The patient wanted to know if you get an allergic reaction like breaking out and one of the symptoms is rash. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.