chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given a dose of Kinrix on 4/19/23 that expired on 4/1/23. Error was not found until 4/24/23. Dr. notified. Written order received to re-vaccinate. Parent of child will be notified that vaccine will need repeated in four weeks to reduce risk of reaction.  No harm to child.
Information has been received from a health professional who was informed by a physician's office concerning a 5 year old patient who on an unknown date was vaccinated with a dose of PEDVAXHIB instead of a dose of hepatitis A injection (unknown manufacturer). No adverse reactions were reported. This is one of several reports received from the same source. This is an amended report. The number of patients included in this report was changed from three to one. No further information is available.
Vaccine was expired on 01 Apr 2022 and was stored in refrigerator on 04 Apr 2022 and was administered on 09 Apr 2022; Vaccine was expired on 01 Apr 2022 and was stored in refrigerator on 04 Apr 2022 and was administered on 09 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was stored in refrigerator on 04 Apr 2022 and was administered on 09 Apr 2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01 Apr 2022 and was stored in refrigerator on 04 Apr 2022 and was administered on 09 Apr 2022) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was stored in refrigerator on 04 Apr 2022 and was administered on 09 Apr 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01 Apr 2022 and was stored in refrigerator on 04 Apr 2022 and was administered on 09 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was stored in refrigerator on 04 Apr 2022 and was administered on 09 Apr 2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01 Apr 2022 and was stored in refrigerator on 04 Apr 2022 and was administered on 09 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that when the pharmacy received the vaccine on 23 feb 2022 that a staff member looked up the expiration date and came up with an expiration date of Jun 2022. However another pharmacy member looked up the expiration date of the moderna covid-19 and confirmed 01 Apr 2022 was the expiration date. Date the vials was initially stored in refrigerator was 04 Apr2022. Total 80 numbers of doses was  administered. Date of administration of vaccine was from 05 Apr 2022 to 19 Apr 2022. Vials did not undergone any temperature excursions. No treatment information was reported.
A report has been received from a Health Professional concerning a 51 year old, female subject, who had been receiving FLUMIST (INTRANASAL) 0.5 mg 1m. The patient's medical history included EXCESSIVE MENSTRUATION. The patients concurrent disease(s) included TYPE 2 DIABETES and ANEMIA. Concomitant medications included trazodone hydrochloride, metformin, glipizide and ferrous sulfate. FLUMIST (INTRANASAL) started on 05-Nov-2013. The patient over 50 years of age received FLUMIST on 05-nov-2013. The outcome of the event of RECEIVED FLUMIST is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 17-Dec-2013 from Health Professional:  A dosing regimen added: Concomitant drugs and concomitant diseases added.
my heart rate got elevated; felt tingling in my tongue and palate; then my tongue and mouth went completely numb; my throat got tight; I had trouble breathing; My mouth was very dry; some swelling around lips; all my salivary glands got enlarged and swollen; pins and needles in my tongue; I developed severe nerve pain; burning in my tongue and throat; Had taste alteration; still have pain and crawling sesation in tongue and throat; I developed joint pain; swellings in fingers; fatigue; low grade fever; brain fog; migraines; elevated anti-nuclear antibodies; high blood pressure; inappropriate tachycardia with trouble and elevated heart rate; constant dizziness; vertigo; loss of balance; insomnia; This is a spontaneous report from a contactable consumer(patient) reported for self that. A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, dose 1 via an unspecified route of administration, administered in Arm Right on 10Apr2021 13:30 (Batch/Lot Number: EW0158) as DOSE 1, SINGLE for covid-19 immunization (Age at vaccination:46 years). The patient past Medical history included systemic lupus erythematosus from an unknown date and unknown if ongoing Lupus in remission, autoimmune thyroiditis from an unknown date and unknown if ongoing Hashimoto in remission, drug hypersensitivity from an unknown date and unknown if ongoing and known allergies: Sulfa, maybe penicillin. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 10Apr2021 13:45, 15 minutes after the shot the patient experienced heart rate got elevated, felt tingling in her tongue and palate, then her tongue and mouth went completely numb, her throat got tight, and she had trouble breathing. Her mouth was very dry, some swelling around lips. In the following days she stopped producing saliva, developed an extremely dry mouth and all her salivary glands got enlarged and swollen. Along with the pins and needles in her tongue she developed severe nerve pain and burning in her tongue and throat. Had taste alteration, still have pain and crawling sensations in tongue and throat. she developed muscle pain, joint pain, swellings in fingers, fatigue, low grade fever, brain fog, migraines, elevated anti-nuclear antibodies, high blood pressure, unstable blood pressure, inappropriate tachycardia with trouble breathing and elevated heart rate, tingling, and pins and needles in her legs and arm, muscle twitching, cramping and crawling sensations in legs, constant dizziness, vertigo, loss of balance and insomnia. The patient underwent lab tests and procedures which included antinuclear antibody: Elevated and heart rate: increased on 10Apr2021. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care and Disability or permanent damage. The patient is treated with saliva producing medication. The event outcome was Not recovered.  No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of swelling in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling, fatigue, rash and pain. On an unknown date, the outcome of the swelling, fatigue, rash and pain were unknown. It was unknown if the reporter considered the swelling, fatigue, rash and pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The reporter stated that she was speaking with her pharmacist and pharmacist had a patient who experienced adverse events after receiving a dose of SHINGRIX. This was one of five cases which were reported by the same reporter.
A few seconds after the shot, patient's eyes rolled to the back of his head and he passed-out. He shook a few times and regained consciousness a few seconds later. He complained of chest pains and was semi-responsive. There were no issues with breathing. Emergency personnel were called and arrived within 10 minutes. Paramedics took blood pressure, checked oxygen and EKG. Patient considered normal. Patient given a drink and a snack. Paramedics said he was fine to leave when felt comfortable to do so. He left store approximately 15 minutes later stating he felt much better.
patient stated that she had symptoms of chest pain starting the night of  04/13/21. and following morning she felt abdominal pain as well. (patient reported her adverse effects when she called in to request for the duplicate card for vaccination proof and per patient she was going for ER and needed her vaccination proof copy as she was not able to find her vaccination card that was provided at the time of vaccination.)
no adverse event; patient received a 2nd dose of VARlVAX on day 26 instead of day 28; This spontaneous report was received from a pharmacist and refers to a 59-year-old patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On approximately 08-NOV-2021 (26 days before 04-DEC-2021), the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #, expiration date, route of administration and dose were not reported) for prophylaxis.  On 04-DEC-2021, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # T010309 and expiration date: 24-MAR-2022 (route of administration and dose were not reported) for prophylaxis. It took place on day 26 after first dose, instead on day 28 (inappropriate schedule of product administration).
Tender axillary lymphadenopathy on the right, no erythema, no fever
saw a Dermatologist on or about 1APR2021 and was diagnosed with vitiligo; This spontaneous case was reported by a patient and describes the occurrence of VITILIGO (saw a Dermatologist on or about 1APR2021 and was diagnosed with vitiligo) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (cleaning substance used for surgeries) and Lichen planopilaris (pre-existing autoimmune condition which is a form of alopecia, in remission and in stable status) since 2019.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In April 2021, the patient experienced VITILIGO (saw a Dermatologist on or about 1APR2021 and was diagnosed with vitiligo). The patient was treated with RUXOLITINIB PHOSPHATE (OPZELURA) for Adverse event, at an unspecified dose and frequency; TACROLIMUS (topical) for Adverse event, at an unspecified dose and frequency and DESONIDE for Adverse event, at an unspecified dose and frequency. At the time of the report, VITILIGO (saw a Dermatologist on or about 1APR2021 and was diagnosed with vitiligo) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that after receiving the 2nd dose, the discoloration started to show much more and became the size of a quarter. After 2 weeks of applying the medications, the discoloration became bigger and started spreading towards the neck area. Patient never had positive COVID test.   This case was linked to MOD-2022-608387 (Patient Link).
He struggled with COVID-19 for weeks; He struggled with COVID-19 for weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001223 (Novavax).  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He struggled with COVID-19 for weeks".  Additional information: it was reported that the patient started treatment on unreported dates with Pfizer BioNTech COVID-19 vaccine for the primary series and "at least 1 Pfizer booster" for COVID-19 immunisation. It was reported the patient had COVID-19 once, and then COVID-19 again. She struggled with COVID-19 for weeks.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
1st one flu like systoms was sick 2days sme as 2nd 2nd one at first ok later had dry heaves,slight fever body aches and fatigue
Aching muscles, severe shivers and teeth chattering, temp 100.7, headache (8/10; 10 worst), next day fever between 99 and 100, loose stools, nausea, slight headache. All symptoms improved over 2nd day and were minimal by 3rd day.
Break out rash 3/14/2012.  Spots lots - face, hand, trunk, fever but no temperature taken.  Appointment with Doctor 4/17/2012.
Bad nosebleed; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 12May2021 at 15:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to shellfish allergy and MSG (monosodium glutamate). 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. Concomitant medications included paracetamol (TYLENOL) and goli ashwaganda supplement (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm in Apr2021 at 09:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. On 13May2021 at 09:15, the patient experienced bad nosebleed, which required her to leave her desk and seek paper towels in the bathroom. The nosebleed lasted for about 2 minutes. It was also reported that the patient had experienced extremely rarely every experienced nose bleeding throughout her life. The event resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event nosebleed was resolved on 13May2021 at 09:17, after the duration of 2 minutes.   No follow-up attempts are needed. No further information is expected.
Second dose administered 2 weeks after; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Second dose administered 2 weeks after).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 06-OCT-2023 The vaccine administration facility was the same as primary reporter, The reporter wished to knew how to proceed as the wrong dose was administered and partial information provided. The pharmacist called in to report that a patient received a dose of Arexvy and 1 prior doses being administered, which led to extra dose administered. The reporter consented to follow up.
the top of my hands, the left side of my face  and top of right  of my eye lid all broke out in a rash. It was very itchy, red and rough.
Epi Pen refill at primary care appointment. Same day as 3rd CVOID vaccine dose.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the first dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Developed dry scaling patches on face, neck, and trunk a few days after receiving the flu vaccine. Symptoms are slowly resolving. Using OTC emollient for dryness. Pt is unsure if vaccine is the cause or aggravating factor.
Pt had episode of syncope following vaccination. After walking to observation area, pt felt briefly dizzy and fell backwards, hitting head on floor. No observed open wounds/blood, sensation intact, pt alert & oriented. Did not move pt, remained laying on ground until Emergency Response Team transported to ED.
I exp fever greater than 100.9, fatigue, screaming headache,chills,weakness lasting about 4 day. Also around the injection site was extreme pain. I missed 2 days of work.
Patient had syncope with cyanosis and tonic-clonic UE jerks.  Prescribed with ammonia smelling salts and 02 by mask briefly.  No sleepiness post.  No bowel or bladder disturbances.
4-4 1/2 hours after flu vaccine received, developed total body aches, headache and lightheadness. Had difficulty sleeping that night due to headache. Symptoms subsided by
well child check 1-20-2010. Infant received Hepatitis B vaccine on 1-20-2010. Aunt found infant ,on the morning of 1-21-2010, dead in the bed with mother,who was asleep. suspect SIDS or accidental suffocation.
I received both shots well, with the Yellow Fever vaccine hurting slightly more. Upon completion of dosage, I walked approximately 6 blocks back to my office building to get lunch (I had previously had breakfast, but no lunch). After 20 or so minutes I began to experience tunnel vision, headaches, and an upset stomach. I realized I needed to sit down so I made my way to the elevator bank and had difficulty standing. I placed my arm on the wall prior to passing out briefly (<5 min) before being woken by colleagues. I was able to sit up and drank a glass of water prior to a paramedic examined me for immediate issues. I began to sweat profusely and eventually developed chills. I was then taken to the ER where a number of tests were administered prior to discharge. Results were relatively normal (elevated wbc count, which is unusual for me). The doctors presumed it was the result of a syncope.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. Approximately in October 2017 (reported as 10/20), the patient was administered with an inappropriate storage dose of ZOSTAVAX 19400 PFU for prophylaxis, lot # N021170, expiration date 27-OCT-2018. The dose, frequency, anatomical location and route of administration were not provided. Other concomitant products included sterile diluent, for which no information was provided.  It was reported that at the morning before the administration, approximately on 19-OCT-2017 (reported as 10/19), the reporter realized that the freezer was out of range and after reporting the incidence to the manufacturer, she was advised that the product was still stable until the expiration date. No adverse effects were reported after de administration of the vaccines.   The vaccines underwent a temperature excursion of 15F to 46F during a time frame of 9 hours and 30 minutes. The pharmacist also reported that there were previous temperature excursions of 6F to 14F for 5 hours and 10 minutes and 15F to 46F for 5 hours and 30 minutes. The call was due to a data logger.  This is one of two reports received from the same reporter (MARRS # 1712USA003368); Sender's Comments:  US-009507513-1712USA003368:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported.  On 01-APR-2017, temperature excursions had started. On 25-MAY-2017, the patient was vaccinated with improperly stored ZOSTAVAX via 19400 PFU (plaque-forming units) lot # M033336, expiry date: 11-OCT-2017 (dosing details and route were not reported) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 6 F to 14 F for a duration of 660 hours. Previous temperature excursion was reported. Time frame was cumulative multiple excursions. No data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Client verbalized feeling hotflash sensation over the entire body.  Client was evaluated by county rescue.  Client was released to go home after symptoms resolved and 11:40 am.
Sore arm; Sore neck; Light headed; Headache; Fever; Chills; Joint pain; Skin on fire; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 12Apr2021 at 12:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto hypothyroidism. Patient has known allergies to amoxicillin, nuts and seasonal allergy. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), thyroid (ARMOUR THYROID), cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE) and azelastine hydrochloride (ASTELIN) all for unspecified indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021 at 16:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. 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 12Apr2021 at 13:00 the patient experienced sore arm, sore neck, light headed, headache, fever, chills, joint pain, skin on fire and nausea. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, sore neck, light headed, headache, fever, chills, joint pain, skin on fire and nausea was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
It was reported that a pt rec'd a Menomune A/C/Y/W-135 (lot#UB245AA) vaccination at 1:10pm on 11/14/02. the pt stated 10 minutes after vaccination he went to the bathroom and passed out, he reported bumping his head on a urinal and resulted in a red area on his forehead. th pt reported he has had similar reactions in the past. His vital signs were taken and were stable. The pt was turned over to the university hlth ctr nurse and reportedly recovered from this experience. this case is closed.