chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 12-Apr-2022; Received vaccine which expired on 01-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine which expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 12-Apr-2022) in a 61-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 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine which expired on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 12-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine which expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 12-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the pharmacy received the vaccine on 23-Feb-2022. The reporter stated that, they thought vaccines will expire in Jun-2022 however vaccines were expired on 01-Apr-2022. The vial did not undergo any temperature excursion.  No treatment medications were reported.
Information has been received from a pharmacist concerning a 32 yr old female who in approx 2003 and in approx 2004 was vaccinated with the first and second dose of varicella virus vaccine live. Titers after both vaccinations were negative. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. The outcome was reported as not recovered. Additional information has been requested.
The night of March 31 I had difficulty sleeping due to intense pain at injection site. Pain receded over the following few days until today, April 7. This morning I woke to itchiness at the injection site. The itchiness has intensified over the day, the injection site is now swollen, inflamed, warm to touch. I am also feeling very tired.
erythema, multiforme onsetting 16MAY, 14 days post vax 2MAY & still remitting today p/18MAY-28MAY pred course;mild bilat knee ache whil squatting;
Redness and heat at injection site, followed by lightheadedness, dizziness and nausea later that day and morning of the next day.  Thought she was getting better mid day of the third day after getting the shot.
Two day after my second dose. I started experiencing pens and needles feeling in my body. I had tingling feelings in both hands, legs, and arms. I also experience increased ringing in my ear that goes on for 24 hours a day. I was tested for low B12 and it was low. These have been going on since March. I did see ENT specialist about the ringing in my ears. They are unsure what is causing it.
I travel for work and came back on the 17th of May. I started feeling very lethargic while working. I had taken a home test on Sunday the 22nd which was negative. I started to feel really tired and I had a scratchy throat. I logged off early and went to bed. On Tuesday, I had a runny nose, I was sneezing and was still very tired. I tested again on Tuesday and it came back positive. On Wednesday the cough came and I had chills. I kept checking my temperature but it did not go above 98. I emailed my doctor because it felt like I had sinusitis. I was taking ALLEGRA, NASACORT and DESOLATE for the cough. I was also taking SUDAFED as needed. The doctor recommended a prescription that I did not take. I was also taking MUCINEX. I rested the whole weekend and by Tuesday of the following week, I felt 10 times better. I still had a scratchy throat. The core symptoms lasted about 5-6 days. I still have this thing with my throat. I went to the pharmacy.
3 days after recieving vaccination, site still covered, developed satellite lesion on left thigh. Scratched it not knowing it was a vaccine lesion. Spread to the face where three other lesions developed.
This spontaneous report was received from a registered nurse concerning a currently 4 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# N035177, expiration date: 09-JUN-2019; N028447, expiration date 09-APR-2019 or lot# N025929, expiration date: 18-MAR-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15 degrees F to 46 degrees F (-9 degrees C to 8 degrees C) (19F). The previous temperature excursions were 6 degrees F to 14 degrees F (-14 degrees C to -10 degrees C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of PROQUAD was received by the patient. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1805USA006682; US-009507513-1805USA007511; US-009507513-1805USA007507; US-009507513-1805USA007509; US-009507513-1805USA007504; US-009507513-1805USA007510; US-009507513-1805USA007505; US-009507513-1805USA007506.
This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included cannabidiol (CBD OIL), paracetamol (TYLENOL), multivitamins and ibuprofen (ADVIL), all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0171) via an unspecified route of administration on an unknown date in Apr2021 (at the age of 24-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced fever of 38c that lasted all night after second shot, body ache, headache for 2 days and left arm soreness for few days. The clinical outcome of the events fever of 38c that lasted all night after second shot, body ache, headache for 2 days and left arm soreness for few days were recovered on an unknown date.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Heart racing; hard time breathing; This is a spontaneous report from a contactable consumer(patient). A 91-year-old female patient received BNT162B2  (FIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on Mar2021 as dose 2, single for COVID-19 immunization. Medical history included blood cholesterol, lung disorder and thyroid disorder from an unknown date and unknown if ongoing, atrial fibrillation from an unknown date and unknown if ongoing she has atrial fibrillation predating treatment with the Pfizer COVID 19 vaccine. Concomitant medication(s) included prednisone taken for lung disorder and lovastatin taken for blood cholesterol from an unspecified start date and ongoing. On 15Mar2021 at 02:00, The patient experienced heart racing, hard time breathing. she was having terrible side effects from her second shot. She can't stand it. Her heart was  racing. Clarified she received the first dose of the Pfizer COVID 19 vaccine three weeks ago from this past Saturday. And then received the second dose of the Pfizer COVID 19 vaccine on this past Saturday. Adds she was alright Sunday but then at 02:00AM she woke up with her heart racing and having a hard time breathing. Mentions she had atrial fibrillation predating treatment with the Pfizer COVID 19 vaccine. She took some pills this morning that she had for atrial fibrillation to slow her heart rate down but last time she checked it was still 150 beats per minute. The medication she took to slow her heart down were Metoprolol 25mg, caller does not see NDC, lot or expiration date on product dispensed in a pharmacy vial from (pharmacy name). This morning she took one half then took another one half and another one half trying to bring it down. Caller is breathless when she tries to speak and confirms she is not feeling well. States she waited two hours to ask what to do? Strongly advised caller to contact her HCP or go to the emergency room for her symptoms. The outcome of the events were not recovered.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Pt originally admitted for MSSA endocarditis, and then tested positive for COVID on 12/2.  Pt has CT consistent for COVID pneumonia.
Pt recv vax on 10/20/98; on same day pt exp cough, tight chest, eye itch & swelling, fever &chills X 1 day
About 5 minutes after vaccine administration she felt dizzy and developed rash upper chest and upper back. BP was elevated 170/105 mmHg  RR14 P99 Sat 99% Glucose 130 mg% After sitting in chair with her legs elevated and observed for 1/2 hour BP dropped to 140/80 mmHg, HR 78 and rash resolved
During workout I passed out, lost memory diagnosis transient global amnesia; heart rate became inconsistent and lowered diagnosed with tachycardia.
chest or heart pain; chest or heart pain; tightness on her chest; This is a spontaneous report from Pfizer-sponsored program. A contactable female consumer (patient, unknown age) reported for herself that she received the first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine) at single dose for COVID-19 immunization on unknown date. Relevant history and concomitant drugs were unknown. The patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine and shortly afterwards she experienced chest or heart pain and tightness on her chest. Withheld from Pfizer-sponsored program already told her to seek medical attention but wanted to speak to a medical professional.  The outcome of event was unknown.    Information on the lot/batch number has been requested.
pt recv vax 1995 & approx 48 to 72hr p/vax pt exp noc sweats, fatigue, insomnia, chronic arthritis involving the rt & lt hip, rt shoulder, lt knee & 2nd & third metacarpal joints of rt hand;joints warm, red, swollen & tender;lab eval anemia
breakthrough case admission after 2 vaccines Moderna 3/20/21 lot# 047A21A;  Moderna 4/17/21 lot# 043B21A
A few days after injections intense itching in different parts of the body.  Feet, back, neck, buttocks etc that last for a few minutes to hours. The more I scratch,the more intense the itching. This is not accompanied by any noticeable rash.  This is not constant but occurs at random.  Itching does not appear to be activated by anything eaten or drank.
Dose administer to minor in error.  Family notified.  No adverse reaction as on 11/18/2020.
Patient stated, " Sometime in February and has had some type of problems with his legs since then". He gets left ankle cramps and has noticed increased swelling in left leg.  Patient is now in acute renal failure.
Erythema, edema, tenderness left upper arm.  Benadryl, cool compresses, observation.
pt came to get the second dose appearing to not feel well. several of us asked him several times if he was feeling ok and he responded several times that he was just sleepy.  pt waiting his 15 min in the waiting area and when he was leaving out of the door he vomitted. Rescue was called and his father was called who came to the pharmacy and encouraged him to go to the hospital in the ambulance.
12/16/02 Mom called stating site very red and hot to touch; approximately 3 inches in diameter. No fever. 12/21/02 Large, erythematous area at right injection site. Mom states was warm and itchy (now resolved); has had some diarrhea.
Started with genera malaise, slight chills and some body aches.  After 3 or 4 hours a headache began; it involved pressure and pain around eye sockets, pain over forehead.  It began on pain scale as a "3" or "4" and over the next couple of hours became a "9" or "10".  I have a past history of migraines and it was worse than any headache I have experienced.  I took 1 Tylenol Arthritis and it took the pain to a "7" or "8", but only for a couple of hours, then it was back with a vengeance and nausea began.  By around 8:00 in the evening of the 13th, the pain started to diminish and the next morning I had a dull ache in my head which has since resolved.
When he woke up it is like all of his muscles was not working/his leg did not, it was weak; He can really move it, move his arm and that never happened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 07Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Parkinson" (ongoing), notes: He has Parkinson but the Parkinson he just have like his hand shaking and everything. The patient's concomitant medications were not reported. The following information was reported: MOBILITY DECREASED (non-serious) with onset 08Nov2023, outcome "unknown", described as "He can really move it, move his arm and that never happened"; MUSCULAR WEAKNESS (non-serious) with onset 08Nov2023, outcome "unknown", described as "When he woke up it is like all of his muscles was not working/his leg did not, it was weak". Additional information: reporter was calling for sharing COVID-19 shot in her husband's status that her husband took it yesterday. Reporter believed he could be having a side effect. Patient has Parkinson but the Parkinson he just have like his hand shaking and everything but after he take, this morning when he woke up it is like all of his muscles was not working. He was like when he was getting off the bed his leg did not, it was weak. He said he can really move it, move his arm and that never happened and he took the shot yesterday morning.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This initial spontaneous, was received from other non-health professional on 23-Oct-2017, concerns 55 year-old, adult female patient. The patient's current condition included abnormal blood pressure since an unspecified date. Concomitant medication included lisinopril for blood pressure and azithromycin for an unknown indication. On 23-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: 179604P and expiry date: Apr-2018). It was reported that vaccine was stored below 36 degree Fahrenheit (minimum 30F for an unknown amount of time). On the same day (23-Oct-2017), one vaccine was administered to a patient. The reporter considered the events as non-serious.
Within 3 hrs of Prevnar13, child woke up from nap and begun to stutter. Constant stuttering lasted around 3.5 days. Woke up after this time with no stuttering.
Patient presents to the ED with fatigue, palpitations, diaphoresis and chest pain that radiated down her left arm. She was admitted for further work-up for her chest pain. She was discharged 3 days later in stable condition.
My daughter was taken to the clinic for COVID 19 vaccine by her father. She was given the Moderna vaccine erroneously. When I called the clinic they stated they gave her Moderna bc they had her fathers consent. I asked if they always give the Moderna to children with parental consent and they stated no. They contacted the Chief Medical Officer and relayed to me that she should be fine bc it is almost identical to Pfizer and that I should give her Pfizer for her 2nd dose. 9/3/21 I took her for COVID test to make sure her symptoms were not related to COVID and the test was negative. I am trying to find out if there are any adverse side effects we should be watching for but I cannot find the answers. I contacted the CDC and the Dept of Health and they stated they have not had a case like this so nobody knows. Dept of Health advised me to report to VAERS.
ascending bilateral symmetrical paresthesias in the legs to upper thighs and fingers of both hands; slight weakness; Guillain-Barre Syndrome; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202, expiration date: unknown), via an unspecified route of administration in right arm on 25Feb2021 at 15:30 as single dose for COVID-19 immunization. The patient's medical history included hypertension, type 2 diabetes, and cardiac issues. Concomitant medication included dulaglutide (TRULICITY); metoprolol fumarate; alopurinol; atorvastatin calcium (LIPITOR ORIFARM); acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]); vitamin d3; bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), all ongoing for unspecified indication. The patient previously took Flu vaccine on an unspecified date for immunization. In Mar2021 (reported as after several days), the patient developed ascending bilateral symmetrical paresthesias in the legs to upper thighs and fingers of both hands peaking at 7-8 days and now slightly improving but persistent and associated with slight weakness suggesting Guillain-Barre Syndrome. The patient underwent lab tests and procedures which included blood creatinine: 1.19 (slightly elevated), blood sugar 140-160, complete blood count (CBC): good, haemoglobin: 7.6 (out of range), metabolic function test: all good on 13Mar2021. The patient did not received treatment for the events. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Guillain-Barre syndrome cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
Facial nerve palsy. Intractable facial pain (entire right side). Acupunture and LYRICA.
Started with her menstrual period 10 days before her regular cycle; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Started with her menstrual period 10 days before her regular cycle) in a 35-year-old female patient who received mRNA-1273 (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced POLYMENORRHOEA (Started with her menstrual period 10 days before her regular cycle). At the time of the report, POLYMENORRHOEA (Started with her menstrual period 10 days before her regular cycle) outcome was unknown.            The patient's cycle is consistent with 28 days for about 15 years and she believes is a potential adverse event.   Treatment information not provided
Information has been received from a physician and a 72 year old female with osteopenia, hypothyroidism, urge incontinence and hyperlipidemia and a penicillin allergy who on 16-OCT-2007 was vaccinated SC a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot# 658084/0888U). Concomitant drug therapy included DITROPAN, CRESTOR, ZOLOFT and  SYNTHROID. On 18-OCT-2007 the patient developed 10 lesions that were not in the dermatome. On 19-OCT-2007 the patient was seen by the physician for her "rash that was diagnosed as the shingles." No diagnosis was noted by the physician. A viral culture sample was performed with an expected response in 2-4 weeks and a "swab test" was also performed. The outcome was not recovered. There was no product quality complaint. Additional information has been requested.
Pt recvd Engerix-B on 26APR90, 23MAY90, 23OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
The patient had redness at the injection site that was fairly large, maybe 2 inches around the injection site all around. It started after she received the vaccine. She came by the pharmacy to what she could do. I told her to take some Tylenol or Mortrin for the pain and to let us know if it got any worse.
EXTREME WEAKNESS, HIGH FEVER, LOSS OF APPETITE, NO TASTE, POUNDING HEADACHE, NUMBNESS IN MY FINGERTIPS, UNABLE TO HAVE A BOWEL MOVEMENT
arm swelled down to elbow-baseball size w/redness-lethargic-nausea, diarrhea, fever, chills;
SICK; This spontaneous report received from a patient via a company representative concerned a 25 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included super healthy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) 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 15-JUN-2021, the subject experienced sick. The action taken with covid-19 vaccine  was not applicable. The outcome of sick was not reported. This report was non-serious.