chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration was given as 07-May-2021.  No concomitant medications were reported.  No treatment information was provided.
Pain at site of shot and weakness in (R) arm after shot. Pt seen 1 week later and symptoms are slowly improving.
Ongoing tinnitus on the second day following the second shot.  First shot 4/4/2021 at 16:00.  Second shot 4/25/2021  at 16:05
vomiting x4 from 1:00 - 6:00am, muscle aches to whole body 8:30am, chills, no fever 11-17-09, 10-18-09 c/o pain to hands, arms legs feet & lower back. 10-19-09 swelling noted to all extrimites, wheezing started 6:00am.
Initial and follow-up information has been received from a nurse for the Pregnancy Registry for Gardasil concerning a 24 year old female who on 27-NOV-2006 was vaccinated, intramuscularly in the upper quadrant of the left arm, with a 0.5 mL first dose of Gardasil (lot # 653650/0702F). There was no concomitant medication. On 22-JAN-2007 the patient was vaccinated intramuscularly in the upper quadrant of the left arm with a second 0.5 mL dose of Gardasil (lot # 653650/0702F). On 06-MAR-2007 the patient presented to the office stating that on 06-FEB-2007 she had taken a urine pregnancy test in her primary care physician's office which was positive (LMP: 26-DEC-2006; EDD: 02-OCT-2007). Follow-up information indicated that on 19-SEP-2007 the patient delivered the baby via cesarean section. The baby was reported to be healthy. Upon internal review cesarean section was considered to be an other important medical event. Additional information has been requested.
This is a spontaneous report from a contactable physician from a Pfizer-sponsored program, Pfizer RXPathways. A male patient of an unspecified age (currently 88 year-old), race and ethnicity had experienced allergy on an unspecified date  following the administration of a single dose of pneumococcal vaccine (TRADE NAME UNKNWON) for immunisation. The patient medical history and concomitant medications were not reported. Outcome was unknown. Pfizer is a marketing authorization holder of pneumococcal vaccine in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal vaccine has submitted the same report to the regulatory authorities. No follow-up attempts are needed. No further information is expected.
24 hours fever, 48 hours ?Covid arm?, fatigue, headache, body aches, significant knee pain
she thinks she lost an inch; mild headache; tired, feeling wiped out; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiration date unknown), intramuscular on the left upper arm on 08Jan2021 at 14:15 to 14:30 at a single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications, no additional vaccines administered on the same date of BNT162B2 and there were no prior vaccinations within 4 weeks. The patient previously received flu vaccine and experienced a slight reaction to the flu vaccine, she does not recall when she had it. She got it in the supermarket (she was told one vaccine was super and one flu vaccine was regular, and she had the super vaccine and she thinks that is why she had the side effects). She does not know the name of the flu vaccine or have lot number to provide. The patient was calling about the COVID vaccine that she received a couple of days ago. She received the first dose on Friday, 08Jan2021. She wanted to call and report the side effects. She had a mild headache and was tired. She started feeling tired on Saturday, reported that she felt wiped out. It was reported that the events headache and feeling tired both started on Saturday (09Jan2021). It was also reported that she is about 5'1", she thinks she lost an inch, and that her headache is going away - it was not a major headache, not a migraine. She also took Tylenol as treatment. Her tiredness went away about 48 hours later, and confirmed she recovered completely as of that day. She was alarmed at first and she was wondering where the headache was coming from. She read the paperwork she received, and it is listed as a side effect. She was told that there may be some soreness when she went in to get the vaccine. The event tired, feeling wiped out resolved on 11Jan2021 while the mild headache was resolving and the outcome of the event she thinks she lost an inch was unknown.
Staring & generalized stiffening at about 1140pm on 5-11-11. Episode lasted 20 seconds. Episode was immediately preceded by vomiting. Unresponsive. Eyes open & staring. Jaw seemed clenched. Lips were blue. Fell asleep right after episode & seemed somewhat limp. Had received immunizations at about 3pm on 5-11-11.
received Havrix expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 73-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 01-MAY-2023, the patient received the 1st dose of Havrix. On 01-MAY-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: received Havrix expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 01-MAY-2023 The reporter reported that the patient received Havrix expired dose at the time of reporting. The reporter did not consent to follow up.  The patient received Havrix expired dose, which led to expired vaccine used.
Swelling under left arm to chest muscle. Some edema, slight redness to skin. No infection. One swollen gland under arm, slight tenderness. No fever.
A PNEUMOVAX 23 vaccine adm'd on 5/27/10 without problem. By late afternoon, patient experiencing intense pain over entire right deltoid region. Limiting rang of motion above shoulder. By 9pm, patient had fever of 100.8 with chills and erythema at deltoid, extending to right bicep. Due to fever of 99.8 and bicep erythema and induration 5/30/10, Cipro 500mg OD x 3d resolved symptoms.
pt reported numbness in hand and lips. pt also reported she could taste the vaccine in her mouth. pt was being monitored by store supervisor
Pt demonstrated swelling at injection site. Pt states arm feels heavy and itchy. Cold pack applied. Pt denies any SOB. Pt to wait 30 minutes.    Pt complaining of tongue tingling, pt is mild diaphoretic. heart rate 98  O2- 99% RA  50 mg Benadryl IM administered   Patient's symptoms resolved mostly after 30 minutes patient felt comfortable leaving clinic.  Advised to contact HCP or go to ER if symptoms returned.
STROKE IN THE CEREBELLUM; LOW PLATELET COUNT OF 90,000; DIZZINESS; NAUSEA; DOUBLE VISION; This spontaneous report received from a consumer concerned a male of unspecified age  The patient's weight and height were not provided. Medical history included 5-6 episodes of double vision. Concurrent conditions included inner ear syndrome.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25/MAY/2021) 1 total, dose was not reported, administered on 16-MAR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the patient experienced double vision and could not move. He was taken to hospital and it was discovered that he had a stroke in the cerebellum confirmed via a magnetic resonance imaging scan. On 31-MAR-20201 the patient developed low platelet counts of 90,000 and was hospitalized. On an unspecified date the patient also experienced dizziness and nausea. At the time of reporting his vision was still blurred and he had double vision. He could not drive. He had 5-6 episodes of double vision in the past couple months but the cause was determined to be inner ear syndrome. The patient was discharged from hospital on an unspecified date and was awaiting an appointment with his neurologist and would follow-up with his primary care physician.  he action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from double vision, and the outcome of stroke in the cerebellum, low platelet count of 90,000, dizziness, nausea, was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This male patient of unspecified age was hospitalized for cerebellar stroke and low platelet count 15 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  Symptoms reported were double vision, blurred vision, "could not move", dizziness, nausea.  There was prior history of episodic double vision due to an unspecified inner ear syndrome for the past couple of months prior to vaccination.  Platelet count was 90,000; MRI showed stroke in the cerebellum.  No other laboratory tst results reported.  No treatment reported. Outcome of the events were not reported.  Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per organization causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information is requested
Tinnitus; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 10-Apr-2021.    This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (Tinnitus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Significant medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications are provided Nurse also stated, that this could be a possible side effect from Moderna COVID-19 Vaccine.   Reporter did not allow further contact
I was getting in the car and my leg gave out, a week after that it gave out again - about three days later my head started feeling achy. It is not a headache but its achy- it feels as if I am recovering from a concussion, it is achy in my neck, shoulders, feet, and head. I went to my neurologist, and I had an MRI where I had on this helmet, but it did not show anything. He thinks it may be hypertension, but I did not have high blood pressure, but it was elevated. He put me on a medication, and I took it for about five weeks, but it did not really help with the aching in my head. I am seeing a headache specialist on February 23rd to discuss this further.
Sore arm; Tired; : 1st dose - 05Apr2021, lot number - 025B21A 2nd dose- 27May2021, lot number - 005C21A; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (: 1st dose - 05Apr2021, lot number - 025B21A 2nd dose- 27May2021, lot number - 005C21A) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A, 005C21A, 021H12B and 056A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (: 1st dose - 05Apr2021, lot number - 025B21A 2nd dose- 27May2021, lot number - 005C21A). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (: 1st dose - 05Apr2021, lot number - 025B21A 2nd dose- 27May2021, lot number - 005C21A) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment medication was not reported.   This case was linked to MOD-2023-750219, MOD-2023-750230 (Patient Link).
Muscle aches, fatigue, dizziness, loss of appetite, pain at base of neck, restlessness, inability to sleep
Acute drop in glucose level (my blood sugar dropped to < 60 after completing my lunch) with no other mitigating factors.
On July 17, my baby passed away. I had been breastfeeding my 6 week old baby at the time that I received the first Pfizer vaccine on June 4, 2021.  He became very sick with a high fever about 2 weeks after I got the first Pfizer vaccine on June 21. He was treated for 2 weeks with IV antibiotics for a supposed bacterial infection. However, they never found any specific bacteria, and called his diagnosis culture-negative sepsis. At the end of his hospital stay he tested positive for rhinovirus. After the 14 day course of antibiotics, he was home for one week, but exhibited strange symptoms (e.g. swollen eyelid, strange rashes, vomiting). I took him back to the hospital on July 15, where he presented with what they called an atypical Kawasaki disease. He passed away shortly thereafter from clots in his severely inflamed arteries. I am curious if the spike protein could have gone through the breast milk and caused an inflammatory response in my child. They say Kawasaki disease presents very similarly to the Multi-System Inflammatory Syndrome in children that they are seeing in post Covid infections.   (My baby also had unusual birth circumstances, as he was born at 37 weeks, triggered by a maternal appendicitis.) However, if they know that antibodies go through the breastmilk as a good thing, then why wouldn't the spike protein also go through the breastmilk and potentially cause problems.
Mom lied about the age of her child in order to get her the covid vaccine.  I received a call from the  office letting us know that she received a fax from us stating we gave a covid vaccine to a patient of theirs that was only 10 y/o.  The office staff stated that when she saw the fax she noticed that the date of birth did not match any of their patients.  After looking up the name she saw that the DOB was different so she called the patient's mother.   The office staff member said that the mother admitted that she lied to us about her daughter's DOB in order to vaccinate her child.
administered FLUZONE HD QIV instead of the FLUZONE QIV. with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2022SA447057(CLUSTER), 2022SA446385(CLUSTER) and 2022SA448075(CLUSTER).  This case involves a 23 years old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Oct-2022 the patient developed a non-serious event of administered fluzone hd qiv (dose: 0.7ml, 1X(once), intramuscularly in left deltoid, batch number: UT7729CA and expiry date: 30-Jun-2023 for Immunization) instead of the fluzone qiv. with no reported adverse event (wrong product administered) (Latency: same day).   Action taken : not applicable.  Outcome: Unknown  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.
Metallic taste in mouth 5 minutes after injection, facial numbness( no weakness ) X 3 hours Narrative:  Referred to PCP   Other Relevant History:
This case was reported by a nurse and described the occurrence of injection site pain in an adult female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of BOOSTRIX (unknown route and injection site). Less than one week after vaccination with BOOSTRIX, the subject experienced injection site pain. The event was still unresolved 4 days after vaccination. Follow-up information received on 1 July 2014: Subject details were provided. Injection site pain occurred on 23 May 2014. Vaccine reporting physician details were provided.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 13:38, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
episode of screaming 1 1/2hr stretches on & off x 3wk-onset;local area redness & lump x3wk;local tenderness;fever 99-102 x 2wk onset w/in 24h-irritable onset immed;
I felt dizzy and puked.  Thought I was a robot and was going to have my memory erased. By the time we got to the hospital I couldn?t walk or talk and passed out in the ER. My O2 was at 68%. I was given oxygen and about 2 hours later I was off oxygen and walking around. Felt a little light headed so I was admitted and stayed overnight. Was given a blood thinner not sure which one. But was released the next day with no other problems.
Chills and body aches (12-24 hours post-vaccination) Numbness/tingling in left leg, numbness/tingling in right hand (weeks 2 & 3 post-vaccination) Fatigue, headache, loss of concentration (weeks 5 & 6 post-vaccination) Ruptured vein in left leg (week 6 post-vaccination) Headache and delerium (week 7 post-vaccination)
Patient recievd HPV vaccine dose # 2 on 2/14/22 and  had an episode  of vertigo and fainting at school on 2/17/22.  He was transported to Medical Center.
Patient received flu shot on 9/27/12 at 5:15 pm. The next day she had itching that became intense from head to toe. She went to her after hours clinic at her primary care provider's office and received an injection that made it better. She said itching lasted about a week and continued BENADRYL during that time.
Mild headache and nausea about 30 minutes after injection.  In middle of night had pain and swelling in left eye (same side of body as injection), left arm pain the next day.
Swollen lymph node in left armpit about 5 days after 1st dose vaccine. Still currently swollen and painful
COULD NOT LIFT ARM,  DIZZINESS WHEN LYING DOWN,  SEVERE VOMITING,  DIARRHEA,  HEADACHE,  SWEATS,  CHILLS,
Patient is a 69 year old female who was admitted on 5/27/2021 for CEREBRAL VENOUS SINUS THROMBOSIS. Patient is a 69 year old female "who lives at home with husband. Patient with a h/o DM2, hyperlipidemia, epilepsy followed by Dr. neurology outpatient, hypertension. Patient on keppra and tegretol with some episodes of partial seizures, sensitive to being off medications.  Patient was in usual state of health until today. Daughter noticed around 6 PM patient was confused, altered, dizzy, not able to walk, and had left arm weakness. The patient's sister had a stroke in the past and they were concerned for this and so brought her in for evaluation when she didn't improve. Daughter thinks patient might have started having symptoms around 1 PM.  Daughter reports patient was not taking her aspirin, and they never picked up the lisinopril that was prescribed for blood pressure in the past. She did have the J&J covid vaccine 6 weeks ago.
No rxn after 1st vaccine 2/25/21 Two days 3-27-21 after 2nd vaccine received on 3/25/21 -> pt developed a pruritic rash on his chest. Felt tired Same day as 2nd vaccine as well.
This patient was given a Moderna covid vaccine outside of the age range. They were administered a dose meant for patients six years and older. The patient was observed for 15 minutes following vaccination, and was in normal state of health with no concerns or symptoms. The doctor of the patient was informed.
Syncope immediately following vaccines. Lasted 5-10 minutes post injection. Fading hearing and ?blackout? experienced. Applied cool rag & juice at clinic. Exhaustion and fatigue lasted additional 8 hours, paired with repeated episodes of dizziness, pale skin and repeated left eye twitching. Will update provider with any further changes.
Patient came in for 6month WCC 04/27/23. She received vaccines that day. When receiving and reviewing hospital records child received vaccines when she was in the hospital 03/27/23. When this was discovered I contacted all 3 manufacturers and reported incident along with requested information on what to monitor. I called mother 04/27/23 1330 x2 left voicemail. Text messages sent. Mother called office 04/28/23 I explained the situation to the mother. Mother reports that child is doing well. Having no symptoms. We discussed what to look out for and when to medical attention. Child was asymptomatic at WCC.