chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 25 patients (age and gender not reported) who was vaccinated with 0.5 ml expired dose of FLUBLOK QIV (Batch number: QFAA1703, expiration date: 26-MAR-2018 and site of administration was not reported) via intramuscular route on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It was an actual medication error due to expired vaccine used. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Patient received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.   This case was linked to MOD-2022-549411, MOD-2022-549494, MOD-2022-549450, MOD-2022-549461 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2022: Follow-up received, contains report type changed from invalid to spontaneous. Reporter added, patient demographics and suspect drug information added.
This vaccine combo was given in a pharmacy 3 to 4 weeks before the onset of ataxia. Our current diagnosis is acute cerebellar midline ataxia. This patient has also been evaluated by a neurologist and ENT specialist and another internist. He has had a negative workup for other causes of ataxia, to include (viral, AB studies, nutritional/vitamin deficiencies and autoimmune disease). The ataxia is not getting better or worse since its onset which was 4/30/2018. It would be nice to talk to a real MD and not have to fill out this form!!
Caught COVID; Caught COVID; This is a spontaneous report from a contactable consumer. This consumer reported for a 31-year-old male patient. A 31-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: ER8737; Expiration Date: 31Jul2021), via intramuscular route of administration in arm left on 06Apr2021 (age at vaccination was 31-year-old) as dose 1, single dose for covid-19 immunization. The patient had no known allergies. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 24Jul2021 patient caught Covid (drug ineffective). The patient underwent lab tests which included sars-cov-2 test by using nasal swab, positive on 26Jul2021. No treatment received for the events. The patient recovered from events on an unspecified date in 2021.   The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8737 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER8737, fill lot EW3426, and the formulated drug product lot EP8586. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up attempts are completed. No further information is expected.
hive noted @ site of vax;w/in 5min of inj given DPH elixir;when rechecked p/20-30min-hive gone, doing well
Last night I realized I have developed redness and swelling on the site of injection but after 9 days of receiving the injection. I?m also experiencing mild axillary tenderness. It is looking better today but I thought it was strange that those side effects took more than a week to show up. I did experience some pain for 3 days after the injection but it had completely resolved and my arm was looking totally normal until yesterday evening
temperature; fatigue; soreness; Exposure during breast feeding; Redness; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (breast feeding), VACCINATION SITE SWELLING (soreness), ERYTHEMA (Redness), TEMPERATURE DIFFERENCE OF EXTREMITIES (temperature) and FATIGUE (fatigue) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for an unknown indication.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event and No adverse event.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breast feeding), VACCINATION SITE SWELLING (soreness) and ERYTHEMA (Redness). On an unknown date, the patient experienced TEMPERATURE DIFFERENCE OF EXTREMITIES (temperature) and FATIGUE (fatigue). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (breast feeding), VACCINATION SITE SWELLING (soreness), ERYTHEMA (Redness), TEMPERATURE DIFFERENCE OF EXTREMITIES (temperature) and FATIGUE (fatigue) outcome was unknown.            Treatment information were not provided.   This case was linked to MOD21-070697, US-MODERNATX, INC.-MOD-2021-068350 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-070697: US-MODERNATX, INC.-MOD-2021-068350:CROSS LINKED WITH MOTHER'S CASE
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 04Apr2022 at 20:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The vaccine received was yes. The patient received other medication in 2 weeks was no. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19. Antiviral details: product was COVID 19 Treatment, brand-Pfizer, Treatment start date -04May2022, Treatment stop date-09May2022, Indication: Treatment of COVID-19. Adverse event: I had stomach issues with Paxlovid. Adverse events start date: 06May2022. Adverse events start time 12:00 PM. If patient recovered: Recovered. Adverse events stop date: 09May2022. If treatment ae: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information was received on 10-JUL-2017 from a nurse who reported that an 18 year old unspecified patient (gender not reported) received the first dose of GARDASIL 9 (unspecified lot/expiration) on an unspecified date in April 2016, the second dose of GARDASIL 9 (lot# N003703, expiration 29-OCT-2019) on 26-JUN-2017 and the third dose of GARDASIL 9 (lot# N003703, expiration 29-OCT-2019) on 07-JUL-2017. No adverse effect reported. No further information was provided. Additional information has been requested.
paralyzed arm for over 24 hours . woke up to fever in the middle of the night of 101.2 Passed out trying to make it to the bathroom woke up on the floor not sure how long was out .next morning dizzy and lightheaded . Arm is still sore but not paralyzed .
Systemic: hearing loss in left ear <1 min after dose...see below-Mild, Additional Details: pt reported that immediately after dose <1 minute he experienced a decline in his hearing to the left ear.  I called the patient this morning for follow up (06/25/2021 @ 10:05 am) and the patient reported that some of his hearing has returned, but is still "muffled".  I asked the patient to report to his physician especially if the problem persists and/or gets worse.  I also asked the pt to report any progression to me.
-Headache -Fever -Couldn?t lift left arm (injected arm) -Swollen lymph node left arm pit  -Fever range 99.6-101.3 -Chills -Muscle and body aches  (Above symptoms lasted for 48 hours)  -Disoriented/feeling of outer body experience  (Above symptom still current 64 hours later)
c/o of fever, joint pain, fatigue and tiredness starting on 05/27. Has been using tylenol at home.
2 months later / only administered the lyophilized powder mixed with normal saline; Inappropriate dose of vaccine administered; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. In June 2021, the patient received the 2nd dose of Shingrix. In April 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In June 2021, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the 1st dose of adjuvant suspension only, and came back 2 months later and only administered the lyophilized powder mixed with normal saline. No adverse events reported by patient. This was 8 of 9 linked cases reported by same reporter for different patients. The reporter consented to follow up.   Follow up information received from sales representative on 25 June 2021: The reporter stated that, the health care professional mixed the adjuvant portion with saline solution and administrated it as a first dose and later reconstituted the powder portion with saline solution as second dose. The event inappropriate preparation of medication for 1st dose updated to wrong solution used in drug reconstitution as stated that the health care professional mixed the adjuvant portion with saline solution. The reporter did not know exact date, patient's involved and outcome.  No further events were reported. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR138555:Same reporter US-GLAXOSMITHKLINE-US2021AMR138557:Same reporter US-GLAXOSMITHKLINE-US2021AMR138556:Same reporter US-GLAXOSMITHKLINE-US2021AMR138546:Same reporter US-GLAXOSMITHKLINE-US2021AMR138554:Same reporter US-GLAXOSMITHKLINE-US2021AMR138552:Same reporter US-GLAXOSMITHKLINE-US2021AMR138553:Same reporter US-GLAXOSMITHKLINE-US2021AMR138559:Same reporter US-GLAXOSMITHKLINE-US2021138628:FU1 deleted
Localized reaction with swelling, induration, erythema at the injection site right lateral thigh.  24 hours after injection measuring 5cm (Ant/Pat) 3 1/2 cm.
About two hours after flu shot, patient suddenly felt like an elephant was sitting on her chest, ears felt on fire, throat had egg in it, headache & dizziness.
Patient fully vaccinated and boosted with Pfizer on 6/5/21, 6/26/21, and 1/8/22. Patient presented to ED with weakness and a fall at home. Patient has MS and uses a wheelchair to transfer, however he fell in the shower trying to transfer to the chair for which EMS was called. Patient was admitted to hosptial for further care.
Mild Fever, Myalgias, shortness of breath, chest pain, cough and general fatigue
I left the vaccination feeling nothing at all. I awoke the next morning with a moderate pain/discomfort in my left upper arm at the vaccination site. I went to work because I felt okay.  I have five years of recovery.  As a result every 8-12 moths I undergo an episode of about three days where my brain forgets how to sleep properly.  So the morning after my injection, I was on my second day of irregular sleep. Around 10 am, the side effects started kicking in.  I had a slight to moderate pain above my ear on the right side of my head.  I probably had a slight fever as I felt warm and sweaty for about four hours.  I felt slight to moderate chills during the height of my discomfort for about four hours.  I could hardly walk the five blocks to my girlfriend's home because I was very conscious of my breathing.  (I have been a heavy cigarette smoker for 4o years and an developing a heightened awareness of my breathing and pulse as I feel that I am overdue for a stroke or heart attack after 40 years of heavy smoking.)  Therefore his side effect was largely hypochondriacal.  I took off work yesterday even though the side effects had subsided. Today, I feel great. I feel so great that I laughed at the entry below - "Patient Died".
Patient complained of R chest pain 15 minutes after administration. Vitals were  taken and all wnl. Chest pain self-resolved after patient was reclined and given  water po. Patient monitored for another 30 minutes and reported complete  resolution of symptoms and declined further assessment by ED. Pt left clinic  ambulatory and in NAD.
On 4/21/00 the pt experienced a burning sensation down the right arm which was considered by the physician to be persistent paresthesia in an ulnar distribution. The pt was treated with anti-inflammatories. The outcome is resolving. On 4/24/00, the pt experienced pain and tingling sensation in the pt's fourth and fifth fingers with decreased grip and tenderness, in addition to a burning sensation to the arm/hand. Outcome of this event is ongoing.
was semi-okay; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, 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: MALAISE (non-serious), outcome "unknown", described as "was semi-okay".  Additional information: It was reported that they got the Omicron shot, here it says shot at 09:00. She woke up having serious reactions right now. Right now her fever only about 100 but she was shivering and freezing and it has been since last few hours and vomiting too. The reporter stated, she had 4 of your shots, the first one she was semi-okay with it but the other three shot she got pretty bad high fever, chills, really not well. This is her 5th shot, with Pfizer, yes with the Omicron variant (Hence, suspect product name captured as COVID-19 Vaccine) but want to know what the best thing to do but can't get anything for her."When informed to contact nearest emergency room or health care provider in case of emergency, reporter stated, She was having vomiting now and have to go.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201252978 same product, patient, different AEs, different dose;
Lower muscle pain in morning, have taken ibupro. and TYLENOL. Pain in thighs, restless have to move around a lot to try and relieve pain. Pain level (10).
Pt c/o feeling light-headed, nausea, and pinching headache 15 min post vaccination.
Got the vaccine, a week after she got them; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-APR-2022 Reporter's Comment: This case was reported by the patient's son/daughter via interactive digital media. The patient received dose of Shingles vaccine and a week after she broke out with them (Shingles). Additional supportive information: The follow-up would not possible, as no contact, details were available.
At 6:15am, approximately 18 hours after I received the vaccine, I experienced blurred vision that lasted for one hour.  I was unable to read (my prescription glasses did not help any), unable to see my own eyes in the mirror, and was told my pupils were very dilated.
Rash on arm below injection site, warm to touch  Tinnitus in left ear persisting for months
This spontaneous report as received from a healthcare worker refers to a 5 day old male Neonate. On 17-OCT-2013 (first day after birth while infant was still in hospital) the patient was vaccinated with first dose of RECOMBIVAX HB 5 mcg/0.5 ml, 5 Microgram, intramuscular in the left leg (lot # not reported). On 21-OCT-2013, a second dose of RECOMBIVAX HB was inadvertently administered. No adverse effects reported. Additional information has been requested.
Area of induration (14x17cm) to L deltoid muscle region of arm (I+7); quarter sized induration (I+4); no reaction, date immunized (I). Mild pruritus at site.
Employee reports 20-25 min after receiving the vaccine he developed a headache. He took tylenol at first. Then he took his imitrex which he has for his usual migraine. The imitrex didn't help. 1/5 mid-day the headache resolved.
8mm indurated irregular sl bluish sc nodule @ inject site lt arm noted by mom p/inject;
Information has been received from a registered nurse concerning a 25 year old female who in approximately June "last week", was vaccinated with a first dose of GARDASIL. Shortly after vaccination, the patient experienced tenderness and a pea size lump at the injection site. Subsequently, the patient recovered. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. On an unspecified date the patient recovered. No product quality complaint was involved. Additional information has been requested.
didnt start feeling bad until that night chilled all night long. fever stayed at 99.9 even with taking Tylenol every 6 hrs . fatigued, chills and body aches and fever.
Within about 30-60 seconds of vaccine administration, patient became lightheaded and experienced loss of consciousness.  He was sitting in a chair at the time and was prevented from falling.  He was moved into the supine position on a cot with feet elevated and rapidly regained consciousness.  Over the course of several minutes, his condition improved and he experienced a complete recovery.
Patient was expecting to receive a regular dose influenza vaccine today with her COVID vaccine. The technician pulled the dose for the pharmacist and got the medication ready for administration by placing a needle on the vaccine.  The pharmacist went to administer the vaccine and did not realize the the prefilled syringe was a HIGH DOSE flu shot instead. This patient is only 56 years old. It was administered in her right arm.  We explained to patient what had happened. She remained in the pharmacy for 15 minutes after vaccine administration to verify she was not going to have an immediate serious reaction.  We followed up with patient that evening (11/21/23 at 6:00 pm ) and again the next morning (11/22/23  at 8:30 am) . She was not experiencing any side effects, except a sore arm. She did not have fatigue, body aches, headache, chills, fever, or nausea.
First said her head felt funny and injection site hurt, by 3:50 PM injection site red, swollen and felt heat from site, said she was dizzy during school and nauseated. On 10/24/2009 woke at 10:30 AM took shower she was dizzy, nauseated and felt as if she were going to vomit. I thought these symptons would pass.  I called Dr. office on 11/01/2009 about 11:30 AM left message with nurse concerning side effects was told some patients have show to have some of her symptoms and to make appt with the doctor.  Appt with Dr. on 11/03/2009 at 4:00 PM seen Dr 5:15 PM he said her symptoms were not side effects of the flu shot and ordered blood test.  A CBC and Metabolic Profile which results called today were normal 11/04/2009 at 12:02 PM.  Now the injection site is normal but still has spells of dizziness and nausea and states her head just feels funny at times.
No adverse event occurred but patient received second booster too soon. Initial booster was 02/03/2022.
Local RX to vaccine MMR-V 2/13/07 1" x 1" swollen red, hot to touch area on R arm.
Severe multiple joint pain that felt like someone took a bat to each joint. Lymph nodes at neck, armpits, elbows,groin, and knees, swollen and tender. Headache . Feeling forgetful.  The first 3 days were bad. I stayed in bed, needed a cane to walk to the bathroom.  Symptoms lessening each day, but persist still to this day .  Today, difuse shingles rash appeared.
Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves Infant patient who received ACT-HIB with expiry date of 01 Jun 2018. The patients past medical history and concomitant medication were not provided. It was an actual medication error due to Expired vaccine used. On an unknown date, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot U1795AA, expiry date 01 Jun 2018 via unknown route in the left thigh. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.