chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant medication information was provided. The vial was initially thawed on 10Jun2023. No treatment drug information was provided.   The case corresponds to 26th out of 30 patients as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow-up significant information received, updated vaccination date and initial vial thaw date.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Pt symptoms were headache, dizziness, fever, chills, drainage (nasal), clogged ears.
Pt received ZOSTAVAX on Monday 9/26/11. Shortly after the injection area became red, inflamed, & itchy. The area of irritation is now around 3-4" & is growing. Pt was told to take BENADRYL & apply hydrocortisone. She works for a doctor who is closely watching the area.
This spontaneous report as received from a physician who reported that 90-100 patients were inadvertently administered 5 vaccines for prophylaxis from December 2013 to March 2014 that had been improperly stored. This report refers to unknown number of these patients who were vaccinated with RECOMBIVAX HB had been improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
At approx. 48 hours after dose, experienced sweating lasting approx. 4 hours with return to normal, no treatment was given; At approx. 30 hours after dose, experienced chills also lasting ~2 hours with return to normal, no treatmentwas given.; At approximately 18 hours after dose, experienced fever lasting ~2 hours with return to normal, no treatment had been given.; Dose number: 3; This is a spontaneous report from a contactable reporter (nurse).  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Dec2021 at 10:30 (Lot number: FF8839) at the age of 63 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EL3247; Route of administration: Intramuscular), administration date: 25Feb2021, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EN6203; Route of administration: Intramuscular), administration date: 18Mar2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 at 10:30, outcome "unknown", described as " Dose number: 3"; PYREXIA (non-serious) with onset 16Dec2021 at 04:30, outcome "recovered" (16Dec2021 at 06:30), described as "At approximately 18 hours after dose, experienced fever lasting ~2 hours with return to normal, no treatment had been given"; CHILLS (non-serious) with onset 16Dec2021 at 16:30, outcome "recovered" (16Dec2021 at 18:30), described as "At approx. 30 hours after dose, experienced chills also lasting ~2 hours with return to normal, no treatment was given"; HYPERHIDROSIS (non-serious) with onset 17Dec2021 at 10:30, outcome "recovered" (17Dec2021 at 14:30), described as "At approx. 48 hours after dose, experienced sweating lasting approx. 4 hours with return to normal, no treatment was given". Therapeutic measures were not taken as a result of pyrexia, chills and hyperhidrosis.  Additional Information: Patient had no known allergies. 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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Allergic Reaction, left arm turned red. That same day in the evening was prescribed Tylenol for pain and to apply cold compress.
no adverse event; administered after temperature excursion; 0.5 ml IM; This spontaneous report was received from a medical assistant, and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 13-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL, intramuscularly for prophylaxis (lot number U015682, was verified to be valid, expiration date reported and established as 18-MAY-2021); (site of administration was not provided).   The administered dose of vaccine experienced a temperature excursion of 38 Fahrenheit degrees (F) for 4 hours. The patient did not experience any additional adverse event.
Swelling, redness, hard lump at injection site; body aches, fever -102.6, chills, nausea, headache, felt like I was hallucinating while I was in and out of sleep...  the next day fatigue, weakness mostly. Had headache, chills and mild fever next night...  mostly better the next day however a cough and sore throat developed..
No additional AEs; Vaccine administered after temperature excursion; This spontaneous report as received from a nurse referring to a specified patient (age and gender not provided). The pertinent medical history, concomitant therapies and drug allergy or reactions were unknown.  On 17-DEC-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 ml (lot #T030945, which has been verified to be valid, expiration date: 09-MAR-2022, therapy type: rHA) subcutaneously for prophylaxis after temperature excursion (Product storage error). No additional adverse events reported (no adverse event).  The vaccine was stored at temperature of 6.8 degrees Fahrenheit for 8 hours and 5 minutes. There was no previous temperature excursion.
My arm is a little sore; I was a little sleepy the first day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 05Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset Jul2022, outcome "unknown", described as "I was a little sleepy the first day"; PAIN IN EXTREMITY (non-serious) with onset Jul2022, outcome "unknown", described as "My arm is a little sore".  Additional information: Caller was a consumer (patient) who received fourth dose Adult Pfizer Covid Vaccine on 05Jul2022. She was then contacted by the Pharmacist who told her they recorded the wrong expiration date on the vaccination card "03Jul2022" when it was not actually expired. The vaccine administration facility put a sticker on the vaccine card with extremely small print. The expiration date listed on the vaccine card for fourth dose Adult Pfizer Covid Vaccine is 03Jul2022, two days before caller was administered the fourth dose Adult Pfizer Covid Vaccine on 05Jul2022. The patient did not notice the expiration date because it was like a pen drop on the vaccine card. Got call from pharmacist yesterday, 07Jul2022, stating the wrong information was placed on the vaccine card the Adult Pfizer Covid Vaccine administered was not expired. The pharmacist wanted to send a new vaccine card with the correct information. The patient was uncertain on whether or not she received an expired vaccine. She wanted to know if she should be concerned if the efficacy of the vaccine dwindled or if she would need an additional vaccine. The patient also stated "I am looking it at this way, I had no adverse reaction, I am quite fine, my arm is a little sore, I was a little sleepy the first day. That was it. If there's no real issue and they send the corrected card". The patient stated her concern was if she had received and expired dose, if she should be getting another booster by the end of the year, or if she assumed that they made a mistake and send her a corrected card and she was good for however long. She was just trying to factor in how she need to do her protection going forward. Caller asked "If they made the mistake, do I have any efficacy here? Should it last a few months? I just need to know if I need to assume I need to get one maybe a little quicker than most people who had got one that was not possibly expired".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My arm immediately swelled up at injection site probably a little smaller than a golf ball. Applied ice pack immediately. After about 15 minutes I became lightheaded, nauseous and severely diaphoretic, lasted about 45 minutes. I was laid down on a mat snd monitored by several nurses. Taking my blood pressure, monitoring my oxygen and heart rate. Applied ice packs to neck and forehead. I felt better when I left but kind of out of it and fatigued for a few days. The healthcare professionals were great!
Patient experience hives on face (1 on forehead, 2 beneath lower lip) approximately 1.5 hours after 1st dose administered of Pfizer COVID vaccine. Patient also reported headache, dizziness, and general malaise after injection. Patient took benadryl 25mg capsule that evening and again the next morning. Rash was much improved by 1/6/21 after 2nd dose of benadryl and was resolved by 1/7/21.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-OCT-2015 12:26, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L004754, expiry date: 10-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.0 and 0.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a female patient who on an unknown date, was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported). Secondary suspect therapy included hepatitis A virus vaccination (manufacturer unknown) received at the same time. The physician reported that on an unknown date, a niece of a nurse in the physician's office developed pancreatitis after the first vaccination with GARDASIL. The niece of the nurse was not the patient of the reporting physician. The patient was being treated by another physician. On an unknown date, the patient recovered from pancreatitis. Upon internal review the pancreatitis was determined to be an other important medical event. Additional information is not expected.
Patient started developing a cough on Saturday, November 13 around 7:45 PM.  She started fevering, having body aches, and an upset stomach Sunday, November 14 around 2:30 PM.  On Monday, November 15, she early in the morning, she started throwing up.  She decided to stay home from school.  Late that morning, we called into her doctors office to see if she should be seen and if they had an appointment.  They wanted her to be seen but didn't have any available times to be seen that day and instructed us to go to an urgent care clinic.  Upon doing so, they checked her out, said all her vitals were good, ran a rapid strep test, and a 3-in-1 Flu, Covid, and RSV test.  The strep test, Covid test, and Flu test all came back as negative.  The RSV test came back positive.  As such, there was no adverse reaction to the vaccine, and instead, she had come down with RSV.
This spontaneous report was received from a female patient of unknown age regarding herself. The patient's concurrent condition, historical condition, historical medication, drug allergies and concomitant medications were not reported. On an unknown date in May 2017, the patient was vaccinated with ZOSTAVAX (dose, unit, route, frequency not reported) (expiration date and lot number not specified) for shingles prophylaxis. On an unknown date in May 2017 (since administration with ZOSTAVAX, the patient experienced visual impairment. The patient reported that her vision has been declining since being administered ZOSTAVAX. The patient reported that since May 2017, her vision had become progressively worse. The patient reported that her glasses were "not doing anything". The patient had her vision test results showing the decline from May 2017 and January 2018. The patient reported that she did not make a connection between the vision and the ZOSTAVAX until she saw a commercial on television on 07-FEB-2018. The patient did not mention any legal action, even though she saw a legal commercial. The outcome of visual impairment was unknown. The reporter did not assess the causality of the event with suspect therapy.
Optic nerve edema in left eye a few days after COVID booster. Unclear if related but other possible diagnosis would be NAION and he does not have risk factors nor anatomy for that. Nerve swelling has since resolved but he still has vision deficit.
9APR97 pt called c/o localized skin rxn on the back of lt arm; area 5cm & 4 1/2cm red, raised warm to touch very sensitive to touch;itches when touched;also c/o h/a & crankiness;informed to place cold packs to area;
This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX, (lot # L048466, expiry date 02-DEC-2017, lot # M000761 expiry date 01-JAN-2018, lot # M005974 expiry date 02-FEB-2018, lot # M009764 expiry date 28-FEB-2018, M009768 expiry date 23-FEB-2018. No adverse effects were reported. Temperature -13.3 degrees centigrade, time 10 minutes. There was no previous exposure. This is one of the two reports received from the same reporter. Additional information has been requested.
Complaining of pain with swelling in the L nostril at site of entry of the nose ring. Patient with existing pierced nose for 6 months at the time of intranasal flu vaccination. Patient complained of itching and burning at the site of the piercing after the vaccination. Started on Bactroban on 11/19/10.
Information has been received from a physician and a nurse concerning a 17 year old female who in April 2007, was vaccinated with Gardasil (lot number unknown).  Right after administration of the vaccine, the patient experienced hot flashes, reddening of the face, dizziness and sweating on her head.  The patient had an unspecified blood test performed (results not provided) and sought unspecified medical attention.  Subsequently, the patient recovered from hot flashes, reddening of the face, dizziness and sweating on her head the same day as the vaccination.  Additional information has been requested.
Headache for 4 days, full body rash on day 2, reoccuring on day 4 but not as bad, little or no sleep for 3-4 days
Child received rotateq on 4/3/09 and was admitted to the hospital for intussusception on 4/9/09.  7/24/09 Hospital records received DOS 4/9/09 to 4/27/09 (Inpatient 4/9/09 to 4/13/09). Discharge Diagnosis: Status post exploratory laparotomy with manual reduction of intussusception and appendectomy. Parent reports child has bloody stools, projectile vomiting, and fever, 'grape jelly' stools. Unwilling to lay flat on her stomach. Abdominal pain. Has not been urinating as much as usual. Operative reduction of intussusception with appendectomy performed. 7/28/09-Diagnosis, 560.0; Abdominal Procedure, 46082; Surgery, 47.19  7/31/31 Hospital records received DOS 12/15/08 to 6/17/09. Additional information abstracted. ASSESSMENT: URI, wheezing, bronchospasm. Several months post surgery (exploratory laparotomy with manual reduction of intussusception and appendectomy) patient presents with wheezing, runny nose, and cough. A few episodes of posttussive emesis. Slight decreased by mouth intake.
Headache; Knee pain/ Joint pain; Back pain; Pain in side of injection; This is a spontaneous report from a contactable physician. A 29-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscular, administered in Arm Left on 27Jan2021 14:00 (Batch/Lot number was not reported) as SINGLE DOSE for an COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. No Other vaccines in four weeks. No other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. On 28Jan2021 patient experienced headache (headache) (non-serious), knee pain/ joint pain (arthralgia) (non-serious), back pain (back pain) (non-serious), pain in side of injection (injection site pain) (non-serious). Tylenol was given as treatment for all the events. The outcome for all the events was recovering.  Follow-up attempts have been completed and no further information is expected.
pretty sick with a high fever; pretty sick with a high fever; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (pretty sick with a high fever) and PYREXIA (pretty sick with a high fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (pretty sick with a high fever) and PYREXIA (pretty sick with a high fever). At the time of the report, ILLNESS (pretty sick with a high fever) and PYREXIA (pretty sick with a high fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. It was reported that After each of the primary doses patient was pretty sick with a high fever.   No treatment details were reported.   This case was linked to MOD-2022-630786, MOD-2022-630787 (Patient Link).
This spontaneous report was received from a physician assistant and refers to a 17-year-old patient of unknown gender. The patient pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 23-OCT-2018, the patient was vaccinated with fourth dose of GARDASIL 9, intramuscularly (exact dose, lot# and expiration date were not reported) for prophylaxis (Incorrect dose administered). No adverse effects reported.
One spot on the face turned scabby; Light Headedness; Chills; Itchy; 2 spots one on each side of the face; Rash on the neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), SCAB (One spot on the face turned scabby), DIZZINESS (Light Headedness), RASH MACULAR (2 spots one on each side of the face) and RASH (Rash on the neck) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN and SIMVASTATIN for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Apr-2021, the patient experienced PRURITUS (Itchy), RASH MACULAR (2 spots one on each side of the face) and RASH (Rash on the neck). On 03-Apr-2021, the patient experienced CHILLS (Chills). On 06-Apr-2021, the patient experienced DIZZINESS (Light Headedness). On an unknown date, the patient experienced SCAB (One spot on the face turned scabby). The patient was treated with AVENA SATIVA (EUCERIN ECZEMA RELIEF) for Eczema, at an unspecified dose and frequency. On 06-Apr-2021, PRURITUS (Itchy), RASH (Rash on the neck) and CHILLS (Chills) had resolved. At the time of the report, SCAB (One spot on the face turned scabby) and RASH MACULAR (2 spots one on each side of the face) outcome was unknown and DIZZINESS (Light Headedness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
p/recv vax pt screamed violently & uncontrollably for 4 to 5 hr; surrounding inject site was reddened 2-3cm; subsequently given DT shots at all further inoculations; resulted in autism Per follow-up dated 9/27/00, the pt's adverse reaction resulted in autism. He has also been tested with autoantibodies to myelin, resulting in demyelination. These are expected to be long-term conditions.
2 clients were given Moderna Monovalent Booster Dose before information was received to discontinue monovalent doses as booster doses.
redness & swelling of most of left upper arm, required treatment in ER, resolved completely on 7/20/21
This spontaneous report as received from a Doctor pharmacist refers to a female patient of unknown age who was vaccinated with an unspecified dose if ZOSTAVAX (dose, route and lot number not reported) on 16-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that on 19-AUG-2012 the patient was itchy all over after receiving ZOSTAVAX. The pharmacist noted that the patient did not have hives. The patient was treated with BENADRYL. Patient called pharmacist. The outcome of "was itchy all over" af was unknown. Additional information has been requested.
Throat swelling and tongue felt raw was given Benedryl (2) by Dr. in attendance and observed for around 45 minutes. Later that evening (about 4 hours later) heart had a series of strong, short, contractions. Continued for the next few day but less each day.  Followed up with cardiologist and was in regular rhythm but show him my left arm where I had a red circle (3 inches or so)  around injection site. Referred to PCP and they suggested no 2nd vaccination. If deemed in need of another Covid vaccination allergist should be consulted first.