chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; states she inadvertently gave a patient an expired Moderna COVID19 Vaccine, Bivalent; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (states she inadvertently gave a patient an expired Moderna COVID19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 03-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.   On 04-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-May-2023, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 24-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (states she inadvertently gave a patient an expired Moderna COVID19 Vaccine, Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (states she inadvertently gave a patient an expired Moderna COVID19 Vaccine, Bivalent) 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 (states she inadvertently gave a patient an expired Moderna COVID19 Vaccine, Bivalent).    Concomitant medication details not reported by the reporter. Patient did not  received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vial size was reported as 2.5 ml. Vial was initially stored in refrigerator on 23-MAY-2023. Vial did not undergo temperature excursion. Treatment details was not reported by the reporter.   This case was linked to MOD-2023-726230 (Patient Link).
first signs of a headache and body aches started on 12 Jan about 10:00 am and persisted into next day. At 0200 on 13 Jan suffered from headache, body aches, temperature of 99.8, chills.   Evening of 13 Jan at about 2000 rash was discovered across front of torso from armpits to bellybutton on the front plane.
Narrative:  71yo male patient with medical hx of: Parkinsons allergic rhinitis CAD- MI x2 djd htn hyperlipidemia copd ED copd tobacco use- asthma cad hearing loss erectile dysfunction tinnitus diverticulosis died on 11/5/2021 outpatient. No info provided on pt's death. pt received covid vaccines on 2/26/21 & 3/27/21 from outside facility. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
Patient was administered the dose of the Moderna COVID 19 vaccine after 30 days use by date.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered the dose of the Moderna COVID 19 vaccine after 30 days use by date.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered the dose of the Moderna COVID 19 vaccine after 30 days use by date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered the dose of the Moderna COVID 19 vaccine after 30 days use by date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not provided. Treatment details were not provided. Number of doses/vials- 1 Date the vial was initially stored in the refrigerator was 10 SEPT 2021 Date(s) of administration of vaccine was 14 OCT 2021 The vial did not undergo any temperature excursions.
Patient received his single Janssen COVID-19 vaccine on 4/6/2021 and is admitted to the hospital on 5/17/2021 and tested positive for COVID-19 on 5/17/2021. Currently hospitalized, not discharged
Diarrhea lasting for a few days. Took Pepto-Bismol which didn't help. Had to take  Immodium  to check the problem.  Also had a very sore shoulder/ arm for three days...could not lift my arm.
patient told physician she could not lift her arm and it was very sore.  being treated with diclofenac 75mg which is helping with symptoms
8 weeks post Pfizer 2nd dose had routine baseline mammogram and discovered 2 cysts in right breast and loose grouping of calcifications near right axilla. One cyst was a simple 0.5cm and one was "mildly complicated" at 2.5cm due to a small septal deformation. No biopsy was required. Doctor determined the findings to be benign after ultrasound was performed. I am scheduled for routine 6 month follow up in December 2021.
Site: Pain at Injection Site-Severe, Additional Details: patient states pain in enjection site and trouble lifting arm over a certain level since injection on 01/21/2022. patient states injection was lower on arm so brusitis seems unlikely
infection NOS; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection NOS) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced INFECTION (infection NOS). At the time of the report, INFECTION (infection NOS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-162176, US-MODERNATX, INC.-MOD-2021-162133, US-MODERNATX, INC.-MOD-2021-162267, US-MODERNATX, INC.-MOD-2021-162303 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: NNI received; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162176: US-MODERNATX, INC.-MOD-2021-162133: US-MODERNATX, INC.-MOD-2021-162303: US-MODERNATX, INC.-MOD-2021-162267:
Patient had vasovagal episode after vaccination. Patient felt dizzy and weak but never lost consciousness. The episode lasted about 10 seconds. Patient was assisted by elevating head, provided ice pack to the nape of neck and was cooled down with fans. Emergency rescue was contacted but patient refused to have them show up. Rescue canceled called themselves after hearing patient refuse service. Patient recovered fairly quickly and expressed fear of needles after the fact.
I ou in a ash all over my back, arms, and behind my legs, neck. stomach. itchy and burning. Six hours after receiving my second  Moderna shot. I took Benadryl twice a day for three weeks.  No change, On April 12, 2021, at 7:30 pm. I met with NP. She examined my back and chest area and prescribed Hydroxyzine 25 MG 3 times a day. I've been taking the medication for the last three days. no effect on the itching or rash. I continues to hurt and be very itchy. I have an appointment with Doctor.
Fever, chills, body aches, nausea continued all night and into the following day.
Mother brought child in concerned about immunization sites.  Left upper outer thigh with round area=3inches around injection site.  No warmth, redness or drainage, skin slightly darker on right thigh area, smaller and less noticable.  Mom said very red yesterday.  No redness, drainage, warmth today.
Sore throat, vomiting, chills, fever, body aches, fatigue start about 12 hours after vaccine, lasting approximately 36 hours.  Treatment: tylenol
received his first dose of the Covid vaccine 1/6.  Since that time he has endorsed fatigue, body aches, headache, and nausea.
I had the first shot  then when new one came out I got the 2 shots like said to do and I have shingles today/ Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (one dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the first shot  then when new one came out I got the 2 shots like said to do and I have shingles today/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 23-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she had the first vaccine and then when new one came out he or she received two doses of Shingles vaccine. The patient stated that he or she have shingles today. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Took paxlovid with diagnosis of covid; Took paxlovid with diagnosis of covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), on 12Apr2021 as dose 2, single (Batch/Lot number: unknown), on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 05Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "varicose veins" (unspecified if ongoing); "mucocele of maxillary sinus" (unspecified if ongoing), notes: mucocele of maxillary sinus; "vit d deficiency" (unspecified if ongoing); "recurrent UTI's wtih voiding dysfunction" (unspecified if ongoing), notes: recurrent UTI's; "recurrent UTI's wtih voiding dysfunction" (unspecified if ongoing), notes: voiding dysfunction; "s/p mastectomy" (unspecified if ongoing), notes: s/p mastectomy. The patient's concomitant medications were not reported. Past drug history included: Ciprofloxacin, reaction(s): "Known allergies: ciprofloxacin", notes: Known allergies: ciprofloxacin.  The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Took paxlovid with diagnosis of covid". Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: Adverse event: Took paxlovid with diagnosis of covid and 3 days after completion of paxlovid, became very ill with cold symptoms, severe fatigue, "feeling feverish", head congestion. Never did testing in between to determine if she was negative following treatment but felt much better at that time. now with pounding heartbeat feeling,  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Patient took the Flu vaccine  at 2:20 PM on 1/17/06.  Around 7PM my son started experiencing dizziness then around midnight spiked a high fever of 102 which lasted for two days.  The redness around his injection site was the size of a large orange. He became very lethargic sleeping most of the next day after the injection.  Also complained it felt hard to breathe and had stiffness.  He also said his feet tingled.  Gave Advil to bring down the fever.  This is the first time the patient has taken the flu vaccine.  He had no other symptoms such as coughing, sore throat, etc. to indicate other illness.
tested positive for covid One person was hospitalized for days; tested positive for covid One person was hospitalized for days; This is a spontaneous report from a contactable consumer reporting for a patient.   An adult patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date in Feb2021 (at an unspecified age  of vaccination) as dose number unknown, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19.  On an unspecified date in Jul2021, the patient experienced tested positive for COVID although receiving the pfizer vaccine in Feb. The patient was hospitalized for days (as reported). Treatment received for adverse events was unknown. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included: Nasal Swab (Sars-cov-2 test): positive on an unspecified date in Jul2021 (COVID test post vaccination), Nasal Swab (Sars-cov-2 test): positive an unspecified date in Jul2021 (COVID test post vaccination). The patient has been tested for COVID-19 since the vaccination.  The reporter assessed events as serious with seriousness criteria of Caused/prolonged hospitalization and did not result in death, life threatening, disabling or incapacitating, congenital anomaly or birth defect.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
3 days after vaccines; mother describes two episodes staring with qurgling sounds, eyes rolled back & fluttered, body seemed limp, tongue hanging out.  Both very brief; cried at first episode.  seemed to be ok after.  Did seem more irritable remainder of day.  Two episodes happened within 15" of each other.  unsure if febrile at time.
Information has been received from a health professional concerning a male baby.  On 06-APR-2009, the baby's 17 year old mother was vaccinated with a dose of GARDASIL when she was 7 weeks pregnant.  On 16-OCT-2009, the baby's mother delivered the normal, male baby via preterm forceps delivery at 32 weeks and 3 days of pregnancy.  The baby's weight was 1910 grams, Apgar score was 7/9.  The mother's experience has been captured in WAES # 0904USA03198.  No further information is available.
Had 0.5 mL influenza vaccine 11-7-11 at 17:00. Mom states awoke at 0300 et 0600 on 11-8-11 with cold sweats, shakes/tremor, pale. Was improved by 1000 on 11-8-11.
Started with a dry pink rash to one side of her body 5 days after vaccine. Rash continued to spread and now is over both sides of her torso, buttocks and posterior legs.
71 year old female complained of shortness of breath. Onsite EMS responded vitals BP 155/80  100% O2 HR 78. She used her Albuteral and felt better than she was released to go home.
4 papules erupted on right lateral thigh 20 days after injection of varicella vaccine.
neck pain; ear pain; throat pain; can not swallow; no appetite; can not speak; severe headache; 102F fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (neck pain), EAR PAIN (ear pain), OROPHARYNGEAL PAIN (throat pain), DYSPHAGIA (can not swallow) and DECREASED APPETITE (no appetite) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #626A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (102F fever). On 14-Mar-2021, the patient experienced HEADACHE (severe headache). On 16-Mar-2021, the patient experienced NECK PAIN (neck pain), EAR PAIN (ear pain), OROPHARYNGEAL PAIN (throat pain), DYSPHAGIA (can not swallow), DECREASED APPETITE (no appetite) and APHASIA (can not speak). On 14-Mar-2021, PYREXIA (102F fever) had resolved. At the time of the report, NECK PAIN (neck pain), EAR PAIN (ear pain), OROPHARYNGEAL PAIN (throat pain), DYSPHAGIA (can not swallow), DECREASED APPETITE (no appetite), APHASIA (can not speak) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102f (High) Patient had fever for next 2 days after vaccination..         No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
This spontaneous report as received from a 23 year old female consumer refers to herself. Current condition included drug reactions or allergies to amoxicillin and cetrizine. The patient's medical history included anxiety and traumatic brain injury. The patient reported that on 08-AUG-2011 she received first dose of GARDASIL (dose, route of administration, anatomical location and lot number was unknown in upper right arm) and second dose on 11-JUN-2013 and she received third dose on an unknown date in September 2014. Concomitant medications were unspecified by reporter. On an unknown date in 2014, the patient developed anxiety and stomach cramp after third dose of GARDASIL. Patient also stated that "she was trying to get pregnant". The patient also stated that she called nurse (name and contact information were unknown) regarding this and she was advised to take a fourth dose by Nurse. There was no treatment given for the event. The outcome of the events was unknown. The causality for the events anxiety and stomach cramp was unknown. No additional information adverse event information was provided. Additional information has been requested.
Infection after receiving the pneumonia vaccine (PCV13). Shot on 10/13/15 went to urgent care 3x was hospitalized on 10/23/15 for skin infection - on antibiotics until Nov. 2 - very weak.
Received 1st injection 01/19/2021.  Has red warm rash approximately 5-6 cm to left deltoid.  She reported it had been present for 1 week and it was worsening.
This spontaneous report has been received from a nurse and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In July 2013, the patient was vaccinated with the first dose of quadrivalent GARDASIL (dose, route of administration, lot # and expiration date were not reported), in September 2013 with the second dose and on 23-MAR-2017, the patient came into the office to receive her third dose. No adverse effect were reported. No product quality complaint was involved. Additional information has been requested.
ON 2/28/2021- HEADACHE, NAUSEA , FEVER, FATIGUE AND CHILLS- LASTING UNTIL 3/2/2021. ON 3/2/2021AND 3/3/2021- SINUS HEADACHE , EYE AND EAR PRESSURE BEGAN.  ON 3/4/2021 WOKE WITH SYMETRICAL RASH TO ARMS, HIPS, UPPER LEGS AND BUTTOCKS. NOT ITCHY UNTIL EVENING OF 3/4/2021.  RASH BECAME BLOTCHY, RAISED "HIVE-LIKE" PROMPTING TO SEEK MEDICAL ATTENTION AT URGENT CARE.  THEY PRESCRIBED- BENADRYL AND CALAMINE LOTION.  STATES NO RELEIF AS OF TODAY.
Patient is a 3.5 year old male.  He has a food allergy to egg whites, egg yolk and chicken.  Symptoms to these foods include urticaria, vomiting, angioedema, and coughing.  Allergy has been confirmed with both skin test and IgE blood work.  On 4/5/22 he had his influenza vaccine in the left thigh.  No immediate reaction was noted but he did complain of pain several times that day.  The next morning swelling of the left thigh, from hip to knee, was noted with warmth and pain.  Patient was unable to walk with a normal gait the day after the injection.  A maculopapular rash was noted on the medial portion of the thigh approx. 6 cm from the injection site.  The rash does NOT encompass the injection site.  The rash was itchy.  Patient was treated with Ibuprofen and attempted to administer Benadryl and Zyrtec but Patient refused to take either of these antihistamines.  Leg swelling and rash resolved within 4 days.
pt recv vax 7JAN98 & exp redness & swelling on 9JAN98;adm to hosp w/abscess on lt deltoid;discharged 11JAN98 now on IV Rocephin;
Rotarix given on 7/22 was not mixed properly and thus only diluent was given. RN tc to GSK who did not have any data to recommend when vaccine should be administered again and leave it up to discretion of provider.
Child slept abnormally for 14 hours. Woke up, ate went back to sleep. Began running 103.5 fever at 2:00pm on 5/15/2012 thru 5/17/2012, required 2 doctor visits with a urine analysis to determine if there was any other cause which none could be found. He lost a pound thru the week due to loss of appetite.
pt recvd vax;began v for several hrs;to er & hosp;md noted that pt was pale & shock like state for approx 45 mins;md suspect sxs caused by excess loss of fluid while v;was lethargic;tx w/ IV fluids & disch next day;
Seen in ER Hives (influenza Vaccine) last 24 hours. Urticaria on legs,feet, and buttock. TX Orapred.
Extreme swelling of left shoulder, pain 5 hrs after injection. Swelling and loss of vision left eye. Heat and antibiotics.