chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days; Administered moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Products were reported.  The vaccines were tend to store with 1 to 3 bottles in the fridge to thaw out and to be ready for the patients when needed and at worst scenarios vaccines would have been in the fridge for about a week if no one came in to be vaccinated.  No Treatment information was reported.
Tetanus booster given at appointment. **I am unsure of the specific vaccine name/manufacturer/lot. THE ABOVE INFORMATION IS A GUESS, BUT I HAD TO INPUT SOMETHING IN ORDER TO MOVE AHEAD IN THE REPORT, AND THEIR OFFICE IS CLOSED** It was an IM injection into the left deltoid.
Patient returned to vaccination clinic 1 week after his first dose of the Moderna vaccine. Patient states he woke up this morning with a golf ball sized lump that was red, hot, and firm. Patient denied any allergies and any previous vaccine reactions. He was utilizing an ice pack upon arrival and was told to continue using this, as well as use NSAIDs if able and an antihistamine if pruritic. Patient was also encouraged to reach out to his PCP for education/counseling on receiving his second dose of the series and to counsel on cellulitis symptoms.
On  day 8 after vaccination a 1.5-2 inch large red circle formed. It was hot to the touch and was very itchy.  On day 9 the large circle was now just a large raised ring with a smaller raised red circle in the middle (it resembled a bullseye) . Both areas were very hot to the touch and very itchy. There was also a hard lump in the center of the smaller red circle but it was not directly over where the vaccine was given.  I took over the counter Zyrtec and ibuprophen. I placed a cold pack on the spot as well.  I also applied topical anti-itch cream. They lessoned the symptoms but not completely. On day 10 the bullseye shaped raised area was almost completely gone. My left arm was back to normal on day 11.
Given to left deltoid IM 12/29/09. C/o significant pain in left arm and shoulder, inhibiting activities x 14 days. Has since resolved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Sulfa medications" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Fatty Liver" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID from 06Sep2023 to 10Sep2023.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Mom indicated p/immun fussy & irritable running low grade fever, diminished appetite, to ER;PE in ER indicated inflamed posterior pharynx w/o exudate;14MAR91 experienced resp arrest mom called to ER in complete cardiac & Resp arrest;
Red burning rash on chest, stomach, back and forehead.  Lasted 2 days and then itching.  Took Benedryl
1st dose/ December 29th 2020/second dose has not been received yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on  29th December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follow: This case was reported by a Pharmacist. The pharmacist reported on 7th June 2021 that the male patient received 1st dose of Shingrix on 29th December 2020. The patient did not received second dose yet which led to incomplete course of vaccination. The patient wanted to delay the 2nd dose due to financial issues.
Extreme fatigue, weakness, slept 36 hrs, stomach cramping, nausea, diarrhea, chills, muscle aches, headaches, chest pain, tachycardia up to 201, bp up to 210/101 with no cardiac history
I had sore throat and the next day I took the test. I contacted my doctor after I took a home test and it came back as positive. I contacted my doctor via telephone. He prescribed me Paxlovid, the sore throat stopped in a couple of days. There were other symptoms with cough, congestion and fatigue. I am now having continuing shortness of breath and cough.
24 hrs after MMR was given mom noticed chicken pox type rash which faded overnight and then noted bruising and linear petechial (1 cm long, scratches on right thigh where MMR was injection. Pt was irritable but consolable on 2nd night after injection. Fussy with exam but alert and smiling with mom.
This is a spontaneous report from a contactable nurse communicated to a Pfizer field representative. A female patient received PREVNAR 13 and experienced rash and swelling at injection site 4cm X 5cm, and cellulitis was suspected.
I started to feel pins and needle all over my body, the doctor prescribed gabapentin. I am still dealing with the pain currently.
I had severe pain in my opposite arm; My arm with lymphedema started paining terribly, it was so bad I couldn't move it, I couldn't drive my car; The pain was excruciating I could not move my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6202) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "AFib" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "I have slightly raised blood pressure" (unspecified if ongoing), notes: I have slightly raised blood pressure; "lymphedema", start date: 1995 (ongoing), notes: I have had lymphedema since 1995; "Breast lumpectomy" (unspecified if ongoing), notes: I had a breast lumpectomy and the severe pain I had in the entire arm was unbearable.; "15 lymph nodes removed" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; DIGOXIN; FUROSEMIDE; METOPROLOL; VALSARTAN; ATORVASTATIN; METOPROLOL SUCCINATE. The following information was reported: LYMPHOEDEMA (non-serious) with onset 08Mar2021, outcome "recovering", described as "My arm with lymphedema started paining terribly, it was so bad I couldn't move it, I couldn't drive my car"; PAIN (non-serious) with onset 08Mar2021, outcome "recovering", described as "The pain was excruciating I could not move my arm"; PAIN IN EXTREMITY (non-serious) with onset 09Mar2021, outcome "recovering", described as "I had severe pain in my opposite arm". Relevant laboratory tests and procedures included Blood test: unknown result and Weight:125 or 126 on an unspecified date. Therapeutic measures were taken as a result of lymphoedema, pain, pain in extremity and treatment included with she took was 1 Tylenol in the morning and one Tylenol at night.  Additional information: On 05Mar she had her first Pfizer vaccine and it was fine, she had no problem at all, no soreness no nothing. However, 3 days later on the 08Mar2021, she have to back track a little bit, she had her vaccine in her left arm which she have all her vaccines in because she have lymphedema in her right arm. So now 3 days after she had the vaccine her arm with lymphedema started paining terribly, it was so bad she couldn't move it, she couldn't drive her car and she have never had any pains in that arm, she have had lymphedema since 1995 so she never had any pain in it but it lasted until yesterday. It was very very painful so she began to wonder if she should have another vaccine or she shouldn't have the second vaccine." Very lightly, it feels like it's almost gone. She  just roll her shoulder now to try, She kept trying to move it, to get rid of it but it took a long time.  No follow-up attempts are possible. No further information is expected.
No additional AE; Caller explained a patient started the GARDASIL 9 vaccination series at the age of 17 years old on 08JUN2020. Caller stated the patient did not receive his second vaccination until JULY 2022.; This spontaneous report has been received from a nurse referring to a male patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitants therapies were not mentioned.  On 08-JUN-2020, the patient started his vaccination series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dosage, vaccination scheme, route of administration, anatomical site of injection, lot number and expiration date were not provided). However, did not received his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) until unspecified date in July 2022 (inappropriate schedule of vaccine administered).
She tested positive for Covid19; She tested positive for Covid19; This is a spontaneous report from a contactable consumer. A 32-year-old female patient (reporter's daughter) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for covid19 on 21Jan2021. The patient wanted to know can the patient get a 2nd vaccine if they are positive or will she have to start with dose 1 again. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Pfizer-Bio Tech COVID 19 Vaccine EUA #18  Facial flushing, facial warmth, fever 101.4 (post 650mg Tylenol) headache, dry mouth, loss of appetite
Swelling, redness and numbness of the left side of body and severe pain. On annual report received 04/21/2003, patient states, "still experiencing numbness on left side of body that comes and goes."  Follow up on 10/01/02 states: "Vaccine receipient has not recovered from adverse events. Still experiencing numbness on the left side of the body."
24 hours after the shot, I started getting loud ringing on my ears.  It is now 7 days since that shot, and the ringing in my ears is still very loud.
pt recv vax 20JUN95 & 17DEC97 pt devel chickenpox;
Flu symptoms appeared 36 hours later - fever, headache. naseua, loss of voice, coughing
slept for 40 hours; shaking so bad; fever of 103; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept for 40 hours), TREMOR (shaking so bad), PYREXIA (fever of 103) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced HYPERSOMNIA (slept for 40 hours), TREMOR (shaking so bad), PYREXIA (fever of 103) and HEADACHE (headache). On 25-Feb-2021, HYPERSOMNIA (slept for 40 hours), TREMOR (shaking so bad), PYREXIA (fever of 103) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Body temperature: 103 (High) fever of 103.         Concomitant product use was not provided by the reporter.   Patient took pain medication (oxy).  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable
Severe stomach pain on the left side. It felt like acid coming up to my esophagus. The pain was severe like a heart burn from my heart to the left side of my rib cage. I am still not healed. Every year I have nose bleeds that last a month or two after flu shot. I also had shortness of breath. This was reported to the pharmacy I had the flu shot at and also to my doctors office.
I had COVID-19 (diagnosed on 1/7/2021) and the main symptom I had was a total loss of sense of smell. I got the Pfizer vaccine on 3/9 and 3/30/2021 because it was available to me. I started having symptoms of irritated eyes (at the bridge of my nose), tinnitus, sensitive teeth (upper and lower) when eating or drinking and even when not eating or drinking, itchiness around my jaw line and upper arms after the second dose of the vaccine. I thought it was seasonal allergy-related, so I took Allegra for a couple of weeks, and then asked my PCP about a Kenalog shot on 4/15/21  for seasonal allergies. After the Kenalog shot, my symptoms heightened (itchy upper arms and eyes) mostly in the morning upon waking. I started taking Benadryl, and took the lowest dose 3 times per day from 4/17 to 5/20.  I went to an acupuncturist on 4/28, 5/8 and 5/22 with some herbal tea formula prescribed. I went to an allergist on 5/27/21
The day after the vaccination (10/13) patient reports his scalp started breaking out and getting very itchy. Over the next several days it spread to his chest, back, shoulders, and face. He reported face redness/swelling and red spots on his chest, back, and shoulders. He initially took Benadryl and used anti-itch cream. He went to urgent care and got prescriptions for triamcinolone cream and oral prednisone on 10/18. On 10/20 he saw a dermatologist and they prescribed valacyclovir for treatment of chicken pox virus.
ROA OF R-ARM, VZA ADMINISTERED 7/25/2007 IN THE AM.  BY EVENING PT C/O DISCOMFORT, MOM BROUGHT PT TO HEALTH DEPT 7/27/2007 W/ROA OF R-ARM SLIGHTLY SWOLLEN AND RED TO 50MM.
who was vaccinated with Prevnar 13 one year ago and reports to have recurrent Pneumonia needs to be revaccinated.; who was vaccinated with Prevnar 13 one year ago and reports to have recurrent Pneumonia needs to be revaccinated.; This is a spontaneous report from a contactable pharmacist.  A 41-year-old female patient receive first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date in 2019 at single dose for immunisation. Medical history included recurrent Pneumonia infections previous to the initial vaccination.  The patient's concomitant medications were not reported. The patient who was vaccinated with of pneumococcal 13-val conj vac (dipht crm197 protein) one year ago in 2019 had recurrent Pneumonia on an unknown date and needed to be revaccinated. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: The association between the event drug ineffective (pneumonia) with pneumococcal 13-valent conjugate vaccine can not be fully excluded.
Incontrollable shaking began about 10 hours after the injection and lasted several hours. This included painful teeth chattering and clinching, accompanied by profuse sweating.  About 18 hours after the injection I experience a hallucination -like daze for several hours. Throughout the entire 24 hours following the injection I had severe pressure in my head, fatigue, nausea, and no apatite.  I am still having a hard time sleeping.
Moderna dose 1  on 12/23/20, dose 2 1/20/21, received 1cc of lip filler in 9/30/21- developed granulomas inlet, needed to be dissolved by doctor, 2 treatments required , had raised hives for 6 days requiring Benadryl, Claritin and medrol dose pack treatment
This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe flu like symptoms for 2 days. The reporter agreed to be contacted by GlaxoSmithKline. This case has been linked with case US2018GSK188965, reported by the same reporter.
2/24/2021- Patient was brought to ED by caregiver because of concerns of redness to the left arm at the site of injection, increased fatigue and tiredness.  Patient is a resident of supported living facility and received her second COVID dose on 2/23/2021.  Patient in no acute distress.  The physician explained that this is a normal reaction to a vaccine.  Patient was discharge back to Supported living facility.
swelling after 3 days; This case was reported by a consumer via (Shingrix chatbot) interactive digital media and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received Shingrix on an unknown date and 3 days after vaccination, he/she experienced swelling.
headache; fever of 100.2; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 36-year-old female patient (not pregnant) received her first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand Pfizer-Biontech, lot EL1284), via an unspecified route of administration in left arm 15Jan2021 13:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included joint hyper mobility and allergy to grapefruit and beestings. No Covid prior vaccination. No other vaccine in four weeks. Other medications in two weeks was daily multivitamin (unspecified). On 19Jan2021 (4 days following injection), she developed headache, fever of 100.2 and fatigue. No treatment was given. The outcome of events was recovering. No Covid tested post vaccination.
This spontaneous report as received from a medical assistant and the patient's mother refers to a 5 year old female patient. On 14-MAR-2013 the patient was accidentally vaccinated with a dose of GARDASIL (lot # H013831, exp 06-MAR-2015) in error. The medical assistant stated that the patient was supposed to receive a dose of DTaP. On the evening of 18-MAR-2013, the patient was observed to have an elevated temperature and fever blister on her mouth (also reported as lip). The patient was seen by the physician, who prescribed ZOVIRAX four times a day and TYLENOL for the patient's fever. At the time of reporting, the patient's outcome was unknown. Action taken and the causality of events and GARDASIL were not reported. Additional information has been requested.
No adverse event after vaccination.  Pediatric Pfizer vaccine administered without reconstituting.  No adverse signs or symptoms noted after administration of vaccine.
Student was under-immunized. Vaccination for ages 6mos<5y (maroon cao) was mistaken for the 5-11y vial (orange cap) and diluted with 1.3 ml and 0.2 ml were injected into patient (dose was .47mg). No adverse effects were experience by patient.
pt recvd vax devel redness, swelling & warmth in the arm of inject
Nausea: 1hr Palpitations: 24hr Restlessness: 8hr Insomnia: 8hr Fatigue: 36hr Pain at injection site: 5hr Headache: 12hr
Within two hours after injection, an area about 1 inch by 2 inches around the injection site was red, hot, swollen, and painful. Within two days, that area grew to 3-1/4" in diameter, red, hot, swollen and painful. The bright red color persisted for 10 days and took another week to fade to a dark area occupying the same area. Now, nearly four weeks later, the skin color has returned to normal, but the skin is peeling on that part of my arm, as if it had been sunburned.
Redness at the injection site; Itchiness at the site of injection; Soreness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the site of injection) and VACCINATION SITE PAIN (Soreness at the site of injection) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-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 20-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the site of injection) and VACCINATION SITE PAIN (Soreness at the site of injection). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the site of injection) and VACCINATION SITE PAIN (Soreness at the site of injection) had not resolved.            Concomitant medications were not reported by the reporter. Treatment details was not reported by the reported.