chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took flu shot in January 1993, and was hospitalized with Guillain-Barre Syndrome in February, 1993. Acute phase lasted 4 months, with total paralysis. ICU, ventilation, and step-down for 4 months, and then rehabilitative care for 2 months. Took immunoglobulin, steroids and plasmapheresis treatments. Per 60 day follow up: I contracted GUILLAIN-BARRE syndrome as a result of recv'g the vaccine. The residuals of total paralysis include numb legs and feet & other issues. We need a disclaimer on the flu shot form!
This spontaneous report was received from a registered nurse referring to a 12 year old patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 11-AUG-2016 the patient was vaccinated with a dose of PROQUAD (lot # M006104 and expiration date: 01-AUG-2017) subcutaneous instead of VARIVAX. No adverse effects were reported. Additional information has been requested.
13 hours after 6 mo vaccines and flu shot were administered, child spiked fever to 101.5 and started jerking spasms of head and arm. Admitted to Hospital for evaluation for infantile spasms. MRI-normal. EEG-normal-but needs follow up as spasms have continued. Working diagnosis is myoclonic jerks, but infantile spasms not fully ruled out.
No adverse events; Administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a male patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 10-DEC-2019, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, anatomical location were unknown) with lot # 1621934 and expiration date 29-JAN-2022 for prophylaxis (product storage error). Reporter stated that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) shipment was received on 09-DEC-2019 and "received by date" was 06-DEC-2019. Reporter unable to provide temperature excursion timeframe or estimated temperature the vaccine was exposed to. No additional adverse events were reported. There was no previous temperature excursion. Data logger was not involved. There was no product quality complaint associated with the case.
?COVID arm?  Itchy welt at injection site. About the size of a quarter.
Information has been received from a physician concerning a female who in approximately August 2007, about 8 months ago was vaccinated with her first dose of zoster vaccine live (Oka/Merck). On approximately 02-MAR-2008 about 4 weeks ago, the patient was diagnosed with shingles. The patient sought unspecified medical attention. The outcome was unknown. No further information was provided. There was no product quality complaint. Additional information has been requested.
Onset of symptoms started with severe headache mid afternoon day of immunization.  Symptoms progressed to generalized body aches, nausea, fever/chills, swollen glands in neck and sore throat, fatigue by evening and persisted to following day.
About 4 hours after injection Patient says her arm developed a large hive, it was raised and about 4" by 2" started at the top injection site. The hive/welt was "hard, red, hot. A little itchy but not bad" Pt said she used ice to help alleviate the hive, it helped a little bit.  She came in 6 days later to show me the picture of the hive/welt and show me her arm currently. She did not call or come by before today. 11/16/2020.  Today, her arm was still a light pink color about the size of 4" x 2" starting at the injection site that was the Shingrix injection. When depressing on the site, you could feel the hard know behind the injection site, the knot is about the size of a qtr.   Pt says the hive was at it's worst the night of the injection and gradually improved from there. But the redness went down her arm over the next few days and stopped at her elbow.
Diffuse Pruritus.  treated with 125 mg of Solu-Medrol, she responded quickly.  Provided her with a 6 day dosing of prednisone as well as anti-histamines.
Tightness in chest, Angina and troubles catching my breath. All symptoms occurred within a few days of booster shot. Similar symptoms after 2nd dose in series although not as acute and noticeable.  Breathing issues and heart pain persisted for approximately 3-4 months. I was working in the operating room on Jan. 25th and could not catch my breath. The anesthesiologist took my BP. Blood pressure was high for me (~145/90). I was immediately relieved of my duties and wheeled to the E.R. A full EKG was performed and the E.R. doc noted Intraventricular conduction delay as well as high BP.  This subsided after an hour or so.  I was sent home 3 hours later feeling light-headed and not well.  January 29th I was sent to the E.R. a 2nd time. This was at a different facility. A full lead EKG was performed. No signs of a heart attack and I was sent home 3-4 hours later.
Redness, swelling, and very mild itching at injection site and surrounding area (spreading to majority of back upper arm).
Infant experienced infantile spasms following 1st HIBTITER; MD recognized sx 6 to 8 wk p/immun; Infant was afeb p/immun; Referred to Peds neurologist; Pt has since rec'd 2nd & 3rd HIBTITER had 3-4 sz p/3rd;
This spontaneous report as received from a pharmacist refers to a patient of unknown age. It was reported that on 11-AUG-2015, the patient was inadvertently administered less than full dose of ZOSTAVAX (lot number K016322, expiration date 24-DEC-2015) (dose and route not reported). No adverse experiences were reported. Additional information has been requested.
A physician reported that a 21 month old male received a dose of Prevnar and within 12 to 18 hours, post vax, he developed fever, vomiting and diarrhea. The pt recovered after 3 to 4 days. As of this date, no further information was available. The pt remained recovered.
I was given a Pfizer vaccine that was diluted with 0.9mls of 0.9% of sodium chloride instead of 1.8mls of 0.9% of normal saline. No adverse reaction
Can barely move her arm; Diarrhea; Body aches; Very swollen at the injection site; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Can barely move her arm), DIARRHOEA (Diarrhea), PAIN (Body aches), INJECTION SITE SWELLING (Very swollen at the injection site) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Suspected COVID-19 in July 2020. Concurrent medical conditions included No adverse event (Denies allergies).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced LIMB DISCOMFORT (Can barely move her arm), DIARRHOEA (Diarrhea), PAIN (Body aches), INJECTION SITE SWELLING (Very swollen at the injection site), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Can barely move her arm), DIARRHOEA (Diarrhea), PAIN (Body aches), INJECTION SITE SWELLING (Very swollen at the injection site), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
APPROXIMATELY TEN MINUTES AFTER RECEIVING THE VACCINE, I EXPERIENCED NUMBNESS TO THE LEFT SIDE OF MY FACE. TOOK BENEDRIL AND WENT TO THE EMERGENCY ROOM. AFTER BEING TRIAGED I LEFT BECAUSE THE SYMPTOMS SUBSIDED. SLEPT THE REST OF THE DAY AND NIGHT. TOOK VACCINE AROUND 1:30 P.M. LEFT THE BUILDING AROUND 2:30 P.M. WENT HOME AFTER LEAVING THE EMERGENCY ROOM.. SPARATIC NUMBNESS ON SAME SIDE YESTERDAY AND SLIGHT NUMBNESS TODAY.
Product given to patient expired on 6/17/22, but was given on 6/22/22. Patient has reported no adverse reaction.
vaccine 23-03-2023 pm  fever (38.9 celsius) start 24-03-2023pm, end 26-03-2023 diarrhea start 25-03-2023, end 29-03-2023 vomit start 26-03-2023, end 27-03-2023 Fatigue start 24-03-2023, end 04-04-2023  Treatment : patient tried probiotics and consulted clinic the 28-03-2023 ( they took their vitals and suggested rest)
Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.; No Adverse Event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Vial was individual vial with multi dose 0.5 ML. Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.  This case contains information about patient 3rd out of 19 adult patients.    This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master Case (Patient 1)
administration of the Shingrix vaccine to a/ 47 year old patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old female patient who received Herpes zoster (Shingrix) (batch number 59lk9, expiry date 18th December 2022) for prophylaxis.   On 12th July 2021, the patient received Shingrix. On 12th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The reporter stated that, 47 years old patient received dose of Shingrix, which led to inappropriate age at vaccine administration. No further events were reported. The health care professional agreed to be contacted for follow up.
ARM HURT; FELT LITTLE UNDER THE WEATHER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the patient experienced felt little under the weather. On an unspecified date, the patient experienced arm hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt little under the weather on MAR-2021, and arm hurt. This report was non-serious. This case, from the same reporter is linked to 20211242175.
Patient started feeling a "little off." Patient has history of severe allergic reactions to meds. Encouraged patient to lie down for a bit. Patient reported feeling better after 5 mins. Most likely anxiety after receiving vaccine.  Patient left feeling normal reporting no dizziness or feeling "off" upon discharge from EMS room.
Muscle pain, stiffness onset approximately 2 hr after admin.  At approximately 4hr after admin had a "  " in both arms accompanied by chills.
Patient presented to ED for nonintractable headache. was not admitted. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.
2 days p/shot a rash devel & rt side of head hurt around jaw bone;
Flu shot given on Sat afternoon. Next morning (Sunday) noticed large red circle around shot site. It continued to feel hot, was swollen, raised, red, and sore - about 3 to 3.5 inches in diameter.  This continued all day Monday with it not being swollen on Tuesday but still red and hot.  On Wednesday the redness disappeared but left a purple/redish bruise instead and was itchy.  The bruise slightly remained on Thursday.
After vaccine skin started to peel all over body, arm, legs included lasted for more then 2 weeks.
patient 17 years old when she received vaccine, EUA is for 18 years and older
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot # 670821/0744AA, expiration date 18-AUG-2012) on 22-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was not experiencing any known symptoms. It was unspecified if the patient had sought unspecified medical attention. Additional information has been requested.
rt eye watering, partial paralysis of face nerve rt side w/ptosis;rt corner of mouth not totally paralyzed;pred given;
pt recvd vax; 9:10am, itching & swelling at inject site; ice applied; dph given; pt monitered until 10:30am;
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 02-DEC-2009, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 665413/1128Y with expiry date of 07-AUG-2011. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Complained of increased fever of 103, abdominal cramps/pain, diarrhea, watery stools x3, Emesis x2 undigested food - Donor said she did not eat prior to donating - Donor received Tetanus Toxoid injection 0.5 mg - Donor state she went to ER about 12AM 11-16-2007 State she is okay Now.
numerous sz, aphasia, contusion, unresponsiveness treated w/acyclovir erythema for presumptive encephalitis;pt was intubated & sz activity cont through hosp;pt currently hosp day 7 w/relatively little change;
no ad; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no ad) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Mar-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no ad). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no ad) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no ad) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported. Patient received Moderna vaccine beyond the 30 day beyond use date. Beyond use date for lot was 17-Feb-2022 and patient received vaccine on 03-Mar-2022. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non Significant follow Up received; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 11-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 Lot # L037339, 0.5 ml - 10 Pk SD PFS, expiry date 09-FEB-2018; route of administration was not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to three separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.1 degrees Celsius), the second one lasting for 40 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius) and the third one lasting for 40 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.1 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. The patient had no known drug allergies and no illnesses at time of vaccination. On 19-OCT-2017, the patient was vaccinated with an expired dose of ZOSTAVAX vial, 19400 PFU, 1 dose, lot # M041510, expiration date: 27-JUL-2017, subcutaneously for prophylaxis. Concomitant therapies included FLUVIRIN lot# 172070, intramuscularly and sterile diluent (STERILE DILUENT) lot# M044953. No adverse effects were reported. A prescription drug treatment was not required. The medication error occurred at the time of administration.
Patient returned to clinic 30 minutes after vaccine administered. Facial swelling and redness noted. Wheezing with O2 Sat 91. Received nebulizer treatment with XOPENEX .63 and BENADRYL 12.5 mg. After treatment and within 15 min O2 Sat was 97% without wheeze and NAD. Allergist consulted.
Pt recvd vax 2-3 hrs following the vax & exp fatigue, flu-like sx w/o nausea, vomiting or achiness & a sore arm; sx resolved in 3 days;
Patient stated that she has a previous history of fainting when receiving vaccination, and was nervous to be vaccinated. Patient was seated but became pale, sweaty, and fainted for approximately 5 seconds after receiving the vaccination. Conversation was maintained with the patient through out the entire transaction. Pt was evaluated by emergency personnel, refused treatment, and went home to rest.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was not pregnant. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot # H014196; Expiration unspecified) (dose, route and injection site were not reported). On an unknown date the patient had a lump as well as a red area around the injection site. The outcome was unknown at the time of report. Action taken and causality were not provided. The patient had sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
History of terminal cancer, entered hospice care 1/2021,  expired 2/28/2021.  No reported adverse events from patient or family after receiving vaccine
"The patient contacted 5/4/21  pharmacy stating her arm was still sore from 2nd Pfizer vaccine given on 4/26/21.  She stated she saw NP 5/4/21 for soreness and was informed the shot was given too high in arm. We have left two messages with NP to discuss findings and she has not returned our call.
From telephone contact received at manufacturer on 6/10/02, it was reported by the nurse that a 20 month old female received Tripedia on 6/7/02. Patient seen in the emergency room on 6/9/02 and treated with IV antibiotics for diagnosis of cellulitis to the injection site (right thigh).
On May 31st I went to Medical Center. When I went there, I went to the ER, and they did a blood test because I had stomach pains from my stomach to my intestines back and forth. I was nauseated every morning I woke up. When they did the blood test, they found that my liver enzymes where higher for AST and ALP. They were higher than normal in the 500 range and the highest was 660. They also did a CT scan and ultrasound but didn't find anything. My liver and gallbladder were okay. I got discharged then I went to my PCP and had more blood test done. The results were slightly lower than what I had in the ER. My PCP referred me to a liver specialist. I was still experiencing stomach pains and nausea. I didn't experience and vomiting or diarrhea. The liver specialist did a test for EBV. They concluded that I did have EBV. In the meantime, I had an MRI, and the internal organs of my abdomen were good. My liver doctor may do a liver biopsy to see if my counts are still high and if something is still going on with my liver.
Within 24 hours post vax, the pt developed an injection site reaction characterized by erythema, induration, and swelling. She was seen by the physician who prescribed a Medrol Dosepak. This is one of two pts from this facility who developed an injection site reaction following receipt of vax.
Patient fainted shortly after being vaccinated and then had a seizure which lasted a few seconds. We called 911. While waiting for EMS, we kept patient seated and upright. Her mother made sure she stayed awake and was talking. Patient felt overheated and nauseous, and vomited into a trash bin we provided. We fanned her and also brought a plug-in fan to help cool her. When the EMS team arrived, they checked her vitals and stayed with her for about 10 minutes. After about an hour from the time patient got vaccinated, patient and her mother left.