chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; incorrect product storage; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.  On 21-MAY-2017, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # S020241 (expiration date: 23-AUG-2020) for prophylaxis (no additional dosage regimen information was provided). No adverse event was provided.  The vaccine was exposed to a temperature of 12 Celsius degrees for a timeframe of 16 hours and 11 minutes. It was found because of a digital data logger. There were no previous excursions. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S020241; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: No; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Low grade fever 101-102; aches in bones and muscles all over body similar to the flu, low energy, headache, sweats at night. Lasted 4 days. Reported to nurse- advised to take Tylenol 1000mg TID and Benedryl if rash. Rash/redness appeared on left arm at site with itching.
Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (Insomnia). The patient was treated with TRAZODONE for Insomnia, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Insomnia) had not resolved.            No concomitant medication information was provided  Action taken with mRNA-1273 in response to the events was not applicable.       Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information received on 17-JUN-2021 contains no new information.
Shortness of breath,  weakness, unresponsiveness lasting about 1 minute, ambulance was called and he was taken to hospital and admitted.
Tingling, numbness and weakness in my lower extremities. This is occurring in both arms and legs. It lessened for about 2 days on July 24, 2021 but came back with the same intensity.
Swelling, redness, tenderness and lump formed at injection site. Redness approximately 1.5" in diameter. Per patient, swellling and redness has decreased since injection on 1/22/03.
Pt recvd vax & & w/in 24 hrs of vax pt had either an onset of or an inc in apnea & required supplemental 02 & stimulation;
Localized swelling; Flu Like Symptoms; Headache; Fugue like reaction for about 4 hours where she could not remember anything; This case was reported by a physician via call center representative and described the occurrence of swelling in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced swelling, influenza-like symptoms, headache and fugue state. On an unknown date, the outcome of the swelling, influenza-like symptoms, headache and fugue state were recovered/resolved.   It was unknown if the reporter considered the swelling, influenza-like symptoms, headache and fugue state to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 77 or 78 years. The patient received her first dose of Shingrix about 3 weeks ago at pharmacy.  The patient experienced localized swelling, flu like symptoms, headache and fugue like reaction for about 4 hours where she could not remember anything.  The patient recovered from everything within 24 hours, except the swelling which was almost gone. No further details were provided. The reporter gave permission to follow up.
It looked like a huge hive 2 x 3 1/2 inches. It was red and hot and lasted 5 days. (It was on the injection site).
Fever of 103, Mental Confusion and unresponsiveness, Incontinence, extreme lethargy
Information was received from a Medical Assistant regarding a female patient of unknown age who inadvertently was administered one expired dose of (MMRII) injection (lot L024264, exp. 01-JUL-2017) which was reconstituted with sterile diluent (lot # M019490, exp. 09-OCT-2018). Concomitant medication, medical history and concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
Cardiopulmonary arrest at home @ 1 hour after vaccine administration. CPR by EMS to today hospital for asystolic cardiac arrest. Pt. Intubated then terminally extubated
Started 6/8/23 with 100.3 temperature, fussiness, and decreased appetite. Seen in ER 6/8/23 where developed recurrent vomiting. Had IV rehydration and labs which were reassuring per ER provider. Family elected to leave after reassuring labs completed. Returned to ER 6/10/23 with complaints of continued vomiting and refusing bottle. Mom reported he was interested in eating but was vomiting after every feeding. Had US positive for intussusception. Attempted air enema without success and was admitted to surgical services. Attempted laparoscopic repair but also unsuccessful and needed open laparotomy for manual reduction of ileocolonic intussusception and ileocecectomy.  All bowel viable. No perforation. Antimesenteric wall mass removed and sent for pathology.
Information has been received from a physician assistant concerning a 24 year old female who on 16-APR-2007 was vaccinated IM with 0.5 ml of the second dose of Gardasil (Lot #657617/0384U). On 16-APR-2007 the patient received the vaccine but the needle hit the bone in her upper arm an she has has soreness and pain in the site since then. The patient did not have any adverse symptoms after the first dose. Medical attention was sought. Additional information has been requested.
Confusion; Severe and continuing headache;  Unusual and continuing sleepiness; Unusual tiredness, weakness (sudden and severe); Severe and continuing vomiting; Moderate pain at injection site; Chills; Body aches
Patient reported to facility with 5 1/2 cm x 8cm reddened and indurated area on left deltoid are. Area was warm to touch and patient reported feeling a "knot" in shot arm on 1/8/09. Knot is now dissipated at time of this being filled out.
Patient fainted after getting the TDAP and HPV vaccines. She came to very quickly and was checked by a provider before leaving the clinic. Vitals were stable and patient was given juice and crackers.
At site of injection and spreading was a red, raised area that was hot to touch. Also had a knot. Started day after vaccine ws given.
This case was reported by a healthcare professional and described the occurrence of rash in a 65-year-old male subject who was vaccinated with ENGERIX B pediatric, GlaxoSmithKline), IPV (non-gsk) and Hib (non-gsk). The subject's medical history included stem cell transplant. Concurrent medications included Doxazosin and Albuterol. On 9 June 2014, the subject received 2 doses of ENGERIX B pediatric (route unknown, right arm), 2nd dose of IPV (Non-GSK) (unknown) and 2nd dose of Hib (Non-GSK) (unknown). The administration of 2 doses of ENGERIX B pediatric instead of 1 dose of ENGERIX B adult let to a wrong technique in drug usage process. On 9 June 2014, 3 days after vaccination with ENGERIX B pediatric, Hib (Non-GSK) and IPV (Non-GSK), the subject experienced rash all over his arms and legs. At the time of reporting, rash was unresolved. This case is linked to a pharmaceutical product complaint. Follow-up information received on 25 July 2014: Considering safety evaluation, it is unlikely that the reported events are related to a manufacturing problem. No further manufacturing investigation is required for the time being. GlaxoSmithKline Biologicals considers this complaint as unsubstantiated. Follow-up information received on 19 August 2014: On 20 June 2014, rash was resolved.
Large, red, hard, swollen area around shot site the next day - then 2 days later I broke out with chicken pox pustules on the side of my body where I had shingles earlier.
dad phoned office, suspected chicken pox & told NTBS;dx w/varicella in office & zovirax prescribed;
Patient received 12+ Pfizer monovalent COVID-19 vaccine dose instead of the authorized for their age 5-11 years Pfizer monovalent COVID-19 vaccine dose.  Parent notified via letter on 3/15/2023.
Patient reported having pain in the right arm, right wrist and right hand.  She complains of swelling in the vein in her right wrist,  and swelling in her right hand.  She showed me the swelling in her vein and right hand.
Rash on upper chest and breast.  No itching.  Onset 3-20-08.
Fatigue; Aches; This case was reported by a physician via call center representative and described the occurrence of fatigue in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th June 2019, the patient received the 1st dose of Shingrix. On 7th June 2019, 1 days after receiving Shingrix, the patient experienced fatigue and pain. On 8th June 2019, the outcome of the fatigue and pain were recovered/resolved.   It was unknown if the reporter considered the fatigue and pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The doctor called in to inquire that how to proceed with 2nd dose. The patient experienced fatigue and aches the following day after dose of Shingrix. The healthcare professional stated side effects lasted one day.
On the 4th day after my booster I had a flair up of herpetic kerititis in my left eye.  Had not had a flair up for approx 18months until this flair up.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Approximately 10-12mins after the J&J shot was administered, the patient got our attention to let us know he wasn't feeling well and might faint. I quickly tended to him as he slowly passed out. I craddled his head to make sure he did not hit it on the countertop. Pateint was seated. After approximately 30 second the patient started to come to. We gave him some water, took his bp, had him wait 30mins and took his bp again before he left with his wife.
mom stated a few days ago pt felt tired for approx 3 wk following vax;this was not reported until then even though the nurse checked the students @ school for several days following vax;? true reaction
Patient is experiencing discomfort; Aches around her body / she is just achy; Slight headache; Fever; Chills with aches; Could not sleep; Having flu like symptoms; Feels like crap; This case was reported by a consumer via and described the occurrence of discomfort in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 13th January 2021, less than a day after receiving Shingrix, the patient experienced discomfort, general body pain, headache, fever, chills and insomnia. In January 2021, the patient experienced influenza-like symptoms and feeling unwell. On an unknown date, the outcome of the discomfort, general body pain, headache, fever, influenza-like symptoms and feeling unwell were not recovered/not resolved and the outcome of the chills was recovering/resolving and the outcome of the insomnia was unknown.   It was unknown if the reporter considered the discomfort, general body pain, headache, fever, chills, insomnia, influenza-like symptoms and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient had received the second dose of Shingrix and she was experiencing discomfort which included aches around her body, slight headache and fever which started on the night of before reporting date. The patient also had chills on the night of before reporting date with aches and she could not sleep. The chills were better on the day of reporting but she was just achy at the time of reporting. She described it as having flu like symptoms and she felt like crap.  The reporter consented to follow-up.
Information has been received from a physician concerning a 12-year-old white male with no pre-existing allergies, birth defects or medical conditions, who on 26-OCT-1995 was vaccinated with a dose of Varivax. On 07-OCT-2006 the patient developed papules, vesicles and crusted lesions on his trunk, neck and arms. he was diagnosed with chickenpox. No outcome information was reported. Follow-up information indicated that the patient recovered on an unspecified date. No further information is expected.
CDC reports 6 yo child developed local rxn at inject site which lasted 4 days.
sore arms; fever; body aches/pain; sore throat; diarrhea; This is a spontaneous report from a contactable consumer (patient) via a medical information team. A male patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that during the first dose of BNT162B2, the patient experienced sore arms, fever, body aches, pain, sore throat, and diarrhea. The patient has tested negative for COVID on unspecified date. The patient stated, "Can I use Benadryl after getting vaccinated?" The outcome of the events was unknown.  Information on the lot/batch number has been requested.
inflammation; extreme pain; headaches; This is a spontaneous report from a contactable consumer (patient) received from a Xelsoure. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as dose 1, single for covid-19 immunisation; tofacitinib citrate (XELJANZ), via an unspecified route of administration from an unspecified date (Lot number was not reported) to an unspecified date, at 5 mg tablets for an unspecified indication. Medical history included blood pressure - also taking a medication for blood pressure. On an unspecified date Apr2021, after the shot of vaccine the patient experienced inflammation and extreme pain. so, patient did go off of it for a while so she have some extra pills and also experienced headache so her doctor also told her to go off. The patient off it for about a week or also been monitoring her blood pressure. The doctor also put her on a diuretic for having to go to the bathroom a lot. She just started taking it, but she hasn't noticed much of a difference. She also taking a medication for blood pressure and what her doctor said was a water pill, and she had noticed that it has raised her blood sugar up a bit so she also watching that. The patient underwent lab tests and procedures which included blood sugar Level: raised- raised her blood sugar up a bit , blood pressure measurement: unknown -Monitoring blood pressure. Therapeutic measures were taken as a result of events. Outcome of events was unknown.   Information on Lot/Batch information has been requested
Raised red patch at injection sight. Very warm to touch and itchy. By 7:30am on 3/22/21 site become more red and inflamed and itchy. By noon on 3/22/21 redness and swelling has gone down but still very itchy.
pt recv vax; welts mostly on face; few on extremities;welts came back & went away for 3-4 days; improved w/ dph & now have completely subsided;
Patient said after vaccine was given that night, "My arm was swollen, hard, red, hot, and itchy at the vaccination site. I could not move my arm for 4 days and my arm felt very weak."
Technician called 2/25 to schedule 2nd Moderna dose when patient stated that she had a reaction a day after receiving the vaccination:  unspecified pain (pain scale 9) around rib cage (breast line to waist) - saw urgent care as well as PCP and was prescribed Diclofenac tabs, muscle relaxer. Patient also takes Tylenol and intermittent Motrin - does not seem to help. I advised the patient to return to PCP for further clinical evaluation. Patient stated she is unable to work since 2/17/2021
Received vaccine on Wed 1/6/21. Eyelid swelling, redness, itchiness noted on Thursday 1/7/21 at 7:00am
From initial information received on 17Sep04 from a RN regarding an adverse event occurring, it was reported that a one year old male pt received an Acthib vaccination, lot UE424AA, administered IM in the left thigh and an Ipol vaccination lot X1189, administered SC in the left arm on 10Sep04. Five days later on 15Sep04, the pt developed a temp ranging from 102.7 to 103.1 degrees F, slight congestion and shallow breathing. On 17Sep04 the pt's fever was 100 degrees F and he had a decreased appetite. The pt's recovery status was not reported. The reporter of this case is the same reporter as case 2004-03064. Follow up - From additional information from a registered nurse, it was reported that the patient had one previous dose of ACTHIB and two previous doses of IPOL. He was treated with TYLENOL and MOTRIN for his fever during this event. The patient was seen for rosacea by the physician on 16/Sep/2004. At the time of this report, the patient has recovered from these events. No further information is anticipated, this case is considered closed.
awakened the morning of 12SEP94 w/a rash on face, arms, trunk; t99 & sl sore throat;
Severe joint pain of hands, fingers, feet and toes. Unable to hold even a glass of water or drive.
Fever of 101 degrees; Mild pain at injection site; Muscle pain (legs); This is a spontaneous report from a contactable consumer (patient). A non-pregnant 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCCINE; Lot Number: EN6199), via an unspecified route of administration in left arm, on 24Mar2021 at 16:45 (04:45 PM), at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took cefalexin (CEPHALEXIN) as antibiotic and experienced allergies; and the first dose of BNT162B2 (Lot Number: EN6205) on 03Mar2021 at 05:00 PM in left arm for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Mar2021 at 02:45 AM approximately 10 hours after shot, the patient experienced mild pain at injection site and muscle pain (legs) (also reported as on 24Mar2021 at 22:00) that were increasing until approximately 30 hours after shot. On 25Mar2021 at 10:45 PM approximately 18 hours after shot, the patient had fever of 101 degrees (also reported as on 24Mar2021 at 22:00). All reactions cleared by 36 hours after shot. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 26Mar2021 at 04:45 AM.
acute onset left sided hemiplegia,  new opacification--may represent increasing pleural effusion, consolidation, and/or atelectasis, decreased lung volumes.
My second pfizer vaccine was administered to me on Monday October 11th.  On Wednesday October 13th I started to notice vision impairment issues with my right eye which got progressively and noticeably worse on Friday October 15th.  The vision in my right eye seems to be deteriorating - noticeable vision loss compared to my left eye.  My right eye is extremely blurry and has a yellowish tint.
PATIENT HAD COVID-19 VACCINE DOSE, Dose 1 date: 12/29/ 2020,  Dose 2 date: 01/19/2021, AND TESTED POSITIVE TO COVID.
No additional AEs; temperature excursion; Inappropriate age at vaccine administration; This spontaneous report was received from a registered nurse and refers to a 19 weeks old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 06-DEC-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892790, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7205AA, expiration date: 23-OCT-2024, administered intramuscularly for prophylaxis (strength and dose were not provided); and pneumococcal vaccine conj (PCV 13) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (strength, dose, formulation, and indication were not provided) (product storage error, product administered to patient of inappropriate age).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA007828:Same Reporter US-009507513-2212USA007829:Same Reporter US-009507513-2212USA007830:Same Reporter US-009507513-2212USA007831:Same Reporter US-009507513-2212USA007838:Same Reporter US-009507513-2212USA007833:Same Reporter US-009507513-2212USA007834:Same Reporter US-009507513-2212USA007835:Same Reporter US-009507513-2212USA007836:Same Reporter US-009507513-2212USA007837:Same Reporter
Patient was given Hep A 1st, then HPV. After HPV was administered pt tensed up and began to loose her color, she then began to lean backwards and started to have a seizure. Seizure only lasted for 10 seconds. Vasovagal Syncope.
Transient Global Amnesia along withHeadache, Nausea, Vomiting, Fever, chills, Arm soreness
Progressive lower extremity weakness with markedly diminished reflex: Per the history it appears that patient has had a progressive course of this problem over the last 1 week.  His symptomatology is mostly consistent with gait ataxia with some lower extremity weakness.  He mentions that his weakness of the lower extremities became more and more pronounced towards the end of the week when he would start trembling in his legs whenever standing for some time.  Although he had some numbness and tingling few days ago but that does not seem to be the predominant symptoms.  There was no preceding symptoms of any viremia prior to this.  Although he has Covid in January, however he did not have cough expectorations upper respiratory infection or any diarrhea in the last 1 month.  He has not been exposed to any new pets or any new medications.  His clinical exam suggest a lower extremity weakness more proximal than distal although there appears to be some sensory sparing.  He has diminished reflexes all over including absent reflexes in his lower extremities and many of the upper extremities.  His imaging study did not show any specific etiology for the cause of his problem.  He does not have any spinal etiology and his exam does not show any upper motor type of involvement.  His spinal fluid shows a high protein with no cells consistent with cytoalbuminogenic dissociation.  So he definitely fits with the diagnosis of acute immune mediated demyelinating polyneuropathy or Guillain-Barré syndrome.  On IVIG therapy.  Overall appears to be some improved however not still able to walk.