chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received from a consumer on 12 November 2013. The reporter who is also the patient reported another event which is captured in case # 2013SA117468. A 70 year old patient was vaccinated with Td vaccine at her doctor's office in 1999, date, manufacturer, route and site not reported. The patient experienced lightheadedness and passed out approximately 15 minutes after vaccination. The patient had a history of receiving Td vaccination in 1965, 1969 and 1985 and also passed out after these vaccinations. The patient reported having the same reaction after having had polio vaccines in 1956, 1957 and 1962. The patient reported having YF-VAX, date not reported and passed out after vaccination. The patient's medical history and concomitant medications were not reported. Treatment details were not reported. The patient recovered on an unreported date. Further details were not available at the time of this report. Documents held by sender: None.
sore at the site of injection; AST elevated; ALT elevated; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2021, the patient received the 1st dose of Shingrix (intramuscular). In October 2021, less than a week after receiving Shingrix, the patient experienced injection site pain, aspartate aminotransferase increased and alanine aminotransferase increased. On an unknown date, the outcome of the injection site pain, aspartate aminotransferase increased and alanine aminotransferase increased were unknown.   It was unknown if the reporter considered the injection site pain, aspartate aminotransferase increased and alanine aminotransferase increased to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced her arm was sore at the site of injection. The reporter also reported that her AST (Aspartate aminotransferase) (58 units per liter of serum) and ALT (Alanine aminotransferase) (78 units per liter of serum) lab values were elevated after receiving the first dose of Shingrix. The reporter consented the follow up.
cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 35 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold".  Additional information: Patient was scheduled to get a second dose of PFIZER-BIONTECH COVID-19 VACCINE tomorrow reported that he had cold. If patient will not get second dose tomorrow, when can patient get it?. Patient was asking, can second dose be administered later than 3 weeks?.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complained of shortness of breath/tightness in chest.  3 RNs present to assess and evaluate with epilepsy-pen on hand to administer as necessary.  Patient has not had any reactions to any previous vaccinations.  Upon assessment, the patient was alert & oriented and was responding to questions.  Patient was not tachycardia nor did she have any tachypnea with heart rate @ 86, RR @ 18, SPO2 @ 99%.  Breath sounds were reported to be CTA bilaterally (conducted by RN & director of clinical operations).  Patient's legs were evaluated, cold compress applied to back of neck, & she was instructed to take slow, deep breaths (in through nose, out through mouth to prevent hyperventilation).  Patient remained conscious, alert, and responsive entire time.  EMSA/emergency response arrived at 1200 to evaluate.  Care relinquished at that time.
COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.   There are 22 patients who received the COVID vaccination during this time frame.  The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Information has been received from a registered nurse concerning a male who on 04-JUN-2011 was vaccinated with a second dose of VARIVAX (Merck) (Lot#664451/0693Y, route not reported) that expired on 15-MAY-2011. No adverse effects reported. Follow up information was received which reported that the 25 year old male patient on 04-JUN-2011 was vaccinated with the first dose (previously reported as second dose) of VARIVAX (Merck), intramuscular in the deltoid. It was reported that the patient did not seek medical attention. This is one of several reports received from the same source. Addition information has been requested.
?MAY92 pt recvd Engerix-B immed exp an allergic reaction p/the inject described as a severe swelling @ inject site;
Swelling left side lower back rib area swollen and reddish from the next day the first days with difficulty when urinating these symptoms have passed but that inflamed area still continues.
blisters on different areas- arms, legs, chest and some on his back/get blisters all over his body; Has dry skin; Skin is itchy but not sure if its from the blisters; chest is the worst part of it and he has bad scars left from them; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that,  A 85-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0172) (at the age of 85 years old), dose 2 via an unspecified route of administration, administered in arm left on 04May2021 as dose 2, single for covid-19 immunisation (age at the vaccination 85-years-old). Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EB8737), dose 1 via an unspecified route of administration administered in arm left, on 04Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient's first dose was on 04Apr2021, and he developed blisters on his chest that lasted for a month and did not resolve before receiving the second dose. He received his second shot on 04May2021. On an unspecified date in May 2021, he had blisters on different areas arms, legs, chest and some on his back. His chest was the worst part of it and he had bad scars left from them. Some were berry small and some were quite large, smaller than a penny about half an inch by quarter inch. The small ones were like a ball point pen. He had dry skin and tried to keep lotion on them. Skin was itchy but not sure if it was from the blisters. He also had one blister on his arm and one on his leg. He has burst some, but he saw his doctor told him not to burst anymore and was prescribed some cream that he still had to pick up from the pharmacy. He saw his family doctor and he couldn't find any reason why they would be developing. Treatment for the events was received. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. There was no prior vaccination within four weeks. The relevant tests were reported. The outcome for the events were unknown.  No follow-up attempts are needed. No further information is expected.
Extreme tiredness; nausea; headache; injection soreness; This is a spontaneous report from a contactable consumer (patient herself). via an unspecified route of administration, administered in left arm on 05Mar2021 12:30 (age at vaccination: 61 years) as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 05Mar2021 15:30, the patient experienced extreme tiredness, nausea, headache, and injection soreness. The patient had no other vaccine in four weeks. The patient did not receive any treatment for the adverse events. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
1st Covid shot- hives, swollen lips 2nd Covid shot -took allergy meds beforehand as prescribed.  Fatigued but no other symptoms. 1st booster - took allergy meds beforehand as prescribed.  Fatigued but no other symptoms 2nd booster - took allergy meds shortly beforehand.  Eye lid developed large lump that did not go away despite hot compresses, showers.  Friend shared article on adverse effects to eye.  I saw opthalomologist who prescribed Eysuvis & Tobradex & continues to monitor.
Low heart rate 38-45 consistently for 48hrs; Couldn't stand for long periods both days; Fatigue with dizziness; Fatigue with dizziness; Nausea; Vomiting; Cold extremities; Low Blood pressure; This is a spontaneous report from a contactable (patient). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Aug2021 16:30 (at the age of 14-year-old) (Lot Number: FD8448) as dose 1, single for COVID-19 immunization. Medical history included murmur as a toddler with irregular HR. There were no concomitant medications. The patient previously took cefalexin monohydrate (KEFLEX) and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks of COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced fatigue with dizziness, nausea, vomiting and low heart rate 38-45 consistently for 48hrs, cold extremities, low Blood pressure, couldn't stand for long periods both days. The onset of events was reported as 19Aug2021 19:00. The patient did not receive treatment for the events. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Rash, UrticariaPruritus, Lichen Planus Narrative:  Employee has scarring and ongoing rash from lichen planus which he and his dermatologist attribute to vaccine.
First shot I had pain i my arm, mild swelling and the site was itchy. 2nd shot I got ?covid arm? and the site was extremely swollen, and itchy.
started w/nasal congestion; pressure/pain face; laryngitis; cough-non productive; dec grade temp/chills; dx sinusitis pharyngitis;
4 weeks prior to admission-patient-received varicella vaccine booster dose, developed mild respiratory symptoms about 2 weeks later, about one week patient developed small bumps on face, started zithromax 2 days patient, admitted 11/08/2007 with respiratory tract symptoms, high fever, decreased oral intake, sore mouth, dehydration and cough. Dermatology consultation; multiple discrete and some confluent erythematous targetoid macules, 1-1.5 cm in size, many with central bullae, most prominent on face and trunk, mucous membrane involvement of the eye, genitalia and mouth with prominent labial and intraoral erosions. Dx Steven Johnson syndrome, ID consultation Dx: Vaccine- associated varicella, erythema multiforme ophthalmology consultation: minimal ocular manifestation of questionable Steven-Johnson syndrome vs post varicellar booster. TX: pt rec'd Acyclovir, Rocephin, IVIG, hydration, steroids iv, steroid eye drops and artificial tears, pain medication, transferred to burn unit at hospital.  01/08/2008 MR received for DOS 11/8-12/2007 with Transfer DX:  Stevens-Johnson syndrome of unknown etiology.  Pt presented to ER with hx of cough (on and off) x 2 weeks, rash, vomiting and fever x 2 days. Pt initially dxd with bronchitis and given Zithromax. However pt continued to develop high fever, aches, sore throat and decreased appetite. Consults by ID, Ophthalmology, and Dermatology.  PE by ID (+) for fever with sinus tachycardia, glassy eyes, injected conjunctivae, parched lips, sloughing of oral mucosa, scattered vessicles in various stages on the body. Ophth for ocular involvement and photophobia.  Derm noted erythema multiforme like rash. TXd with abx, acyclovir, steroids, and then IVIg. Transferred to higher level of care. Lot # obtained from Tag-2 report and updated in database. 03/12/2008 D/C summary received from transfer facility for DOS 11/12-19/2007 with DX: Erythema multiforme major.  Stevens-Johnson syndrome. Per 60 day follow up: Status unknown, pt was transfered to hospital.
Initial just a small area of redness and swelling the day after injection, followed by increasing redness and itching and swelling.
Lethargy; Muscle and Joint Pain; Muscle and Joint Pain; random Tremors; This is a spontaneous report received from a contactable consumer (patient). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 31Jan2021 10:45, at single dose, for COVID-19 immunization. Medical history included HIV undetectable. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient has no allergies to medications, food, or other products. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY); clonazepam; divalproex sodium (DIVALPROEX SODIUM ER); and lurasidone hydrochloride (LATUDA). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 01Feb2021, the patient experienced lethargy, muscle and joint pain, and random tremors. No treatment was given for the events. The patient underwent lab test which included Blood HIV RNA on an unspecified date with result HIV undetectable. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
I made sure to stay very hydrated before and after my vaccine and took an extra strength Tylenol right after. That evening I was tired and had a bit of a fever, but felt fine.  The following days were fine, except I was under a lot of stress at work and on the 3rd day I flew to  for a Bachelorette party weekend where I drank alcohol and stayed out a little later than usual. I get fine however. On the 5th day we spent it drinking on a boat and after leaving the boat exhaustion and the vertigo of being on a boat never left. I?ve been feeling this way since May 15 and it is now June 4. I?ve seen an ENT that thought it might be allergy related so I was tested for that, but I?m fine. I?m awaiting a full panel of blood test results from my Functional Doctor. Rest, relaxation haven?t helped. I?ve had brain fog, exhaustion and vertigo for almost 3 weeks now.
My head is burning up with a fever while my arms and legs are freezing and getting chills. Soft and green colored stool. Joints are stiff and sore. Arm where the injection was administered hurt and bruised.
Had the shot Saturday 6:00 pm 9/7/13. Had fever of 99.5 and 99.7 with a flush face some redness on Sunday 9/8/13 Monday a little redness on face but body and arms ached all day woke up Tuesday 9/10/11 with a rash on arms, shoulders, legs no fever woke up today Wednesday 9/11/13 with rash all over, chest, back, arms, legs, no fever. Went to doctor at 9:30 AM this morning. They told me to take ZYRTEC and see tomorrow how rash is.
Information has been received from a medical assistant referring to a 16 months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to an adult patient of unknown gender. On 03-NOV-2015, the patient was vaccinated with two doses of pediatric/adolescent formulation of RECOMBIVAX HB 5mcg/0.5ml, lot # H012250, expiration date 06-FEB-2015, intramuscularly to get the appropriate dosage for an adult, however, these two doses of RECOMBIVAX HB were both expired. This was the first dose in the RECOMBIVAX HB series this patient has been administered. No adverse effect was reported. Additional information has been requested.
2 years and 6 months old male patient who inadvertently received a dose of Quadracel with no adverse event; 2 years and 6 months old male patient who inadvertently received a dose of Quadracel with no adverse event; Initial information received on 18-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years and 6 months old male patient who inadvertently received a dose of diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel] with no adverse event.     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine for Prophylactic vaccination.  On 06-Apr-2022, the patient received a dose of 0.5 ml total of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/IPV (MRC5) Vaccine (lot C5916AA expiry date: 06-Jul-2023 Strength: standard Frequency = once) via intramuscular route in the right thigh for immunization.   On 06-Apr-2022 patient inadvertently received a dose of Quadracel with no adverse event (product administered to patient of inappropriate age) and (product prescribing error) (Latency: same day).  Action taken was not applicable.  Outcome was Unknown for all the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
vaccinated for shingles and has had it for 20 weeks/suspected vaccination failure; He has been miserable; vaccinated for shingles and has had it for 20 weeks; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: vaccinated for shingles and has had it for 20 weeks/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: vaccinated for shingles and has had it for 20 weeks) and feeling miserable (Verbatim: He has been miserable).  The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 20 weeks) and the outcome of the feeling miserable was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 The case was received from the patient via interactive digital media. The reported stated his/her friend had shingles for 20 weeks even after administration of shingles vaccine. The patient was miserable. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
On the 20th, had significant nausea that improved with zofran, and on the 21st, my ears started burning and when I looked in the mirror saw that they were extremely red, and then saw that my neck was red, pulled my long sleeves up and noticed a rash forming and within 5 minutes had a full blown body rash and redness;  I was given a Benadryl and then I drove to the Urgent Care Clinic and was treated with Dexamethasone, and a Pepcid which resolved the rash within 20 minutes .
16AUG96 Td given;6SEP96 evening c/o deep aching pain & heaviness of both arms;12SEP96 sx cont;relieved w/APAP;
Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: was laid down and legs elavated once calmed down, ems were called and further treated by them
Blood sugar dropped minutes after the shot. It did balance itself out after a day. I got a cough after the shot which continued for about four days of bronchial cough
Pt presented to Peds on 8/15/04 with local reaction on right deltoid with red, indurated area 4cm x 5 cm. Doctor documented pt had a local reaction to DTAP and gave pt prescription for Keflex 250 mg. po. tid. x 7 days for cellulitis. This was reported on 8/16/04.
Large blotchy area of redness; Swelling; General tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Large blotchy area of redness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (General tenderness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Large blotchy area of redness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (General tenderness). On 17-Jan-2021, VACCINATION SITE ERYTHEMA (Large blotchy area of redness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (General tenderness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
States today after receiving shot yesterday that her arm is red, hot to touch, and itches.  Notes some swelling on left side next to site.
This spontaneous report as received from a registered nurse refers to a currently 1 year old male patient. The patient had no pertinent medical history. On 11-APR-2014, the patient received the first dose of LIQUID PEDVAXHIB and a second dose on 31-JUL-2014 (lot #J010382 and expiry 28-MAY-2016; dose, route not provided). There were no concomitant medications. On an unspecified date in 2014 (reported as "since November 2014 or December 2014"), the patient experienced MRSA in one of his ear. The patient seek medical attention and saw a doctor. The patient was on unspecified antibiotics for a couple of months, which had been given as treatment. At the time of the report the patient was still fighting with the ear infection. Relatedness between the event and suspect vaccine was not specified. Additional information has been requested.