chrisvoncsefalvay/vaers-outcomes huggingface dataset:
postherpetic neuralgia; shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Information about medical history, concurrent condition and concomitant medication was not reported. In or around May 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered shingles and post herpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events shingles and post herpetic neuralgia were not recovered. The lawyer considered shingles and post herpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).  The events shingles and post herpetic neuralgia were considered by the lawyer as disability.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient with a history of anemia and an unspecified reaction to COMPAZINE. On 04-JUN-2014, the patient was vaccinated with ZOSTAVAX via 19400 PFU, 0.65 ml subcutaneous injection on the left arm (lot number and expiration date not reported). On an unspecified date in June 2014, the patient contacted the pharmacist to report that her injection site where she received of ZOSTAVAX was red, swollen, and warm to the touch. The pharmacist does not know when the adverse effect was first experienced by the patient. The patient reported that she contacted her physician who prescribed Cephalexin, unspecified dose, for treatment of her injection site adverse effect. At the time of this report, the pharmacist reported that the patient's injection site was improving, and the patient stated that she was recovering. The pharmacist reported that the patient did not experience a rash at her injection site or anywhere else on her body. Additional information has been requested.
This spontaneous report as received from a nurse (also reported as a healthcare worker) refers to an unspecified patient born in 1992. The patient was vaccinated subcutaneously with first and second doses of 0.5 ml VARIVAX (Merck) (lot number, expiry date unspecified) on 11-JUN-2001 and 19-MAR-2013 respectively. The action taken of VARIVAX (Merck) and outcome were unknown. Additional information has been requested.
Information has been received from a registered nurse concerning a 11 month old patient who on unspecified date was vaccinated orally with the second 2.0 mL dose of ROTATEQ (Lot # 663711/0107Y). No adverse effect was reported. This is one of several cases from the same source. Additional information has been requested.
The next morning after the vaccination the patient woke up with an extremely painful arm, with redness and swelling of the entire upper left arm. Patient reported she had a low-grade fever, night  sweats, was nauseous, and had a metallic taste for 2 days after the immunization. The third day after immunization patient reported a headache and sweats. The fourth day patient just had night sweats. Patient reported to the pharmacy on the 5th day and is feeling better. Her upper left arm is still slightly swollen and red 5 days after immunization.
Patient was given KINRIX earlier date. Recommendation of age for vaccine is 4-6 years old. Spoke with manufacture GlaxoSmithKline Pharmacist stated that is a valid dose for patient. And does not need to be repeated.
Tired; Headache; His hands and feet are very cold and he was worried about circulation issues; His hands and feet are very cold and he was worried about circulation issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. The mother was reporting for her son.  A 28 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tired"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PERIPHERAL COLDNESS (non-serious), ANXIETY (non-serious), outcome "unknown" and all described as "His hands and feet are very cold and he was worried about circulation issues".  Additional Information: It was reported that had a second Pfizer shot yesterday and he was nearly tired and it was not a big problem. He was not too worried it was just headache usual symptoms but he called us because he was worried that his hands and feet are very cold and he was worried about circulation issues.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had foot pain in both feet, more so in the left foot before the vaccine. 12/23/2020 foot pain worsened and increased in the left foot. It?s worse when she walks. Monday, 12/28/2020 she went to see her PCP and was told that this is not related to the vaccine. She was diagnosed with tendinitis. EE stated that she also got an x-ray that was normal.
No additional AEs, no PQCs.; Medical Assistant called in to report a temperature excursion.  VAQTA was administered.; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-MAR-2023, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) 1 time dose, lot #W021491, expiration date: 14-DEC-2023, administered for prophylaxis (strength, dose, and route of administration were not provided) following a temperature excursion of 46.4 degrees Fahrenheit for 5 minutes (product storage error), it was stated that previous temperature excursion did occurred of 47.9 degrees Fahrenheit for 47 minutes. No additional adverse event was reported.
Patient was given a maroon top indicated for patients 6 months to <5 years. Patient should have received an orange top vaccine indicated for ages 5-<11 years. Contacted CDC for direction, they sent information regarding how to handle. Shared information with Dr, he advised to contact patient and inform them to have the correct vaccine dose administered ASAP. Patient's mother states she will contact the resource provided to her to schedule the vaccine.
Within minutes of receiving the Moderna booster, I got dizzy and my hands and arms began to tingle. At this point, my vitals were taken-- Temperature 97.2, Blood pressure 110/60, oxygen 99, heart rate 115, respiration 24. My hands became stiff and immovable (my fingers bent backwards and my thumbs pressed into my palms). My arms became stiff. My legs up to my knees began to tingle. My stomach began to tingle. After 45 minutes, my symptoms then quickly went away. I then felt a bit tired and shaken up. I went to the ER and they said I was fine (but they called it a vagal episode, which my primary doctor later said it definitely was not). My primary doctor said it sounded seizure-like. The symptoms did not return. That night, my back was unusually sore, like I had been carrying a very heavy backpack.
Extreme lethargy, body felt hot no fever, chills, joints pain, dizziness, large swelling of the left side lymph nodes from armpit to breast hard and painful at touch.
so dizzy I cannot walk in a straight line; so dizzy I cannot walk in a straight line; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (so dizzy I cannot walk in a straight line) and GAIT DISTURBANCE (so dizzy I cannot walk in a straight line) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 22-May-2021, the patient experienced DIZZINESS (so dizzy I cannot walk in a straight line). On an unknown date, the patient experienced GAIT DISTURBANCE (so dizzy I cannot walk in a straight line). At the time of the report, DIZZINESS (so dizzy I cannot walk in a straight line) and GAIT DISTURBANCE (so dizzy I cannot walk in a straight line) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown
Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chickenpox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information form the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 10 year old patient (Grade 03:5St) who on 11SEP1996 was vaccinated with a dose of varicella virus vaccine live. On 03DEC2002, the patient developed chickenpox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chickenpox post vaccination with varicella virus vaccine live were also identified. Additional information is not expected.
Fever 101.8 and broke out with rash that mother felt was chickenpox so took child to ER on 6-14-15-Dr felt insect bites but took child back to see NP on 6-16 et "bites" had white pustules et couple broke open-mother was told child does have chickenpox from Varicella vaccine told to alternate TYL et MOTRIN for fever et calamine for itching.
My uterus feels like it?s massive, I started my period exactly 2 weeks after the beginning of my last period (very early), and I?m experiencing much heavier bleeding than normal.
w/in 12 hrs p/immun on 3DEC90, pt exp fever of 104 & was treated w/APAP; following day had temp of 101-102; On 6DEC90 mom reported that pt was afebrile; No other rxn reported;
Sick; Missed the 6 month window; Administered it intramuscularly into her left thigh; This case was reported by a nurse via call center representative and described the occurrence of sickness in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number H4H34, expiry date 27th November 2021) and (batch number J3M5J, expiry date 6th February 2022) for prophylaxis. This case was associated with a product complaint.   Previously administered products included Zostavax (live shingles) injection and Shingrix with an associated reaction of product administered at inappropriate site (1st dose received on 29th February 2020 with batch number H4H34 and expiry date 27th November 2021 refer case US2020AMR206531).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced sickness, drug dose administration interval too long and vaccine administered at inappropriate site. On an unknown date, the outcome of the sickness, drug dose administration interval too long and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.   Additional information was provided as follows: The case was reported by patient herself who was a nurse. She said that she was very experienced.  She had been a nurse for 45 years and had given thousands of shots.  She bought the dose of Shingrix from the pharmacy and they allowed her to reconstitute and administer the injections at their home.  She stored the un-reconstituted vials in the refrigerator.  The pharmacy dispensed her two of the one dose combo packs and both had the same lot number and same expiration date.  She administered the Shingrix shot to herself about 2 weeks ago.  She did not remember the exact date because she said that both she had both been "sick" recently. Prior to reconstitution, when she was pulling the liquid adjuvant out of the vial into the syringe she said it leaked/sprayed all over the place.  She said that at the time you could see the hole where the needle had pierced the rubber stopper but you cannot see it anymore thus she will not be sending any pictures.  Because the first adjuvant vial leaked she used the second adjuvant vial instead and was able to draw it up with no problem and reconstitute it and administer it to herself.  She administered it intramuscularly into her left thigh which led to vaccine administered at inappropriate site The patient had missed the 6 month window which led to drug dose administration interval too long. The case also linked with US2020204764 same reporter. It was unknown if the reporter considered the sickness to be related to Shingrix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020204764:Husband's case
I began to notice I was feeling achy the next morning, around noon, I was beginning to experience pain in my joints across my body, muscle spasms in back and legs. A few days later the pain became worse and that is when I reached out to the telehealth doctor and they stated that it may be a strong immune response, no upper respiratory issues and I am continuing to experience these pains and symptoms, they stated to also get a COVID test, muscle spasms are still happening as well.
Disease recurrence; Treatment of COVID-19; Treatment of COVID-19; Dose 2, 1 are Pfizer vaccine and Dose 3 are Moderna vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 13Apr2021 as dose 2, single (Lot number: ER8729) at the age of 33 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Dec2021 as dose 3 (booster), single (Lot number: 013H21B), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CLARITIN ALLERGIC; LUTERA. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Dec2021, outcome "unknown", described as "Dose 2, 1 are Pfizer vaccine and Dose 3 are Moderna vaccine"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 05Nov2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: I rebounded with symptoms and tested positive a few days after finishing the Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. The patient received Paxlovid from 28Oct2022 to 02Nov2022 and she rebounded with symptoms and tested positive a few days after finishing the Paxlovid treatment on 05Nov2022; she was recovering.
the pt that I reported was +covid post moderna vaccine #1; This spontaneous case was reported by a nurse and describes the occurrence of SARS-COV-2 TEST POSITIVE (the pt that I reported was +covid post moderna vaccine #1) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (the pt that I reported was +covid post moderna vaccine #1). At the time of the report, SARS-COV-2 TEST POSITIVE (the pt that I reported was +covid post moderna vaccine #1) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) reported positive for covid post moderna vaccine..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug information provided. No concomitant drug information provided.    Reporter did not allow further contact
Information has been received from a medical assistant concerning a 52 year old female patient with asthma who on 13-DEC-2010 was vaccinated with a dose of PNUEMOVAX 23 (Lot # 667916/1066Z, expire date 12-MAR-2010), 0.5 ml, intramuscularly. Suspect vaccine included FLULAVAL (Lot #, expire date and route not reported). On 13-DEC-2010 right after receiving of PNEUMOVAX 23 the patient experienced swelling at the injection site. Patient was given the FLULAVAL shot in the same arm and after that the patient reported feeling dizzy, light headed and she was tremulous. The medical assistant stated that the patient had received the flu shot in the past without any negative effect. The medical assistant also stated that physician treated patient while in the office with BENADRYL and epinephrine. About one hour after the treatment patient was feeling better and the swelling at the injection site went away as well as the patient's complaints of feeling dizzy and lightheaded. The only thing patient stated prior to leaving the office that she felt sleepy. The medical assistant stated that might have been from BENADRYL. There were no laboratory diagnostics studies performed. Upon internal review patient's treatment with epinephrine was considered to be other important medical event. This is one of two reports from the same source. Additional information has been requested.
I know 4 other women with injuries ER8731 all neurological Bad Batch; I know 4 other women with injuries ER8731 all neurological Bad Batch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: ER8731) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), INJURY (non-serious), outcome "unknown" and all described as "I know 4 other women with injuries ER8731 all neurological Bad Batch".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200642426 same vaccine/reporter/AE, different patient
"Very itchy, red and swollen around site injection, another blister appeared near site. Given Cephalexin and Hydroxyzine on 26 May 08, Uregent Care."
Suspected vaccination failure; shingles anyway on my face; Still have a scar on my forehead; left eyebrow is strange looking; can't see so well with my left eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, scar, damaged eyebrows and abnormal vision. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the scar, damaged eyebrows and abnormal vision were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, scar, damaged eyebrows and abnormal vision to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for himself/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles on his/her face.  At the time of reporting, the patient still had a scar on his/her forehead, left eyebrow was strange looking and could not see so well with his/her left eye.  The patient was not willing to pay for removing the scar.  The patient stated that he/she was glad that he/she was married and not in the market. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for shingles were not provided.
patient had red rash around arms X 4 days came to clinic regarding that on 4/14/22. Prescribed  Tylenol.
Pfizer COVID-19 Vaccine EUA Patient received dose #1 of Pfizer COVID-19 vaccine on 7/26/2021. Within 30 minutes patient complained of itching, wheezing and swelling in throat. Patient was treated with diphenhydramine 50 mg, methylPREDNISolone 125 mg, Epinephrine 0.3 mg IM. Emergency response was called and patient was able to walk to stretcher and left facility without further incident.
Received Pfizer covid booster L Arm around 1015AM 2/12. Later same day around 8pm Left armpit became swollen and tender. When I woke up in morning armpit had severe lymphedema size of softball in armpit as well as tender swollen lymph nodes up my left neck/ jaw nodes.  Applied warm compress which did not help much and took Advil. Nodes did not go back to normal until today 2/17.
Approximately 2 hours after dose he felt flushed, nauseous and dizzy. At the time he was masked and gowned and gloved in a laboratory setting. He left the lab, removed his protective items, rested and ate. After 30 minutes, he felt little improvement. He went to the ER for treatment. In the ER he received IV fluids (NS) and Zofran IV for nausea. He left the ER approximately 2 1/2 hours later when his symptoms resolved. He returned to work for the balance of his shift and went home to sleep. His symptoms have not returned. He reports he ahs had intermittent nausea related to his medications in the past.