chrisvoncsefalvay/vaers-outcomes huggingface dataset:
almost fainted; 102 temperature,; missed 3 days of work; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, activities of daily living impaired and felt faint. On an unknown date, the outcome of the fever and activities of daily living impaired were recovered/resolved and the outcome of the felt faint was unknown.   It was unknown if the reporter considered the fever, activities of daily living impaired and felt faint to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that got first vaccine and ran 102 degree Fahrenheit temperature for 2 days. The patient missed 3 days of work and almost fainted 2 times. The patient went back to work and asked should he/she get the follow up dose.
No adverse effects reported; 8/15/2019, one male patient was administered improperly stored VARIVAX; 8/15/2019, one male patient was administered improperly stored VARIVAX; This spontaneous report was received from a Medical Assistant and refers to a 16 year old male patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 15-AUG-2019, the patient was administered improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S003448 with expiration date of 04-FEB-2021, for prophylaxis (route and frequency were not reported). The varicella virus vaccine live (oka/merck) (VARIVAX) dose was reconstituted with properly stored sterile diluent (DILUENT MRK) (lot R022280 with expiration date of 06-OCT-2019). No adverse effects reported.       It was stated that the vaccine underwent a temperature excursion of 6°F (degrees Fahrenheit) to 14°F (14 F) for 15 minutes and 15°F to 46°F(29 F) for 1 hour; 32°F to 35°F (34.68) for 6 hours. No previous temperature excursion was done. The call was because of a "data logger".
Patient reported reaction to Zostavax.  Vaccination given Monday AM.  Tuesday AM wok with headache that was resolved temporarily with Tylenol.  After continued dosing, headache continued to get worse, to the point that member went to ER Tuesday night with severe headache pain.  ER concluded headache was due to a reaction to the Zostavax, as all tests ran came back unremarkable.  Sent patient home with instructions to alternate Tylenol and Ibuprofen every four hours.  As of Friday, patient still having headache issues and spouse contacted pharmacy to report the adverse reaction.  Reaction will be reported to Dept of Health and Human Services utilizing the VAERS on line reporting system.
Patient received smallpox vaccine 10/10/06. Vaccine site read 10/17 - major reaction. Reported to clinic 10/20with body aches, axillary and supraclavicular LA, afebrile, pustule draining moderate amounts clear fluid, 2" surrounding erythema with streaking pattern toward anterior axilla. 12x with Levaquin 750mg x5. Follow up visit 10/23/06, cellulitis resolved, no LA, afebrile.
Patient given a Td along with a Tdap. Patient asymptomatic. Physician, patient, and parent notified.
At first I felt dizzy and for a few hours later my heart was racing on April 10. Yesterday, April 18, the injection site started to hurt again and feel hot. There is now a red hot rash over it.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "known allergies: Sunflower seeds" (unspecified if ongoing); "known allergies: nectarines" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (06Jan2023) Positive, notes: Rebound positive test after return of symptoms 5 days after end of paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This case was reported by a physician and described the occurrence of HEPATITIS B surface antigen positive in an adult female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Previous and/or concurrent vaccination included ENGERIX B; (GlaxoSmithKline); unknown; unknown given on an unspecified date.  In November 2007, the subject received 2nd dose of ENGERIX B (20 mcg, unknown).  In November 2007, 1 day after vaccination with ENGERIX B, the subject gave blood and experienced HEPATITIS B surface antigen positive.  At the time of reporting the outcome of the event was unspecified.
Patient reported itchy throat that seemed like it was closing.  Given epi pen. In ED, given solumedrol and pepcid.  Monitored for >3 hours and discharged to home with an additional epi pen as needed.
Callers done with the first dose 3 weeks ago next schedule will be on 16Feb; infection of the nose; Steroids for the sinus; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number unknown), via an unspecified route of administration in Jan2021 as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was done with the first dose 3 weeks ago; next schedule would be on 16Feb2021. On 02Feb2021, patient had infection of the nose and sinus. The reporter started to take treatment last Tuesday, Levaquin for the infection of the nose and Steroids for the sinus. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:40 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 51.46 No concomitant medications were reported. On 03-Apr-2021 at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and vial was initially moved to the fridge on 30-Mar-2021 and beyond use date was 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was stored on cooler 1, on 03-Apr-2021, Excursion duration At 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a  traceable temperature monitor at every hour. No treatment medications were reported.
The patient noticed a rash and mild pain at the injection site at approximately 9:00pm on 4/30/18.  Approximately 24 hours after the vaccination (5/1/18 at 3:00pm) the patient experienced nausea, sweating, and felt feverish. He did not record his temperature. He observed that the rash looked larger and felt warm to the touch. The patient took ibuprofen 200mg and acetaminophen 500mg over the counter for the next few days and continued to experience the rash, intermittent pain, nausea, and feverish feeling in the evenings. The patient called the pharmacy on 5/3/18 to report his side effects and the pharmacist suggested that he also apply an ice pack and follow up with his physician if his symptoms did not improve. The patient was seen at an urgent care on 5/4/18; he came by the pharmacy afterwards. The rash appeared about 5 inches in diameter at the injection site; it was red, raised, and bumpy in appearance. On 5/4/18 the patient reported that the rash appears slightly smaller and the pain is mild, dull, and intermittent at the injection site. He also felt some tingling in his fingers and toes on the right side and is unsure if that is related.
Information has been received from a PharmD concerning a 61-year-old female who on approximately 02-FEB-2008 ("last week") was vaccinated subcutaneous in the arm with a dose of ZOSTAVAX (Oka/Merck). On approximately 02-FEB-2008 "last week" the patient experienced warm, red circle approximately 2 inches in diameter with a paler circle around it at the injection site. The pharmacist mentioned that it resembled a bull's eye. 'It has been a week since it appeared and it is just starting to subside". The patient sought unspecified medical attention. A product quality complaint was not involved. Additional information has been requested.
Throbbing in the right temple. Also, tingling from the middle of the top of the head, via the right temple, down the right side of the head. This showed up a few days after the first shot of the Pfizer vaccine and persists until now (two months later). This is not a headache, but rather pressure/throbbing in the right temple that is uncomfortable. Since it does not severely impact my daily life, I have not taken any steps to treat it.
Rapid heartbeat,  skin became bright red, itching, naseau, headache, bloodshot eyes, difficulty breathing
a lot of bruising/bruising was 2 cm below the injection site; Can not mover the arm; Sore; This case was reported by a pharmacist via call center representative and described the occurrence of contusion in a 62-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5723N, expiry date 19th November 2022) for prophylaxis.   On 3rd September 2020, the patient received the 1st dose of Boostrix (intramuscular). On 3rd September 2020, immediately after receiving Boostrix, the patient experienced pain. On 8th September 2020, the patient experienced contusion and mobility decreased. On an unknown date, the outcome of the contusion, mobility decreased and pain were unknown.   It was unknown if the reporter considered the contusion, mobility decreased and pain to be related to Boostrix.  Additional details were provided as follows: The pharmacist reported that a patient received 1st dose of Boostrix on left deltoid and right after the shot patient experienced sore. On Tuesday 8th September 2020 patient went back to the facility and reported to the pharmacist that there was a lot of bruising about 7 cm and also reported she could not move her arm.  Pharmacist was not aware if patient recovered from these events yet. After call was transferred, the Pharmacist stated the bruising was 2 cm below the injection site. The reporter consented to follow up. The case had been linked with US2020182601 and US2020182602 same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020182601:same reporter US-GLAXOSMITHKLINE-US2020182602:same reporter
2nd dose given too early, 1st dose 2/13/21, 2nd dose 3/7/21.
automatic metal taste in mouth following but nasal blockage, SVTs, increased anxiety and panic attacks on going for 3 weeks, changes to menstration  cycle
sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (sore right injection site arm). At the time of the report, VACCINATION SITE PAIN (sore right injection site arm) had resolved.            No concomitant medications were reported. The patient had a sore right injection site arm for a week after the second Moderna COVID-19 vaccination. No treatment medications were reported.
It was reported that a 24 year old female pt received a TD Adult on 9/15/00 and the next day, the pt developed an enlarged lymph node over clavicle. From additional information received on 2/1/01, "Reviewed-no additional information at this time MRB 1/30/01".
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient came into the facility and requested the Pfizer Covid-19 Vaccine. He stated that he received the Janssen Covid-19 Vaccine in April and was leaving the country in 2 days. He stressed that he talked it over with his PCP and they decided the he should get the Pfizer vaccine before he leaves. He stated that he was worried about the Delta variant. It was administered 07/21/21
One blister on balm where skin started to peel away one day after shot, redness at injection site one day after shot, palms have slight peeing / dry skin since shot 6 days ago.
Sever fever, 101. Severe body aches and fatigue to the extend I couldn't rise out of my bed during the day. Couldn't walk to the bathroom until more than 24 hours later. This reaction happened with both the first and second booster.
Lots of systemic Sx- Mild H/A; myalgia pretty strong; injection site pain; Fatigue; Poor appetite; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05May2021 at 15:45 (at the age of 61-years-old) as unknown, single for COVID-19 immunisation. Medical history included hypertension (HTN), hypercholesterol, hypothyroidism and possibly cephalosporin allergy. The patient's concomitant medications were not reported. On 06May2021 at 11:00, patient experienced lots of systemic Sx (symptoms)- Mild H/A (headache), myalgia pretty strong, injection site pain (unlike from past vaccines like flu and TPD), fatigue and poor appetite which lasted nearly entire next day after 3:45 pm shot. Patient reported it prevented her from attending to normal activities. No treatment was given to the patient. Patient did not have COVID prior and post vaccination. Outcome of events was recovered on an unspecified date.   Information on lot/ batch number has been requested.
COVID positive with multiple thrombotic complications including bilateral PE, mobile aortic thrombus and DVT.  Mildly hypoxemic, which I presume may be multifactorial related to her pulmonary emboli, body habitus and right lower lobe consolidation versus pulmonary infarct.  She certainly does have significant risk factors for complications COVID,
30 year old patient who received a dose of Shingrix / administered shingrix by mistake; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 30-year-old male patient who received Herpes zoster (Shingrix) (batch number E9C7K, expiry date 14th October 2022) and (batch number MM59F, expiry date 14th October 2022) for prophylaxis.   On 3rd March 2021, the patient received Shingrix. On 3rd March 2021, the dose was an unknown dose. On 3rd March 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 30 year patient received shingrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.   Follow up information received from other health care professional on 29th March 2021: The patient's demographic details were updated. The reporter stated that, the patient received shingrix vaccine by mistake. The patient was feeling fine and no reactions. The VAERS details were updated.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  The vaccine was stored in freezer, took out one to two vials and place in fridge each day as needed. Patient took booster shot.  No Treatment medications were reported.
High fever of 102 degrees.  Took 2 caplets of Tylenol at 9pm on 04/09/2021 that had little to no effect.  At 3am on 04/10/2021 took 2 gel caplets of Advil hoping to do better.  The Advil brought the fever down to 100-101 for several hours but the fever went right back up.  Arm was sore and had headache.  My fever went down to 99 degrees 48 hours after taking the shot on 04/11/2021 at 3pm. Later on 04/11/2021 around 9pm my temperature went back to normal including any pain or swelling at the injection site.  I had to re-hydrate myself but felt better.  Overall I would do it again to protect my family from this virus.
A day after injection was given, patient had reaction of swelling & redness. Day 3 after reaction, was still swollen and red & puffy & warm to the touch.
Mother c/o bump to R thigh after immunization. Came in 2/27/06 with same complaint on visit. Tx: Massage;return in 1-2 mo.
rash at injection site; itchiness at injection site; hot to touch at injection site; soreness at injection site; stomach pain; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash at injection site, itchiness at injection site, hot to touch at injection site, soreness at injection site, and stomach pain.  The patient's medical history was not provided. Concomitant medications reported were doxycycline, xarelto, atenolol, and hydrochlorothiazide for drug use for unknown indication.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the events rash at injection site, itchiness at injection site, hot to touch at injection site, soreness at injection site, and stomach pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 12 Feb 2021 the outcome of event(s), stomach pain was resolved. The outcome of event(s), rash at injection site, itchiness at injection site, hot to touch at injection site, and soreness at injection site was unknown.
This spontaneous report as received from a consumer (patient's mother) refers to a 16 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patient was vaccinated with her first 2 doses of GARDASIL (exact doses, routes, lot numbers and expiration date were not reported). On an unknown date, the patient received her third dose within the series with GARDASIL 9 (dose, route, lot# and expiration date were not reported). On an unknown date, the patient made a blood donation wand and later tested positive for syphilis. The outcome of syphilis test positive and interchange of vaccine products was not reported. The reporter was concerned that the positive result for syphilis could be linked to the patient's receipt of the GARDASIL and GARDASIL 9. The relatedness between the event interchange of vaccine products and suspect therapies was not reported. Additional information is not expected, as no contact details were provided.
The day after receiving, both the seasonal and the H1N1 vaccinations pt became pruritic and developed a rash all over his arms, chest, back and legs. Sx ongoing x1 wk. Pt rx CLARITIN.
The first bout of Vertigo happened as I lay down to bed that evening.  This continued the next day as soon as I tried to sit up.  I tried to get up and failed.  Vertigo lasted all day and I was unable to perform my job.  Vertigo continued into the next day, but it was not as severe.  Went into doctor?s office.  Doctor performed a physical exam.   Diagnosed Vertigo based on observations.  Doctor recommended  Cawthorne Exercises and proscribed Meclizine as needed.  No vertigo since the doctor?s visit on 3/29.