chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt had fever starting around 5PM-fever went to 103 & lasted 3 days;lt leg swollen & hot @ inj site & favored leg for the 3 days;pt given APAP & cool compresses
This spontaneous report was received from a Registered Nurse (R.N) regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 29-DEC-2015, the patients were vaccinated with two doses of PROQUAD (Merck), Lot # L014401, (dose and route of administration not provided), which was improperly stored. There were no concomitant medications reported. There were no adverse effects reported. This is one of several cases from the same source (MARRS # 1601USA011654, 1602USA002862, 1602USA002864 and 1602USA002865). Additional information has been requested.
Pt felt flush after injection. Started to sweat. Gave a cool drink, checked BP 138/108. Pt calm down and was monitored for a 30 minutes and he returned to work.
Information has been received from a registered nurse (RN) concerning a 23-week-old male who on 06-JUL-2006 was vaccinated by mouth with the first 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653915/0389F).  It was unknown if medical attention was sought and no adverse were reported.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/11/2006.  Information has been received from a licensed practical nurse (LPN) concerning a 23-week-old white male who on 06-JUL-2006 was vaccinated PO with the first 2.0 mL dose of ROTATEQ (Lot #653915/0389F).  Concomitant vaccinations administered on that same day included the second IM dose in the left thigh of PEDIARIX (Lot #AC21B065AA), the second IM dose in the right thigh of ACTHIB (Lot #UE793AA) and the second dose in the right thigh of PREVNAR (Lot #B08558C).  It was unknown if medical attention was sought and no adverse events were reported.  On 03-AUG-2006, the patient was vaccinated PO with the second dose of ROTATEQ (Lot #853915/0389F).  Additional information is not expected.
Second made me sicker than all; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, for tolerance of previous dose refer case US2022AMR123589).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR123589   Additional Information: GSK Receipt Date: 22-AUG-2022.  Reporter's Comments: This case was reported by the patient via interactive digital media. The patient had 2nd shingles vaccine and it made him/her sicker than all get out. The patient thought it better than 2 months of shingles pain though. Additional Supportive Information: The follow up would not be possible as contact details were not provided. It was reported that "Patient had 2 shingles vaccines and second made patient sicker than all" from this line it was not clear if patient was comparing sickness happened after 2nd dose with 1st shingles dose or any other vaccine hence conservatively sickness was captured as event for 1st dose. Also, it was reported that "this sickness was better than 2 months of shingles pain" from this it was not clear if patient had experienced shingles pain or was only using it as a general statement for comparison hence shingles pain was not captured.; Sender's Comments:  US-GSK-US2022AMR123589:Same reporter
Case previously recorded as MA2009-4308. Received the following information via Novartis Vaccines and Diagnostics, on 10 NOV 2009:  Multiple patients were vaccinated with influenza vaccine (manufacturer and batch no. unknown) on unknown dates. They experienced dizziness and injection site reaction with pain and local reaction on unknown dates. The outcome of the symptoms was unknown at reporting date. We received the following additional information via Novartis Vaccines and Diagnostics, on 16 NOV 2009: FLUVIRIN (unclear if H1N1 (pandemic or seasonal) was vaccinated.
Patient received first dose in December, 7 months ago; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received first dose in December, 7 months ago) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received first dose in December, 7 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received first dose in December, 7 months ago) outcome was unknown.        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 concomitant medication was reported. No treatment medication was reported.
On 12/21/99, the pt received his first dose of Infanrix, subsequently he screamed and was difficult to console. Additionally he had a fever of 100.6 degrees (rectal). Outcome of pt is resolved.
KIDNEYS STOPPED FUNCTIONING; WORSENING OF ENLARGED PROSTATE; SEVERE REACTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: enlarged prostate. The patient was previously treated with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination. It was unknown if patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s(unspecified manufacturer) (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on DEC-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had a severe reaction to the vaccine, which put him in the hospital (date unspecified). His kidneys stopped functioning and his prostrate enlarged got worsen (dose number in series 2). The number of days hospitalized was not reported, and it was unspecified if the patient was discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe reaction, kidneys stopped functioning and worsening of enlarged prostate was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220649710- COVID-19 VACCINE AD26.COV2.S- KIDNEYS STOPPED FUNCTIONING, WORSENING OF ENLARGED PROSTATE, SEVERE REACTION. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
sore arm; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm) and headache (Verbatim: headache). The outcome of the pain in arm and headache were unknown.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix.     It was unknown if the company considered the pain in arm and headache to be related to Shingrix.   Linked case(s) involving the same patient:  US2023072482   Additional Information: GSK Receipt Date: 22-MAY-2023 The consumer was the reporter. The consumer reported that after first dose of Shingrix she had sore arm and headache. The reporter consented to follow up. For tolerance to the 2nd dose refer case US2023072482.; Sender's Comments:  US-GSK-US2023072482:Same reporter, Other dose
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 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 15Aug2023 to 19Aug2023.  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.
(L) upper shoulder pain; hurt when lifting arm up above head, forward or backward motion. Hurts to lay on for long period of time. Still hurts 5-6 wks later.
These symptoms began the morning after I received the second vaccine (4:30 pm). Symptoms started at 0630 the next morning: Fatigue, chills, headache, foggy brain, heavy feeling. This is how I feel right before a fever with the flu.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Nov2021 11:30 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Prior to vaccination, the patient was diagnosed with COVID-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, Location of injection: Arm Left), administration date: 01May2021, when the patient was 49 years old, for COVID-19 immunization, reaction(s): "lymph node swelling", "lymph node tenderness", "tenderness at the site of injection", "moderate lethargy"; Bnt162b2 (Dose 1), administration date: 01Apr2021, when the patient was 49 years old, for COVID-19 immunization, reaction(s): "lymph node swelling", "lymph node tenderness", "tenderness at the site of injection", "moderate lethargy". The following information was reported: IMMUNISATION (non-serious) with onset 04Nov2021 11:30, outcome "unknown", described as "booster"; PAIN (non-serious) with onset 05Nov2021 12:00, outcome "recovering", described as "severe body aches"; LETHARGY (non-serious) with onset 05Nov2021 12:00, outcome "recovering", described as "extreme lethargy"; CHILLS (non-serious) with onset 05Nov2021 12:00, outcome "recovering", described as "gave me the worst chills I have ever had in my life"; HEADACHE (non-serious) with onset 05Nov2021 12:00, outcome "recovering", described as "severe headache"; PYREXIA (non-serious) with onset 05Nov2021 12:00, outcome "recovering", described as "102.5 fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, lethargy, chills, headache, pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Expired Engerix-B administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 45-year-old female patient who received HBV (Engerix B adult) (batch number AN599, expiry date 8th November 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th December 2022, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 19th December 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: The reporter relayed information for adverse event report yet declined to be sent the medical information or package insert.  Accepted to be contacted to follow-up the event. The vaccine administration facility was the same as primary reporter. Information was given but reporter declined it being sent to them. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Engerix-B adult, which led to expired vaccine used.
8 days 10/13/2005 after vaccine administration child developed a red, slightly raised rash around mouth and fever 103. Was hospitalized  (hydro tic IV fluids) for 5 hours then released.
shortness of breath, very dehydrated, dry skin, bloody nose due to being so dry, sore arm
Patient experienced soreness at the site where the Pneumovax was given (left deltoid).  Client reports chills, fatigue, and fever of 103 degrees for about 6 hours immediately after immunization was given.  Soreness remains at the site (left arm) over 3 months later.  Client describes it as a "dull" sensation.  Client reports soreness increases when affected arm is used (gardening, chores, etc).  The soreness subsides but never has been completely alleviated since the vaccine was given
Hives to entire body, Benadryl given x 2; pt went to ER and was given Zyrtec, discharged home
No reaction to first dose. However, 12 hours after receiving the second dose, I experienced the following reactions, which lasted about 12 hours.  Projectile vomiting and dry heaves Nausea Muscle aches, cramps, and spasms Chills Fever Sweats  Headache in upper shoulders, neck, and back of head (intense)
Vomited; Nausea; Chills; Exhausted; Arm very red and the circle is 2 inches; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomited), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (Exhausted) and ERYTHEMA (Arm very red and the circle is 2 inches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced VOMITING (Vomited), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (Exhausted) and ERYTHEMA (Arm very red and the circle is 2 inches). On 14-Feb-2021, VOMITING (Vomited) had resolved. At the time of the report, NAUSEA (Nausea), CHILLS (Chills), FATIGUE (Exhausted) and ERYTHEMA (Arm very red and the circle is 2 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with improperly stored doses of PROQUAD lot # M002053, expiry: 11-JUL-2017 and lot#: M017337, expiry: 15-OCT-2017. Excursions for PROQUAD of lot# M002053 (also included VARIVAX) occurred on multiple days were listed below: -12C for 16 hours, -12C for 8 hours, -13C for 8 hours, -12C for 16 hours, -12C for 8 hours, -12C for 23 hours and 45 minutes, -14C for 7 hours and 45 minutes, -13C for 32 hours, -11C for 11 days, -11C for 8 hours, -13C for 24 hours and 15 minutes, -13C for 24 hours, -12C for 25 hours, -13C for 8 hours, -13C for 24 hours, -12C for 72 hours, -13C for 25.5 hours, -14C for 16 hours, -12C for 88 hours, -12C for 48 hours, -12C for 72 hours, -12C for 98 hours, -12C for 93 hours, -12C for 23 hours and 45 minutes, -14C for 24 hours, -12C for 24 hours. The temperature excursions for PROQUAD of lot#: M017337 administered to unspecified number of patients which occurred on multiple days were listed below. -13C for 24 hours and 15 minutes, -13C for 24 hours, -12C for 25 hours, -13C for 8 hours, -13C for 24 hours, -12C for 72 hours, -13C for 25.5 hours, -14C for 16 hours, -12C for 88 hours, -12C for 48 hours, -12C for 72 hours, -12C for 98 hours, -12C for 23 hours and 45 minutes, -14C for 24 hours, -12C for 24 hours. No further details were provided. This is one of two reports received from the same source. Additional information has been requested.
Developed swelling in glands under tongue. Still persistent some 8 days after onset. Did not notice any swelling when I went to bed and then woke up at 5 am with extreme swelling. Swelling reduced some over the next 24 hours but is still present and causes discomfort. Especially when eating. Had quite a bit of pain at injection site for 3-4 days.
coroner called hlth dept to report death-COD SIDS;death certificate requested from RCHD;
One day post vax, the pt left for a visit to another country. Approximately 2 weeks into the trip, the child developed a "febrile illness" which resolved on its own. The pt had no reported rash or symptoms other than the fever. However, approximately 1-2 weeks after the febrile illness, the child developed seizures followed by "progressive neurological deterioration". He returned home and was hospitalized in August. MRI and CT scan were normal, however the child continued to deteriorate neurologically. The physician stated that the pt is now at the "lever of a 6 month old infant" and has completely regressed. He is incontinent, unable to feed himself, unable to walk etc. Additionally she stated he appears to have some form of dementia. Numerous cultures and lab results are pending including a test for the West Nile virus. The physician stated that she does not think the child's experience was related to the vaccination with varicella, but she wants to explore every possible avenue. Additional information has been requested.  Follow up on 03/28/2001: "Patient date of birth and Lot # for vaccine 1 is not provided."
Started to have trouble breathing, tight chest, throat started to get tight. Had trouble talking, voice going hoarse. Became very hard to breathe. 04:30 pm gave myself a shot of EPI and took Benadryl and my inhaler.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. The reporter stated that on 16-NOV-2015, the patient was inadvertently administered an expired dose of VAQTA lot number L001627, expiration date 11-NOV-2015 (dose and route not reported). No adverse effects reported. Additional information has been requested.
Very white in the face, chilling and shivering from being cold. Heart rate 140.  Went to MD, Ekg, blood work done, injected with Benadryl.  After he went home, he slept for 13 hours.
Adverse reaction to IM Influenza vaccine occurred 8/23/17. Employee had pain and pressure of left side of body, pressure in back of head. Seen by ER and diagnosed with Acute Sinusitis.
Pt given Flu Vaccine 5 days after B12 Injection in the right arm, within one week of flu vaccine, pt developed nodules under the skin at site of both injections with bruising and swelling. Pt was given next B12 Injection on 10/1/2014 in the left arm with same symptoms.
Vaccines on 12/4/2020. Called on 12/9/2020 inquiring about side effects. Reports pain to left arm even at rest, but pain traveling from the shoulder to the elbow periodically as well.  ROM not effects. States site is not swollen,  does report small bruise to injection site.
Client states that she woke up on Saturday 10-29-22  morning with chills, no fever, and severe achiness all over her body and this did not stop until later on Sunday 10-30-22.  No treatment was necessary.  She took OTC medications
Fevers palpitations (24hrs.) Globys sensation COVID - at URGENT Care CBC CMP mild transamitis Trop - IVF Tylenol Omeprazole  URGENT Care ER. This was patients 2nd dose of Shingrix He had no problem w/ the first dose The night started palpitation & fevers next day went to urgent care who then sent pts to ER. Today felt well- no symptoms  on note- pt has not had issues w/ other vaccines
Rash at injection site - chickpox like bumps at injections site two weeks after vaccinated.
p/vax pt felt dizzy 15 second later pt passed out & looked to be convulsing for 20sec;then came to & couldn't remember what happen-only that began to feel dizzy;