chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GUILLAIN-BARRE SYNDROME; This spontaneous report received from a patient via company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced Guillain-Barre syndrome and it was reported as "Yea don't tell the truth. I got GIALLIA BARREA SYDROM FROM YOUR SHOT. TELL THE TRUTH." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220957375-covid-19 vaccine ad26.cov2.s-Gullian-Barre syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
Admitted to hospital for 1/22/22 for left hip pain related to fall.  1/24/22 surgery for left hip stabilization. Tested positive for covid 19 that evening after an episode of hypotension and mental status change. Her hospital course was complicated by postoperative anemia, delirium and aspiration pneumonia. Patient was transition to Hospice and died 2/3/22 at 03:38.
left arm pain beginning 3 days post vaccination; treated at home with OTC pain relievers and active ROM; presented to clinic 2 days after symptom onset; scant ecchymosis noted to vaccination site; site visibly high on deltoid muscle; diagnosed with bursitis and treated with Ibuprofen prescription and rest
-Extreme allergic reaction to 2nd dose, 103-degree fever, headache, dizziness -Multiple infections -3 eye infections - 1 in right eye on May 12th, two weeks after first dose. After 2nd dose, other eye symptoms manifested, blurred vision, tearing, crusting, itching, burning, pain, light sensitivity. Infection in left eye, July 7th, then a second infection a month later. Ophtamalogist's final diagnosis was blepharitis following these infections. -Irregular periods since 1st dose
Left arm has giant hive, red , hot and swollen. Did not have this reaction to the first two shots.
From initial information received on 16/Jan/2004 from a registered nurse regarding an adverse event, occurring in the USA it was reported that a 37-year-old female patient received a TD adult vaccination, lot number U1015AA, administered intra-muscular in the left deltoid on 13/Jan/2004. Later that same day the patient experienced leg cramping in areas of both shins. It was reported that the leg cramping persists and the patient has not yet recovered after 3 days.
Patient states she developed "frozen shoulder". She also states the same thing happened to her years ago from a Shingles Vaccine.
12FEB92 presented in ER w/lump in arm; stated that pt has had severe pain & tenderness in area since inject; ultrasound 1x2 cm area of fluid; collection in the muscle; this was I & D & had WBC/bacteria; pt had immediate local rxn;
progressively worsened; pins and needles in her toes/Pins and needles have traveled to her hand and progressively worsened with each week; nerve pain; complete severe inflammatory red rash all over body; Burning rash all over her face; flu-like symptoms; body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (pins and needles in her toes/Pins and needles have traveled to her hand and progressively worsened with each week), CONDITION AGGRAVATED (progressively worsened), RASH ERYTHEMATOUS (complete severe inflammatory red rash all over body) and RASH (Burning rash all over her face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (body aches) and HEADACHE (Headache). On 05-May-2021, the patient experienced PARAESTHESIA (pins and needles in her toes/Pins and needles have traveled to her hand and progressively worsened with each week) (seriousness criteria hospitalization and disability), RASH ERYTHEMATOUS (complete severe inflammatory red rash all over body) (seriousness criterion disability) and RASH (Burning rash all over her face) (seriousness criterion disability). On 12-Jun-2021, the patient experienced NEURALGIA (nerve pain). On an unknown date, the patient experienced CONDITION AGGRAVATED (progressively worsened) (seriousness criterion hospitalization). The patient was treated with GABAPENTIN ongoing since an unknown date for Nerve pain, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (pins and needles in her toes/Pins and needles have traveled to her hand and progressively worsened with each week), CONDITION AGGRAVATED (progressively worsened), RASH (Burning rash all over her face), INFLUENZA LIKE ILLNESS (flu-like symptoms), NEURALGIA (nerve pain), MYALGIA (body aches) and HEADACHE (Headache) outcome was unknown and RASH ERYTHEMATOUS (complete severe inflammatory red rash all over body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I developed tinnitus in my left ear and some loss of hearing in my left ear.; I developed tinnitus in my left ear and some loss of hearing in my left ear.; This is a spontaneous report from a contactable consumer reporting for self.   A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 10Mar2021 (Batch/Lot Number: EN6205) as a single dose for COVID-19 immunisation.  Medical history included high blood pressure increased from 2001 ("for 20 years") and cancer (first time was in 2004 and then in 2008).  The patient was receiving unspecified concomitant medications ("I am taking a lot of different medication").  The patient previously received first dose of BNT162B2 (Batch/lot number: EN6205) on 09Feb2021. On 17Mar2021, the patient developed tinnitus in her left ear and some loss of hearing in her left ear. The patient underwent lab tests including blood work on 14Apr2021 with normal results and MRI brain 15Apr2021 with normal result. The patient had not yet received any treatment for the events at the time of reporting. The patient states she doesn't know for sure, but she believed she had a side effect from receiving the Pfizer vaccine. The outcome of the events tinnitus in her left ear and some loss of hearing in her left ear was unknown.
expired TENIVAC was administered to a patient with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient to whom expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (strength, lot number, expiry date: unknown) not reported via unknown route in unknown administration site for Immunization and expired tenivac was administered to a patient with no reported adverse event (expired product administered) (unknown latency).  Action taken with diphtheria and tetanus toxoids (Tenivac) was not applicable.  Outcome: Unknown.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with (Oka/Merck) PROQUAD lot # L046509, 17-MAY-2017. 12 doses were administered. Temperature of 32.9F for 6 hours and 30 minutes. There were no previous excursion. This is one of the 2 cases received from the same reporter. Additional information has been requested.
The top layer of my skin came off in a quarter-sized chunk while removing the bandage from the vaccine (muscle NOT visible). Clear, yellow liquid has been leaking out of the area. I cleaned the area with an antiseptic wipe, applied a topical triple antibiotic ointment, and applied a bandage.
high fever x 24 hrs; several local react of the lt upper arm; whole upper arm was swollen & red;
Patient received 2 doses of Bexsero on the same day.  She was supposed to get a Men B and MCV, but accidently received 2 Men B vaccines instead.
PT was given an expired vaccine. Vaccine was 4 days past the expiration date on the vial.  GSK was called and event reported.
patient says action site got red, hot grown enlarged over the arm. She came back and pharmacist Dr. informed her that is the normal side effects and monitor for symptoms more than pain, redness, at the action site. Patient said she started having chest pain and went to see her PCP. They gave her an antibiotic and hydroxyzine. Spoke to patient 11/24 Monday, and she said redness, hotness, area of action site is gone. She says she has intermittent chest pain and will follow up with the dr. Last year she came here for the flu shot with no issues. Our procedure:with washed hands, we glove ourselves, alcohol the action site, use a sterile inject safe barrier, use sterile 1'' needle and inject through the inject barrier sticker. Patient saw us doing that and assumes it could be a fluke on her body where she was exposed somewhere after the shot.
Mixing error occurred, patient may have received only diluent. Patient was revaccinated 05/05
A nurse reported that a 2 month old female received injections of Prevnar (1st dose), Infanrix, IPV and Act-Hib on 8/28/01. Several hours, post vax, both of the pt's legs turned purple from the hips to toes. This lasted over 20 minutes. The responsible physician did not believe the reaction was due to the vaccination, but a different physician felt there was indeed a causal relationship.
The day after he gave me the vaccine, headache, vomiting, dizziness, fatigue, body ache and I tried to vomit, I did not vomit. He had a low fever. I went to bed and slept from morning at 9:00 AM to 5:00 PM. After sleeping I felt better. I ate something. I didn't have to go to the doctor. And the next day I slept, everything happened to me.
Vaccinations given (DTaP and VZV) 8/11/04. Noted swelling on site of injection 8/12/04 and 8/13/04. Hospitalized 8/14/04. I & D (Abscess) done 8/16/04.  Nurse follow up on 11/01/04 states: "fever; pain; induration."
states that she received her second Covid vaccine on Monday 03/01/21, and that yesterday she had side effects of body aches, and just feeling yucky. 3/3/21, she woke up with Hives covering her body.  No difficulty breathing, or swelling of Face at this time, per NP, pt to take Benadryl OTC and if Sxs worsen or do not improve she will need to come into to be seen, and if any difficulty breathing, swelling of face/tongue/throat patient is to call 911.    3/4/2021 11:52 AM  71 yo female seen today with c/o hive like rash,, first onset noted on both forearms yesterday 3/3/21 associated with severe itching,   she took some benadryl last night, this may have helped for a while, however notes spreading of hive like rash to the entire body including the face starting this morning,   bodyaches and chills with extreme fatigue Pt had her 2nd pfizer covid shot 48 hours ago,  she denies any other new medications or products.
ACUTE  PERICARDITIS - treated with colchicine, took colchicine for 2 month after the hospital visit.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 22nd June 2018, the patient received the 1st dose of SHINGRIX 50 ug. On 7th October 2018, 107 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving. The reporter considered the shingles to be unrelated to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. After vaccination with the first dose of SHINGRIX, a week ago before the date of reporting, the patient experienced Shingles. Till the date of reporting the patient was not vaccinated with the 2nd dose of SHINGRIX. The patient had not associated experiencing shingles as a lack of efficacy of the vaccine, however the patient also stated that she filled this adverse event to be safe since she experienced shingles.
Tinnitus lasted for about one week after first dose and came back again after second dose. Tinnitus gets worse these days.
Pt was given PREVNAR 13, pt left clinic room within 5 minutes pt had welts under eyes, down face, ear lobe swelling, hives were itching. Pt was re-roomed. Dr was notified. No respiratory involvement. Pt was given 12.5 mg of BENADRYL and kept in clinic for 45 minutes. Pt left, hives were almost gone.
Started with intense headaches right after the 2nd dose of the Moderna vaccine on 03/06/2021.  Had the headache for over two weeks, and eventually went to the hospital with loss of speech and movement on her left side of her body. They at first said it was strokes, then after the CT scan results came back they found multiple abscess in her brain. She does not have a history of strokes or brain abscess. Speech and motor functions never returned, and one abscess was so large that it caused a brain shift ( the two hemispheres separated) they performed brain surgery and it was not successful. She passed away on 3/31/2021 at 431 am.
This is a spontaneous report from a contactable consumer, the patient. A 40-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 26Apr2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no allergies to medications, food, or other products. Concomitant medication included spironolactone (SPIRONOLACTON) from an unknown date, for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 05Apr2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021, the next day of vaccination at 09:00, the patient experienced site soreness, fatigue (physical and mental) and swollen lymph node around left side collar bone; on the following evening, the patient experienced fever 100 (body temperature). The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. On 27Apr2021, body temperature for the patient was 100 (unit not specified). The clinical outcome of the events site soreness, fatigue (physical and mental), fever 100 and swollen lymph node around left side collar bone was recovering.No follow-up attempts are needed; information about lot/batch number cannot be obtained.Amendment: This follow-up report is being submitted to amend previously reported information: updated laboratory data (Body temperature date updated to be 27Apr2021), onset date for Fever updated to be 27Apr2021 and narrative data amended.
This spontaneous report was received from an office manager, referring to two 12 months old patients of unknown gender. It was reported none concomitant medications, none medical history and none drug reactions or allergies. On an unspecified date in 2018 (reported as "in the last 3 weeks"), the patients were vaccinated with (wistar ra 27-3) M-M-R II and Oka/Merck VARIVAX both subcutaneously in the same leg (strength, doses, dose numbers, lot numbers and expiration date were not reported), for prophylaxis. Other suspect therapies included a DILUENT MRK INJ (lot number and expiration date were not reported). In 2018, each patient reported tenderness, warmth, swelling and a lump at injection site. It was reported that treatment was not given for the adverse events; however, it was also stated that the treatment given was ice to the injection site for each patient. Lab diagnostics or studies were not performed and patients sought medical attention by contacting the office. The outcome of injection site mass, injection site swelling, injection site pain and injection site warmth was unknown. The causality assessment between (wistar ra 27-3) M-M-R II, Oka/Merck VARIVAX, the DILUENT MRK INJ and the aforementioned events was not provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1804USA008467.
Information has been received from a registered nurse concerning a 61 year old male with hypercholesterolemia who on 10-DEC-2008 was subcutaneously vaccinated with a single dose of ZOSTAVAX (Oka/Merck) (lot #662858/1558X). Concomitant therapy included unspecified cholesterol medication. On 10-DEC-2008 the patient experienced a feeling of generalized weakness immediately after administration of ZOSTAVAX (Oka/Merck). The patient's vital signs were normal and he was being monitored in the office. The patient was administrated orange juice and was recovering at the time of the report. Follow up information was received from a registered nurse who reported the male patient was subcutaneously vaccinated with the first dose of ZOSTAVAX (Oka/Merck) (lot #662858/1558X) into the right deltoid at 11:30 on 10-DEC-2008. On the same day at 11:45 the patient began to experience weakness and light headedness. He performed blood pressure monitor for 1 hour and results included BP 120/80 and 120/82, P 78. In about 1 and 1/2 hours patient recovered completed. No residual problems. Additional information is not expected.
Rash on both legs behind the knees. It is a flair up of the same rash I had with the first vaccine shot. This rash is not as wide spread at this point. My dermatologist has me taking Hydroxyzine HCL 10 mg at night and applying Triamcinolone Acetonide Cream USP .1% cream to the rash twice a day. This seems to be helping some. The rash feels hot like a sunburn, raised  and itchy with red bumps.
Dizziness and nausea. Had to sit without moving head until 2:00PM when symptoms ceased. Just movement of head caused room to spin.
pt recvd vax; devel approx five lesions of a localized rash on opposite arm;
Covid19 breakthrough.  1st vaccine received on 04/15/2021.  30 y/o with no chronic past medical history except on Descovy for HIV PrEP and with infected pilonidal cyst treated several times with bedside I&D and antibiotics.  Pt returns to ED with continued sacrococcogeal pain and swelling, admitted for further management.  Pre procedure Covid testing positive.  ID states pt with no Covid19 symptoms.  Afebrile on IV antibiotics.
Patient came into get his 2nd Pfizer COVID shot, but was administered the Moderna COVID shot by mistake. No adverse events noted after shot was given.
migraines, vision issues within 12 hrs.  On 4-29 I had a TIA (complete loss of right side and couldnt speak for 10 min).  I went to hospital and had CT, ekg, blood work, all were ok.   Cardiologist determined I did have a TIA and after an Echocardiogram discovered a Patent Ovale Foramen (hole in heart) and recommended immediate closure.  Surgeon also said to get the procedure but as of now my insurance has not approved payment.  I have been having numbness and pain in hands and feet (mostly left side) along with vision issues, dizzyness, problem finding words and concentration, fatigue.  I went to Hospital again on 6-27 due to pain and numbness in left hand and foot and doctor said he could admit me but I did'nt stay.   I have gone from a healthy person who is very active to  someone who is always tired and is constantly worried about having another TIA.
This spontaneous report was received from a nurse practitioner via company representative regarding a 19 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2016 the patient was vaccinated with first dose of GARDASIL (lot#, expiration date, route of administration and dosing details were not reported), for prophylaxis. On an unknown date in 2016 the patient was vaccinated with second dose of GARDASIL and it was unknown if the patient received the second dose at the recommended time interval as specified in the prescribing information. It was reported the patient has not received the third dose in the HPV series (inappropriate schedule of drug administration). No adverse effects were reported.
Pt. received 4 vaccines on 5/21/15. Patient presented to health dept. on 5/22 stating that her left arm was very swollen. I observed the swelling from the shoulder to elbow area. Pt had previously asked a ER nurse to look at the area and advised cold compresses and ibuprufen. Same treatment recommend at HD.
Information has been received from a registered nurse concerning an "18 or 19" year old female who on 19-JAN-2007 was vaccinated with the first dose of HPV vaccine (yeast). On 19-JAN-2007, the patient developed a cyst at the injection site.  The patient sought unspecified medical attention. The patient was referred to a dermatologist. At the time of this report, the outcome of the event was unknown.  Additional information is not expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 07-NOV-2012, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, she was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.