chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles rash; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 09Mar2021 (at the age of 49-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. After the patient got the vaccine, he developed a "shingles rash". He would like to know if there are any reports regarding the vaccine causing this side effect. He is due to get his second dose of the vaccine tomorrow (unspecified date) and has considered about that dose causing the same reaction. It was further reported that he is supposed to go get the second dose tomorrow and he is not sure if he should go. Stated after getting the first vaccine he experienced a shingles outbreak 4 days after getting that first dose (13Mar2021), and the shingles was in the same area, on the same shoulder, that he got vaccine, so he thought it might be related. He stated he took a medication; it was a herpes drug, but he forgot the name. It is a drug to stop the duplication of the herpes virus. Therapeutic measures were taken as a result of the event. The outcome of the event was recovering.
PATIENT RECEIVED MENACTRA ON 10/10/2005. THAT EVENING SHE HAD FEVER, HEADACHE, DIZZINESS AND A SUBJECTIVE FEELING OF DIFFICULTY BREATHING. SHE ALSO FELT LIKE HER ENTIRE BODY FELT NUMB FOR ABOUT 5 MINUTES. HOWEVER WHEN SHE RETURNED THE NEXT DAY FOR CHECK MOST OF THESE SYMPTOMS HAD RESOLVED AND SHE HAD A NORMAL NEUROLOGIC EXAM.
Shingrix instead of Menveo; 17 year old was administered Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Herpes zoster (Shingrix) (batch number 3BD9E, expiry date 6th April 2023) for prophylaxis.   On 13th December 2021, the patient received Shingrix. On 13th December 2021, unknown after receiving Shingrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The reporter was the clinic director. The reporter stated that the 17 years old patient was administered Shingrix instead of Menveo, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter did not consent to follow-up.
Soreness, swelling and heat by injection site, at first.   Followed in early evening with severe pain and difficulty moving arm.  Around 10PM,  I began having severe chills and couldn't stop shaking even with my electric blanket on.  I developed a headache.  My husband gave me Ibuprofen for headache and soreness which I immediately threw up.  I heaved for about 15 minutes more and once that stopped, the whole event was over.   The next day the injection site was a bit red, but the soreness was nearly gone.   The second day only slight redness and no more pain.
Left Arm pain; This is a spontaneous report from a contactable consumer.  A 90-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283 expired date 30Apr2021 in left arm  via an unspecified route of administration on 10Jan2021 at a single dose for COVID-19 immunisation. Medical history included arthritis. Concomitant medications were not provided. On 11-JAN-2021 the patient experienced pain in her left arm. She would like to know if she can use a heating pad on it. The event outcome is not recovered and action taken is not applicable.
Mom states on Saturday "leg that got two shots" started swelling to the size of a silver dollar and was warm to touch. Mom states by Sunday thigh was "the size of an orange" and hot and child would not let anyone touch it. Mom states he has not had fever because she has been rotating Motrin/Tylenol.
I am a  retired Registered nurse. I have had Trigeminal Neuralgia-1999 and Shingles twice ( 2006 and 2013). Approx 22 hrs. after receiving the second Covid vaccine  ( 2/25/2021),I started exhibiting  flu like symptoms ( which is what I expected). I also started having Shingle like symptoms. Any movement would trigger a burning sensation in my hands, feet, lower abd.  inner legs and back.  Chills and a subsequent fever above 102 continues  as do the neuritis  on 2/27/2021
Injection site swelled, was warm to touch and red. Had severe headache, backache, diarrhea, fatigue, chills, lower abdominal pain but no fever. Lasted 24 hours.    Question: Will it be safe to take the second dose on March 25?
the evening of the shot my arm was very heavy and painful to move.  This continued to several weeks - I had 3 rounds of physical therapy to relief the pain.  I would have put the pain level at a 6 out of 10 before the PT.   I am continuing the PT - seems like pain level is a 1 -2 depending on the day.   Much improved.  The pain felt like a torn bicep (I had a torn bicep in 2017 surgically repaired in my right arm).   So hence refence to the type of pain.
Patient reports that she received her first dose of the Pfizer Covid vaccine and within an hour developed flushing and diarrhea and states that her blood pressure was elevated 160/100. She states that flushing resolved after 24 hours but diarrhea has persisted to some degree.
Numbness in finger tips, ongoing headache, chest pain, sore throat, Running nose, dizziness, chills, pressure behind eyes, back of head numbness and tingling
Pain in the Left arm at the injection site (lasted for about 4 days).  Redness in the injection site still around 4 days later. 24 hours after injection, felt tired and had headache.  Took Advil to alleviate symptoms. 36 hours after injection, had mild fever and chills, tired and headache.  Went to sleep for 90 minutes and then got up and took Advil.  Felt better afterwards.
2nd dose pfizer vaccine was given to patient on 07/05/2021. We found out on 07/09/2021 vaccine was stored outside the recommended 31 day expiration window.
Screaming upon nursing and defecating.  Diarrhea. Doctor described as an intestinal infection. Lasted for 6 days.  Advised to give Tylenol every 4 hours for pain and Pedialyte if he became dehydrated.
no adverse event; vials were set to expire June 01, 2023 / Vaccines have been administered to 1 patient as well. Lot number 022H22A; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vials were set to expire June 01, 2023 / Vaccines have been administered to 1 patient as well. Lot number 022H22A) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (vials were set to expire June 01, 2023 / Vaccines have been administered to 1 patient as well. Lot number 022H22A). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vials were set to expire June 01, 2023 / Vaccines have been administered to 1 patient as well. Lot number 022H22A) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that vaccine was administered this morning, no side effects. Expiry date of the vaccine was 01-Jun-2023 reported as vials were set to expire on 01-Jun-2023.  Treatment information was not provided.
DID NOT FEEL WELL RIGHT AFTER THE VACCINATION; FEVER; CHILLS; NAUSEA; FACT SHEET MISLEADING; This spontaneous report received from a consumer concerned a 44 year old female. The patient's height, and weight were not reported.  The patient's relevant medical history included no known allergies, no alcohol consumption, non smoker. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1808980) dose was not reported, administered on 06-APR-2021 at 02:45 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient didn't feel well right after getting the vaccine and at 17:30 she started experiencing fever, chills and nausea, which lasted throughout the day and continued until next day.  The reporter also complained that the fact sheet had misleading information as it stated that "The Janssen COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19, then "The FDA has authorized the emergency use of the Janssen COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older under an Emergency Use Authorization." So does the Janssen COVID 19 Vaccine prevent people from getting COVID 19 or may not?" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, and nausea, and the outcome of fact sheet misleading and did not feel well right after the vaccination was not reported. This report was non-serious. This case, from the same reporter is linked to report.
Subsequent to receiving first and second doses of varicella virus vaccine live the pt experienced 20 lesions red with clear center located on legs, arms and face.
Body aches; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
At abut 8am  March 11 - about 12 hours after receiving vaccine -  I got very achy, particularly in my arms and back.  I had a headache.  My temp reached 102.2 but went down by taking Tylenol.  I was very tired and slept most of the day.  The second day, March 12, I felt somewhat better but was still very tired and I slept about 3 hours.  By 6pm that night - 48 hours after having my vaccine - I felt fine.   Note:  I think I had Covid last November.  I was sick for about 5 days.  My test at that time was negative, my husband's positive.  We had the same symptoms.
24 Hours after left thigh pnuemonia vaccine, child had fever of 102.5, redness and swelling in thigh with pain. When I saw pt, I felt this was more like a local cellulitis and treated with Keflex 125mg PO QID x 7D.
4 days after dose 3 of Pfizer vaccine, patient seen in ED for wide spread rash, incidental finding of glucose in urine, hyperglycemia, anemia.
Patient denied any allergies to the components of the vaccine, or reaction to an earlier Pneumococcal vaccine. Patient's wife called on 6/30/15 and stated that patient is feeling feverish (does not have thermometer, unsure if he has fever), also reported patient had a cold recently. Explained that patient;s complaints might be side effects from PCV13 and also since he just had a cold; advised adequate fluid intake, rest, applying ice on injection site.
The adverse event was that the live virus vaccine was administered too close to another live virus vaccine. When givning the vaccine I did not realize the patient had received the varicella vaccine on 8-25-2012. When I looked at the immunization record I noticed where it said patient had the actual varicella disease 01/01/1977 and did not notice she had the vaccine also 08/25/2012. The clerks had wrote on the paper that she needed the Hep B and MMR and had listed that she had paid for both vaccines in travel. She had checked that she had vaccines in last 4 weeks but that is what most of my patients do when they have the Hep B 4 weeks earlier before second dose. I administered the vaccines and the patient commented that the mmr stings like the varicella vaccine. I then realized she had the varicella 08/25/2012. I called nurses with the immunization program and was unable to reach them. I then contacted someone who stated that the mmr dose was invalid and would have to be repeated in a month. I let the patient know this and scheduled an appt for the patient to return in one month.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about January 2011, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about January 2013, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not provided. In 2013, the patient was vaccinated with the zoster vaccine live (ZOSTAVAX) (strength, lot # expiration date, dosage, injection anatomical location and route of administration were not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, he was treated at a clinic, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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, he had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Therefore, the outcome for herpes zoster was not recovered, and for vaccination failure was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Tested positive for COVID 19 on 2/17/2021, asymptomatic
pass out; vomiting; Severe muscle pains; Severe headache; This is a spontaneous report from a contactable Other HCP (patient).  A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 at 10:00 at single dose in left arm for COVID-19 immunisation at the age of 48-year-old. Lot number was EL3248. Medical history included asthma, migraine headaches, thyroiditis. Concomitant medications included levothyroxine, fluoxetine, bupripion, clonazepam. The patient was not pregnant. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Jan2021 at 15:00 at single dose in right arm for COVID-19 immunisation at the age of 48-year-old. On 02Feb2021 at 23:00, the patient experienced severe vomiting which kept the patient up most of the night, she had to stay by toilet; the patient was feeling like she was going to pass out with any movement, the patient experienced severe muscle pains that felt almost like bones were breaking inside; the patient experienced severe headache; the patient almost took her-self to the emergency room in the middle of the night, but she did not want to expose her compromised immune system to others. The patient was not treated for the events. The patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the LOC and other reported events  due to temporal relationship  Additional information is needed to better assess the case, including complete medical history, diagnostics including chemistry panel, Head CT/MRI and EKG, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Day after vaccine Nausea, Headache, Body Aches, Stuffy nose, sore throat, cough on Day 2, 3, 4, 5, 6, 7, Day 8 went to urgent care for cough sinus infection and coughing phlegm. Was given Zpack, cough syrup and steroid inhaler. Recovered by day 13.
rash/Drug Eruption; 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 medical history, concurrent conditions, drug reaction, allergies or concomitant medications. On or around 25-MAR-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location not provided) for routine health maintenance and for prevention o shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) the patient suffered rash/drug eruption which lasted several months following vaccination. As a direct and proximate result 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. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of Zoster Vaccine Live (ZOSTAVAX). At the reporting time, the patient had not recovered from the event of rash/drug eruption. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   The reporter considered rash/drug eruption as a disabling event.  Additional information has been requested.
itching at the injection site; burning sensation at the injection site; redness at injectrion site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE PAIN (burning sensation at the injection site) and VACCINATION SITE ERYTHEMA (redness at injectrion site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE PAIN (burning sensation at the injection site) and VACCINATION SITE ERYTHEMA (redness at injectrion site). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. On 01-Feb-2021, VACCINATION SITE PAIN (burning sensation at the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (redness at injectrion site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included Cortisone with aloe.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Hard, raised lesion on upper Rt arm. Warm to the touch. Afebrile dx with cellulitis to Rt upper arm 2 days Td injection. Keflex 500mg po Q 6 x 10d, warm compresses to Rt upper arm good for 30 min x 3d, Ibuprofen 800mg po tid x 7d.
Left side of body, head face became numb plus pins & needles. Hard to walk for 1-2 wks, left arm seemed to be at half strength for 9-12 months (dropped mugs, plates). Currently symptoms are mostly isolated to left palm. When stressed 1/2 of left arm becomes numb/tingling. Emergency room ruled out stroke, heart attack, neuropathy, etc. No treatment offered.
Body aches, fatigue, swollen face/eyes, rash all over body, with welts, cough, itchy . Headache. I still have swollen bilateral eyes!
fever; chills; A spontaneous report was received from a consumer concerning a 54-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever, chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012A21A) via unknown route for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the events, fever, chills.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, fever, chills was unknown.