chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lil sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21-JUN-2023, the patient received the 1st dose of Shingles vaccine. On 21-JUN-2023, less than a day after receiving Shingles vaccine, the patient experienced pain (Verbatim: lil sore). The outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 21-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received 1st dose of Shingles vaccine and experienced lil sore, nothing major.  The patient states that he/she had his/her 2nd shot in a few months. Follow up was not possible, as no contact details were available.
Developed a rash, inflammation, even with and directly under shot spot on left arm, size approx 4 1/2" long and 2 1/2" wide, kind of sporadic.  It itched, became red, warm.  Starting to become lighter in color on 1/29/21.   Left message for Dr. he/she was not in on 1/28/21.  Still waiting for call back.  Hopefully it will go away.   Since it has not totally gone away, I said "No" to Item 20.
perceived odors; taste became more acute; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (perceived odors) and TASTE DISORDER (taste became more acute) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (8-10 years ago, a patient lost his sense of smell because he had a surgery where some polyps in his nose had to be removed, and where the septum was straightened.). Concomitant products included MONTELUKAST, CANNABIS and ALBUTEROL SULFATE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced ANOSMIA (perceived odors) and TASTE DISORDER (taste became more acute). At the time of the report, ANOSMIA (perceived odors) and TASTE DISORDER (taste became more acute) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Seizures and mental retardation after 1st DPT. Also had a poor appetite before and after vaccination. The 1st seizure occurred 20 minutes after vaccination of routine DPT. A month later, she had another seizure and grand mal seizures every 3-4 days after, for 17 years but less in the last year. Follow up letter state: MD was not pt's doctor in 1984. He became her doctor on 08/15/1987.  Pt's MD before was taken over by New MD who never saw pt.
Patient received both PNEUMOVAX 23 and FLULAVAL on 10/19/2011 at pharmacy. Next day ran 101.5 temperature and painful red swelling on arm 6" below the injection sites. Red swelling and pain worse on 10/21/2011. Patient returned to pharmacy where pharmacist advised her to see her doctor. Patient went to local walk-in clinic, where cellulitis was diagnosed and she was prescribed KEFLEX. Doctor drew outline on her arm of the red area and advised her to go to ER if the area grew larger and she continued to feel malaise and pain. On 10/22/2011 patient went to Emergency Room, where ER doctors confirmed diagnosis of cellulitis and gave IV vancomycin, in addition to prescribing clindamycin and KEFLEX. Patient suspects poor swabbing of her arm prior to the injections. Patient is still under treatment, but cellulitis seems to be resolving.
On 2/26/01 Mom reported immunization site was red and baby had a fever. Was seen on 2/28/01, and dime size red area on skin under IPV site with area of induration 1x2cm beneath. No tenderness, baby happy. Temp not taken.
hot flushed;splotchy rash on back, chest, arms;temp not taken 2:58AM-no fever spoke w/ER MD to phone to ER call back if stiff neck etc;
Local rash and pruritis. Treated with Benadryl (PO) and topical cortaid. Developed painful swelling and redness.
Patient up to date with COVID vaccinations who admitted with positive COVID test.  Provider d/c note:  "27 yo F with a PMH of Chron's, Anxiety who presented to Urgent Care due to generalized weakness and worsening bloody stools at home. Found to have acute blood loss anemia requiring 3uPRBC in setting of likely crohn's flare and EPEC. She was also COVID +. She was not hypoxic but did have a sore throat. She was initiated on IV solumedrol 20mg q8 per GI and transitioned to home Prednisone 40mg daily upon discharge. She should continue a low residue diet. She had "normal" stools prior to discharge with no further bleeding noted. She was discharged home in stable condition with strict return precautions".
Shot given on 03/16/18 was painful, the next day she developed swelling, itching, and felt feverish and achy. She started to get better and then on 03/21/18 she developed redness, more swelling, and aching to the circumscribed area distal to the shot site.
Redness on all four of her extremities; Pruritis on all four of her extremities; Areas has a vesicular appearance; Mild chills; This case was reported by a physician and described the occurrence of erythema of extremities in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced erythema of extremities, pruritus, vesicular rash and chills. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the erythema of extremities, pruritus, vesicular rash and chills were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, pruritus, vesicular rash and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix, 3 weeks ago from the date of reporting. Past few days after vaccination, the patient experinced few areas of redness and pruritis on all four of her extremities and few of the areas has a vesicular appearance and mild chills. The reporter at first thought it was related to some kind of bites, but inquiring if this could be related to the vaccine. The patient had no fever and no sweats and had no improvement on benadryl.
given MMRV Proquad which is not indicated for under 4 years old.
tiny red extremely itchy dot appeare on both arms, injection sit extremely swollen and itchy.
Shingrix that expired on 8/24/2023 was administered to a female patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult female patient who received Herpes zoster (Shingrix) (batch number 49N3S, expiry date 24-AUG-2023) for prophylaxis.   On 30-AUG-2023, the patient received the 1st dose of Shingrix. On 30-AUG-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Shingrix that expired on 8/24/2023 was administered to a female patient).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 01-Sept-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. The patient received an expired dose of Shingrix, which led to expired vaccine used.
Right arm noted swelling and warm to touch, reddened. Able to move but slight pain. Ibuprofen every 6 hours and ice pack to arm.
On 08/09/2000 the patient developed approximately 50 chicken pox lesions on the torso and face. The patient sought unspecified medical attention. Additional information has been requested.
Chills, fever (up to 101F), headache, muscle aches starting about 6 hours after injection, getting worse for about 36 hours, then getting better, recovered in 4 days. Had to spend most of day following injection in bed.
Low grade fever, body aches and headaches that began on 4/9. On 4/13 vomiting.  Low grade fever came back on 4/15 and has occurred every night since.
Moderna vaccine given to 17 y/o. No adverse reaction noted after 15 minutes of observation.
Information had been received on 20-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 18-JUL-2008 at clinic as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of Herpes Zoster. On or about 23-JUN-2016, the patient was treated by a physician at the clinic for a painful rash that was diagnosed as shingles. On or about 18-JUL-2016, the patient was treated again at the same facility (as reported) by another physician for an ongoing outbreak of shingles. On or about 06-SEP-2016, the female patient was diagnosed with neuropathy, a painful and chronic residual condition caused by nerve damage after contracting the shingles. Although postherpetic neuropathy is an incurable condition, the patient has been prescribed NORCO to manage her symptoms. As a direct and proximate result of these malfunctions, 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, pain and suffering and other damages. Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EN6199) at the age of 59 years as dose 1, 0.3 ml single and administered in arm left, administration date 01Apr2021 (Lot number: ER8732) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Barrett's esophagus", start date: Jun2019 (unspecified if ongoing); "High cholesterol", start date: Dec2008 (unspecified if ongoing), notes: takes Simvastatin 40mg once daily. There were no concomitant medications. The following information was reported: CARDIAC FLUTTER (medically significant) with onset 2021, outcome "unknown", described as "heart  fluttering that was beating"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "heart pounding and her heart beating fast and hard"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "her heart beating fast and hard"; THYROID DISORDER (non-serious), outcome "unknown", described as "It has affected her Thyroid". The patient underwent the following laboratory tests and procedures: heart rate: fast and hard, notes: her heart beating fast and hard. Clinical course: First, right she got the first vaccine on 11Mar2021, she did not have a fevers or anything like that. At night time, her heart was beating hard and racing. It started either 11Mar2021, or 12Mar2021. It dissipated after 2-3 weeks with first shot, then she got 2nd shot on 01Apr2021, and the same thing happened again and it dissipated within 2-3 weeks. The whole summer was great, and she worked hard and was active. Agent states the caller had her heart beating fast and hard after all of the doses but after the 1st and 2nd dose it had dissipated but after the 3rd it has not dissipated. Agent states the caller found out she has an overactive thyroid which was not a problem before and her doctor believes it is the thyroid that is causing this but the caller believes it is the vaccine. No follow-up attempts are possible. No further information is expected.
Received Hepatitis A, IPV, Td on 11/6/02. Within several hours developed nausea, HA, fever, abdominal cramps. Evaluated 11/8 at hospital. 11/9 developed icterus. 11/15/02 Sent to medical center for further work up.
Approximately 2 hours after injection, site became red, itchy, rash at injection site, painful and feeling of right arm being on fire.  Within an hour, the right arm was burning, itching, swelling from injection site location to right shoulder, collarbone, down right breast and under arm, to right elbow and middle of right shoulder blade.  The entire area was warm to touch, painful with erythema from injection site to elbow.  Skin became tight within the swollen area and unable to lift arm without assist.   Was unable to sleep for 48 hrs due to itching, swelling, pain and discomfort.      2/15/2021 - Ice pack to site 15 minutes and off for 20 minutes and Benadryl 50 mg every 4 hours around the clock for 48 hours for itching and swelling.   2/16/20221, 2:00 pm  - Virtual office visit with PCP.  Received prescription for Methylprednisolone 4 mg dose pk.  Started dose pk at 8 pm.  2/17/2021 - Itching improved, pain and discomfort less.  2/18/2021 - Swollen areas not as tight with improvement to swelling overall. 2/19/2021 - Swelling, itching, pain greatly improved and able to lift arm without assist.  Erythema remains.  2/22/2021 - Erythema remains but less red and warm.  2/24/2021 - All adverse reactions appear to be resolved.
Pap smear abnormal; This spontaneous report was received from a nurse referring to a 24 years old female patient. Information about pertinent medical history, drug reactions or allergies was not provided. Concomitant therapies included albuterol(VENTOLIN INHALER).    On 02-DEC-2010, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot # 0597Z, expiration date not reported, but upon internal validation established as 19-AUG-2012) intramuscular for prophylaxis. On 16-FEB-2011, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (lot # 0653X, expiration date not reported) intramuscular for prophylaxis.     On 09-DEC-2019, the patient had an abnormal papanicolaou (PAP) test. The patient was referred to another practice for follow up care, where she had a cervical biopsy and a colposcopy. The patient is scheduled for a loop electrosurgical excision procedure (LEEP)  later this month. The outcome of abnormal PAP test was reported as not recovered. Causality assessment was not provided.
4-13-15 at noon dizzy, fever, lethargic went to ER developed muscle tremors, migraine and temp >103. Sent home. 4-14-15 in AM. Woke up with chest pain, muscle cramps, joint pain back to ER, diagnostic testing done as listed below and given prednisone (sent home with Rx).
Woke up feeling foggy, achey, low grade fever (98.8 F). Just moved slow for most of the day, really had to concentrate as I went through my work day. Not as sharp or quick with mental processing and decisioning making. Work from home, so it's really obvious when I am off my game. Drank 6 x water at 12 oz per. Took two ExStrength Tylenol about 130, no fever, knocked down achey joints, head began to clear, but still not sharp. Not sharp mentally continued into morning of 31 March.
Nausea, diarrhea, headache, Fever (101.0) general aching in muscles.
Prior to recieving her vaccine , the patient stated she was nervous and has anxiety.  After recieving the vaccine she said she felt fine. I told her to stay there for few minutes make sure she was ok. Her husband was getting the vaccine next so I went to start reviewing his paperwork. 5 minutes later he said she didnt feel good. She said she felt like she was going to pass out and wanted to sit or lay down on the floor. Her husband and I helped lower her to the ground and she lay on her side. I asked if she wanted water or anything she said yes. I got her a cold water and she put it against her forehead and said she just needed a minute.   After 10 minutes she got up and sat in the chair and said she felt better.  I then gave her husband his vaccine.   10 minutes later as they wanted after his he said she did not feel well again. She was laying on the floor and said she did not feel like she woulf pass out but just didnt feel right. I asked if she wanted me to call 911 she said yes, just to be checked out.  They came with in 5 minutes and then she said she felt better and was sitting again.   They talked to her and watched her stand up. They checked her pulse and said it was normal and her color was good. She ended up not going with the ambulance and agreed it was probably jsut anxiety  / panic attack.  She walked away fine and also stated she needed to eat dinner.
Information has been received concerning a pt who was vaccinated and subsequently developed cellulitis. The pt was treated with antibiotics.
Started getting full body hives and redness and itchiness 2 weeks after getting the Moderna booster shot. More than 2 months in, still getting hives and dermographia. I?ve been asked by my allergist to take Allegra.
This case was reported by a nurse via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received SHINGRIX. In April 2018, less than a month after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the rash was unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional called and reported that the patient received vaccine and experienced shingles outbreaks since on the arm where the vaccine was administered. The rash seems to be following the nerve line down her arm. The 2nd outbreak was in the crusting over stage at the time of reporting.
Refrigerator went in and out of range while there was flu vaccine in it. Doses were administered - no adverse effect This spontaneous case initially received on 02-Nov-2016, was reported by a health professional and concerns an 71 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported. Route of administration: Not reported. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Narrative:  Nausea occurred after patient had received a dose of COVID-19 vaccine. Patient did not note that he needed medication to treat nausea.
Upon waking up the day after receiving the booster shot, I have a minor cough and tightness across the chest when taking a deep breath. I have also lost most of my sense of taste. I have a metallic taste in my mouth and when I eat food it tastes terrible. Smell seems to be unaffected so far. I have not been exposed to COVID-19 as far as I am aware, but these symptoms are consistent with a COVID-19 infection and from my searching are not typical side effects from just the vaccine.
12/16 9:30pm chills, headache, body aches, tiredness until 12/18 10:00am;  12/19 eyelids and upper torso became itchy, continued through 12/20, took an Allegra allergy pill at 10:00 pm and waiting to see if itching stops.
third shot of Moderna, 2 Pfizer shots previously; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third shot of Moderna, 2 Pfizer shots previously) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third shot of Moderna, 2 Pfizer shots previously). On 30-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third shot of Moderna, 2 Pfizer shots previously) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.  Patient got their 2 shots of Pfizer previously, one of them got 2nd Pfizer shot on 25 Aug and took modern booster after 5 days.
Provider concerned due to patient ended up with Shingles/Active Chicken pox 4 months after receiving 1st varicella vaccine. Patient came into clinic on 6/21/18 due to outbreak of rash, vesicles to left thigh and left buttock noted in clusters. Patient sent home on acyclovir suspension and topical cream for treatment. Patient had varicella titers drawn which came back active for chicken pox/shingles. Patient to follow up in clinic in 1 week.
The day of the vaccine, Pt had a weird feeling and sat down. She did some breathing exercises but she started breathing faster, leaned over & fell & hit her head slightly. She started jerking for about a minute but she used her magnet and it started to bring her out of it. The very next day, she had 2 more seizures, within a 30 min period, & similar episodes.
Information has been received from a market research agency concerning unspecified patients of unknown ages (less than 65 years old) and gender. No information regarding current condition or medical history was reported. In the last 3 months, on unspecified dates the patients received PNEUMOVAX 23 (lot#, dose, route not reported) (inappropriate schedule of vaccine administered). Concomitant medications were not provided. Additional information has been requested.
Child fainted 1-2 minutes after receiving shot. Took 30 minutes for child to gain color and energy back into the body.
I  went to work and went to work clinic for my booster 3rd shot. Waited for 15 minutes and continue working. 1 month I notice itchiness and a visible rash all overt my arms and legs and it started spreading with burning sensation, That lasted for about 1 week and half took over the counter medication and creams. This worst was gone but  I still have eczema flare ups.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Nausea-Medium
ground level fall, hypoxia, O2 at 10L oxymask ; + covid PN; acute resp failure; AFIB on eliquis; Zinc, Vit C. Pt experiencing some bradycardia. Made DNR on 2/2. O2 increased to 15 L NRB on 2/3. remdisiver held. Decadron. more lethargic, placed on comfort care.
ERYTHERMA/REDISH AND LUMPY FEEL ON THE LEFT ARM AROUND THE INJECTION SIDE