chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received his first dose of Pfizer Covid-19 vaccine on 5/15/2021 and the second dose of Pfizer Covid-19 vaccine on 6/5/2021.  After an abrupt onset of mid thoracic back pain and leg weakness on 6/16/2021, the patient rested for the night.  In the morning, he was unable to walk, characterized by dragging his feet and falling o the ground.  He was unable to void.  Mother sought care for him at the Emergency room on 6/17/2021.  In the ER, he had an MRI scan of his spine which showed no significant central canal foraminal stennosis.  He was catheterized and had urinary residual of 600ml after an episode of urinary incontinence. Neurology at the Clinic was consulted and patient was transferr
Headache, NauseaVomiting, chills, sore throat Narrative:
Rash all over body, spreading, complain of itchiness for 2 days.
Left arm at injection site felt cold after five minutes after injection. Lasted a minute.  Dizziness. Has lasted so far four hours  Jaw bones hurt  Running temperature. Started three hours after injection. Current temp is 100.2. taken orally at 4:15pm PST  I called in sick for work, stating it's vaccine related for my shift on 2/5/2021. My shift would have started at 11:00pm.
Was given another dose of Tdap on 12/15/2022 and had already received on 12/09/2022. Current pregnancy EDD is 01/05/2023.
Had both  my shot got the shingles/suspected vaccination failure; Had both  my shot got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had both  my shot got the shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had both  my shot got the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 02-JUL-2023 The case was received from the patient interactive digital media. The patient had both shot and got the shingles, this was his/her 10th week and had them (at the time of reporting). This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
black particles in it/ pharmacist administered three doses to three patients from this vial; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT CONTAMINATION PHYSICAL (black particles in it/ pharmacist administered three doses to three patients from this vial) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT CONTAMINATION PHYSICAL (black particles in it/ pharmacist administered three doses to three patients from this vial). On 13-Apr-2021, PRODUCT CONTAMINATION PHYSICAL (black particles in it/ pharmacist administered three doses to three patients from this vial) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Per reporter: Vial with black particles in it was administered to three patients.  Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Dizzy, feeling very faint at random times, spikes in blood pressure, increased heart rate, fever
"Patient reports that just after she was administered the Pfizer COVID-19 vaccine (first dose) on 1/16/21, she developed redness around the area that resolved in "two to three days". However, she then developed a wheal-like lesion around the injection site in the last day after the initial redness resolved. She noted diffuse warmth around the proximal left upper arm/left deltoid region. She denies tenderness on palpation. She reported feeling a "knot" underneath skin where lesion occurs. She did not complain of SOB/wheezing, swelling."
chills; fever of 100.3; aches in his groin area and on both sides of his legs; soreness in his arm; aches in his groin area and on both sides of his legs; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever of 100.3), GROIN PAIN (aches in his groin area and on both sides of his legs), VACCINATION SITE PAIN (soreness in his arm) and PAIN IN EXTREMITY (aches in his groin area and on both sides of his legs) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 041L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced CHILLS (chills), PYREXIA (fever of 100.3), GROIN PAIN (aches in his groin area and on both sides of his legs), VACCINATION SITE PAIN (soreness in his arm) and PAIN IN EXTREMITY (aches in his groin area and on both sides of his legs). The patient was treated with ACETYLSALICYLIC ACID, PARACETAMOL (EXCEDRIN BACK AND BODY) at an unspecified dose and frequency. At the time of the report, CHILLS (chills), PYREXIA (fever of 100.3), GROIN PAIN (aches in his groin area and on both sides of his legs), VACCINATION SITE PAIN (soreness in his arm) and PAIN IN EXTREMITY (aches in his groin area and on both sides of his legs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided. It was reported that the patient took 2 Excedrin this morning, and 2 this afternoon.
The day after my shot I noticed some hives, but I thought they were bug bites at first. But everyday I?m getting more and more bumps, and when I looked at a picture of hives, these bumps look very similar. The first ones look like big mosquito bites or spider bites. But the next day I got small bumps that looked more like hives. The big bumps are on my right arm, but not next to where I got my shot. The hives are on my right ankle, and now are popping up on my right arm. They are every itchy, and a bit disconcerting because they are growing in size and spreading more each day.
Patient started with a rash and a fever of 101 the night of the injection.  The next morning, the rash had spread up and down and along the sides of the leg.  Mom states that leg was warm to the touch.  Gradually the rash has started to go away. The rash is just spotty right now.  There have been no other symptoms.
Fever, chills, headache, muscle pains.  Headache is gone, fever and chills and muscle pains not completely gone at time of this report but these symptoms are definitely improving.
Pt had a recent history of ear infection when on 4/4/01, 2 days post vax, he experienced a seizure and developed a fever of 103. He was taken to the ER. He was not admitted to the hospital according to ER note because the pt was older than 1 year and they felt he experienced a febrile seizure. He was treated with acetaminophen and discharged.
Mother report:Temp 101-102 on 10/14-15. No higher as child has run frequent temps and mom familiar with how he responds. Itchy, red, raised (like mosquito bites) on hands, feet. Facial swelling followed by "huge" swelling of upper lip 10/15.  Benadryl q 4 hours post Dr. call 10-15.  Saw Dr. 10-16. Decreased swelling.  Dr. report: concurs with above, papular rash of abdomen.  Call to mom 10-17 and child recovered.
A nurse reported the occurrence of hives in a female subject of unspecified age who received an injection of Hep B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not provided. On an unspecified date, the subject received an injection of Engerix-B. Following the injection, the subject "broke out in hives." Treatment was not specified. The outcome of the event was reported to be resolved.
Information has been received from a 69 year old male with thyroid disorder and blood pressure who on 26-OCT-2007 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included insulin, SYNTHROID, simvastatin (MSD), DIOVAN and NEURONTIN.  On 26-OCT-2007, 8 hours after vaccination the patient took his blood sugar on his meter at home and it was reported that it read extremely high levels.  The patient contacted his physician immediately.  It was reported that the patient had the highest blood sugar level he had ever seen.  The patient stated that he his blood sugar had lowered since then but was still in the 300's.  Unspecified medical attention was sought.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
A day after patient receive vaccine patient noticed swelling and redness of the arm below injection site, around mid bicep area.  Erythema noted from lateral to proximal side of bicep, and about 2 inches up toward deltoid
patient states the evening after her shot, her face started to swell up and moved down to her eye. The area over her left eye feels warm to the touch and is visibly swollen.
This injection was administered much higher than normal.  Immediate pain was felt as well as ongoing pain since.  Also, a subclavical lymph node became swollen the day after the immunization.  I had it checked out by, ARNP.  She said that it was probably from the immunization and that is should go away in a few days, which it did.    Lymph node resolved, still experiencing shoulder pain.
This spontaneous report ws received from a 68 year old female patient regarding herself. The patient was allergic to chromium diphosphate. The patient's pertinent medical history included bronchitis which occurred in Autumn of 2013. The patient was not a pregnant. On 14-AUG-2014 the patient was vaccinated with PNEUMVAX23. (Dose/Frequency: 0.5ml/single dose) (lot # K005957, expiry date: 08-MAR-2015) subcutaneously to avoid recurrence of bronchitis. Concomitant therapies included TENORMIN 50 mg, LIPITOR 10 mg, CITRACL +D 630 mg and BIOTIN 10,000 microgram. On 15-AUG-2014, the patient experienced vomiting, nausea, dizziness, weakness, light headedness, chills, feeling not herself and pain when moving her arm in the location where the PNEUMOVAX23 was injected. The patient reported that the pain in the arm occurred directly after vaccination but went away shortly after. The lab tests performed included blood work but the results were not reported. The patient sought medication attention, contacted the physician but was unable to reach her and no treatment was provided for the events. The outcome of nausea, feeling not herself, chills, light headedness, weakness and dizziness was reported as recovering. The outcome of  vomiting was reported as recovered on 17-AUG-2014 and pain when moving her arm in the location where PNEUMOVAX23 was injected ws reported as recovered. The causality of vomiting, nausea, dizziness, weakness, light headedness, chills,feeling not herself and pain when moving her arm in the location where PNEUMOVAX23 was injection was not provided. No product quality complaint (PQC) was reported for PNEUMOVAX23. Additional information has been requested.
Right arm pain since 11/18/03. Unresolved as of 12/30/03, but states her arm is getting better. She is going to physical therapy due to this event, and being followed by her doctor(s) for treatment.
Per employee this morning started running a low grade fever of 99 and felt out of the ordinary fatigue.
Arm pain for two days. Fatigue; muscle ache; headache , nausea that day - which lasted three to four days. The day after vaccine - I had a regular scheduled appt with neurologist - she prescribed a new med - Nurtec - I have taken twice since getting the vaccine. I'm still having ongoing fatigue; headache and nausea as well.  Got period and it is more heavier than usual - almost went to ER. I have had a lot of pain and cramping associated with it. Have a lot of fluid and tissue coming out now that it's stopped.
8 hours after vaccine #2, I had a heaviness on my chest, tightness, checked pulse ox at work as well as bp, all normal-subsided 24 hrs later, 3 mos later started developing joint pain everywhere, saw multiple doctors, finally in November had labs drawn and positive ana with current work up of MCTD vs Rheumatoid arthritis,  rheumatologist recommended dose 3 which I received 1/24/22 with same response of chest pressure with heaviness and tightness resolved after 24 hrs, Monday 3/14/22 Emergency visit with chest pain and Shortness of breath, work up in progress by Cardiology.
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 09-JAN-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 24-JUL-2017, the patient was treated at a Family Practice for the onset of blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Itchy rash with small bumps flaring up all over body (not at injection site). Taking antihistamine which helps keep it down. Has not gone away yet.
After the first shot on 03/25/21- I had extreme muscle/joint pain. I debated whether to get a second shot out of concern. I received the second shot on 04/19/21 and neurolgical nerve pain is intensified. I have a history of spine issues, but after the vaccine it intensified. Nerve pain started going into both hips, knees, and ankles. Meaning I received new symptoms. Also, I have disc replacement at C4/5 and while I've had difficulty with the disc, the pain now goes down both arms into my elbows and then I get more pain in the fingers. While, I certainly had pain before the vaccine, I would say it was taken to a new level. I've been to several doctors including traditional and holistic.  Neurosurgeon said spine is stable, primary MD has heard of people getting flared up after vaccine. I've seen a functional med practitioner to ensure I am taking care of my body in all ways. And finally, a counselor due to the flare up being difficult to deal with mentally.
Localized reaction to flu vaccine: redness 3 1/2 cm and swelling, slightly warm to the area. To ice area and return if symptoms become worse.
LIGHT HEADED; This spontaneous report received from a patient via a company representative concerned a 96 year old female. 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 not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On MAR-2021, the subject experienced light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed on MAR-2021. This report was non-serious.
Vaccinated on 1/22/2021 around 0945. By 2100 that night, symptoms began to set in.  No fever but felt febrile, body aches, joint pain, and "it felt like all my organs were under attack.  I felt better Sunday morning', January 24th.    After the 1st dose, arm swelled to elbow and had minor body aches but nothing too significan.
loss of vision; herpes zoster; Information has been received from a lawyer regarding a case in litigation which referred to a currently elderly (approximately 77 years old) patient (pt) of unknown gender. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On or about 02-JUN-2008, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided) at a physician's office. Subsequently (on an unknown date), the pt was treated for herpes zoster and loss of vision (blindness). The outcome of the events was unknown. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Upon internal review, the event blindness was determined to be medically significant.
nipple drainage; itchy and watery eyes; itchy and watery eyes; sore arm; metallic taste; This is a spontaneous report from a contactable nurse (Patient). A 55-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. The patient took vaccine for work, and to get back to a normal life. The patient's medical history and concomitant medications were both reported as none. Shortly after her first dose of the vaccine, she developed nipple drainage. She didn't know if it was coincidental or what. She hadn't noticed it prior to the vaccine. She a work up with a mammogram and ultrasound. There were no masses or anything else. They showed no reason to have the drainage. She was unsure of her weight, but would get 140 or 150 lbs. With the first vaccine, she experienced a sore arm. It started the evening of the 30Dec2020 about 4-6 hours after the vaccine. That resolved, and she recovered completely. She also experienced a metallic taste in her mouth. It happened initially on 30Dec2020. She recovered completely. It only lasted a couple of hours. They were both not serious. She had noticed an increase in the itchy and watery eyes on an unknown date. It was ongoing and persisting. The patient underwent lab tests and procedures which included mammogram: normal, ultrasound breast: normal, weight: 140 or 150 lbs, all on an unknown date. The outcome of the nipple drainage was unknown, the outcome of the events sore arm and metallic taste was recovered on 30Dec2020, the outcome of the events increase in the itchy and watery eyes was not recovered.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 06-JUN-2017 the patient was vaccinated with VARIVAX lot # L020001 for prophylaxis. Concomitant therapies included sterile diluent lot # M014698. On 06-JUN-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to VARIVAX. Additional information has been requested.
Received Engerix as First Does, and Heplisav-B For Second Dose; Product administered to patient of inappropriate age; Initial Report Received on 17-Apr-2023   A physician reported that a 16-year-old female patient (race and ethnicity unknown), received Engerix for the first dose and was mistakenly given HEPLISAV-B (hepatitis B vaccine) as a second dose for hepatitis B immunization.    Medical history and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.    On an unknown date, the patient received Engerix as the first dose (no details provided).   On 10-Apr-2023, the patient received HEPLISAV-B vaccine (Lot # 941580, expiration date 06-Jan-2025, and NDC # unknown) intramuscularly in the left deltoid as the second dose. The patient did not report any adverse effects.   No additional information was provided.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Pt's leg has been stiff since immunization. No redness or swelling noted at time of administration or during office visit today. Advised to take ibuprofen, cool packs 3-4x per day and massage 3-4 x's per day.
indurated area noted during routine cardio follow-up on 01nov95, poss. abcess
Vomiting, fever, chills & red swollen arm - at site of PNEUMOVAX injection (arthus type).
Within days to weeks after 2nd Pfizer Covid imm: reports new onset syncopal events, little to no prodrome, and reports palpitations. Had previously had occasional palpitations but describes: frequency and intensity increased after covid imm. Concerned there may be cardiac side effect
Case was admitted on 5/10/2021 and released on 6/15/2021. because case showed symptoms like nausea, vomiting and diarrhea, her vitals were low and she is a diabetic.
15 min after vaccination dizzy, nausea,  30 min later sob and tight chest, vomit (x1) . F/U with ER visit pt left ER after having EKG exam, pt was not discharged and left at own will. Symptoms continue for patient dizziness, nausea, chest tightness.
08/30/22 presents to EC ED for "abdominal pain". PMHx of "DM, HTN"
Patient received PEDIARIX, PREVNAR and a accidental TDAP dose instead of Hib dose given by LPN. Patient had no adverse effects.
Moderna COVID-19 Vaccine EUA Muscular pain at the injection site Back pain Abdominal pain
Started getting rashes and then hives on both arms after flu shot administration. Patient took Benadryl and symptoms resolved.
Shortly after receiving 1 yr immunizations, pt. began developing hives on face and trunk. 12.5mg benadryl + 20 mg orapred were given. Pt observed + d/c when condition improved. Script for epi pen jr + additional dose of 12.5 mg benedryl given for PRN use. time observed 35 min.
p/ pt recv vax in 12/97 pt exp a lack of seroconversion
64 yo male given High Dose Flu vaccine which is indicated for patients over the age of 65.
Pt noticed pumps on face when she sitting outside.  Dermatologist diagnosed it as Herpes Zoster.  Dr. gave RX for VALTREX 1 GM.