chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had a sharp pain and tightness across her shoulder and arm that was the opposite arm of her flu shot.  She also had complete paralysis from the waist down for approximately 3 hours.  She also had numbness that resonated from her waist down that still comes and goes.  She was constipated and could not urinate for about 24 hours even though she felt she needed to. She consulted her accupuncturist because she thought it could be gall stones and she has had them in the past.  That doctor told her to go see us and have us report the event.  She is going to see a neurologist in the end of January because that is the earliest she could get seen.
Breakthrough case admission after three doses Moderan 2/28/21 Lot# 025A21A Moderna 3/24/21 Lot# 045A21A Moderna 11/27/21 Lot# J000429
Hives, Itchiness, Difficulty Breathing Benadryl and later when difficulty in breathing increased an Epipen Administered Symptoms Reduced, no further issues
3 events with the following symptoms that happened on 6/21/21, 6/23/21, and 6/25/21.  Called 911 on 6/23/21.  Firefighters responded.  Rapid heart rate (Fitbit said 145 for heart rate), body felt like it was on fire, pins and needle over body, blacked out, racing heart, felt like I was going to faint, wasn't sure if I was having a heart attack.  Woke me up from sleeping.  Never had this ever before in my life.
@ 6PM achiness & flu like sx occurred; 630 didn't feel well went to hosp adm via ER;  10PM rash "flush", no lip swelling-felt SOB, temp came down to nl @ 4A; highest temp 102 @ 1030PM; rash maculopapular; fatigue;
Sudden increase in PVCs; have noticed them once or twice before, but increased to 1/4-7 beats. Noticed first at 11:00am, and continued at the mentioned interval until the present moment. Headache present as of June 14 PM.
Information has been received from a physician and a registered nurse concerning a 25 year old female who on 01-SEP-2006 was vaccinated IM with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 08-SEP-2006, one week after vaccination, the patient developed "small bumps under her skin" at the injection site. The patient sought unspecified medical attention. Subsequently, the patient fully recovered.
Neck ache - immediately; Humming in ears - immediately; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-01) via an unspecified route of administration in the left arm on 01Sep2021 at 16:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (treated). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ascorbic acid (VIT C), zinc (MANUFACTURER UNKNOWN), colecalciferol (VIT D3) and hydrochlorothiazide/irbesartan (IRBESARTAN HCTZ); all for unknown indications from an unknown date and unknown if ongoing. On 01Sep2021 at 16:00, immediately after vaccination, the patient experienced neck ache and humming in ears. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events neck ache and humming in ears immediately was not recovered at the time of this report.
Long term weakness and pain in location where shot was administered.  Also curious about my diagnosis with RA after my first full vaccination (Pfizer/EL3249 on 1/29/21 and Pfizer/EL9269 on 2/19/21).  Wondering if it is Reactive Arthritis, not Rheumatoid.  Also feel long spells of exhaustion.
Information has been received from an educator concerning a 7th to 9th grade female student, who "within the last 12 months" was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL. The patient may have been vaccinated in combination with other vaccines that was needed to go back into middle school. "Within the last 12 months", when vaccinated, the patient almost fainted. Subsequently, the patient had recovered at the time of vaccination. The reporter did not know if the patient experienced the adverse event with their 1st, 2nd or 3rd dose. The patient sought unspecified medical attention. This is one of several cases from the same source. Additional information has been requested.
51 hours after receiving the 2nd Pfizer vaccine does, I began to experience pain severe in my vaginal area. This pain grew into an ulcer type of sore. I visited three doctors, was tested once for a yeast infection and twice for herpes.  All three labs results were negative, while a minor strep B growth was identified. The area grew more severely painful over the course of 10 days, then it slowly began to resolve. After 17 days, the pain has gone and the site has almost completely resolved itself.  I am taking penicillin to address the strep.
Rash beginning on abdomen spread across body. Treated at home with BENADRYL.
pt recvd vax; throat tightness, trouble swallowing, & hot sweaty; epi given, solumedrol, prednisone;
dT administered 7/19/04. Child had pain at site, continuing through 8/9/04 . Then much more severe left shoulder pain MR/X-ray shoulder normal. No obvious weakness.
Increasing swelling at site of injection.  Hot to touch and itchy.  Other common side effects were headache, low grade fever, body aches, and exhaustion.  Both doses caused a sore arm, but pain traveled into the shoulder and neck of the arm injected for approximately 72 hours.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 75-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine 2017-2018 season for prophylaxis and PNEUMOCOCCAL VACCINE for prophylaxis. Concurrent medical conditions included heart disorder (Patient did not mention what condition). On 22nd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular), Influenza vaccine 2017-2018 season and PNEUMOCOCCAL VACCINE. In October 2018, less than a week after receiving SHINGRIX, Influenza vaccine 2017-2018 season and PNEUMOCOCCAL VACCINE, the patient experienced headache, scalp blister, scalp peeling and skin eruption. The patient was treated with HIBICLENS and Cortisone Cream. On an unknown date, the outcome of the headache, scalp blister, scalp peeling and skin eruption were unknown. It was unknown if the reporter considered the headache, scalp blister, scalp peeling and skin eruption to be related to SHINGRIX and Influenza vaccine 2017-2018 season. Additional details were received as follows: On 22nd October 2018, the patient received flu shot and pneumonia vaccine in left arm. After an hour later, the patient went to pharmacy and received SHINGRIX vaccine in right arm. The patient experienced headache and her scalp broke out. She also experienced scalp oozing and peeling of the skin on her scalp like a burn. The oozing was on different spots on the head and the biggest one was on the hair line. She called her pharmacy on Tuesday morning and she was advised to use HIBICLENS skin cleanser and apply cortisone cream. She visited her endocrinologist on Wednesday for her current situation. The patient gave permission to contact her physician. The patient would follow up with her physician. No further details were provided.
Tiredness all the time, lost of strength in arms and legs, pain in all articulations (hands, shoulders, knees, ankles) dizziness every now and then, a sensation of burning in the site of injection that comes and goes,  sore throat the first two weeks. But the most unlikely effect is the constant tiredness and weakness and arthritis like feeling in upper and lower extremities. At first I though  is will be a week or two,  but now is almost three months and it continues.
developed large red, hot swelling at injection site.; redness; hot; pain; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day 12 hrs after receiving Shingrix, the patient experienced injection site swelling, injection site pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, injection site erythema and injection site warmth to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. A day and a half after receiving Shingrix, the patient developed large red, hot swelling at injection site.  The patient had lot of pain at first, and 2 and half days from injection he pain hadsubsided, but was still red, swollen and hot.  The patient was concerned as to whether or not to have the 2nd dose.
Headache onset 03-Apr2021 at approximately 02:30 EDT continues as of submission of this AE. Arm pain onset 02-Apr-2021 at approximately 18:00 EDT continues as of submission of this AE.
1 YO recived Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-DEC-2022 Reporter's comment: The licensed practical nurse (LPN) stated that Kinrix was inadvertently administered to a 1 year old patient. No side effects so far. The reporter consented to follow up via postal. Additional supportive information: 1-year-old patient received Kinrix, which led to inappropriate age at vaccine administration.
My period started and it was abnormally heavy compared to how it has been most of my life. The blood no longer was clotted and I was saturating my pants after about an hour of changing my cup. It was very strange to have this happen and my body change after having my vaccine.
chills; slight headache; mild nausea; elevated heart rate; This is a spontaneous report from a non-contactable other hcp.   A 26-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular into Left arm on 15Feb2021 11:15 at SINGLE DOSE for covid-19 immunisation. Medical history included Allergies to medications, food, or other products: shellfish, plant pollen. Historical vaccine included first dose of bnt162b2 on 27Jan2021 11:00 AM Intramuscular into Left arm for covid-19 immunisation. Concomitant medication included estradiol, bicalutamide, progesterone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported acute onset of chills and slight headache beginning 13 hours after injection, followed by mild nausea and elevated heart rate lasting 3+ hours, events started on 16Feb2021 12:15 AM. No treatment received for the events. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Had both doses, got shingles/Suspected vaccination failure; Shingles; Lot of pain; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Had both doses, got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Lot of pain). The outcome of the vaccination failure, shingles and pain were unknown.   It was not reported if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.     It was not reported if the company considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 06-MAR-2023 The patient had a friend that had the Shingrix series administered (both doses) and got shingles (lack of effect).   The patient was in a lot of pain due to shingles. The reporter provided minimal information about her friend.   Minimal information obtained for adverse event. The reporter was not asked for consent to follow up.
serious allergic reaction; breathing was labored; red scratch marks all over her upper body; heart beat was getting very rapid; vision was wonky; right eye was swollen; face was beet red; nauseous; A spontaneous report was received from a consumer's mother who state's a 21 year female experienced a serious allergic reaction(hypersensitivity) to the vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 03-MAR-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03-MAR-2021around 15:00, she received the Moderna COVID-19 vaccine in her left deltoid muscle at Shop Rite Pharmacy. 6 hours later she noticed red scratch marks all over her upper body, her heart beat was getting very rapid, her breathing was labored, her vision was wonky, her right eye was swollen and her face was beat red. 911 was called, upon arrival the EMT administered IV diphenhydramine (Benadryl) 50 mg and at the emergency room they gave her famotidine (Pepcid) and a steroid drip (methylprednisolone). After receiving treatment, the reporter states the patient felt great and was discharged. The doctor prescribed her methylprednisolone. Additionally she states the patient was also nauseous last night which went away around 2:00am. They told her to consult her primary care provider about the second Moderna COVID-19 vaccination  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event, serious allergic reaction is unknown.; Reporter's Comments: This case concerns a 21 Y/O F with serious unexpected events of hypersensitivity, dyspnea, and nonserious unexpected heart rate increased, vision blurred, eye swelling, erythema, scratches and expected nausea. Event onset on Day 1 after first dose mRNA-1273. Treated with diphenhydramine and methylprednisolone. Hypersensitivity resolved. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.
Upper shoulder pain, pain running up from shoulder to the left side of neck towards the ear, no pain in the actual ear just in the neck. Underarm pain expanding into the left side of left breast. All pain was an aching pain with tenderness if touched. Took Tylenol for some relief.  There was no redness or rash. Lasted about 2 days with heavy pain on day one and lighter pain on day two.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 09-APR-2014, the patient was vaccinated with ZOSTAVAX, ZOSTAVAX VIAL 19400 PFU (plaque forming units), for unknown indication. No concomitant medications were reported. Pharmacist reported that patient also received ZOSTAVAX on 19-NOV-2012. No adverse symptoms reported. No product quality complaint was involved. The outcome of events was unknown. No further information provided. Additional information has been requested.
Symptoms started in evening, next day progressed and hit hard at about 5PM, approximately 24 hours after injection. Symptoms were typical of flu:  Fever (101 F) Chills Nausea Exhaustion Achiness/Soreness Less mental acuity
Fever of 99.4F; Fatigue; Slept all; swollen arm of injection site; very tender; black/blue bruise on same arm as injection site under elbow; This spontaneous case was reported by an other health care professional and describes the occurrence of TENDERNESS (very tender), VACCINATION SITE BRUISING (black/blue bruise on same arm as injection site under elbow), SOMNOLENCE (Slept all), VACCINATION SITE SWELLING (swollen arm of injection site) and PYREXIA (Fever of 99.4F) in a 71-year-old female patient 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced TENDERNESS (very tender), VACCINATION SITE BRUISING (black/blue bruise on same arm as injection site under elbow) and VACCINATION SITE SWELLING (swollen arm of injection site). On 16-Feb-2021, the patient experienced SOMNOLENCE (Slept all) and FATIGUE (Fatigue). On 17-Feb-2021, the patient experienced PYREXIA (Fever of 99.4F). At the time of the report, TENDERNESS (very tender), VACCINATION SITE BRUISING (black/blue bruise on same arm as injection site under elbow), SOMNOLENCE (Slept all), VACCINATION SITE SWELLING (swollen arm of injection site), PYREXIA (Fever of 99.4F) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Body temperature: 99.4 DF.     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.   Concomitant medications were not provided. The patient used warm compresses on the arm of the injection site to subside the pain of the black/blue bruise.
R arm sore and feels heavy (arm of Td inj). R arm 1/2" larger in circumference than the L arm. Sl. redness and sl. warmth noted mid R deltoid to above R elbow. She did see branches with the L arm the day after the Td injection. She used a cool compress and took an OTC analgesic.
Information has been received on 21-FEB-2017 from a nurse who reported that on 01-FEB-2017, a 13-year-old patient (gender unknown) was administered a PROQUAD vaccination (Route and site of administration were not reported) for prophylaxis. Lot number reported as M032496. Expiration date reported as 02-JAN-2018. No adverse effects were reported. There was no quality complaint involved. No further information was provided. Additional information has been requested.
After my second vaccine shot I got very sick with the next symptoms: fever, bad headache, joint pain, muscle pain, skin rash, burning feet and hands, stabbing pain in my calves.  After 24 hours most symptoms disappeared but burning feet and hands left. I started experience suddenly stabbing shots in my right calve. I was afraid of blood clots and went to check my veins. I had varicose veins ablations in 2010. Doctor checked my veins on both legs and said there is nothing wrong with the veins. She advised me visit neurologist, and assumed a neuropathy. I visited many doctors multiple times. I was diagnosed by Neurologist with peripheral neuropathy, by Oncologist with MGUS, he is still in research. Doctor prescribed me Duloxetine to help me sleep, though I still suffer from constant burning pain in my leg and hands. I already have balance problem and almost constant dizziness. No one can find what causes my neuropathy. X-Ray, MRI, PET, blood work. I was pretty healthy before VAX.
Pt was brought to ED due to altered mental state, apparently after pt received first Covid vaccine, she didn't feel quite well, fatigued; after recent 2nd Covid vaccine, pt had been noted to be confused with poor appetite. Pt also with recent dx hypopituitarism - has been on desmopressin/ prednisone - per report from family members, pt had been drinking a lot of water. In ED, Pt was noted with hyponatremia - NA 124, Lactic acidosis 2.1, low grade temp - PCT wnl.
On 01/20/2022 around 3:15 pm, patient came into the pharmacy for the 1st dose of Pfizer COVID-19 vaccine from an online appointment. In the immunization room (with his mom's presence), I reviewed the consent form with him and confirmed he has no known allergies to medications, foods and other vaccines. He expressed he is very anxious about the vaccine and has to get vaccinated due to school requirements. I explained to him about possible common side effects of the vaccine. I recommended him to rest, take a Tylenol tablet if he needs some relief and definitely relax tomorrow. I also said we're open everyday so he can always contact us if he has any concerns. Then I gave him the vaccine and told him please take a seat for 15 minutes post vaccine observation. About 5 minutes after sitting down, he felt tingling in his feet, then passed-out and leaned over his mom. His mom yelled out for help. Our pharmacy staff and front store managers came over to give him water, lollipop and asked if everything is ok. He gained consciousness and was able to respond to us. He told us he felt anxious all day knowing he will be getting the vaccine and he did not eat lunch before coming to the pharmacy. About 10 mins later paramedics arrived and took over. Afterwards he left the store riding 1 of our electric scooters and his mom walked beside him.
Intense pain when dose administered. Within 18 hours large bump. redness, and heat spread on arm and shoulder. Within 20 hrs high fever, up to 103.7, with shaking and severe muscle aches. Was prescribed anti-biotics.
Lowgrade fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Lowgrade fever), HEADACHE (Headache) and NAUSEA (Nausea) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PYREXIA (Lowgrade fever), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PYREXIA (Lowgrade fever), HEADACHE (Headache) and NAUSEA (Nausea) was resolving.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  In 2021, the patient experienced events after took booster shot. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.