chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting having spasms, got worse over several weeks. Went to ER. Diagnosed with Infant Spasms
This spontaneous report as received from a pharmacist refers to a 26 year old female patient. In June 2012 the patient received her first dose of GARDASIL (lot # not reported) (0.5ml dose and intramuscular route). On 28-SEP-2012 the patient was vaccinated with the second dose of GARDASIL (lot # not reported) (0.5ml dose and intramuscular route). Concomitant therapy was not reported. It was reported that at the time of the report the patient had not received the third dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Autoimmune disease relapse; Balance issues; Other issues/Physically wasn't able to go get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Autoimmune disease relapse) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder (Autoimmune disorder before receiving the Moderna vaccine.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Autoimmune disease relapse) (seriousness criterion hospitalization), BALANCE DISORDER (Balance issues) and MALAISE (Other issues/Physically wasn't able to go get the second dose). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, AUTOIMMUNE DISORDER (Autoimmune disease relapse), BALANCE DISORDER (Balance issues) and MALAISE (Other issues/Physically wasn't able to go get the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. The patient was out of work with some balance issues and some other issues. It happened like three weeks after the vaccination. The patient said he has MSNRA, but that the doctors are not sure what it was. The patient received first dose on 24-Dec-2021 and then could have been 5th. The patient never received the second dose because it was hospitalized. Treatment information was not provided. Company's comment: This is a spontaneous case concerning a 44 years old, male patient with clinical history of Autoimmune disease who experienced the unexpected events of AUTOIMMUNE DISORDER, BALANCE DISORDER and MALAISE. The events occurred unknown days after the first dose of mRNA-1273 vaccine The rechallenge is not applicable as the events occurred after the first dose and no more doses were received by the patient  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow up received included no new information.; Sender's Comments: This is a spontaneous case concerning a 44 years old, male patient with clinical history of Autoimmune disease who experienced the unexpected events of AUTOIMMUNE DISORDER, BALANCE DISORDER and MALAISE. The events occurred unknown days after the first dose of mRNA-1273 vaccine The rechallenge is not applicable as the events occurred after the first dose and no more doses were received by the patient  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
pt recvd 1 dose of Engerix-B 9JUL92 exp arm felt hot; 16JUL92 then exp chills, diarrhea & earache; pt recovered;
Pt had redness/inflammation/pain at site that was getting worse over two days. Per provider pt did not require an exemption.
Mild headache 10/17/02 until 11/18/02 when had onset very severe headache unresponsive to multiple meds. Progressed to Rt 3rd cranial nerve palsy which persists. 10/16/02-had flu shot. 10/17/02-bad headaches on Rt side of head only (started on Rt side 10/17/02. 11/21/02 with unreal severe headache). 11/18/02-middle of night, woke up to a severe headache on Rt side and faint feeling. 11/21/02-middle of night, woke up to the unreal severe headache. Had to go get medicine. Fainting, nausea, hot/cold sweats, pain was unbearable. 11/25/02-saw MD-got two temple injections-did not help pain. 11/27/02-got 1 shot immetrex in leg and prescriptions filled. 11/28/02-Thanksgiving day-eye started closing. 12/2-5/02-in hospital and eye closing more. By 12/5/02-eye closed. 12/10/02-appt with MD. 12/11/02-muscles around eye seems to be loosening up, causing less headaches and can seem to move eye today. 60 day follow up states pt has not recovered. Has CNS vascular with severe headaches and total ? 3rd C N palsy which has improved with large doses of steroids. Headaches started day after injection. (unknown) any realtionship
Patient states she experienced pain in her arm and tingling/loss of sensation in her immunized arm.
Received Synagis 1.49 mL im in divided doses right and left thighs. Within 20" after injection developed hives all over tummy and both thighs. Resolved with Benadryl. No swelling or resp distress. Referred to allergies Dr to followup.
Localized reaction to varicella vaccination on Rt thigh SQ. Given KEFLEX and prednisolone. Silver dollar sized raised area with surrounding erythema.
Subcutaneous (L) arm Varivax injection given. Bled small amt. Immediately (L) upper arm 3-4" in diameter became very red and hot, we had child stay 1/2 hour later she c/o of itchy throat. Motrin 1 1/2 and Benadryl 2 tsp given. 15 min later small area size of 1/2 dollar remained red and child had no more itching.
Difficulty walking, sharp pains in all joints (including fingers),  sharp pains down legs,  extreme fatigue and malaise (slept from 7pm 4/12 to 6am 4/14)  Feeling better on 14, but still very fatigued.
Within 2 weeks of injection developed shingles on shoulder near site of injection.  Never had shingles before.  Slow healing.
The 3rd day after my 2nd Pfizer shot, I got sharp dental nerve pain in several teeth on the right side to the midline.  Since it is only on one side, it does not seem to be teeth grinding at night.  Since it is both upper & lower jaws, it does not seem to be related to seasonal allergies/sinuses. (upper jaw)  The pain intensity varies day-to-day and tooth-to-tooth.  Pain occurs without eating/chewing.  Upper right - teeth #5,4,3 and roof of the mouth near those teeth.  Sometime between teeth #8 & 9.  Lower right - teeth #29 & 30, with pain under the right jaw near those teeth.  Sometimes between #25 & 24.    There is also new dental sensitivity to chewing and food temperatures on the right side. I have been treating the sharp dental nerve pain with OTC aspirin and Aleve every day.  Today (6/4/21) is the the first morning when the pain is dull enough that I have not taken an OTC pain medication ... yet.
Sore left arm at injection site shortly after shot administered.  Mild chills approximately 14 hours after injection, followed by initiation of a mild fever (~99-100 deg F) approximately 16 hours after injection.  Fever appeared to last approximately 10 hours.  Body temperature is currently back to normal with no chills or  other adverse side effects (aside from continued left arm soreness, some muscle ache, fatigue).
Information was received from a physician concerning a male, about 6 years old, who was vaccinated with vericella virus vaccine live (Oka/Merck). On 01-November-2006 he "broke out in zoster". The patient's present status was unknown at the time of this report. There was no concomitant medication. Unspecified medical treatment was sought. This is in follow-up to report(s) previously submitted on 5/16/2007. Information was received from a physician concerning a male about 6 years old who was vaccinated with VARIVAX (Merck). On 01-November-2006 he "broke out in zoster". The patient's present status was unknown at the time of this report. There was no concomitant medication. Unspecified medical treatment was sought. There was no product quality complaint. No additional information expected.
NO ADVERSE EVENT DESCRIBED PER PATIENT  patient was given Bivalent as his first dose having never been given the primary series
Pt. had 1st GARDASIL injection 5/29/12 had itchy rash starting early AM 5/30/12 - seen in office & assessed by Dr as hives - possible reaction to injection.
I started having an increase in coughing, sore throat, more pronounced fatigue, sinus congestion, I couldn't go to work, I had a fever. I made a doctor's appointment to see what was going on. I had taken a home COVID-19 test that came back negative, the doctor's office did an Influenza A and B test came back negative. They said it may be a viral infection, my body was building up antibodies from the vaccine. I was prescribed benzonatate, promethazine.
This spontaneous report as received from a male patient of unknown age refers to himself. On an unknown date (reported as "over 4 years ago"), the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, frequency were not reported). No concomitant medications were reported. On an unknown date the patient developed cancer (reported as: he now has a cancer). At the time of report, the patient did not recover from cancer. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review, the patient's cancer was considered to be medically significant. Additional information is not expected due to lack of patient's or physician contact details.
tachycardia, shortness of breath, especially when lying down, cramping, muscle spasms in legs
Janssen COVID-19 Vaccine EUA -Rapid heart 9:30 p.m. ish until approx. 1:00 a.m. (not consistent - on and off) -Body Aches & Chills 9:30 p.m. ish  -Fever - maxed at 101.3 (fever through the night - fever broke around 5:30 a.m.) Took Aleve for fever and aches around 10:30 p.m.
About 5 minutes after second dose covid 19 vaccine patient got nauseated and started vomiting and complained of headache. Vital signs checked with in normal limits. Denies any respiratory distress or any chest pain. Wet cloth applied to forehead and ice chips with lemons for patient to put in mouth. Monitored for 35 minutes patient stated symptoms were improving. Instructed to notify primary care M.D. Go home and lay down in dark room and increase fluids and have husband stay with here and monitor her if any problems with breathing, nausea, vomiting, severe headache go to the Emergency Room.
No Adverse reaction occurred. Learned that Moderna had been approved, believed it to be from the CDC but it was however another committee.
Headache, Diarrhea, Pain/redness/swelling at injection site (left arm) - increased every day, currently 3.5" x 3.5" area (VACCINE FOR SHINGLES).
This spontaneous report has been received from a medical assistant and a nurse referring to a 13 years old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-MAY-2015, the patient was vaccinated with a dose of GARDASIL (dose, route, lot # and expiration date not reported) for prophylaxis. Then the patient was vaccinated with a dose of GARDASIL 9 (dose, route, lot # and expiration date not reported) for prophylaxis on 22-JUL-2016(interchange of vaccine products and inappropriate schedule of vaccine administered). The patient was currently (in approximately July 2017) in the office to receive another dose of GARDASIL 9(inappropriate schedule of vaccine administered). No adverse effect was reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA010344.
The evening of the vaccine (Day 1 Jan 29), my arm was extremely painfully sore. That night, I developed a fever. Day 2 (Jan. 30), I had a fever, body aches, muscle aches, fatigue, and nausea throughout the day. My fever went up to 100.6. I treated it with Tylenol (2 extra strength every 6 hours).  The fever broke around 9 PM (24 hours after it started) Day 3 (Jan 31), I just had severe fatigue and a sore arm. The fever and aches and nausea were gone. Day 4 (Feb 1), I just was more tired than usual. and my arm was still sore. For the first week, my arm got less sore each day, and by Day 7, I was feeling great with no other adverse reactions remaining.
Nightmare; Did not feel right; This case was reported by a pharmacist via call center representative and described the occurrence of nightmare in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number GX25K, expiry date unknown) for prophylaxis.   Co-suspect products included diphtheria toxoid + pertussis toxoid + tetanus toxoid (Adacel) for prophylaxis.   Previously administered products included Antipsychotic.   On 13th June 2019, the patient received Shingrix and Adacel at an unknown dose and frequency. In June 2019, less than a month after receiving Shingrix, the patient experienced nightmare and feeling unwell. On an unknown date, the outcome of the nightmare and feeling unwell were unknown.   It was unknown if the reporter considered the nightmare and feeling unwell to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and Adacel and experienced nightmares, and did not felt right.
Itching; Redness; Swelling; Rash increasing in size on right arm, triangular shape pink; Only received one moderna vaccine/42 Plus days after 1st shot, no 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), ERYTHEMA (Redness), SWELLING (Swelling), RASH ERYTHEMATOUS (Rash increasing in size on right arm, triangular shape pink) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Only received one moderna vaccine/42 Plus days after 1st shot, no 2nd shot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diverticular disease.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), ERYTHEMA (Redness), SWELLING (Swelling), RASH ERYTHEMATOUS (Rash increasing in size on right arm, triangular shape pink) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Only received one moderna vaccine/42 Plus days after 1st shot, no 2nd shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching), ERYTHEMA (Redness), SWELLING (Swelling) and RASH ERYTHEMATOUS (Rash increasing in size on right arm, triangular shape pink) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Only received one moderna vaccine/42 Plus days after 1st shot, no 2nd shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.    Action taken with mRNA-1273 in response to the event, only received one Moderna vaccine, was not applicable.   This case was linked to MOD21-055323 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: New event inappropriate schedule of vaccine administered was added. On 03-May-2021: Follow-up information received on 03-May-2021 contains non-significant information.; Sender's Comments:  MOD21-055323:
Right arm pain in joints. Hands and finger joints. Elbow joints and shoulder joints; Muscle pain in entire arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose number=1, Product=COVID 19, Brand=Pfizer, Administration date=22Mar2021, Administration time=12:00, Vaccine location=Left arm), administration date: 22Mar2021, when the patient was 45-year-old, for COVID-19 Immunization. The following information was reported: MYALGIA (disability) with onset 31Jan2022 at 12:00, outcome "not recovered", described as "Muscle pain in entire arm"; ARTHRALGIA (disability) with onset 31Jan2022 at 12:00, outcome "not recovered", described as "Right arm pain in joints. Hands and finger joints. Elbow joints and shoulder joints". The events "right arm pain in joints. hands and finger joints. elbow joints and shoulder joints" and "muscle pain in entire arm" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Dec2021) Negative, notes: Nasal swab. Therapeutic measures were taken as a result of arthralgia, myalgia with Anti inflammatory meds and pain meds. The patient did not receive any other vaccines within four weeks prior to the vaccination. COVID-19 prior vaccination was unknown. Patient did not have any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
As she was driving home about an hour after the vaccine she felt extremely hot from head to toe. She started to feel weak and having headaches. On the next she started having a very pounding rapid heartbeat which lasted the whole month of Oct. She felt faint for about 3 months.
Since my first Moderna vaccine shot on 4/13, I've experienced increased tinnitus (random buzzing) in my right ear. This was only subtle, and infrequent after the first shot. However, after my second shot of Moderna lot 022B21A on 5/11/21, that buzzing is now almost constant with very few breaks.
moderate pain at injection site; overall muscle soreness and flu-like body aches; fatigue; mild nausea started on day 2 and went away upon waking on day 4 after injection.
Sudden onset of lower extremity and trunk weakness on 11/18/09. Fever 102 degrees - 103 degrees F 11/19/09. Weakness increased to affect speech, chewing, diaphragm, chest wall muscles. Treatment included IVIG, BiPap, supportive care. PT, OT, Speech Therapy.
Participant FAINTED AFTER FLU SHOT, experienced convulsions, bleeding from her head/nose area after receiving vaccinations/ epi was administered/ 911 called/ participant regained consciousness and was transported to hospital.
swelled arm, high fever, arm was warm to touch for 3 days, pt is now experiencing heart problems, tingling down the arm, two weeks ago pt started getting sharp pain in chest, pt was cleared to have no blockages to heart, and blood pressure is under control.
Patient  received Tetanus Vaccine on 02/26/2021.  Error was made by administering Pfizer Vaccine on 03/10/2021., two day before the recommended fourteen day waiting period.
HURTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hurts was not reported. This report was non-serious.
Severe headache; Fever of 101.6; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the parent. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in the left arm on 18Sep2021 at 14:30 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and the known allergies were reported as "not that we knew". 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. The patient did not receive any concomitant medications. It was reported that the patient was small for her age and the patient was mandated to get the shot by the school a week before the school started. The patient was healthy. On 19Sep2021 at 14:00, (also reported as 24 hours after vaccination), the patient experienced severe headache, fever of 101.6 (unspecified units), and also had symptoms related to the fever which were chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken for the events of fever 101.6 (unspecified units), chills, and fatigue (reported as managed fever). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache, fever of 101.6 (unspecified units), chills, and fatigue was recovering at the time of this report.
On 5/16/2022, I began to experience edema in my lower right and left legs along with a migraine headache on the left side of my head. The swelling increased significantly in both legs on 5/17/2022, warranting a visit with my doctor on 5/18/2022. The edema continues to be a problem in both legs as well as swelling my in my lower abdomen and a swollen feeling under my left underarm.
Pt received 1 dose of PENTACEL & 1 dose of PCV 13 on 4/4/11. On 4/5/11 she presented to ER with Bell's Palsy affecting the Rt. side of her face. Remainder of neuro exam was wnl. ROS neg for fevers, rash lesions.
16 hours after administration had a syncopal event lasting 5 minutes.  Occasional tingling in both feet, both hands, and jawline.  Woke up in the middle of the night 2/23/21  and 2/25/21 with sensation of ball rolling in chest.  Noticed high blood pressure on 2/26/21 ranging 130-163/80-86.
Light red circle around injection site.  Painful to the touch, warm, itchy, and feels like there is a bump under my skin.
Pt. states that after receiving the 1st dose of Shingrix 02/01/2022, started experiencing symptoms of tingling in the jaw and surrounding areas (Lasting for 1 1/2hr) . Weakness throughout the body, Primary communications with no recommendations.
Extreme body pain and chills, fatigue, migraine headache. Pain killers and time were treatment
This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. On 18-APR-2014, the patient was vaccinated with a properly stored expired dose of ZOSTAVAX (lot # H011426, expiration date 12-SEP-2013) (route not reported). No adverse events were reported. Additional information has been requested.