chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/4/00 At 3:00 PM patient received her 4th DTaP shot (combined with HIB called Trihibit) and a polio shot. After her crying stopped (due to fear) her head to toe tremors/shaking were seen. Her entire body shook from the time of the shot until at least the following day. Tremoring was observed at the doctor, in the car and while she stared blankly at the TV at home. When the shaking didn't stop, I called clinic and told doctor of the tremoring. She said that the tremors were not caused by the shot. I stated that she wasn't tremoring  when I brought her in the doctors office and that the tremors began at the time of injection and were continuing still hours afterward. I did not take her to the hospital because I knew that vaccines had caused her tremors and was afraid that the doctors at the hospital would attempt to eliminate the tremors by performing tests or injecting her with medication that would cause her more harm. She shook head to toe while she slept. She shook in the morning. On 4/5/00 between 8AM and 9AM, I called the CDC Immunization Hotline. I spoke with a woman who told me to call VAERS. I immediately called VAERS and spoke with a man for at least 20 minutes concerning her reaction (still ongoing). I asked him if other babies reacted to the same shots in the same way that my daughter was reacting. He said it certainly falls under the umbrella of what could be considered a reaction to the DTaP shot. My report of my daughters adverse reaction to her shots was made to a man on 4/5/00 between 8AM and 9AM. I made this report by calling. After this day, my daughter was a different child. She never made eye contact again and withdrew from her family and her world. Patient is autistic and receives 40 hours/week at home  intense behavioral therapy. The 60 day follow up states as previously stated in my report filed, she is autistic. Her autism was caused by the vaccines.  Annual follow up on 02/17/04: "Pt did not recover from adverse events.  My child became autistic when she was given these vaccines and is still autistic!
Extremely heavy periods, with large clots and 10 days long. Lasted until September.
FULLY VACCINATED, SEVERE COVID-19 CASE. DIAHHREA, SHORTNESS OF BREATH.
Since being treated for Hashimoto's in November my symptoms had resolved, after my vaccine all symptoms slowly crept back in. I noticed about a week after the shot that my arm pain had moved into my right upper shoulder and into my neck, my tiredness, and foggy thinking also returned, with extreme chest tightness and pain in my neck (when I had undiagnosed Hashimoto's I also had right sided neck pain)
pt recvd vax;24 hrs p/ dose 2 exp, blisters at inject site;unresolved
Fever; Frequent chills; Irritability; Fatigue; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 17-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown", described as "Frequent chills"; IRRITABILITY (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of pyrexia, chills, irritability, fatigue, headache. The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
Small, persistent shingles-like rash. Ongoing 3 weeks in. Periodic fatigue.
I got my menstrual cycle in April but it didn't come in May, June, or July. In August, I was spotting and in September and October, it was really heavy. This is not normal for me. I went to see my OBGYN in August and expressed my concerns about my period. She came to the conclusion that getting COVID-19 in between the doses of the vaccine was a lot for my body and we agreed to let it play its course instead of her giving me medication to make me have a period. This is very frustrating because my periods have always been normal and now I'm bleeding heavily most of the time with small breaks in between.
Injection site reaction 1 week after injection. My arm become very red, raised, itchy, painful and hot to the touch.
Patient was given Pneumococcal vaccine- developed reaction, swelling at site, pain and induration. (Patient had been admitted to hospital on 2/11/06 for colic, abdominal pain, syncope and collapse, vertigo.
DONT FEEL GOOD AT ALL; I SLEPT ALL THE DAY; DRY HEAVES; VIOLENT HEADACHE; EXTREMELY NAUSEOUS; This spontaneous report received from a patient 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, and batch number were not reported) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-JUL-2021, the subject experienced dry heaves. On 09-JUL-2021, the subject experienced violent headache. On 09-JUL-2021, the subject experienced extremely nauseous. On 10-JUL-2021, the subject experienced i slept all the day. On 12-JUL-2021, the subject experienced dont feel good at all. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry heaves on 09-JUL-2021, and i slept all the day on 11-JUL-2021, had not recovered from violent headache, and extremely nauseous, and the outcome of dont feel good at all was not reported. This report was non-serious.
10/7/23, WOKE UP WITH TENDERNESS TO BOTH AXILLA AND MULTIPLE, PALPABLE ENLARGED LYMPH NODES, BILATERAL
I woke up because I started shaking violently. I calmed down but every time I moved I started shaking again. This lasted for about a half hour. I also had a headache which lasted until later that day even though I took Tylenol. The first Shingrix shot resulted in a fever and chills and feeling awful for 3 days. While this time the shaking was very bad and my head felt like it wanted to explode, the recovery from the effects was quicker. I felt fine after one day of resting.
Breakthrough case admission after 3 vaccines Pfizer 2/27/21 Lot# EN6202; Pfizer 3/20/21 Lot# EN6206;  Pfizer 5/12/22 Lot# FP4554
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unspecified dates, the patients were vaccinated with improperly stored VAQTA (lot # M033611 / expiration date 02-MAR-2018, lot # N005796 / expiration date 26-MAY-2018, dose and route were not reported) for prophylaxis. The vaccine (lot # N005796) was exposed to temperature excursion between 0 degrees Celsius to 1 degrees Celsius for 2 hours and 41 minutes. The vaccine (lot # M033611) was exposed to temperature excursion between 0 degrees Celsius to 1 degrees Celsius for 6 hours and 42 minutes. There was no previous temperature excursion nor data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA003853: US-009507513-1709USA003852: US-009507513-1708USA009093.
I received the shot on 05Feb. About 4-5 days later I noticed a small bump on my collar bone. On the same side of the shot I received.; This is a spontaneous report from a contactable consumer (self reported). A 38-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch number and expiry date was not reported) via an unspecified route of administration in left arm on 05Feb2021 14:00 as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. No Known allergies. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. On 09Feb2021 at 12:00 am, About 4-5 days later he noticed a small bump on his collar bone on the same side of the shot he received assessed as non-serious. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of the event was not recovered.
Patient was offered a different option for COVID booster, however, patient verbally stated that she still wanted to receive Pfizer bivalent booster. Patient was then asked to stay for 30 minutes to be monitored. At 1440, the Pfizer bivalent booster was administered to the left arm.  AT 1505, RN assessed patient. Patient stated that she is starting to experience tingling of her fingers and swelling of her lips. Patient stated she would take benadryl immediately after receiving her previous Pfizer doses. RN administered Epi Injection, USP Auto-Injector 0.3mg (Lot #: 1FM458, exp: MAY 2023) to left outer thigh. Provider was notified of the event and to come down immediately to location.  At 1509, PT stated that she was starting to feel better and denies feeling tingling on fingers and swelling of her lips. Vital sign are as follows: BP = 173/105 SPO2 = 98% in RA Pulse = 63  At 1520, patient is AAO X3. vital signs are as follows: BP = 147/85 SPO2 = 96% in RA Pulse = 66  At 1527, PT appears stable and was transferred to the ER via wheelchair.
Immediately after injection patient was getting out of chair and lost balance; they were caught and sat down to recover. Patient was instructed to either lay down with feet up or sit with head between knees, due to age, patient sat with head between knees. They shortly developed nausea and vomiting. After 15-20 minutes patient continued with symptoms and EMS was called. They evaluated patient and took them to hospital for further evaluation and care. According to patient's son, patient was kept at hospital for a few days for care and recovery. Patient had disorientation and uncontrollable hypertension the following days and nothing further was reported from family. Patient is now at home recovering, still a little disorientated but moving around and back to normal duties.
Mom called stating patient had numbness, tingling, fever and muscle weakness. Advised pt to go to emergency room for further evaluation.
Within four hours of vaccination, bumps like chicken pox appeared on my right calf.  Itchy.  Day 2 pm bumps appeared on my left thigh.  Currently on day 3 giving this report.
Within 1-2 minutes, post vax, pt was complaining of itching and erythema and urticaria developed to about 1-1 1/2mm. Ice pack applied and Benadryl Elixir given. No complaints of breathing difficulties. Client in office for 1 hour and returned to home and advised to call MD's office because he wanted client to be seen.
redness; itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness) and PRURITUS (itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 ERYTHEMA (redness) and PRURITUS (itching). At the time of the report, ERYTHEMA (redness) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. No treatment information was provided.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; Poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ).    No concomitant medicine were reported. No treatment medicine were reported. This case was for 79th out of 100 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Later that night after the shot my child was unable to move her legs then the next day she began throwing up and just recently stopped.
Swollen red lump two inches below injection site as of 24 hours and lasting through three days.
I had an episode of not being able to breathe on 2/27/21. I had shortness of breath fatigue, reactive airway, aches and pains, reactive pulse rate, internal tremor, blood blisters on tongue and cheek, anxiety, pressure in chest, rash on chest, exercise intolerance, emotional and physical fatigue, sleep disturbance, high sensitivity to what I was eating with my digestion being disturbed. I was put on 5 days of prednisone for the breathing issue. Otherwise, what has been most helpful to me was going on a low histamine diet. I got my 3rd booster shot which caused about a week of aches and pains. I believe this is due to the increase of histamines in my system. I went to the ER because of the inability to breathe. I saw my PCP and a pulmonologist and a cardiologist. They cardiologist diagnosed me with dysautonomia. I have had to retire from my job because standing is an issue for me. I am unable to stand for long periods of time and therefore unable to work a full day. Though I am not entirely better, I have improved from my initial state of health.
Heart attack; Blood clot; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) and THROMBOSIS (Blood clot) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033b21a) for COVID-19 vaccination.     No Medical History information was reported.  On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant) and THROMBOSIS (Blood clot) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and THROMBOSIS (Blood clot) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Patient received first dose of Moderna COVID-19 on 19-MAY-2021 with lot number 045b21a intramuscularly.  No concomitant medications were provided.  No lab data was provided.  No treatment information was provided.  Company comment: Based  on temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Based  on temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the events has been provided at this time. Further information has been requested.
THE INDIVIDUAL RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 60-year-old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin, batch number and expiry were not reported), 01 in total, dose was not reported for prophylactic vaccination. No adverse event was reported following covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, 01 in total, administered (dose number in series was 2) on 01-DEC-2021 to left arm for prophylactic vaccination which was an off label as the patient received less than 0.5ml (milliliter) of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported. As per the report, the health care professional (HCP) withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL. It was reported that she would filed VAERS report for all of these individuals tomorrow after she informed each of them. She also communicated these incidences with New York Department of Health who suggested to contact the Janssen. She provided all available information. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5 ml of vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210588, 20211210112, 20211209775, 20211210610, 20211210159, 20211210409, 20211210555, 20211210408, 20211210733, 20211209880, 20211209816, 20211209782, 20211212088, 20211212082, 20211210662, 20211209679, 20211209740, 2021121067, 20211210824, 20211210350, 20211210141, 20211210684, 20211209706, 20211209874, 20211209843, 20211209798, 20211209884, 20211209912, 20211209921, 20211210019, 20211210106, 20211210107, 20211210143, 20211210165, 20211210180, 20211210334, 20211210385, 20211210549, 20211210590, 20211212082 and 20211210684.
I was vaccinated on 1/19/21 and had no symptoms the first 48 hours. On the 3rd day through the 5th day I had a non stop headache and extreme body fatigue.
Information has been received from a registered nurse concerning a 2 year old male who on 11/26/2002 was vaccinated subcutaneously with a dose of varicella virus vaccine live.  Subsequently the patient developed breakthrough varicella with less than 50 lesions and a low grade fever.  It was noted that there was no office visit.  Recommended therapy included acetaminophen and diphenhydramine hydrochloride for fever and itching.  At the time of the report the patient had recovered.  There was no product quality complaint involved.  Additional information has been requested.
Progressive Shortness of breath, cough, headache, fever  SOB started around 1900 then progressed to moderate/severe by 0430. Benadryl 50 MG PO x 2 doses 1900 and 0440  Albuterol inhaler 1900 Albuterol via nebulizer x2 doses 0430 and 0450 Tylenol 650 MG PO @ 0440
19 weeks pregnant at time of 2nd vaccine, June 18th, 2021 due date for delivery.
Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves Adult female patient (age was not reported) who had facial swelling and truncal rash, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect FLUZONE QUADRIVALENT (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patient experienced facial swelling and rash. (Other relevant tests included no lab data.) Final diagnosis was facial swelling and rash. The patient was treated with BENADRYL. The outcome of the events was reported as recovered on an unknown date. List of documents held by sender: none.
Right shoulder joint ache continuous but notices more in arm a.m. and p.m. Client received her flu shot on 11/14/2006 at approximately 1:30 pm in her right deltoid of FluLaval manufactured was reported, Lot#2F600311, expiration date 7/07. Saw her again on 11/22/06 while I was giving flu shots to her co-workers. She states her right shoulder joint started aching the next day, 11/15 and has ached ever since. General ache in joint and around back of neck with increased awareness of aching in the morning and evening. She is right handed. Hurts to raise arm above shoulder height. Shoveled snow yesterday with increase pain afterwards. Approximately ten years ago she received a cortisone injection to the right shoulder for rotator cuff with good results from injection, no problems with shoulder since that time. Treatment since 11/15 has been Ibuprofen 600 mg at 5 and 10 pm (States it makes her tired so she can not take it during the day) and Aspirin-cream at bedtime. Suggested ice/heat, rest of shoulder, and above medications. No swelling, redness or any abnormal findings on exam. Will follow up in a few days. 11/28/2006 consulted with MD about above situation then called client. "No improvement with shoulder". MD visited with her via phone then prescription for Prednisone 40-40-20-20 20mg every day for 5 days ordered and called into pharmacy. 12/4/06 at 3:10 pm follow up call to client. States "it still aches, the medication didn't make a difference". Last dose taken Friday, December 1st. Phone consult with MD after visiting with client with return call to her at 3:30 pm. Recommended to follow up with her doctor, if shoulder doesn't improve. I will follow up with a form for the client in the near future.