chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx 18 hours later I was urinating when I had a sudden onset of pain start from the nape of my neck and go up into my head - it was like brain freeze times 10, the initial feeling lasted about 15 seconds but after it went away I was left with residual pain in the head and my head felt sore when touching my forehead and I was all of the sudden tired. I was working from home so I notified my manager about this and asked to go lay down. I went any lay down and fell asleep for a few hours, when I woke, I still have the pain and was nauseous. The pain, nausea and tiredness lasted about 3 days. Since then I have been having intermittent issues with speaking a full sentence without stuttering, getting a full thought out, typing properly (constantly misspelling words and having to go back and correct them), completing every day tasks correctly (for example, I was making my coffee and went to get the milk but past the refrigerator and walked to the other end of the kitchen, opened my broom closet and reached up for the milk, immediately realizing what I did I said to my self I was injected with "stupid juice"). I have been saying I was injected with stupid juice since about a week after my first injection as this is when I began to realize all these "stupid" things were happening. I forgot it was fathers day and when speaking with my son at the end of our conversation he asked if I was ok and I said yes why and hew said becasue you always wish me happy fathers day, then I wished my brother a happy birthday on facebook and my other brother commented that I freaked him out thinking he forgot it but then realized I was a day early- many were shocked because I am known for remembering dayes and events.
herpes zoster; postherpetic neuralgia; Information has been received regarding a case in litigation from a lawyer and referred to a patient (pt) of unknown age and gender. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. On unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (route, strength, dose, lot number and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown date (reported as after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered herpes zoster, and postherpetic neuralgia. As a result of those symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experience mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causality was related.  The reporter considered the events to be disability.
Td/Tdap VIS 11/18/08 was given to parent/guardian or patient. (hmf16) _05.17.10 13:46 TC from pt. ID verified. Pt states she has swelling and pain in her L armpit. Pt states she had swelling there before due to excess breast tissue and had that removed. Advised pt to f/u PF this afternoon for physician evaluation. Pt voiced understanding.
I had a pain in the left arm; I had a very tiny stomach ache after the vaccination it was very tiny; I have little dizziness and I continued; I felt like little dizzy and I think I was little nervous but it continued little bit; I feel like lethargic from a week or more actually 8 days today; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 64 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 15Mar2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Inflammation" (unspecified if ongoing), notes: Takes ginger and turmeric for this condition. The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 15Mar2021, outcome "recovering", described as "I have little dizziness and I continued"; NERVOUSNESS (non-serious) with onset 15Mar2021, outcome "recovering", described as "I felt like little dizzy and I think I was little nervous but it continued little bit"; LETHARGY (non-serious) with onset 15Mar2021, outcome "recovering", described as "I feel like lethargic from a week or more actually 8 days today"; PAIN IN EXTREMITY (non-serious) with onset 20Mar2021, outcome "recovered" (Mar2021), described as "I had a pain in the left arm"; ABDOMINAL PAIN UPPER (non-serious) with onset 20Mar2021, outcome "recovered" (Mar2021), described as "I had a very tiny stomach ache after the vaccination it was very tiny". Therapeutic measures were not taken as a result of dizziness, nervousness, lethargy, pain in extremity and abdominal pain upper.  Additional information: Consumer stated that she was taking zero medicine. She only took organic vitamins like vitamin D3, B3, A, B, C, D for females and it was a complex that she took once a day. She took ginger and turmeric for inflammation. Consumer had her vaccine on 15Mar and she felt okay. She didn't have any issue. The night she took the shot, she felt like a little dizzy and she thought she was a little nervous, but it continued little bit. She felt like lethargic from a week or more, for 8 days. She felt dizzy when she woke up and when she moved after taking the vaccine. She had pain in the left arm but after 2-3 days it disappeared. She had a very tiny stomachache after the vaccination, more with water and after food but felt it more with water, but it disappeared later like after 3 or 4 days. She doesn't have fever and headache but sometimes felt a little dizzy and had it for exact 8 days. Consumer stated that her second dose was due on 05Apr. She was querying if she should take the second one or not, because of the reaction that she was having. She doesn't know if this was normal, or it was something that she needed to stop.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, swelling, redness x 3 days. Clinical exam on 2/16/12 -> local redness & swelling at injection site. (+) Bronchitis.
This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with PEDVAXHIB lot # N003701, expiration date 01-NOV-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010748.
The following is history obtained from family after the event: The patient left the office, went for breakfast, developed difficulty swallowing in the restaurant and was making sounds in her chest when breathing, was driven home by family, was not answering her family verbally, then EMS was called and they could not revive her, she was sent to the ER.
I noticed my left arm becoming quite sore within 2 hours of the injection, and not able to raise my arm by the evening time. At 1:30 AM I was letting the dog outside and became dizzy, then became nauseated and diaphoretic, then vomited. The pain was quite severe. I noticed a large hive forming yesterday which is very sore to the touch, like a bad bruise. I had a 'washed out' feeling all day yesterday. The soreness in my arm is better today and I can raise my arm up now.
pt recv vax & devel an inj site rxn characterized by a 6x4 area of redness, hardness & warmth;
9/17/03 Mother, here for vaccination follow-up mentioned that on 8/13/2003 (her baby girl) had received Dtap, IPV, Hib, Hep B, Prenar. That eve she had a high fever temperature 103. very fussy, changed color, breathing funny. Treated with cool bath, Motrin (gtts). Tylenol and Pedialyte. 8/15/2003 taken to emergency room with continued increased fevers temperature 103. The medication only relieved the temp about 30 minutes. She was not dehydrated she did not receive treatment. She was sent home to be hospitalized if she did not improve. Mother gave Motrin Elix with Pedialyte and baby responded nicely. The rash had clusters of lumps web like, persisted over the body for 1 week. Baby improved.
Vaccine given at 9:30am, 05/08/2021 -- Symptoms began at 9:40pm, 05/08/2021 -- Symptoms subsided fully at 9:30pm, 05/09/2021: Just over 12 hours after getting the 2nd dose, within minutes, I had a 103.2 fever and chills. Body was so achy and sore and I could barely keep my eyes open or even move. It lasted about 6 hours until my high fever broke. The following 12 hours, I had a low grade fever and was alternating taking tylendol and motrin every 4 hours.  By 9:30pm the day after the vaccine, I was completely fine.
Patient is feeling pain in his right lower leg, left arm, and left torso. It is consistent and has not been helped by Tylenol
First, sever Asthma, following immunization person had Asthma. Epinephrine injection, USP 0.3mg X2. Oxygen, Ems care has Transport
Following #2 DTP pt had unusual high pitch cry & unconsolable for a long period of time;
unusual continous cry from 11AM-6PM; mom was giving APAP also had an ecchymotic area on lt leg @ site of inject; approx size of quarter;
Pt recvd vax 25JAN92 & 19MAR92 was hospitalized w/shoulder pain & bilateral phrenic nerve neruopathy; respiratory insufficiency; readmitted because of cont resp insufficiency;
pt recv vax & devel chickenpox described as nontraditional, no fever, cranky only two lesions looked like typical chickenpox;
Patient verbalized he was dizzy and fainted for about 5 seconds while sitting on chair. Physician and NPs on site attended to him. He is assessed, vital signs monitored. EMS was called. Patient stabilized. He was talking and alert and oriented to person, place, and time. EMS arrived and patient was transported to local hospital. Patient's wife was present and was made aware of where her husband would be transported.
has dime size pimple on lt thigh @ site of varivax immun given 5/24/99 per mom;
Talking to imaginary man; Exacerbation of Mental health disorder; talking to himself (full conversation); Mild Angry outburst; Diarrhea; insomnia; Not communicating with family members; This spontaneous case was reported by a patient and describes the occurrence of SCHIZOPHRENIA (Talking to imaginary man) in a 35-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 Mental disorder NOS.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SCHIZOPHRENIA (Talking to imaginary man) (seriousness criterion medically significant), MENTAL DISORDER (Exacerbation of Mental health disorder), SOLILOQUY (talking to himself (full conversation)), ANGER (Mild Angry outburst), DIARRHOEA (Diarrhea), INSOMNIA (insomnia) and SOCIAL AVOIDANT BEHAVIOUR (Not communicating with family members). At the time of the report, SCHIZOPHRENIA (Talking to imaginary man), MENTAL DISORDER (Exacerbation of Mental health disorder), SOLILOQUY (talking to himself (full conversation)), ANGER (Mild Angry outburst), DIARRHOEA (Diarrhea), INSOMNIA (insomnia) and SOCIAL AVOIDANT BEHAVIOUR (Not communicating with family members) outcome was unknown.        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 product used was not provided. Treatment information was not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Woke up with Severe abdominal pain such as I have Never had before in my whole entire life.  Could barely walk across room, thinking I might need bathroom.  I did not.  I figured it was a side effect of the vaccine, but determined if it did not subside pretty soon I would need to go to the hospital.  It did ease up somewhat after about 40 minutes, but did not go away completely.  Felt mild pain for 5 days afterward.
Patient was given an extra dose outside of the permitted age range for vaccine. No reactions to the vaccine at this time. Patient was notified by provider and given reassurance of the extra dose.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER2613) and on 10Apr2021 as dose 2, single (Lot number: EW0153) at the age of 43 years for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 27Dec2021 as dose 3 (booster), single (Lot number: 030H21B), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "MS; HX colon cancer stage IIB" (unspecified if ongoing); "tree fruit (mild) allergy" (unspecified if ongoing); "MS; HX colon cancer stage IIB" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: 01Feb2022; LORAZEPAM, start date: 01Jan2012; TYLENOL; ADVIL [IBUPROFEN]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment/ Positive Antigen test on day 13". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: On Day 10, with no fever and other symptoms abated, I tested negative on an antigen at home test; Positive, notes: Day 13 (today) I took an antigen at home and it is positive. I have the same symptoms as yesterday. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical information: Patient did have receive other medication in 2 weeks, product for COVID-19 Treatment, brand: Paxlovid, treatment start date 29May2022, treatment stop date 02Jun2022, lot number (PAA183750/GA6206), indication: Treatment of COVID-19. Adverse event: Covid rebound. On Day 10, with no fever and other symptoms abated, He tested negative on an antigen at home test. On Day 11, he noticed some congestion, on Day 12 it was a runny nose and chest congestion with a minor cough. Still no fever. Day 13 (today) he took an antigen at home and it is positive. He have the same symptoms as yesterday. adverse event start date: 08Jun2022.
Dizziness and chest discomforot -vitals @3:33 PM: BP 140/57, HR 61, O2 98% -patient given ~4 cups of water and took deep breathes and symptoms resolved
my right leg has been hurting bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of leg pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In SEP-2023, the patient received RSV vaccine. In SEP-2023, immediately after receiving RSV vaccine, the patient experienced leg pain (Verbatim: my right leg has been hurting bad).The outcome of the leg pain was not reported.   It was unknown if the reporter considered the leg pain to be related to RSV vaccine.   It was unknown if the company considered the leg pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 25-SEP-2023 This case was reported by a patient via interactive digital media. The reporter wanted to know what side effects you had. The patient got his/her RSV vaccine a week ago from the day of reporting and his/her right leg had been hurting bad immediately after the shot. The follow up would not possible as no contact details were available.
The patient is 15 years old and received the Moderna vaccine which is approved for EUA for ages 18 and above.  The patient had no symptoms post shot.
Tongue swelling started within 15 minutes of vaccine. Was given benadryl which helped but did not resolve symptoms for up to 24 hours. Patient did take more benadryl at home the evening of the vaccine to help. After 24 hours, symptoms resolved and have not returned.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot # reported as L033508, expiration date reported as 12-MAY-2017; lot # reported as L033543, expiration date reported as 30-MAY-2017, oral (dose was not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 56.8 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter. Additional information has been requested.
Begining approx. 1/8/21, 11 days after the vaccine injection, the injection site is randomly very itchy and has a large red circle/ ring surrounding it. The red ring around the injection site is very large in size, about 3- 4 inches long and wide across my arm.
administration of the second dose after 2 weeks of receiving the first dose / first dose / on 5/13/2021 /second dose on  5/29/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 89-year-old female patient who received Herpes zoster (Shingrix) (batch number F5XN2, expiry date 8th October 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th May 2021, the patient received the 2nd dose of Shingrix. On 29th May 2021, unknown after receiving Shingrix and 16 days after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were reported as follows: The patient received 2nd dose less than 2 month apart from the 1st dose, which led to shortening of vaccination schedule. No further event was reported. The health care professional consented to follow-up
Very sore arm; generally sore muscles in entire body.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 16:45 (Batch/Lot number: unknown) at the age of 18 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Aug2021 05:15, outcome "recovered" (2021), described as "Very sore arm"; MYALGIA (non-serious) with onset 12Aug2021 05:15, outcome "recovered" (2021), described as "generally sore muscles in entire body.". Therapeutic measures were not taken as a result of pain in extremity, myalgia.  Additional information: The patient had not received any other vaccine and other medications in 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable consumer reporting for himself and from a contactable physician. A 74-year-old male patient received PREVNAR 13 (Lot # M06901, Exp. date Mar2017), intramuscular at 0.5 ml, single in the left upper arm on 23Nov2015. Medical history included cholesterol abnormal, coronary artery disease from 2008 and ongoing, hypertension from 2008 and ongoing, hypothyroidism from 2010 and ongoing, vitamin B12 deficiency from 2012 and ongoing, allergies to Penicillins. Concomitant medication included Aspirin, Water pill, SYMBICORT, DUONEB. The patient experienced severe cellulitis of the left upper arm on 24Nov2015 with outcome of recovered, entire left upper arm, swollen, painful on 27Nov2015 with outcome of recovering, malaise/ generally not feeling well on 24Nov2015 with outcome of unknown, loss of appetite on 24Nov2015 with outcome of unknown, some discomfort in left upper arm at injection site on 24Nov2015 with outcome of recovering, reddened area extends from shoulder to antecubital space on 29Nov2015 with outcome of recovering, left upper arm has area that is hard approx. 2' by 1/2' on an unspecified date with outcome of recovering. The patient underwent lab tests and procedures which included on 28Nov2015: Activated partial thromboplastin time (PTT) 24.0 seconds; Alanine aminotransferase (ALT) 21 IU/l; Anion GAP 12 mEq/L; Aspartate aminotransferase (AST) 21 IU/l; Basophil Absolute 0.0 K/uL; Basophil 0.3%; Albumin 3.9 g/dL; Blood alkaline phosphatase (ALKP) 77 IU/l; Bilirubin, Total 0.6 mg/dl; Calcium 9.2 mg/dL; Chloride 99 mmol/L; Creatinine 1.1 mg/dl; Glucose 100 mg/dL; Potassium 4.6 mmol/L; Sodium 138 mmol/L; Urea Nitrogen 17 mg/dl; Carbon dioxide 27 mmol/L; Eosinophil Absolute 0.1 K/uL; Eosinophil 1.3%; Glomerular filtration rate (GFR, Estimated) 69; Haematocrit 39.0%; Hemoglobin 13.6 g/dL; Pulse 64; International normalised ratio (INTL Normalization Ratio) 0.98; Lymphocyte Absolute, 1.4 K/uL; Lymphocyte 14.0%; Mean cell haemoglobin (MCH) 34.4 pg; Mean cell haemoglobin concentration (MCHC) 35.0 g/dL; Mean cell volume (MCV) 98.5 fL; Mean platelet volume (MPV) 8.0 fL; Monocyte Absolute 1.1 K/uL; Monocyte 11.2%; Neutrophil Absolute 7.1 K/uL; Segmented Neutrophil 73.1%; Oxygen saturation (O2 Sat) 97; Platelet count 174 K/uL; Total Protein 7.2 g/dL; Prothrombin Time 12.5 seconds; Red blood cell count (RBC) 3.96 M/uL; Red cell distribution width (RDW) 11.9 cv; respiratory 18; White blood cell count (WBC) 9.7 K/uL. Therapeutic measures were taken as a result of severe cellulitis of the left upper arm, entire left upper arm, swollen, painful, some discomfort in left upper arm at injection site reddened area extends from shoulder to antecubital space, left upper arm has area that is hard approx. 2' by 1/2' included CLEOCIN oral at 300 mg four times daily. Follow-up (22Feb2016): New information obtained from a contactable physician includes: Lot # and expiration date, route, dose, date of administration, anatomical location for PREVNAR 13, medical history, lab data, additional events, treatment onset and outcome.