chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events reported.; Nurse reported adose of PROQUAD was administered to a patient on 11/18/2020 that had been involved in a temperature excursion that was not reported. Temperature: Unknown at this time, alarm went off but nurse is unable to read the data logger.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.      On 18-NOV-2020, the nurse reported a patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number T015261, which has been verified to be valid, the expiration date was reported and validated as 31-OCT-2021), at a dose of 0.5 milliliters (ml) as prophylaxis (dose number, vaccination scheme, and route of administration were not provided). Concomitant therapies included sterile diluent (lot number was not provided).  The vaccine had been involved in a temperature excursion that was not reported. Nurse had not finished the temperature excursion information at this time and will have to email it in at a later time, outcome was unknown if supported or not. Temperature was unknown at this time, alarm went off but nurse was unable to read the data logger at this time (product storage error). No additional adverse events were reported.
shortness of breath< heavy tight chest, dry cough, occasional; fluttering/ arrhythmia
Get weak as well as other neurological symptoms and lack of mobility; Get weak as well as other neurological symptoms and lack of mobility; Get weak as well as other neurological symptoms and lack of mobility; This is a spontaneous report received from a contactable reporter   An female patient received BNT162b2  as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROLOGICAL SYMPTOM (non-serious), ASTHENIA (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Get weak as well as other neurological symptoms and lack of mobility".  Additional information: The reporter was reporting about the possible side effects on his mother (the patient) that have continued for 1.5 years. The patient continues to get weak as well as other neurological symptoms and lack of mobility. The reporters has identical symptoms. They thought it was due to the Alzheimer's and everyone has the same symptoms. The reporter does not know which vaccine they received it was just ironic they are having that too. A total of 4 patients that experienced identical symptoms which he had reported. Reporter reported that he does not have any other patient information to provide on any of the patients.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
He states he received his 3rd dose of GARDASIL 9 on 11Jun2023 in unspecified deltoid muscle and as of today, he still has a dark red quarter sized circular spot in the area where he had the vaccine. He also reports a "bump."; He states he received his 3rd dose of GARDASIL 9 on 11Jun2023 in unspecified deltoid muscle and as of today, he still has a dark red quarter sized circular spot in the area where he had the vaccine. He also reports a "bump."; This spontaneous report was received from a 34-year-old male patient referring to himself. The patient's pertinent medical history included heartburn. His drug reactions/allergies were reported as no known allergies (NKA). His concurrent conditions were not reported. Concomitant medication included esomeprazole magnesium trihydrate (NEXIUM).   On 11-JUN-2023, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly (IM) in unspecified deltoid muscle as prophylaxis (strength, dose, lot #, and expiry date were not provided).  On an unknown date in 2023, the patient had a dark red quarter sized circular spot in the area where he had the vaccine (vaccination site erythema). He also had a "bump" (vaccination site mass). He asked a pharmacist if this was normal, and he was referred to his primary care. He had not reached out to his primary care physician at this time. There was no treatment given for the events. At the reporting time, the patient had not recovered from vaccination site erythema and vaccination site mass, the symptoms still presented. He was requested information on whether the events were normal or if the events were seen before.   The causal relationship between the events and the suspect vaccine was not reported.
On the evening of 4/29/02, pt states a fine, pink rash was beginning on wet areas of body (underarms, groin). It spread to cover all of body. Pt complained of severe pruritus at "welts" with scratching. Pt  took tepid bath and used Calamine lotion. Pt did not see or call PCP. Rash resolved in 3 days. Pt stated she also had "fever" (no temperature taken). No SOB.
I am afraid that the patient may not have received the full dose 0.5 ml of flu vaccination because upon admistration (IM left deltoid) some medication escaped from the needle cap.  Some vaccination was injected, some vaccination escaped.  I have no way of confirming the amount injected & the amount escaped.  The patient reported feeling some vaccine on his arm.  I observed some come out of the needle cap.  So I know the full amount injected was not 0.5 ml.  I check with the CDC; they informed the best practise is to reinject the dose in any event that the full dose is not administered. I will readminister the vaccination.
t99.6 presents w/c/o upper arm red, warm, swollen, painful; lt upper arm & shoulder painful on ROM
My whole stomach is covered in hives; Rash; This is a spontaneous report from a contactable pharmacist (patient). A 52-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: unknown, expiry date: unknown) via an unspecified route of administration on 07May2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included propranolol taken for an unspecified indication, start and stop date were not reported. On May2021, the patient had rash and her whole stomach was covered in hives. The patient stated that she had never had hives in her whole life. Pharmacist stated that, I don't think I should get the second shot if I am covered in hives. So I will call them tomorrow and let them know about the hive, then the rash and see if I should not get the second shot then. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No additional AE/PQC reported; Expired vaccine used; This spontaneous report was received from a medical director referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 04-FEB-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  (recombinant human albumin (rHA)) (M-M-R II) (lot # R030806, expiration date was 24-OCT-2020, strength, frequency and route were not reported) for prophylaxis (expired vaccine used). No additional adverse event was reported.
Fever (39.8 degrees C) 11/8/13 with irritability. Refused to walk without Ibuprofen 11/9 - 11/11/13. Poor sleep, overtired. Snapped out of it 11/13/13.
Gradual onset of symptoms of severe diarrhea after his MMR in 4/94, including screaming at night, not sleeping, preoccupation of an object, loss of language and has never regained any speech and is now 8 years old. He has had dx and evaluations by local doctors and pediatric neurologists as well as specialists. Has stopped shots. The 60 day follow-up reports states the baby lost all of speech and has never regained any of it. In addition to this, the baby has a significant issue of gut problem and a metal metabolism. Dysfunction (zinc, copper imbalance). He also has a lot of mercury in his body as well as aluuminum, lead, etc. Doc 212155, annual follow up, states the following: autistic symptoms, nearly as severe as ever. No speech, uncontrollable behavior, no appropriate play. Doc also states that metal level in body coming down.  Follow up letter states: Sending a copy of your letter back tou you to help you recall our situation. Sorry it took so long to reply. However MD is aware of his being called. Pt has been to the center one time and it is at the center that we found out he has a M/T dysfunction (mental metabolism dysfunction) and he is now taking nutritional therapy which is being compounded at their pharmacy. MD is working with another MD at center regarding pt. I hope this will help you. If you have further questions please call.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:41 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:41 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 52.12. Concomitant products were not provided. On 03-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021 and vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
she did not react to both doses of the Pfizer COVID-19 Vaccine, except having sore arm.; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received first dose of bnt162b2 (BNT162B2; Batch/Lot number was not reported), via an unspecified route of administration on Jan2021 as single dose, Second dose via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included immunodeficiency from an unknown date and unknown if ongoing Caller stated that she is immunocompromised and is concerned about getting sick , illness from an unknown date and unknown if ongoing verbatim: Caller stated that she is immunocompromised and is concerned about getting sick. The patient's concomitant medications were not reported. The patient experienced she did not react to both doses of the pfizer covid-19 vaccine, except having sore arm. Clinical course reported as has received both doses of the Pfizer BioNTech COVID-19 vaccine. She received her first dose in Jan2021 and her second dose 3 weeks later in early Feb2021. Caller is concerned about getting the booster dose and she would like to know when to get and if she is eligible. Caller stated that she is immunocompromised and is concerned about getting sick. She heard that an Infectious disease doctor at the national health department said that the efficacy of the Pfizer COVID-19 vaccine decreases to 84% after 6 months. Caller stated that she did not react to both doses of the Pfizer COVID-19 Vaccine, except having sore arm. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Lymph node developed on left collar bone and have yet to see a doctor about it. It can be move around slightly and doesn't hurt or cause much discomfort.
Shortness of breath, itch, eye pressure, Bilateral hand tingling, jaw tightening, numb in throat.
230 - vaccine administered. 5pm - started itching with hives on lower extremities & back of hand.
Continued aching and soreness in the left shoulder joint for 30 days now. Injection seems to have been administered a little too high and went into the shoulder joint instead of the muscle. No treatment sought yet. Considering having a Dr look at it if aching / soreness continue for a few more days or gets worse.
Patient admitted for observation after allergic reaction to vaccine.  Her reaction consisted of hives and lip swelling, and she received one dose of epinephrine in the clinic, followed by prednisone and antihistamines.  No worsening of her symptoms and resolution of her hives overnight.  Symptoms: Hives, Swelling of lips.  02/04/2008 MR received from reporter for o/n ER observation 1/31-2/1/2008 for allergic reaction to vaccine (probably Japanese Encephalitis, but Typhoid and IPV could not be excluded).  Pt developed a non-pruritic rash, facial flushing and H/A within minutes of receiving vax. Pt given epi and Benadryl and sent to ER for observation.  Approx 1 1/2 hours later the pt developed lip and tongue swelling w/o respiratory distress. Stable o/n and D/Cd with Epipen, antihistamines and prednisone. Per TC with reporter, pt presented again to ER on 2/4/08.   03/03/2008 Additional records received describing a "rebound" anaphylaxis from above incident on 2/4/08.  Pt began to feel malaise, then developed chest tightness and flushing. A splotchy rash developed which was itchy. (+) lip and hand swelling, increased RR and tingling of hands. Pt txd with steroids, benadryl, and zantac and admitted for observation o/n. No further sx.
Severe chills and severe muscle ache, especially in the legs, woke me up in the night. Taking 209 mg Ibuprofen helped me finally sleep.  Severe chills lasted for one hour,  which was 20 min after taking Ibuprofen. Muscle ache continues even now (2/17/2021 at 5:30 pm). Still in bed, taking rest as I don?t have the energy to do any work.
10/17/19 Dr.'s office sent an email stating this employee has a serious reaction to the egg-free flu vaccine yesterday.  Dr. will start her on steroids and document findings. Cellulitis and myositis documented. She is said to have swelling on her left side, left shoulder, chest (breast), back, neck and left arm and into her ear.  Treated with Decadron 10/17/19; Depomedrol 80 mg 10/21/19 10/24/19 F/U employee is recovering but the symptoms are not completely resolved as of today.
The patient had a nosebleed that lasted more than 12 hours starting a few hours after getting the SHINGRIX.
Swelling; Got very sick after third covid-19 booster; Achy; Sore arm; Big lump; Fever; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), IMMUNISATION REACTION (Got very sick after third covid-19 booster), PAIN (Achy), PAIN IN EXTREMITY (Sore arm) and MASS (Big lump) in a 55-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third 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) 40MG/0.4ML cf. In 2021, the patient experienced PAIN (Achy), PAIN IN EXTREMITY (Sore arm), MASS (Big lump), PYREXIA (Fever) and NAUSEA (Nauseous). On an unknown date, the patient experienced SWELLING (Swelling) and IMMUNISATION REACTION (Got very sick after third covid-19 booster). At the time of the report, SWELLING (Swelling) had not resolved and IMMUNISATION REACTION (Got very sick after third covid-19 booster), PAIN (Achy), PAIN IN EXTREMITY (Sore arm), MASS (Big lump), PYREXIA (Fever) and NAUSEA (Nauseous) outcome was unknown.            Concomitant medications were not reported.  All doses of Moderna COVID-19 vaccine were taken one in once with ID.  Humira 40mg/0.4ml solution for injection was single dose pen with citrate free (CF) daily dose.  The reporter's causality for the events of fever, achy, big lump, got very sick after third covid-19 booster, nauseous, sore arm and swelling with Humira (Adalimumab solution for injection) were not provided. AbbVie's opinion on the causality for the events of fever, achy, big lump, got very sick after third covid-19 booster, nauseous, sore arm and swelling with Humira (Adalimumab solution for injection) and Moderna COVID-19 vaccine were not provided. No treatment information was provided.
Headache  INJECTION SITE PAIN, INSOMNIA  Narrative:   Other Relevant History:
PATIENT REPORTED FEVER, CHILLS AND SEVERE SHAKING AS WELL AS SEVERE SORENESS FOR 24 HOURS AFTER DOSE.
09:11 - 76 y.o. female with h/o Graves disease brought in by EMS presenting with altered mental status after COVID vaccine. The pt reports that she received the first COVID vaccine several weeks ago and immediately afterwards she felt warm and had some difficulty focusing and walking. This resolved and she has since felt well. Today at 0800 she had her second dose of the COVID vaccine. About 15 minutes later she had an acute change in her mental status. She became disoriented and slow to answer questions. She also started having difficulty walking. She was also noted to be hypertensive with systolic BP in the 200s. She was subsequently sent here by the doctor at the vaccine clinic via EMS. Currently the pt is feeling somewhat improved and more back to her baseline. She notes that she still does not feel quite herself. Notes that her symptoms feel similar to her reaction after the first vaccine except much worse. Sates she takes Levothyroxine but no other medications. She last had her thyroid numbers checked in January and they were somewhat "off."
This spontaneous report as received from a nurse practitioner refers to a 23 years old female patient. The patient was vaccinated with the first dose of GARDASIL (lot# unspecified) intramuscularly on 08-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. After the injection that she was driving home and vomited for an hour straight. The outcome of vomited was reported as recovering. Additional information is not expected.
Pain at injection site, redness, feels like there?s something stuck in there....like a piece of the needle broke off.  This is 3 weeks after the injection!
On the 26th I began to have itching all over my body that kept me up at night. I went back to taking Claritin and it worked I did get relief when the Claritin wore off I had more intense itching. I tool Claritin around the clock the 24 hours and it stopped after two days. It was a delayed reaction, caught me by surprise. I had no new foods, medications.  I did call the after hours Dr to maybe get a steroid injection but he didn't feel it was the best choice and told me to continue the Claritin
Hives on body; Feeling horrible; fever; headache; aches; fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th July 2019, 1 days after receiving Shingrix, the patient experienced fever (serious criteria clinically significant/intervention required), headache (serious criteria clinically significant/intervention required), pain (serious criteria clinically significant/intervention required), fatigue (serious criteria clinically significant/intervention required) and feels awful. On 19th July 2019, the patient experienced hives (serious criteria clinically significant/intervention required). The patient was treated with ibuprofen (Motrin), benadryl (nos) (Benadryl) and methylprednisolone (Medrol). On 19th July 2019, the outcome of the fever, headache, pain and fatigue were recovered/resolved. On 20th July 2019, the outcome of the hives was recovered/resolved. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the fever, headache, pain, fatigue, hives and feels awful to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. On 17th July 2019, in the evening the patient received Shingrix on the left arm. The patient did not have any information about the vaccination. The patient felt horrible and experienced fever,headache, fatigue, and aches. States she The patient was treated at home with Motrin. The patient also experienced hives on her body and went to urgent care and received Benadryl and medrol/steroids to treat the hives. The reporter consented to follow up.
Information has been received from a physician concerning a female patient over 60 year old who on an unspecified date was vaccinated with ZOSTAVAX. The patient experienced nerve root distribution on the left side 2 weeks after vaccination. The patient experienced hyperesthesia prior to eruption on the left side. The patient nerver developed blisters. The patient, 8 weeks after vaccination, developed same nerve root distribution on the right side, then shortly, after a few days, developed blisters. The patient was treated with an unspecified antiviral agent. Within 5 days, the blisters on the right side and dysesthesia on the right and left disappeared. The patient then experienced dysesthesia on the left side one week after the blisters and the dysesthesia on the right and left sides. The patient does not have diabetes. At the time of reporting the patient had not recovered. The patient sought medical attention: she contacted and unspecified dermatologist. There was no product quality complaint. Additional information has been requested.
Pt recvd vax 14OCT88 & 21OCT88 exp swelling around knee joint & was unable to walk on leg; during the following wk swelling spread to include all joints & exp pain & discomfort for approx 2 wks; devel rash & discomfort & swelling of joints;