chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have pain/Aches and pains all day; Headache/head was killing; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0196), via an unspecified route of administration in right arm on 17Jun2021 (at the age of 66-year-old) as dose 2, single for COVID-19 immunization. The patient was taking the Pfizer COVID vaccine to try not to get COVID work in the business with a lot of people. The patient's medical history was none. Concomitant medications included blood pressure pill and vitamins NOS every day. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178), via injection in right arm on 27May2021 (at the age of 66-year-old) as dose 1, single for COVID-19 immunization. Patients medical history (including any illness at time of vaccination) was none. Family medical history relevant to adverse events was none. Prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine was none. Additional vaccines administered on same date of the Pfizer suspect was none. No adverse events following prior vaccinations. Patient stated she has received the Pfizer COVID vaccine and wanted to know if she could take something for pain, most specifically for a headache. She stated, "her head was killing her on an unspecified date in 2021." Reporter stated she was calling about the Pfizer COVID Vaccine. She stated she just has a question on what she could take for pain after receiving the COVID vaccine yesterday. Reporter stated she was having pain, so she was taking off work today and that was why she was home today. Reporter stated it really just her head. She has aches and pain all day and night all the time anyways. She stated it was on 18Jun2021 about 02:10 am almost exactly 12 hours after the second dose. Reporter stated that it was worse this morning. Reporter stated the outcome of having pain was the same. The adverse events did not require emergency room visit and physician office visit. No relevant tests. No investigation assessment. The outcome of the event pain was not resolved and unknown for the other event.  Information on Lot/Batch number was available. Additional information has been requested.
patient had rebound symptoms with positive test after completion of Paxlovid; patient had rebound symptoms with positive test after completion of Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 49-year-old male patient received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolaemia" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "patient had rebound symptoms with positive test after completion of Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: patient had rebound symptoms with positive test after completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and Covid 19 cannot be ruled out.
This event was caused by human error. The nurse inadvertently administered the Moderna Bivalent dose to patient instead of the primary dose. Patient was monitored for 15 minutes and did not show any adverse side effects. The patient was contacted on 10/13/2022 by the Chief Operations Officer and the patient indicated that he had no  symptoms except soreness at the site of injection.
Diagnosed roseola 03/02/2000 rash gone 03/07/2000 from roseola dx. Mom states generalized rash developed on 3/13/2000, and continues thru 03/31/2000. Dx Vasculitis. No treatment.
patient was diseased; a dose from the recalled batch was meant to be administrated; pharmacy dispensed a dose from the recall batch; This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 9lh3y, expiry date 7th February 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On 7th May 2021, unknown after receiving Shingrix, the patient experienced drug dispensing error. On an unknown date, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and recalled drug administered. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the recalled drug administered and drug dispensing error were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, their pharmacy dispensed on 7th May 2021 a dose of Shingrix from the recall batch. The vaccine was meant to be administrated to a female patient but the facility was unaware of the date of the administration.  The health care professional clarified that, the patient was diseased but did not clarify if there was a relationship between the death of the patient and the administration of the vaccine.  No further events were reported.  The Shingrix doses were administrated in another facility and the reporter did not know when (exact date) or if the vaccines were in fact administrated, they only have the date in which the vaccines were dispensed from the pharmacy which were after the date of the Shingrix recall.  The reporter did not know if the patients had adverse events after the administration of the vaccine. The health care professional agreed to be contacted for follow up. This is 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021202998:same reporter US-GLAXOSMITHKLINE-US2021203000:same reporter; Reported Cause(s) of Death: Unknown cause of death
Pt received 5 year old imms on 9/18/07. 2 days later returns to the office with a swollen, warm and tender left arm. Suspect cellulitis. Pt treated with Benadryl and Cephalexin.
The pt states that she developed chills and fever and her left arm and lymph nodes under her left arm became very sore and aching as well as into back, approx. 12 hours post vax. She had a light facial rash, 24 hours post vax, that faded quickly. No reaction at the injection site.
Given vaccine at approximately 3pm on 3/4/08 on 3/5/08 in the afternoon developed appproximately a 4X2 inch hardened, reddened and warm to touch area where the varicella vaccine was administered.
This spontaneous report was received from a licensed practical nurse concerning a patient of an unknown age and gender. Medical history and concurrent conditions were not reported. On 21-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (frequency reported as once) lot # K000996 expiration date 13-MAR-2014, 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The licensed practical  nurse stated patient received ZOSTAVAX that was exposed to 1C for 31 hours (supported by stability data). No adverse effects reported. This is one (1) of two (2) reports from the same source. Additional information has been requested.
PATIENT STATED THAT HER LEFT ARM STILL HURT. NO REDNESS AT SITE OR PAIN WHEN TOUCHED. SHE STATED THAT IT HURT WHEN LIFTING THE ARM.
No additional AE reported; adult patient located at an offsite facility received a pediatric dose of RECOMBIVAX HB.; adult patient located at an offsite facility received a pediatric dose of RECOMBIVAX HB.; This spontaneous report as received from a pharmacist refers to an adult patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 12-JUL-2021, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.
fever x 1 day; chills; vomiting x 4 days; treated w/Amoxicillin;
Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 16-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Had Covid in December 2020 after long history of ITP my platelets were normal. I work at a health are facility and was told after 90 days to get the vaccine. I received my first dose of Moderna on 3/24/21 with just severe swelling of lymph nodes under arm for a week. After, 4 weeks received 2nd shot. Approx. 2 to 3 weeks after shot starting experiencing rashes and extreme itching of the skin. I didn't receive treatment at that time thinking it would go away and it has been 9 months and I have been to my family Dr,  an Allergist, and Dermatologist. My platelets are starting to come below normal levels again so I am hoping this goes away but I am now going to see a hematologist.
Pt reports nausea, fever, and severe headache with onset approximately 12 hours after second dose of SHINGRIX. Said symptoms lasted approximately 1 day.
Chills with uncontrollable shivering, headache, body aches and joint pain
Reaction began to appear on 02 Jan 2021 (Day+2).  Sore neck muscles 03 Jan 2021: Neck muscles stiffen and preclude rotation of the head.  Pain radiating from shoulders up through neck to top and side of head.  Neck and muscles sore to the touch.  Fatigue. Loss of appetite. Joint pain in all major joints.  Inability to sleep from pain.
developed mild swelling, itching, redness, tenderness to palpation of right eyelid on the next day after vaccine - treated with antihistamine that evening at HS Day 2 post vaccine- increased swelling, itching, redness, tenderness of right eye lid- antihistamine in AM Day 3 post vaccine - increased swelling, redness, itching, tenderness of right eye, swelling did effect vision-  prednisone and antihistamine in evening Day 4 post vaccine - symptoms decreased in the AM however resumed about 3-4 pm that day - prednisone and antihistamine in evening Day 5 - continued with increased itching, mild swelling, redness, local tenderness to right eyelid - antihistamine in PM- seen by provider Day 6 - continues with mild swelling, tenderness and itch to right eye lid - prednisone in AM
(L) arm - nerve, irritation down to hand between thumb and forefinger; onset 5-10 secs post IM administration of Hep. A vaccine; discomfort followed by numbness; 20 mins showed increase in comfort.
This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), ERYTHEMA (Redness) and TENDERNESS (Achy and tender arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR), ROSUVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN C;VITAMIN D NOS;VITAMIN E, ZINC and POTASSIUM for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced TENDERNESS (Achy and tender arm). On 16-Feb-2021, the patient experienced SWELLING (Swelling) and ERYTHEMA (Redness). At the time of the report, SWELLING (Swelling), ERYTHEMA (Redness) and TENDERNESS (Achy and tender arm) outcome was unknown.            Treatment medication included acetaminophen and ice compress.
sore arm; aches; memory loss; she had started to feel a strange effect with memory loss and neurological fogginess; fever; headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (aches), AMNESIA (memory loss), BRAIN FOG (she had started to feel a strange effect with memory loss and neurological fogginess) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was reported that patient didn't received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 24-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (aches), AMNESIA (memory loss), BRAIN FOG (she had started to feel a strange effect with memory loss and neurological fogginess), PYREXIA (fever) and HEADACHE (headaches). At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (aches), AMNESIA (memory loss), BRAIN FOG (she had started to feel a strange effect with memory loss and neurological fogginess), PYREXIA (fever) and HEADACHE (headaches) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient had received a flu shot somewhat recently but not within 4 weeks of any of the COVID-19 vaccines. She had never taken any Pfizer vaccines.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-737365 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737365:monovalent dose case
FEVER, BODY ACHES, CHILLS, RASH ON INJECTION SITE
Pt received flu shot and w/in a few mins R shoulder became red and swollen. Pt was crying but no c/o SOB, dizziness, or pain. Parents refused medical care @ clinic site
The patient received an expired vaccine. The label on the vaccine, and online Moderna website had conflicting discharge dates. Call placed  Moderna case opened. Call to mother notified of Moderna suggested options. Mother will call the pediatrician to decide if she will repeat the first dose or continue to the second dose. Mom reports the patient is doing well, tolerated the vaccine well, No s/s of adverse reactions.
Patient has full body myalgia, irritabilty, sleep problems, fatigue, and weakness. Patient is still currently feeling symptoms.
Pt reports post vaccine he saw red spots around injection site. Pt was treated with Benadryl, epinephrine, treated with Epi, Benadryl and O2. Released home after 1 hr.
pt received the Moderna Covid 19 vaccine on 2/8/21. PT stated having muscle ache/pain at injection site and then on approximately 2/16/2021, the pt developed a rash at the site on the injection that covered a majority of the deltoid area
Swollen red arm that patient stated was extremely painful to move. Could not move her arm without the help of the left arm. Had fever and chills as well. When I saw her arm looked like she had a flexed bicep meaning red and swollen. Told her to take BENADRYL and TYLENOL to help with symptoms.
experienced pain in his arm; tired; This is a spontaneous report from a contactable consumer or other non health care professional. This female (daughter) consumer reported for a 60-year-old male patient (father).  A 60-year-old male patient (father) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6202, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that reporter father has experienced pain in his arm this morning and feeling tired. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Patient states joint pain, rash with shooting pain on right breast, pain in rib cage on right side, gas and bloating.
The day of vaccine in couple of hrs stared feeling dizziness,still on & off,Injection sight hurting,also started getting bad headaches.About third day I started getting weakness in my legs & it increase with numbness.I made an appointment with my Primary care doctor on 18th of Jan because the numbness still continues.Doctor order lab work which I did on Jan 19th morning & I have follow up virtual appointment with my doctor on 21st Jan @ 4:45 PM.
Itching, tingling, prodrome like symptoms, progressively getting worse and painful; no lesions seen, some erythema, headache and neck pain.
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On 24-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml Prefilled Syringe (PFS) (lot # K020795, expiration 19-MAR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
pt was found blue & unresponsive p/put to nap by mom; unsure if this is related to vax but feel that because it was only w/in 7 days perhaps its helpful in statistics;
She has reported no issues to me.  I have not been able to reach her by phone.  Told me to report this as adverse event since I gave the second booster (shot #4) to someone under 50.  She works around elderly people.
5/26/12 Pt daughter called to report swelling & redness at injection site, swelling greater than 1 inch & redness to elbow from injection site. Daughter reports pt looks pale & pt states she is fatigued. No fever & the other symptoms; 5/28/12 swelling down, no heat, had spot at inj site - otherwise fine.
No adverse reaction seen or reported. Contacted manufacturer and the vaccine is still viable. Revaccination not needed.
Fever(102.4), headache, chills, body aches, vomiting symptoms varying/lasting from 9 pm feb 3 until 8 am feb 5
Patient received first dose of Moderna Covid vaccine on 09/01/2021.  Patient did not put a date on the information and consent form of her first covid shot.  She stated she was here today for her second covid vaccine shot.  She stated it had been a month since her first dose.  The nurse did not look up the date in GRITS and the patient did not have her Covid record vaccination card with her to verify the date of the first covid shot.  The nurse administered the second Moderna Covid vaccine as requested.  The time frame between the first and second Moderna Covid shot was too soon (20 days).
pt recv vax;at noon pt was fussy; screaming cry off & on all day & noc;T 102 ax;apap given;noticed shivering "tremors" during noc;to er; on amoxicillin;f/u by MD;
Information has been received from a physician concerning a 13 year old female patient who on 12-NOV-1997 and 14-MAR-2000 was vaccinated with the first and second doses of MMR II (HSA).  On 02-JAN-2010 the patient experienced mumps. On 03-JAN-2010, the patient was diagnosed with mumps. The parotitis was on the left side. The parotitis count was 48. At the time of this report the patients status was unknown. Follow up information from the physician indicated that the patient experienced mumps on 03-JAN-2010 (previously reported as 02-JAN-2010). On 04-JAN-2010 the patient was diagnosed with mumps. The patient was afebrile. On 04-JAN-2010, a first blood work was performed and showed that: IgM, <1:10; IgG, 9.25; serum amylase, 56. Additional information has been requested.
Narrative: unsure if correlated but pt got covid-19 vaccine on 2/24/21, then on 3/10/21 presented to ED with Right sided facial droop, right UE weakness/numbness, and slurred speech. Admitted for CVA in region of left MCA.
Started having abdominal pain early '22. Dx with C diff. Colonoscopy revealed large mass.  Ultimately dx with Goblet cell cancer and needing major surgery and chemo
keloid (scar)/from BCG Vaccine; This spontaneous report was received from a patient (who was also a pharmacist) of unknown age, who was referring to himself/herself. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with bcg live (BCG VACCINE USP) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for tuberculosis bladder.  On an unknown date, the patient experienced keloid scar. The outcome of the event was unknown.  The reporter considered the event to be related to bcg live (BCG VACCINE USP). combinationproductreport: Yes; brandname: BCG VACCINE USP PUNCTURE DEVICE (DEVICE); commondevicename: BCG live; productcode: LDH; devicetype: SYSTEM, DELIVERY, ALLERGEN AND VACCINE (LDH); manufacturername: Organon Teknika Corporation LLC; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Initial report received from a healthcare professional on 01 February 2013. This is an invalid case as patient identifiers were missing. Cluster of 2 patients who had no illness at the time of vaccination and concomitant medication were not reported, had received a dose of MENACTRA (dose, number in series and site of administration were not reported) intramuscularly on an unspecified date. On an unspecified date (within 24 hrs. of vaccination) the patients developed fever, chills, headache, body aches, dizziness, and generalized weakness. It was reported as symptoms lasted 48-72 hrs. One patient had improved and the other patient still has a few lingering symptoms, but has improved. Corrective treatment details were not reported. No laboratory investigations were done. The patient's outcome was not recovered. List of Documents held by sender: None.