chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I still was not feeling well; Joint pain; I thought I was having fever; the highest temperature I got was 101.3; my vision was really blurred; This is a spontaneous report from a contactable consumer. This consumer of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for Covid-19 immunisation. The medical history and concomitant medications were not reported. The consumer got the shot on the 23Dec2020 probably around little bit after 6 PM and the consumer was working that night.  The consumer thought he/she was having fever and checked temperature and think the highest temperature got was 101.3 on 23Dec2020. After his/her shift when the consumer came home and took ibuprofen (MOTRIN) and the fever was controlled. The consumer went home and developed joint pain and still have fever when the consumer woke up so that was the 24Dec2020. On 24Dec2020 when the consumer woke up because worked night. When the consumer woke up late in the evening and woke finally at 4:30 in afternoon the consumer still was not feeling well on 25Dec2020. So the only think he/she felt differently the previous night my vision was really blurred. The consumer had difficulty in reading stuff that he/she read before in Dec2020. The consumer do use reading glasses but this time when he/she say blurry even when was focusing alone, it was hard for him/her. The outcome of fever and not feeling well was not recovered. The outcome of other events was unknown.  Information on the batch number has been requested.
Shingles without history of chicken pox (vaccinated against chicken pox in 1996)
pain, redness, hardness where shot given, better the next day.  tiredness, chills on and off but gone the next day.
The vaccine was administered high on the shoulder.  The needle mark left in the skin was less than 1 inch from the top of the shoulder.  The morning following the injection I woke up in severe pain, unable to easily move my shoulder.  The main marginally improved over the course of the first day following naproxen 440mg bid and apap 1g q6h, however I was still experiencing pain (which felt like joint pain as opposed to muscle pain) and limited range of motion.  Given the placement of the injection and my symptoms I'm fairly confident the needle entered part of my shoulder joint rather than being placed in my deltoid.
Arm red, hot, and slightly swollen down to my elbow for 2-3-4 days.  Note: due to COVID shots scheduled to be released advised to wait on second Shingrix shot.  Moderna received in February and March.  Forgot about second Shingrix shot until July 2021.  Now advised to start Shingrix over with both shots.
Information has been received from a Licensed Practical Nurse concerning a female patient who on an unspecified date was vaccinated with a first dose of GARDASIL (date, dose and lot number unspecified). The nurse reported that the friend of one of her parents was diagnosed with an abnormal pap smear "about the same time she received her first dose of GARDASIL". At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information is not expected.
Fever, NauseaVomiting, Chills, Rigors Narrative:  Other Relevant History:
pt recv vax 5SEP96 & 17DEC97 pt exp a moderate case of chickenpox & pruritus;the lesions were described as blister-type;
Deep, moderate localized  to one spot: throbbing in right calf - lateral side; not muscular feeling in nature Lasted one day and resolved the following day after hiking and biking activities
She got the vaccine, had no reactions and made her feel good, super charged.  She then went home and in the evening had fatigue and a little aching all over  The next day she had the fatigue again and then it subsided and able to get up and do things around the house.  Then about 2 weeks later she had a bump/lymph node to pop up under her arm, which continued and swelled until it had a core on it.  It then popped on 3/17/21 and now it's open and draining and has a padding to keep it from ruining her clothes.  It is hard to touch, but the soreness has gone away.   She did put Neosporin on it, and a cotton ball, but it is trying to go away and is probably going to have to go to the UC for FU.
A nurse reported that PROQUAD and VARIVAX were administered concomitantly to a patient.  No Additional AE's and no PQC's were reported.; This spontaneous report was received from a nurse via an administrator and refers to a patient of unknown gender and age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, unk, Lot number W017571 (expiration date: 29-NOV-2023) has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (strength, and route of administration were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, unk, Lot number T041687, (expiration date: 10-DEC-2022) has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (strength, and route of administration were not provided) diluted in sterile diluent (manufacturer unknown) use as directed with vaccine (strength, lot #, expiry date, route of administration, and indication were not provided). Both vaccines were administered concomitantly for prophylaxis (Inappropriate schedule of vaccine administered).
Within approx. 6 hours of receiving vaccines patient experienced flu-like symptoms (fever, chills, aches); recovered within a day.  Has never had an adverse reaction to prior Moderna vaccines (1st - 4/5/21, 2nd 6/3/21).  Within approx 10-14 days after receiving Moderna booster, began to experience an intense itch (at first in groin area - mistook for yeast infection but creams only seemed to make worse), then the itch spread to any & all body parts as an intensely itchy, red & raised welts (hives).  Seemed to be no pattern to where hives would occur except that simply scratching the skin could instigate raised hives & continued scratching makes it much worse.  If ignored, will fade within the hour or less but will recur elsewhere without respite; some form of global migrating dermatographic urticaria?  All areas of body seem susceptible (including scalp, soles, palms, ears - excepting does not occur directly on the face - no eyelids/cheeks/lips, forehead...)  Most OTC antihistamines did not mitigate the hives, but just 1/2 zyrtec (generic) almost made them disappear when taken daily; if this does is missed, hives become apparent again & gradually worsen as when first appeared.   Patient tired of taking Zyrtic daily due to perceived side effects & discontinued in April 2022 - hives were still present & just bearable if itching resisted.  In May 2022, family tested postive at home for Covid-19 (patient was asymptomatic except for tiredness), but hives all but ceased to exist during the week of illness in the household.  Within a week of illness in the household, hives have now returned, but at a lesser intensity.  Patient manages without medication at the moment.
By 9 pm I had a 102 degree fever with a severely swollen arm. I was down for about 2 days again. This seemed to exacerbate my past conditions of high blood pressure, sinus Infections and neck and back aches.
I started having tinnitus in both ears after serveral days of having the first vaccination.  I have a hearing problem  from birth but when the tinnitus started I had noise and more hearing loss.  I have not had treatment yet but I have an appoinment for my physical next month. I will have it checked out then if I can stand the loss.
My migraine exacerbated. Having attacks after the second dose almost every day. Affecting my daily living. My work, my time with family, my day-to-day events; My migraine exacerbated. Having attacks after the second dose almost every day. Affecting my daily living. My work, my time with family, my day-to-day events; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Feb2021 09:15 (Lot number: EL8982) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing), notes: Other medical history: asthma/ADHD; "Asthma" (unspecified if ongoing), notes: Other medical history: asthma/ADHD; "allergies penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "allergies: cipro", notes: Known allergies: penicillin/cipro. Vaccination history included: Bnt162b2 (Product=COVID 19, Brand=Pfizer,, Lot number=EK9231,, Administration time =08:30 AM,, Vaccine location =Left arm,, Dose number =1), administration date: 15Jan2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 15Feb2021, outcome "not recovered" and all described as "My migraine exacerbated. Having attacks after the second dose almost every day. Affecting my daily living. My work, my time with family, my day-to-day events". The event "my migraine exacerbated. having attacks after the second dose almost every day. affecting my daily living. my work, my time with family, my day-to-day events" and "my migraine exacerbated. having attacks after the second dose almost every day. affecting my daily living. my work, my time with family, my day-to-day events" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, loss of personal independence in daily activities.  Additional information: My migraine exacerbated. Having attacks after the second dose almost every day. Affecting my daily living. My work, my time with family, my day to-day events. Patient did not receive any other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient did test for covid post vaccination. It was unknown if covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Increased blood pressure to  to 162/99 to 150s over mid to high 80 for an extended period lasting from 3-5 days post vaccine.    Chills and body aches the day after the does but ended by the morning.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; Moderna COVID-19 vaccine administered to patient post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 97th of 104 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
No adverse event; 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-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 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant medications were reported. The vial was initially thawed on 10-Jun-2023.  Treatment medications were not reported.  This case is for 4th patient out of 30 patients reported by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up significant information received: Drug start date was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:
Started with sore arm ad raised injection site and two hours later started with headache fever (103.7) and chills as well as achy all over.  Continued thru the night and following day have headache and less achy and no fever. Symptoms are starting to get better but not resolved yet. I had known covid in Oct 2020.
Received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
body and Joint pain through out the nigh ,  took Advil/Tylenol through out the night
Was given immunization Tdap, pt became dizzy 5-6 min after vaccine, she was sitting down and fainted for a few seconds. She was taken to exam room to lay down x10 mins to recover, a cool damp towel was placed on forehead and behind the neck. She felt better and was released home.
Platelet count of 28,000; Generalized body pain all over; Weakness; On and off Chills; Low grade fever; Injection site soreness; A spontaneous report was received from a consumer who was a 64-year-old, female patient who developed a platelet count of 28,000 (thrombocytopenia), generalized body pain all over (general body pain), weakness (asthenia), on and off chills (chills), low grade fever (pyrexia), and vaccination site soreness (injection site pain).  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (lot number 039K20A) on 31 Dec 2020.  On 28 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (lot number 209K20A) in the left arm for prophylaxis of COVID-19 infection.  On an undisclosed date the patient experienced injection site soreness, generalized body pain all over, chills, low grade fever and weakness.  She also went to the hospital because she had a platelet count of 28,000.   Treatment of these events was not provided.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   The outcome of the events, platelet count of 28,000, generalized body pain all over, weakness, on and off chills, low grade fever, and vaccination site soreness, was unknown.; Reporter'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.
A day after the vaccine, a large baseball size knot appeared at vaccine site, later that evening it grew to softball size, hot, and very painful. When I got the first dose, was not as drastic as this second dose. After the first does, it lasted around 10 days.
having full body tremors. treating with primidone and losartan. on going treatment and no better
Presented to dr office 1 hour after immunization administration with fever and chills. Patient reported tachycardic and was quickly found to be in A.fib. Patient did have prior history of A.fib, not disclosed to the pharmacist.
102 fever, chills, headache, muscle and joint pain, fatigue (moderate) which started around 10 pm on 2/1/2021.  At 2 am on 2/2/2021, I had a fever of 102.  I took Tylenol at 2 am and 9 am.  Fever down to 99.
Patient received vaccine inadvertently after published expiration date. Moderna Company analyzed vaccine and advised lot 031L20A maintained activity necessary to  protect against covid 19 on date vaccine was administered. Also patient did not call in in complain of adverse event.  This is administrative error without adverse event.
Information has been received from a licensed practical nurse for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female with drug reactions/allergies to BACTRIM and penicillin and no pertinent medical history who on 19-JUL-2011 was vaccinated intramuscularly on left deltoid with the first dose of GARDASIL (lot# not reported), 0.5 mL and on 03-OCT-2011 was vaccinated intramuscularly on left deltoid with the second dose of GARDASIL (lot# 668262/0841AA, expired on 08-APR-2013), 0.5 mL. There was no concomitant medication. The nurse reported that the patient called the doctor office on 10-NOV-2011 stating she took a home pregnancy test and it was positive. The patient was seen at the office on 21-NOV-2011 and ultrasound performed on that day confirmed pregnancy at 5 weeks 6 days gestation. The patient's LMP was 13-SEP-2011 and estimated delivery date is 19-JUN-2012 (also reported as 17-JUL-2012). The nurse confirmed the patient was not experiencing any adverse effects. Follow up information has been received from the physician concerning the patient with no pertinent medical history, no pre-term deliveries, spontaneous abortions, elective terminations or fetal deaths and with chlamydia infection, equivocal RPR and FTA Ab (negative) during pregnancy. Concomitant medications used during pregnancy included prenatal vitamins and TYLENOL. The physician reported that on 23-JUL-2012, at 40 weeks, the patient gave birth a normal baby boy with no congenital anomalies, complications or abnormalities, who weighed 6 pounds. Apgar score was 9/9. The physician reported that the patient did not have complications during pregnancy. During labor the patient experienced a placental abruption of 10%, light meconium and it was needed the use of forceps assisted vaginal delivery (FAVD). There was not diagnostic test during pregnancy. The baby's experience was capture in (MARRS # 1209USA009632). Additional information is not expected.
dizziness; nausea; headache; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 at 10:15 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 04Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Sjogren's Syndrome" (unspecified if ongoing); "asthma" (unspecified if ongoing); "migraine" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; ORTHO-CEPT. The following information was reported: DIZZINESS (non-serious) with onset 05Oct2023 at 07:00, outcome "recovering"; FATIGUE (non-serious) with onset 05Oct2023 at 07:00, outcome "recovering", described as "extreme fatigue"; HEADACHE (non-serious) with onset 05Oct2023 at 07:00, outcome "recovering"; NAUSEA (non-serious) with onset 05Oct2023 at 07:00, outcome "recovering". Therapeutic measures were not taken as a result of dizziness, nausea, headache, fatigue.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Pt's mother stated that the swelling started the  next morning after given the vaccine on the  LT thigh ,  mom stated it's a size of a golfball, redness minimal , w/ warmth . Advised pt to apply cold compress and children's benadryl 2.5 ML  every  4hrs.