chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; patient received Moderna Monovalent shot instead of Bivalent; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received Moderna Monovalent shot instead of Bivalent) and NO ADVERSE EVENT (No adverse event) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (dose 2), PFIZER BIONTECH COVID-19 VACCINE (dose 1) and PFIZER BIONTECH COVID-19 VACCINE (dose 3). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 30-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (patient received Moderna Monovalent shot instead of Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received Moderna Monovalent shot instead of Bivalent) had not resolved 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 assessment was provided for WRONG PRODUCT ADMINISTERED (patient received Moderna Monovalent shot instead of Bivalent).    No concomitant medication was reported. No treatment medication was reported.
Flu like symptoms for 3 days including fever chills and body aches not allowing me to work.
Hard red area swollen. Mother took pt. to ER, since reaction happen on Saturday. ER doctor prescribed steroid and BENADRYL.
It started as a small red circle about 1/2 " in diameter with a red dot in the center. It keeps getting bigger and now on day 15 it is 3 1/2" in diameter.
Child came in for DTaP, he received dose in left deltoid, tolerated well. No adverse reaction noted during 15 minute observation period. Mother of child called the next day to report that he had vomited  at 2am, then again at 3am and again at 8am. No fever noted in AM, but at time of the call, 2:30pm, temp of 99. Mom notes poor appetite, malaise. Mom states injection site and arm are unremarkable.  This nurse did suggest she also notify the child's PCP.  Called mother back on Monday to check in and she reports Saturday energy was better but still low appetite but seemingly starting to feel better, then Sunday vomited again and had diarrhea. Explained to mom that it is very possible this illness is unrelated but that I would put in a VAERS just to be cautious.
Abdominal pain at first, in lower right, followed by back pain in lower right the following morning. Both have continued with varying degrees of severity. Abdominal pain has been mild to moderate; back pain has been moderate to somewhat severe but is now mild.
Patient states that she received both flu shot and moderna bivalent booster in the same arm (left arm) on 11/3/2022 and since then she has not been able to fully use her left arm.  She states that she has trouble shaving her under arms, but does not state whether it is pain or what sensation is. She states that she contacted her doctor and has been doing physical therapy since then.
On the 8th day after the vaccine, my arm stated to itch, noticed a bruise, not in the exact area I received the shot. The itching turned into welts and became hot.
pt recv vax 26JUL94 & w/in 12 hr pt exp flu-like sx & arthritis;pt exp insomnia, extreme fatigue, weakness & electric-like nerve shocks @ noc;flu like sx resolved;other sx cont;
Shingles/ Rash in the back of neck/ it hurts on touch; pain from where he got shot; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles/ Rash in the back of neck/ it hurts on touch) and VACCINATION SITE PAIN (pain from where he got shot) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Shingles.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain from where he got shot). On 16-Jan-2021, the patient experienced HERPES ZOSTER (Shingles/ Rash in the back of neck/ it hurts on touch). At the time of the report, HERPES ZOSTER (Shingles/ Rash in the back of neck/ it hurts on touch) and VACCINATION SITE PAIN (pain from where he got shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; 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. Although, based also on the known available information and mechanism of action for the Moderna vaccine, the event of PT herpes zoster is unlikely related to the vaccine.
10/05/14 pt came to pharmacy to report rxn to Flu shot vaccine. Pt has a large rash below site of injection. Touch is tender and red.
Pulsatile tinnitus.  Started night of second shot, has not stopped since, almost 1 month.
Given covid vaccine booster from vial that was expired by a couple of hours (vial was refrigerated the whole time). No adverse effect reported.
Onset began with pain in left jaw.  By 2/20/12 developed pain in tooth on left, painful tongue with blisters, blisters on lips and jaw line, sensitive to touch and water.  She saw her dentist regarding the tooth pain and a root canal was scheduled for 2/23/12.  No relief of pain was noted.  Patient saw physician on 2/23/12, began on Acyclovior without relief, changed to Valtrex on 2/24/12.  Some relief noted on 2/27/12.
Was given Hep B vaccine on her (L) deltoid on 9/30/14 and develop swelling and redness around the vaccination site and warm to touch. Was given antibiotic KEFLEX 500 mg BID x 7 days. Pt w/ several medical problems lymphoma and receiving radiation.
shortness of breath; headache; fatigue; pneumonia; This is a spontaneous report from a contactable other health professional. A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on Feb2021 as a single dose for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR, Batch/Lot number was not reported), oral from Jan2021 and ongoing, at 11 mg, 1x/day for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. Patient reported receiving samples from medical doctor (MD) office to start in January. Patient reported having COVID vaccine at the end of February, 9 days later started having COVID symptoms including shortness of breath, headache, and fatigue; called primary MD and was instructed by MD to go to urgent care 10Mar2021 where she was treated with steroids and given prescription for antibiotic and sent home. COVID test negative, treating as rule out pneumonia on Feb2021 as they are unsure if it is related to vaccination as a delayed reaction or separate infection. Prescribing MD not aware. Patient has not stopped XELJANZ therapy as she has not been able to speak with prescribing physician. She has appointment for second shingles vaccine. Encouraged patient to inform MD of illness/infection and being on XELJANZ prior to receiving vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on an unspecified date. The action taken in response to the event for tofacitinib citrate was dose not changed. Therapeutic measures were taken as a result of shortness of breath, headache and fatigue. The outcome of the events was unknown.; Sender's Comments: Reported event pneumonia is probably associated to tofacitinib based on its drug safety profile but is unlikely related to BNT162B2.
Headache starting 48 hours later; Fatigue moderate - Severe - missed work started 36 hours after injection; Diarrhea mild starting same day in the evening - lasting 48 hours.; This is a spontaneous report from a contactable healthcare professional, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 06Mar2021 at 10:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, neuropathy in feet and seasonal allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), vitamin d nos (MANUFACTURER UNKNOWN), fluticasone propionate (FLONASE), fluticasone propionate, salmeterol xinafoate (ADVAIR) and testosterone undecanoate (TESTOS). On 06Mar2021, patient experienced diarrhea mild starting same day in the evening - lasting 48 hours. Headache starting 48 hours later, fatigue moderate - Severe - missed work started 36 hours after injection. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea was recovered on 08Mar2021; while that of the events headache and fatigue was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
5 minutes post vaccine, patient reported pain in arm and shortly after warmth/ flushing. Pt was warm to touch. Water, diphenhydramine, ice packs were administered to the patient. BP 77/44, HR 66.  Ambulance called for assistance. BP came up to 103/60 then 132/66 within 15 minutes and ambulance arrival. Ambulance team evaluated and advised patient to not drive.  Next day follow up with mother-  Mother reported son  to be fine and was at track practice. She described minor Headache and lethargy resolved with ibuprofen. Son went to track practice at school.
Vaccine administered. Patient started coughing, scratchy throat, and mucous within 8 minutes. Pt was treated for anaphylaxis with epinephrine, albuterol, prednisone, xyzal. Pt recovered in the office and was monitored for 2 hours.
Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a patient of an unknown demographics who was received DAPTACEL instead of ADACEL, via unknown route in unknown administration site, on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
The morning after receiving the vaccine I woke up with a painful tongue. It felt like I burned my tongue on a hot coffee but I hadn?t don?t that recently. My tongue was also slightly swollen. The following day (2 days after the vaccine) I woke up with that same symptom but the effect/discomfort was worse. Third day post vaccine it got worse again. Then starting on the 4th day post vaccine, it started to get better and return to normal a little bit each day. I?m 5 days post vaccine and still have this burned feeling lingering on my tongue.
Four hours post vax, child became hysterical crying and shaking. 03/20/90 child expressed abnormal reactions around 1:00 PM. She was making some kind of noise. Her leg was kicking, her eyes were bright colored. At physicians office, reporter described event. Physician conveyed that child was alright. "She was only have those baby thing." 04/03 child has the same symptoms experienced on 03/20. Parent sought medical treatment and she was admitted to the hospital. Parent told she was having a seizure. Tests were conducted and pt was released. 04/06 pt experienced "several" seizures.  Parent was told that she did not have to seek medical attention every time her child experienced a seizure. She just needed to watch her.  "I did not know what to do. I was a nervous wreck every day. All I did was crying every day about my baby."
Itching; changed from red to purple at this time; Fever; Lethargy; Red blotches; Back pain; Knee pain; Allergic reaction; Injection site aching; Injection site redness; This case was reported by a consumer via call center representative and described the occurrence of red blotches in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 16th August 2019, 1 days after receiving Shingrix, the patient experienced red blotches (serious criteria clinically significant/intervention required), injection site pain, injection site erythema, allergic reaction, back pain and knee pain. On 17th August 2019, the patient experienced itchy rash (serious criteria clinically significant/intervention required), skin discoloration, fever and lethargy. The patient was treated with paracetamol (Tylenol) and prednisone. On 17th August 2019, the outcome of the lethargy was recovered/resolved. On an unknown date, the outcome of the red blotches, itchy rash and skin discoloration were not recovered/not resolved and the outcome of the injection site pain, injection site erythema and allergic reaction were recovering/resolving and the outcome of the fever, back pain and knee pain were recovered/resolved.   It was unknown if the reporter considered the red blotches, itchy rash, injection site pain, injection site erythema, skin discoloration, allergic reaction, fever, back pain, knee pain and lethargy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and next day woke up in the evening on with red blotches on her thighs are arms. The patient notified her physician at that time. Next day, the red blotches spread to her back and ears and started itching. At that point her physician treated her for an allergic reaction and started her on a prednisone taper. The patient also experienced injection site redness and aching that started on 16th August 2019 in the morning. On 17th August 2019, she had fever that resolved with Tylenol. The patient had back and knee pain that started on 16th August 2019 in the evening that she treated with Tylenol as well. On 17th August 2019, she states she had lethargy that resolved after 4-6 hours. The reporter stated that the blotches remain, but have changed from red to purple at this time. emergency room (ER) visit was required. The reporter did not consent to follow-up.
supraclavicular, axillary and neck adenopathy. pt did get second dose as well and adenopathy worsened.  it has been 6 weeks since first injection labs normal. CT significant adenopathy still present on her left side both injections were on left
tested positive for Covid-19 despite having 3 doses of the Pfizer vaccine; tested positive for Covid-19 despite having 3 doses of the Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid-19 despite having 3 doses of the Pfizer vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient age group is elderly (65+ Years). Patient was tested positive for Covid-19 despite having 3 doses of the Pfizer vaccine. Patient was doing well, very mild symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No previous history of miscarriages. Miscarriage began 4 weeks after first covid vaccine dose. Est. Date of birth October 2021  Unusual menstrual cycles following miscarriage.  Unsure if there is any relation.
Horner's Syndrome; A spontaneous report was received from a physician who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Horner's syndrome.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, two days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 30 Dec 2020 the patient developed Horner's syndrome. The specific presenting signs and symptoms experienced by the patient were not provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, Horner's syndrome, was not reported.; Reporter's Comments: This spontaneous report refers to a female patient who experienced unexpected Horner's syndrome on day 3 after administration of the first dose of mRNA-1273, lot # unknown, Exp date-unknown. There is limited information to assess this case as the exact symptoms and confirmatory diagnostic test results were not provided. However, based on temporal information provided a causal association cannot be excluded.
fatigue; chills; Sore; Soreness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness) and PRURITUS (Itchiness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness) and PRURITUS (Itchiness). On 08-Feb-2021, PAIN IN EXTREMITY (Soreness) and PRURITUS (Itchiness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   This case was linked to MOD-2021-079358 (Patient Link).
This non-serious spontaneous case initially received from other non-health professional on 07-Nov-2018, concerning a 49-year-old, adult, female patient. On 02-Nov-2018, the patient was administered FLUCELVAX QIV (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unknown date, after vaccination, the patient felt she felt achy, tired, and have been congested with a runny nose. The patient stated her glands in neck starting swelling and small lumps forming on lymph nodes in her neck. The outcome of the events was not reported.
Miscarriage  First vaccine administered prior to knowledge of being pregnant. First pregnancy, EDD May 31, 2022
Patient was given a dose of the vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given a dose of the vaccine from an expired vial) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given a dose of the vaccine from an expired vial). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient was given a dose of the vaccine from an expired vial) had resolved.        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.   Pharmacist stated that this morning, a couple doses of the Moderna Covid-19 vaccine was given from a bottle that was left out from yesterday. The vial was first punctured at 8:52 am yesterday 26/Jul/2021 and left at room temperature. It was administered today at 12:03 pm and 12:16 pm, 2 doses were given. Lot number is 091D21A, one vial. This lot number had not undergone any excursion. Upon inspection before administration, the vaccine was thawed, and it looked normal. it was the first doses for both patients that received the vaccine and caller stated that none of the patients had reported any adverse event.   This case was linked to US-MODERNATX, INC.-MOD-2021-268254 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-268254:Same reporter (CASE CROSSLINKED)
received the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (received the vaccine while pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication, THYROID (ARMOUR THYROID).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 09-Oct-2021. On 08-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (received the vaccine while pregnant). On 08-Feb-2021, EXPOSURE DURING PREGNANCY (received the vaccine while pregnant) had resolved.        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.   No treatment information provided
Patient has large bruise at and surrounding injection site. Patient states no pain or heat and doesn't affect his range of motion.
Several days after 1st vaccine my period started overnight and was suddenly extremely heavy, I had never experienced the start of a period like that before.  No cramps or advance spotting to hint I was getting my period.  No other symptoms occured.  After second shot on 4/23/21 I had a low grade fever the day after along with a headache, chills and fatigue.  No period issues so far.