chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient took 1st pill on 1/9/2020 at 5:30 am, she states that shortly after she developed abdominal pain. She looked it up and found that was a common side effect. When it was time to take the second pill on 1/11/2020 she immediately vomited the pill back up. She states that her abdominal pain has progressed to a sharp radiating pain that shoots up her abdomen into her neck and she is having fever, nausea, vomiting and hot flashes. She has taken nyquil which has allowed her to get some sleep. As of today 1/13/2020 the pain is not getting any better so told the patient to go to urgent care/emergency department. She states that is what she will do.
Pt recv vax 02Oct97 & devel fever,dec activity.13Oct97 generalized measles-like rash. 14Oct97 pt to MD who stated "classic case of measles". 28Oct97 pt recovered.
Patient was asked to move forward in the waiting area, staff noticed he was checking his pulse.  Asked if he felt okay and he stated he felt flushed.  EMS and clinical lead notified. Patient reports he felt like his heart was racing and had palpitations (hx of palpitations). HR 97, usually in the 80's).  Patient cleared by EMS and stated he felt basically back to baseline.  Patient asked to wait 15 more minutes before leaving.  Instructed patient to call PCP, 911, or go to the nearest emergency room for any further issues.  Also advised to sign up for Vsafe.
Projectile vomiting 5-10 mins after giving the vaccine. BENADRYL was given in the clinic. Child was stable, active and playful.
Had period for 6 weeks then went into pelvic floor dysfunction with pudendal neuralgia   In May 2022 got Covid. Caused 3 weeks of menstrual bleeding then again pelvic floor dysfunction and pudendal neuralgia
Vaccinated and boosted. And then I got COVID; Vaccinated and boosted. And then I got COVID; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 42-year-old female patient 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) all with onset Jan2022, outcome "unknown" and all described as "Vaccinated and boosted. And then I got COVID".  Additional information: I have attached the AE report forms for the above referenced project. The information regarding the patients and physicians in the reports are very limited due to the de-identified nature of our data. However, if you have any questions regarding the reports please don't hesitate to reach out. It was reported that the patient got COVID despite being vaccinated. The course of conversation were as follows: DR: Now, over the last, um, couple of months, we've seen more and more people get exposed and, and come down with, uh, COVID but you've been -, PT: Hm., DR: Doing okay?, PT: Yeah., DR: As far as that's concerned?, PT: Yeah. Totally fine., DR: Okay. And were you vaccinated?, PT: Yes., DR: Okay., PT: Vaccinated and boosted. And then I got COVID in, um, Jan., DR: Okay. And which vaccine did you get?, PT: Uh, Pfizer., DR: Okay. [DEIDENTIFIED]. And a lot of people have been asking if they need to get their second booster., PT: Um-hum. The outcome was unknown and causality was not reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After three hrs left hand snd fingers numb kiss of feeling difficulty using hand tool, typing a mess, loss of grip, involuntary. Now three weeks still not better cannot button shirt.
Vaccine Name -  Pfizer Vaccine Date - ?8/5/2021   Is this your first or second dose-1st dose Date of symptom onset - ? 8/6/2021 Symptoms - ? Fever of 101.0 and diarrhea Last day of work and shift - ?Unknown Home remedies-None Any improvement-Fever ceased on 5/6/2021 and diarrhea ceased on 8/8/2021. Recommendation-Continue to self monitor for returning or new onset of symptoms Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
felt like a bad bruise; injection site felt like I had been extremely punched hard in that spot/the pain was not debilitating; The next day, I slept for most of the day; Anaphylactic shock; allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (codeine), Drug allergy (sulpha drugs), Drug allergy (tetracyclines) and Allergy (Bites of insects).    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant) and HYPERSENSITIVITY (allergic reaction). On 08-Apr-2021, the patient experienced SOMNOLENCE (The next day, I slept for most of the day). On an unknown date, the patient experienced VACCINATION SITE BRUISING (felt like a bad bruise) and VACCINATION SITE PAIN (injection site felt like I had been extremely punched hard in that spot/the pain was not debilitating). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergic reaction, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), VACCINATION SITE BRUISING (felt like a bad bruise), HYPERSENSITIVITY (allergic reaction), SOMNOLENCE (The next day, I slept for most of the day) and VACCINATION SITE PAIN (injection site felt like I had been extremely punched hard in that spot/the pain was not debilitating) outcome was unknown.            No concomitant medication information was reported. Other treatment medications include an unspecified medication the patient received at the hospital for the allergic reaction.  This case concerns a patient of unknown age and gender with a serious unexpected event of anaphylactic shock, and nonserious hypersensitivity, somnolence, vaccination site bruising and vaccination site pain. Event latency 5 minutes after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a patient of unknown age and gender with a serious unexpected event of anaphylactic shock, and nonserious hypersensitivity, somnolence, vaccination site bruising and vaccination site pain. Event latency 5 minutes after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
THE VACCINE WAS NOT RECONSTIUTED WITH 1.3 MLS OF DILUENT , IT WAS GIVEN DIRECTLY 0.2 ML FROM THE ORANGE CAP VIAL WITH NO DILUTION I INFORMED THE MOM AND SHE SAAID HER SON DIDN'T GET ANY SIDE EFFECT YET
This spontaneous report as received from a pharmacist refers to a 71 year old male patient. On 04-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot# unknown) 0.65 ml subcutaneous in the right arm. No other co-suspects were reported. No concomitant medications were reported. The reporter stated that client was vaccinated with ZOSTAVAX on 04-JUN-2013 and developed adverse events of redness, itching and burning at the injection site. Pharmacist stated client went to local emergency room, unspecified name, on 07-JUN-3013, with what he thought was allergic reaction; redness, itching, and burning at injection site. At the emergency room client was given a injection and 2 different unspecified pills. Client was not hospitalized. Pharmacist stated client now had a upset stomach and still has redness at the injection site. Action was not provided. Additional information is not expected.
patient had arm swelling and redness starting the day of vaccination through the next day.   **vaccine was administered at school, I am unsure of brand name/manufacturer information, it was an influenza vaccine**
Initial report was received on 23 September 2011 from health care professional, who is also the patient. A female patient (date of birth not reported) had received on 23 September 2011 an intramuscular left deltoid injection of FLUZONE SV 2011-2012, lot number UH463AB and shortly after vaccination, experienced swelling of the throat, lips, neck, jaw and eye. She also reported her eyes became bloodshot and she had a hard time swallowing. she was evaluated in the ER (emergency room). Treatments in the emergency room included DECADRON, BENADRYL and PEPSIN. "RX for home" included prednisone and BENADRYL. The patient has a thyroid history. Concomitant medication included SYNTHROID. Illness at the time of vaccination, adverse events following prior vaccinations and any other vaccines within four weeks of suspect vaccine was reported as none. Documents held by sender: none.
Patient received expired vaccine on 24-Sep-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 24-Sep-2022) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 24-Sep-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 24-Sep-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   This case was linked to MOD-2022-531880 (Patient Link).
Pt reported neck discomfort starting within 10 minutes of second vaccine dose, progressed to right submandibular pain over the next few weeks clinically consistent with sialoadenitis. Patient subsequently had a severe viral UTI a month after the vaccine and developed symptoms of hyperthyroidism following the viral URI. Patient was subsequently diagnosed with thyroiditis.
pt states she had a sore throat and difficulty swallowing at 9pm and when she looked in the mirror, her lymph nodes around her throat was swollen to the size of a golf ball. she took a tylenol and went to sleep. in the morning, swelling had gone down and sore throat/difficulty swallowing resolved.
Patient described slight warmth on her  chest after vaccination. She said the sensation was similar to many months ago when she received her lidocaine/hydrocortisone shot. After 30 minute of observation, patient says feeling has dissipated. No signs & symptoms of anaphylaxis. Counselled patient about calling 911. Mentioned all the symptoms to watch out for on Moderna's EUA. I spoke to patient a week later and she said the "warmth" dissipated in about 8 hours. She said she could smell & taste the vaccine. I encouraged her to see her PCP for evaluation. She has an appointment in 1 week. She will talk about whether to receive a 2nd dose.
The patient reported having symptoms the morning after injection, 9 a.m. on 9/26/2018. The patient reported having flu like symptoms, achy, tired and dizziness. The patient reported feeling better after 3 days, however she had had episodes of dizziness for the last 3.5 weeks.
p/vax pt cried for awhile, then calmed down & became pale, limp & had a weak cry for 3hrs;these rxns were reported to clinic 2JAN95;
Pain on movement of left arm. Pain starting in shoulder and radiating down left arm. I believe this represents SIRVA, resulting from inadvertent injection into the subdeltoid bursa. Pain improved but not resolved with ibuprofen.
11MAR97 8PM vomited running fever of 103-104 ran fever consistently saw MD on 15MAR97 fever remained @ 103-104 until it broke on 17MAR97 in the evening;
Loss of consciousness with some mild convulsions lasting 10-15 seconds. 2 events roughly 3-5 minutes apart. Emergency services contacted and patient transported to hospital.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. B07C21A and D33R21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 04-Jun-2021 and the estimated date of delivery was 11-Mar-2022. On 22-Apr-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information was not provided. Patient believes she became pregnant on 15JUN2021 and believes that she was 25 weeks pregnant.
4/13/22 history of SLE with nephritis and ESRD on PD. Presented with symptoms of SOB, fevers, chills, and diarrhea that began about 3 days PTA.
Supraventricular tachycardia, multiple PVC's, small pericardial effusion. Hospitalization for observation. Sudden onset, no prior history of heart conditions.  Treatment, failed cardiac ablation. Current treatment with flecainide and metoprolol succinate. Undercare of cardiologist.
Right arm is swollen on upper arm and 0.5 of forearm. Marked area 0.5 of arm, not warm to touch. Elbow with full flexion. Treated with Orapred, Atarax, ice compress.
patient became unresponsive and blood pressure and pulse were both low.  shortly patient came to and was very dizzy and cold.  911 was called.  her blood pressure became better and she was given water to drink.  her feet were elevated.  ems arrived and monitored patient for approximately 15-20 minutes.  It was decided by EMS that the reaction was from anxiety, which was confirmed by her boyfriend who said he saw her have this happen before.  Patient left on own volition approximately 45  minutes after IMZ
5 inch shingles type rash on abdomen the night of vaccination, itchy,  rash and all symptoms gone by morning following vaccation 10/14/11.
issues with her vision; swelling and redness in her left eye; swelling and redness in her left eye; herpes zoster / extreme pain; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) who at the time of vaccination was approximately 63 years old. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 26-NOV-2014, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by healthcare providers for the following injuries resulting from her zoster vaccine live (ZOSTAVAX) use: herpes zoster, extreme pain, swelling and redness in her left eye, and issues with her vision. The outcome of the events was not provided. The reporter considered the events of herpes zoster, extreme pain, swelling and redness in her left eye, and issues with her vision to be related to zoster vaccine live (ZOSTAVAX).
pt recvd vax; w/in 12-24 hrs devel inflam at inject site & a knot below inject site
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates the patients were vaccinated with VAQTA (lot#, expiration date, dose and route not reported), which were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
No additional AEs; patient was supposed to received PNEUMOVAX 23 today, but was administered VAXNEUVANCE today by mistake; This spontaneous report was received from a pharmacist and concerns a 77-year-old female patient. Her historical vaccinations included Pneumococcal vaccine polysacch 23V (PNEUMOVAX 23) administered on 14-APR-2009. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-JUN-2022, the patient was supposed to receive the second dose of Pneumococcal vaccine polysacch 23V (PNEUMOVAX 23), however she was administered with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection in dose of 0.5 ml once, lot number U036156, expiration date: 25-MAY-2023 (route and anatomical site of administration were not provided) for prophylaxis (wrong product administered). The patient experienced no side effects from administration and no additional adverse events were reported (no adverse event).
erythema, swelling, warmth & 3cm diameter induration @ inj site;painful;
Received flu vaccination in a.m. of 11/19/2018, and went on to Café to eat breakfast.  Returned to Employee Health approx. 2.5 hours later with a very red face and a visible hive on her ant. neck.  Stated she felt warm.  Not sure if reaction from flu vaccination or something she ate.  No other signs of distress.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse reaction (No medical history provided by the reporter.). On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (Body aches), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN (Body aches), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment medication was reported by the patient.
NO ADVERSE REACTION. DUE TO AGE PATIENT SHOULD HAVE RECEIVED PFIZER INSTEAD OF MODERNA
I had a mark on my face under my chin and on my face, my face was tingling as well. I was given an antiviral and an ointment which healed the area in one week to one and a half weeks. Two weeks later I went back to urgent care and was diagnosed with a sciatica problem.
I had extreme joint pain in the knees and bilateral arms, legs and hips. I have had two prednisone shots for the left hand and I have cortisone shots as well. The doctor offered to put me on low dose cortisone. I am managing it with ibuprofen. I am still having joint pain.
Zoned out and passive with blank stares, then projectile Vomiting, fussiness, loss of sleep, screaming/pain
pt called at 18:30 reporting redness and pain to right arm. Received Benadryl. She called back and said the redness had spread to entire body. Advised to go to the ED.
migraine/So far he had 41 Migraine attacks since; stuffy nose; Covid 19; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (migraine/So far he had 41 Migraine attacks since), NASAL CONGESTION (stuffy nose) and COVID-19 (Covid 19) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 003A21 and 030B21A) for COVID-19 prophylaxis.     Family history included Migraine (Brother also had 3-4 migraines per year prior to vaccination). Concurrent medical conditions included Migraine (3-4 Migraines per year prior to vaccination.). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Discomfort in nose, SUMATRIPTAN for Headache, ZINC and MAGNESIUM for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (Covid 19). On an unknown date, the patient experienced MIGRAINE (migraine/So far he had 41 Migraine attacks since) and NASAL CONGESTION (stuffy nose). The patient was treated with CAFFEINE at an unspecified dose and frequency; ACETAMINOPHEN at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRINE) at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine/So far he had 41 Migraine attacks since), NASAL CONGESTION (stuffy nose) and COVID-19 (Covid 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: (Positive) Since COVID Disease, his mouth and tongue still has metallic taste..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Because patient's migraine frequency increased he did not get any more shots. He used to have 3-4 Migraines per year prior to vaccination. The Migraine appeared when they were 13-yrears-old. Doctor prescribed Amitriptyline 10 mg once a day at bedtime but he has not been taking it. He was afraid of the medication side effects. After vaccination, a lot of times, he needed that second Sumatriptan 50 mg dose. 3-4 times, the headache was so bad, and not controlled with medicine, that he had to visit the emergency room.   This case was linked to US-MODERNATX, INC.-MOD-2023-734525 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2023: Patient details, medical history, lab, concomitant and event information reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734525:Patient's brother case
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history was reported. On 06-APR-2015, the patient was inadvertently vaccinated with expired dose of ZOSTAVAX (dose and route were not reported) (lot # J008528 and expiration date 19-OCT-2014 also reported as 12-OCT-2015) after the labeled expiration date. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.