chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was given the pneumococcal vaccine polyvalent Pneumovax 23 on 11/7/05. The patient was given the shot subcutaneous on the left thigh. On 11/9/2005 mom called our office stating the child had a pancake size reaction to the shot. The pt had fever 101.0 and neck pain. The pt was treated with Prednisone 20mg and Keflex 500mg.
Patient was waiting for observation for 15 minutes, after that time she came to the pharmacy counter stating she was about to leave when she starting feeling hot and seeing a red rash appearing. Patient took 50mg diphenhydramine and was further observed for 30 minutes.  After that point she was looking and feeling better and decided to go home. She declined to be seen by paramedics or emergency services.
Swollen throat, tongue and difficulty swallowing. Tingling lips and inside mouth.  Today's Visit Reason for Visit Allergic Reaction Diagnosis Acute allergic reaction, initial encounter Lab Tests in Progress Blue Top Tube-Hold Blood Lavender Top Tube-Hold Blood Red Top Tube-Hold Blood Done Today Discharge Home Insert PIV Medications Given diphenhydrAMINE (BENADRYL) Last given 4/18/2021 1:30 AM famotidine (PEPCID) Last given 4/18/2021 1:30 AM lactated ringers (LR) Stopped 4/18/2021 3:06 AM methylPREDNISolone sodium succinate (Solu-MEDROL) Last given
Pt came to ER c/o nonproductive cough, fever, and body aches for the past few days.
vomiting (only once); lower back pain; fever,fever still isn't breaking,(fever) has reached to 102-103 Fahrenheit; chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), PYREXIA (fever,fever still isn't breaking,(fever) has reached to 102-103 Fahrenheit), CHILLS (chills) and VOMITING (vomiting (only once)) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M1A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced BACK PAIN (lower back pain), PYREXIA (fever,fever still isn't breaking,(fever) has reached to 102-103 Fahrenheit) and CHILLS (chills). On an unknown date, the patient experienced VOMITING (vomiting (only once)). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, at a dose of 25 mg. At the time of the report, BACK PAIN (lower back pain), PYREXIA (fever,fever still isn't breaking,(fever) has reached to 102-103 Fahrenheit), CHILLS (chills) and VOMITING (vomiting (only once)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication included pills.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received and contains no new information
Sneezing started 1-2 min. after shots. Coughing and rash, itching in throat 5 min. after shots. Rash worsened with hives 10 min. after shots.
Once I received the second Moderna Covid Vaccine I started to have these symptoms.   1. Headaches almost daily.  2. High Blood Pressure  3. Feet and Legs Swelling alot  4. Numbness and Tingle in Both Arms and Both Legs  5. Chest Pain (Seeing a Cardiologist now).....Determined I have a Extra Heartbeat
With first COVID-19 vaccine her arm was hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (With first COVID-19 vaccine her arm was hurt) in a 74-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    The patient's past medical history included Surgery in 1992. Concurrent medical conditions included Crohn's disease (Intestines out due to Crohn's disease in 2018.) since 2018.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (With first COVID-19 vaccine her arm was hurt). At the time of the report, PAIN IN EXTREMITY (With first COVID-19 vaccine her arm was hurt) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication was not provided. The Causality as per reporter for Humira was Not reported and the Causality as per Mfr. for Humira was No reasonable possibility. Treatment information was not reported.   This case was linked to MOD-2022-587763 (Patient Link).   Reporter did not allow further contact
Left arm red, swollen, heat to touch, tight. Mother brought daughter back to clinic, reffered to ER. Mother said hospital ER gave 2-3 different kinds of meds-don't remember the names.
inconsolable crying, unable to comfort, duration, approx 1 1/2 hr; inject site red, swollen & tender; no fever; no further crying episodes;
received both the Pfizer and Johnson & Johnson vaccine; nervous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program via Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; covid-19 vaccine janssen (COVID-19 VACCINE JANSSEN) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), described as "received both the Pfizer and Johnson & Johnson vaccine"; NERVOUSNESS (non-serious), described as "nervous".  Additional information: Got covid vaccine. She received both the Pfizer and Johnson & Johnson vaccine. She is nervous that she received both vaccines.   Follow-up attempts completed. No further information expected.
Initial report received from a healthcare professional on 16 December 2013. A female patient of unknown age had received an intradermal first dose of FLUZONE (lot number: unknown) on last year. Last year, the patient had hives. Laboratory investigations and corrective medications were not reported. At the time of this report the patient recovered from the event. Documents held by sender: none.
Patient was given the wrong vaccine. Patient was due for MMR, and was given Menveo.
bad fever; bad chills; throwing up; A spontaneous report (United States) was received from a consumer, a female patient (age not reported), who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced bad fever (pyrexia), bad chills, and was throwing up (vomiting).  The patient's medical history, as provided by the reporter, included she tested positive for COVID in approximately November 2020 (reported as about a month and a half ago from the time of this report) at which time she quarantined for two weeks and then her test came back negative on an unknown date.  The reporter spoke to her healthcare professional, who told her it was okay for her to receive the vaccine.  Concomitant product use was not provided.  On 09 Jan 2021, one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number unknown) for prophylaxis of COVID-19 infection. On 10 Jan 2021, the patient experienced bad fever, bad chills, and she was throwing up.  No treatment information was provided  Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the events, bad fever, bad chills, and throwing up, 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.
Fever same day, then stomach upset, dizziness, right sided "numbness". No muscle weakness on testing at visit on 2/17/09. All symptoms resolved in 2-3 days.
Client waited for 15 minutes after vaccine, said she felt "off," but proceeded to her car. Once in her car she noticed she was red, flushed, had one hive on her chest. AT 2:20 She proceeded back into the building and was taken to the emergency area for observation. 2:30 pm, she had bilateral redness in cheeks, BP 138/85, 97% O2, 74 HR., red spot on chest. 2:47pm 97% O2, BP 178/98. 2:55 BP 182/102,   Dr called for consultation. Dr. gave verbal order to proceed with IM Benadryl, and monitor for another 15 minutes to see if epi pen was indicated. 3:01, Benadryl given  IM in left deltoid.  Lot# 080012, expiration: 08/2022.  3:03 O2 97%, HR 80. 3:04, patient became panicked that she could not swallow, Nurse administered Epinephrine autoinjector into left thigh. Lot # 0FM534, Expiration: 9/2022. EMS called 3:06pm.  Vital signs stable, client reported feeling cold and had chills. Client reported ease in swallowing almost immediately. Client taken to hospital around 3:15.
she can't walk; Intense pain all over the body; This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (she can't walk) and MYALGIA (Intense pain all over the body) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3834B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 01-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MYALGIA (Intense pain all over the body). On an unknown date, the patient experienced GAIT INABILITY (she can't walk). At the time of the report, GAIT INABILITY (she can't walk) and MYALGIA (Intense pain all over the body) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided.
Pt recvd 3 doses of Engerix-B 17JAN92 tested & determined to be a non-responder; 12FEB92 recvd a 4th dose of Engerix-B; titer results pending;
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
half of the dose leaked out; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th December 2019, the patient received the 1st dose of Shingrix. On 13th December 2019, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse administered Shingrix to the patient but half of the dose leaked out.  The patient only received 0.25ml of the dose which led to accidental underdose. The reporter did not had additional information at the time of reporting. The reporter consented to follow up.
Blood spotting 8 days before regular period, extremely light. Then after one day it stopped.; This came along with cramps the next day; extreme gas not painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Sep2021 (Lot number: Fc3182) at the age of 29 years as dose 1,single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: KLONOPIN. Past drug history included: Macrobid, reaction(s): "Known Allergy: Macrobid", notes: known allergies :Macrobid. The following information was reported: HYPOMENORRHOEA (non-serious) with onset 09Sep2021 12:00, outcome "not recovered", described as "Blood spotting 8 days before regular period, extremely light. Then after one day it stopped."; DYSMENORRHOEA (non-serious) with onset 09Sep2021 12:00, outcome "not recovered", described as "This came along with cramps the next day"; FLATULENCE (non-serious) with onset 09Sep2021 12:00, outcome "not recovered", described as "extreme gas not painful". Therapeutic measures were not taken as a result of hypomenorrhoea, dysmenorrhoea, flatulence.  Additional information: No other vaccine in four weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had blood spotting 8 days before regular period, extremely light. Then after one day it stopped. This came along with cramps the next day. Another side effect extreme gas not painful, but no normal bowel movement without lots of gas released in between. Since the vaccination, the patient had not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
ON JANUARY 21, 2021 THE PATIENT REPORTED THAT THEY HAVE ALLERGIES FROM MAPLE AND ELM TREES CAUSING SHORTNESS OF BREATH AND ASHTHMA. PATIENT RECEIVED A TETANUS INJECTION AND WENT INTO ANAPHYLATIC SHOCK
This spontaneous report was received from a medical assistant and refers to an unspecified patients of unknown demographics. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unspecified dates since 15-FEB-2017, the patients received an improperly stored doses of VARIVAX injection (lot # M039316 with expiration date at 20-SEP-2018, lot # L045956 with expiration date at 17-NOV-2017 and lot # reported as M040138 with expiration date at 28-SEP-2018; dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of -0.2 (unit not provided) for 3 hours and 9 minutes (189 min). Data logger was used to track the temperature. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013034:
Client reports that with second dose of Moderna COVID vaccine, he awoke the next day with a fast heart beat, lasting 30 minutes.  Client reports taking Tylenol and sleeping a few hours.  He awoke and fast heart rate had resolved.  Client denies  any shortness of breath,  no trouble breathing, no difficulty swallowing, no chest tightness.  Client did not follow up with primary care provider.  Client reports similar reaction when he "gets drunk" and wakes up the next morning "hung over".  Client denies medical conditions, not taking medications, denies allergies.  Client reports he had an EKG 7 years ago, was told results were normal.
Information has been received from a registered nurse concerning an 8 year old female with no medical history and no allergies who in approximately April 2003, 4 to 6 weeks ago at another practice, was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 27-May-2003 the patient was seen for the first time in the physician's office with lesions and a papular rash that had appeared that morning. The patient was diagnosed with varicella and treated with triamcinolone cream 0.025% bid to qid as needed for itching. On 27-May 2003 it was reported that the patient had not recovered. It was also reported that the patient's mother might be pregnant and probably in her first trimester. The reporter noted that the mother was concerned regarding contagiousness. No product quality complaint was involved. It was also noted that the patient's 7 year old brother was vaccinated with a dose of varicella virus vaccine live and developed varicella (WAES #0306USA00129). Additional information has been requested.
Had no had menstrual cycle since receiving 1st doses; sore left arm; did not eat for two days "I do not know if it is because it was the weekend and I was busy or if it; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (Had no had menstrual cycle since receiving 1st doses), PAIN IN EXTREMITY (sore left arm) and DECREASED APPETITE (did not eat for two days "I do not know if it is because it was the weekend and I was busy or if it) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced AMENORRHOEA (Had no had menstrual cycle since receiving 1st doses), PAIN IN EXTREMITY (sore left arm) and DECREASED APPETITE (did not eat for two days "I do not know if it is because it was the weekend and I was busy or if it). On 14-Mar-2021, PAIN IN EXTREMITY (sore left arm) and DECREASED APPETITE (did not eat for two days "I do not know if it is because it was the weekend and I was busy or if it) had resolved. At the time of the report, AMENORRHOEA (Had no had menstrual cycle since receiving 1st doses) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. Treatment information was not provided.    This case was linked to MOD-2021-116650 (Patient Link).
Fleeting mild headaches in recovery; 24 hours later, sudden tiredness; Nausea; Fierce diarrhea; Very sick for two hours; Muscle aches instead still there; This is a spontaneous report from a contactable consumer. An 80-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 13:15 at a single dose for COVID-19 immunization.  Medical history included diabetic, Obese and COPD.  The patient's concomitant medications were not reported. It was reported that the patient had fleeting mild headaches in recovery on 20Jan2021 13:30. 24 hours later, sudden tiredness. Two hours later nausea and then fierce diarrhea, very sick for two hours. Waited an hour, took a shower and went to bed. Fatigue and diarrhea lasted two more days but sick feeling gone. Muscle aches instead still there. The outcome of the event sickness was recovered in Jan2021, myalgia was not recovered while recovering for the remaining events.  Information about batch/lot number has been requested.
Pt vaccinated with Engerix-B developed chest pain increased w/deep inspiration. After the second dose chest pain radiated into lt arm. Some gastroinstestinal disturbance; See WORM for more details.
Got vaccine during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during pregnancy) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Accessory Tragus Live, full-term birth) on 18-Jun-2019 and Alcohol use (1-2 drinks per week) on 01-Nov-2020. Concomitant products included VITAMIN D NOS from 2019 to an unknown date and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 2018 to an unknown date for an unknown indication.    On 09-Jan-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Nov-2020 and the estimated date of delivery was 12-Aug-2021. On 09-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  On 09-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2020, Pregnancy test: positive (Positive) Positive.     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.   Estimated date of conception was on 18-Nov-2020. Number of fetus was found to be one. On ??-???-2012, lab test included genetic predisposition test, however the result included heterozygous for factor 5 Lieden.  Concomitant product Vitamin D was used for the indication to help breast milk.  Treatment information was not provided.
LETHARGIC, PALE, DROWSY,  TREATMENT- AMMONIA INHALANT  OUTCOME- FEELING FINE, DISCHARGED HOME WITH MOTHER
purple area on his arm around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (purple area on his arm around the injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included NAPROXEN for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (purple area on his arm around the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (purple area on his arm around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Tinitus, hearing loss, fatigue Anti biotics, no effect Steroid pills, no effect Hearing aids for loss of hearing Nothing prescribed for fatigue
Immediately my left arm was sore at the side of the vaccine. It remained sore for a few days, then it continued to be sore and I felt perhaps have damage. After several weeks it was throbbing and I had very little range of motion. I sought medical treatment.
HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.; This spontaneous non -serious safety report, with reference number  was received by a partner on 20-SEP-2023 and forwarded to agency on 21-SEP-2023, from a HCP.  The causal relationship between Vaxelis and the reported event "HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.Temperature:8.74 C, Time frame:35min." was assessed as not applicable due to the nature of the event.  Further information is expected.
Arm pain in full arm and shoulder, starting 1.5 hours after injection, worsening overnight. Tylenol, ice & rest provide minimal relief. Fatigue & lightheadedness for 12 hours following injection.
Hot; heaviness in right arm / sore; feeling flushed; feeling hot in legs.  Monitored for total of 40 minutes. Laid on a stretcher and systems resolved. Released to home.
Arm pain, redness, and swelling extending over entire upper left arm and shoulder. Began 1 day after injection. Prescribed KEFLEX x 7 days, Prednisone x 5 days.