chrisvoncsefalvay/vaers-outcomes huggingface dataset:
abd pain, vomited x 3, weakness, dizziness, chill, pale & tachycardia;
pt recv vax 24SEP97 & that evening exp soreness rt deltoid-noticed sorenessinc by next noc & this AM redness & firmness;pt described as hot & sore w/deep aching pain;denies any home tx but states is going to MD;
No adverse event; 12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 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. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) 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 (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date).    No concomitant medications were reported.  The patients involved were all over the age of 65.  Date(s) of administration of vaccine on 22-Apr-2023 (3 patients) 21-Apr-2023 (5 patients), 20-Apr-2023 (2 patients), 16-Apr-2023 (1 patient) and 12-Apr-2023 (1 patient). No other adverse events had been reported.  No treatment medications were reported.  This case contains information for the 12th of 12th elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:patient 1
This spontaneous report was received from a consumer regarding herself a 58 year old female patient. Hypothyroidism was reported as pertinent medical history. Drug allergies and reactions was reported as none. On an unknown date in November 2014, the patient was vaccinated with ZOSTAVAX dose 1 (1 shot), subcutaneous. Concomitant therapies included SYNTHROID and hormones. On 15-MAR-2016, two weeks ago the patient developed shingles, rash, muscle aches, fever and strong nerve pain. She was given VALTREX for treatment as well as a topical steroid cream for the rash and sought medical attention. Therapy with ZOSTAVAX was not reintroduced. She recovered from the strong nerve pain. The outcome of shingles, rash, muscle aches, fever was reported as resolving. Adverse events improved when patient was on therapy with ZOSTAVAX. Causality between shingles, rash, muscle aches, fever and strong nerve pain and ZOSTAVAX was unknown. Additional information has been requested.
Sugar levels became abnormally high. Over 400. Insulin given to bring level back to correct level but took all afternoon and evening to get it down.
PATIENT HAD VACCINE NINE DAYS AGO NOW HAS REDNESS, WARMTH, FIRMNESS AND DISCOMFORT AT VACCINE SITE.
None. ADACEL given to 10 yr old girl instead of BOOSTRIX.
very high fever (~104) starting 12-14 hours after vaccination, moderate fever (~101) for two additional days, low fever for period of a few more days; heavy fatigue and general muscle weakness (throughout body) accompanied the high and moderate fevers
same night woke up with 1/2 of her face numb; tingling sensation; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (same night woke up with 1/2 of her face numb) and PARAESTHESIA (tingling sensation) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced HYPOAESTHESIA (same night woke up with 1/2 of her face numb) and PARAESTHESIA (tingling sensation). At the time of the report, HYPOAESTHESIA (same night woke up with 1/2 of her face numb) and PARAESTHESIA (tingling sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After receiving the vaccine, the same night she woke up with 1/2 of her face numb and had tingling sensation. Patient did not take any medicine to subsided the face numb and tingling sensations.  No concomitant medications were provided by reporter. No treatment medications were provided by reporter.
Edema & mild erythema of injection site left upper arm (6 cm X 6 cm).  No fever.  Very tender.  Suspect edema closer to injection site of DTAP.
Period began early while taking birth control pill. Period was extremely heavy compared to the spotting I normally get for a few days. Heavy bleeding lasted at least 4 days. Increased cramps occurred as well.
Patient presented in full cardiac arrest, reportedly found down and not breathing. She was coded for > 20 minutes without success - presented to hospital 4/11/2016.
Pressure in right eye and vision was somewhat blurry, it lasted about 24 hours and then went away.
very heavy menstrual cycle after vaccine and pain in arm at location of shot. The pain in my arm is rather painful and will not stop. The pain in my arm may be permanent, but my menstrual period may change again, but i am not sure.
That vaccine almost killed me; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced near death experience (Verbatim: That vaccine almost killed me) (serious criteria GSK medically significant and life threatening). The outcome of the near death experience was not reported.  It was unknown if the reporter considered the near death experience to be related to Shingles vaccine.  It was unknown if the company considered the near death experience to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient did not get the second shot.  The follow up would not possible as no contact details were available.
Shingles, left L2 distribution. Week of 11/15/2002. No history of wild vericella disease.
Starting the day of and continuing for 24 to 36 hours I had fatigue, mild muscle aches, sore arm.  Starting after a few days I developed a rash and discoloration on my left arm.  It was very itchy and slightly swollen.  Over the next two weeks the rash spread down my arm, across my chest and abdomen, to my other arm, and across my back.  It was similar to hives, but antihistimines, topical oatmeal treatment, hydrocortisone ointment did not affect the itching for more than a few minutes.  Gold Bond medicated lotion helped the most, as well as exposure to cool air.  It took at least two weeks to disappear.
Chills, slight fever, dizziness, and cough since 01/02/21.
Patient developed hives which required ER visit, treatment with steroid, hives lasted one week. Hives covered large parts of her body. No respiratory distress.
Hives/rash quarter size on upper torso, neck and arms. Hives are hard, raised, burning and itchy. Patient complains of nausea/high blood pressure/burning and swelling in arms.
adacel was given intradermally into a forearm, which is incorrect route of administration no reported adverse event; ADACEL was given intradermally into a forearm instead of the intended TUBERSOL with no reported adverse event; Initial information received on 29-Aug-2023 from an unsolicited valid non-serious case received from a physician.  This case involves a 16-years-old female patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was given intradermally into a forearm, which is incorrect route of administration instead of the intended tuberculin test [Tubersol] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect diphtheria-2 /tetanus /5 AC pertussis vaccine, suspension for injection (batch number and expiry date not reported) via intradermal route in the forearm NOS (not otherwise specified) instead of the intended tubersol (Tuberculin Test) Solution for injection for Immunization with no reported adverse event (incorrect route of product administration) (wrong product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive. 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.; Sender's Comments:  US-SA-2023SA265538:TUBERSOL
This spontaneous report as received from a Medical Assistant refers to a male patient of unknown age. No patient's concurrent conditions, medical history or concomitant medications were reported. On an unknown date, the patient was vaccinated with GARDASIL the first dose (dose, route and location of administration, LOT# were not reported). On 06-NOV-2015, the patient was in the reporter's office to receive GARDASIL 9 (dose, route and location of administration, LOT# were not reported) as a second dose of the Human Papillomavirus series. No adverse effects were reported. The outcome of the events and causality assessment were not provided. Additional information has been requested.
missed dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) outcome was unknown. Not Provided      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 concomitant medications were reported. Treatment information was unknown.
Left arm became sore approximately 24 hours after the Td vaccine was administered in Employee Health at the hospital. Approximately 30 hours after the injection, she developed a fever of 101. Took 800 mg of Motrin with little relief. Site began to swell and has localized fever at site of injection.
Malaise, start of fever, some nausea.  Progressed to 101.5 fever, rapid heart beat, aching joints stomach cramps and headache lasting until afternoon the following day.
low grade fever 100.4  & dizziness chills I took an Advil per Pharmacist
Employee reports Left Arm Pain with Swelling and Redness a few hours after receiving her Pfizer Booster vaccine.
Felt like he was running a slight fever.; There were bumps and lumps in his neck; He has fatigue today.; His glands are swollen; Very weak; Swelling on his neck on the left side; He had a hard time breathing/ short of breath; Chest pain; This is a spontaneous report from a contactable consumer (patient).   A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FE3184), via an unspecified route of administration, administered in Arm Left on 29Aug2021 16:00 as (at the age of 43 years old) dose 1, single for COVID-19 immunization. The patient's concomitant medications were not reported. The patient did not receive any vaccine prior Vaccinations within 4 weeks. The patient's Medical History was not reported. Patient denied having diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient had blood work done a couple weeks ago, on an unspecified date in 2021 (prior to vaccination) which revealed cholesterol was high vitamin d extremely low. The patient received his vaccine on Sunday 29Aug2021. On 30Aug2021 around 1-2 pm, the patient had chest pain. It was a severe sharp pain. He had a hard time breathing. It lasted about 20 minutes. The patient was still short of breath (at the time of report) and just feels drained. On 31Aug21, the patient woke up and felt like he was running a slight fever and noticed the swelling in his neck this morning. The patient got to work and started to feel weaker and weaker. The patient was very weak and had swelling on his neck on the left side. It was reported that the patient drives a truck. He put his arm up on the window and felt pain in his neck. So, he rubbed the left side of his neck, and it hurt. There were bumps and lumps in his neck. His neck is swollen. His glands are swollen. He has fatigue today (31Aug2021). The patient called the pharmacist, and the pharmacist looked up the side effects. The pharmacist said his neck is probably like that because he probably had the Delta variant and didn't know it. The stuff said his neck would swell up because of that. The events did not result in Emergency Room visit nor Physician Office visit. Outcome of event chest pain was recovered on 30Aug2021, after 20 minutes of onset. Outcome of events asthenia, swelling, dyspnoea, neck mass, fatigue, Glands swollen was not recovered at the time of report. Outcome of event pyrexia was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
No additional AE reported; HBP responsible for vaccines reported a dose of PROQUAD was administered after a temperature excursion. No additional information provided. No additional AE reported. No PQC reported.    ?    Names of vaccines involved (including lot/exp) PROQUAD (; This spontaneous report was received from a health business professional (HBP) responsible for vaccines and refers to a patient of unknown age ang gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-SEP-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot #W017570, expiration date: 29-NOV-2023, administered for prophylaxis (strength, dose, anatomical location and route of administration were not provided).   The vaccine was stored at the temperature that was reported as 5.7 degrees of Fahrenheit (F) for 30 minutes. There were previous temperature excursions reported as 6 degrees F up to 14 degrees F (9.1 degrees F) for 1 hour and 6 minutes, and on 18-JUL-2022 as 6 degrees F up to 14 degrees F (10 degrees F) for 1 hour and 8 minutes.   No additional adverse event was reported.
FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever. This report was non-serious.
No additional AE reported; The patient was accidently administered MMR II via the intramuscular route not the subcutaneous route; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 10-AUG-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), 0.5 milliliter (strength, lot number and expiration date were not reported) accidently via the intramuscular route not the subcutaneous route for prophylaxis (incorrect route of product administration). No additional adverse event was reported. The outcome of the event was unknown.
PATIENT DEVELOPED A RED RASH ON ARMS AND ABDOMEN WITHIN AN HOUR AFTER ADMINISTRATION OF INFLUENZA VACCINE. THE PROVIDER ADMINISTERED AN ORAL BENEDRYL. THE PATIENT WAS MONITORED FOR AT LEAST ANOTHER HOUR BEFORE SHE WAS RELEASED.
It was like a bad flu; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. This consumer reported similar events for 3 patients. This is 1st of 3 reports.  A patient of unknown gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The consumer reported that everyone that she/ he knew had gotten the vaccine so far, they had all gotten sick for 24 to 48 hours (that's only three people); it was like a bad flu. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021040406 same reporter,event, suspect and different patient;US-PFIZER INC-2021040405 same reporter,event, suspect and different patient
Ear pain; Sore throat; sinus drainage; felt like she had a fever, but she did not; flu-like symptoms like her body hurting, and not feeling well; Nausea; Tiredness; flu-like symptoms like her body hurting, and not feeling well; Lightheadedness; flu-like symptoms like her body hurting, and not feeling well; Stomach pain; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 26Feb2021 14:45 at the age of 55-year-old as dose 1, single for covid-19 immunisation.  Patient medical history and concomitant medications was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no additional vaccines administered on same date of the bnt162b2. On 27Feb2021 patient experienced lightheadedness, nausea, tiredness, flu-like symptoms like her body hurting, and not feeling well. She said she felt like she had a fever, but she did not. She said she had stomach pain, as well. On 03Mar2021 something had developed in her ear and throat, clarifying she believed sinus drainage maybe making her ears and throat sore. Patient did not visit either emergency room or physician office. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected
pt recv vax w/in 5min or less arm @ inj site became swollen, warm & painful;pt felt faint;resp & pulse were WNL;ice applies to site;pt monitored for 1hr-no further effects-arm was swollen from shoulder to elbow;
Arm was sore however at day 7 post injection, the site became red, raised, very itchy. The area was approx. 4 inches long and3 inches across. Continues to be red, tender and very itchy even now at day 11
With the first dose: Headache (came and went frequently) dizzy(2-3 days) nausea (2-3 days) sore arm (3-4 days) gave ibuprofen for about 2 days and most symptoms went away. She continued to complain about a headache every once in awhile. About a week later I noticed  her eyes seemed a little yellow but it didn't seem to get worse and thought maybe she just need to drink more water and get some sleep.  After second dose: Bad headache (3-4 days) dizzy and nauseous (3 days) gave ibuprofen for 2 days. Two days after the vaccine she was fully jaundice. Hadn't notice because she was feeling bad from the vaccine so I just let her sleep mostly. Next day we got into see her primary care dr who ordered stat bloodwork and stat ultrasound. That same day she got some blood work back and told us to go to the er because her platelets were really low. At the er they diagnosed her with autoimmune hemolytic anemia, which explained the jaundice. She was admitted and put on steroids. Her hemoglobin got as low as 5 and they cross matched her incase they needed to do a blood transfusion. They were concerned that there was a possibility that her immune system would attack the donor blood since it seemed to be attacking her platelets as well. Luckily the steroids started working and he levels creeped up a little. She also recieved 3 vitamin k transfusions and pain meds. When she was switched to oral steroids and her numbers were still rise they released her. She is still taking steroids and has weekly follow ups with Dr. . We are also in the process of getting a rheumatology referral to see if there is an underlying condition we didnt know about.
The evening of the shot, extreme pain in arm.  Received pneumonia innoculation in other arm and it was a dull ache for comparison.  The pain moved to the underarm, side of the breast and down the side.  That night a fever of 104.0 degree F oral. Not 100.4 but 104.0.  Severe chills, muscle ache. Arm was NOT paralysed but from the pain could not be used.  Two days later, the same fever, same pain and same chills.  Called physician he called in Tylenol 3 for the pain and recommended putting ice on the innoculation site.