chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 10:08 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 73.24.  Concomitant products were not provided.  On 22-Jun-2021, Excursion time was 08 AM, temperature was 35, total doses given for the day was 36, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 27-May-2021, vial was moved to clinic on 22-Jun-2021. 4 vials were sent to clinic. Vaccine BUD date was 26-Jun-2021.  On 22-Jun-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 39, 10 AM: 47, 11 PM: 36, 12 PM: 42, 1 PM: 43, 2 PM: 43, 3 PM: 43 and 4 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
1st dose several years ago didn´t get 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received several years before the date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-Apr-2022 Reporter's comments: This case was received from Shingrix. This case was reported by the patient. The patient did not know that two doses of Shingles vaccine were needed. The patient did not receive 2nd dose of Shingles vaccine and asked if there would be a need to start the both doses again. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Day of administration = pain at injection site/soreness. Day after administration = soreness/nausea. Approximately 5 to 6 days after administration = site redness/pain/hot to touch.
Increased sporadic menstrual spotting.  I have an IUD, current one for 1.5 years prior to onset of symptoms, and have had 4 other IUDs (all Mirena) in the past with no spotting following the first 2-3 months of initial insertion. Directly after receiving the Pfizer COVID vaccine, I began spotting of various amounts with random occurrence. Most recently I was mandated to have a ?booster? to remain at work and within 7 days of receiving I had enough blood that a tampon was required to control flow.  Since that first week, I have been spotting, again randomly, with no pattern of occurrence and am on week 3 following my 3rd dose.
a sore L arm with moderate pain after, started 11pm on day of vaccine and is still occuring.  Took ibuprofen at 11:30pm on 8/11.  redness and swelling at the site of vaccination, , started 11pm on day of vaccine and is still occuring.  Took ibuprofen at 11:30pm on 8/11. Starting 8/12 at 7:30 am:   headache, nausua, shivering, fever, stomach pain  and is still occuring.,  Took two tums.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2 NOS), on 17Oct2022 at 09:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Post-traumatic stress disorder (PTSD)" (unspecified if ongoing). Patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 16May2023 to 21May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse effects reported; rubella was "less than 25.0"; This spontaneous report has been received from an office staff referring to a child patient of unknown  gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.   On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis.            On 16-JUL-2019, the results from recent titers showed that the rubella was less than 25.0. No adverse effects reported. The outcome of the event was unknown.  The causality between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not provided.
Blisters on gumline, extreme nerve sensitivity on upper roof of mouth with swelling, unable to wear dentures.
the patient was inadvertently administered a dose of VARIVAX which expired on 9/17/2020; no adverse effects reported; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant drugs and allergy to drugs were not reported.  On 30-OCT-2020, the patient was inadvertently administered a expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number was R026548, expiration date was 17-SEP-2020, route and strength were not reported) for prophylaxis (Expired product administered). This was supported. No adverse effects reported.
Extreme pain in all of left arm all the way thru left hand, major pain at injection site, was unable to move my left arm in excess of 4 days.  Severe rash around injection sight into the armpit, sweats for 5 days and a fever that reached 102.7.  Excessive swelling in my left arm mostly in the muscle near the injection.  Followup visit was made with administering doctor to confirm all side effects/illnesses.  Medication, prescribed to counteract effects.
Patient claims he got shingles from the vaccine. I explained to him that this should not have happened and perhaps he was exposed before the vaccine could cause immunity to the virus. He went to his physician and got acyclovir 400mg three times a day for 7 days and prednisone 20mg three times a day for 7 days.
I received the Prevnar pneumonia vaccine on 8/10/22. By that evening, I had arm pain, which I expected. By 8/11/22, I could not lift my left arm, my entire arm including my fingers were tingling, along with facial tingling. , I had a fever and extreme fatigue to the point I could not get out of bed. Gastrointestinal issues for 3 days, and I missed a day of work. And I was unable to function normally because the fatigue lasted until 8/14/22. I am immune compromised, as I have Lupus, Sjorgens and Ankliosing Spondylitis. My Doctor highly recommended that I get this vaccine based on my diagnosis. I felt this was odd because I don't suffer from neuropathy at all. The Prevnar by Pfizer was from Lot # FJ2605
Patient received pediatric dose for his first primary dose at 50 mcg and should have received the adult dose of 100 mcg because he is 12 years old.    Patients returned on 12/7/2022 to receive an additional dose of 50 mcg to equal the full dose of 100 mcg.
Pain to left arm, numbness, tingling.  Heavy periods and often 2x a month.
A pharmacist reported that a 33 year old male pt received Flu Shield '00-'01 and Pneumovax on 11/28/00. On that same date, the pt developed an injection site reaction characterized by a hard knot. The event has since resolved.
After pushing plunger to inject vaccine into patient's arm, syringe malfunctioned and vaccine poured out of hub on syringe instead of going into patient's arm. Immediately had patient pull over and explained to him what had happened. Then proceeded to call our regional Doctor who was able to pull our protocol and directed me to give patient full dose of vaccine in opposite since over half of the vaccine did not go into patient's arm on first attempt. Patient was aware of and approved having another dose of vaccine injected into opposite arm. No other issues with second injection.
diagnosed with covid; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of COVID-19 (diagnosed with covid) and MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for covid-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced COVID-19 (diagnosed with covid) and MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, COVID-19 (diagnosed with covid) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was 6 months pregnant when she received first dose of vaccine.  No relevant concomitant medications were reported.  No treatment information was provided   Reporter did not allow further contact
On Thursday, 8/19/21 at 2am, Patient begin to experience severe symptoms of fever, chills, pounding headache, fatigue, and unbearable body aches. These symptoms lasted until Saturday, 8/21/21.  By Sunday, symptoms had improved and Patient was feeling better and able to do normal activities. On the morning of 8/23/21 at approx. 5:30am, Patient was woken up by chest pains. He experienced severe chest pains, heaviness, and described the pain as a stabbing pain that would come in waves. He experienced tingling/numbness down his arm (left side) and in his jaw (right side).  He experienced nausea, was extremely anxious, and his breathing was compromised. Patient let me know that he needed medical. attention.  The walk-in clinic sent us immediately to the emergency room at the local hospital for medical attention.  We spent the entire day in the ER where they took tests and did lab work to determine why Patient was having these adverse reactions.  See Q 19 for all tests/lab and diagnosis.   Note that Patient is still not feeling "himself" since the vaccine and visit to the ER.  He experiences a lack of motivation to work on projects at home that have never been an issue for him before and forgets things easily as many describe as "COVID brain".
The patient returned to the pharmacy two days after receiving the Shingrix vaccination with a shingle like rash from the back of the scalp , down the nech and onto the from of the chest. The patient was refered to her primary care physician, Dr.  When the patient reported that she was unable to be treated by her physician, the pharmacist reached out to the physician, who instructed the pharmacist to treat the patient because the pharmacy administered the vaccination, not the doctor.  Since that is outside of the scope of practice of a pharmacist, the patient was refered to urgent care, where she recieved a prescription of valacyclovir 1 gram to be taken 3 times a day for 7 days. As of 7/3/2020, she says she is feeling better and reports only occasional headache.
partial first dose; A spontaneous report was received from a Healthcare Provider (HCP) concerning an unknown age female patient who was administer Moderna Covid- 19 Vaccine patient only received a partial dose. It was reported by the register nurse is the Director at vaccine clinic, and they had a patient received a partial first dose, wanted to see recommendation for that patient. The reported was unaware that this will be reported as an adverse event AE.  The patient medical history was not provided, no concomitant medications were reported.   On 05 Feb 2021, the patient received her first dose of two dose of mRNA-1273(Batch number 007M20A) for prophylaxis of COVID-19 infectious route unknow. It was reported by the Register Nurse the patient only received a partial dose.  The patient was administered first dose of mRna-1273 Vaccine. the patient only received a partial dose.  Action Taken with the second dose, is unknown.  The event patient reported only received a partial dose was administrated was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # 007M20A with no associated AEs.
Fever, chills, body aches, coughing, fatigue, swelling under armpit on side of injection
Mother reports child had a seizure after leaving him. She brought child to the doctor's office. He admitted him to the hospital. Consult with neurologist. had EEG, CT scan, CBC. All WNL. Scheduled for 24hr EEG on 06/10/2002.
I feel a little weakness; diarrhea; headache; my joins hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (I feel a little weakness), DIARRHOEA (diarrhea), HEADACHE (headache) and ARTHRALGIA (my joins hurts) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (I feel a little weakness), DIARRHOEA (diarrhea), HEADACHE (headache) and ARTHRALGIA (my joins hurts). At the time of the report, ASTHENIA (I feel a little weakness), DIARRHOEA (diarrhea), HEADACHE (headache) and ARTHRALGIA (my joins hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Tachycardia around 5am the next day. Woke up to tachycardia following sleep and checked pulse and it was over 140. Emergency room advised over the phone to come in.  Prior to that, flu like symptoms all day following vaccine; headache, muscle pain, body aches ? unable to ease symptoms through liquids and flu medication.
VACCINE REMAINED IN FREEZER BEYOND MANUFACTURER RECOMMENDATION. AFTER CONSULTATION WITH PFIZER AND agency REVACCINATION WAS RECOMMENDED  TO ENSURE PROPER EFFECTIVENESS.
Moderna COVID-19 Vaccine EUA. Approximately 4 hours of extreme chills, followed by a heavy sweat. Returned to "normal. Following morning, period of lightheadedness, followed by a  brief fainting spell.  Return to "normal" but experienced recurring vague headaches, treatable with double doses of aspirin for about a week afterwards. Nothing since.
Client called on August 28, 2019 to state that she had done a home pregnancy test and it was positive.  She stated she was going to call and get an appointment with her physician to verify pregnancy and inform them of the vaccines she received while not knowing she was pregnant.
head fell forward, eyes rolled back, teeth clinched & then lip smacking, arms were moving rhythmically, legs stiffened out;pt moved from chair to exam table, was diaphoretic, episode lasted 2-3mins
On day after of vaccine had fever; chills; headache; sore arm; This is a spontaneous report from a non-contactable other HCP. A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number=EH9899), via an unspecified route of administration on 24Dec2020 07:00 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  Other medications in two weeks was no. On day after of vaccine had fever, chills, as well as headache, and sore arm on 25Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Fell; flu like reactions including chills, exhaustion, and weakness; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell) and INFLUENZA LIKE ILLNESS (flu like reactions including chills, exhaustion, and weakness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and RA (Rheumatoid arthritis).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FALL (Fell) and INFLUENZA LIKE ILLNESS (flu like reactions including chills, exhaustion, and weakness). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FALL (Fell) and INFLUENZA LIKE ILLNESS (flu like reactions including chills, exhaustion, and weakness) outcome was unknown.     No relevant concomitant medications were reported. Patient took aspirin or Tylenol for their symptoms.   This case was linked to MOD-2022-557675, MOD-2022-557548 (Patient Link).
I have heart palpitations.; It feels like its a lump where I got the shot. It's a big circle of red and it's swollen.; site is red, warm to the touch, and swollen; swollen with a lump; site is red, warm to the touch, and swollen; Vaccination site pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 21-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (I have heart palpitations.), INJECTION SITE MASS (It feels like its a lump where I got the shot. It's a big circle of red and it's swollen.), INJECTION SITE ERYTHEMA (site is red, warm to the touch, and swollen), INJECTION SITE SWELLING (swollen with a lump) and INJECTION SITE WARMTH (site is red, warm to the touch, and swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (NO RELEVANT HISTORY PROVIDED.).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PALPITATIONS (I have heart palpitations.), INJECTION SITE MASS (It feels like its a lump where I got the shot. It's a big circle of red and it's swollen.), INJECTION SITE ERYTHEMA (site is red, warm to the touch, and swollen), INJECTION SITE SWELLING (swollen with a lump), INJECTION SITE WARMTH (site is red, warm to the touch, and swollen) and VACCINATION SITE PAIN (Vaccination site pain). On 14-Apr-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. At the time of the report, PALPITATIONS (I have heart palpitations.), INJECTION SITE MASS (It feels like its a lump where I got the shot. It's a big circle of red and it's swollen.), INJECTION SITE ERYTHEMA (site is red, warm to the touch, and swollen), INJECTION SITE SWELLING (swollen with a lump) and INJECTION SITE WARMTH (site is red, warm to the touch, and swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There were no concomitant and treatment medications provided in source document.
My temperature went up to 101.8 and I had body aches, a headache, leg pain and my arm swelled up slightly. These symptoms lasted for about 2-3 days then resolved.
Swelling, redness, itching, mild fever, persisting multiple days. (Also received other vaccinations at the same time, so I suspect the combination made the reaction worse than any previous Covid shot.  I did not receive any text from vaers like I did for previous shots, so I don't know if this one was entered into your system.  The response differed from when I got only Covid or Covid plus Pneumovax last year, so I thought information on the combination might be useful when making recommendations for what to get together)) (Flu, Shingles, Covid Bivalent)