chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received dose after the beyond use date; Vial initially stored on 31-JAN-2022 and then administered on 10-MAR-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 10-MAR-2022) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022 at 8:37 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 10-MAR-2022). On 10-Mar-2022 at 8:37 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 10-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that HCP provided doses of the Moderna COVID19 vaccine after the beyond use date as the HCP didn't know that the vials shouldn't be used past 30 days from thawing the vials Vial did not undergo any temperature excursions. Total 20 doses were administered. Total 15 vials were used. Thaw expiration date was reported as 02-Mar-2022. No treatment medications were reported   This case was linked to MOD-2022-583498, MOD-2022-583519 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2022: Follow up received contains patient information , reporter email and suspect product information and additional event of product storage error was added.
The symptoms were flu like. I had a headache, sore arm, then it settled into my chest. The headache turned into a sinus infection. I had a hard time breathing. That's when I called the doctor and I was prescribed antibiotics and did some steaming which did help. I also took Mucinex and that would help take it out as well. Then I seemed to get better. I also had heart palpitations, it felt like someone was squeezing my heart in their hand. My doctor gave me an ECG and stress test. I experienced swollen lymph nodes as well. It lasted about 2 weeks before it finally cleared out. Then I got the 2nd dose and it started up again with the same symptoms and I completed the same regimen to clear it out. Then I had the same symptoms with the 3rd dose and completed the same regimen as well.
DVT, bilateral subsegmental PE presenting with right calf pain 6/10, tachycardia (110-150). Treated with 1 dose of lovenox, subsequent Xarelto x3 months with full resolution.
10/092021  Fatigue and moderate pain at injection site 10/10/2021  Awakened  at 4am with a pinching pain in armpit, same arm as injection site (left) Applied warm heating pad to armpit. Pain subsided, but needed to reapply several times throughout the day.  Severely fatigued, slept several hours throughout the day, loss of appetite, and lo-grade fever (100 degreesF) 10/11/2021 Temperature normal (97 degrees F)  Pinching pain in left armpit. Swelling in armpit is visible to the eye.
Information has been received from a physician concerning an 81 year old female with an allergy to codeine who on 23-FEB-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot #656608/0032U).  Concomitant therapy included ADVAIR and VENTOLIN.  On 27-JUL-2008 the patient developed shingles.  Shingles began with pain on her left lateral chest wall.  On 30-JUL-2008 the patient was seen in the office and had a small, "quarter size" rash and severe pain on her chest wall.  No laboratory diagnostics studies were performed.  The patient was prescribed VALTREX and PERCOCET.  At the time of the report, the patient's shingles persisted.  The reporting physician felt that the patient's shingles were an other important medical event.  Additional information has been requested.
34 yo female walk-in, new to area. Two weeks ago she received "whooping cough" shot at center. It was recommended by staff who saw her child as she is day care provider. Given in RUE. Starting that night, pain started at injection site and has been unrelenting x 2 weeks interfering with ROM, dressing and sleep. Movement worsens it. Ibuprofen 1000 mg helps (she took this dose twice). Warmth helps, cold worsens. She saw her PCP GYN MD after one week who recommended F/U with PCP. Center recommended cold alt with heat, "stop babying it" so she has been working out at gym. No radiating paresthesia. Pleasant young lady holding onto (R) arm RUE - no redness, induration or edema of (R) arm, neck or chest. No axillary lymphadenopathy ROM - forward and lateral extension 90%, external rotation only to shoulder level. Passive ROM less painful than active. Point tenderness distal deltoid area.
bad itchiness; around her mouth tingling; Painful rash; facial swelling; This is a spontaneous report received from a contactable female consumer. This female consumer (patient) of unspecified age reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 09Apr2021 as single dose for COVID-19 immunisation. The patient was on sulfadiazine (route of administration, start and stop date, batch/lot number and dose were not reported) for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported that after the vaccine which she had on 09Apr2021, she had bad itchiness on the trunk and tingling around her mouth. She had a painful rash on her leg, left shin on the inside of the leg which kind of burned. It was red dots among a pink rash, painful, odd and intense. She took a cup of Benadryl and fell asleep. She was still itchy the next day. She had reactions to IV antibiotics and they had to discontinue them and give her steroid and Benadryl. She was still itchy the next day. Maybe it was something in the suspension she might have been allergic to. She is due for second dose of the vaccine on 30Apr2021. The patient had underlying auto immune issues maybe that was making her more susceptible. She enquired if she had to get the second shot or take Benadryl before. The oral drug she reacted to was a Sulfa drug. She had facial swelling with it. Outcome was unknown for all the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
About 3 days after vaccination, had headache, usual symptoms. Had paresthesias, mostly in left arm, some in right arm, have continued numbness in left hand and left arm (pointer finger, middle finger, dorsal forearm). Limited motor control in left arm (probably due to numbness). Contacted vaccine administrator, have messaged PCP but have not had a response yet.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN6208), on 09Apr2021 as dose 2, single (Lot number: EP7533), on 27Nov2021 as dose 3 (booster), single (Lot number: FJ1620) and on 23May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTROGEN; PROGESTERONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jun2022) Positive, notes: tested positive for Covid (rapid test). Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information expected.
about 2-3 days after shot, I began having Vertigo.    It lasted a week.  I called Primary physician and received medicine.  After my second shot, once again about 2 days after shot, I had vertigo.  It lasted only an hour or two.   I have never had Vertigo before or since.
Patient compliained of dizziness and feeling lightheaded. Reported that he had peviously fainted from needlesticks. Patient vomited x 2. Remained alert and oriented. No chest pain, no shortness of breath, no drug allergies, no medical history. Vitals- BP- 93/61, 44-HR, 99 02 sat. 2nd HR- 58. 3rd set of vitals- 118/74, HR-72, 98%O2, Blood Glucose-148. P:atient was placed on EKG, and assessed by doctor. MD recommended that patient be transfered for further evaluation based on EKG results and unstable heart rate. Patient was given asprin 325mg. Patient was transferred to Encino Hospital by LA fire department paramedics at 12:34pm
Patient began to have tongue tingling and an elevated heart rate about 45 minutes after receiving the 1st dose of the Pfizer vaccine.  She was given 50mg Benadryl IM. Her tongue tingling resolved after 30 minutes.
Pt exp pain @ inject site p/TD; also noted shoulder pain, which was not felt to be related to vax;
Covid-19 first and second immunizations (Both Moderna) presented nothing out of the ordinary. Sore arm resolved within two days, headache and fatigue likewise.  Just short of 2 weeks after a booster shot (Pfizer) taken 6 months after initial series, began developing hives across body. Have not resolved within 4 days. No other symptoms.
6/6/13 - Pain (8/10) on day of vaccination which interfered with sleep. 6/8 - "clavicle lymph node" swollen and tender (8/10); unable to raise arm. Treated with ibuprofen. No swelling or tenderness at injection site. 6/11 - took last ibuprofen. 6/12 - Treated with KEFLEX by another MD (curbside, no labs drawn). 6/14/13 - "100% better except for lump on (L) clavicle".
Patient received the 1st COVID vaccine (Janssen Lot #201A21A expiration date 09/21/2021) at 1035. At 1050 patient alerted PHN that he was feeling "shortness of breath and feeling dizzy." PHN responded and helped patient transfer to the zero gravity chair and raised the feet of the chair. Patients skin was pale and diaphoretic. PHN black out for about two to three seconds. I'm starting to feel normal again though." Vital signs were taken by PHN at 1052 (blood pressure 120/70, heart rate 68, oxygen 95%). At 1053, color had returned to the patients face. Patient was alert and oriented times four. Patient stated, "I haven't eaten yet today, and I had coffee this morning." At 1056 PHN offered the patient a snack which he accepted and ate. At 1056, patient said, "I'm feeling much better. I feel normal now. I have no shortness of breath." Vital signs taken at 1103 (blood pressure 128/70, heart rate 65, oxygen 97%). Vital signs taken at 1111 (blood pressure 130/80, heart rate 59, oxygen 99%). Vital signs taken at 1119 (blood pressure 130/78, heart rate 58, oxygen 99%). Patient denied any medical issues, or medications, and stated that he is allergic to penicillin. PHN provided education to patient on life threatening symptoms and advised the client to follow up with his primary care provider. At 1120, patient stated, "I feel fine," and left the building unassisted with a steady gait.
Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Covid-19) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The patient birth year was reported.  No concomitant product use was reported.   Reporter stated that got the Covid for son-in-law who came from a trip. The patient was vaccinated but reporter was not sure whether it was Moderna or Pfizer that the patient got.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-660892, US-MODERNATX, INC.-MOD-2022-660893, US-MODERNATX, INC.-MOD-2022-660877. Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660892:Daughter case US-MODERNATX, INC.-MOD-2022-660893:Granddaughter case US-MODERNATX, INC.-MOD-2022-660877:Reporters case
has been 10 weeks since first dose/ patient says they were not called to get their second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has been 10 weeks since first dose/ patient says they were not called to get their second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has been 10 weeks since first dose/ patient says they were not called to get their second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has been 10 weeks since first dose/ patient says they were not called to get their second dose) had resolved.        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.   No concomitant medications were reported.  No information regarding corrective treatment was reported by the patient.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration (has been 10 weeks since first dose/ patient says they were not called to get their second dose) for mRNA-1273, lot # unknown is assessed as not applicable.
102 degree fever for 36 hours following the vaccine starting at 10 P.M. that night.
29 YO received 1st vaccines; hernia surgery; This spontaneous report has been received from a licensed vocational nurse (LVN), referring to a 29 years old male patient. The reporter stated patient had unknown vaccination history and needed vaccines. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were unknown by reporter.  On 26-JUL-2023, the patient was vaccinated the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) (lot # W022943 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 06-APR-2024) and varicella virus vaccine live (oka/merck)(VARIVAX) (lot # W025274 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 10-AUG-2024), both for vaccinations (product administered to patient of inappropriate age). On the same day, the patient was also vaccinated with hepatitis b vaccine rhbsag (yeast) (ENGERIX B) and diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (BOOSTRIX) (lot number and expiration date were not reported for both suspect vaccines), both for vaccinations. The route, dose and strength were unknown for all suspect vaccines.  In 2023 (reported as last week), the patient received hernia surgery. The patient sought medical attention and received treatment. It was unknown if the laboratory diagnostics or studies performed. The outcome of hernia surgery was reported as unknown. The causality assessment between the hernia surgery and all suspect vaccines was not provided.
Mom phoned ofc. 3/26/03 with c/o low grade temp and rash all over. Seen by MD that day w/ diagnosis of chicken pox, given Zovirax. Mom called the next day 3/27/03 w/ increased rash, spoke w/ MD.
This spontaneous report was received from a registered nurse concerning to an unspecified patient of unknown demographics. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA lot # M047658, expiration date 28-OCT-2017 for prophylaxis. The storage conditions were reported as follows: temperature 50° F, time frame 2 hours, with not previous temperature excursion. Data logger was involved. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013208.
Around two and a half weeks after my second dose, I woke up in the middle of the night to a sensation like by brain was rolling around in my head.  It last for around an hour, then stopped.  From that point on, I would wake up in the middle of the night several times, or experience during the day, a sensation of pressure without pain against the middle of my forehead, sometimes centered a little higher up towards the top of my head, and other times closer toward my nose, almost causing the sensation of my nose being stuffy, but not.  Other times I would experience the sensation like my head was filling up with air.  This lasted daily/nightly for two weeks, then because every other day, then every three days, and now currently occurs on rare occasions, at least once  a week though.  I had initially gone to Urgent Care after this occurred for a week,  but was just tested for COVID.  I then scheduled a meeting with a PCP, which I initially didn't have.  When I met with the NP at the PCP's, the symptoms had started to lessen.  I was told it could be allergies, though I had never experienced allergies or anything like this before.  I am not sure if this is due to the vaccine?  The timing suggests it could be, but I honestly have no idea. I also had an instance of passing out on 6/5/21; again, not sure if it was related to the above, or the vaccine.  It was the first time I had ever passed out.  I had just eaten dinner, with it consumed one alcoholic beverage,  I was outside (in the shade on a warm but not hot day), and had been under some stress, so it is possible that these could have contributed to passing out.  I was told it was a vasovagal syncope.
Administration of third dose of Shingrix; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number PH2R2, expiry date 5th October 2023) for prophylaxis.   On 9th September 2022, the patient received the 3rd dose of Shingrix. On 9th September 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 09-SEP-2022 Reporter's comment: The health care professional reported that the patient received a third dose of Shingrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received a third dose of Shingrix, which led to extra dose administered.
Patient given Moderna vaccine at age 17, few months before turning 18.  No other adverse reaction
This non-serious initial spontaneous case, was received from a Pharmacist on 06-Oct-2017, concerning a 75-year-old male patient. This was a quality complaint report (PTC number: 1025081). On 06-Oct-2017, the patient was administered FLUAD (TIV) (dose: less than 0.5 ml, batch number: 178302A, expiry date: Apr-2018, route of administration, anatomical location: not reported) (explicitly coded to Incomplete dose administered). It was reported that the patient received partial dose due to leakage of syringe (explicitly coded to drug administration error and syringe issue). It was reported that, no adverse event was experienced by the patient. It was reported that the dose leaked out of the syringe of 25-gauge 1 inch during the use. Hence partial dose was administered. The location of the leak was needle/syringe connector with no signs of damage on the syringe. E-Z pointe needle, retractable needle technology was used. The reporter assessed the report as non-serious. Follow up report received on 16-Oct-2017: It was reported that, no adverse event was experienced by the patient. Non-significant follow up report received on 18-Oct-2017: Added batch number in the screen. The narrative was amended accordingly. Non-significant case correction received with IRD 07-Oct-2017 CRD 02-Dec-2017: PTC number (1025081) was added. Amended narrative accordingly.
a high level of inflammation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure; "pulmonary embolism" (unspecified if ongoing); "blood clots" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "a high level of inflammation".  Additional information: I had reaction with every shot yes, with the vaccine and everything, I had a high level of inflammation from it, from COVID."
Information has been received from a nurse referring to an unspecified number of patients of unknown gender and age. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with doses of VAQTA (lot # J011712 and expiration date 21-SEP-2015) (strength, dose and route were unknown), which were improperly stored. No adverse experiences had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Right after I got home, I was really thirsty and the water I drank didn?t taste right. My tongue felt weird and I was excessively thirsty throughout day and night. Monday, I had a fever, body aches everywhere, my skin hurt to the touch and my left arm was very red & swollen and hot to the touch. Tuesday, no fever and my body wasn?t as achy, but I still felt weird,  my teeth started hurting and I had unquenchable thirst. Wednesday, my gums and tongue were now  tingling with a burning sensation. This morning, that burning sensation spread to my lips, face,  eyelids, scalp, forearms and fingers. And still excessively thirsty and everything tastes strange still and my mouth feels like I ate a bunch of black pepper. I?m very concerned  about this
Had the vaccine and had no reactions until the 3rd day where you had itching and hives on 2/25/21.  She used Aquifer which she got from her dermatologist, who a friend recommended for her to get this medications, which worked.   She is still having the hives, not as bad, but they are resolving.
DAILY DIZZINESS/ VERTIGO; RANDOM AND SPORADIC EPISODES OF FEELINGS OF "FIGHT/FLIGHT", CHEST AND HEAD PRESSURE, TINGLING ALL OVER, PALPITATIONS, BLURRED/ DIMINISHED VISION (VERY BRIEF), TIGHTNESS FEELING IN THROAT, (NONE OF THE ABOVE SENSATIONS INCLUDED ANY PAIN). DAILY DIZZINESS/ VERTIGO WAS TREATED WITH NON-DROWSY DRAMAMINE (WHILE AT WORK), AND MECLIZINE (PRESCRIBED BY MD) WHICH I HAVE NOT USED YET. DRAMAMINE WAS EFFECTIVE MOST OF THE TIME. SYMPTOMS WHICH I HAD WITHIN THE FIRST WEEK AFTER ADMINISTRATION WHICH HAVE SINCE RESOLVED: FATIGUE, MYALGIA (AT INJECTION SITE); ANERGIA.