chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax;child fainted, fell & hit back of head, LOC briefly but recovered; cold compress applied to back of head; BP 90/50; P 84/min; referred to er;
Unilateral gastrocnemius spasm on left leg (opposite) duration ~ 72 hours, preventing plantar flexion or ambulation. Initially painless. Fully resolved. No other muscle involvement or myalgia. No precipitating activity. First and only experience of this phenomenon for patient.
Covid vaccine monitoring documentation. PT admitted 10/17/21 ? 10/22/21 documented as covid vaccine breakthrough. PT received Pfizer dose 1 3/2/21 lot EN0202. Pfizer dose 2  3/23/21 lot EN6204.
Redness, swelling left upper arm after administration of DTaP. This is not the same lot number as 2 other patients who had similar reactions.
temp to 104 p/vax given, pt required partial septic work-up which is neg to date;
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. The reporter stated that, on 02-SEP-2016, the patient was vaccinated with an expired dose of M-M-R II once via subcutaneous route (# lot M001200, expiry date 28-AUG-2016, dose, strength, vaccination site unspecified). No adverse effect were reported. Product quality complaint (PQC) was not involved. No further information was provided. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient pertinent medical history, current conditions and concomitant medications were not reported. On 17-AUG-2016 the patient was vaccinated with ZOSTAVAX (dosing details were not reported) (lot # L006382 expiry date: 25-MAY-2016), subcutaneously, which was expired. No adverse effects reported. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a 67-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-SEP-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N023650, expiration date: 20-MAY-2019 (also reported as 22-MAY-2018) and a dose of FLUZONE (manufacturer unknown) lot# UJ004AA, expiration date: 09-MAR-2019 in the same arm (dose and route of administration were not reported for both vaccines). On 13-SEP-2018, the patient felt bad with a fever of 101 degrees and had a redness, swelling and hardness spreading up her arm. She took acetaminophen (TYLENOL) as a treatment. On 14-SEP-2018, the patient developed redness and swelling from her elbow to shoulder 13 inches by 6 inches around and sought medical attention. She was diagnosed with possible cellulitis, received clindamycin 2 g for the treatment and was sent home with one week of oral clindamycin. The outcome of cellulitis was unknown. The relatedness between the event and PNEUMOVAX 23 and FLUZONE was not provided. Upon internal review, cellulitis was considered to be medically significant.
I felt really tired starting at about 11 PM, then overnight I had a fever, dizziness, nausea, headache, and muscle aches.  I felt really terrible, barely able to move.  This morning  I was feeling better - no fever, less dizziness.  I took some Advil at 8:00 AM and am waiting for the headache to resolve.  I was able to move around slowly as the dizziness is less.  I still feel drained but not so terrible any more.  I ate some breakfast and am drinking a lot of water and resting.
16 year old patient received Moderna vaccine instead of Pfizer. There were extra doses at end of day and we were calling to get additional people in for vaccination.  We used the "golden ticket" process, so cars were not marked as Pfizer or Moderna and all vaccines were on one lane.  Registration identified the patient as needing Pfizer. During vaccination, Moderna was administered. Pt should get 2nd dose of Moderna per CDC. Communicated with mother on error and plan.
Army medic did not dilute the Pfizer vaccine and the patient received a full undiluted dose of the vaccine
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-JUN-2014, the patient was vaccinated with an improperly stored dose of M-M-R II 0. 5ml, (HSA, lot # J006995, expiration date 14-JUN-2015). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 40 hours with the highest recorded temperature of 6 Fahrenheit degree. The storage criteria were refrigerator/freezer (R/F) and the type of excursion for this vaccine was freezer (F). This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 2 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054:
Patient has a round 6.5cm diameter size bruise with red/pink outer limit outline, slightly raised warm to touch (WNL) on his right thigh.  Patient denies itching and pain.
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 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 1:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 1:11 PM, 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 27.38.  Concomitant products were not provided.  On 27-Apr-2021, Excursion time was 09 AM, temperature was 35, total doses given for the day was 42, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. 08 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  On 27-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 35, 10 AM: 36, 11 AM: 38, 12 AM: 43, 1PM: 43, 2 PM: 44, 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 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.
Patient received Pfizer COVID vaccine on 2/5/22 and 2/28/22. On 3/5/22, patient admitted to our inpatient facility with acute respiratory failure with hypoxia due to COVID-19 pneumonia needing BiPAP (also positive COVID test during admission).  Patient was intubated on 3/7/22 and as of today (3/8/22), patient is still intubated in.
Night sweats (2-3times daily) and 2-3 times during sleep; back in full blown menopause; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 03Mar2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history included menopause (at the age of fifty-five years old). Concomitant medications included sertraline hydrochloride (ZOLOFT) and lorazepam (MANUFACTURER UNKNOWN). The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 25Feb2021 at 11:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, the patient experienced night sweats (two-three times daily) and two-three times during sleep since the patient received the last vaccine and the patient honestly felt back in full blown menopause. The clinical outcome of the event night sweats and back in full blown menopause was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Acute metabolic and toxic encephalopathy from comorbid c. diff and COVID-19 infection requiring hospitalization
It was determined that the pharmacy buyer ordered the incorrect hep A vaccine for an ambulatory clinic. Therefore 7 patients received ped doses of hep A vs the intended adult vaccine. All patients have been contacted and will be revaccinated. Our sites do no used barcode scanning at this time. Vaccines are rarely ordered by provider - but usually placed as the v/o for documentation during vaccination.
After receiving the second shot of covid vaccine (pfizer), the patient started experiencing severe pain on the right side of her head. Her eye shut closed, and she couldn't keep it open. Her eye was also watery. She then started experiencing difficulty breathing and chest tightness. She was also sweating.
Fever to 102F, swollen lips, rash starting on face and spread to arms and legs, ulcers on throat.
Patient had syncopal episode seconds after receiving vaccines.  Regained consciousness after approximately 15 seconds.  Pt states she felt lightheaded and like she was "going to pass out" prior to episode.  Patient lied down on exam table, w/ feet elevated.  Patient was given crackers and juice.  BP was taken x 2.  Physician performed exam.
After first gardasil shot on 03/27/08 my symptoms included: Pain in my arm, dizziness,  acute pharyngitis, sore joints and mucles. After my 2nd Gardasil shot on 05/27/08 my symptoms were arm was sore, dizzy, weak, fatigued, whole body ached, severe lower pelvic pain a couple times, Flue off and on, colds, acute pharyngitis a few times, ear aches and infections, sore joints, back and neck pain, headaches off and on, IBS with constipation and bouts of diarrhea,had colonoscopy done, frequent UTI's, kidney infection, hard to concentrate, confusion, had rash on left shoulder for awhile then went away,sensitivity to light, racing heart sometimes, when dizzy my palms sweat, I become clumsy and heart races, grinding teeth, and on 05/29/09 went to OBGYN for Yearly Pap smear and every year it has been normal, no problems but this year, one year after I had my second Gardasil shot the results came back as abnormal. Showed HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION moderate dysplasia CIN 2. Doctor then gave me a colposcopy on 6/26/09 my protien level in urine was high +3 as well said I had ACUTE CERVICITIS. Then had Leep Biopsy done on 7/15/09 for the HIGH GRADE SIL the results were, I had HIGH GRADE SQUAMOUS INTRAPITHELIAL LESION CIN 3 SEVERE DYSPLASIA. They removed all abnormal cells. now bleeding on and off. Been on antibiotics 6 different times in one years time since I had the Vaccine. Never got sick before the shot. I believe these symptoms are caused by the Gardasil Vaccine. I believe I might have something wrong with my immune system or nervous system now.  8/5/09 PCP medical records received DOS 08/16/06 to 7/20/09. Assessment: Acute Cervicitis. High Grade Squamous Intraepithelial Lesion (CIN 3, Severe Dysplasia of Cervix. Patient presents with sore throat, productive cough, and sinus drainage. Oral contraceptives. Pharyngitis. Ear ache. Hurts to swallow. Neck anterior lymphadenopathy. Strep throat. Fatigue, headaches, needing more sleep at night. Bronchitis, chest discomfort with hx of rib contusions. Constipation, bloody stools, stomach cramps. Anal fissure. Runny nose, itchy skin. Allergy symptoms.  Irritable bowel syndrome symptoms. Dysuria, flank pain, pyelonephritis. Lightheaded with dizziness. Serous otitis. Abdominal pain. LEEP procedure.
Severe fatigue, achy everything down to the joints in my fingers, 103.8 fever with chills starting at 4:30 PM 1/20/21. Fever broke mid day 1/21/21. No medical attention needed just rest, fluids and alternating of tylenol and alleve.
upper arm soreness for about 28 hrs; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Left Arm on 05Feb2021 (Batch/Lot Number: EL3247) at a single dose for COVID-19 immunization. Patient had no medical history and concomitant medications. The 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. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Feb2021 13:00, the patient experienced upper arm soreness for about 28 hrs. The outcome of event was recovered on 06Feb2021 17:00. Patient did not received any treatment for the event.  Follow-up attempts are completed. The information on the batch/lot number has been obtained.
Hypotomic-Hyporesponsive, very pale, about 4 hrs after 1st DTP injection
No Adverse event; reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No Adverse event) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 069H21A, 021C21A and 047B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:master case
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with "few" doses of improperly stored MMR II, lot # K016153, expiration date: 24-SEP-2016, (dose, route and injection site were not reported). No adverse effects were reported. Additional information has been requested.
A couple of hours after shot - difficulty breathing, paleness, chills, weakness, headache, sore muscles, symptoms lasted about a day + 1/2.
Patient developed Polymyalgia Rheumatica within 7 days of vaccination.  she did not get the second shot due to this outcome.  she required steroids and a prolonged taper with good results over a very slow steroid taper.  her pain was severe, esr/crp were very high, and she had proximal weakness.
Information has been received from a female registered nurse concerning a 22 year old female who on 10-SEP-2007 was vaccinated with her first 0.5 ml dose of Gardasil (Lot #658556/1060U) intramuscularly in the left arm. The patient developed a 2 inch by 2 inch area at injection site which remains hypopigmented. On 24-OCT-2007 patient was seen in the doctors office and hypopigmentation continued on the left arm. Patient has not been wearing a bandaid or sun tanning. No additional information is available at this time. Additional information has been requested.
Within seconds of injection, I passed out, turned white, stopped breathing for about 15 seconds.  As I came out, my pulse was very weak and about 40 per minute, I was quite nauseated and sat still. In about 2 minutes I lost consciousness again this time for 10 seconds. It was decided to call 911. By the time medics arrived my pulse was stronger and about 60. TheY took me to the ambulance and assessed me and decided to go to the hospital. I needed ZOFRAN by IV route for nausea. I was checked out it the emergency for 7 hours. I needed more ZOFRAN to settle the nausea before they could do bloodwork and x-rays. My husband was with me and a witness helping me make this summary.
Approximately 48 hours after immunizations her left leg at injection site began swelling and turned reddish purple, swelling continued and covered her entire upper leg.  Took her to dr on Monday and she was given Cephalexin, Benadryl, and Prednazone.  As of today leg is still swollen, angry but is looking a little better.
Vomiting began around 10:30PM on 4/7 and lasted until about 7:15AM on 4/8, with vomiting at least once an hour.  Chills. Low grade fever (99.9 before taking Tylenol). Body aches. Headache lasting more than 24 hours.
positive for Hepatitis C; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series complete), for COVID-19 immunization; Bnt162b2 (Booster dose (DOSE NUMBER UNKNOWN)), for COVID-19 immunization. The following information was reported: HEPATITIS C VIRUS TEST POSITIVE (non-serious), outcome "unknown", described as "positive for Hepatitis C". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Description of Event Outcome: Reporter had been vaccinated with the Pfizer COVID-19 vaccine and boosters. Recently reporter was tested and found to be positive for Hepatitis C (which to the best of reporter knowledge, reporter never had). Reporter wife's sister also had the same thing happen to her. Reporter thought this was rather strange and asked if there was any relationship between COVID-19 vaccine and Hepatitis C.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s): PFIZER INC-202300022264 same reporter/drug/event, different patient;
Rash over right upper arm. Pruritic, erythematous area 3 x 5 inches. Pain around injection site. Progressed to weeping desquamation with reduction in erythematous area to 4 x 7.5 cm. Treatment: Claritin, Allegra, Bacitracin, cold compress.
Dark Red inflamed area (1 in x 2 inch on skin) by the evening of the injection, tender to touch.  Area around the injection continued to redden for several days, growing to 6 inch diameter area around the injection site. Continued to worsen for about 4 days.  Started improving on day 5 and lasted several more days.  No fever or difficulty breathing.
1st: 1/24/2021, 2nd: 2/21/2021 1st: 029L2019, 2nd: 039K20A Headache and dizziness with chills beginning last night around 1900. Took ibuprofen which seemed to help with symptoms. Denies chest pain, shortness of breath or difficulty breathing. No other complaints. Patient continues to have headaches and body aches, took Tylenol with some relief. Recommended to see primary provider if symptoms worsen.