chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer Vaccine for 5-11 has a beyond use date of 10 weeks once it is removed from Ultra Low Storage.  This patient was administered a dose that was out of Ultra Low Storage and stored in the refrigerator.  The vial used to delivery the dose had been in the fridge for approximately 11 weeks so the dose administered was one week past the beyond use date.  The patient did not experience any adverse outcomes.
Hungrier; Thirsty; Headache; Nausea; Chills; Dizziness; Legs felt like fire; Did not taste; Extremely tired; She couldn´t sleep; A spontaneous report, was received from a consumer (patient), a 58 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced dizziness, chills, legs felt like fire (burning sensation), headache, nausea, did not taste (ageusia), extremely tired (fatigue), hungrier (hunger), thirsty (thirst), and she couldn't sleep (insomnia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A), intramuscularly for the prophylaxis of COVID-19 infection.  On 20 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028L20A, expiry date: 09 Jul 2021), intramuscularly for the prophylaxis of COVID-19 infection.  On 20 Jan 2021, after the second shot, the patient stated that the vaccine hit her worse than the first shot to the point that she was out from work. She was dizzy, experienced chills, her legs were like fire, headache, nausea, did not taste, extremely tired. The following day on 21 Jan 2021, the patient woke up hungry and thirsty. The patient does not have a primary care physician. On an unknown date in Jan 2021, after the shot, the patient could not sleep and received treatment medication with migrotin. No further information was available.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.   The outcome of events, dizziness, chills, legs felt like fire, headache, nausea, did not taste, extremely tired, hungrier, thirsty, and she couldn't sleep were not reported.; Reporter's Comments: This case concerns a 58 Y/O F with PMH headache, fatigue, dizziness, injection site pain after first dose mRNA-1273, who had NS unexpected dizziness, thirst, hunger, insomnia, burning sensation, ageusia and NS expected fatigue, headache, chills, nausea. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient passed out about 5 min after receiving first dose of HPV. Patient was instructed to sit for 15 min, stood up after 5min.
On 12/26/14 Patient stated has had pain in arm since shot was given. On movement has pain on upper left side of chest, upper left side of back and shoulder. Plans to see MD.
pt recvd vax & devel fifteen or more lesions on back one of which was a vesicle which resembled wild type chicken pox;reporter felt the pts exp was related to vax;
Administered 10 doses of Moderna COVID Vaccine after the 30 day refrigerator guideline; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jul-2021 and was forwarded to Moderna on 08-Jul-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 10 doses of Moderna COVID Vaccine after the 30 day refrigerator guideline) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 10 doses of Moderna COVID Vaccine after the 30 day refrigerator guideline). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 10 doses of Moderna COVID Vaccine after the 30 day refrigerator guideline) 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.   Medical history and Concomitant medications details are not provided by the Reporter. Vial was first moved to the fridge on 03JUN2021. On 05JUL2021,06JUL2021 and 07JUL 2021 10 doses of Moderna COVID Vaccine was administered after the 30 day refrigerator guideline. Doses were meant to be expired on Sunday July 4th but overall 10 doses were administered to 10 patients between 05JUL2021 and 07JUL2021 while they were stored in the refrigeration between 35 and 46 Degree F. No treatment information is provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up information received on 8 JUL 2021 contains no new information.
Patient received 3 doses of Pfizer vaccine on 2/2/21, 2/23/21, and 12/9/21. and was hospitalized on 12/29/21 with hypoxia due to COVID.  patient remains hospitalized on 12/31/21
Stated tricep hurt very had when given. By evening arm was tight and sore-knew that could be expected. No redness or swelling. Bad pain in arm, tried to lift arm and bad pain shot down arm. States had spasms in arm when injected-wondered if it hit nerve or something? A few days ago so bad could not lift arm. Went to ER. 11/30/14 and was given pain pills that did not help. On 12/2/14 went to PMD-put on non steroidal to loosen arm up 12/3/14 arm loosening up today-has more movement-if lifts high-very painful still.
Covid-arm. Red, swollen ring around the vaccine arm site. It was sore and itchy. I took Claritin and resolved 3 days later.
Headache, Sedation, Myalgia, Fever, NauseaVomiting, chills and fatigue. pain at injection site. Narrative:
mom reports pt had irritability, fever to 104, high pitched screaming the day p/vax given; fussiness, some coughing, runny nose, no appetite & some diarrhea cont thru weekend; took pt to MD 9MAY p/vax; pt was listless;
11/27/21 @0350:  Arrived to ER with c/o severe SOB sat 67% on home pulse ox.  Denies fever, chills, N/V, or any other S/Sx.  RR 30-40, HR 100-120, sat 80% on RA with noticeable respiratory difficulty at rest, BP 193/87, 36.9 degrees C.  CRP 5.2, EGFR 47, INR 1.62, WBC 16.1, ABG 7.40/42/26/25.6/BE 1.2 sat 98% on 6L NC.  CT shows no new PE, new multilobular atelectasis with RUL consolidation and small bilateral pulmonary effusions with mildly enlarged mediastinal lymph nodes.  Started on dexamethasone, vitamin cocktail, baricitinib, changed home Eliquis to Lovenox, and admitted to telemetry unit. 11/28/21 @ 0830:  weaned off oxygen to 95% on RA.  Mild SOB with activity.  Discharged home in late afternoon with COVID Hospital Care at Home program from other provider in patient's local area.
Tachycardia; dizziness; flushed feeling; sweating to hands and back of neck; This is a spontaneous report from a contactable nurse reporting for herself. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:Ek4176), via an unspecified route of administration on the left arm on 12Jan2021 17:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, melanoma in situ, diverticulosis, allergies to sulfa, betadine and reacted to depo-medrol injection. Concomitant medication included lisinopril (LISINOPRIL), estradiol (ESTRADIOL), ibuprofen (MOTRIN) and cyanocobalamin (B12). The patient experienced tachycardia, dizziness, flushed feeling and sweating to hands and back of neck on 12Jan2021 17:30. Therapeutic measures (Benadryl 25mg) were taken as a result of the events. The outcome of the events was recovered on an unspecified date in Jan2021.
I had massive menstrual hemmohaging and large blood clots for 11 days.; I had massive menstrual hemmohaging and large blood clots for 11 days.; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left in Sep2021 at 04:45 PM (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation at age of 55 years old. Medical history was none. There were no 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 has not been tested for COVID-19. The patient previously took ceclor and experienced allergies to ceclor. The patient reported that she had massive menstrual hemmohaging and large blood clots for 11 days on 15Sep2021. This started 7 days after getting the first shot dose. The events resulted in physician office visit. The events were serious per life threatening. Therapeutic measures were taken as a result of the events. The outcome of the events was recovered with sequelae in 2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
28 YEAR OLD FEMALE COMPLAINED OF WEAKNESS. ONSITE EMS AND PHYSICIAN REQUESTED. BP 102/65 GLUCOSE 92MG/DL  O2 100% ON ROOM AIR. SHE WAS RELEASED AGAINST MEDICAL ADVISE.
RED ITCHY RASH ABOVE INJECTION SITE APPROXIAMATELY 2 INCHES WIDE--OBLONG SHAPE.
Headache immediately following the first doze. Dizziness and vertigo started  two hours later and has worsened with time.
Moderna COVID-19 Vaccine EUA  Sore Injection Site Nausea Severe Upper Back Pain
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included sterile diluent. On 05-JUN-2017, the patient was inadvertently vaccinated with one expired dose of ZOSTAVAX 19400 plaque-forming unit (PFU) with lot number reported as N014310 and expiration date of 26-MAY-2017 (dose, route of administration and anatomical location were unknown) for prophylaxis. No adverse effects were reported.
Extreme nausea and headache, dehydration, body pains, weakness, inability to move easily from bed, care for children, drive. Chest pain and heaviness.
Strong pain in her muscles; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced strong pain in her muscles on an unspecified date in 2021. The outcome of the event was unknown.   No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Pt w/ G-6-PD vaccinated w/Recombivax HB.  Developed nausea, vomiting, diarrhea & a fever 103. Admitted to ER. Dx: hepatitis based on labs.  Hep A, Hep B, Hep C and Epstein-Barr virus were neg.  Gradual improvement; at 4 wks, LFT's wnl.
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history or concomitant medications were not reported. The nurse reported that on an unknown date, the patient was vaccinated with a expired dose of ZOSTAVAX lot # M015926 expiration date on 28-JUN-2017 for prophylaxis. At the reporting time no adverse event was reported.
She received her vaccine and at 9:00 PM she got an injection site reaction on the left side where she got the reaction.  It was very painful and swollen, large golf ball lump on her arm.  Painful red, swollen and lasted through Saturday, but then started getting better.  The following morning she woke up with body aches, chills, fever of 103.  She took Tylenol.  The next morning the fever came down to 101, was having stabbing muscle pain similar to her COVID pain in her large muscle groups in her legs.  The body aches continued, was having joint swollen in wrist, knees and shoulders, and fever continued to 103 throughout the day and wavered from 101 to 103. She then took 2 qadvvils at 6:00 PM.  On the 17th she became very dizzy, had chest heaviness, legs were very heavy to the point not aqble to lift them or walk.  Her heart rate remained in the 140.  at 8:00 PM she had fever of 102.9.  The next day still dizzy, off balance, still had the stabbing muscle and flank pain.  She was still tachycardia fever still at 101.  That same day she checked her VS, her SATs were 96%.   The light headedness continued and 2 syncopal episodes on that Saturday but recovered from that.  She then Sunday had the light headaches, had trouble walking and by Monday she started feeling a lot better, and little by little the symptoms continued to improve.  Now she feels completely better, the swelling and pain is gone, she can walk again.   These symptoms were similar to when she had the COVID virus.
This spontaneous report as received from a 44 years old male patient referring himself. The patient had no medical history. The patient's concurrent condition included amoxicillin allergy (drug hypersensitivity). On an unknown date in June 2017 (reported as first week of June), the patient was vaccinated with first dose of GARDASIL 9 0.7 ml rather than 0.5 ml (Lot # and expiry date was not reported) for prophylaxis. Subsequently on an unknown date, the patient also received the second and third dose of GARDASIL 9 0.7 ml rather than 0.5 ml (Lot # and expiry date was not reported) for prophylaxis (overdose and drug administered to patient of inappropriate age). Concomitant therapies included emtricitabine, tenofovir disoproxil fumarate(TRUVADA) and cetirizine hydrochloride, pseudoephedrine hydrochloride(ZYRTEC-D). On an unknown date in 2017 (reported as after receiving the vaccine but it was not specified if that was after one or all doses), the patient experienced chills, muscle fatigue and felt like "he weight 4000 pounds" (discomfort). There was no treatment given for adverse event and there was no lab tests performed. The outcome of chills, discomfort and muscle fatigue was reported as recovered/resolved. There was no product quality complaint involved. The reporter did not provide the causality assessment for the events.
Patient was administered vaccine on 10/28/21. Vaccine was moved from  Freezer to refrigerator on 9/24/21 and therefore was expired on 10/28/21 at time of administration.  No known adverse reactions have been reported by patient
Tingling sensation around right knee, then it was developed to muscle twitching around the same area. It happened randomly. No treatment for this condition.
Patient is stating that he is still having arm soreness and discomfort at the injection site as of 04/05/2019. He states that he cannot lift his arm any higher than the height of his shoulder.
This spontaneous report as received from a healthcare worker refers to a 8 week old patient of unknown gender. Pertinent medical history, concomitant medication, drug reactions and allergies were not provided. On 05-MAY-2014, the patient was administered an expired dose of ROTATEQ orally (lot # H015715, expiration date 15-MAR-2014) (dose and frequency were not reported). No adverse effect was reported. Product quality complaint (PQC) was not reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Red, swollen, warm, painful area to upper right thigh 24 hours post vaccination.  Approx 24 cm X 19cm.  Also noted several fluid - filled vesicles at injection site.  24 cm X 19 cm
Developed palpable purpura over lower legs then over thighs, forearms and abdominal wall. Purpura of lower legs became necrotic pustules.
97y.o. male with history of dementia, anemia, L1 compression fracture, urinary retention, and atrial fibrillation. He was brought in yesterday after he had fallen outside and hit his head on the concrete, unsure if any LOC. CT head was negative for any acute process. Labs including CBC, BMP, and troponin were all unremarkable. He was found to be positive for COVID but was saturating well on room air and otherwise asymptomatic. Inflammatory markers were checked, he did have elevated CRP and d-dimer. Patient deemed medically stable for discharge by physician. Hospital accepted patient.
Information has been received from a physician concerning a 63 year old female who on 31 Oct 2006 was vaccainted SC with a 0.65 ml dose of varicella zoster virus vaccine live. On approximately 31 Oct 2006, the patient developed a red area that was pretty painful at the injection site. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information had been requested.
12 hours after first dose, had extremely painful and swollen R lymph cervical node and fatigue. Continued for three days. On 12/25 awoke with painful gums, fevers of 102.1, chills in addition to symptoms. 12/26 had sore throat and worsening sores on tongue. Went to urgent care that morning, was tested for Covid, strep, influenza, RSV. All negative. Had overwhelming fatigue. 12/27 worsening tongue sores and thrush, had another appointment where given nystatin. At this appointment was diagnosed with an immune over response to the COVID-19 vaccine. The thrush still was not improving and extremely painful. Was started on Fluconazole for 14 days after another appointment on 12/29. No history of thrush, have good oral hygiene and follow all recommendations to prevent thrush with my inhaler. I lost 12 pounds due to the thrush and the extreme discomfort. Fever went away 8 days after vaccine dose, still have lingering thrush symptoms and R lymph node slightly enlarged.
After patient received the shot she was sitting on a chair and she pass out and hit her head on the floor . As per mom she has history of passing out. So I called the 911 and they came check her blood pressure and she was ok. And mom took her home.
Rash on chest, itchy arms, headache, joint pain, leg pain, headache
My COVID-19 symptoms started in the morning around 8:00AM on 12/09/2022. I had cough, sore throat and stuffy nose. I did COVID-19 home test which was positive. On 12/11/2022 I went to the urgent care and they prescribed me with PAXLOVID for 5 days. They advised me to take TYLENOL as per needed. On 12/14/2022 I tested negative for COVID-19 infections. After my 2nd vaccine I developed Eczema which I had when I was very young now after the 2nd dose it came back. I think this is an Autoimmune side effect which should be noted. I also developed Alopecia areata on my beard and top of my hands. I used hydrocortisone and ROGAINE to treat it.
Patient had syncopal episode post vaccine. Loss of Consciousness was about  minute.Vitals signs stable, trandelenburg position, ice packs applied to neck, water given and snacks. Monitored for an additional 30 minutes with no signs of concern. Patient was able to ambulate on own out of clinic.
This case was received from a patient on 16 June 2008.  SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  A female patient, with a history of codeine and multiple other drug allergies, received an injection of yellow fever vaccine (manufacturer and lot number unknown) in June 1970.  Approximately one week after vaccination, the patient began experiencing a puffiness and a red, blotchy rash on her face and chest area.  She also had vomiting, and an episode of syncope where she fainted on the street.  She was seen by a physician, and diagnosed with an allergic reaction.  No treatment was provided, and the event subsequently resolved.  No other information was available.
Next day had a headache that would not go away. In the afternoon, I felt exhausted and had to lie down. An hour later, I was completely fine. My concern is that since then, I have had this same thing happen to me twice. Headache (medication would not help) and I had to lie down.
18SEP91 pt given APAP following shot had high pitched screaming began 2 hrs p/shot despite APAP; arm was extremly red & hot; also pain, shuddering;
second dose, when the nurse took out the needle from the injection site there was blood.; This is a spontaneous report from a contactable consumer or other non-hcp (Patient's mother). A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number and Expiration date not reported) intramuscular on 19Jun2021 (age at vaccination 12-year) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) as dose 1, single on May2021 (at the age of 12 years) for COVID-19 immunization. On19Jun201 the patient experienced after the second dose, when the nurse took out the needle from the injection site there was blood. The nurse said that she might have nicked a vein or a blood vessel. The nurse cleaned it up with alcohol and band aid to stop the bleeding. Re-porter was concerned it may affect the vaccine although patient did seem fine. Reporter was also asking if there was a danger on the vaccine going into your blood stream or if the vaccine will still work. Reporter said that patient was vaccinated from a vaccination site and they cannot talk to the nurse. Reporter called about the Pfizer Covid-19 Vaccine. She has a question because her 12-year-old daughter received her vaccine back at the end of May and in June for the second dose. The clinical outcome of vaccination site bleeding was recovered on an unspecified date in 2021.  Information about lot/batch number has been requested.
Patient with local reaction of swelling and erythema. Patient's mother instructed to keep an eye on it and use cool compresses.
Abnormal eye movements, abnormal behavior, Seizure like symptoms for months. Trouble waking. Glazed over eyes.
Patient reported awakening in the early morning after receiving his booster dose with chills and later developed redness and swelling along his right arm extending to the elbow.