chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A lot number with beyond used date of 31-Dec-2021 and one dose was given out of this lot; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A lot number with beyond used date of 31-Dec-2021 and one dose was given out of this lot) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A lot number with beyond used date of 31-Dec-2021 and one dose was given out of this lot). On 02-Jan-2022, EXPIRED PRODUCT ADMINISTERED (A lot number with beyond used date of 31-Dec-2021 and one dose was given out of this lot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Number of doses/vials: 1 dose was given; date the vial was initially stored in the refrigerator was 01-Dec-2021 and the vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
The patient had a syncopal event immediately following administration of the HPV vaccine. She recovered quickly and was fully alert and oriented. Normal BP and pulse.
Burning, swelling, itching, water blister on hand of injection (right hand). Treated with Hydrocortisone 1% cream and ice and oral BENADRYL.
" injection site red hot swollen and itching getting worse.  having symptoms of nausea, vomiting, tired and a headache that feels like a migraine."
About 5 days after injection started itching at injection site. Itching continued down the upper arm in the following days. Red rash appeared. 2 weeks later itching and rash are starting to subside. Used cortisone cream.
Patient reported redness, swelling, itching near injection site. Area of redness and swelling was not at injection site but lower on arm and more forward. Patient also reported headache but was unsure if that was associated with reaction or due to concern over reaction. Symptoms improving with time. Patient saw prescriber for other Rx and to get order for BENADRYL.
Patient states he has some soreness in his upper right arm and states he noticed it after he had his flu vaccination 11/17/2020, he states its sore to lay on it and sometimes when he lifts his arm. He denies any pain down the arm. Denies redness and denies any knot. Just states it has just bothered him since then. States he has not reached out to his provider regarding his arm. Suggested patient reach out to primary care physician.
a little pain in his left arm where he got both shots; flu; sick on his stomach; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu), ABDOMINAL DISCOMFORT (sick on his stomach) and VACCINATION SITE PAIN (a little pain in his left arm where he got both shots) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery in January 2020.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced INFLUENZA (flu) and ABDOMINAL DISCOMFORT (sick on his stomach). On an unknown date, the patient experienced VACCINATION SITE PAIN (a little pain in his left arm where he got both shots). At the time of the report, INFLUENZA (flu), ABDOMINAL DISCOMFORT (sick on his stomach) and VACCINATION SITE PAIN (a little pain in his left arm where he got both shots) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.
Patient was vaccinated with COVID-19 vaccine at the age of 17 yrs and 10 months old . The recommended age for this vaccine is 18. No adverse reaction reported.
On 4-19-21 patient received 1st dose Moderna vaccine on  R deltoid (10:30am), that same day he had malaise, fever 101, h/a's. Next day, and around 5:00PM he noticed intense pruritis on legs and whole body with hives. He denied any laboured breathing, wheezings, facial/lips/tongue swelling. States the pruritus and hives faded away in 1/2-1 hour after initial reaction. He did well and staff called the whom directed him to ER for evaluation despite he was doing well. He went to ER around 12:00 am and while waiting for the Doctor he once more developed pruritus and hives w/o any symptoms of respiratory compromise. was treated with Benadryl, got better and released around 4:30 am without medication.
Moderate to severe coughing episodes when laying down. Symptoms last for approximately 24 hours. Over-the-counter cough medication helped to alleviate symptoms.
This spontaneous report as received from a medical assistant refers to multiple 1 to 4 year old patients. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. Multiple unidentified patients received VARIVAX (Merck) doses ( 0.5 ml, intramuscular) (unspecified in series) between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects reported. The lots affected include "private stock and VFC stock" with lots and expiration dates: private: Lot J006695 expiry 30-MAY-2015, Lot J005691 expiry 07-MAY-2015, Lot J012260 expiry 01-OCT-2015, VFC Lot J006358 expiry 23-MAY-2015 and lot J012210 expiry 28-SEP-2015. Follow up information was received. All telephone attempts to obtain follow-up information have been unsuccessful. The follow up was received from a medical assistant regarding 15 months old child of unknown gender. The child was vaccinated intramuscularly with a 0.5 ml dose of VARIVAX (Merck), lot # J006358 expiry date 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. This report is one of several reports from the same source. Additional information has been requested.
Patient came in and received PCV-13 on 10/08/2018, on site of vaccine left arm it was swollen, red and hot on the touch... Patient was seen by provider Dr. and has prescribed Bactrim abx, pt verbalized understanding and consent and teaching was given, if symptoms get worse pt to go to Urgent care or ER....
Patient said his arm hurt from top of the shoulder down to elbow. Said there was red then in the same location but when I checked in person her redness or swelling
This patient developed COVID-19 about 3 weeks after being vaccinated.  The patient had the Janssen adenovirus COVID-19 vaccine at a local pharmacy.  She developed COVID-19 on 6/19/2021 and was diagnosed at the urgent care, placed on Zithromax, medrol dosepak, and albuterol MDI.  Also was placed on hydroxychloroquine.   She developed hypoxia on the 25th of June, and acute on chronic renal failure, was transferred for higher level of care to medical Center.  Discharged eventually and re-presented on 7/1/2021.  Was sent home with continued oxygen.  Patient was confused and kept taking oxygen off at home and was direct admitted by myself on7/1/2021.  I was treating her daughter for the same infection (COVID-19).  The patient rebounded, had normal mental status, but continued to have signs and symptoms of a severe COVID-19 pneumonia.  On 7/4/2021, the patient had a sudden escalation in oxygen requirement, sudden drop in blood pressure,  and she became febrile and hypotension and septic.  She did not recover.  Eventually family elected to withdraw care and the patient expired.  Was on remdesivir,dexamethasone, had a dose of actemra, had vitamin C, Vitamin D,  zinc
I gave a 3rd Rotarix.  I checked system and am aware that typically only 2 are given however there was a schedule posted that displayed Rotarix 2,4,6 months therefore I was under the impression that this was the schedule for this office.  I have worked within  different offices that have different schedules.  I take full responsibility for my error.
5/20/2023: 5:30am started with 102 fever went to petting zoo on 5/20/2023, then went to beach on Saturday 5/21/2023.  5/21/2023: Started with tiny rash on stomach
Fell twice due to weakness, next day didn't feel good, admitted to hospital, after MRI it was determined a stroke had occurred
Beyond tiredness, weak muscles, mild to painful headache behind both eyes going to the back of the head, still have cramping/stabbing pain in left shoulder.
Extremely tired; Body and joint pain; Body and joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (Age: 58; Unit: Unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9265) via an unspecified route of administration on 04Feb2021 at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 07Feb2021 the patient experienced extremely tired, body and joint pain. Reporter stated she received first dose of the covid vaccine on 04Feb and experienced some side effects started on Sunday. she said she is experiencing body and joint pain, extremely tired and wanted to know if they are common. Reporter received the Covid-19 vaccine on 04Feb2021. She started having side effects on Sunday. She is still having side effects today. Outcome of the events was not resolved.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
I was star gazing and fell backwards onto my bum and then my head.  911 contacted as I was unable to get up.  I went to the ER and had a CAT scan to determine if there was any bleeding as I am on blood thinners.  Everything was ok at that time.  Since then, there have been spells of dizziness that I attribute to low blood pressure.  These are off and on, usually in the morning.  This happens several times a week.  In February 2023, I was leaning over a bathtub, not after a shower.  I fell sideways and down, my head made contact with the toilet on the way down.  There was some slight bleeding, but 911 not needed.  Saw Doctor shortly after and doctor was unconcerned.  The third fall, 3/9 I missed a step going into my daughter?s apartment and fractured my leg.  Due to cost concerns, I didn?t get to the doctor until 3/13.  I was X-rayed and fitted for a boot.
On the evening and day following receiving the second dose of the Pfizer vaccine, I experienced chills, body muscle aches, headache, and fever (99.7-100.2 degrees). I was unable to get out of bed or go to work. I took ibuprofen at first, for my muscle pain but was told I should instead take Tylenol to reduce my fever and address my pain. My fever and chills recurred last night at about 8pm and I took more Tylenol.   Today, I am still experiencing some pain in my arm (injection site) and some chills/dizziness, but am taking Tylenol and have not experienced any recurring fever since last night. I am continuing to drink a lot of fluid and take a low dose of Tylenol at regular intervals.
Very tender area under (L) breast that radiates around the trunk to the spine. Tender to light touch. Prescribed VALTREX 1 gm TID, topical lidocaine.
Sores in mouth Not healing, bruising without injury, respiratory issues, weakness and pain in legs, loss of appetite, possible siezures, falls and stroke.
Shingles started 2 days after vaccine administration, still have them. Pain at injection site for 2 days after Numbness of left arm on and off for 3 days, occasionally still have this Foggy brain - ongoing Body aches and feverish (no fever) - ongoing Severe diarrhea- ongoing since injection Headache - slight one daily  Nausea - daily since injection
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 29-OCT-2015, the patient was vaccinated with GARDASIL first dose (lot number, expiry date, dosage and route were not reported). On 21-DEC-2015, patient was vaccinated with GARDASIL second dose (lot number, expiry date, dosage and route were not reported). On 29-FEB-2016, the patient was administered in less than the recommended interval with the third dose (inappropriate schedule of drug administration) of the GARDASIL lot# K009482 (expiry date: 06-MAR-2017). No adverse effects were reported. There were no product quality complaints (PQC) involved. No further information provided. Additional information has been requested.
The NEXT day: chills, headache, heavy nausea, dry cotton mouth, but couldn't drink.  Dizzy. Couldn't barely lift legs to walk. No bladder control. Hard to get to bathroom. Fell twice. Second time hitting head. Then, Difficulty breathing. And heart racing. (Please note:  I did actually have Covid last summer from July through August).
Patient presented to the emergency department on 8/24/22 with complaint of shortness of breath for 4 days. Patient claimed she tested positive for COVID on 8/23/22.  She also had generalized body aches and fatigue as well as low grade fever. Patient was admitted until 9/3/22.
This spontaneous report was received from a certified medical assistant and refers to a 17 year old patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On 28-MAR-2016, the patient was accidentally vaccinated with an adult dose of VAQTA, 1 ml (lot number expiry date, anatomical site of injection and route were not reported). No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 17th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, joint pain, muscle pain, headache, back pain, chills, fever, stiff neck, tiredness, pain in arm, malaise, sleeplessness, feels awful and heaviness in arm. The patient was treated with TYLENOL. On an unknown date, the outcome of the influenza-like symptoms, joint pain, muscle pain, headache, chills, fever, stiff neck, pain in arm, malaise, sleeplessness and feels awful were recovered/resolved and the outcome of the back pain and tiredness were recovering/resolving and the outcome of the heaviness in arm was not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, joint pain, muscle pain, headache, back pain, chills, fever, stiff neck, tiredness, pain in arm, malaise, sleeplessness, feels awful and heaviness in arm to be related to SHINGRIX. Additional information received as follows: The retired pediatrician reported the case for herself. Around 10 am, the patient received SHINGRIX on the left arm. The patient experienced flu like symptoms, joint pain, muscle pain, headache, back pain, chills, fever, muscle aches, uncontrolled shivering, neck stiffness, tiredness, sore and achy arm, so much malaise and she could not sleep. The patient felt awful. These symptoms put her in bed. She took TYLENOL. Till the reporting day, she was tired and had back pain but it was much better. Her arm felt heavy but did not hurt. The patient's other symptoms had resolved. Lot number and expiration date was not available. The patient gave consent to follow up.
Fever Blood in rine per urine analysis and flank pain  Narrative:  2 DAYS AFTER 2ND DOSE DEVELOPED BLOOD URINE PER  UA CBC AND CHEM GREATINE 1.32 THE REST UNREMARKABLE FEVER ON THE 29TH AND FLANK PAIN ON THE 29TH. INSTRUCTED TO F/U PCP ASAP
fever chill nausea sharp pain left side of head and ear redness at injection site and arm swollen
She got the expected soreness that was listed on the side effects as we went over. However, she called me today (5/21/2018) in response to our follow up with our reaching out to see when she wanted to get her second shot to complete her SHINGRIX course. She told me that around April 23rd (2 months after her initial shot) she woke up with "intense pain" in her knees. She also had pain in her elbows to a lesser extent. She describes the pain as a "burning, radiating pain" - as an active person, she has been unable to exercise as normal. She has noticed some slight swelling, but no bruising. She doesn't have a primary doctor as she is very healthy. She wonders if the vaccine has triggered a autoimmune response or something else. We have determined to hold off on getting the second shot at this time.
pt recv vax 29APR pt became febrile & was hospitalized; H. influenzae type b isolated from CSF & blood cultures; dx HIB meningitis; tx w/cefotaxime; pt is stable @ time of this report; 25MAY is anticipating discharge fr hosp; pt recovered;
I started feeling fatigue, sore throat, coughing, a slight running nose, and tightness in my chest when breathing. The symptoms progressed in that order as the day went and after a couple of days. And then, my eyes began watering constantly beginning in my right eye to my left eye. I spoke to my PCP on 12/03/2021 about the coughing, tightness of chest, and fatigue; he had me go get a PCR COVID-19 test. My results were negative, so my PCP thought it was a common cold. The wateriness of my eye continued so I called again on 12/10/2021. I was prescribed antibiotics (tobramycin) to help the wateriness for 7 days. It was speculated that I had a pink eye infection that spread eye to eye, and the antibiotics only helped fight the irritation and itchiness of the eyes, the wateriness continued. So when I went to see the eye doctor, he thought it was a viral infection known as conjunctivitis.
Patient stated Left arm numbness, pain Limit of movement and Function Affecting Back, Arm, Fingers, Shoulder
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent medications and medical history were not reported. On an unknown date, the patient was vaccinated with incorrect stored VARIVAX (Merck)(unknown strength, route and dose). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Pain at injection site - immediate and went away within a few minutes Dizziness, fuzzy head - started 10 minutes after shot and has continued consistently (now 6 hours later)
This spontaneous report was received from a 37 year old female patient reporting on herself, as part of a marketing research program conducted by the agency. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot#, dose and route not provided). On an unknown date the patient had a reaction (unspecified). At the time of the report, the patient's outcome was unknown. Additional information is not expected, as the patient did not give consent to disclose personal details.
tested positive for covid on 19Mar2021; has a slight cough; This is spontaneous report from non-contactable consumer (patient) via medical information team. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration on 18Mar2021 at a single dose for COVID-19 immunisation. The patient medical history concomitant medications were not reported. Patient stated that she had her first dose of the pfizer covid 19 vaccine on 18Mar2021 and tested positive for covid on 19Mar2021. She wanted to know if she can get her second dose on 02Apr2021. Patient stated that she knows of others that tested positive for covid after the first dose. She also stated she was out of quarantine but had a slight cough on an unspecified date in 2021. The outcome for the events was unknown.  No follow-up attempts are needed. No further information expected. Information about lot/batch number cannot be obtained.
numbness on left side of face; sharp pain from back left side of ear; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient reported that she received her first dose of covid vaccine on an unspecified date and 30 minutes after receiving the covid vaccine, she started experiencing numbness on left side of face and sharp pain from back left side of ear. She wanted to know if this side effect had been reported. The patient refused to provide age. The patient was responded from reference fact sheet, section (WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?) Revised: 10May2021 and replied from attachment. The outcome of the events was unknown.  Additional information about Batch no/ Lot no. has been requested.
Developed blood clot in lower calves; It was in deep inside lower left calf; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose 4 (booster), single (Lot number: GH9697) at the age of 69 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Patient route of administration: Intramuscular, Anatomical location: Left arm, lot number: PAA165969), administration date: 01Apr2021, when the patient was 68-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Patient route of administration: Intramuscular, Anatomical location: Left arm, 11:45), administration date: 22Apr2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Patient route of administration: Intramuscular, Anatomical location: Left arm, lot number: EW0150), administration date: 22Nov2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Developed blood clot in lower calves; It was in deep inside lower left calf". Therapeutic measures were taken as a result of thrombosis. Clinical course: The patient reported that she does not know if this was coincidence or what, had developed blood clot in lower calves. The patient stated she was very-very active, she just bike, runs, and walks. She was just very shocked to see that she had developed blood clot. So, she was on Eliquis, which is the extremely expensive drug. The patient have been on Eliquis about 3 weeks. So, she just started was very unusual that, she got blood clot. She had never have this in her life. So, she just wanted to call and report it and see if any one else has been calling in and to say that they have developed any kind of blood clot. Patient reported they did not put the time down for the vaccines but it was for dose 1 and dose 3 around 16, 16:30 in the afternoon.
Breakthrough COVID-19 case with symptom onset 8/28/2021: Fever, Shortness of breath/difficulty breathing, Nausea/Vomiting, Loss of smell or taste, Fatigue or tiredness. Patient admitted to hospital on 8/30/21 with fever, shortness of breath (OXygen sat 87%), abdonminal pain, nausea, and vomiting. General A/P included acute respiratory failure with hypoxia, COVID-19 pneumonia. Patient never received mechanical ventilation and never entered the ICU. Discharged 9/8/2021