chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Muscle aches; Joint aches; Brain fog; Anxiety; Headache; Increased tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0173) via an unspecified route of administration in the left arm on 04Apr2021 at 11:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis and allergy to wheat. Concomitant medications included ferrous gluconate, vitamins nos, herbal nos (FLORADIX) taken for iron supplementation from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05Apr2021 at 12:00, the patient experienced fever, muscle aches, joint aches, brain fog, anxiety, headache and increased tinnitus. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, muscle aches, joint aches, brain fog, anxiety, headache and increased tinnitus was resolved on an unknown date in 2021. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 02May2021 at 11:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Mild headache, intermittent,mild arm pain, intermittent...tylenol 500mg decreases the headache and minimizes the arm pain.
feeling yucky; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 08May2021 as dose 2, single (Lot number: EW0199) at the age of 54 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT: ER8731), administration date: 15Apr2021, when the patient was 54-year-old, for COVID-19 immunization, reaction(s): "feeling yucky". The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "recovered", described as "feeling yucky".  Additional information: Had three or 4 other injections prior and had no other side effects other than feeling yucky for a day but never had rashes. Clarified injections as all Pfizer COVID-19 Vaccines.
1/5/21-About an hour after receiving vaccine, I had mild nausea, my left arm kind of hurt after receiving the vaccine.. which is weird because I got it in my right arm.  1/5/21- Around 8:00 PM I noticed raised red bumps on both of my forearms.. it?s worse on the right arm. It looked like a mild rash. Around 10:00 PM I developed chills, muscle aches, my right arm was in a lot of pain, I had a slight headache, nausea, and my temperature kept going up. I?ve been taking Advil/ Tylenol to try and get my temperature down.. but after every dose wears off my temp goes back up. I kept waking up multiple times in the middle of the night. In the middle of the night around 2AM, my temperature was as high as 102.9.  Later on in the night around 4AM, my chills had stopped and I actually felt really warm.   1/6/21- I woke up about 6:30 AM and had to call out of work. My temp was about 98 something at this point and I still had muscle aches.  I slept most of the day and my temp continues to go over 100 now every time a dose of Advil wears off. I still have muscle aches and there is still a lot of pain at the injection site. My arm doesn?t hurt as bed as it did though. However, the rash on my forearms is still there. On my right forearm it looks worse than it did yesterday.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-OCT-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot number N011867 and expiration date of 08-NOV-2018 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 9°C to 25°C with a time frame of 1 hour. There was no information regarding previous temperature excursion nor data logger involved. There was not product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA002495: US-009507513-1711USA007577: US-009507513-1712USA002494:
During the night following the vaccination, I experienced chills, aches, loss of bladder control and extreme fatigue the following day.   I have since had interim dizziness and rapid heart rate.  My left arm is slightly swollen, red and sore.
pt recvd vax & had fever, chills; t 103; aches x 3 days;
2 days after receiving my 2nd Covid Pfizer vaccine, I noticed a burning sensation on my Bilateral Upper Inner thighs. It felt like a sunburn. In the next few days the "burn feeling" became more pronounced, especially when clothes would rub against my thighs. The area only appeared slightly pink, but would become more pronounced after irritation from clothes. What really intrigued me was the Exact Identical appearance on Both inner thighs. There were no raised areas or bumps. Only pinkness that would get redder with wearing loose pants that would rub area. When area was rubbed I felt like I had a severe sunburn...burning pain. For a week I tried Benadryl cream....switched to Non-allergic Washing liquid and re-washed all my clothes. I stopped ALL medications/supplements that I was taking...tried all creams that I had (RX & non-RX)....Nothing helped. I eventually saw a Dermatologist. They took pics, consulted about what it could be....Vehemently told me it was NOT vaccine related & DX me with Old Age Dry skin! But I came home and TRIED all the Creams they RX.....After another week of no improvement, I contacted my hospital employee health and explained my condition & IDENTICAL symptoms on Bilateral thighs.....They immediately told me that I needed oral Prednisone due to it being systemic at this point....I was prescribed a course of oral steroids....and the condition improved....However, it took over a month for me to be able to wear loose clothes that did not irritate the area and for most of the sxs to go away. I decided to report this event after I find the sxs to return slightly occasionally even now.
About 4 hours after vaccine developed fever to 102, diarrhea, vomiting, full body pain.
Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) in a 74-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  The vial did not undergo any temperature excursions Total of 173 doses were given from LOT 070H21A It was reported that the date vial initially stored in refrigerator was unknown  Treatment medication was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non Significant  follow up was received
Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a patient of unknown demographics who was vaccinated with an expired dose of IPOL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 28-Feb-2019, the patient received a dose of suspect IPV (VERO) (lot number: N1A45 and expiry date: 05-Feb-2019) (dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to expired vaccine used. It was not reported if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
pt exp localized rxn which include pain, redness & knots lasting for as long as two months;pt sought unspecified med attention; addtl info has been requested;
Patient arrived to obtain the Moderna Bivalent booster.  He was given the Pediatric Moderna Vaccine Age 6m - 5years in error.
States she had severe arm pain following vaccination.  Reported it to us by e-mail 12/2/2015; did not return multiple phone calls.  We advised a physician evaluation and do not know if she went.
blood drops in my urine and possibly passed a blood clot.; blood drops in my urine; When I woke up to use the bathroom, I noticed some blood coming out of my penis.; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 13:45 (at the age of 36-years-old) (Batch/Lot Number: ER8735) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. The patient received first dose of BNT162B2 for COVID-19 immunization on 31Mar2021 (Product=COVID-19, Brand=Pfizer, Lot number=ER8734, Lot unknown=False, Vaccine location=Left arm, Administration date=31Mar2021, Administration time=14:00 PM, Dose number=1). Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); cetirizine hydrochloride (ZYRTECNO). On 22Apr2021 06:30, When the patient woke up to use the bathroom, he noticed some blood coming out of his penis. At 06:45, it was reported, The morning after his second dose, he had blood drops in his urine and possibly passed a blood clot. The outcome of the events was unknown. The event "blood drops in my urine and possibly passed a blood clot" and "When I woke up to use the bathroom, I noticed some blood coming out of my penis" was assessed as serious (medically significant).
11/16/2022 drove to town couldn't breathe, Contacted neurologist to see if there adjustments to C-pac machine, on day 6 talked to doctor went to urgent care.  12/06/2022 symptoms improved but didn't fully recover.  Shortness of breath remains. 01/05/2022 saw Dr heard crackling in lungs, was sent for CT Lung and heart are being checked.
Chills, achiness, fever 104F; 24 hours, post vax. Slept for 12-14 hours. As an infant his DPT was given in 1/2 doses due to increased temperature after initial dose. Same with his sister.
Chief Complaint: Shortness Of Breath. Patient tested positive for Covid. Pt had COVID in December 2021 .  Covid infection was mild and was treated at home.  Continue supplemental oxygen.  home with home health and home oxygen.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy mind), PAIN IN EXTREMITY (pain and soreness in the arm of injection), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (Headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Acid reflux (oesophageal). On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced FEELING ABNORMAL (Foggy mind), CHILLS (Chills) and FATIGUE (Tiredness). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain and soreness in the arm of injection) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Foggy mind), CHILLS (Chills) and FATIGUE (Tiredness) outcome was unknown and PAIN IN EXTREMITY (pain and soreness in the arm of injection) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications included medications for acid reflux. This case was linked to US-MODERNATX, INC.-MOD-2021-089453 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-089453:Case for wife.
Information has been received from a physician concerning a patient who on approximately 08-DEC-2006 was vaccinated with a dose of hepatitis A virus vaccine inactivated. On approximately 29-DEC-2006 the patient presented with a positive IgM. The physician declined to share any further information, but stated that she will be conducting another IgM test, and if that was positive she would call back to share more. There was no product quality complaint. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a female with no pertinent medical history and no known allergies who on 21-DEC-2006 was vaccinated into the right arm with a 0.5 ml first dose of Gardasil (yeast) (lot#654389/0961F). Concomitant therapy included unspecified over the counter vitamin supplements. Subsequently the patient experienced severe deep pain in her right shoulder. Unspecified medical attention was sought and there was no treatment given. At the time of the report, the patient had not recovered. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received the first dose of PREVNAR 13 (Lot number: T08483 and Expiration date: Sep2019, NDC number: 00005197102), intramuscular in left deltoid on 11Nov2017 at 0.5 ml, single for routine vaccination. The patient received the vaccine in a Pharmacy/drug store. Patient medical history, family medical history relevant to adverse events and relevant tests were none. The patient was on other medications (unspecified; the reporter does not think that these were relevant to the adverse events). The patient previously received flu vaccine (but it was not within the 4 week time frame). The patient was having red and swollen arm, the patient also experienced headache, body ache, and runny nose on unspecified date after receiving the vaccine. The events required a visit on physician office. The patient's doctor treated the events. The reporting pharmacist assessed the events as non-serious. The outcome of the events was unknown.
pt recv vax & exp fever that evening; the following day pt devel a gen macular & vesicular rash; No further details were provided;
on 1/2 to 1/4 experienced extreme fatigue on 1/4 developed chills and fever of 102 which lasted 2 days along with body aches and headache  last day of fever was 1/5 returned to work on 1/7. was feeling fine then on 1/9 at night started with chills, fever of 102 extreme weakness, tiredness, headache dizziness,  on 1/10 continued with chills and fever, tiredness, weakness, and dizziness vomited x1.  had loss of appetite but was able to keep fluids down fever continued until the evening of 1/11 which was 101.8 but was unable to keep fluids down but only vomited x 2.   I remained NPO for 2 hrs and then was able to tolerate small sips of fluids  on 1/12 no fever in am was able  to tolerate plain toast and fluids  appetite returning later that night and was able to tolerate soup had no fever since 1/11 Monday evening and was able to return to work on 1/13. I was unable to work on 1/11 and 1/12
3 hours after shot, experienced headache, fatigue and general aches and pains. last 24 hours 7 days after shot, experienced "covid arm" - raised, red, swollen, hot, slight itch large area around shot.  cleared after 3 days 20 days after shot, area of "covid arm' is now a bruse. Does not hurt, but is noticeable. still have it at 27 days
This is a one shot booster to an original Janssen vaccine from May 2021.    At +12 hrs -injection site pain. More than usual, but dissipated after a day.  +18 hours - lymph nodes under both arm swollen to size of golf balls. Discomfort, but not painful.  +40 hrs, time of reporting, seems to be decreasing in size, still tender. Other near surface nodes appear normal
I tested positive for COVID - 19 on March 11,2023. I had fatigue, sinus congestion, mild fever (100.3), and a headache. The fever lasted about 3 days, my wife got COVID first and gave it to me an we both took and antiviral.
Incredibly bad period cramping. Worse than I?ve ever had. Period was on time and flow was normal.
A report has been received from a Pharmacist concerning a 9 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced RACING HEART and HEAVY CHEST which started on 15-Oct-2012. The patient recovered from the event of RACING HEART and HEAVY CHEST on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received by Astrazeneca/MedImmune 01-Nov-2012 from Physician via Pharmacist: Reporter's details added. Corrected Report 12-Nov-2012: Additional reporter of Physician and Administered by added.
11-12-14 2.5 in. redness, swelling and warmth at site. 12-1-14 intermittent fever, wheezing, headache, green nasal discharge.
5 minutes after receiving vaccine, patient became syncopal, per EMT she was slumped over in her chair. EMT able to wake her and get her to antigravity chair.  BP 166/110, R 22. Patient dizzy and in and out of consciousness. 911 called at 2:15pm. Assessment by Paramedics showed BP 178/107, HR 204, BS 105.  Patient reported no respiratory distress but having feelings of nausea.  Alert and Oriented x3. Patient refused ambulance transport and wanted her "caregiver" to pick her up.   2:55pm Ambulance left.  3:10pm client stated she took her inhaler from her purse because she was having "chest tightness", reported immediate relief. Patient also reported she took her own Klonopin to "decrease her heart rate". 3:15pm  HR 92, BP 170/90.  Patient's caregiver arrived helped her up with  a use of her own cane, and helped her to caregiver's car to be taken home with caregiver.
thigh induration, painful swelling, and erythema onset 5 days post vaccination, with sudden onset erythema with streaking prompting ER visit; exam reassuring, supportive treatment provided
pt recv vax 31MAY96;fever, t99.4 ax, rash 1JUN96;saw MD @ ER no tx given;f/u visit to clinic, exam by nurse suggested antihistamine;pt was afeb 3JUN96;
Vaccine was administered too early in the series - given after 14 days rather the full 28 day interval.  Patient did not report any adverse effects.  Patient is scheduled to receive an additional dose to account for the early dose 28 days following the dose administered early.
Left arm edema from deltoid to wrist with tongue tingling.  Sx. started a few hours after injection on 01/24/22,  progressed on 01/25/22. She with cool compresses. We treated with Benadryl and Solumedrol .
This spontaneous report as received from a medical assistant refers to a 15-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 04-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M024683 with expiry date on 18-MAY-2016; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1610USA004609.
Hard mass/swelling in left arm with redness at/near injection size (about the size of three fingers) and a "stretching" (sore/numb) sensation upon lifting of the arm.
booster shot side effect; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (booster shot side effect) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (booster shot side effect). At the time of the report, VACCINATION COMPLICATION (booster shot side effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  Treatment information was not provided