chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Extremely achy; Rash on leg that flared up again and burned; Rash on leg that flared up again and burned; Felt very feverish; Got very hot; Sweaty; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 20Apr2021 at 17:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. 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 vaccination. Concomitant medications included levonorgestrel (NORTREL) for birth control from unknown date and unknown if its ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 30Mar2021 at 17:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 14:00, the patient experienced chills and couldn't get warm for about 4 hours. On 21Apr2021, the patient was extremely achy and had a rash on leg that hadn't bothered for several days and again had a flare up and burned. The patient finally was able to warm up but felt very feverish and then got very hot and sweaty. The patient felt much better by 20:00. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, extremely achy, rash on leg that flared up again and burned, feverish, got very hot and sweaty was recovered on 21Apr2021 at 20:00.   No follow-up attempts are needed. No further information is expected.
atient called Re: symptoms she is having after she received her 2nd COVID vaccine. Patient received 2nd shot of Moderna vaccine 02/16/2021. Patient could not give a specific time frame for when symptoms started but states that "she knows it was after her 2nd COVID vaccine." Patient c/o pain across the back of her shoulder blades, hair loss and numbness in left thigh, swollen left ankle and calf.  Patient states that she "has had left ankle swelling in the past but not to this extent." Patient states that  she has appt with dermatologist on 03/24/2021 and that she has appt with her primary care doctor in May but that she is going to call and get appt moved to a sooner time. Advised patient that I would complete a VAERS report. Encouraged patient to F/U up with doctors as scheduled.
1 previous pregnancy with living child born Jan 2020 Current pregnancy during vaccination, due date 9/25
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 9:01 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient 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.   Age of patient was reported as 71.62 for dose administered on 27-Oct-2021.  No concomitant medications were reported.  Batch number 035C21A underwent temperature excursion on 27-Oct-2021 with temperature 29 degrees Fahrenheit at 09:00 AM, 32 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 29-Sep-2021, 05-Oct-2021 and beyond use date for the vial was reported as 29-Oct-2021, 04-Nov-2021. Product moved to clinic on 27-Oct-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
expired dose of pentacel administered to a patient with no reported adverse event; Initial information received on 02-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 9-month-old male patient who administered expired dose of pentacel with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Immunisation.  On 25-May-2022, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine unknown: strength and formulation, lot UJ465AA, expiry date: 21-MAY-2022, frequency: once, via intramuscular route in the left thigh as immunization.  On 25-MAY-2022 the patient developed a non-serious event expired dose of pentacel administered to a patient with no reported adverse event (expired product administered) latency: same day following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  At time of reporting, the outcome was Unknown for the event expired product administered.    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 the guidelines. 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.
The vaccine was administered by pharmacist at my workplace.  On July 19th, while doing some light gardening chores, my left arm suddenly got numb. From my neck down to my fingers. It lasted for more than 30 mins. I cant stretch my arm and I cant move it. When I tried to move it using my right arm, it goes back to its previous position as soon as I let it go. Sometime in August it happened again. The same experience that lasted for about 10 mins while I was driving.  On November 18th, while I was driving I had this chest tightness that turned to chest pain. It lasted for about 10 mins.
Patient under 18 years of age was given Moderna vaccine.  Patient presented to clinic with father, requested vaccine.  Vaccine questionnaire reviewed, age was not acknowledged and vaccine administered by medical assistant.
large area of erythema, induration lt shoulder started 5/18/99;seen in office 5/21/99;sx resolving slowly
PFIZER COVID 19 VACCINE LOT FL8095 (PEDIATRIC DOSES) 0.2 ML DOSE WAS GIVEN TO PATIENT WHO IS 13 YEARS OLD NO ADVERSE EVENT ARE PRESENT ON PATIENT
Patient presented to emergency department on 11/15/2021 with shortness of breath and was found to be COVID-19 positive. He was treated with dexamethasone and remdesivir. He required 6L of oxygen and intermittent use of BIPAP.  He was discharged home on 12/31/2021 with home health care.
Four hours after the shot I had a fever, slept for more than 12 hours and I had a rash on my arm from where the shot was given  to my elbow.  It took a week for the rash to go away. Then in October 2021, I tested positive for COVID-19. I lost my sense of taste and smell and it has not went back to normal since I contracted COVID-19.
PT'S FAINTED WITHIN ~ 1 MINUTE AFTER ADMINISTRATING VACCINE, FOUND ON THE FLOOR IN PRONE POSITION (FACE DOWN). IMMEDIATELY WENT TO PT'S ASKED  HER IF SHE CAN HEAR ME, CHECK HER PULSE FOR RESPONSE, PT'S RESPONDED WITHIN FEW SECONDS, ASKED PT'S HOW SHE IS FEELING, WHAT IS HAPPENING TO HER, PT'S WANTED TO SIT UP AGAINST THE WALL FOR SUPPORT, HELPED HER GET UP SLOWLY TO SIT UP AGAINST THE WALL, PT'S SAID WAS OKAY TO SIT AGAINST THE WALL, ASKED IF WANTS ME TO CALL 911, PT'S SAID NO AND PT'S WANTED TO CALL HER MOM (MOM IS PHARMACIST), PT'S FAINTED AGAIN IN FORNT OF ME, HELPED HER LAYDOWN, WITHIN FEW SECOND PT'S RESPONDED, ASKED PT'S IF SHE FELT ANY SWELLING ON HER TONGUE OR MOUTH, PT'S SAID NO, PT'S FELT LIGHT HEADED BUT SAID WAS GETTING BETTER, ASKED HER IF SHE CAN AND WANTED TO TAKE DIPHENHYDRAMINE 25 MG CAPSULE, PT'S WAS OKAY TO TAKE DIPHENHYDRAMINE 25 MG CAPSULE (EXPIRATION: 01/2023, LOT #194300), TOOK DIPHENHYDRAMINE 25MG CAPSULE @ ~ 1300. CHECKED PT'S BLOOD PRESSURE @ ~ 1305 88/53 MMHG, PULSE 59/MIN WHILE SITTING DOWN, ASKED PT'S TO LAY DOWN ON THE FLOOR (PROVIDED SLEEPING MATT) WITH HER LEGS/ FEET ELAVATING ON CHAIR FOR BETTER BLOOD CIRCULATION, PT'S UNDER MY WATCH THE ENTIRE TIME. PT'S CALLED HER MOM AND EXPLAINED HER SITUATION WHILE PUTTING PHONE ON SPEAKER, WHILE I LISTEN TO HER CONVERSATION AND HELP HER. CHECKED BP AGAIN @ ~ 1310 WHILE PT'S LAYING DOWN BP: 94/61, PULSE 67/MIN, ~@ 1325 BP: 95/72, PULSE 62/MIN, ~@ 1330 BP: 101/72, PULSE 63/MIN, ~@ 1340 BP: 102/72, PULSE 63/MIN. PT'S BP GETTING BETTER, BACK TOWARDS NORMAL. ASKED PT'S IF SHE GOT INJURED, PT'S SAID NO SHE DID NOT GOT INJURED. PT'S MOM ARRIVED @ ~1345 EXPLAINED HER SITUATION AGAIN, ASKED HER IF SHE HAS ANY QUESTION OR CONCERN, MOM HAD NO QUESTION. MOM WAS AWARE OF THE COMMON SYNCOPE EFFECTS IN ADOLSCENTS AGE 12 TO 18 YEARS OLD. MOM HELP PT'S GET UP FROM THE FLOOR, PT'S SIT ON THE FLOOR FEW MINS AND PT'S LEFT WITH THE MOM FROM THE PHARMACY @ ~ 1350. THROUGH OUT I (PHARMACIST) WAS PRESENT WITH/ ARROUND PT'S CHECKING ON HER AND AKSED HER IF SHE WANTED TO CALL 911. PT'S ACTIVELY TALKING TO ME THROUGH OUT AFTER HER SECOND FAINT. WHEN PT'S LEFT FROM PHARMACY WITH MOM, PT'S WAS FINE TO LEAVE THE PHARMACY WITH HER MOM @ ` 1350.
Post injection patient experienced cold sweats and fainted. EMS contacted and physicians came to give medical attention. Patient transported to the emergency department.
Information has been received from a physician via a company representative referring to a 73 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, lot #, expiration date and route not reported) at a pharmacy. On 01-JUL-2016, the patient went to the physician's office and was diagnosed with a case of the shingles. The outcome of the event was unknown. The causality between ZOSTAVAX and the event was not provided. Additional information has been requested.
(vaccine was only 4 weeks after prevnar 13 but was necessary for protection for an upcoming procedure per mom, and therefore by DRs precription) Pt was vaccinated at 3:20pm and mom called the pharmacy at about 6pm stating the vaccination site had swollen to about the size of her fist, was warm to the touch, and that the patient could not lift his arm much.  Recommended ibuprofen/acetaminophen and cold compress as well as monitoring.  mom said there was no sign (yet) of any systemic reaction.
redness, swelling, and warmth as well as itching in R arm near injection site 3inches by 1.5 inches in size
Summary web report received by the Health Department. Patient presented to ER 9/3/201 with complaints of increasing shortness of breath. Symptoms started approximately 13 days ago: Shortness of breath, non-productive cough, nausea, diarrhea and stated he had a fever, but did not take temperature at home. He was not vaccinated prior to symptom onset. Received 1st Pfizer on 8/31/2021. Patient's pulse ox was 70% on room air and attained 94% on 10 L. heart rate of 117 and a temp of 100.1 degrees. Respiratory exam was significant for decreased breath sounds bi laterally without retractions. EKG was done on patient's arrival in the ER and showed sinus tachycardia with a heart rate of 112 and no significant ST segment abnormalities, no evidence of an ST segment elevation MI, and a normal QT interval. Cardiac monitor revealed no arrhythmias. Chest x-ray did show diffuse bilateral ground glass opacities suggesting pneumonia. CBC was unremarkable. CMP was significant for mildly elevated glucose of 290 with a normal bicarb. Cardiac enzymes were negative.   D-dimer done for a pulmonary embolus and was significantly elevated at 2090. CT of the chest showed no evidence of a pulmonary embolus. Revealed extensive bilateral ground glass opacities. Chest x-ray did show extensive infiltrates bilaterally. Patient was given Decadron for presumed COVID-19 pneumonia with no significant change in symptoms. The patient was given Tessalon for cough. The patient was given Rocephin and doxycycline for treatment of pneumonia pending COVID-19 test. The patient was placed on the RT protocol and was given a DuoNeb treatment without significant change in his symptoms. Symptoms of 10 day history of cough, transient loss of taste and smell were deemed highly suspect of COVID-19 pneumonia. Patient was admitted to the Hospital on Covid-19 protocols. Patient was given albuterol nebulizer treatment, Tessalon Perle, and dose of p.o. doxycycline and ceftriaxone. 9/4/2021 Patient shortness of breath increased and patient oxygenation's saturation getting worse, frequent desaturation, was on BiPAP. Patient was transferred to ICU. Health department does not have any further information. Please contact Hospital.
Pt experienced shoulder pain 2 days after getting vaccine that is still unresolved. Pt describes not being able to sleep on that shoulder.
Shot given 11/12/06 at 12:20 pm, by 8pm arm swollen by 11/14/06. Red arm swelling, chills, fever and achiness went to primary doctor. Doctor gave antibiotics and Benadryl.
This spontaneous case received, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 37-year-old, adult female patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252227 and expiry date: 31-May-2019] which underwent temperature excursion. The patient did not experience any adverse reactions after the vaccination. The reporter assessed this case as non-serious. Follow-up report received from other health professional on 28-Nov-2018: The age of the patient (37-year-old), route of administration (intramuscular), anatomical location (left deltoid) of suspect vaccine were added. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment was amended accordingly.
Left Thigh noted to get red, swollen & splotchy in the evenings since Vaccine given - looks fine in the AM, when this is noted he states that entire thigh is itchy.  playing and acting fine.  afebrile
This is a spontaneous report from a contactable physician Pfizer via a sales representative. A patient of unspecified age and gender received first dose of PREVNAR 13 (lot number and expiration date were not reported), via an unspecified route of administration on 17Oct2018 at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient came back 2 days (unspecified date in 2018) later with reaction- redness, swelling below injection site. The outcome of the events was unknown. Information on the batch number has been requested.
This spontaneous report was received from a registered nurse regarding a patient of an unknown age. Information on the patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 17-SEP-2018, the patient was vaccinated with M-M-R II that was reconstituted with expired sterile diluent (lot# M009800, expiration date: 12-SEP-2018) for prophylaxis. No adverse effects was reported. There was no product quality complaint. Sender's Comments: US-009507513-1901USA009966: US-009507513-1901USA009967: US-009507513-1901USA009968.
pt described pain and numbness at entire left side of body post vaccination. Pt was seen in ED (acquiring records still). At most recent visit (for 2nd injection), pt able to move Left side of body, but she says there is decreased sensation, etc.
20 hours after receiving the vaccine I felt very dizzy and nauseous for a moment and then fainted and was unconscious for a minute. I had developed a fever about 8 hours after receiving the vaccine, but by the time I fainted the fever was pretty much gone.
the arm was really tender; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (the arm was really tender) in a 90-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (the arm was really tender). At the time of the report, TENDERNESS (the arm was really tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
I started bleeding from my vagina 5 days after getting the Pfizer shot. My period is almost exact to the day & has been for a loooooong time. I will not be getting the 2nd.
Fever, fatigue, red enflamed circle around injection sites very hot to touch tissue and flesh hard and swollen up. We are four days out and it is still swollen red hot to touch bruised swollen and hard.
headache [after second dose] for a couple hours; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache [after second dose] for a couple hours) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020821A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEADACHE (headache [after second dose] for a couple hours). In March 2021, HEADACHE (headache [after second dose] for a couple hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment medication were reported   This case was linked to MOD-2021-400113 (Patient Link).
Breakthrough case admission after four vaccines Moderna 2/24/21 Lot# 010A21A;  Moderna 3/24/21 Lot# 017B21A; Moderna 10/27/21 Lot# 041C21A;  Moderna 7/11/22 Lot# 038A22A
Patient had gone into cardiac arrest two days later, mom was breastfeeding and baby went blue and stopped breathing, treated in intensive care unit for over 1 month, outcome with poor tone with neurological impairment.
WORSE SIDE EFFECTS AND FOR A LONGER PERIOD OF TIME; REALLY SICK FOR A WEEK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced worse side effects and for a longer period of time, and really sick for a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the worse side effects and for a longer period of time and really sick for a week was not reported. This report was non-serious.
Presented with worsening cough, chest congestion and shortness of breath for 3 days. Admitted for COVID-19 pna; was treated with steroids, antibiotics, O2. Weaned to RA for dc home.
Presented to the Clinic on 7/31/06 with c/o rash on back, fever and fatigue times 2 days. Rash is painful and itchy. Pustular inflammatory eruption on back. Diagnosed as cystic acne vs smallpox vaccine complication vs follucilitis dermatitis. Orders given for Keflex and recheck at SRC shot room in 24-48 hours.
Pt with known history of severe asthma, tolerated first vaccine well.  Second shot given this am, stable after 30 min observation period.  Returned ten minutes later with chest tightness and sob c/w asthma exacerbation, taken to ED
Within hours after receiving the vaccine patient became fussy and irritable, he seemed tired and fell asleep earlier than usual. Over the next three days he showed significant signs of neurological changes such as decreased eye contact, decreased response to verbal/ tactile/ and visual stimuli, decreased cooing/ babbling; stopped smiling, and slept more than usual. Neurological symptoms lessened after 3-4 days but some symptoms persisted for over a week. Parents noted changes in bowel movements, specifically decreased bowel movement frequency from 4+ bowel movements a day to 2 or fewer per day for a period of 4 days. In the weeks following vaccination, patient developed an eczema rash over his entire body, which took approximately 3 months to clear up. No medications or other treatments were offered to treat symptoms.