chrisvoncsefalvay/vaers-outcomes huggingface dataset:
burning sensation on skin; red spots; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (burning sensation on skin) and RASH ERYTHEMATOUS (red spots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 SKIN BURNING SENSATION (burning sensation on skin) and RASH ERYTHEMATOUS (red spots). At the time of the report, SKIN BURNING SENSATION (burning sensation on skin) outcome was unknown and RASH ERYTHEMATOUS (red spots) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient took "some unidentified text" and it cleared up.   Reporter did not allow further contact
States 15 minutes after administration of vaccine, mouth began to feel numb & tingly; lasted about 1 hour.  Headache then started at back of head & aching down entire spine.  Shortly after, began to feel nauseous & vomited.  Felt fine at 4:15pm.
Fever of 100-102 for 4-5 days, refusal to eat, ended up in a rash on day 5.
This spontaneous report was received from a healthcare worker refers to multiple unknown patients of unknown age and gender. Medical history, concurrent conditions and concomitant medication were not reported. On multiple unknown dates, patients were vaccinated with improperly stored (temperature: 1.3C, for 1 hour and 30 minutes, because of a "data logger") PNEUMOVAX 23 (Pre-Filled Syringes), lot # M005287, exp: 08-OCT-2017; lot # M000592, exp: 12-OCT-2017, (dose and frequency not reported). No adverse effects were reported. No previous temperature excursion was reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Approximately 10 mins post vaccination, patient experienced vertigo, diaphoresis and decreased mental status. Evaluated by staff and found to be diaphoretic, hypotensive and tachycardia. Patient observed and recovered with no further intervention. Discharged home 45 mins later. Also evaluated by EMS.
No additional AE reported; a dose of VAQTA was inadvertently administered after its labeled expiry date; This spontaneous report as received from a registered nurse referring to a 64-year-old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On 21-JAN-2021, the patient was inadvertently vaccinated with hepatitis a vaccine, inactivated(VAQTA) 50U/1.0 ml (lot # S036494, expiration date not reported, upon internal validation established as 09-JAN-2021, 1 dosage form) after its labeled expiry date for prophylaxis (expired product administered). There were no known temperature excursions on the involved vaccine. No adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036494; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Bells Palsy L side of face- sx began 11/06/09 question if related to vaccine, labs drawn, CBC, Lyme titer. Sx somewhat better 11/9/09. Not recovered as of yet.11/12/2009 PCP record for 11/9/2009, patient with c/o's "face not working right, lop-sided smile and lt eyelid droop and lt eye slow to close. Tx: Medrol dose pak, Dx Bell's Palsy
This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 7, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1ZM20A) for COVID-19 vaccination. The patient's past medical history included Spontaneous abortion (x5) and Pregnancy (live-full term birth). Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs allergy), Allergy (Allergy to bees) and Illness (Not feeling well due to pregnancy). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, PROGESTERONE for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 29-Nov-2020 and the estimated date of delivery was 12-Sep-2021. On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy. On 13-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound foetal: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Treatment information was provided. 07-Jan-2021: pregnancy test results positive She had to do IVS and had 5 miscarriages, unexplained where it was natural. Company Comment : This case involves a 34 year old pregnant female with LMP of 19 Nov 2021 and EDC of 13 Sep 2021 who received the mRNA-1273 on 13 Jan 2021. The causality for the event Maternal exposure during pregnancy is Not applicable. Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Internal review on 29-Jul-2021 resulted to updated number of pregnancy, medical history, birth type and fetal outcome, event dates and outcome, new event and narrative.; Sender's Comments: This case involves a 34 year old pregnant female with LMP of 19 Nov 2021 and EDC of 13 Sep 2021 who received the mRNA-1273 on 13 Jan 2021. The causality for the event Maternal exposure during pregnancy is Not applicable.
Back pain, neck pain, neck tightness leading to headache and throbbing pain in the back of head since the 2nd dose of covid vaccine  on 11/6/2021.
Fever: 104 degrees, disoriented, chills. Treatment: taken to Urgent Care and administered Tylenol and Motrin regimen, also cold compress and chilled bath.
?Covid arm? spider bite spot appeared 1 1/2 weeks after shot.  Area size of silver dollar was hard, inflamed, red, itchy, painful.  Felt sick all over again as I had following the shot itself.  Lasted 4 days.
feel nauseous.; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2021, the patient received Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient received Shingrix vaccine three days ago and felt nauseous. The follow-up could not be possible as no contact details were available.
Rash noted on right side of back from beneath the bra line to slightly below the waist.
Pt developed a temperature of 105F, reported by mom. Did not call healthcare provider and was not seen by physician. Seen by physician on 5/15/01 for high fever, cold and ear pain. Physician's note red "since 4/20/01 treated with 3 different antibiotics with no effective relief. Still crying a lot."
Arm tenderness; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 26Jul2021 at 10:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included vertigo and COVID-19. Concomitant medications taken within two weeks of vaccination were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Jul2021 at 16:00, the patient experienced arm tenderness, headache and fatigue. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events arm tenderness, headache and fatigue was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
PATIENT DEVELOPED EFFORT INTOLERANCE, CHEST PAIN, PALPITATIONS.
Information has been received from a  RN concerning a  39 month old female who  on 04/15/03 was vaccinated with a dose of varicella virus vaccine live. Subsequently on 03/04/2005  the pt presented with a 6 chicken pox like lesions on her face and neck. Unspecified medical attention was sought. At the time of this report the pt was recovering. No further information was available. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2005. Information has been received from a registered nurse concerning a39-month-old female child with an allergy to AMOXICILLIN who on 15-APR-2003 was vaccinated subcutaneously in the right thigh with her first dose of VARIVAX (Merck) (lot# 643925/0936X). Concomitant vaccination given on that same day included the fourth dose of PREVNAR (lot # 490896) given intramuscularly in her left thigh. There was no illness at the time of vaccination. Subsequently, on 04-MAR-2005, the patient presented to the physician's office with about 6 chickenpox-like lesions on her face and neck. There was no report of a fever. No laboratory or diagnostic studies were performed. The patient was sent home on PO BENADRYL for itching. The patient recovered as of 06-MAR-2005. No product quality complaint was involved. Additional information is not expected.
Got vaccine 5 days ago (1/7), fever since 11Jan; Second dose on day 24; This is a spontaneous report from a contactable pharmacist reporting for himself. A 25-years-old male patient received the second dose of bnt162b2 (BNT162B2) vaccine, in the left arm on 07Jan2021 18:00 at single dose for Covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  The patient received the first dose of BNT vaccine on 14Dec2020. The patient  got vaccine 5 days ago (1/7), fever since 11Jan  on 11Jan2021 with outcome of not recovered. The patient received the second dose on day 24.   The patient underwent lab tests and procedures which included body temperature: 100.3°F   on 12Jan2021.  Information about lot/batch number has been requested.
Started with fever and rash. I've had a consistent rash and malaise in various stages since the vaccine. Initial fever from 1st vaccine lasted 36 hours. 2nd dose fever lasted 72 hours. I've had to take methylpredisolone for the rash. Tonight, my fever and rash are back and I figured it was worth reporting. Anytime my stress level spikes, I get sick. This did not happen prior to the vaccine.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and/or zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. As a direct and proximate result of patient' use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Left upper arm with swelling - pain- Developed hives after cold  compress (Pt gets hives with cold exposure)
Tingling on tongue, lips, and throat a few hours after the vaccination and. Muscle spasms in legs started later that night. Symptoms constantly coming and going. Going to seek medical attention.
Flush feeling, and increased heart rate that last 5-7 minutes. Started about 5 minutes after the covid vaccine.
Flublok was given to 6 months old patient with no reported adverse event; Initial information received on 31-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old and unknown gender patient where Flublok was given to 6 months old patient with no reported adverse event while receiving vaccine influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrivalent recombinant vaccine in unknown administration site (dose, frequency, route, formulation, strength, lot/batch number and expiration date and indication: not provided) as immunization.  On an unknown date the Flublok was given to 6 months old patient with no reported adverse event (product administered to patient of inappropriate age) (unknown latency) following the administration of influenza quadrivalent recombinant vaccine.  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event inappropriate age at vaccine administration with no reported adverse event.  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 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.; Sender's Comments:  01435784:
1-2 hr p/vax whelps w/erythema;tx w/DPH & Celentoni;
Patient received Janssen COVID-19 vaccine on 6/25/21. Patient stated that on 6/29/21, he biked to work and after arriving, his wife had to come pick him up and take him home due to dizziness. Beginning on either 6/30/21 or 7/1/21, patient stated that he began having morning vomiting that would then go away each day and that at the time of his contacting the pharmacy, on 7/7/21, this morning vomiting still persisted. Recommended that the patient go to urgent care to see a physician, but patient declined recommendation.
Chest pain and pressure lasting for more than one hour. Pain subsided .  Pain recurred on March 18 and lasted through the night.  Dr was consulted after this episode.   Dr prescribed protonix 1 tab QD
Rash beginning on 6/10/05, fever 101.8F beginning 6/11/05, diarrhea, moderate vomiting, coryza, occasional cough.
left arm hurting; some headache.; started taking cefuroxime, for urinary infection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (left arm hurting), HEADACHE (some headache.) and URINARY TRACT INFECTION (started taking cefuroxime, for urinary infection) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Diabetes. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and FISH OIL for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced URINARY TRACT INFECTION (started taking cefuroxime, for urinary infection). On an unknown date, the patient experienced PAIN (left arm hurting) and HEADACHE (some headache.). At the time of the report, PAIN (left arm hurting), HEADACHE (some headache.) and URINARY TRACT INFECTION (started taking cefuroxime, for urinary infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was included Cefuroxime
CP OF CHEST PAIN X 4 DAYS.  PT WAS TRANSFERED TO MEDICAL CENTER. 2/25/08-records received for DOS 12/19-12/21/07DX: Post small pox vaccine myopericarditis. Chest pain, EKG changes, elevated Troponin. Presented to ED with 4 day history of chest pain. No cough, vomiting or diarrhea.  02/02/2010 Patient recieved smallpox inoculation. Developed myopericarditis. Still recovering. Following up with the vaccine healthcenter.
Severe pain in upper right quadrant extending to spine upon going to a sitting position or turning.  Pain not so bad when walking.  Started 2 days after flu vaccine.  Feeling of fullness like a balloon inside.  2 days earlier rash, possible shingles.
Initial unsolicited report received from a consumer (patient's parent) on 25 July 2015. A male child patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of Meningococcal vaccine (batch number, route of administration and site of administration were not reported) on an unspecified date. On an unspecified date, two days later the patient died of viral meningoencephalitis. Laboratory investigations and corrective treatments were not reported. Documents held by sender: none.
Chills, T99.8, headache, nausea, stomach pain About 11:45 1/6/21 above s/s awoke me and continued throughout night. T97.4 about 9am, no chills, other symptoms remained but milder. No treatment other than increased hydration.
He had pain in his leg, it was slightly red and swollen. He would not bear weight on it for 3 days or would cry in pain if tried to stand on it. Mom thinks it was his right leg.
fussy & crying for 3hr, leg swollen & painful, t104;mom stated started about 2PM, was given APAP & motrin;630PM took pt to hosp ER given Motrin, cold compress to leg
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients. No patient information or product information available.  It was unknown if the patient received any other vaccines prior to 4 weeks of COVID-19 vaccine.  Treatment details were not reported by the reporter.  This case was considered for 18th adult patient out of 40 adult patients who were received expired bivalent dose of moderna.
No adverse event; patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) in a 91-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD).    No relevant concomitant medications were reported.  No treatment information was provided.
Fever 101.5, chills. Aches, cough, and the worst headache ever. Still have slight fever and no taste or smell slight cough. 4 days later. They said that is a    " mild reaction". I lost more weight than when I had covid. 5 pounds in 4 days.
On 9/25/05 increased temp and rash. Tx: Acyclovir 200/5 1/2 tsp qid x 5 days.
Headache, Myalgia, Fever, Neck swelling, Axillary swelling and tenderness, Fatigue Narrative:
I experienced a raw, oozing, very painful blister about the size of a pinto bean located approximately 1 inch from the outside radius of my injection site. Regarding the injection site itself, it was about the size of a plum and became raised/bumpy with what appeared to be extremely tiny papules.
Fever 101 initially with nausea, severe headache, muscle pain. Fever elevated to 103 with chills on 10/18/14 with tennis ball sized reddened, raised, hot to touch. Treated with anti fever medications. 10/19/14 continued with fever up to 103, chills, headache, muscle aches. 10/20/14 to 10/23/14 some improvement in symptoms, but continues with chills, fatigue, headache, and muscle pain. unable to attend school. Flu vaccine was given on same day. Reddened area was to site of Pneumovax 23.