chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness and pain in armpit; Fever; Chills; Nausea; Severe achiness; Soreness in arm; Nose bleeds; Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), EPISTAXIS (Nose bleeds), DYSPNOEA (Difficulty breathing), AXILLARY PAIN (soreness and pain in armpit) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm), EPISTAXIS (Nose bleeds), DYSPNOEA (Difficulty breathing), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Severe achiness). On 09-Mar-2021, the patient experienced AXILLARY PAIN (soreness and pain in armpit). On 09-Mar-2021, DYSPNOEA (Difficulty breathing), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Severe achiness) had resolved. At the time of the report, PAIN IN EXTREMITY (Soreness in arm), EPISTAXIS (Nose bleeds), AXILLARY PAIN (soreness and pain in armpit) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
She developed confluent red rash at injection site 11 days after vaccination.    No systemic symptoms.   Rash resolved with topical steroid treatment.
Have not had my period; Severely impacted my menstrual circle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2021 at 16:00 as dose 1, single (Lot number: ER2613) at the age of 35 years, in left arm, on 03May2021 at 16:00 as dose 2, single (Lot number: EW0176), in left arm and on 21Mar2022 at 15:00 as dose 3 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; LAMOTRIGINE; ROSUVASTATIN; OZEMPIC. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 12Apr2021, outcome "not recovered", described as "Have not had my period"; MENSTRUAL DISORDER (non-serious) with onset 12Apr2021, outcome "not recovered", described as "Severely impacted my menstrual circle". The events "have not had my period" and "severely impacted my menstrual circle" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, menstrual disorder.  Additional information :The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination: Wellbutrin, Lamotrigine, Rosuvastatin, Ozempic, NR .Patient have not had period since she got first two doses back in Apr/May of 2021. She is 36 and healthy without any hormonal or reproductive issues, and been checked out by Gynocologist. There is no other explanation other than the vaccine has severely impacted the menstrual cycle. She worries this may be permanent.Device Date was documented as 08May2022.
Itching,redness at site and  4cm firm area Injection was given im.cottec6.part and I rubbed after injection Symptoms of itching lasted 30 hrs. Still javr.redness.and 25 .cent.size swellinh
Fatigue, muscle pain, joint pain, chills, fever 102  Tylenol taken for fever. symptoms lasted 24hrs
facial urticaria - eyelids and cheeks.  lasting 3 weeks.  tx with topical steroids and oral antihistamines
Instance of break thru menstruation - followed by an additional menstruation cycle; Instance of break thru menstruation - followed by an additional menstruation cycle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Jul2021 (Lot number: FA7484) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 01Aug2021 13:15, outcome "unknown" and all described as "Instance of break thru menstruation - followed by an additional menstruation cycle". It was unknown if therapeutic measures were taken as a result of menstrual disorder, menstrual disorder.  Additional information: The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Covid vaccine details: Administration date: Jul2021, Administration time: 12:45 PM. Facility type vaccine Pharmacy or Drug Store Known allergies: none. Other medical history: None  Follow-up attempts are completed. No further information is expected.
3/13 my entire scalp, neck and chest broke out in hives,welts. Treated with Benadryl with minimal relief. 3/14 symptoms worsened and spread, in the evening my tongue tingled. Went to ER and was treated as an allergic reaction. 3/16 went to an allergist as symptoms returned. Was told it was an immune reaction. Treated with Zyrtec, prednisone and as needed Benadryl. 3/30 symptoms still occur sporadically even while medicated.
this was  the second shot - joints ached fever, chills, redness on left forearm which then developed into painful rash and blisters. As of today the 16th of September blisters have popped and pain  is less but still  present. On  Sept 13 doctor prescribed Valacyclovir 1 gram 3 x day for 10 days
Approx 4wks p/inject at injection site arm became red, swollen, & sore no chills or fever; Rx Naprosyn 375mg BID & warm compresses; 1wk later arm spontaneous drained & area cleared;
Reported to Employee Health on 10/22/15 of pain to left arm with abduction since receiving flu shot. Evalutated in Occupational Health. Neurologically refelxes intact, grip strong, but notes decreased pin prick sensation in anterior shoulder and mid deltoid. Prednisone taper pack. If not improved may be referred to neurology or EMG testing.
04/07/2021  I had headaches, diarrhea, muscle aches, fatigue and fever that reached 103. I would cycle through the headaches, fever and diarrhea. The muscle aches and fatigue remained. I went twice to the doctor, I don't remember if any tests were done. I finally worked out of all this in October 2021.
Tongue became numb could not feel anything  and then it was swollen.   Started at 7 pm      I took a Benedryl and let it work, but still had  not gotten much better .  At 10 pm took second 25 mg capsle of Benedryl and went to ER
MISCARRIED WITHIN A WEEK OF HER J&J VACCINE; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer via a company representative via social media concerned a 30 year old female. The patient's height, and weight were not reported. The patient was pregnant at the time of vaccination (gravida 1). The date of the patient's last menstrual period and expected delivery date was not reported. The patient's obstetrician (OB) told her that it was safe to get vaccinated. 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, 1 total administered for prophylactic vaccination (vaccine exposure during pregnancy). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, within a week after vaccination, the patient had miscarriage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy, and the outcome of miscarried within a week of vaccination was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210648705.; Sender's Comments: V0: 20210648176 -Covid-19 vaccine ad26.cov2.s-Miscarriage within a week of her J&J vaccine. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  V0: 20210648176 -Covid-19 vaccine ad26.cov2.s-Vaccine exposure during pregnancy. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Post injection epileptic episode. Approx 10 minutes after receiving first dose of Modern vaccine:  Tonic Clonic, Grand-mal seizure.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. In October 2017, "1 year ago", the patient was vaccinated with a dose of PREVNAR 13 (dose and lot # not reported) and was administered a dose of PNEUMOVAX 23 (Lot # R018741 exp date 06-APR-2020) (dose and route not reported) 23 days earlier than the recommended interval in the prescribing information. No adverse effects were reported.
Withinin24 hours, had trouble breathing, low grade fever, body aches, lethargy.  After 24 hours, the wheezing remained.
A 23 year old student received a single dose of rabies vaccine on November 7, 2007 at 8:15 a.m.  Three hours later presented dizziness, nausea, vomit and abdominal pain.  Patient vital signs were observed for one hour and discharged home in stable condition.  Twelve hours later, she had to be evaluated at the emergency room when she presented generalized urticarial rash and pruritus.  No respiratory distress was referred.
This spontaneous report was received from a registered nurse and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored ZOSTAVAX (lot # K007985, expiration date: 03-SEP-2015, lot # K007987, expiration date: 03-SEP-2015) (dose and route of administration were not reported). No adverse effects were reported. Administered doses of ZOSTAVAX experienced the temperature excursion of -6.5 degrees Celsius for 1 hour and 12 minutes. Data logger was involved. The previous temperature excursions were at -7.4 degrees Celsius for 2 hours and 36 minutes. Since dates of ZOSTAVAX administration were not known, it was unknown whether the vaccines, that at the time of the report (also reported as currently) were expired, were administered to the patients prior to expiry or after expiry (considered as expired vaccine used). Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse affects reported; improperly stored doses of GARDASIL 9 have been administered to the patient on 5/21/2020; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 21-MAY-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1621931, expiration date 26-JAN-2022; strength, dose and route were not reported) for prophylaxis (product storage error). Temperature excursion was 30.2 Fahrenheit degree for 1 hour. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
pt recv vax 28FEB97 & in JUN97 pt exp titers negative;
My forehead felt like it was swelling. Lips were tingling. Took 2 Tylenol. Stayed home and rested. Disappeared in a couple of hours, around 1:30PM. Felt fine thereafter.
Information was received on 25-APR-2017 from a licensed practical nurse who reported that unspecified patient was administered subcutaneously an expiry dose of M-M-R II (lot # M032153, expiration 22-APR-2017) on 25-APR-2017. Medical history, concurrent conditions and concomitant medications were not reported. No adverse effects were reported. No further information was provided. The action taken was not applicable and the outcome was unknown. Additional information has been requested.
HEADACHE; FATIGUE; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805029, and expiry: not reported) dose was not reported, administered on 12-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fatigue. On 12-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, headache, and fatigue. This report was non-serious.
Seen 6 days p/short/rxn; Quarter-size area of hyper-pigmentation @ shot site, surrounded by 3" area of sl red papular rash, which itched; No fever, no systemic signs;
sore arm; fever; Pain in left abdominal; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received the 2nd dose of Shingrix. On 8th August 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, fever and abdominal pain. On an unknown date, the outcome of the injection site pain, fever and abdominal pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever and abdominal pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the left arm and had a sore arm and a fever of 102. While speaking to her on the call, she mentioned she felt a pain in her left abdominal that presented at that moment while we were talking.  The reporter did not consent to follow up. There is discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Very cold fingers/cold ears, right leg and then entire body; Numbness; Tingling fingers; cold ears, right leg and then entire body; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for inection), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 10:00 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization. The patient's medical and concomitant medications were not reported. The patient experienced Very cold fingers, numbness, cold ears, right leg and then entire body and tingling fingers on 24Mar2021 11:00. No treatment was given for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-NOV-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 03-NOV-2015, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was prescribed acyclovir and tramadol for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested
3 red welts at injection site & around (round in nature), hot to touch, & slightly painful. Use Benadryl, hydrocortisone cream, and ice to site.
Headache; Body ache; Fever/chills; Fatigue; Upset stomach; This is a spontaneous report received from a contactable consumer, the patient. A 65-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no. EP6955) via an unspecified route of administration in left arm, on 23Mar2021 at 13:45 hours (at the age of 65-years), as a single dose for COVID-19 immunisation. The patients medical history included high blood pressure and  paroxysmal atrial fibrillation (parox afib). The patient had no allergies to food, medications or other products. The Concomitant medication included chlorthalidone (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) 81 milligram (mg). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no. EN6198) via an unspecified route of administration in left arm, on 02Mar2021 at 09:30 hours, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19. On 24Mar2021 at 02:30 hours, the patient experienced headache, body ache, fever chills, fatigue and stomach upset. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of headache, body ache, fever chills, fatigue and stomach upset were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Started with a body rash on Thursday 4/1/20.  Rash is more on upper chest and Rt ear.  "Big blotches" According to client.  She went to the Urgent Care on 04/04/2021 and was giving medication..Steroid shot, Hydroxyeine HCL 50 mg at night for itching,  Predisone 10 mg daily 3..2..1.. and Famotidine 20 mg 1 daily.  Client states rash is still viable but not as itchy.  It is lighter in color.
Diarrhea began 8 days after.  A Crohn's flare began is still continuing.  I have gone on Entyvio and take 3 packs of Prevalite daily to prevent diarrhea.  Diet has been extremely limited in an attempt to limit diarrhea.  I am gradually increasing variety and amount of fiber.  Other symptoms were pain at injection site, tiredness, headache, achiness for 1 day after first shot and 2-3 after the second vaccine.
Itching, redness, swelling started 10/25 unable to sleep night of 10/25 due to these symptoms - took Motrin
Swollen left supraclavicular lymph nodes began 2/17/21; still present 2/18/21
diagnosed with COVID-19; When got first shot, arm hurt; Felt nauseous; every time he threw up; Couldn't eat after first dose;; When got first shot, was sick; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Couldn't eat after first dose;), ILLNESS (When got first shot, was sick), COVID-19 (diagnosed with COVID-19), VACCINATION SITE PAIN (When got first shot, arm hurt) and NAUSEA (Felt nauseous) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced FEEDING DISORDER (Couldn't eat after first dose;), ILLNESS (When got first shot, was sick), VACCINATION SITE PAIN (When got first shot, arm hurt), NAUSEA (Felt nauseous) and VOMITING (every time he threw up). On 23-Jan-2022, the patient experienced COVID-19 (diagnosed with COVID-19). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, FEEDING DISORDER (Couldn't eat after first dose;), ILLNESS (When got first shot, was sick), VACCINATION SITE PAIN (When got first shot, arm hurt), NAUSEA (Felt nauseous) and VOMITING (every time he threw up) had resolved and COVID-19 (diagnosed with COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2022, Pneumonia: negative (Negative) Negative. On 23-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient visited to hospital on 23-JAN-2022.  No concomitant medication was reported by the reporter.  Company comment: This case concerns a 21-year-old male patient with no medical history reported, who experienced non-serious unexpected AESI of COVID-19, that occurred after the 1st dose of the mRNA-1273 . The exact time to onset was not provided. The rechallenge was not applicable due to nature of the event of COVID-19 and no information on the 2nd dose. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 21-year-old male patient with no medical history reported, who experienced non-serious unexpected AESI of COVID-19, that occurred after the 1st dose of the mRNA-1273 . The exact time to onset was not provided. The rechallenge was not applicable due to nature of the event of COVID-19 and no information on the 2nd dose. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Felt really drowsy and cold, both hands were tingling; that lasted 2 days. There was redness around the shot and then a lump formed under the skin which is still now diminishing weeks later.
Cellulitis to left arm. Keflex 250/5 1.5 tsp BID x10 days.