chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 2:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 2:11 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 73.56.  No concomitant medications were reported.  Batch number 025L20A administered on 07-Jan-2021 underwent temperature excursion with temperature range 34 degrees Fahrenheit from 09:00 AM to 10:00AM. This vial was moved to fridge on 05-Jan-2021 and beyond use date for the vial was reported as 27-Jan-2021. Product moved to clinic on 07-Jan-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).
stiff sore joints, sweating of joints, hands, feet; fever lasted approx 2 1/2 wks;
Toxoplasmosis; Herpes simplex 1; Vaccine exposure during pregnancy; This is a serious observational study case, initially received from other health professional on 11-Jun-2019, concerning a 33-year-old, adult female pregnant subject of body weight: 151.5 lbs, height: 68.8 inches and body mass index (BMI): 22.5, enrolled in a prospective observational study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine during pregnancy.   The subject did not have any previous pregnancy. On an unknown date, the subject's family history of major congenital malformation was collected, and the subject had no maternal or paternal history with major congenital malformations. The subject's current condition included fibroadenomas of breast. The subject's concomitant medications included vitamin B6, Prenatal Plus (minerals NOS, vitamins NOS), calcium and vitamin D3; all as a supplement.  The subject's last menstrual period (LMP) date was 26-Dec-2018. The type of pregnancy was singleton. The subject did not consume alcohol, tobacco and illicit-drugs during pregnancy.   On 18-Feb-2019, approximately at gestational age of 7 weeks, the subject was administered Flu Vaccine Egg Split QIV CSL (influenza Vaccine, batch number: YF41608, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On the same day, after vaccination, the subject noticed to have herpes simplex 1 and toxoplasmosis. On the same day of vaccination, the subject underwent ultrasound scan and no major congenital malformations were noted.   On 07-Mar-2019, the subject underwent ultrasound scan, non-invasive prenatal testing and no major congenital malformations were noted. On 22-Apr-2019, the subject underwent (maternal serum alpha-fetoprotein screening) MSAFP/serum marker test and no major congenital malformation were noted.   The outcome of all the events was not recovered.  The subject's estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were reported as 02-Oct-2019.; Reporter's Comments: A 33-year-old pregnant female patient had diagnosis of toxoplasmosis and herpes simplex type 1 on the same day after vaccination with Flu Vaccine Egg Split QIV CSL. Considering the infectious aetiologies of the events and inactivated nature of the vaccine, the causality assessed as not related to suspect vaccine. The event vaccine exposure during pregnancy was assessed as not related to suspect vaccine due to intended use of the vaccine. The company assessed the case as serious (medically significant).
1) MAJOR RIGHT ARM PAIN 2) PARALYSIS OF RIGHT AR 3) WAITING FOR MRI RESULTS
Narrative: COVID infection following completion of COVID vaccine series 03/09/21 COVID vaccine dose # 1 03/31/21 COVID vaccine dose #2 07/30/21 Pt calls and reports testing COVID POSITIVE 7/29; reports cough and loss of taste/smell 08/03/21 Rx given for zinc, DM/guaifenesin, vitamin C 08/05/21 Pt reports loss of taste/smell resolved
Headache; Body-ache; Redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of headache in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th December 2019, the patient received the 1st dose of Shingrix (intramuscular). In December 2019, less than a week after receiving Shingrix, the patient experienced headache, general body pain and injection site erythema. On an unknown date, the outcome of the headache, general body pain and injection site erythema were unknown.   It was unknown if the reporter considered the headache, general body pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The reporter stated that, after vaccination with dose of Shingrix, the patient had headache, body-ache and redness at injection site. The reporter did not consent to follow up. This case has been linked with case US2019224139 reported by same reporter.
03/02/23 presents to ED for "palpitations, shortness of breath". PMHx of " htn, asthma, atrial firbillation on eliquis, DM, NICM EF 20%, s/p AICD"
Patient told administering RN that she thought her throat was feeling a little tight. 11:05 = B/P 140/104, P 112, Benadryl 25 mg po. 11:08 = O2 mask @ 8 L; 11:14 B/P 145/90, P 100, Epinephrine 0.3ml IM; 11:26 B/P 182/90, P 100, NS 1000 IV started by paramedics. Color remained pink, no palor, no diaphoresis, skin warm to touch throughout. She was transported to Medical Center by paramedics per protocol. No loss of consciousness. She returned to the health center on 10/07/13. The vaccine was administered in a seasonal flu clinic provided by the employer. She had been notified to inform us immediately on return to work, but she did not return until 10/07 BUT she did return to work on 10/02/13. She stated that she had no exacerbation of her symptoms at the hospital. She was given Rx for Prednisone and an Epi pen. She was released to return to work by the ER MD on 10/02/2013. She was released from the ER on the same afternoon, spending approximately 4 hours there.
Fainting episode after HPV vaccination on 7/10/13 at approx 2 PM. Patient out for approx 15 sec. Eased to floor with 2 nurses present and patients mother. Sat for approx 5 min and was able to stand independently.
Day 1 & 2 (Feb 3-4): vomiting, fever, diarrhea, nausea, fatigue, sore muscles, pain in the injection site Day 3-8 (Feb 5-10): no symptoms  Day 9 (Feb 11): redness, swelling, itching at the site of injection
He already have his first 2 doses and 1st booster dose however he is still got Covid/being positive with Covid; He already have his first 2 doses and 1st booster dose however he is still got Covid/being positive with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He already have his first 2 doses and 1st booster dose however he is still got Covid/being positive with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he is asking for the best time he can get his 2nd booster dose after being positive with Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red itchy rash on upper left arm  at injection site, lasting approximately 3 days.  Started as just itchy with  small raised bumps that grew to about 5 inches long by 2 inches wide.  I rubbed Benadryl cream on the rash twice daily until it went away.
The next morning after the vaccine my arm at the injection site was swollen to about 2" across and about .5" tall,  I felt very queasy and sluggish the whole next day which diminished by that next day and the swelling diminished within the next 3 days.
This spontaneous report as received from a pharmacy technician concerning a currently 2 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 13-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot # J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
pt admitted to hosp with SOB that's been increasing over past 5 days; on 4L O2 via NC at home; positive test for COVID; pt experienced Atrial flutter/RVR and was found to be positive for C.Diff; pt requested comfort measures; he expired in the hosp
Per patient's daughter-   Patient presented to the ED on 10/8/23 and was discharged with a prescription for Keflex. He presented to ED again the next day and was admitted. The patient was found to have developed Autoimmune Hemolytic Anemia secondary to vaccine and passed away on 10/12/23. Prior to this Moderna vaccine, the patient had received 5 Pfizer Covid vaccines and opted to receive Moderna as that was the vaccine in stock at the time.
beneficial side effect; pain due to inflammation disappeared; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (beneficial side effect) and INFLAMMATORY PAIN (pain due to inflammation disappeared) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (beneficial side effect) and INFLAMMATORY PAIN (pain due to inflammation disappeared). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (beneficial side effect) outcome was unknown and INFLAMMATORY PAIN (pain due to inflammation disappeared) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided.
Pain at injection site - swelling of lymph nodes. Saw private M.D. who treated with KEFLEX and without improvement. Pt went to ER and was admitted.
I've had nerve pain before the vaccine, but starting 1 or 2 days later after receiving it, the nerve pain in my face and head got remarkably worse. It was to a degree that I never had before. I wasn't able to sleep, and it was really bad. That lasted for about a week. The nerve pain has lessened, but it is still higher since getting the booster. I am not fully recovered from it. At the end of the December 2021 I had went to my endocrinologist appointment. My prediabetes I had is now diabetes at 8.4 for my A1C. I was prescribed metformin 500mg 2xday which is now increased to 1000mg 2xday. My cholesterol was also high so they prescribed atorvastatin 10mg 1xday. They also added on Jardiance 25mg 1xday. My diabetes is under control now..
Rash, itching, used Aveeno anti-itch topically. Rash/itching on trunk, legs, arms, face. PHN observed rash. Referred to Urgent Care. Denies swelling, SOB or redness at site.
This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 23rd January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd January 2019, 6 hrs after receiving SHINGRIX, the patient experienced joint pain and shivering. On an unknown date, the outcome of the joint pain and shivering were not recovered/not resolved. The reporter considered the joint pain and shivering to be related to SHINGRIX. Additional details were reported as follows: The patient stated she started to experience joint pain and shivering 6 to 7 hours after the vaccination. The reporter did not consent to follow up. The lot number and expiration date were unknown by the patient.
cellulitis at/around injection site with swelling and erythema txd with Keflex 500 BID x 14 days
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient was not taken any other medications/products within 2 weeks of starting COVID-19 treatment. Previously the patient was taken COVID-19 Vaccine.  No follow-up attempts are possible. No further information is expected.
This retrospective pregnancy case was reported by a consumer and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female subject who was vaccinated with influenza vaccine (manufactured unspecified). A physician or other health care professional has not verified this report. In fall 2009, the subject received unspecified dose of Influenza vaccine (unknown route and injection site; lot number not provided). The subject's last menstrual period was on unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during unknown trimester. On unspecified date, after unknown weeks of gestation, the subject gave birth to a live infant with no congenital anomaly, by unspecified delivery method. This is 1 of the 2 cases reported for the same subject.
On 01/31/2001 the patient developed a mild case of chicken pox with less than 20 lesions. No other symptoms were present. The patient sought medical attention at a physician's office. On an unspecified date the patient recovered. It was also reported that the patient's sibling received varicella virus vaccine live and at 14 months of age, and experienced a similar adverse event. No further information is expected.
Daughter has adverse reaction to Gardasil, she has had continuous fever 104 07/10/09 nausea Dr thought might be strep, however strep test negative.  Continues to have high fever, no appetite, sore throat, cough.
-Severe shoulder pain  -Rash developed 4 days later  -Sore arm upon reaching  -Fever
Male patient had 2 doses (initial doses) and tested positive January 4th and presented with mild Covid symptoms; Male patient had 2 doses (initial doses) and tested positive January 4th and presented with mild Covid symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "Male patient had 2 doses (initial doses) and tested positive January 4th and presented with mild Covid symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
On 4-7-10 child received DTAP in left thigh, IPV in right thigh, MMR left arm, VARIVAX right arm. Evening of 4-8-10 Mom noticed reddened area on right arm, C/O itching, some pain. Seen AM on 4-9-10. Treat with cool compresses. Monitor for worsening.
Severe fatigue, muscle pain in legs/arms back, chills/shivering/headaches...could barely walk without experiencing much pain. I am a healthy and fit athlete, and it took me down for 2 full days. Could not sleep through generalized muscle pain. This was worse then any full body flu symptons ever experienced.. I had just completed my annual physical 3 days prior..perfect lab work. Expected many of these symptons as it was listed in the information and warnings..however..this was far more debilitating and scary then anything described in the warnings, and the incidence of these symptons are more frequent on online information than described in the literature.
Client received AstraZeneca COVID vaccine, no reaction. AstraZeneca vaccine unavailable in the US, Janssen given as an alternative on 09/20/21.
I had a sore throat, severe headache, sneezing, slight cough. I took an at-home COVID-19 which came back positive, so I went to a clinic to take a PCR test to confirm which came back positive. My doctor recommended that I got the monoclonal antibody infusion and sent someone to my home to administer it. Within 36 hours later, I was symptom-free and doing much better. He also prescribed me PAXLOVID but suggested I didn't take it and do the infusion instead. As of now I'm fine, but have been having some bladder issues since then. I visited my urologist who said I was diagnosed with bladder cancer.
POSSIBLE THROMBOCYTOPENIA; RASH FROM KNEE TO FEET /SPOTTY RED DOTS ON LEG; SLEEPINESS; NECK ACHE; TIREDNESS; MUSCLE ACHE; HEADACHE; This spontaneous self-report concerned a 53 year old male patient. 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 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the patient received the vaccine, waited at facility for 15 minutes, and everything was okay.  On 17-APR-2021, the patient experienced neck ache, muscle ache and felt a sense of tiredness, headache, sleepiness, which he treated with Aleve (naproxen sodium). He also noticed his feet had a rash from his knee to feet, and according to his sister (who is a healthcare professional) it looked like small micro-embolisms (thrombocytopenia). The patient went to his physician who said the spotty red dots could be petechiae caused by thrombocytopenia.  As recommended by his primary care physician, the patient has an appointment for lab work, including platelet counts, on 20-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, tiredness, neck ache, rash from knee to feet (red dots), muscle ache, and possible thrombocytopenia, and the outcome of sleepiness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 53-year-old male patient was found to have petechiae-like rash on his knees to feet, that according to attending physician could be caused by thrombocytopenia, 2 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. The patient underwent laboratory procedure including platelet count (results not reported).  The patient complained of neck ache, muscle ache and felt a sense of tiredness, headache, sleepiness that he treated with Aleve (naproxen sodium) on the day the petechiae-like rash appeared.  No other details reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information as requested.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.  On 13-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter. 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. devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability