chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I rebounded after 6 days of finishing Paxlovid treatment. Symptoms returned, strong positive test result after 3 days negative. Incred bly upsetting and disruptive.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I rebounded after 6 days of finishing Paxlovid treatment. Symptoms returned, strong positive test result after 3 days negative. Incred bly upsetting and disruptive.) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient did not take any other medications/products within two weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  Concurrent medical conditions included Allergy.   On 25-Apr-2022 at 4:45 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 15-May-2022 at 1:00 AM, the patient experienced COVID-19 (I rebounded after 6 days of finishing Paxlovid treatment. Symptoms returned, strong positive test result after 3 days negative. Incred bly upsetting and disruptive.). At the time of the report, COVID-19 (I rebounded after 6 days of finishing Paxlovid treatment. Symptoms returned, strong positive test result after 3 days negative. Incred bly upsetting and disruptive.) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: strong positive test (Positive) strong positive test and negative (Negative) Negative.         No concomitant medications were reported. No treatment medications were reported. COMPANY COMMENT: This is an spontaneous case concerning a  51-years-old male patient with  medical history of Allergy, non-company product NIRMATRELVIR, RITONAVIR for COVID-19 treatment who experienced the unexpected AESI event   of COVID-19, 21 days after  receiving the  4th  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a  51-years-old male patient with  medical history of Allergy, non-company product NIRMATRELVIR, RITONAVIR for COVID-19 treatment who experienced the unexpected AESI event   of COVID-19, 21 days after  receiving the  4th  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
knot or rt thigh @ site very mild swelling & erythema-MD dx very mild localized rxn to vax;
On 11/30/17 patient received 3 immunizations intramuscular DTaP in left lateral thigh and influenza and HIB in right lateral thigh with no complications. Patient presented at urgent care on 12/2/17 for evaluation.
Patient recently obtained a booster then shortly after (within a few weeks began having seizures - 2 of which he went to ER via ambulance. Subsequently discharged. Last seizure I am aware of.  Patient was found deceased on his apartment on Feb 12. It *s believed he died 3 days
very high blood pressure; shortness of breath; his arm redness; sweating; dizziness; his head was pounding; weakness in his legs; This is a spontaneous report received from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at an unspecified age on 15Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. Medical history included allergic to penicillin and iodine, when he took what he was allergic to he broke out in rash, hives. Concomitant medications were not reported. The patient had side effects: shortness of breath, very high blood pressure, his arm redness, sweating, dizziness, his head was pounding, weakness in his legs and dizzy. The patient was treated and was taken to the hospital till his blood pressure went down and they gave him some diphenhydramine hydrochloride (BENADRYL) for his side effects. They were looking the answer for if he can take a second shot or not. Since he went through all of these side effects. The patient did not want to take a second shot after what he has experienced after the first shot. He was doing ok right now. The patient did not have COVID. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Information on the batch/lot number has been requested.
she got her Booster shot on Saturday 25Sep2021; she got her Booster shot on Saturday 25Sep2021; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on 25Sep2021 dose 3 (booster), single for covid-19 immunisation (booster dose and off label). The patient medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on unspecified date as dose1 and dose 2 for covid-19 immunisation. Patient wants to raise her experience in getting her Booster shot, she said she got her Booster shot on Saturday 25Sep2021, and she noticed that the lot number she received on her email is different from the lot number what was written on her vaccine card. Caller said her mother who is 91-year-old also received her Booster dose at a different, and also in her case she had two different lot numbers, 1 that was handwritten and one that was on the email. In her case, they said the email was wrong, but the handwritten number was probably correct. Patient wants to know which lot number is correct.  lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
Nurse at Clinic misunderstood about the third dose of vaccine and was giving patients that came in the third dose of Moderna. After explaining the guide lines for the third dose of Moderna no more was given. It was explained to her that Pfizer was the only vaccine at this time that was cleared to give a booster dose and that Moderna third dose was only for immunocompromised.
1 Day after vaccines, pt developed nausea. 2 Days later left wrist soreness. 3 Days later red eyes and pain in other wrist. 4 Days later both wrists swollen & left ankle pain. Monday decr. use of hands & swelling of elbows. Blotchy, rash.
This literature marketed report was received from the authors in a published literature article, concerning to three patients of unknown age (reported as median patient age was 21 months) and gender. On an unknown dates, the patients were vaccinated with two doses of M-M-R II (dose, route, lot# and the expiration date were not reported) for prophylaxis. There was no concomitant medication provided. Among the 65 confirmed cases and during April 10 - May 31, confirmed measles patients were identified in five schools, 12 child care centers, three health care facilities, and numerous households; an estimated 8,250 persons were potentially exposed to measles in these settings. Rash onset dates ranged from March 30 - May 27, 2017. Sixty Two (95%) cases were identified in unvaccinated persons, including 50 (77%) in children aged >=12 months (i.e., age-eligible for M-M-R II vaccination). Specific ethnic children accounted for 55 (85%) of the cases. Among the three patients with a history of measles vaccination, all had received 2 M-M-R II doses before illness onset (measles post vaccine and vaccination failure). As of May 31, 20 (31%) patients had been hospitalized, primarily for treatment of dehydration or pneumonia; no deaths had been reported. The outcome of measles post vaccine and vaccination failure was unknown. The reporter considered vaccination failure and measles post vaccine to be related to M-M-R II. Upon internal review, measles post vaccine was determined to be medically significant.
Intense aching and tightness over entire body for two days. Headache and neck soreness both remain present four days later.
This spontaneous report was received from a healthcare worker regarding to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 11-APR-2016, the patient was vaccinated with an improperly stored dose of VAQTA (lot # L031196, expiry date 05-FEB-2017) dosage regimen and route unknown. Concomitant medications were not reported. The vaccine was subjected to temperature excursion of 25.6 F for a time frame of 132 hours. It was reported there were no previous temperature excursions. Product quality complaint (PQC) was not filed. This report is one of the several reports received from the same reporter. Additional information has been requested.
hives noted @ inject site only; pt in no other apparent distress; no temp, cold compress applied to site; MD called mom instructed to give pt DPH for hives;
Over a week after my injection, a round rash around the injection site appeared. It was warm and I still have it today
Patient received the improperly reconstituted dose; Patient received the improperly reconstituted dose; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   In 2022, the patient received Menveo. In 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comments: The reporter stated that a patient that received a dose of Menveo that was reconstituted with sterile water instead of the supplied CWY diluent.   The office had narrowed it down to five patients, but they were unsure which one of those five was the one that received the improperly reconstituted dose.  The dose was given sometime between 26th May 2022 and 7th June 2022. At the time of reporting, pharmacist did not have lot number or expiration date and patient information available.   A repeat dose had not been administered. The reporter gave permission for follow-up. Additional supportive Information: patient that received a dose of Menveo that was reconstituted with sterile water instead of the supplied which leads to Wrong solution used in drug reconstitution.
I had a minor headache and fatigue; I had a minor headache and fatigue; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247 and expiry date were not reported), via an unspecified route of administration at left arm on 16Feb2021 at 13:30, as single dose for COVID-19 immunization. The patient did not have any allergies to medications, food or other products. Patient medical history was not reported. Concomitant medications included birth control pill, cetirizine hydrochloride (ZYRTEC) and womens multivitamin. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccina-tion. Patient has not been tested for COVID, post vaccination. On 16Feb2021 at 23:30, patient experienced minor headache and fatigue. Patient received treatment as 500 mg paracetamol (ACETA-MINOPHEN). The headache pain was alleviated by taking paracetamol (ACETAMINOPHEN). The out-come of events was recovered on 18Feb2021.
Varicella vaccine given 1/9/08, broke out with varicella on 1/12/08.  102 degree fever on 1/12/08 and 2 blisters of varicella on abdomen on 1/12/08.
This medically  confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 30 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Large Rash 4"x 2.5"  developed under the left breast.  Red/purpleish in color.  No pain or itching reported by patient. Patient never had a rash under breasts in past 7 years of care after TBI .   Treatment with OTC Gold Bond Medicated Extra Strength Body Powder and tissue to prevent skin from breast touching skin on the rib cage.  Rash has not gotten any worse or better since first found a little over 24 hours prior to reporting this
Janssen, Dose: 1; Pfizer, Dose: 3, 4; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: FP7135), in left arm and on 10Jun2022 as dose 4 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 11Mar2021 as dose 1, single (Lot number: 1502072), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Stroke" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Janssen, Dose: 1; Pfizer, Dose: 3, 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient does not have other medication in 2 weeks. The patient does not have known allergies.
Almost immediate (next day) started having numbness in left fingers 3-5, heavy, glove like feeling in left hand, pain down left arm gradually intensifying in frequency and severity over 6-7 weeks.  Cervical MRI ordered due to intense, sharp, stabbing left arm pain and numbness down ulnar side of left arm.  Admitted to Medical Center on June  11,  2021 due to findings on MRI and worsening of symptoms.  Drs. have narrowed down the DX to likely Acute Transverse Myelitis- pending results from a spinal tap done June 12, 2021.  Currently still admitted for pain control and IV steroids to control swelling on spinal cord.
feverish warm area at the site; Streak about inches down feels itchy; the site is about 3 inches around, swollen and tender; the site is about 3 inches around, swollen and tender; red swollen tender; little bit of warmth on the arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (little bit of warmth on the arm), INJECTION SITE WARMTH (feverish warm area at the site), INJECTION SITE PRURITUS (Streak about inches down feels itchy), INJECTION SITE SWELLING (the site is about 3 inches around, swollen and tender) and INJECTION SITE PAIN (the site is about 3 inches around, swollen and tender) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ulcerative colitis, Glaucoma, Atrial fibrillation, Blood pressure high and High cholesterol. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, CARVEDILOL and LOSARTAN for Blood pressure, ROSUVASTATIN for High cholesterol, MESALAZINE (ASACOL) for Ulcerative colitis, CALCIUM, XYLOMETAZOLINE HYDROCHLORIDE (FACOL) and LATANOPROST for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced SKIN WARM (little bit of warmth on the arm). On 07-Jan-2021, the patient experienced INJECTION SITE WARMTH (feverish warm area at the site), INJECTION SITE PRURITUS (Streak about inches down feels itchy), INJECTION SITE SWELLING (the site is about 3 inches around, swollen and tender), INJECTION SITE PAIN (the site is about 3 inches around, swollen and tender) and INJECTION SITE ERYTHEMA (red swollen tender). The patient was treated with PARACETAMOL (TYLENOL) for Injection site tenderness, Injection site swelling and Injection site warmth, at an unspecified dose and frequency. On 02-Jan-2021, SKIN WARM (little bit of warmth on the arm) had resolved. On 17-Jan-2021, INJECTION SITE WARMTH (feverish warm area at the site), INJECTION SITE PRURITUS (Streak about inches down feels itchy), INJECTION SITE SWELLING (the site is about 3 inches around, swollen and tender), INJECTION SITE PAIN (the site is about 3 inches around, swollen and tender) and INJECTION SITE ERYTHEMA (red swollen tender) had resolved.            Action taken with mRNA-1273 in response to the event/s was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received via ADR form. Patient address, email, medical history and outcome of events were updated. Dose 2 information was reported, no adverse events were reported.
Seven days after the vaccine was given to me, my right arm, where the injection was administered, was red,  swollen and itchy. It was circular around the injection site about 2  inches in diameter.  It was mild. Not much pain, but itchy. I took one dose of Benadryl on the second night and I applied hydrocortisone cream topically to the site for about two days. It lasted about 2 days. The Benadryl and hydrocortisone cream seemed to help.
Diarrhea; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 28Feb2021 at 09:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food, or other products. 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 ethinylestradiol, norethisterone acetate (JUNEL FE 1.5/30) for an unknown indication from an unknown date and unknown if ongoing. On 28Feb2021 at 20:30, the patient experienced diarrhea and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea and nausea were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
The day after the dose of the vaccine I had a headache and body aches with severe back pain in my lower and mid back. My arm became swollen to the size of a baseball around the site of injection. It was a lump on the side of my arm and my arm was numb like maybe a nerve was damaged. My arm was very painful and swollen and itchy. I had the issues with my arm for 10 to 14 days after each dose of the vaccine. I have been having severe backache and like something is sitting on my chest. I still very fatigued after 10 weeks and I have severe back ache. I have been using Lidocaine for the pain and Naproxen and a muscle relaxer at times.
Cough/Persistent non-productive cough; Throat irritation. A 30 year old female consumer reported that she received a dose of Flumist influenza virus vaccine, live intranasal 2003-4 formula nasal solution frozen on 12-Dec-2003 and developed a persistent cough and scratchy throat. on 01-Jan-2004, the patient experienced a perisistent cough and scratchy throat/ throat irritation. At the end of January 2003, she was examined by a physician, a diagnosis of allergies was made. She was treated with Claritan (loratadine) and Entuss (guifenesin/hydrocodone bitartrate) cough syrup. The reporter indicated that these medications helped the throat problem, however she continued taking Entuss. The reporter indicated that her physician is not aware that she received Flumist. As of 26-Feb-2004, the cough persists. No further information was available at the time of this report.
Struggling with Menierre's attack post Covid vaccine.  Not clear if related, but doctor indicated that it could be, so decided to report this as possibility.  Experiencing ear fullness, vertigo, and sudden hearing loss.
Information has been received from a physician concerning a 10 year old male who was vaccinated with a subcutaneous dose of Varivax. Subsequently, the patient developed chickenpox (100 lesions). Unspecified medical attention was sought. The outcome of the patient was not reported. There was no product quality complaint involved. NO further information was provided. Additional information has been requested.
Severe chills and shivering that quickly exhausted me. A headache that wrapped around my entire head and did not respond to ibuprofen. both of these happened around 10 hours after the vaccine.
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 06-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