chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (mild fever) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (mild fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 12-Feb-2021, PYREXIA (mild fever) had resolved.            No concomitant medications provided.
Upper arm swollen & itchy at site of injection. Swollen 10cm x 5 - red & hot to touch. Seen by provider given shot of Kenalog 40mg IM. incident started 1 HR after administration or vaccine. Cold compress given. After several Hrs after Kenalog site & swelling Administered got better No more itch less redness patient was prescribed steroid by mouth & loratadine for Allergic reaction.
Evening of shot wasn't feeling well. Early AM woke with 102 fever and rapid heart rate 160's. Taken to ER, fluids given, took a few hours to get heart rate down.
just a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 06May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Cirrhosis From Hepatitis C" (unspecified if ongoing); "Hepatitis C" (unspecified if ongoing), notes: Hepatitis C She got this from a hospital 40 years ago.; "Encephalopathy" (ongoing); "She was in a car accident" (unspecified if ongoing), notes: She was in a car accident. Concomitant medication(s) included: XIFAXAN taken for encephalopathy, start date: 2020; ZINC; GENERLAC taken for hepatic cirrhosis; LACTULOSE taken for hepatic cirrhosis. Vaccination history included: BNT162b2 (Dose: 01, Lot: EN6199, NDC/Expiry: Unknown, this is not on the CDC vaccine record card., Sore arm: From date: 06Mar2021, Stop date: Unknown other than a couple of days later. , Outcome: Recovered completely.), administration date: 06Mar2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "Sore arm"; BNT162b2 (Dose: 02, Lot: ER8733, NDC/Expiry: Unknown, this is not on the CDC vaccine record card., Administered at 14:00., Sore arm: From date: 30Mar2021, Stop date: Unknown other than a couple of days later. , Outcome: Recovered completely.), administration date: 30Mar2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "Sore arm"; BNT162b2 (Dose: 03, Lot: FH8020, NDC/Expiry: Unknown, this is not on the CDC vaccine record card., Administering facility name on CDC vaccine record card: Withheld, Sore arm: From date: 22Oct2021, Stop date: Unknown other than a couple of days later. , Outcome: Recovered completely), administration date: 22Oct2021, when the patient was 74-year-old, for COVID-19 immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06May2022, outcome "recovered" (2022), described as "just a sore arm". Therapeutic measures were not taken as a result of pain in extremity.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300073682 same patient, different dose and event;
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 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 13:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, 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 received Paxlovid from 17Mar2023 to 21Mar2023 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This case was reported by a healthcare professional and described the occurrence of injection site atrophy in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL (details unknown). Less than one year after vaccination with FLULAVAL, the subject experienced injection site atrophy. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Headache, Myalgia, fatigue missed work following second dose due to the above symptoms
On 02/15/2021- I had a sensation of a sunburn on the right side of my neck and my right shoulder. An area that was radiated when I was being treated for cancer. It stopped bothering me in October 2021. On 04/13/2021- I saw Dr. - She did exams, x-rays, I was referred to a neurologist for a neurological exam. And I also had a CAT scan. Unknown,  because I am more affected on warm day. So I don't know what is going to happen when the weather warms up, but I have not had any pain since October.
DIARRHEA; VOMITING; ABDOMINAL PAIN; LIGHT FEVER; RUNNY NOSE; A spontaneous report has been received from a consumer. The report concerns a female patient.    No medical history was reported.     No concomitant products were reported.    No malfunction has been reported for FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced diarrhea (preferred term: Diarrhoea). On an unknown date, the patient experienced vomiting (preferred term: Vomiting). On an unknown date, the patient experienced abdominal pain (preferred term: Abdominal pain). On an unknown date, the patient experienced light fever (preferred term: Pyrexia). On an unknown date, the patient experienced runny nose (preferred term: Rhinorrhoea).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v).     The outcome of the event(s) of diarrhea, vomiting, abdominal pain, light fever and runny nose was unknown.     The events were considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Product Role: Suspect
Tuesday afternoon, onset of hypotonia like muscle control. falls from walking would result in hitting head because he would be unable to control the forward movement of the head. Drooping eyes, unable to sit, to stand. Unable to look up while in crawling position, has to roll to his side. No ? symptoms as of 7/23/01.
very frequent urination; This spontaneous case was reported by a patient and describes the occurrence of POLLAKIURIA (very frequent urination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POLLAKIURIA (very frequent urination). At the time of the report, POLLAKIURIA (very frequent urination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Numbness in right arm. Loss of feeling in fingers x 3 days. Following up with PCP.
Patient given an expired lot. Vaccine expired 07/02/2022. Received vaccine 07/07/2022. No adverse events occurred.
Shot given 12/23. Pt had ache front to back 12/30 and reported to MD. Rash break out under left breast 1-2-09, patient said all symptoms gone except tender skin, today 1/31/09, patient was treated with VALTREX.
Dead arm; Pain at the injection site; A little tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Dead arm), VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (A little tired) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included OMEPRAZOLE, VITAMIN B12 NOS, VITAMIN D3, PLECANATIDE (TRULANCE), AMLODIPINE and LIDOCAINE for an unknown indication.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced HYPOAESTHESIA (Dead arm), VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (A little tired). The patient was treated with PARACETAMOL (TYLENOL) on 21-Jul-2021 at a dose of 500 mg. At the time of the report, HYPOAESTHESIA (Dead arm), VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (A little tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Sea Moss used for unknown indication.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow- up document received on 27-JUL-2021 Event outcome was updated from unknown to recovered/resolved.
Initial misuse report received from a healthcare professional on 27 February 2014. The cases were received on 21 March 2014. A male patient received two doses of TENIVAC at one time (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Diagnosed with Myocarditis - was hospitalized for 3 days. Now taking one colchocine everyday for the next 3 months and taking 2 tablets of 325mg aspirin 3 times a day.
This spontaneous report was received from a registered nurse concerning a currently 1-year-old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, and drug reactions/allergies was reported. Concomitant therapies included sterile diluent (MRK). On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot number N014630 and expiration date 11-AUG-2019 or lot number N014371 and expiration date 09-MAY-2019 or and lot number reported as N012699 and expiration date 09-JUN-2019) for prophylaxis (dose and route of administration were not reported). The specific lot number of VARIVAX administered to the patient was unknown by the reporter. The vaccine had been improperly stored prior to the administration at a temperature of -14° C to -10° C for 2 hours and 55 minutes, however, the vaccine did not have a previous temperature excursion and the call was made due to a data logger. The reporter also stated that the sterile diluent (MRK) (lot number and expiration date were not reported) used to reconstitute the VARIVAX, did not undergo a temperature excursion. No adverse effects were reported and no further information was provided. This is one of several reports received from the same reporter. Lot number N012699 is an invalid lot number varicella virus vaccine live (oka/merck).
Information has been received from a health professional concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient developed "significant amount of erythema" 3 days after vaccination. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Bivalent vaccines have undergone several temperature excursions and have been administered to patient; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 39-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed or tested positive for COVID-19.     On 23-Sep-2022 at 3:12 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Sep-2022 at 3:12 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    No concomitant product reported by the reporter. Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. Bivalent vaccines stored in the refrigerator that underwent several temperature excursions in August 2022. Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation.  No adverse reactions were reported for any of the patients at the time of the report. No treatment medication reported by the reporter.
Soreness of arm injected, can barely move it. Fever. Body aches all over. Dizziness. Headache.
Gout flared up one day after getting Pzier Vaccination. The day after getting the Pfizer vaccine my feet were swollen and by day two I could not walk. I used epson salt and all of the other standard practices(bed rest, foot elevation, etc) until it went down a little and I went to the doctor 2 weeks later to confirm and get a prescription for my gout. which helped it go down.
Myalgia, CoughWheeze, Diarrhea, malaise, abdominal cramps Narrative:
Information has been received from a medical assistant on 02-JUL-2015, concerning a patient of unknown age and gender. On 21-MAY-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 159 hours temperature excursion. No adverse effects had been observed or reported. This is one several reports from the same reporter. Additional information has been requested.
Pain, slight itching, swelling at injection site, increasing over time (day 1- 1inch to 3 inches in diameter - day 2) redness, fatigue, dull headache, knot in upper arm.
Patient came to the emergency department experiencing  shortness of breath with exertion with some chest pressure/discomfort for the last two days prior to ED visit
C/O HA since day of booster (x 5 days). Motrin not effective. Has 1 1/2cm red hard lump at site; entire upper arm painful to touch.
PATIENT STATED SHE WOKE UP THE DAY AFTER RECEIVING HER BOOSTER SHOT WITH 2 BOILS ON HER FACE AND 3 BOILS ON HER NECK. ASKED HER IF THEY ITCHED OR WAS IRRITATED AND SHE SAID NO - JUST LOOKED LIKE THEY WERE COMING TO A HEAD. ADVISED PATIENT TO SEE DOCTOR AND TO CALL THE VAERS NUMBER TO REPORT AS WELL.
Information has been received from a physician concerning a 16 year old female with fibromyalgia, Ehlers-Danlos syndrome, migraine and insomnia and no know drug allergies who on 16, Dec 2006 was vaccinated intramuscularly with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 654885/1424F). Concomitant therapy included amitriptyline hydrochloride (AMITRIPTYLIN), ramelteon (ROZEREM), cephalexin (KEFLEX) and fludrocrtisone acetate (FLORINEF). On 18, Dec 2006 (also reported as "several hours after receiving HPV rL1 6 11 16 18 VLP vaccine (yeast)") the patient developed mild hives on her neck. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. On 19, Dec 2006 ("by the next morning") the hives resolved without treatment. No further problems were reported. No product quality complaint was involved. Additional information has been requested.
Case number PHEH2012US008119 is an initial spontaneous report received from a nurse on 11 Apr 2012. This report refers to a 12-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that on an unspecified date, she received only the MenCYW liquid conjugate vaccine component of MENVEO (batch number: X10127B) intramuscularly and did not receive the MenA lyophilized conjugate vaccine component. No adverse reaction was reported following this maladministration.
3 weeks after receiving my vaccine. I began to have pain in my lower back and shooting pain down my right leg to the lower calf. The pain occurred at night when sleeping and when walking I can have the shooting pain down the leg. I am experiencing muscle spasms along with the shooting pain. I have since been seeing a chiropractor for this pain. The doctor has changed my medications. I have been taking arthritis TYLENOL, extra strength, and blue emu cream and one for muscle spasm. It is getting better but the pain is not gone. I am unable to perform activities that I used to do. It is difficult to climb the stairs and an I'm unable to garden anymore.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. Since 17-JUN-2014, (in approximately 2014, exact date was not reported) Unknown number of patients were inadvertently vaccinated with PROQUAD (lot#, expiration date, dose not reported) that had been improperly stored (since unknown date). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
10 days of headache. Dizziness or lightheaded when standing. Decreased poor appetite. Weight loss. Subdued behavior.
INSTANTLY STARTED TO BLEED ENOUGH THAT IT WAS RUNNING DOWN ARM; THE VIAL WAS GELATINOUS WITH LOTS OF BUBBLES; BECAME VERY ILL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 185519, expiry: UNKNOWN) dose was not reported, administered on 18-JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On JAN-2022, the patient experienced became very ill. On 18-JAN-2022, the patient experienced instantly started to bleed enough that it was running down arm, and the vial was gelatinous with lots of bubbles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the instantly started to bleed enough that it was running down arm, became very ill and the vial was gelatinous with lots of bubbles was not reported. This report was non-serious. This case is associated with product quality complain number: 90000213424.
Information has been received from a physician concerning a 26 year old female with no illness at the time of being vaccinated, asthma, and no history of drug reactions/allergies who on 17-JAN-2007 was vaccinated with first dose of Pneumovax 23 (lot # 654977/0888F) in the deltoid at 8:30 AM.  Concomitant therapy included influenza virus vaccine (unspecified) was also given on 17-JAN-2007.  Other concomitant therapy included birth control, ADVAIR, albuterol, and ZYRTEC.  On 18-JAN-2007, at 8 AM, the patient experienced fever, nausea, chills, dizziness, swelling, redness, and soreness at the injection site.  The patient sought medical attention.  The injection site had a softball size swelling with tenderness.  Treatment was supportive.  No diagnostic studies were performed.  At the time of reporting, the patient was recovering.  Additional information was received from the physician.  The patient was treated with non-steroidal anti-inflammatory drugs (NSAIDS), rest, and fluids.  On 20-JAN-2007, the patient recovered. No additional information is expected.
86 year old male received pneumococcal polysaccharide vaccine PPSV23 IM  x 1 dose right deltoid in clinic afternoon of 7/27/16. On 7/29/16, pt returned to clinic complaining of right arm swelling, warmth, and erythema since 7/27. Patient also had episode of dizziness the evening of 7/27 and almost fell going to the restroom, now resolved. No visible knot or redness at the injection site itself. Pt also had blood drawn in right upper forearm on 7/27, no bruising noted. Right arm cellulitis vs allergic reaction to PNEUMOVAX: prescribed amoxicillin/clavulanate 875 mg/125 mg PO BID x 10 days and diphenhydramine 25 mg PO every 6 hours as needed for allergic reaction.
Immediately after she received MMR, Varicella, IPV, DTaP vaccines she broke into a urticarial rash to cheeks and around eyes. She was given 12.5 mg oral BENADRYL and rash resolved within 15 minutes. Child was observed for 1 hour in the office and no distress noted at discharge.
headache, sore throat, cough, chills, chest tightness, body aches, nasal congestion, sneezing. starting 10/10/21
Info has been received from a physician concerning a male who was vaccinated with a dose of varicella virus vaccine live. The physician reported that in 2004, the pt developed breakthrough characterized by five pox on his skin. It was unknown if medical attention was sought. At the time of this report the outcome was unknown. The  physician also reported that another pt could not sleep at night while taking montelukast sodium. No further info is available.