chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Spasm on the opposite arm of injection site (left arm); Pain on the opposite arm of injection site (left arm); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Spasm on the opposite arm of injection site (left arm)) and MYALGIA (Pain on the opposite arm of injection site (left arm)) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and BUPRENORPHINE for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced MUSCLE SPASMS (Spasm on the opposite arm of injection site (left arm)) and MYALGIA (Pain on the opposite arm of injection site (left arm)). At the time of the report, MUSCLE SPASMS (Spasm on the opposite arm of injection site (left arm)) and MYALGIA (Pain on the opposite arm of injection site (left arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This spontaneous case, initially received from pharmacist on 17-Oct-2018, concerns a pregnant patient of an unspecified age. The patient had no medical history. The patient's concomitant medications included Prenatal vitamins and levothyroxine. On 17-Oct-2018, at a gestational age of 9 weeks and 3 days (first trimester of pregnancy), the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date not reported). The patient had not experienced any adverse event after vaccination. The reporter assessed the case as non-serious.
Face became hot and red, erythema and heat right cheek, nose and left cheek.
Pain surrounding the injection site lasting for 48 + hours. Used Icy Hot pain patch and Ibuprofen for pain relief. Symptoms decreased on 3rd day.
Patient became lethargic with a fever of 105. She was taken to the emergency room and kept for observation for several hours. Tylenol suppository was given, and fever decreased. Patient had a low-grade fever that lasted 3-4 days.
Slight fever; Cold sweating; Stomach pain; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Slight fever), HYPERHIDROSIS (Cold sweating), ABDOMINAL PAIN UPPER (Stomach pain) and VOMITING (Vomiting) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 036B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (Slight fever), HYPERHIDROSIS (Cold sweating), ABDOMINAL PAIN UPPER (Stomach pain) and VOMITING (Vomiting). At the time of the report, PYREXIA (Slight fever), HYPERHIDROSIS (Cold sweating) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown and VOMITING (Vomiting) had not resolved.            No concomitant medication reported.  Treatment for the event include 500 mg ibuprofen.  Action taken with mRNA-1273 in response to the events was not applicable.
A nurse reported that a patient received an injection of Prevnar and subsequently developed cellulitis at the injection site. The patient was hospitalized. No further information was available at the date of this report. Manufacturer's comment: The reporter indicated that 3 patient's experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
On approximately 03/20/00 the pt developed shingles. The pt was seen in the physicians office. Additional information has been requested. Follow up data states the diagnosis was made on clinical symptoms only. No specimens were obtained. It was noted the patient healed uneventfully. No further information is expected.
This spontaneous case reported by a consumer, describes the occurrence of myalgia (still experiencing arm soreness), peripheral swelling (swollen) and erythema (red) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. On Apr 2, 2021, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 2, 2021, patient experienced myalgia (still experiencing arm soreness), peripheral swelling (swollen) and erythema (red). At the time of the report, myalgia (still experiencing arm soreness), peripheral swelling (swollen) and erythema (red) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Information is being entered for reporting purposes.  Vaccine was drawn up but not used on Friday,  5/19/2023.  The Vaccine was labeled with expiration time of 1800 hours and placed in refrigerator but not removed at expiration.   Vaccine was administered by LPN on 5/22/2023, 2 days, 14 hours and 52 minutes after expiration time.    Patient did not experience symptoms and has not required treatment.
On 2/11/2000, noticed pt wouldn't walk and had lumps (1) on each leg. Rubbed legs with alcohol and give Tylenol. The next morning was alright. That evening (night) she became fussy and lumps were still there. No fever. On 2/14/2000 was running a fever and lumps still present but smaller. The left leg lump was larger (DTAP). Encouraged mother to call Pediatrician.
The patient became dizzy after the 15 mins observation. The initial VS taken as : 150/87 ; T 98F/oral and  the MD was notified and patient was assessed. Patient was discharged home without noted pain, dizziness/headaches; no changes, gait is stable.
Had 2 shots, still got an outbreak/suspected vaccination Failure; still got an outbreak; Still having pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had 2 shots, still got an outbreak/suspected vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: still got an outbreak) and pain (Verbatim: Still having pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the two shingles shots but still got an outbreak of shingles.  The doctor said that it could have been worse without the shingles shots but 3 weeks into, he/she was still having pain. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concomitant products included ETANERCEPT (ENBREL) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced TENDERNESS (Tenderness at injection site). On 05-Mar-2021, TENDERNESS (Tenderness at injection site) had resolved.            It was reported that patient taking Immunosuppressant medicine as concomitant medication.  No Treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-Up was received on 02-JUL-2021 and contain Non-Significant information
No adverse event; Received PNEUMOVAX and PREVNAR concomitantly today; This spontaneous report was received from a pharmacist concerning a 67-year-old female patient. There was no information reported about the patient's medical history, drug reactions/allergies, concomitant medications or concurrent conditions.  It was reported that on 29-SEP-2020, the patient was vaccinated with one dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) syringe injection; lot number: T009743, expiration date reported as: 27-JAN-2022, and one dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) injection, lot number: DF1307, expiration date reported as: August 2022) both administered concomitantly as prophylaxis (duplicate therapy with same active substance); dosage regimen, anatomical injection site and route of administration were not reported.  The caller wanted to know about timing for subsequent pneumococcal vaccines administration and the possible sequalae or adverse events. At the reporting time, the patient was not experiencing any side effects. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T009743; expirationdate: 27-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
Information has been received from a physician concerning a 2 yr old white male who on the morning of 19Feb05 was vaccinated with the first SC dose of varicella virus vaccine live (lot647270/1103N). The physician reported that in 2005, the pt developed 10-15 lesions and a fever. Medical attention was not sought. The pt was noted to have recovered from the lesions and fever three days after the symptoms began. No further information is available.
Severe exacerbation of my arthritis.  I am now needing to use a cam to get around  because of the severe pain I have.  I am now needing a total hip replacement.
Information has been received from a pharmacy student concerning a female who was vaccinated with an unknown number doses of GARDASIL.  The patient experienced hair loss on the top of her head "about 2 weeks ago", on approximately 31-OCT-20088.  The patient's mother called pharmacy.  At the time of reporting, the patient recovered.  Additional information is not expected.
Information has been received from a physician concerning a female who on 23-JUN-2007 was vaccinated intramuscularly with the first dose of the Gardasil. Concomitant therapy include "other vaccines". On 23-JUN-2007, the patient fainted. The patient was "unconscious for about 15 minutes". Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information is not expected.
Vaccination failure; he did get COVID; was sick enough that he was hospitalized; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An 84-year-old male patient (height probably 5'9") received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 19Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 84 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; ACETAMINOPHEN; ATORVASTATIN; CALCIUM CITRATE; CARVEDILOL; CLOPIDOGREL; COENZYME Q10 [UBIDECARENONE]; VITAMIN B12 [COBAMAMIDE]; EZETIMIBE; FEXOFENADINE; TAMSULOSIN HCL; ZINC; VITAMIN D NOS. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant) with onset Sep2022, outcome "unknown"; COVID-19 (hospitalization, medically significant) with onset Sep2022, outcome "unknown", described as "he did get COVID; was sick enough that he was hospitalized". The events "vaccination failure" and "he did get covid; was sick enough that he was hospitalized" required emergency room visit. Therapeutic measures were taken as a result of vaccination failure, covid-19 (he received the IV drug in the ER and in the hospital. It was the IV drip. No further information provided). He just finished rehab for 5 weeks following his hospitalization.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Initially had 4x5 inch area of swelling/induration directly below injection site a few hours after vaccine, blanched in the middle and red peripherally. Very painful; edges itchy/burning. Continued to grow. By next morning entire upper arm circumferentially from elbow up and including shoulder was swollen, indurated, and painful. No redness till later in the day when redness appeared over some of affected area. Very painful. Went back to MD's office. Now on KEFLEX for suspected cellulitis, and prednisone.
w/in 24 hr post vax pt exp jerking episodes of abd muscles, head tilted to rt, inc in bradycardia & dragging of rt leg; pt also held rt arm up; muscle spasms cont a few days; pt recv next vax w/DT w/no problems;
Initial unsolicited report received from a consumer via other company (Pfizer) on 14 December 2015. Manufacturing report number: 2016SA098885. This case involves a female patient who was vaccinated with a dose of FLUZONE HD (injection) (batch number, expiration date, dose, dose number, route and site of administration were not reported) on 29 September on an unspecified year. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination the patient's arm got too much of pain and the patient was not able to move them without hurting, she is sick of her stomach, more tired, does not want to eat and added that there are so many other side effects which patient could not describe. It was reported that consumer wanted to get some information about a flu shot that she received and for how long side effects last. Laboratory investigations and corrective treatment were not reported. The patient was not recovered from the event. List of documents held by sender: none.
Headache, body aches, arm pain, chest pain, rapid heart rate, weakness of head and arms, numbness and tingling of bilateral upper and lower extremities. Patient denies having any shortness of breath or fevers. No noticeable rash or hives. Patient rates chest pain at 6/10. Patient stated onset of symptoms started two hours ago 04/23/2021 0830.
Pt woke up on 3/23/15 with fever of 102 degrees F and pimple-like rash on neck. Over the next several hours, pt developed red macular-papular rash on face, neck, abd, chest, back and groin. Pt has been more tired with rash. Also, started with clear nasal drainage on 3/23/15. Pt seen in office on 3/26/15, afebrile. No changes with rash.
Pfizer BioNTech Covid 19 vaccine- got Covid; Pfizer BioNTech Covid 19 vaccine- got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), on 10Feb2021 as dose 2, single (Batch/Lot number: unknown), on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 82 years 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 2022, outcome "unknown" and all described as "Pfizer BioNTech Covid 19 vaccine- got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Caller took Paxlovid and finished it a month ago. Still having a very pronounced loss of taste and cotton mouth, mouth is totally dry all the time and is somewhat hoarse from it. Has shortness of breath but he has breathing problems anyway. Wondering if these are made worse by Paxlovid. Also has swallowing problems. Read about skin rash and hoarseness too but the hoarseness could be related to his vocal cord and is something he had beforehand. Swelling of mouth and lips, cotton mouth and loss of taste are all related. It's strange as he finished it a month ago and within a week taste was better but the last few days his taste is worse than it ever was. Has that overhand metallic taste. When he took Paxlovid it was pronounced metallic odor in his perspiration, to everything, it was fine at the time as it was for the benefit. Got Covid again half dozen days after he finished Paxlovid and got on an antibiotic and prednisone afterwards Has had a real time of the whole thing. Still feeling effects for sure with breathing problems.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
4" circular area - redness. Sore touch itchy, started 1 wk ago after injection was given Prednisone.
a total of 8 pts had local reacts following immunization; 6 of these 8 pts exp inject site react which included erythema, hot to touch, pain & swelling w/in 15 mins of immunization; dx allergic topical reaction;
Information has been received from a nurse for the pregnancy registry for GARDASIL concerning a 17 year old female patient with history of anger issues, who on 03-DEC-2008 was vaccinated with the second dose of GARDASIL (Lot 660553/0070X). Concomitant therapy included HAVRIX and hormonal contraceptives (unspecified). Nurse reported that a patient who is now pregnant received her second dose of GARDASIL on 03-DEC-2008. Nurse reported that the patient had received her first dose of GARDASIL over a year ago. A pregnancy test on 22-SEP-2008 was negative and a pregnancy test on 08-OCT-2008 was positive. At the time of the report the patient had a confirmation test done (sonogram). No specific adverse event was reported related to the pregnancy. The patient sought unspecified medical attention. Follow up information has been received from a physician who reported that on 24-JUN-2009 the patient delivered by C-section due to bradycardia a male healthy baby at 41 weeks of gestation. The baby's weigh was 7 pounds 4.6 oz. The physician also reported that on an unknown date the patient experienced a group b streptococcus infection. The patient present status was unknown. Upon internal review C-section due to bradycardia was considered to be other important medical event. Additional information has been requested.
Inflammation 3/4 of arm between shoulder and elbow.  Six inch diameter at injection site hard and red.  Patient experienced hot flashes. NP under Dr. diagnosed patient with cellulitis. Pt received cefadroxil 500mg BID x10days.  Pt symptoms resolved within 7 days.
One week after I received the shot, I started having headaches and dizziness off and every day for  3 weeks.  I had one day on February 11 that I had fever and chills that lasted for 2 hours.
An employee of the pharmacist (later told to me by the pharmacist to be an intern) injected me, my wife, and my father-in-law each with an expired Moderna vaccine dose, rather than the Johnson & Johnson dose we had ordered (note: the Johnson & Johnson dose and its lot number were written on our vaccination cards). Our vaccines were administered one after another by the same intern between 11:15am and 11:45am. We were unaware of the error until the pharmacist, called me after I had returned home and eaten lunch (around 12:40pm). The pharmacist explained that his intern had administered the Moderna doses from a stock that was supposed to be disposed of on 4/26/21, suggesting that the doses were expired. Unbelievably, those expired Moderna doses were apparently drawn from their vials into syringes on 4/26/21 and left, at room temperature, in a non-segregated area of the pharmacy, near the Johnson & Johnson doses. My wife, father-in-law, and I were completely distraught and unsure of what would happen. Each of us called our primary care physicians, but the advice was unclear given the uncertainty. Our online searches of Moderna and related vaccine studies also revealed no information on what we could expect to occur from receiving expired doses. In my case, my arm was sore on 4/29 and 4/30, and on 4/30 I was extremely fatigued. My wife and father-in-law experienced similar symptoms, although my wife's were more severe.
patient describes her lower right arm, the same arm of the vaccine swelled and was red, hot to the touch
Sore/stiff shoulder, neck, and collar bone, right arm weak and hard to raise. Plan to consult doctor if not better by 22nd of October.
STARTED FEELING POORLY SHORTLY AFTER INJECTION. BY 5:20PM DRY HEAVES, NAUSEOUS, AND DIAPHORETIC. SENT TO ER BY DR FOR IV AND MEDS. PRESENTED IN ER WITH SAME SYMPTOMS AND CRAMPY UPPER ABDOMEN. NO CHEST PAIN OR SHORTNESS OF BREATH. GIVEN IV'S, PEPCID, BENADRYL AND ZOFRAN. ABDOMEN BENIGN. CHEST X-RAY CLEAR. BLOOD WORK NORMAL. SENT HOME AROUND MIDNIGHT THE SAME DAY. NO FURTHER SYMPTOMS.
Headache, no other symptoms woke with headache done by noon drank fluids, recovered.
Rash on left arm, swollen arm. Headache, heart palpitations for 4 days after vaccination. I noticed the swollen arm and rash a few hours after vaccination.
Intense fever, chills, headache, soreness at injection site and immediate loss of strength once symptoms started.  Onset of symptoms was quick, without warning. I was actually feeling very good in the hours immediately after injection.
Pt reported that her throat itches. Vitals: 136/86, 93, 20, 100%, 98.7F -- > 121/89 -- > 128/77, 81, 20, 100%Lungs clear all quadrants, pt c/o SOB and itchiness around neck.  Denies Chest Pain. Pt given benadryl 50mg PO @18:13. Recommended pt f/u w/ PCP.  Pt stable and released from the vaccination site. Pt followed up w/ PCP the following day.  Records unavailable to this writer.
Patient felt faint about 25 min after vaccination. Patient continued to feel unwell for about 2 hours after vaccination. Patient left the facility with a mild headache, but had otherwise recovered.