chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Headache; Fatigue; Break out at the time of the first shot and symptoms went away after receiving that dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), FATIGUE (Fatigue) and THERAPEUTIC RESPONSE UNEXPECTED (Break out at the time of the first shot and symptoms went away after receiving that dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Lymphadenectomy (lymph node removed out of patient right leg prior to chemotherapy) and Chemotherapy. Concurrent medical conditions included Autoimmune disorder and Cancer (Finished treatment with rituximab, and Eulaxa a day before first dose of Moderna vaccine). Concomitant products included TRIAMCINOLONE and LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN EXTRA) for an unknown indication.    On 27-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), FATIGUE (Fatigue) and THERAPEUTIC RESPONSE UNEXPECTED (Break out at the time of the first shot and symptoms went away after receiving that dose). At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved and THERAPEUTIC RESPONSE UNEXPECTED (Break out at the time of the first shot and symptoms went away after receiving that dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had an autoimmune problem where she broke out in an alligator skin-like blisters on her legs that itch. It was presumed to be Wells disease, and she was having a break out at the time of the first shot. The symptoms went away after receiving that dose. The patient received second dose on 24-FEB-2022. No treatment information was provided.   This case was linked to MOD-2022-595679 (Patient Link).
No symptoms.  2nd dose of Pfizer was administered on 8/28/21 Came in for booster. Date overlooked not due for booster 2/28/22 Monitored patient for 15 minutes , Informed dose administered to early.
Dad noted area 1/2" above injection site down to 4"-5" below (elbow area) a pink blushing/fading bruise like area on 10/28/16 9 AM. On 10/29/16 patient seen at ED for increased redness/warmth. BENADRYL given with good effect. Script for azithromycin given if no improvement from BENADRYL - not needed due to improvement after BENADRYL.
No adverse events reported; Caller reports improperly store vaccines were administered; This spontaneous report was received  from a medical assistant referring to a patient of unknown age and gender. The patient´s concurrent conditions, medical history and concomitant therapies were not reported.  On 15-JUN-2022, the patient was  avaccintaed with 1 dose of improperly stored   rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, , lot # 1 42084, expiration date: 05-OCT-2022,  for prophylaxis. (strength and dose  were not provided) (product storage error). The temperature was 41.17 farenheit degrees for 15 minutes and there was no previous temperature excursion. No other adverse event and no product quality complaints were reported.  This is one of several reports from the same reporter.
Chills, vomiting, nausea, lightheaded within 5 minutes of vaccine administration
On 3/6/01 the pt developed choking, eyes rolling to the back of the head, and tremors in all extremities. She also appeared to stop breathing with perioral cyanosis. She received cardiopulmonary resuscitation and was transported to the ER. Upon arrival to the ER she had a fever of 102.
Came to health dept 6/5/14 to report reaction. States redness and burning right after injection that got worse that night with onset of itching also. Worse the following day and today. Area on posterior (L) upper arm of redness measuring 2 1/2 inches x 3 1/2 inches which is firm and very warm to touch and painful. States nurse did say she was giving it "at an angle". Hx of chickenpox disease but needed for nursing sch.
Patient stated she felt the vaccine go into her arm and she continues to have pain in her neck and arm 4 days later. She also mentioned pain in her feet after having them elevated for a period of time. She has also complained of having diarrhea since getting her shot. I told her to take Tylenol for the pain and use the form to report concerns along with talking to her doctor.
Immediately after varicella vaccine, which was given last, client c/o nausea & dizziness. BP 100/60 x2. Juice was given. Remained seated for 15 min. Last BP was 118/78. Pt left with mom.
on X/XX/22. 57 y.o. female patient came into the clinic to receive 2nd Moderna Covid 19 booster. 0.25 mL of Moderna covid 19 vaccine was administered to patient's left deltoid. Moderna Covid 19 vaccine 12 and older. Lot #; 083B22A Exp: 11-28-2022 NDC: 80777-273-10
Upon review, discovered that Dtap - IPV was administered to a child 2 years of age. This vaccine is approved for ages 4-6 years. No adverse event reported by mother. Telephone call to Mother.. This telephone number is not in service. Checked for updated contact information without success.  Dtap is a valid dose, IPV was not due at the time of immunization.
Tiredness; Injection site pain; This is a spontaneous report from a contactable consumer.   A 54-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247), at single dose into the right arm on 22Jan2021 at 09:30AM for COVID-19 immunization. The patient medical history was not reported. On 11Jan2021 the patient had a negative  nasal swab covid_test.  The patient did not receive any concomitant medications. On 23Jan2021 at 08:00AM the patient experienced tiredness and injection site pain. No treatment  was received. The outcome of the events was not recovered.
Information has been received from a pharmacist concerning a 61 female who on 22-FEB-2007 was vaccinated with a 0.65 ml. subcutaneous dose of Zostavax (Oka/Merck).  On an unspecified date, the patient developed an injection site rash after she received the vaccine.  Treatment date was reported as 26-FEB-2007.  Treatment and current patient status was not reported.  At the time of this report, the reporter felt that VZV Analysis by PCR was not necessary because there was no current rash.  A product quality complaint was not reported.  Additional information has been requested.
Case number PHEH2014US018445, is an initial spontaneous report received from a pharmacist on 11 SEP 2014 with a combined follow-up received from a pharmacist and quality assurance department (QA ref number: 325083) on 12 SEP 2014 and a follow up received from QA department on 19 SEP 2014. This report refers to a 31 year old female patient. Past medical history and concomitant medication was not reported. Pharmacist reported that during the administration of FLUVIRIN 2014/2015 (batch number: 1410901) intramuscular from a multidose vial "quite a bit" of FLUVIRIN leaked out from the injection site on the patient's arm on 08 SEP 2014. A week later, the patient was revaccinated with FLUVIRIN and "only a little bit" leaked out (see related case: PHHY2014US121197). The patient did received FLUVIRIN last year, but this was the first time it leaked out of the injection site on the patient. The patient did not experience any adverse events to FLUVIRIN. No sample was available for return. Upon the follow-up from QA department, it was reported that investigation cannot be performed as they refer to FLUVIRIN vial batches. Hence this presentation does not include a syringe, therefore this was not an event which could be related to the FLUVIRIN product. No further information provided.   Combined follow-up received from a pharmacist and quality assurance department on 12 SEP 2014. Vaccination history, narrative and quality reference number updated.   Follow-up received from quality assurance department on 19 SEP 2014; Updated QA department comments.
hey had a clinic on Saturday and they gave out expired doses to one patient and found it was 1 week expired.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (hey had a clinic on Saturday and they gave out expired doses to one patient and found it was 1 week expired.) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (hey had a clinic on Saturday and they gave out expired doses to one patient and found it was 1 week expired.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (hey had a clinic on Saturday and they gave out expired doses to one patient and found it was 1 week expired.) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (hey had a clinic on Saturday and they gave out expired doses to one patient and found it was 1 week expired.).    No concomitant medications were reported.  The patient was 65 and older.  No treatment medications were reported.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 20-SEP-2013, the patient was vaccinated with ZOSTAVAX (lot # J002777 and expiry date 07-JUN-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 5F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would had been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his records didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which lot# was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administered. This is one of several reports from the same source. Additional information has been requested.
pt recvd vax & 18 hrs p/vax exp rash under rt arm which became diffuse; pt was seen by MD; treated w/Medrol & DPH; pt made a complete recovery in a matter of few days;
Information has been received from a physician concerning an infant who one month prior to the time they were scheduled to receive a third dose of ROTARIX, they were taken to the hospital and diagnosed with rotavirus. At the time of reporting it was unknown if the infant was hospitalized or had just received treatment in the emergency room. Unspecified medical attention was sought. There was no product quality complaint. The patient's status was not provided at the time of reporting. Additional information has been requested.  09/02/2008 This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow up information has been received from a physician concerning a 7 month old male who on 12-NOV-2007 was vaccinated with a second dose of ROTATEQ (lot # 657045/1053U). It was noted that a first dose had been administered on 29 AUG 2007 (lot # 657515/0668U). On 07-DEC-2007, one month prior to the time the patient was scheduled to receive their third dose of ROTATEQ the patient was taken to the emergency room, at which time a stool culture was obtained. Results of the stool culture were positive for rotavirus. It was noted that patient was not admitted to the hospital, but received unspecified medical treatment in the ER. There was no product quality complaint. The patient's status was not provided at the time of reporting. Additional information has been requested.
Rash at the vaccine shot spot on the right arm. Have lasted for more than 7 days now and is slightly swollen and warm as compared to the rest of body / surrounding skin. Minor ache on the right arm and right shoulder.
I have begun to experience covid symptoms, achy; Fever; Tired; No appetite; Cough; Cant sleep on 10Jul2021 for 3 days now; This is a spontaneous report from a contactable consumer or other non hcp. A 68-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 11May2021 17:30 (age at vaccination: 68-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, skin cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not receive other vaccines within 4weeks prior to vaccination. Patient had received other medications within 2 weeks prior to vaccination. Patient had no allergies. Patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 21Apr2021 09:00 as (age at vaccination: 68-year-old), as single dose for COVID-19 immunisation. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested with COVID-19 to post vaccination. On 10Jul2021 the patient experienced I have begun to experience COVID symptoms, achy, fever, tired, no appetite, cough, can't sleep on 10Jul2021 for 3 days now. The outcome of the events pain, pyrexia, fatigue, decreased appetite, cough, insomnia was not recovered.  No follow-up attempts are needed. No further information is expected.
I developed facial swelling and hives all over my body. My body felt like it was on fire. My  skin was red and hot.  I begin to have SOB and my tongue  was tingling
Patient presents for appt with PCP.  Patient was given yearly flu vaccination.  Patient has received 4 doses of flu vaccine previously.  All the same brand.  Mother called the next day at 1510 stating that her daughter had a swollen face and a rash. Mother was directed to take child to ER.  Mother did take child to local ER.  ER doctor drew a CBC and diagnosed child with a viral illness.  Swelling was around child's nose area.  Rash was on the face, chest and back.
Inflammation of shoulder with burning pain in L shoulder starting 6 weeks after vaccination,  short term relief with ice and change in sleep position, persisting to May when physician diagnosed inflammation and gave cortisone injection into joint capsule, this treatment relieved pain to this date (6/1/22 in for next vaccination - gave on opposite shoulder)
Right arm where PNEUMOVAX given red, hard, painful, swollen. Red all the way to mid forearm. Hard to raise arm. Left arm flu shot not an issue. Patient has recovered and able to use right arm with no pain.
Lump on left collar bone (side of injection); Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump on left collar bone (side of injection)) and CHILLS (Chills) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced CHILLS (Chills). On 29-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump on left collar bone (side of injection)). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, VACCINATION SITE MASS (Lump on left collar bone (side of injection)) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.
Sweaty palm and tingling in hand on same side of injection. Severe pain radiating from my shoulder down to my hand, my shoulder up to my head and my shoulder over to my spine. Date of report is July 4th. Pain is still persisting.
The Janssen vaccine was administered to this patient 5 minutes after the beyond use time (must be used within 6 hours).
Seizure arrival at ER temp-102 deg. cough. The ER summary received on 1/29/04 states fussy.
No additional AE reported; VAQTA and MMR II being administered to a patient before 12 months of age.; This spontaneous report was received from a nurse (also reported as customer) referring to a 11-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 29-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (1 dose, lot # T020109, expiration date was reported as 31-DEC-2022, but upon internal validation established as 26-JAN-2022; route was not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (1 dose, lot # T001214, expiration date was reported as 31-DEC-2022, but upon internal validation established as 12-JAN-2022; route was not reported) for prophylaxis (product administered to patient of inappropriate age). Sterile diluent used for reconstitution. No additional adverse event (AE) reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T020109; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Hospitalized post MAB for COVID positive 6/5 given MAB, then  on 6/7 patient with increased dyspnea on exertion O2 sats into the 70s while on 6L/ min via nasal cannula.
The next day swollen lymph nodes, eye floaters (beginning Oct2021), body felt inflamed, arm soreness. Nov got my eye checked. Saw my rheumatologist in Dec2021. Had to get physical therapy for my back.
L shoulder capsulitis, began day of vaccination, severe, limited ROM and activities of daily living. No other joints affected. Minimal improvement with NSAIDS, acetaminophen and amitryptiline. kenalog injection given 3/10/20, will assess improvement next month.
This spontaneous report as received from a pharmacist via company representative refers to unspecified patients of unknown age and unknown gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, route and frequency unknown). Other suspect therapy included unspecified influenza vaccine (defaulted to AFLURIA). The reporter states that she had witnessed some unspecified severe reactions with ZOSTAVAX. The company representative did not know specifically when these reactions occurred, if the unspecified patients consulted healthcare providers, or if any treatment was administered for the severe reactions. The representative stated that the pharmacist told her that the patients had consulted her, but the pharmacist did not clarify any more details about the severe reactions. The company representative states that, one person may have received ZOSTAVAX with an unspecified influenza vaccine (AFLURIA) and one of the events may have occurred in July or August 2014. The pharmacist did not specify how many patients experienced severe reactions after receiving ZOSTAVAX. Reporter stated that no patient died after vaccination. The outcome of the reactions was unknown. The causality of events was not reported. No product quality complaint was involved. Additional information has been requested.
erythema multiforme began evening of 7FEB96;initially treated w/DPH & cortaid cream;progressively worsened;saw in the office 9FEB96 began course of pediapred & APAP for fever;throat culture taken to r/o strep
Vaccination was given a few days after beyond use date. Moderna certified that vaccination was safe and effective at time given. No need to revaccinate. Patient reported no adverse effect, only sore are for 2 days.
Diarrhea  temp  fatigue  muscle aches     no appetite.       seen dr      Blood tests done. White and red blood cells elevated.    Dx with reaction to vaccination.
This spontaneous report was received from a licensed practical nurse refers to unspecified number of patients of unknown demographics. The VAQTA (lot#, expiration date and route not reported) that underwent an unsupported temperature excursion "may have been administered" to these patients. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Information has been received from a healthcare worker (also reported as medical assistant (MA) referring to unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. ON unknown dates the patient was vaccinated with doses of improperly stored (Oka-Merck) PROQUAD or (Oka-Merck) VARIVAX (lot # and dose not reported). Information regarding concomitant medications was not reported. No adverse effect reported. Additional information has been requested.
Patient stated they felt extreme muscle aches in lower back which radiated to chest. Feel shortness of breath and a dry cough