chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported onset of nausea, vomiting, L arm pain with swelling, headache one day following receiving anthrax vaccination. Symptoms lasted until 3/10/08.
Patient had trouble breathing, passed out, and defecated oneself about an hour after receiving shot.  Store manager called EMT services and they took care of patient. Store manager informed pharmacy of the event after patient was taken care of. Pharmacy reported event afterwards.
12/31/2020--within the hour of vaccination, tingly sensation of the right arm with mild soreness. 01/01/2021--immense soreness of the right arm, unable to even lift arm above head without feeling pain, extreme sensitivity on the area where shot was given. Extreme weakness, unable to even rip a napkin.  01/04/2021--unexplainable neck and shoulder pain on the right side (where vaccine was administered).  Tensed neck and should joints, fatigue, lacked appetite.  01/05/2021--continued neck and shoulder pain on right side.
I had a runny nose and a slightly sore throat. I also had a low-grade fever. It was very mild but since I was scheduled for an operation the following day, the symptoms became more severe than the previous day. I called my doctor and was prescribed. I began taking the treatment the next day. My symptoms had worsened by this point. I began to feel alright for 3 or 4 days and remained positive until December. I had mild symptoms that had been gone before the test reflected that I was negative for the virus.
Initial information received on 13-Jun-2018 regarding an unsolicited valid non-serious case received from a physician. This case 18 year old patient who received two doses of MENACTRA (batch number, expiry date, route and site of administration were not reported) on the same night at two different offices when she supposed to get MENINGOCOCCAL VACCINE B "meningitis B". It was a case of actual medication error due to Wrong vaccine administered and Extra dose administered. No adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Dizziness, fatigue, felt faint. In medical tent, patient closed her eyes and looked very tired. Has hypertension -- NP thinks it is possibly undiagnosed hypertension. 911 called at 3:05PM, patient taken to emergency room.
Headache; Body chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Body chills) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (Fever). On 12-Mar-2021, the patient experienced HEADACHE (Headache) and CHILLS (Body chills). At the time of the report, HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Body chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
One day after vaccination, developed papulo-vesicles isolated in face, spreading to rest of body (few in arms, trunk, legs), no mucous involvement, not in palms or soles, dry lips present until today, little pruritus. Low grade fever on day 2-3 after vaccination. Fine otherwise Seen today (day 6) at our office, to observe if  rash resolves spontaneously
No additional AE details or PQC; HCP stating a patient was inadvertently administered an expired dose of ROTATEQ which was expired. No additional AE details or PQC.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 21-MAR-2022, the medical assistant stated that a patient was inadvertently administered an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 ml orally, lot# T033634, expiration date 16-MAR-2022, for prophlaxis (strength and frequency were not reported)(expired product administered). No additional adverse event or PQC reported.
No additional AE; The patient was vaccinated with an expired PNEUMOVAX23 vaccine; This spontaneous report was received from an officer manager concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.     On 10-AUG-2020, the patient was vaccinated with an expired vaccine of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml (route of administration and anatomical location were not reported, lot number: R034249 and expiration date: 07-AUG-2020) for prophylaxis (expired vaccine used). No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: R034249; expirationdate: 07-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
After receiving BEXSERO she has been throwing up, chills and felt lightheaded yesterday after 2 hours of receiving shot pt. State she did not faint and has no lump or redness were vaccine was given.
Developed shortness of breath.  To ER and then hospitalized.  Oxygen therapy and lasix given.  Possible excerbation of HF.    Hospitalized 2 days at Hospital .  Discharged home with PCP follow up.
approx 16 hours after I received the vaccine I awoke in excruciating pain. My back hurt so badly I was having trouble walking and both upper arms felt as though they were in a vice. I had been warned that side effects might be significant but this was like nothing I had ever experienced. I spent the next 15 hours in pain and at first I worried that somehow I had gotten the virus. At about 4:30 am the pain disappeared and it was like I had never even experienced it.  I am reporting this because of the extreme pain I had and the odd way it just disappeared with no after effects. I did not seek medical attention because I felt fine by the time doctors offices would have been open.
As I was documenting inputting vaccine information in patients chart I realized vaccine had expired 4 days ago. Patient had already left office and I reached out to leadership right away to let them know and informed the provider about vaccine expiration.
Patient came into the office on 7/26/2019 with sudden onset of severe weakness, fatigue, intermittent muscle cramps, headache, chills and dizziness 12 hours after Shingrix vaccine.   Magnesium, CBC and CMP labs were done at visit.  Patient was advised to take Meloxicam and Tylenol for the pain/body aches, stay hydrated and maintain a light diet.
pain in the right forearm; shoulder joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: ER8734) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "pain in the right forearm"; ARTHRALGIA (non-serious), outcome "not recovered", described as "shoulder joint pain". The events "pain in the right forearm" and "shoulder joint pain" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of pain in extremity, arthralgia.  Additional information: One week after the first dose, the pain in the right forearm started till now (6 months). Later, he felt shoulder joint pain until now. The patient visited urgent care for arm pain and told the doctor he recently got COVID19 vaccine. The doctor said that the arm pain was due to the problem with his working gesture, like using computer for long time, so there was no treatment for the arm pain. Because he still have right lower arm and shoulder joint pains now and they happened just after he got vaccine, he believe that arm pain came from the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
This report was received from the investigator on 20 May 2010. A 20 year-old male subject with medical history significant for dizziness/fainting spells received the following vaccine on 17 October 2009: ACAM2000 (lot number not reported). The subject was vaccinated two weeks prior to that on 03 October 2009 with influenza split virus vaccine (manufacturer and lot number not reported). Nineteen days after vaccination with ACAM2000, on 05 November 2009, the subject was diagnosed with non-specific myocarditis. The subject had an abnormal electrocardiogram result on 30 October 2009 and an abnormal Troponin I result of 7.90 on 30 October 2009. Echocardiogram results were not reported. No further information was provided. Additional information will be requested from the investigator. There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Starting roughly 10 days after second dose, developed chest pain down center of sternum, regular shortness of breath, and intermittent heart racing\palpitations.   Issue has continued for nearly 6 months, and does not seem to have improved.
AFTER RECEIVING THE VACCINE SHE FELT NERVOUS AND ANXIOUS. ON SITE EMS RESPONDED AND VITALS ARE BELOW. SHE WAS GIVEN GRAHAM CRAKERS SINCE SHE HADN'T EATEN YET TODAY. SHE FELT BETTER AND WAS RELEASE TO HOME
This is a spontaneous report from a contactable other healthcare professional, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 16Mar2021 at 07:30 (at the age of 47-year-old) as a single dose for COVID-19 immunization. The Patient's Medical history included Depression, arthritis, hypothyroidism and rhinitis from unknown date. Concomitant medications included Escitalopram (MANUFACTURER UNKNOWN), Levothyroxine (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates.  Allergies to medications, food, or other products were reported to Iodine contrast dye. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not tested positive for COVID-19 since the vaccination. The patient experienced lightheaded and Dizziness on 17Mar2021. Adverse event was resulted in Doctor or other healthcare professional office/clinic visit and Treatment included  Hydration by drinking water and vertigo medication. The clinical outcome of the Dizziness was unknown. No follow-up attempts are needed. No further information is expected.
Case number PHHY2011CA83756 is an initial literature report received on 16 Sep 2011. Authors described about novel influenza (H1N1) infection in pediatric renal transplant recipients who were vaccinated with influenza H1N1 vaccine. This report refers to a pediatric patient (age less than 18 years) of unknown gender. The patient's medical history included renal transplant. The patient received induction therapy consisting of five doses of daclizumab (1mg/kg) at two weeks intervals starting the day of transplant. Concomitant medications also included prednisone 0.08 mg/kg/day, mycophenolate mofetil 675.7 mg/BSA/day and sirolimus 0.06 mg/kg/day. The patient was vaccinated with influenza H1N1 vaccine (manufacturer and batch number: unknown) on an unspecified date. After vaccination (within 10 days), the patient developed H1N1 influenza infection which got confirmed. The patient received either oseltamivir or antibiotic medications and supportive treatment for the same. The length of H1N1 course was in range between 3 to 14 days. Authors stated that the clinical course of influenza (H1N1) infection in pediatric renal transplant recipients was generally mild and posed neither significant morbidity nor mortality when supportive treatment and oseltamivir were administered. Authors also mentioned that it is unlikely that H1N1 vaccine administration played a significant protective role as longest interval between vaccine administration and presentation with illness observed was only 10 days.
This is a spontaneous report received from contactable other HCP (patient). A 33-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 33, in left arm, on Jul 6, 2021, at 18:00, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient had chest pain/tightness in chest/chest discomfort; all onset Jul 7, 2021, at 12:00, with outcome of unknown. The events were evaluated at an emergency room visit. It was unknown if therapeutic measures were taken as a result. Follow-up attempts completed. No further information expected.
She thought it may be mass on her breast because  there is pain right under her breast; there's nothing wrong with her; She thought it may be mass on her breast because  there is pain right under her breast; there's nothing wrong with her; This is a spontaneous report received from a contactable consumer (Patient's friend). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on an unspecified date as unknown single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient thought it may be mass on her breast because there is pain right under her breast; there's nothing wrong with her. It was reported that, patient got her mammogram because she thought it may be mass on her breast because there was pain right under her breast and there was nothing wrong with her but she was having these symptoms on left side where she got the shot. The outcome of events was unknown.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021442419 same reporter/ product, different patient
Slightly swollen red area around injection site.  Slightly sore and warm.  It happened sometime during the second day after injection.   Vaccine was given on Friday at 1:30 and sometime later on Sunday evening I noticed the red area when getting ready for bed.  Sorry I can't be more exact on the timing.
I received the vaccine on December 28, 2021. I started to notice symptoms of a red rash / hives spread on my back neck chest area on Sunday, January 9 and I took Claritin. The rash continued to get worse and popping up in random spots on my body even while taking Claritin or Benadryl.  By Tuesday, December 11 I started to have chest pains too. Feeling like squeezing sensation in the middle of my chest behind my breast bone also felt hard to swallow and like something was stuck in my chest. The chest pains continued through Wednesday until it got bad enough to go to the ER early in the morning on Thursday, January 13. At this point I had also noticed the injection site had become red with pus and had a small lump under it that was tender to the touch. Upon my visit they performed an EKG 12 lead imaging test as well as a chest x-ray and some bloodwork which came back normal. They believed it was likely  all the symptoms could be allergic reaction from booster they thought that chest pain may be pericarditis and to treat with 600 mg of ibuprofen every six hours for two days and also acid reflex and to take over-the-counter anti-acid like Tums. For the postulate they started a five day course of antibiotics of 100Mg doxycycline hyclate. For the rash they prescribed 50 mg tablets of prednisone for four days and also instructed to take 10 mg of Zyrtec three times a day and 20 MG of Pepcid as well as Benadryl until it goes away. Chest pain symptoms seem to improve with these regimen however the rashes and hives continued. The prescriptions finished on Monday January 17th. I had an already scheduled appointment on Tuesday the 18th with a dermatologist who noted all the information and instructed to continue using the Zyrtec 2 times a day. By Tuesday night the chest pains returned and continued to become worse and I reached out to the doctor and she prescribed another round of prednisone taper to help with the allergic reaction. I started that on Thursday Jan. 20th and chest symptoms began to improve immediately however rashes still pop up randomly. At this point in time the steroids seem to keep the chest pain at bay however the rashes keep popping up and it seems more now that whatever touches my skin leaves a mark. The steroid prescription will be done on February 1 and I have a follow up doctor appointment on 31 January to review everything.
Feels sick; Diarrhea; Muscle ache; Feel fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Feels sick), DIARRHOEA (Diarrhea), MYALGIA (Muscle ache) and FATIGUE (Feel fatigued) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION COMPLICATION (Feels sick), DIARRHOEA (Diarrhea), MYALGIA (Muscle ache) and FATIGUE (Feel fatigued). At the time of the report, VACCINATION COMPLICATION (Feels sick), DIARRHOEA (Diarrhea), MYALGIA (Muscle ache) and FATIGUE (Feel fatigued) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant medications were reported.No treatment medications were reported. At the time of reporting patient noticed they had the symptoms of the virus infection.
Information has been received from a certified nurse midwife concerning a 14 year old female who on 10-JUL-2008 was vaccinated with a second 0.5 ml dose of GARDASIL by intramuscular injection (lot number and injection site not reported).  Several days later, the patient developed pharyngitis, pain (unspecified), swelling (unspecified), fever, dizziness and malaise.  The patient was hospitalized for several days.  She was treated with a MEDROL dose pack.  At time of this report, the patient's events persisted.  Additional information has been requested.
Hospitalization for fatigue and low urine output and then diagnosed with COVID-19  on dates 5/19/2022- 5/21/2022.  Treated with Vitamin C 1000mg PO daily, Vitamin D3 25mcg PO daily, zinc sulfate 50mg PO daily,
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: patient states unable to take her maintenance meds for 3 days
One week after the injection I had redness , swelling  and itching to injection site. The redness, swelling and itching continued to spread throughout my upper arm and was almost to my elbow. On 01/06/21 I was seen by physician and received a Kenalog 40mg IM injection and oral steriods for the reaction. Also have been taking benadryl.
Patient briefly passed out  within 5 minutes of receiving the vaccination.  He came around within 15 seconds of passing out.  He was responsive.  He was sitting down when he passed out.  He did not fall or injure his head.
vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reported no adverse reaction.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that other medical history and known allergies were noted as unknown. Other medication in 2 weeks reported as unknown. Antiviral details noted as patient received Paxlovid (administrator route noted as oral) for treatment of Covid-19. Treatment start date was reported as 05Jul2022 and stop date was reported as 09Jul2022.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known the information available the Causal relation between the events and suspect drug cannot be excluded completely.
Circular red rash on injection arm, adjacent to the actual injection site. No pain, but some itchiness.