chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm soreness; pregnant at the time of vaccination (gestational period: 20 weeks); pregnant at the time of vaccination (gestational period: 20 weeks); pregnant at the time of vaccination (gestational period: 20 weeks); This is a spontaneous report from a non-contactable other healthcare professional (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1681), via intramuscular route of administration on 18Jan2021 at 12:00 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included allergies to penicillin. Concomitant medications included prenatal vitamins and cetirizine hydrochloride (ZYRTEC).The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that patient was pregnant at the time of vaccination (gestational period: 20 weeks). On an unspecified date, the patient experienced arm soreness but did not receive any treatment for the event. The event arm soreness was considered non-serious. The last menstrual date was reported as 28Aug2020. The mother was due to deliver on 04Jun2021. The patient underwent lab tests and procedures which included nasal swab test and PCR on 18Jan2021 and both were negative. The outcome of the event arm soreness was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
The day following my vaccination, I woke up to cramps and some spotting. I don?t typically bleed or have periods on my birth control, so this was out of the ordinary. It lasted for the day.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date RECOMBIVAX HB (lot#, expiration date and route not reported) that underwent an unspecified temperature excursion "may have been administered" to these patients. No adverse effects reported. This is one of the several reports from the same source. Additional information has been requested.
Excessive crying - screaming throughout the evening with shot given at 4:30 pm.  Difficult to sleep - up x2 after down for the noc. Crying episodes lasting 30 min x2. Child was fretful - finally quieted after walking. Nightly episodes have continued from that initial noc.
Within 30 mins of getting the shot I had a headache and a tingling face.  Within an hour and 15 mins the glass in the throat in the front and back started to swell and face remained tingly.
Information has been received from a medical assistant concerning a 14 year old female with type 1 diabetes mellitus and no known drug allergies who on 13-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine. On 16-JUN-2008 the patient was vaccinated with the second dose of GARDASIL vaccine. The patient was vaccinated at another facility. On 18-JUN-2008, the patient experienced vomiting. Subsequently, the patient recovered from vomiting. The patient sought unspecified medical attention. No further information is available.
9/13/21: Patient arrived at the ER due to worsening cough and shortness of breath.  Per patient she returned from traveling on last Tuesday and since then experiencing worsening shortness of breath with exertion and dry cough.  Associated with chest tightness and congestion and fatigue.  The patient also reported recurring fevers.  The patient was exposed to COVID-19 cases while traveling.  The patient went to Clinic on Friday, COVID test was negative and the patient was started on doxycycline.  Despite taking the medication her symptoms were getting worse therefore she decided to come to the ER. Patient tested positive for COVID on 9/13/21.
Cellulitis bilateral deltoid area; red swollen both sides. Rx: KEFLEX 400mg tab siq: 1 PO BID x7 days.
This spontaneous report as received from a pharmacist via a company representative refers to multiple patients of unknown age and gender. On an unspecified date because of a system error this multiple patients received 2 doses of ZOSTAVAX (lot # unspecified), subcutaneous injection, dose and location unspecified. No adverse effects were reported. The patients did not seek medical attention. Additional information is not expected.
neuropathy; dermatomal pain; suffered multiple outbreaks of herpes zoster; suffered multiple outbreaks of herpes zoster; myalgias; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 04-OCT-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On an unknown date, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster, dermatomal pain, neuropathy and myalgias. As a result of these symptoms, the patient was seen and treated by a medical provider and was still under their care. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using Zoster Vaccine Live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental, anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of neuropathy peripheral, shingles, herpes zoster reactivation, pain and myalgia was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event Neuropathy peripheral was considered to be medically significant.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 14-year old male patient, who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 13-FEB-2014. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Parents were informed and declined to revaccinate. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Redness and swelling of L shoulder. Area of erythema is about 10 cm in diameter, no fever, pain, mild itching, started a little over 24 hours after vaccine.
Intense joint swelling, most significant at knees and elbows with some involvement of the wrists, ankles, and fingers.   Arm rash that spread to upper left chest
pt being seen for exam p/Er visit for asthma, about 15-20min p/vax start wheezing;devel some rash on neck & back (erythemic ? hives);over course of an hr relieved albuterol nebs x 2;prelone & DPh w/complete recovery;
29JUL91 had diarrhea; 30JUL91 had severe h/a & vomiting, also had large area of erythema around inject site; On 31JUL91 vomiting, diarrhea & h/a had gone, but continued w/erythema;
HIGH FEVER ONSET ON 10/20/2009.  MOM REPORTED TEMP OF 106.
My left arm is very tender in the underneath side, deep into my arm. Doctor feels it was a vaccine reaction. Muscle pain that is somewhat sore and at times very painful when moving arm.
This is a spontaneous report from a physician referring to a 60 year old female who, 7 days post vax, on 3/20/2000, experienced elevated liver function tests and intense pruritis. A doctor visit was required. No treatment was given. Havrix was discontinued. Her liver function continued to deteriorate. The most recent information, received on 3/24/2000, reports the vaccinee is now well and presumable disease free since all her pathology was negative. She is also symptom free and her itching and liver function tests have returned to normal.
headache; fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021 at 4:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications  were not reported
weird pain right beneath chest  in upper part  of ribs; had pain whenever turn back , lift or push out of the bed; pain right beneath chest  in upper part  of ribs and also right behind the back; body sore/  body ache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (weird pain right beneath chest  in upper part  of ribs), PAIN (had pain whenever turn back , lift or push out of the bed), PAIN (pain right beneath chest  in upper part  of ribs and also right behind the back) and MYALGIA (body sore/  body ache) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (weird pain right beneath chest  in upper part  of ribs), PAIN (had pain whenever turn back , lift or push out of the bed), PAIN (pain right beneath chest  in upper part  of ribs and also right behind the back) and MYALGIA (body sore/  body ache). At the time of the report, CHEST PAIN (weird pain right beneath chest  in upper part  of ribs), PAIN (had pain whenever turn back , lift or push out of the bed), PAIN (pain right beneath chest  in upper part  of ribs and also right behind the back) and MYALGIA (body sore/  body ache) outcome was unknown.
Patient is 60 years old with past medical history of diabetes presented to the hospital with a chief complaint of shortness of breath associated with hypoxia.  Patient was found to have a low pulse ox.  She was placed on 2 L nasal cannula which helped improve the pulse oxygenation.  Patient was found to have COVID infection.  When seen, patient was resting in bed comfortably.  Otherwise patient has no chest pain, abdominal pain, nausea, vomiting, diarrhea, constipation, difficulty urination, dysuria, fever, chills.   In the ER, patient had a CT angiogram which was negative for PE.  It showed mild COPD changes.  HPI per admitting hospitalist       Clinical Summary   Clinical course Include/ Problem list Acute hypoxic respiratory failure secondary to Covid 19 respiratory infection:   Vaccination Status: Vaccinated   -Symptom onset: Last Thursday, 2/9/2023; however patient states that she has had COVID in January 2023   -Test positive: 2/14/2023, not detected at this facility   -ED presentation: Presented to the emergency department with shortness of breath, and hypoxia oxygen saturation 88% on room air   -Today: Continued hypoxia, patient placed on oxygen oxygen saturations greater than 90%.  Patient long-term smoker   -Decadron: 6 mg daily   -Remdesivir: Initiated today     -Continue: decadron, albuterol inh qid, vitc/vitd/zinc/melatonin, and mucinex   -Monitor inflammatory markers qod (CRP, ddimer, LDH, ferritin, fibrinogen)  ?Begin chest physiotherapy, budesonide.  CTA negative for PE albuterol every 4 MDI  Acute exacerbation of COPD DuoNeb every 4 hours I will continue his steroid Chest physiotherapy
Headache at back of head where tenth cranial nerve is located. Tiredness.Dysphonia diagnosed. Vocal paralysis started right after shot.Three months later I still have the paralysis.
This patient had generalized hives, fever of 105 for 24 hours after his shots. He was vomiting. He was very lethargic and the rash continued. Because of the severity of the reaction the pt was hospitalized. He was observed for 48 hours and then subsequently discharged and he never had any problem. In the past he has never had any adverse reactions to immunizing agents.
Starting July 12, severe chest pains. Eventually went to urgent care and had fluid in my lungs with possible pleural effusion and swelling in the chest. It is now February 2022 and I am still having chest pains and had a swollen chest. My specialist said it was likely an adverse reaction to the vaccine.   Also, shortly after the second injection my period because irregular. It has been regular my entire life. My body no longer ovulated and it wasn't until December 2021 when I started ovulating again. I took the vaccine prior to trying to conceive and it has hampered my progress of getting pregnant as it messed up my fertility.   I'm still not sure if I have permanent damage to my heart from the vaccine and I was recommended to get an echocardiogram. I have selected disability/permanent damage in item number 21 as it is currently causing issues in my day-to-day life.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 04-FEB-2015, the patient was vaccinated with M-M-R II (lot number: K002816 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with M-M-R II was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
pt recvd vax & w/in 30 mins p/vax exp vomiting, nausea & fever; these sx lasted 2 days; pt recovered w/o treatment;
A non-serious spontaneous report of severe headache has been received from a nurse concerning a 13-year-old female, subsequent to FLUMIST. No relevant medical history has been reported for this patient, who also received a HPV injection at the same time as FLUMIST. The patient received FLUMIST on 13-Oct-2008. The patient experienced a severe headache on 13-Oct-2008 after receiving FLUMIST and the HPV. The reporter stated that the patient was apprehensive about getting the HPV injection and thinks that the headache may have resulted from the patients intense apprehension related to receiving the HPV injection. The patient presented to the ER  and CAT scan was negative on 14-Oct-2008. The headache resolved on 15-Oct-2008. Additional information received 08-Jan-2009 and incorporated into the case: outcome and resolution date.
rapid onset, 4-5hrs p/vax receipt, of transverse myelitis sxs; complete paralysis of lower extremities, loss of bowel control; had 2 prev doses of vax; OCT94 prev doses of vax, OCT94, NOV94 because unk past immun history
PATIENT WAS GIVEN PNEUMOVAX 23 FIRST, IMMEDIATELY AFTER GIVING THE SECOND SHOT WHICH WAS BOOSTRIX, PATIENT FELT DIZZY, LIGHTHEADED AND EXPERIENCED FLUSHING AND SHORTNESS OF BREATH. WE OFFERED HER BENADRYL AND EPIPEN INJECTION AND TO CALL 911. SHE REFUSED AND REJECTED THE OFFERS. A FEW MINUTES LATER, SHE SAID SHE FELT BETTER. AFTER WAITING NEAR THE PHARMACY FOR 30 MINUTES, SHE SAID SHE WAS FEELING BETTER AND SAID SHE WAS ABLE TO GO HOME.
This case was reported by a consumer and described the occurrence of Hepatitis in an 11 year old female subject who was vaccinated with Hep A vaccine inactivated (Havrix) for prophylaxis. The reporter is the father of the subject. A physician or other health care professional has not verified this report. The subject medical history included no known allergies. On 10/10/06 the subject received 1st dose of Havrix in the left arm. On 10/10/06, the subject also received tetanus toxoid vaccine. On 10/16/06, 6 days after vaccination with Havrix, the subject experienced hepatitis, fever, abdominal pain, clamminess, jaundice, hives on the back, itching, nausea, vomiting, and fatigue. On 10/22/06 the subject was seen in the ER. At that time, blood work revealed an elevated bilirubin. An ultrasound revealed no gallstones. It was determined that the subject had no food borne illness and Epstein Barr was ruled out. At the time of initial reporting, 10/27/06, the events were ongoing. Hepatitis, jaundice, and elevated bilirubin were assessed as medically serious by manufacturer (OMIC).
Swollen tongue, left arm swelling, warm to touch, difficult breathing, SOB, fever.
Patient administered moderna covid vaccine while temperature excursion was ongoing; Patient administered moderna covid vaccine while temperature excursion was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) in an 89-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter confirmed that patients had been administered doses while the temperature excursion assessment was ongoing.  No treatment medications were reported.
Pt received vaccine 10/22/18 11:30 AM. Pt first experienced soreness at 10/22/18 7:00pm in deltoid. The adverse symptoms later worsened to extreme muscle stiffness in the lower back and lower extremities. The pt described the muscle stiffness resulting in immobility. All symptoms gradually resolved by 10/26/18.
On Thursday, March 11(1 week, 1day after injection) there was swelling of injection site and itchiness .
Diarrhea; Administered only the liquid portion of the vaccine / Vaccine was not mixed with the powder prior to administration; Inappropriate dose of vaccine administered; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2019, the patient received the 1st dose of Shingrix. In October 2019, unknown after receiving Shingrix, the patient experienced pain in arm. On 22nd October 2019, the patient experienced diarrhea, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the diarrhea, pain in arm, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the diarrhea and pain in arm to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the patient's husband. The patient was administered only the liquid portion of the vaccine, which led to drug reconstitution and inappropriate dose of vaccine administered. The patient experienced diarrhea later that evening. The patient also experienced a sore arm. The reporter consented to follow up. This case has been linked with case US2019193748, reported by the same reporter.
Initial health authority report received on 05 Jan 2010: This patient was vaccinated with H1N1 influenza virus vaccine (manufacturer unknown) intramuscularly, on 27 Nov 2009. The patient experienced visual hallucination and dysarthria on 29 Nov 2009. Outcome of the events were not reported.
Tested COVID positive on July 19. Negative test on July 17.  Symptoms: lethargic, congested, slight runny nose, slight soreness in throat Have started taking PAXLOVID. At this point have taken two of the prescribed ten doses.
Swelling. Pt described as "the same as when I get stung by bees".
Local reaction MMR injection, 5cm area of erythema with central urticarial area of 1cm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (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 Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had taken Paxlovid as COVID 19 Treatment from 26Apr2023 to 30Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182610 Same patient, different drug, different event;