chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt a minor pain in my throat, the soft pallet was swollen, this was on Monday. I was wondering if this could possibly be COVID-19 as I had just returned from a trip. On Tuesday I went to the Doctor and had a PCR test done and was alerted late that evening via the online medical record that it was positive for COVID-19. Once I tested positive, I was given a prescription for Paxlovid but did not take it. The sore throat went away fairly quickly, I still have some congestion and a bit of a cough but otherwise in general I feel fine. I never had a headache or fever.
I tested positive for COVID-19 on 12/4/22. I had a cough, congestion, runny nose, and fatigue. I tested positive at home and contacted my doctor through email. They did not prescribe any medications and I did not take any over-the-counter medications either. I am feeling much better now. I still have some sniffles and a slight cough, but that is it.
I noticed a rash on the back of both of my hands two days after in the area where the band aid was at the site of vaccination. The band aid mark was there for eight days Five days after the rash had moved to include a similar spot on my other arm and on my neck. I tried to take antihistamines, but the rash did not get better It was little spots that were red and raised and bumpy but not too bothersome. Six days after the vaccine the rash was on my arms, chest, hand and on the back of my heels. By eight days after the shot most of the rash had continued to decrease and now it is almost gone. Due Date 09/22/2021 Second Pregnancy
fatigue; pain at injection; Chills; low grade fever; This case was reported by a other health professional via call center representative and described the occurrence of fatigue in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, injection site pain, chills and fever. On an unknown date, the outcome of the fatigue, injection site pain, chills and fever were unknown.   It was unknown if the reporter considered the fatigue, injection site pain, chills and fever to be related to Shingrix.  Additional details were received as follows: The age at the vaccination was not applicable for this report. There are many patients have side effects from the Shingrix vaccine that were more common than many other vaccines. The reporter got that and still encourage the patients to get the vaccine. But significant enough that patients were sometimes nervous about the 2nd injection.  The usual side effects were fatigue, pain at injection site, chills, some grade fever. HCP did not have any patient specifics or vaccine details. The reporter was inquiring if the side effects were less severe with the 2nd dose as opposed to the 1st dose. The reporter gave consent to follow up.
ACTHIB vial with an expired diluent twas given to a patient; Initial information received on 14-Apr-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 23 months old female patient who received ACTHIB vial with an expired diluent twas.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  On 13-Apr-2023, the patient received suspect HIB (PRP/T) VACCINE Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test = 0.5 ml (lot UJ671ABA, Expiry date: 27-May-2023) via intramuscular route in the right vastus lateralis for prophylactic vaccination (immunization).  On 13-Apr-2023 the patient diagnosed with a non-serious acthib vial with an expired diluent twas given to a patient (expired product administered) (same day latency) following the administration of HIB (PRP/T) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown    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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Pt reports 3/13/15 that the day of shots she began running a 101 degrees-body aches, HA, nausea et joint pain. Reports she started feeling better 3/12/15 but still feels "like I have the flu."
Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003963 is a spontaneous case report initially received on 05-Oct-2022 from nurse via Communications (reference number: USBAV22-1628) and concerns a patient of unknown demographics (eighth out of ten).  The patient's medical history and concomitant medication details were not provided.  On 3-Oct-2022 and 4-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse via Communications (reference number: USBAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003956, US-BN-2022-003958, US-BN-2022-003959, US-BN-2022-003960, US-BN-2022-003961, US-BN-2022-003962, US-BN-2022-003964 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Client came in 11/19 and bruise was noted in (L) deltoid area. Pt reports 11/6 pm arm became sore. Noted 11/20 arm continued to be sore and seems like it is getting worse. No swelling or heat in area. Pt c/o decreased strength and pain with movement that radiate almost to elbow.
8/11/2021 received vaccine dose #1. 8/13/2021 6 am woke up with heavy bleeding. She was not due for her period. Bleeding lasted 3 days. Started bleeding again 8/29/2021. Started menstrual bleeding again and lasted 2 days. Had already bled at the beginning of the month, so ended up with a total of 3 episodes of bleeding in same month. Bleeding heavier than her usual menstrual bleeding. Also had body aches and severe abdominal pain on 8/18/2021. She thought it was bad gas. She bought Gas-X and was not relieved.
pt recv vax 17APR96 & on 5MAR97 pt devel pox lesions on face & head;6MAR97 pt presented to a MD;@ time  pt had approx 10 pox lesions;
p/last shot in lt arm, burning pain 1-2 min, next day pain up & down rt arm w/ bad h/a on & off  2 days.  July 98 to present, could not sleep until entire lt & rt legs rubbed down w/heat rub to make muscle pain go away, ongoing fatigue
The patient felt tired and describes her eyes going dark, then passed out a few minutes after vaccination.  She was vaccinated and then left the immunization room to sit down for a 15 minute waiting period.  When she went to sit down, she collapsed on the floor.  Her mother assisted her into a chair.  She continued to be incoherent and have her eyes rolling back into her head for a few minutes.  We used a cool cloth on her forehead and the back of her neck.  The parents requested that we call 911.  EMS arrived shortly and evaluated her.  Heart rate, blood pressure, pulse ox, blood sugar and chest sounds were all within normal range.  The patient stated that her arm felt heavy and "funny".  She then stated that her tongue felt funny.  EMS evaluated her tongue and said it looked normal.  To err on the side of caution, she was taken to the hospital to determine whether or not she was having a delayed onset anaphylactic reaction.  This patient has no history of seizures.
This spontaneous prospective pregnancy report as received from a medical assistant refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates the patient was vaccinated with GARDASIL 9 dose 1 and dose 2 (dose, route, anatomical location, lot number and expiration date were not provide). The patient was in the office to receive her 3rd dose, but informed that she was currently 11 weeks pregnant. The patient became pregnant with Last Menstrual Period of 11-MAY-2016 and Estimated Delivery Date of 15-FEB-20176. No other suspect medications or concomitant therapies were reported. No product quality complaint was involved. Then, on an unknown date the patient experienced maternal exposure before pregnancy. The Medical assistant stated that the patient did not received a vaccine during pregnancy.  The outcome of the event was unknown. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On 18-JUN-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot number L005295 and expiry date 17-AUG-2016) (dosing, regimen, route were unknown). No concomitant medications were reported. No adverse effects were reported. There was no product quality issue reported. Follow up information was received on 10-JUL-2015. It was reported that lot number L005295 with an expiry date of 17-AUG-2016 is a valid lot number for PROQUAD (Merck). On 03-AUG-2015, a phone call was made to the certified medical assistant. The phone call went directly to voice mail. A voice mail message was left requesting that the certified medical assistant return the phone call. Additionally, a request was made for patient identifiers, lot number, expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from the reporting Certified Medical Assistant (C.M.A.) during a phone call on 05-AUG-2015. The C.M.A. reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding an 8-year-old patient of unknown gender. On 06-JUL-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L005295. This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, event information and narrative were updated.
About 5 min after receiving her Janssen vaccine she became nauseated, light-headed and flushed. Gave her a cold pack for her head. BP 1st time was 58/38, she stated she had a low BP and that she usually had trouble any time she had any kind of procedure. Gave her some water and crackers(she had not eaten) and the 2nd bp was 72/45 and her 3rd 80/58. She stated she felt better and refused us to call an ambulance. The person with her stated they would take her to the ER. Tried to call pt twice, no response. Will continue to follow-up with patient.
Right arm sensitive to the touch; Injection site is hot to the touch; Fever; hard 1.5 inch diameter around the injection site; redness in right arm; Pain in right arm; Right arm swollen; slight pain on the left arm after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA (Right arm sensitive to the touch), VACCINATION SITE WARMTH (Injection site is hot to the touch), PYREXIA (Fever), VACCINATION SITE INDURATION (hard 1.5 inch diameter around the injection site) and VACCINATION SITE ERYTHEMA (redness in right arm) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERAESTHESIA (Right arm sensitive to the touch), VACCINATION SITE WARMTH (Injection site is hot to the touch), PYREXIA (Fever), VACCINATION SITE INDURATION (hard 1.5 inch diameter around the injection site), VACCINATION SITE ERYTHEMA (redness in right arm), VACCINATION SITE PAIN (Pain in right arm), INJECTION SITE SWELLING (Right arm swollen) and INJECTION SITE PAIN (slight pain on the left arm after the vaccination). At the time of the report, HYPERAESTHESIA (Right arm sensitive to the touch), VACCINATION SITE WARMTH (Injection site is hot to the touch), PYREXIA (Fever), VACCINATION SITE INDURATION (hard 1.5 inch diameter around the injection site), VACCINATION SITE ERYTHEMA (redness in right arm), VACCINATION SITE PAIN (Pain in right arm), INJECTION SITE SWELLING (Right arm swollen) and INJECTION SITE PAIN (slight pain on the left arm after the vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2021-079539, MOD-2021-079539.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Live follow up received on 16-Apr-2021: Event related information added. On 11-Jul-2021: Updated event outcome from unknown to recovered resolved
Hands have turned blue on two occasions for 6-7 hours. Occurring 19 days and 24 days after vaccine. Phone contact made with nurse at doctor's office, after first occurrence, who advised no appointment necessary and to continue to monitor. Last occurrence was yesterday 2/1/20 in the evening, which has now resolved.
Starting on Sat 5/22/21 @ 8pm began to get pain all over body. By midnight I was in SEVERE pain (9). I could not sit, stand or laydown without pain.  I took 3 Tylenol  500 mg tablets and 1 benedryl.  At 6am I took two more Tylenol 500 mg  tablets.  I paced the floor trying to endure the pain,  finally subsided @ 5am and I was finally able to lay down and get some sleep.   Currently, my left arm is red, hot, sore, itchy and swollen at the injection site (this happened with first shot also).   I feel weakness in both arms and some pain in my lower back.
Initial report was received on 19 July 2012 from a healthcare professional which involved a cluster of two infant patients who had received PENTACEL, lot number C4144AA. One of these two patients (not specified) had also received a second dose of PENTACEL (lot number C4165AB). This case captures one patient. The other patient has been captured in case number 2012-07018. A four-month-old patient (sex and date of birth not reported) had received an injection of PENTACEL, lot number C4144AA (route and site not reported; date of administration unknown) and an unspecified amount of time later, the patient was hospitalized and diagnosed with Pertussis. Outcome was not recovered. No additional information was provided at the time of the report. Documents held by sender: None.
Noticeable but relatively minor pain and swelling in armpit of same arm vaccine received; minor pain in shoulder and pectoral muscle same side. Armpit pain 3/10, other pain 1/10
soreness around injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (soreness around injection site) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness around injection site). On 27-Apr-2021, VACCINATION SITE PAIN (soreness around injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-183009 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of ROTATEQ (dose and lot # not reported) orally after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
supposed to receive PENTACEL yesterday, but was accidentally given the HIB component with no reported AE; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who was supposed to receive pentacel yesterday, but was accidentally given the hib component with no reported ae while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Prophylactic vaccination; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination.  On 25-Oct-2022, the patient received 0.5 mL of dose 2 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (formulation and strength not reported; lot UJ684AAA) via intramuscular route in the intramuscular thigh for prophylactic vaccination.  On 25-Oct-2022, (latency: same day) the patient was supposed to receive pentacel yesterday, but was accidentally given the hib component with no reported ae (product preparation error) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  It was reported, a four month old baby was supposed to receive PENTACEL yesterday, but was accidentally given the HIB component mixed with sterile diluent instead of the DTAP and POLIO component.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Patient received COVID 19  Booster shot on 02/10/2022 LOT#33036BD. Upon returning to the clinic on 02/12/2022.  The patient was lethargic and not feeling well.  Vitals were baseline for this patient. She complained fatigue post treatment.  She returned to the clinic 02/15/2022 and was back at baseline without complaint.
Lost my hearing in my right ear and loud ringing in my ear within 48 hours of receiving my booster
The place of injection became red, itching and painful I had fever I felt dizzy and unsteady I felt extremely weak and sleepy
Fever &  body aches for approximately 24-36 hours post-injection. Site tenderness also.
Neck pain, back pain, fatigue, weakness, muscle soreness in back, injection shot pain, headache, out of sorts - all lasted from 3-4 hours after shot for approximately 48-72 hours
Pfizer-BioNTech COVID-19 Vaccine : Pfizer-BioNTech COVID-19 Vaccine : patient presented to clinic with shortness of breath on exertion for one week. Obtained labs and imaging: found to have bilateral pulmonary embolism and left lower extremity DVT and sent immediately to emergency department where vitals were within normal ranges and the patient was not in respiratory distress. Long car ride 26 days prior to arrival. Patient received heparin, admitted to the hospital, transitioned to a direct-acting oral anticoagulant, and discharged to home medically stable.  On follow-up after discharge patient is doing well and compliant with anticoagulation.
brisk reaction after j&j vaccine has photos was worse residual left foot nonpitting edema all rashes resolved had duplex dopplers negative no h/o clotting disorder  history of adverse reaction to flu shot suggest patch test thimersol await resolution of swelling, elevate leg, black physical therapy ice pack
Swelling and redness at LA extending to axillary region, advised cold pks, 1% HC cream and antiinflammatory agent (Motrin PO).
Reaction next day, became completely mute, stopped walking, diagnosed with severe autism (permanent brain damage to child) immediate minor seizure.
Within 3 min of injection - lightheaded, racing heart beat. Increased PAC sensation. Strong metallic taste.. HR/PACs resolved mainly within 10-15 min. Lightheaded, extreme fatigue and metallic taste eased after about 45 min.
A raised red swollen lesion 2 inch by 2 inch at the site of injection of Flu vaccination in the left arm which is sore to the touch and itches.
Shot given 10/10/11 within 3 hrs. cough, freezing, burning of eyes, mouth burn, dizzy, headache, pain around heart, lungs hurt, hard to breathe, back aches, bones feel like a nail being driven through, feel like I was dying. Feel like I'm dying, very scary, last 1 1/2 days I should have went to E.R. The effect I had would most likely kill older people.
Narrative:  Patient developed nausea and vomiting following administration of second moderna covid vaccine. Was sent to ER for follow up where the patient improved and was subsequently discharged.