chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Employee was administered Heplisav B on 10/4/23 and MMR on 10/6/23. Prior to both vaccinations the employee was asked the questions on the Screening Checklist for Contraindications to Vaccines for Adults, which includes asking about being pregnant. Both times the employee denied being pregnant. An interpreter was used during these interactions. She was educated to avoid pregnancy for 1 month following vaccination with MMR. On 10/9/23, the employee called notifying EHS that she found out she was pregnant. She spoke with EHS provider, who referred her to OB/GYN for follow up. No known adverse outcomes at this time, but did want to document since pregnancy was a contraindication, but again, employee was asked the screening question for pregnancy prior to administration, which she denied pregnancy both times.
pharmacist had given Flublok and the patient complained because she wanted the HD Fluzone with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a pharmacist and transmitted to Sanofi on 12-Nov-2020.  This case involves a 77 years old female patient  to whom pharmacist had given QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) and the patient complained because she wanted the QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) (product dispensing error) at an unknown dose, (batch number and expiry date unknown) at an unknown administration site via unknown route, for prophylactic vaccination.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.   It was an actual medication error case since the patient wanted QUADRIVALENT INFLUENZA VACCINE, however, the patient was provided with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE by the pharmacist (product dispensing error).  At the time of this report, no adverse event symptoms reported.  The pharmacist also reported that the patient stated that in the hospital they gave the QUADRIVALENT RECOMBINANT INFLUENZA VACCINE and not the QUADRIVALENT INFLUENZA VACCINE and the reasons were 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 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.  There will be no information regarding the batch number for the case.
No further AE details; HCP called to report a post TE Administration of VARIVAX Lot #W021741 EXP: 7/10/2024.; This spontaneous report has been received from an office manager and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 25-MAY-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (ml) once (valid lot number W021741 [expiration date 10-JUL-2024]) (dose number, frequency, route of administration vaccination scheme, and anatomical location were not provided), administered for prophylaxis, after a temperature excursion out of range for 0 hours 12 minutes and 0 seconds at -14.09 degrees Celsius, with a prior excursion of -2.2 degrees Celsius for 12 hours 30 minutes 0 seconds (product storage error).   No further adverse events (AEs) details.
No reported adverse event from patient thus far.  Patient was accidently administered a pediatric COVID bivalent dose versus an adult COVID bivalent dose.
Pt developed fever, achiness & L arm pain with swelling at injection site. I spoke with pt on 2/6/06 and her symptoms had resolved.  She had slight soreness of L arm.
Admitted for COVID pna. Fully vaccinated 2/2021. Possible superimposed bacterial pna. Treated with O2, steroids, zinc, vit-c, vit-d, rocephin, azithro. Improved and discharged home.
Patient called almost a month later stating her whole arm hurts still from the shot. All the way from injection site to her fingers. Told patient to ice and take APAP or MOTRIN to see if it helps with discomfort.
This case was reported by a lawyer and described the occurrence of stiff neck in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  The subject's medical history included hernia.  Concurrent medical conditions included back pain.  Concurrent medications included Garlic, Fish oil, Cod-liver oil and Calcium salt.  On 4 May 2000 and 4 April 2000 the subject received 2nd dose and 1st dose of LYMERIX (unknown).  In the fall of 2000, the subject developed general stiffness and knee pain.  In 2001 - 2002 the subject developed hip pain for which he took LODINE.  Several years ago, he developed wrist pain and in 2008, neck stiffness.  The subject at an unknown time developed an exacerbation of low back pain.  At the time of reporting the events were unresolved and were considered to be related to treatment with LYMERIX.  Follow-up information in the form of medical records was received on 25 March 2009.  An evaluation due to subject's knee, shoulder and neck pain took place on 07 April 2004.  The subject's physician suspected cervical degenerative disk disease, internal derangement of the right knee and degenerative disease.  A VAERS reporting form indicated that events of joint stiffness and difficulty walking began on 05 April 2000, just one day following 1st vaccination with LYMERIX.  It was noted that these events resulted in permanent disability.
swelling, redness and itchiness of injection site; swelling, redness and itchiness of injection site; swelling, redness and itchiness of injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling, redness and itchiness of injection site), VACCINATION SITE ERYTHEMA (swelling, redness and itchiness of injection site) and VACCINATION SITE PRURITUS (swelling, redness and itchiness of injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, SIMVASTATIN, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling, redness and itchiness of injection site), VACCINATION SITE ERYTHEMA (swelling, redness and itchiness of injection site) and VACCINATION SITE PRURITUS (swelling, redness and itchiness of injection site). At the time of the report, VACCINATION SITE SWELLING (swelling, redness and itchiness of injection site), VACCINATION SITE ERYTHEMA (swelling, redness and itchiness of injection site) and VACCINATION SITE PRURITUS (swelling, redness and itchiness of injection site) outcome was unknown. Not Provided          No treatment information was provided.
first dose 2019, never got second dose; This case was reported by a nurse and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th August 2019, batch number:BX25K, expiry date: 19th November 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was not immunocompromised and never received second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Shoulder was painful got worse until 10/31. Went to family doctor. Gave steroid shot in shoulder, mobility is getting better. MD thinks shot was given to high on shoulder.
Swelling and hot to the touch of entire upper left arm a kit 10 hours after administration. Coughing then SOB immediately  relieved by 2 puffs of albuterol inhaler   From 10 hours-26 hours severe fatigue, body aches, headache, chills, hot, sweat and leg aches and  weakness continuing at 34 hours
Nausea, sweating, shaking, felt like i was passing out  Lasted maybe 10-20 min. Slowly went away
3:00pm vaccine, 11:15pm chills, 1:50am 100.99 fever/headache/body aches
After Dose 1:Exhaustion, severe thirst, extreme depression, lethargy, couldn't get out of bed, swollen tongue, loss of taste, difficulty breathing (I had to remind myself to breathe!), non-stop headache, sore throat, chills, low grade fever, confusion/ brain fog for the entire 2 1/2 weeks.  Slept 10-16 hours a day for 2 1/2 weeks after first dose. I had a Rapid test after a week, as I was afraid I had Covid. Repeated with a PCR test (per my dr) a week later, as symptoms did not abate. After Dose #2- I had 10 days of exhaustion.
pt recv vax 8JUL97 by morning 10JUL97 area reddened & tender;seen again in ER 10JUL97 in afternoon426PM;area reddened, indurated, inc skin temp 9x9 1/2cm oval;
Incorrect Pfizer covid 19 vaccine administered - should have been pfizer covid 19 bivalent vaccine
Arm pain and swelling, which then turned into a lump on arm with a lot of pain. Having pain in shoulder down to injection spot.
Experiencing frn36 hours now fever of 100.8 to 101.4, migraine headache, extreme fatigue, vivid dreams, arm pain at injection site, nausea, lack of appetite, swollen lymph nodes under arm and side of breast of injection side, body she's and extreme back pain, violent bought a of chills and shaking at least 5 times for 30 to 50 minutes each time, and dizziness. None seem to be subsiding either.
Initial information received on 30-Jul-2018 regarding an unsolicited valid serious case received from a office staff. This case involves an unknown age female patient who experienced Bell's palsy, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. The patient developed a serious Bell's palsy following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. (Other relevant tests included No lab data). Final diagnosis was Bell's palsy. Corrective treatment was not reported. The patient outcome is reported as Unknown for Bell's palsy. Sender's Comments: This case involves an unknown age patient who presented with Bell's palsy post vaccination with FLUZONE. Time to onset is unknown. Bell's palsy is expected post vaccination with FLUZONE. However, patient's medical history, medical condition at the time of vaccination and lab/radiological tests ruling out alternate etiologies were not provided. Based upon the reported information, the role of the vaccine cannot be assessed.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 24 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Congenital heart defect" (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 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I was negative for Covid; Positive, notes: showed I was positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid. Clinical course: After completing paxlovid treatment, she immediately felt better. Took a Covid test 3 days after treatment which showed she was negative for Covid. Two days later she began to feel very congested and she took another test which showed she was positive for Covid. Patient took Paxlovid from 29Apr2023 to 03May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300187474 Same patient, different product/event;
Information has been received from a medical assistant referring to a 4 year old female patient. No relevant medical history or concurrent conditions were reported. On 24-AUG-2015 the patient was vaccinated with VARIVAX (Merck) (lot # L001330, expiration date 13-JAN-2017; dose and route not reported) which had been exposed to temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Child started having body tics on 12-25-14. Takn to ER.
Headache, Myalgia & Fever Narrative: employee had fever , body aches and headache, missed work 3/29 and 3/30.
overdue to get her 2nd dose because she had her Covid vaccine/she still has not received the 2nd dose.; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th September 2020), COVID 19 vaccine (received 1st dose in January 2021) and COVID 19 vaccine (received 2nd dose in February 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. The patient was treated with hydrocortisone (Cortisol). On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self reported the case. The patient received first dose of Shingrix and was overdue to get her second dose because she had her Covid vaccine on January and February of 2021  The Health Care Professional recommended not to get the Shingrix vaccine. The patient reported she got a cortisol shot on March 2021. Till the time of reporting, the patient did not receive the second dose of Shingrix vaccine, which led to incomplete course of vaccination. The patient did not get her 2nd dose of Shingrix vaccine because she wanted to make sure it was safe to get the 2nd dose after the Cortisol injection on March 2021. Medical disclaimer was provided and patient was recommended to consult with health care professional that immunosuppressive therapies may reduce the effectiveness of Shingrix. Not all information is available, lot and expiration date of 1st shot was unknown.
Soreness in arm (hurts to mild touch), body aches, fatigue, nausea, lack of concentration - overall just feel disfunctional. (reporting same day of feeling this way. I think I will be ok but thought to report when I was looking up side effects on CDC website)
I had fever; I have body aches; Chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (Pfizer-BioNTech COVID-19), on 05May2022 as dose 3 (booster), single (Lot number: FK9893) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "I had fever"; PAIN (non-serious), outcome "unknown", described as "I have body aches"; CHILLS (non-serious), outcome "unknown".  Additional information: So yesterday I (patient) had I got my Booster first dose and I had some symptoms like a side effects, I had fever, I have body aches and chills. Lot number also reported as USW113 (Not clarified).  No follow-up attempts are possible. No further information is expected.
Patient received vaccine and left our clinic  with father and went to the bank.  About 10 minutes after receiving the vaccine, while in the bank, per the father, "my son fell on the ground and had a seizure".  Patient hit his head on the floor when he fell.  Father estimates the patient was conscious again after 30 seconds but slightly disoriented.  Father put the patient back in the car and drove him the 2 minutes back to our clinic. On the way back to the clinic, father described a second episode that lasted 10 seconds with "shaking and eyes rolled back"  When they entered the clinic, patient vomited in the lobby and was taken back for evaluation by MD and nurse. MD felt that patient had a syncope episode with vasalvagal trigger. Pt was sent to the ER to rule out seizure and head injury,
she felt like she had a virus; Had to keep going to the bathroom; Flu like symptoms; feeling really sore in under armpit and certain spot, sometimes she does not feel it and sore spot in her underarm is the same arm she got the vaccine in; I had burning in my stomach; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunization. Patient received the second dose of the Pfizer COVID 19 vaccine on 05Apr2021 (Monday). Patient stated that flu like symptoms started on Tuesday (06Apr2021). Caller reported that yesterday (07Apr2021) she felt like she had a virus, saying she had to keep going to the bathroom yesterday (07Apr2021). Patient also reported that she was really sore in certain spots of her underarm pit. Caller stated that sometimes she does not feel it. Caller stated this is happening in the same arm that she got the vaccine. Patient stated that she felt fine until she took the shot. Patient had burning in stomach but her concern was soreness in armpit. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
My wrist is discolored and white with white spots. My fingers are turning white. Under my breasts is turning white. The back of my knees at the joints are completely white.
PATIENT FELT LIGHT HEADED AND FAINTED AFTER GETTING THE SHOT AND WAS WALKING OUT OF THE EMS ROOM. PATEINT WAS SWEAT AND FELT NAUSEATED. PATIENT LAID DOWNAND USED COLD PACKS AND GAVE PATIENT A SNACK AND WATER. PATIENT FELT WELL AFTER A FEW MINUTES.
profound widespread body/muscle aches, headache, earache, very sore arm for approx. 12 hours. NO fever.
I was recently out of the country on vacation with my husband. The day we were flying home there had been a couple of people who were not feeling well with cold symptoms on the bus that we were on. The day before, we had been told that one of the people on the bus tested positive for COVID-19. Everyone on our tour had to be vaccinated and test negative to join the vacation but after someone tested positive, everyone wore masks. I began to notice a scratchy throat and a cough the day we were returning home on 07/18/2022. We arrived home late that night after an 18 hour day of traveling. When I woke up the next morning I took an at home COVID-19 test and it was positive. I called my doctor's office and was able to set up a telehealth appointment for 07/19. I was prescribed PAXLOVID and my cough went away over night. The only symptom I am still experiencing now is a slight headache.
Patient's mother stated that since the vaccine in July her menstrual cycle has been irregular and heavy bleeding. She had a period 9/29/15 -> 10/4/15 then 10/18/15 -> 11/01/15 and another 11/21/15 -> 12/2/15.
wasn't able to really exercise, started to feel feverish, ill, wasn't able to work; body ache; nauseous; fever 102.2 ºF; joint pain; chills; fatigue; pain under armpit; became increadibly ill; lymph node pain; headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of MALAISE (became increadibly ill), HEART RATE (low hear rate), LYMPH NODE PAIN (lymph node pain), HEADACHE (headache) and MALAISE (wasn't able to really exercise, started to feel feverish, ill, wasn't able to work) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had Covid-19 infection in March 2020.) in March 2020.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced MALAISE (became increadibly ill), LYMPH NODE PAIN (lymph node pain), HEADACHE (headache), PAIN (body ache), NAUSEA (nauseous), PYREXIA (fever 102.2 ºF), ARTHRALGIA (joint pain), CHILLS (chills), FATIGUE (fatigue) and AXILLARY PAIN (pain under armpit). On an unknown date, the patient experienced HEART RATE (low hear rate) and MALAISE (wasn't able to really exercise, started to feel feverish, ill, wasn't able to work). On 22-Jan-2021, MALAISE (became increadibly ill), PAIN (body ache), PYREXIA (fever 102.2 ºF), ARTHRALGIA (joint pain) and CHILLS (chills) had resolved. At the time of the report, LYMPH NODE PAIN (lymph node pain), MALAISE (wasn't able to really exercise, started to feel feverish, ill, wasn't able to work), NAUSEA (nauseous), FATIGUE (fatigue) and AXILLARY PAIN (pain under armpit) outcome was unknown and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is 5 months Post Partum and not Breast feeding.  Treatment Medicines include Motrin and Tylenol
Patient dx with Intussusception.  07/18/2007 MR received for 2 ER visits 6/24 and 6/26 2007 for c/o persistant vomiting. Initially had diarrhea but none since vomiting started.  No blood in stools.  PE significant for hypoactive bowel sounds and lip pallor. Otherwise WNL.  Air enema sucessful in reducing the IS. Discharge DX: Intussusception.