chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lethargic, stopped drinking, stopped eating on the 21st.  On the 22nd his arms layed limp at his sides when previously they were rigid and locked from the Parkinson's.  He would not eat or drink on the 22nd.
Redness, swelling, tenderness, and itching covering an area of about 2 1/2 inches below injection site. Arm was sore on day of injection and following day. Redness was very evident on the morning of the 2nd day after injection and spreading.
Patient reported hives that were localized to administration arm. Patient said hives lasted a few days and did completely resolve. Patient reported taking benadryl.
Administration Error - upon injection, the needle was not fully injected into the patient's arm. An unknown amount of drug squirted onto the patient's arm and did not make it in. It was recommended to receive another complete dose as we didn't know exactly how much had been received but the patient was uncomfortable with that and she requested we only give her 0.2ml instead of 0.3ml. We drew up another 0.2ml and administered that in addition to what she received initially.  No side effects reported.
I received the shot at 1:30 pm, I felt fine. At about 8:30 pm I felt like I was hot, and my chest was tight, I was just uncomfortable - I checked my BP and it was 187/110. I immediately began drinking water and resting. I felt uncomfortable all weekend, achy and tired. My BP stayed high until Sunday evening. On Monday I felt like my throat was swollen and tired. I was still fatigued. Tuesday my mouth was still sore and Wednesday 1/13  I was diagnosed with oral shingles (blister in center of the roof of mouth). I started medication for shingles on 1/14, was still fatigued and took the medicine for 7 days. I had another shingles outbreak on my stomach (tiny blisters on stomach, burning, itching and red) on 1/23 and the fatigue increased and continues.  I started fancied for the second time on 1/25/21.
Felt a little out of it about an hour after but that wasn't bad. My neck started getting sore and headache that night. Next morning joints are sore, slight headache and slight chills.
Symptoms started in Sept. 2021 with extreme fatigue and weakness of legs, Dr. prescribed provigil was on this for a few months, it worked a little at first and then didn't so I stopped taking.  Then in December I started having problems with my eyes watering all the time and feeling like they had a thick film over them and dry mouth.  Went to see eye Dr. in January and after testing, was told I am not producing tears.  With all this sent me to Rheumatology.  After filling out my V-safe form the CDC called me on  2/17/2022 ask me questions and then told me when I had a final diagnosis to do the Vaers.  I had a lip biopsy which came back positive for Sjogrens disease.  I am now having to go on Plaquenil as well as eye drops.
Patient presents to the emergency department with about 4 this morning the pain was sharp in nature.  Since then the pain come and gone.  She going family doctor and they advised her come here.  She states pain is worse when she takes a deep breath.  Patient did receive her 2nd COVID immunization on October 16. This morning she had some mild chills but no fevers and they spontaneously resolved.
Pt recvd DTP/OPV/HIB approx 315 @ 330 broke out w/red whelps on lower rt leg (DTP given rt leg); MD notified & given DPH;
red, itching, lump-itching lasted 2 days then spontaneously abated;
A dark red coloring , just below the injection site, warm to the touch on the right bicep, measuring about 2 inches high and 3 inches wide. Then a lighter red area spread beyond the borders of the first red area. A rash developed from the spine to the hip area, along the waistband area, and up to mid rib cage. There was also a rash on the underside of the right arm from the armpit to mid bicep. Benadryl and Tylenol were given for the first two days, and then just the Benedryl twice a day for the next 5 days.
Received shot at approx. 10 a.m. on 1/10/06.  Began to feel achy around 3:00pm.  That evening experience muscle and joint pain, headache, heart racing, heart palpitations and dizziness.  Went into work next day still felt ill and called doctor.  Doctor wanted to see immediately. (1/11/06) Physician believes all are side effects of flu shot.  Returned to Doctor on 1/12/06 because still experiencing heart racing, dizziness and palpitations.  Dr. orders heart monitor for 24 hours.  Do not have the results as of yet.  I now have a sinus infection and bronchitis (1/16/06-present).
7 year old was given Quadracel (a delayed vaccine schedule), no AE; Initial information received on 14-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 years old female patient who received a dose of 0.5 mL vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (5th dose for DTap and 4th for IPV) (lot number not reported) via an intramuscular route in the left thigh for prophylactic vaccination, on 31-Jan-2020.   Medical history, medical treatment, vaccination and family history were not provided.  No other vaccines were given.  It was a case of actual medication error due to Product administered to patient of inappropriate age.  The physician charted that the mom follows a delayed vaccine schedule, and that the physician discussed risks and benefits of following a delayed schedule. The patient is behind on vaccination for hepatitis A, hepatitis B, MMR, and varicella.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.
Patient had initial dizziness and syncopal episode.  Patient reported "vision went dark and felt heavy".  Patient vomited x1.  Patient given cold pack and water.  After 10 minutes patient denies headache, dizziness, double vision, or ringing in ears.  No report of difficulty breathing, SOB, numbness or tingling in extremities.   Patient successfully discharged from observation at 4:05 pm.
THROWING UP; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight was 94 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced throwing up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throwing up. This report was non-serious. This case, from the same reporter is linked to 20210627698.
Mother describes the client as having "lower back pain, clammy, and just out of it".
No adverse reaction reported, was given monovalent version of vaccine by mistake which should have been the bivalent vaccine
Bloody stools, diarrhea, vomiting 4-5x a day.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 13 year old, male patient with no pertinent medical history reported. On 18-FEB-2013 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On an unknown date the patient received the another dose of GARDASIL (lot number and expiration date not reported) (route and dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
IMMEDIATE "BURNING" PAIN AT SIGHT OF INJECTION, WHICH SPREAD DOWN LEFT ARM, NOT REACHING ELBOW, THEN ACROSS TOP OF LEFT SHOULDER, BUT NOT PAST NECK. AFTER 5 MIN. THEN FELT TINGLING IN LEFT FINGERS. AT 1:26 PM, PT SAYS THAT THE BURNING, SHOOTING PAIN WAS GONE, LEAVING ONLY A SLIGHT BURN AT THE SITE OF INJECTION AND NO TINGLING. PT LEFT AROUND 1:40 PM TO GO TO THE BATHROOM.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FG2527) at the age of 71 years, in left arm 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 was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: I tested negative at that time but 4 days later retested positive; Positive, notes: I tested negative at that time but 4 days later retested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Slight soreness in left arm injection site appeared months after the booster. Didn't notice at first, then became aware that it was happening off and on, somewhat often.  Not a strong pain; it's just "there." Unsure if it came from 1st, 2nd or booster.
2 days after PREVNAR adminisitered, smlal red patch on (L) side forehead-then progressive areas of urticarial type patches (+) sun photosensitivity rash and chest 10d post vaccine- pt getting new lesions still on UE and torso-topical cortisone prescribed and ZYRTEC po. Still getting rash break outs in new spots.
Case number PHEH2016US023335, is an initial spontaneous report from a consumer received on 12 Sep 2016. This report refers to a 33 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of expired FLUVIRIN (batch number: 157104) intramuscularly at a dose of 0.5 ml on 12 Sep 2016. It was stated that, the 2015/2016 expired vaccine was administered to 05 patients on 12 Sep 2016. No adverse event was reported following this medication error. The case was assessed as non serious by the consumer.
Pemphigus/Valgaris; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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 patient experienced "Pemphigus/Valgaris" on an unspecified date. The reporter was unsure if the Covid-19 vaccine was Pfizer or Moderna. The event took place after use of the product. The outcome of the event was unknown.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Pemphiguswith the suspect product covid vaccine  cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
pt recv vax; crying 1hr p/ vax, lasting x 4 hr;no soreness or swelling or redness;to MD 4may95, less irritable;back to nl behavior 5may;no further pertussis vax per MD;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 9:06 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:06 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 76.05 No concomitant medications were reported. On 30-Mar-2021 at 09:00 A.M., the temperature recorded was 33 degree Fahrenheit and vial was initially moved to the fridge on 23-Mar-2021 and beyond use date was 22-Apr-2021. Product moved to clinic on 30-Mar-2021 and the vial was in not frozen condition at the time administration.     Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
I felt pain in my arm that was extremely painful compared to any other vaccines that I've received except for my other COVID-19 vaccines. I did get a feeling of fatigue as well before going to the hospital on the 30th of May. 05/30/2022 I woke up that morning with pain in my chest and didn't seem to go away. Sharp pain and I went into the ER and was there from the morning till the afternoon around 02:00PM. The pain dissipated while I was there and I was diagnosed with some sort of inflammation from the ER physician. There were no blood markers indicating a heart attack and I was checked for pancreatitis and that came back negative. CT scan showed no types of clotting and since being discharged I have been okay since with no symptoms.
Symptoms very similar to my shellfish allergy.  Throat started to close up, hard to swallow. Note this was a mild reaction but a reaction all the same. A single dose of Benadryl was all that was required.
Patient had redness that was size of her palm which was warm to touch just below the shingles injection site. Reaction happened 1-2 days after the vaccine and rash lasted for 5 days
Gave her the full vial undiluted with the five to six doses in it; she had that large amount; Gave her the full vial undiluted with the five to six doses in it; she had that large amount; Arm soreness; She on the second day did not feel so well; This is a spontaneous report from a contactable consumer (parent). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported), dose 2 via an unspecified route of administration on Sep2021 as dose 2, single for covid-19 immunization. The patient previously received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported) as dose 1, single for covid-19 immunization. The patient concomitant medications was not reported. As it was reported on Sep2021 daughter received the full vial undiluted with the five to six doses in it; she had that large amount and also patient experienced arm soreness and patient on the second day did not feel so well. For the events arm soreness and on the second day did not feel so well was recovering. Outcome of the event gave her the full vial undiluted with the five to six doses in it; she had that large amount was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
CHILD'S AGE WRITTEN AS 12 ON CONSENT SIGNED BY PERSON IDENTIFYING AS MOTHER. CHILD IDENTIFIED IN IMMTRAC (#151163087). CHILD IS TOO YOUNG FOR VACCINE AT THIS TIME.
Right arm red and swollen. Went to ER. Dx: Cellulitis. Antibiotics then oral antibiotics cephalexin 500mg.
Facial swelling; Hives in legs, thighs, buttocks, and torso; Fever of 102.5; Rash in legs, thighs, buttocks and torso; Vomiting; Diarrhea; Lethargy; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 3-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 4th September 2022, 3 days after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced fever and rash. On 5th September 2022, the patient experienced facial swelling and hives. In September 2022, the patient experienced vomiting, diarrhea and lethargy. The patient was treated with benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the vomiting, diarrhea, fever, rash, facial swelling, hives and lethargy were recovered/resolved.   The reporter considered the vomiting, diarrhea, fever, rash, facial swelling, hives and lethargy to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comment: The reporter reported that the patient received Pediarix vaccine. The reporter stated that 12 hours after received Pediarix vaccine the patient experienced vomiting and 48 hours after received vaccine patient had diarrhea. The reporter reported after received vaccine on September 2022 Sunday patient also experienced a fever of 102.5 and a rash that covered the legs, thighs, buttocks and torso. On September 2022 Monday, patient was experienced facial swelling and the rash had turned into hives covered the same areas as the rash.  The reporter stated patient received Benadryl for the rash on Sunday, which seemed to resolve the hives. The hives reappeared later in the week, resulting in patient being taken to the emergency room (ER), where patient was given Prednisone on September 6 2022.  Reporter reported that the several tests were conducted on patient to rule out other possible causes of the reaction and everything came back clear. The reporter reported that the everything was coming back clear from the tests. The reporter believe the Pediarix is the likely cause of patient's symptoms. The reporter stated Prednisone resolved all symptoms.  The reporter does not known the patient previously Pediarix received or which dose patient was received. The reporter did consent to follow up.
Patient had redness and a low grade fever starting 24 hours after administration. She then went to the Doctor 3 days after administration where she had red blotches around two of the vaccination sites. She believes the only site not affected was the FLUARIX site. She came to the pharmacy and showed 2 large 4 inch in diameter blotches and stated the Doctor diagnosed her with cellulitis. She was prescribed AUGMENTIN for the infection.
Pt says that he has had "fuzzy thinking," having trouble recalling words and was off balance.  He had slurred speech.  He also had left side chest pain and trouble breathing.
Swollen, red sore arm, large hard area on left upper arm. Fever reported as 99.9 in pm thru the night.
Case number PHEH2014US000616 is an initial spontaneous report from the physician received on 03 JAN 2014 and a follow up report from the physician received on 12 FEB 2014. This report refers to a 23-months old male patient. His medical history was not reported. On an unknown date, the patient was accidentally vaccinated with only 0.5 nl of Men A lyophilized conjugate of MENVEO (batch number: M11071) mixed with normal saline instead of Men CYW 135 liquid component. It was reported that the patient did not experience any adverse event after the mal-administration. The patient was re-vaccinated with both the components of MENVEO on an unknown date. NO other information was available.   Follow up report from the physician received on 12 FEB 2014. The patient's age and information related to revaccination was updated.
1 week from the booster dose, the patient had blood clots in her lungs, and died in the hospital; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001226 (Novavax).  An 82-year-old female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (primary immunization series), for Covid-19 immunization. On 26Sep2023, it was reported that a patient started treatment on unreported dates with Pfizer BioNTech COVID-19 vaccine primary series and booster for COVID-19 indication. The following information was reported: PULMONARY THROMBOSIS (death), outcome "fatal", described as "1 week from the booster dose, the patient had blood clots in her lungs, and died in the hospital". The patient date of death was unknown. Reported cause of death: "1 week from the booster dose, the patient had blood clots in her lungs, and died in the hospital". It was not reported if an autopsy was performed. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: 1 week from the booster dose, the patient had blood clots in her lungs, and died in the hospital