chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a female patient who received Hepatitis A vaccine for prophylaxis. Concurrent medical conditions included brace user. On an unknown date, the patient received Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced general body pain, tiredness, wrist pain, pain in hand, nausea, weakness, esophageal acid reflux, shoulder pain, anxiety, injection site warmth, stress, sleeplessness, hard to awaken, stomach pain, headache, feeling sad, injection site pain and feels awful. The patient was treated with medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the general body pain, tiredness, wrist pain, pain in hand, nausea, weakness, esophageal acid reflux, shoulder pain, anxiety, injection site warmth, stress, sleeplessness, hard to awaken, stomach pain, headache, feeling sad, injection site pain and feels awful were unknown. It was unknown if the reporter considered the general body pain, tiredness, wrist pain, pain in hand, nausea, weakness, esophageal acid reflux, shoulder pain, anxiety, injection site warmth, stress, sleeplessness, hard to awaken, stomach pain, headache, feeling sad, injection site pain and feels awful to be related to Hepatitis A vaccine. Additional details were provided as follows: The age at vaccination was not reported. After receiving the Hepatitis A vaccine in right arm, the patient experienced extreme tiredness drive down. Eyes hard to keep open. Right wrist was hurted badly, palm was also hurted. The patient forgot brace at home (patient had not enough sleep prior night, hard to wake up), little stressful. The patient's weight went back to 201 (unknown units). The patient experienced shot hurt, and arm hot at injection site. She ate and was walking around the patient, felt little stressful (maybe suspicious looking and followed). The patient was anxious and would get in trouble to drove home, had to get concentrate new brace helped, but still right shoulder, wrist hurting bad and Hurting all over. After household work shoulder hurt was increased. The patient had supper chicken strips. The patient was hurt all over shoulder, wrist, stomach, acid reflux was bad. Felt very nauseous and weak terrible. Finally started to pass. Showered, which helped in bed. The patient had Headache, hurting still, but not as bad.
On 12/20/00, this infant had difficulty breathing, temperature of 100 at 1:00 PM, no other symptoms. Recommended to take the child to the ER immediately for further evaluation and treatments.
Extensive swelling reaction in left arm after 5th dose of DTaP vaccine. Two days after vaccination swelling=60x110mm. Redness=110x130mm. Increase of mid-arm circumference of 2.6cm.
Patient received vaccination 4/24/18 and called 4/25/18 to report reaction. Patient stated he was in so much pain that he was in tears. He was also having chills. He tried a hot bath which helped while he was in the hot bath. He is feeling better now since about 6 am on 4/25/18.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 07-OCT-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of ZOSTAVAX with Lot # reported as M039453 and expiration date of 19-DEC-2017 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccines were exposed to temperature of - 14 Centigrade degrees (°C) to - 10 °C for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000656.
Within an hour after the injection shoulder muscles puffed up and tightened right away. the puffiness went away but my muscle still felt knotted up. I could only lift my right arm part way for several months. muscles would knot up terribly each time I tried to raise my arm more than half way. After months of this I went to Dr. and was given physical therapy.August 2022. With exercise I have regained the ability to raise my arm up almost 100 % but the shoulder muscle still feels"ripped" and hurts when my arm extends, and now I still get knots and palpitations in my shoulder when I do physical activity or sleep on that shoulder. A few times a week I wake up with knots and tension running up to my right side neck, and I have to get up nd try to loosen up the tension in order to sleep. My right arm is still weak when extended up or out, limiting its use for almost a year already. Possible permanent damage to date. not remedied.I know it all came from that first  shot.
Patient was found passed out on ground after leaving the Pediatric Mobile Unit.  Also had a seizure during this time when found unresponsive.  Patient complained of feeling dizzy immediately after receiving Tdap immunization.
The patient not experienced any adverse event associated with the vaccination / No additional AE reported.; 2 month old patient was administered Varivax accidently.; This spontaneous report was received from a nurse and refers to a 2-month-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 09-AUG-2021, the 2-month-old patient was accidently vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml, lot # T035401 was confirmed to be valid, expiration date 16-OCT-2022, (route and site of administration were not reported) for prophylaxis (Inappropriate age at vaccine administration). The patient did not experience any adverse event associated with the vaccination.
Left leg red, swollen and hard knot after immunization on Wednesday.  Friday evening running fever of 103.7 taken to ER for febrile seizure.  Placed on meds at ER.  Today 11/12/2003 left leg knot decreasing in size, no redness.
This case was reported by a consumer via sales rep and described the occurrence of itchy rash in a 39-year-old female patient who received FLUARIX QUADRIVALENT. On 22nd September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 22nd September 2016, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced itchy rash, rash erythematous and skin warm. On an unknown date, the outcome of the itchy rash, rash erythematous and skin warm were not recovered/not resolved. The reporter considered the itchy rash, rash erythematous and skin warm to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The patient experienced rash which was on the neck, under the arm, groin area and breast, the rash was not raised but red, warm to the touch, webbed looking and itchy after vaccination with FLUARIX QUADRIVALENT on an unknown arm. The patient might follow up with her healthcare professional, but had not sought medical attention at this time. The patient did mention that she had the same rash reaction whenever she is used to get sick. The representative was going to try to contact the patient to get permission from her asking for her demographics.
Patient fount out two days later that she had a rosacea all over her body. No other symptoms reported.
The vaccine made my shingles way worse/Suspected vaccination failure; The vaccine made my shingles way worse/I've had them 15 times in 4yrs since the shot.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient stated that the vaccine made his/her shingles way worse. The patient only had shingles once before the vaccination and now the patient had them 15 times in 4 years since the shot.  Additional Supportive information: The case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation was not reported.
Pt reported itchy feeling at injection site, swelling, and hives. She took antihistamines and symptoms improved next morning.
Patient was administered pediatric pfizer vaccine that had not been diluted.  No adverse reactions reported at this time.
Received multiple immunizations during basic training in early March 2005. Immunization records show patient received Twinrix on 9 March 2005, but he specifically recalls receiving a separate shot about 2 weeks after that 3/22/05 and was told it was both Hep A and Hep B.  About 24 hours after receiving that vaccine (am of 3/23/05) he experienced a generalized burning sensation that he describes as 'on fire from the inside out'.  The sensation increased with touch; for example, the weight of his BDUs against no hives or individual lesions were noted; if he scratched, especially on his arms and back, the skin became red and swollen.  He did not experience pharyngeal or glossal edema, hoarseness, dyspnea, bronchospasms, angioedema, or other systemic symptoms.  He sought evaluation the following day (3/24/05) and was prescribed  Calamine lotion, Atarax and something for scabies.  He did not use the Ellmite, but the Atarax and calamine seemed to help.  He had also been prescribed an antihistamine for hay fever previously and took that daily until October 2005. When he ran out, while on leave, he began to experience pruritus; he then took OTC CTM which helped.  More recently he was changed to Claritin 10 mg a day and that controls the itching. Prior to symptom onset, he denies a history of animal or insect bite, trauma, infections, fever, malaise, joint pain, or close contacts with similar symptoms.  In 1999, patient broke out in hives and at the time it was attributed to exposure to mold; however when he moved away from the mold, he continued to experience urticaria.  He later was evaluated by a Dermatologist and was told he had chronic urticaria; he was started on 3 medications to asymptomatic; after he stopped them, he did not have a reoccurrence.  He has +Dermatographism.  His PMH/PSH included hernia repair, cat scratch fever (diagnosed per biopsy of lymph node in August 2005), fracture of his right leg, with surgical repair, and hay fever.  No know drug allergies.  Symptom: Paresthesia Comment: 'on fire from inside out'; generalized burning-type sensation increased with touch like BDUs against the skin. Symptom: Pruritus Comment: itching sensation, but no lesions; skin became red and swollen after scratching, especially on back and arms.
Administered 10/18/02. Developed URI 10/23 migraines with headache, vomiting. Progressed to encephalitis with hospital admission 10/25. Doing fairly well. Onset seizures 10/26. Transferred to another facility. Recurrent seizures. Herniation brain. Death.
This case was reported by a healthcare professional and a sales representative and described the occurrence of seizure in a 2-month-old male subject who was vaccinated with Pediairx (GlaxoSmithKline). Concurrent vaccination included Hib (Pasteur); pneumococcal vaccine (unspecified manufacturer) and Rotateq (unspecified manufacturer) all given on 18 February 2008. There were no concurrent medications. On 18 February 2008 at 13:00 the subject received 1st dose of Pediarix at 0.5 ml in the right hip. On 20 February 2008, 2 days after vaccination with Pediarix, the subject experienced a seizure. The reporting sales representative stated that the subject experienced a pertussis reaction. The subject was hospitalised overnight. At the time of reporting seizure was resolved. No specific outcome was provided for the pertussis reaction. The healthcare professional considered the event seizure was probably related to vaccination with Pediarix.
Cold sweats, loof of breath, severe fatigue, dizziness and upset stomach, vision problems and headache after receiving Hepatitis A & B vaccines.
hot flashes; chills; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced hot flashes and chills in between her vaccine doses. She was scheduled tomorrow 16Apr2021 for the 2nd dose. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received second Modern COVID vaccine on 3/13. On 3/27 she developed shortness of breath. She presented to her local ED and was found to have a large saddle pulmonary embolism. She underwent thrombectomy with IR x2 and was transferred to Medical Center for surgical pulmonary thromboendarterectomy.
I noticed small pink dots all over my sons back on Sunday evening before his bed time.  By Monday morning 3/10/14, the amount of dots had increased by 50% and had become more red and raised.  Now they were on his scalp, neck, back, chest, stomach, arms, legs, scrotum area. And they looked more like hives.  I gave my son 1/2 tsp of Benadryl around 10am.  The Benadryl did not seem to help because now the spots were getting larger and spreading rapidly.  They were looking more like blotches of hives.  I went to my pediatrician around 4pm on 3/10/14.  He said the rash was a common side effect of the MMR vaccine.  On 3/11/14, my son had a fever of about 100 degrees.  I gave him ibuprofen.  The rash started to spread and look more like a net.  His right eye was also swollen.  I continued the Benadryl therapy but it still didn't seem to work.  He had a fever all through the night.  3/11/14 evening my son had difficulty breathing and his face looked really puffy.  The rash was still very present and had started to move around his face. I also noticed areas that were purple that looked like bruises. 3/12/14 his left eye, cheeks and lips were swollen and had a fever of 102 degrees. The rash was all over his body and still had areas that looked like bruises.  I contacted my pediatrician and he suggested I take my son to the ER because he had never seen the rash also cause swelling in the face.  At the ER they gave him higher dose of Benadryl, 5cc and OraPed (Prednisone).  This seemed to reduce the inflammation drastically.
Approx. 8 days /p DTP/OPV/MMR immun., child experienced a fever 101T, rash on face & chest, seizure (1 episode) & fatigue for 24 hrs.
11:50 Pm felt warm sensation and full feeling up back of neck and in ears. 3 pm- woke up from nap covered in Hives, neck to legs, and extreme itching. Took 50 mg Benadryl, called Dr, was told to take 50 more mg of Benadryl at 4:30 pm then every 4 hours. Took picture of hives on arm and my side.
Patient said her arm got red and hard around the injection site and got to the size of a baseball. She chose to use a heating pad on it after (instead of a cold compress) and it took 6 days to resolve. She also told me that because it burned when she got it and it was sore after that she didn't remove the band aid for 3 days. She said when she did remove the band aid brown liquid oozed out. It did not continue to ooze after the initial removal of band aid. It is totally resolved now with no lingering issues.
Narrative: Per notes in CPRS as documented by RN, patient received second booster (4th dose) of covid vaccine on 5/5/22 and then at a TIA/stroke 4 days later on 5/9/22. Decision made to document this as an ADR to the covid vaccine.
elevated fever; blood glucose level has spiked; headache; pain; joint pain; fatigue; She was in bed lethargic; This is a spontaneous report from contactable consumers (one was patient's daughter). A female patient of an unspecified age (reported as 82, unit unknown) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on 16Jan2021 for COVID-19 immunization and experienced shaking for about 5 minutes. On an unspecified date, the patient experienced elevated fever, blood glucose level had spiked, headache, pain, joint pain, fatigue and she was in bed lethargic. The patient underwent lab tests and procedures which included blood glucose: blood glucose level has spiked went up and down on an unspecified date, and blood glucose: normal on an unspecified date. Clinical outcome of the events was unknown.
6 h after injection: 101.7 fever, chills, severe headache (all went away after 24 h of injection) 48 h after injection: severe abdominal pain below the belly button (went away after 1.5 h) loose stools followed for 12 h  10 h after injection: tooth pain due to grinding from chills, still lingering
passed out twice; Headache; severe body aches; severe fatigue; weakness; vomiting & dry heaving; vomiting & dry heaving; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 54-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8727) via an unspecified route of administration, administered in left arm on 26Mar2021 16:00 (at the age of 54-year-old) as dose 2, single for covid-19 immunization. Medical history included asthma and Grave's disease from an unknown date and unknown if ongoing. The patient was allergic to dust, sulfa based drugs, had seasonal allergy, molds allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), rizatriptan benzoate (MAXALT), ibuprofen, estradiol and azelastine taken for an unspecified indication, start on an unspecified date in 2021 and stop date was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205) administered in left arm on 05Mar2021 04:00 PM (at the age of 54-years-old) as dose 1 single for COVID-19 immunization. On 27Mar2021 at 05:00 the patient experienced passed out twice, headache, severe body aches, severe fatigue, weakness, vomiting and dry heaving. Called paramedics. Vitals were okay when paramedics arrived did not go to the hospital. Paramedics checked patient vitals after passing out. The patient visited to emergency room for the AEs. Patient received treatment for the events. Outcome of the events were resolved on an unspecified date in 2021.
sl fever 100.5, noc sweats, joint pain-knees, elbow, severe pain both legs;temp swings 98.1-99.8 over couple days;had trouble sitting, standing-leg pain severe 21OCT-24OCT97;pt states had allerg rxn w/aleve-rash, itching;
Fever; Chills; pain; This is a spontaneous report from a non-contactable pharmacist. A male patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via intramuscular route of administration on Mar2021 as a single dose for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Previously the patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unknown route of administration on an unknown date, for COVID-19 immunisation. Concomitant medications were not reported. On an unknown date in Mar2021, the patient experienced fever, pain and chills for two days. The patient received paracetamol (TYLENOL) as treatment medication for the events fever, pain and chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, pain and chills was resolved on an unknown date in Mar2021(also reported as resolved in three days). No follow-up attempts are possible; information about lot/ batch number cannot be obtained.
Large red, itchy, hard welt on left arm near the injection site  8 days after the vaccine was given.
Pt got flu shot Mon evening and pt experiencing nausea and vomiting on Wed AM. Pt's daughter called and reported adverse effects. Pt's doctor notified by daughter.
Hemorrhagic stroke/bleeding in his brain; He was feeling nauseous and had a very bad headache; He was feeling nauseous and had a very bad headache; Vomitting; This is a spontaneous report from a contactable consumer.  A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06May2021 (Batch/Lot Number: EW0171) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included hypertension. Concomitant medication included unspecified blood pressure medications. The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 15Apr2021 (Batch/lot number: EW0161) as COVID-19 immunization. Then, the 2nd dose on 06May2021. On that same day of 06May2021, he was feeling nauseous and had a very bad headache. He brushed it off as a side effect of the vaccine because that was listed as a common side effect of the vaccine on the CDC website. So, he did not seek medical attention for 5 days. It was later reported that the he suffered a hemorrhagic stroke that day after the COVID-19 vaccine administration. The patient was in the ICU after waiting 5 days to seek medical attention because the supposed to cause headaches, nausea and vomiting. But the nausea and vomiting was from his stroke, not from the normal side effect of the vaccine. They were suspecting that the bleeding in his brain started on the 07May2021. The patient had bunch of blood work (unknown results) done since the past two weeks. Outcome of the events were unknown
Had Numbness in my face and jaw for 2 hours  on 3/7/21 at 12 noon. for the next two weeks numbness returned about twelve times the episodes were brief then disappeared.
Shingles outbreak started on October 29. I had a tetanus booster on Oct 25 th as well.