chrisvoncsefalvay/vaers-outcomes huggingface dataset:
took the shot and got shingles/suspected vaccination failure; got shingles; This serious 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: took the shot and got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Mar-2023 The case was received from the patient's friend via interactive digital media. The patient took the shot and got shingles. The reporter did not believed in that either. The reporter reported that he/she could and have had both and in hospital for kidney stones removal. But shingles worse, which the reporter had probably went down in history for having so many times. The reporter stated that shingles can get in your eyes also and which it did. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Wife fully vaccinated with Moderna has covid virus now.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Wife fully vaccinated with Moderna has covid virus now.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Wife fully vaccinated with Moderna has covid virus now.). At the time of the report, COVID-19 (Wife fully vaccinated with Moderna has covid virus now.) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant product use was reported.   No treatment information was provided.
Information has been received from a physician concerning an 84 year old female who "approximately 6 to 8 weeks ago" in approximately March 2008 was vaccinated SC with a dose of zoster vaccine live (Oka/Merck). On 01-May-2008, the patient returned to the office with a rash around the left mid-section of the abdomen. No diagnostic laboratory studies were performed. No product quality complaint was involved. At the time of this report, the patient was recovering. Physician returned vaccine adverse experience report with no additional information entered. No further information is available.
Client was administered vaccine on the day after vaccine expired.  Nurse contacted Manufacturer GSK and was advised the vaccine is viable for 30 days after expiration.  Client was notified of error before he left the clinic.
Mark near injection site, looks like a scab; This spontaneous case was received on 20-Nov-2020 from pharmacist via Med Communications (reference number: SEQW20-05342) and concerned a 59-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications. As reported, this was the patient's first flu shot.  On 15-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, anatomical location: right arm, indication and route of administration: not reported). The batch number reported was P100240196, expiry date: 19-May-2021.   On the same day, after receiving Afluria Quadrivalent, the patient developed mark near injection site that looked like a scab. No corrective treatment was given for the event.  At the time of initial reporting on 20-Nov-2020, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: The patient developed scab on the same day after receiving Afluria Quadrivalent. Since several days are needed for scab to form, chronology is implausible. The patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship is assessed as not related due to temporal implausibility.; Sender's Comments: The patient developed scab on the same day after receiving Afluria Quadrivalent. Since several days are needed for scab to form, chronology is implausible. The patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship is assessed as not related due to temporal implausibility.
The day after the injection, pt reports intense neck, head, and hip pain on the opposite side of his body from the injection site. Pt states pain did not respond to pain killers and that he felt his hip was popping out of socket. Soreness next day.
No Adverse effects. Patient was to receive Johnson and Johnson, Covid Vaccine Lot 201A21A  Exp 06/23/21 and received by error Pfizer Lot# EW0173 exp 08/31/21.
Information has been received from a nurse practitioner concerning a patient who was vaccinated with a second dose of Rotateq. Subsequently the patient developed rotavirus and was hospitalized for three days. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested.
1545-> patient had racing heart, chest tightness and SOB, patient stated "feels just like the beginning of my anaphylaxis episodes." 1550-> assessed and VS checked, WNL except BP 140/90 1555-> epi given in prefilled injector for adult in left lateral thigh 1558-> patient states she is starting to feel better 1600-> IV 20g started in right hand, given 50mg of Benadryl IVP and 50mg Solu-cortef IVP 1605-> Patient transported to ED with paramedics
Received Td 9/7/04, on 9/8/04 fine. 9/9/04 developed severe fatigue and weakness with chills and fever. Right arm with redness and induration.
strange dreams; fever; myalgia; This is a spontaneous report from a contactable physician (patient) communicated to a Pfizer sales representative.  An adult female (pregnant: unknown) patient received dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, single for COVID-19 immunisation. The patient medical history was not reported. The patient did not receive any concomitant medications. On an unspecified date, patient experienced strange dreams, fever and myalgia. At the time of report, event outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. .
Initial report received from a health care professional on 09 October 2014. Additional information received 02 January 2015 resulted in the case being upgraded to serious. A 37-year-old female patient had received second intradermal dose of FLUZONE ID (lot number-UT4993AA, expiry date 05 May 2014), in left deltoid region, on 06 October 2014. The patient had no illness at the time of vaccination or any pre-existing physician diagnosed allergies and birth defects. The patient had medical history of hyperlipidemia. On 07 October 2014 i.e. 1 day after vaccination, the patient experienced redness, swelling, warm to touch area around injection site up to shoulder of her left arm. On 08 October, the patient came for a MD visit since symptoms became worse. The patient had received FLUZONE ID last year, but did not develop any reaction. The patient was treated with Clindamycin. The patient's laboratory investigations were not reported. At the time of reporting the outcome of the event was unknown. Follow-up information for this unsolicited case was received from a physician on 02 January 2015. The patient had received prior doses of Influenza vaccine, however the reporter noted that this "may be first intradermal flu shot". She presented to the physician on 08 October 2014 with a 4x5 cm area of erythema and warmth along the lateral left shoulder, with a 1x1 cm area of induration along the central area. The area was tender to palpation, and the redness was extending beyond a line which had been drawn around the border. No fever or chills were noted. Physical findings revealed the following: blood pressure 120/80, pulse regular, respiration rate 18/minute, oral temperature 98 degrees F, height 64 inches, weight 256 pounds, body mass index 43.9 kg/m2, body surface area 2.17 m2. The patient was well developed, well-nourished, and in no acute distress. She was diagnosed with local Influenza reaction vs cellulitis, and prescribed clindamycin Hcl 300 mg caps, three times a day for five days. She was instructed to use ice and ibuprofen for discomfort and swelling, and to take probiotics while on antibiotics. She was also instructed to call the physician's office with any worsening of symptoms, including fevers or chills, and to call the doctor's office with an update on Friday (2 days) with an update. Outcome was not reported. Documents held by sender: None.
Initial report was received 24 February 2011 from a consumer, who is the patient's parent. An 18-month-old male patient with an unknown medical history had received a first dose of DTaP vaccine (manufacturer, lot number, route and site of administration unknown) on 15 February 2011 and on the day of vaccination, he became hyperactive, wouldn't let anyone touch him and he was awakening at night. Symptoms persisted until 23 February 2011 at which time they resolved. The event did not require a doctor's visit. The patient had previously received a first dose of Tetanus Toxoid Adsorbed Preservative-free, lot number U3349AA on 10 December 2010 in the ER after sustaining an unspecified injury. According to the reporter, the patient did not experience any of the above symptoms after receiving Tetanus Toxoid Adsorbed Preservative-free vaccination. No additional information was provided at the time of the report. Follow-up information received from a health care professional on 05 April 2011. The patient received on 15 February 2011 a left thigh injection of DAPTACEL, sanofi pasteur lot  number C3577AA (previously reported at DTaP vaccine). Follow-up information received from a health care professional on 05 May 2011. The patient had no past medical history. He had no illness at the time of vaccination and was taking no medications. No treatment was given after vaccination. Documents held by sender: None.
LOCAL REACTION:  SWELLING, REDNESS AND WARMTH OF LEFT UPPER DELTOID WHERE VACCINE WAS ADMINISTERED.
This spontaneous report as received from a health care professional refers to a 27 years old patient. The patient was vaccinated with the third 0.5 ml dose of GARDASIL (Lot # not reported) IM. No further information is available.
Pt recv vax 8Dec97 & 26Dec97 exp ITP. 29Dec97 dx ITP. Also exp nosebleed x 3 hr. No tx required.Lab tests 29Dec97: platelets=2K;31Dec97 platelets=27K; 5Jan98 platelets=424K.Other bc normal
Given FLUMIST on Thursday 3P 10/10/13 3A Friday morning - mother report child began with difficulty breathing. Mother states child is asthmatic. Mother states took child to urgent care on Saturday 10/19/13. Continue albuterol treatments and told to take prednisone BID. Child continued to be on albuterol treatment and prednisone until mother called 10/16 A.M.
SO  SO SO ACHEY; SHIVERS; MASSIVE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were 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, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On JUL-2021, the subject experienced so so so achey. On JUL-2021, the subject experienced shivers. On JUL-2021, the subject experienced massive fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the massive fever, shivers and so so so achey was not reported. This report was non-serious.
This is a 89 year old female with a PMH/PSH as noted below. The patient had been discharged home after right hip repair and PPM insertion on 12/27. The patients daughter is a nurse and wanted the patient home as opposed to rehab. The patient is extremely HOH and can communicate only via lip reading or written messages. Most information comes from the ED, chart and discussion via phone with daughter. Per daughter, the patient had been "doing well" at home but about 4 days after her being home, teh family all developed COvid. Teh patient's husband is currently a patient on 3N. The patient tested positive on 1/2/2022 and per daughter did well. The daughter stated she had given her Ivermectum from the "covid doctor" for 3 days and she started on Zithromax 2 days ago. Today, the patient developed some SOB and needed 6l/m prompting the daughter to call 911. In the ED, oxygen was noted to be low and patient had been on a NRBM wiht sats at 99%. CXR noted effusions, however, patient had this at last admission and CT chest pending. Patient was given Decadron. VS stable. Patient will be admitted to for consult, supplemental oxygen and further monitoring.
They feed him breastmilk; He originally was not growing as quickly; Had around a pound of water weight that he lost after initial birth.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An infant male patient was exposed to bnt162b2 (BNT162B2), transmammary (Batch/Lot number: unknown) as dose 1, single and transmammary (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The mother's relevant medical history included: "has had TBI in 20s" (unspecified if ongoing), notes: has had TBI in 20s and is on blood thinners. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown", described as "They feed him breastmilk"; GROWTH DISORDER (non-serious), outcome "unknown", described as "He originally was not growing as quickly"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Had around a pound of water weight that he lost after initial birth.".  Additional working: Baby came two days before set induction date. He originally was not growing as quickly, but (withheld) started feeding more, and now he is wearing 2-3 month old clothes. Had around a pound of water weight that he lost after initial birth. They feed him breastmilk. "Patient's mother contractions started the day before or estimated 12 hours before labor. Knees locked when her water broke (was leaning over bed)and legs cramped (such as thigh) to where doctors had to roll her onto the bed. She is estimated 36 years old. She definitely has received first shot of vaccine, but cannot remember whether got second. Her husband, early to mid 40s, was also vaccinated and may have been vaccinated 2 dose during pregnancy or conception, unsure timeline (separate AE submitted for this previously). Cannot confirm, but spouses may have gotten Moderna".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101725165 mother/baby case
Patient delayed with vaccinations given vaccines S/P cried but recovered quickly while giving sibling vaccines as well. Waited for after visit and schedule going forward. Dr gave ongoing schedule and.
Pt has rash on elbow, back, left side, down leg, knee and ankle. Rash is spreading  to right side. Pt drove herself to emergency room early in the morning. Was given OTC medication-anti fungal, benedryl. Pt has gone to emergency room and out patient clinic. Pt. will make appointment with doctor.
Pt. was in for Establish care appointment. After ARNP was done with pt., came out of room and asked for me to administer an HPV vaccine to pt. I delegated someone else to administer the vaccine. Vaccine was administer. When I was asked to sign for immunization given I realized that the immunization print out from database was not available, I then asked staff to pull the immunization record and at that time I realized that pt. had already had 3 doses of the HPV vaccine. I then informed staff of what had happened and why this was a mistake. My supervisor was informed of the over immunization. I called and spoke with mother and pt. regarding the over immunization and they verbalized understanding and did not have any concerns regarding the over immunization. I then called the CDC and started a phone note in pt. chart regarding the call to pt. and mother along with call to CDC. Per staff with the CDC there is not likely to cause serious problems and there should not cause safety concern regarding the over immunization of the HPV vaccine. CDC staff is emailing me a copy of instructions and recommendations regarding over immunizing children.
On 02/22/2021 received Pfizer 2nd shot of Covid 19 Vaccine. Next morning, 02/23/2021 around 6am could not lift my head off pillow, the room and everything was spinning around. I called my husband and he tried to get me to sit up but i could not. He took my blood pressure and it was in the high 165+ so he called our neighbor who is a registered nurse, she took the blood pressure and now 179+ and kept going up and at 190+ she called 911 and they took me to the ER at the hospital, they took the blood pressure and it was 212. At the hospital it reached 237 but the dizziness was going away. I came home around 3:14pm. Follow up visit with my doctor on 2/26 and 3/15 by phone call going over testresults. Some of the tests given on 03/02 Electrocardiographics & Vascular lab. Then on 03/15 more test MRI and MRIA. Than on the last Dr. office visit on 03/15 all tests were clean. Before the last visit we did a lot of checking around with people we know (doctors and nurses) about what was going on and mentioned about the Covid-19 vaccine shot given the day before and they mentioned that people were getting dizziness and some vertigo also one we talked with was a nurse, who missed two days of work because she as dizzy the day after the vaccine. So I mentioned this to the Doctor who said he has heard the same thing. He said that this could have caused what happened to me
Psychotic episodes which was progressive every week and he ended up in a mental facility; nightmares; when he got the vaccines it pushed him all the way back to being like a toddler in some cases; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 04Jun2021 14:30 (Lot number: EW0172, Expiration Date: 01Aug2021) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PSYCHOTIC DISORDER (hospitalization), outcome "unknown", described as "Psychotic episodes which was progressive every week and he ended up in a mental facility"; NIGHTMARE (non-serious), outcome "unknown", described as "nightmares"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "when he got the vaccines it pushed him all the way back to being like a toddler in some cases". The event "psychotic episodes which was progressive every week and he ended up in a mental facility" was evaluated at the physician office visit. Therapeutic measures were taken as a result of psychotic disorder.
30 minutes post vax, the pt developed swelling and bruising at injection site. Pt went to ER on 3/23/00 when symptoms worsened. The site increased in size and became red. Pt denies SOB or other systemic reactions. Treated with ice pack and Motrin. Pt recovered from the reaction.
Had Pfizer shot 11/12/21, started having hives 11/20/21 Given Prednisone 20 mg 11/30/21 by her family doc, gradually getting better
Evans Syndrome. Autoimmune hemolitic anemia + idiopathic thrombocytopenic purpura. Coombs positive (warm Ab). Hb=6 & plts. 20,000. Differential Dx and W/U. All negative and comrehensive. Incluging viral studies, lupus serologies and Bone marrow aspirate and biopsy. Cause still unknown. Treated with transfusions, IVIG, steroids and "wait and see" aproach. Ultimately given Rytuxan. Currently on 'remission' 9/28/09 Medical records and DC summary received from date of service 11/1/08 to 11/7/08.  D/C DX:Evans Syndrome. Presented with: malaise x1month,fatigue, fever, sore throat, joint pain/swelling, cough, night sweats, anemia, thrombocytopenia. Insidious onset of symptomatic microcytic hypochromic hyperproliferative anemia with evidence of iron deficiency. TX: IV IG.
Redness, pain, swelling at injection site. Documented latex allergy. Counseled pt to take BENADRYL and ibuprofen and see if sx's decrease. If not in 2+ days check with PCP for possible cellulitis.
Hour long  bad Nose bleeds. I haven?t had a nose bleed since I was a kid. I?ve now had 3 since I got the 2nd dose of COVID vaccine only 3 days ago. I also had the typical cold chills and body ache for 24hours but that wasn?t too bad. I don?t know if these nose bleeds are related but thought I should report it Incase others are having the same problems because they are scary. Almost went to the ER because it wouldn?t stop.
Information has been received from a consumer concerning her 12 months old son who on 13-DEC-2004 was vaccinated with one dose of MMR II along with VARIVAX (manufacturer unknown). A few days after vaccination the patient developed chicken pox. It was also reported that 3 months after receiving measles virus vaccine when the patient was 15 months old, he developed autism. The patient was seen for the medical treatment. Autism persists. Upon internal review autism was considered to be another important medical event. No further information is available.
I had swelling, itching, pain and heat at the injection site that continued to grow to where it was almost my entire deltoid area.
Localized pain, significant and sudden strong redness in right eye and behind eye, with regular spasms, lasted about a week, acute for maybe 4 days