chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No side effects were reported/No addtiional AE/PQC; The patient received VARIVAX and MMRII one day apart; This spontaneous report was received from a medical assistant and referred to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, then, on 17-AUG-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (inappropriate schedule of product administration); both administered for prophylaxis (strength, lot number, expiry dates, vaccination scheme, anatomical locations and routes of administration were not provided).
None immediately after the shot. But I noticed the ringing on my left ear started gradually and it's been several weeks and even with steroids it won't go away.
Could not sleep more than hour, very restless, chills for half the night (4) hours and then I?d get warm.  No fever temp taken was 98, achy tough time waking up , by about 10am today felt better.
pt recv vax 4SEP97 & approx 36hr post vax pt devel a painful rash on lt side of neck;it contained a cluster of mult herpes zoster vesicles approx 1in by 3inches in two patches w/red base along an unspecified dermatome;
Headache developed the day after vaccines given (in the morning). TYLENOL and ibuprofen given without benefit.
During the observation period, the patient's mother came up to the pharmacy to inform that her daughter's vision was "becoming blurry". Pharmacist assessed patient who was alert but was feeling warm, lightheaded, and was having difficulty seeing. Pharmacist obtained cold water bottles for the patient. Patient fainted but was responsive when calling her name. When patient became alert again, BP 88/49 and HR 67 was obtained. EMS was not required. Advised patient to remain seated for at least another 15 minutes. She was provided white soda and a snack. Patient and mother were educated again on the vaccine's potential side effects and how to respond/call for help.
This case was reported by a consumer and described the occurrence of Guillain Barre Syndrome in an 18-year-old male subject who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). At an unspecified time after vaccination with Flu vaccine, the subject experienced Guillain Barre Syndrome. The subject was hospitalised. At the time of reporting the outcome of the Guillain Barre Syndrome was unspecified. The consumer reported that she knew of a male subject that received a flu vaccine (unknown manufacturer) years ago and was diagnosed with Guillain-Barre Syndrome. The consumer reported (or it was reported) that this event occurred approximately seven years ago and the subject was 18. The consumer reported that the subject was placed in intensive care unit in the hospital. The consumer did not want to provide any additional information and did not want any further contact. This was one of two cases reported by this consumer; see case A0811647A for additional report of a subject experiencing Guillain Barre Syndrome after receiving a flu shot vaccine.
Rash began 7/4/13 on stomach, back, legs, neck and head. Patient came "into the office 7/5/13. Dx Post immunization reaction - stop the Hep A series.
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 57-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 56 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 06May2022 as dose 4 (booster), single (Lot number: FL3197), in left arm 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 and concomitant medications were not reported. Past drug history included: Bacitracin, reaction(s): "known allergies: Bacitracin"; Neomycin, reaction(s): "known allergies: neomycin"; Possibly belladonna (atropine), reaction(s): "known allergies: possibly belladonna (atropine)"; Possibly belladonna (atropine), reaction(s): "known allergies: possibly belladonna (atropine)". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
On 01/23/2002 itching then progressed to hives. On 01/27/2002, swelling, redness and approx. 4-5 inches in diameter. Swelling and redness resolved by 01/28/2002 am. Itching resolved on 01/31/2002.
redness 2-3cm above immunization site w/in 10" began fading w/in 5" more above MMR site;
A serious report of nail disorder has been received from a study investigator concerning a 44-month-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 07-Dec-2008, the subject received FLUMIST. The subject was admitted to the hospital for nail disorder on 11-Dec-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.
Pt started with itchiness in her arm 7 days post-vaccination on 1/13 while she was still in bed.  Later that morning, when she started getting ready for the day, she noticed the arm was warm, red, tender, and itchy in the right deltoid.  The redness enlarged a little from the original, site, but pt really did not see much of a change.  The day after, she mentioned it to the DCHS here, who was advised by our Medical Director, who advised her to try Benedryl before bed.  Pt took 50 mg of oral Benedryl.  This morning, the arm appears much better.  Only a slight redness off to the side, no warmth or tenderness.  Pt advised to continue to take Benedryl q hs until done and dose before next injection.  Pt stated understanding,
4 hours after the injection, her face turned red and swelled, she went to sleep and woke an hour later vomiting and with chills.
I lost most of my hearing ability in my right ear approximately 5 days after the shot. It began returning slowly that day but didn't;t fully return for 3 days. I went to a ENT in Boise, ID to get it checked about 3 days after the initial loss of hearing but by then my hearing had returned to normal so they saw no loss of hearing during the hearing tests. I think my ears are back to normal, but I am not entirely certain.
suspected vaccination failure; shingles in the mouth; This case was reported by a consumer via media  and described the occurrence of suspected 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, 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 details were provided as follows The patient was the reporter's friend. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles in the mouth. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This case has been linked with case US2021AMR077206, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR077206:Same reporter
Patient is a 82 y.o. female with a hx of atrial fibrillation (on Eliquis), DM, and HTN who presented to hospital 1/9/23 from ECF with dyspnea and several days of cough. Admitted with COVID 19 PNA and CHF exacerbation.      1. COVID 19: vaccinated and boosted. Symptom onset ~1/7/23; COVID-19 positive on 1/9/23. Discontinued Decadron 1/16/2023 as patient weaned to room air.  2. Acute Hypoxic Respiratory Failure: no hx of O2 dependence. Required 6L NC on admit. Admit CXR with pulmonary edema. In setting of CHF exacerbation and COVID 19. Weaned to room air 1/16/2023.  3. Acute on Chronic HFpEF: Follows with Dr. (cardio). Admit BNP 1.9k, CXR as above. Echo on 1/10/22 with EF of 67% and RVSP of 45-50. Diuresed with IV lasix, discharged on PO lasix.  4. Permanent A fib: s/p AV junction ablation. Pt has known dual chamber pacemaker. Follows with Dr. Continued home Toprol-XL and Eliquis. 5. HTN: per hx. Continued home BB.  6. IDDM2: A1c 7.9 on admit. Continued home insulin regimen.
Information has been received from a company representative concerning a female who in December 2007, was vaccinated intramuscularly with the first dose of GARDASIL. In January 2008, the patient was vaccinated with the second dose of GARDASIL. Subsequently, the patient experienced inappropriate schedule of vaccine administered. Also the patient has experienced muscle pain since the second. The patient's inappropriate of vaccine administered and muscle pain persisted. No further information is available.
COVID vaccine made her lose her hair; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "COVID vaccine made her lose her hair". Therapeutic measures were taken as a result of alopecia.  Additional information: Reporter just spoke with a nurse in this department. She was going in circles here. She gave her information and some phone numbers. This was where she started. She needs help receiving Xeljanz to make her hair grow because the COVID vaccine caused her to lose her hair. She just spoke with (Name withheld). She doesn't want to do another report. She has probably done this a few times now. Anyway, she is trying to get Xeljanz, but they told her she exceeds the financial limit. That was a problem for her. She has been speaking with people since the fall. All they tell her is she makes too much. She will have to buy it out of pocket. She thinks Pfizer should help her pay for this because Pfizer caused this. Reporter doesn't want to do another report. She wants to get over to Xeljanz support. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
suspected vaccination failure; I had the Shingles on my back and in my eyes / came back in my eyes worst this time nothing on my back but it's murder in my eyes; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles on back) and ophthalmic herpes zoster.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had the Shingles on back and in eyes. The age at vaccination was not reported. The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient received 2nd dose of Shingrix and shingles in eyes worst nothing on back but it was murder in my eyes. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event were unknown at the time of reporting.
4/02/21-body aches dizzyness, nausea 4/03/21-body aches, nausea, dizzyness, fever, chills, chest pain 4/04/21- dizzyness, nausea,worsening chest pain
Outbreak of Shingles. I've had chickenpox. I've never had shingles. It's pretty bad.  It covers my right side, spine to midline chest. However, I'm still getting my second shot. Just wanted you guys to know, since other people have reported the same. I'm atypical due to my medical history.
lump on left arm at the injection site; Redness on left arm at the injection site; swelling on left arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump on left arm at the injection site), VACCINATION SITE ERYTHEMA (Redness on left arm at the injection site) and VACCINATION SITE SWELLING (swelling on left arm at the injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE MASS (lump on left arm at the injection site), VACCINATION SITE ERYTHEMA (Redness on left arm at the injection site) and VACCINATION SITE SWELLING (swelling on left arm at the injection site). At the time of the report, VACCINATION SITE MASS (lump on left arm at the injection site), VACCINATION SITE ERYTHEMA (Redness on left arm at the injection site) and VACCINATION SITE SWELLING (swelling on left arm at the injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
The pt developed hard injection site and his whole right leg swelled up larger than his left leg. It was red, hot to the touch, and itched. Applied Ceflex, Zyrtec, and cold compresses.
Patient experienced fever, chills, a large rash around injection site and a hard lump that lasted for 3 weeks.
diarrhea, generalized mild edema, facial eczema w/moderate itching on 10/5/99;sx free on 10/6/99 x/several spots on face & neck;
Patient claimed that the next day woke up with fever of 105. Was sick for 3 days.
Pt developed symptoms of viral URI and irritability, 3 weeks after 2nd Prevnar dose, which progressed to "mild" Guillain-Barre' Syndrome (lower extremity and trunk weakness only, with hyporeflexia). weakness developed 1 week after symptom onset. Treated with IVIG in the hospital. Slow recovery in progress. Physician reported that pt does not have Guillain-Barre Syndrome; instead he has been dx with neuroblastoma unrelated to vaccination.
Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild.
Upset stomach; severe lower left abdominal pain; Fever; increase urination; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd April 2022, the patient received the 1st dose of Shingrix (intramuscular). In April 2022, 8 hrs after receiving Shingrix, the patient experienced upset stomach, abdominal pain, fever and urinary frequency. On an unknown date, the outcome of the upset stomach, abdominal pain, fever and urinary frequency were recovered/resolved.   It was unknown if the reporter considered the upset stomach, abdominal pain, fever and urinary frequency to be related to Shingrix.     Linked case(s) involving the same patient:  US2022104933   Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's Comments:  This case was reported by the patient.  The patient received Shingrix in unknown arm.  About 8 hours after receiving the vaccines, the patient had an upset stomach, severe lower left abdominal pain and fever. The symptoms resolved by morning. The patient had increased urination about 10 hours after both doses and that also resolved by morning. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022104933:Same case
On the evening of the 15th day after my vaccination and a couple of hours after reporting once again that I was perfectly fine, I had a sudden shaking of my body which lasted about 30 minutes. it was so bad I couldn't hold a glass of water without spilling it. I got up and walked around, did some deep breathing, tucked my hands under my armpits and tried to resume watching TV. After about 30 minutes it calmed down but did not go away. I wasn't chilled. my temp was 100. I took to Tylonal and went to bed, shivering. Earlier this same day, around 4pm, I had started dry coughing quite bit but didn't think much about it. In the morning, after a restless night, my temp was 99. I felt sluggish, and weak but not sick. No activity, no walking that day of Saturday. Took 2 more Tylonal mid day. Temp was down to 98. That night, temp 98, I took Niqual and slept soundly. Sunday morning temp was 97.3 and I was feeling a lot better and continued to feel better to normal by Monday morning. A reaction to the drug 15 days after I thought was strange. I had no vaccination site redness or pain t any time. I wondered if I had actually contracted the virus. I'm ok now. Did not call for medical help. I have never been tested for he Covid 19 virus.
clinet c/o fine red rash on both her arms and thighs. Itchy. states started the next day after recieving Tdap.
really bad burning sensation in my for-head that is now down the back of my neck; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (really bad burning sensation in my for-head that is now down the back of my neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced BURNING SENSATION (really bad burning sensation in my for-head that is now down the back of my neck). At the time of the report, BURNING SENSATION (really bad burning sensation in my for-head that is now down the back of my neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medication was received by the patient  No Treatment was received by the patient.
Patient was vaccinated with vaccine that was not properly diluted. We suspect vaccine was diluted with 0.8ml of diluent and not 1.8mL.
Monday, 6/7/21, I developed extreme dizziness that went into exhaustion, body aches, sensory perceptions - as in body feeling heavy and then normal, not being able to look out of both eyes at once, could not walk on my own, could not keep anything in stomach. By Wednesday, 6/9/21 went to ER. Fluids given with Zofran and sent home. Went to my doctor Tuesday, 6/15/21, brain MRI with/without contrast-no problem, prescribed Meclizine for dizziness. Thursday, 6/17/21, went to ENT - all hearing good, sent home to drinks major fluids and be patient to recoup. Today, 8/3/21, still have intermittent dizziness, feeling stronger but still have to be careful of tiredness.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 09-OCT-2014, unspecified amount of patients were vaccinated with RECOMBIVAX HB lot # reported as J014855, expiry date 16-APR-2016 (dose, route of administration, were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
11/06/20: Received vaccine at 11:00 am, felt nausea by 11:05 am, chills/covered in goosebumps at 4:30 pm, tired and weakness rest of night. 11/07/20: Muscle aches and pains, extreme tiredness, felt like I was hit by a truck, headache, continued nausea. 11/08/20: Tired, headache, rapid heartbeat, lightheaded. 11/09/20: My normal blood pressure is 120/80. Fire Department took my blood pressure at work and it was 140/100 at 1:00 pm. Rapid heartbeat, lightheaded, tired, headache, lack of balance/equilibrium and ability to form words. Contacted Triage Nurse and was recommended to go to the Emergency Room. Blood pressure was 172/83 at 5:00 pm and 139/86 at 8:00 pm. 11/09/20: At Emergency Room, EKG and bloodwork done. Doctor said I had a severe allergic reaction to the Shingles vaccine. 11/10/20 thru 11/14/20: Still feeling lightheaded and continued rapid heartbeat.
Narrative: Pt had 3rd dose of moderna on 11/2/2021, was seen in primary care on 1/26/2022 and had a CBC done that showed severe thrombocytopenia, new from last CBC (11/2021). Pt was sent to the ED and admitted, ultimately transferred to a higher level of care where he was evaluated by heme/ onc and was diagnosed with acute B cell lymphoma. Pt went into acute respiratory failure and was intubated and transferred to the ICU, and died on 2/13/2022.
Fever, chills, body aches. Took Tylenol and Ibuprofen. Symptoms resolved at 9am 1/16/21.
This is a spontaneous report from a contactable physician through Pfizer Medical Information. A 75 years old female patient received first dose of PREVNAR 13; lot number J49846, expiry date Feb2015) at 0.5 ml single, on 21Nov2014. Medical history was not provided. The patient was taking omeprazole 20 mg generally twice a day, atenolol at 200 mg once a day, LYRICA at 75 mg once a day and zolpidem occasionally at 10 mg at night. On 25Nov2014 in the evening the patient experienced congestion and increased throat secretions in the vocal cords. The physician reported that he did not see the patient. The physician mentioned that the height of the patient may be 5 feet and 5 inches but he was not sure. The physician reported that the consumer had just taken 1 shot of PREVNAR 13 injection till now. The events were not resolved at the time of the report. The physician did not think that the events were directly related to the suspect vaccine. Follow-up (06Jan2015): Follow-up attempts completed. No further information expected.
After receiving vaccine patient started complain of vision disturbance, confusion, nurses started he was slow to respond. Nurses also documented that he was acting the same way the day before due to UTI. No SOB . no signs of allergic reaction
This spontaneous report as received from a physician refers to an unknown patients of unknown age or gender. On an unknown date the patients might have been vaccinated with GARDASIL (dose, route and lot# not reported) with an unsupported temperature excursion. No adverse effects reported. This is one of several cases from the same source. Additional information has been requested.