chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), in Oct2021 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. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "I received - 2 doses of Pfizer Vaccine + 1 Booster/ Positive COVID test+ symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of Covid-19 and Drug ineffective. Clinical course: It was reported that symptoms resumed after I completed my 5 day dose of Paxlovid. The patient took tylenol for relief from cold/flu symptoms the symptoms that returned after Paxlovid were milder than initial Covid symptoms. The patient received 2 dose of Pfizer vaccine + 1 Booster (Booster was Oct2021). The patient reported that one of those cases where Covid symptoms resumed after he completed 5 day dose of Paxlovid. He never tested negative for Covid and tested positive when he finished the round of Paxlovid. He felt back to normal, but couple of days later he had cold/ flu symptoms return and still testing positive with the at home quick test. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received MENVEO injection and PPD 12/4/13. Pt. started to complain of dizziness about 18 hours after injection. Denied cold symptoms, fever, vomiting, diarrhea. Mother felt dizziness was related to vaccine. Follow-up the next day - pt. had recovered completely.
pt rcvd Pfizer as her first dose and was mistakenly given Moderna as her 2nd dose
dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single; Lot number :unknown), administration date: 11Mar2021, when the patient was 64 years old, for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 12Apr2021 19:30, outcome "not recovered", described as "dizziness". Therapeutic measures were not taken as a result of dizziness.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Started experiencing extreme dizziness last night. 11 Days after the second shot. Did not think it was related until other's at wok experienced something similar. Reporting as this seems to only be reported in forums. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Did not had known allergies, allergies to medications, food, or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was pale, clammy, cold to touch, lethargic, HR 54bpm, for about 20 minutes.
Tested positive for Covid-19; Cough; This spontaneous case was reported by an other and describes the occurrence of COVID-19 (Tested positive for Covid-19) and COUGH (Cough) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00104045) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, CLOPIDOGREL, CARVEDILOL, ACETYLSALICYLIC ACID (ASPIRIN 81) and FAMOTIDINE (PEPCIDIN) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced COVID-19 (Tested positive for Covid-19) and COUGH (Cough). The patient was treated with BAMLANIVIMAB on 02-Mar-2021 at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 08-Mar-2021, COVID-19 (Tested positive for Covid-19) outcome was unknown. At the time of the report, COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included, Corcidin HBP.
Injection site L arm-pain/spasms/twitches from neck radiating to L arm and L side upper back weakness/headache 10/12 pain. Joints crack/hurt. Taking MOTRIN 800 mg as directed for pain but barely takes the pain away. S/S x 2 days almost.
Patient pregnant, Tdap administered on 03/10/22, Accidentally given today 04/01/22 , Patient was notified and so far having no adverse reactions.
Patient fully vaccinated with Pfizer on 4/29/21 and 5/20/21. Patient admitted with COVID PNA on 1/16/22 and is still admitted. Had increased SOB and O2 sats 85% on admission
muscular skeletal pain still on November 4 exhausted, with no relief from sleep Nausea Weakness
This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 30-year-old female subject who was vaccinated with Flu TIV .5 ml on an unknown date. The estimated date of delivery was on 01 November 2014. The subject was exposed to the vaccine during the 3rd trimester. At the time of reporting, the pregnancy was ongoing.
nurses gave the Flubok to 15 year old patient / no AE; Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case received from Non-HCP (Office Staff).  This case involves a 15 years old patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Expiry date unknown) via unknown route in unknown administration site on an unknown date.  The medical history, medical treatment(s), past vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  It was reported that nurses gave the Flubok to 15 year old patient.  At the time of reporting no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
The first few days were the 'typical' side effects I was advised of.    They did not get better.  I had crippling joint pain in my nerves on and off for three weeks.  I slowly lost my ability to walk.  Sometime I was able to shuffle around (like a 95 year old person) .  On 1/10/2022 finally I was bed ridden and had to be carried to the bathroom as I could not get my legs to work.   Then on 1/11/2022 I woke up with SHINGLES!  By late January I was able to walk and function normally.  Then on 3/22/2022 I was knocked out for endoscopy.  My joint pain and inabailty to walk then returned along with 'episodes'  During an episode,  my mind  functions fine but I am unable to make my body work.  I lose the ability to walk, I fall down, speech is slow, I breath through my mouth and it looks like I'm having a stroke.  I've been to two neurologists and had  two MRI's, spinal taps, blood work plus many other tests but I have not had any strokes or seizures or anything else.  From March through August I would have 1-3 episodes a day.  Some episodes were very severe, some were mild.  I was unable to drive for six months or do any kind of activity.
limp, sweaty & w/dec responsiveness 30min p/vax had BM
Initial misuse report received from a nurse on 06 November 2013. The 21-months-old patient had received FLUZONE 0.5 ml intradermal (site not provided). Reporter stated that 21 months old received 0.5 ml dose instead of 0.25 ml age appropriate dose. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Large Red warm area around the vaccination spot appeared 6 days after receiving the vaccine. The spot is approx mentally 5.5" accross
very high fever 105.6 went to ER had a rash that appeared to be spots;MD was not sure what is was;rash lasted 24hr;CBC & CT scan was done & nothing was wrong;not clear on dx;
Subsequent to receiving one dose of varicella virus vaccine live, pt developed a rash consistent with shingles on the right chest.
Day after, fever 101, body aches, headache, fatigue. Day 3 swelling at injection site, red, painful, cannot sleep on arm. Day 4 very painful red swelling and pain in shoulder, pain when coughing in left lung upper quadrant.
recvd immun 29APR that nite devel fever->103 fever persisted thru 3May92. Devel vomiting & diarrhea 2May on exam 4May had 3cm area of induration @ vaccine site on rt thigh as well as lt arm. DX: local rxn, poss febrile rxn to DPT.
the right began to swell, itching, hot to touch happened noticeable about 3 months after second shot; the right began to swell, itching, hot to touch happened noticeable about 3 months after second shot; the right began to swell, itching, hot to touch happened noticeable about 3 months after second shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 2, single (Lot number: EN5318), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time: AM, Site and Route of injection: arm, Batch/Lot number: Pfizer, EN5318), administration date: 26Jan2021, for Covid-19 Immunization, reaction(s): "Swelling of legs", "Itchy legs", "Extremities hot feeling of". The following information was reported: PERIPHERAL SWELLING (non-serious), PRURITUS (non-serious), FEELING HOT (non-serious) all with onset Jun2021, outcome "unknown" and all described as "the right began to swell, itching, hot to touch happened noticeable about 3 months after second shot". The event "the right began to swell, itching, hot to touch happened noticeable about 3 months after second shot" required physician office visit.  Additional information: After receiving second vaccination. patient leg more so the right began to swell, itching, hot to touch happened. Noticeable about 3 months after second shot. As patient have taken boosters the legs have become more bigger. Leg swollen on Jun2021, It caused (illegible) to become worse. Prior Vaccinations: None.
Irregular heartbeat started when contracted Covid-19 in October 2020.  Exacerbated again after receiving both doses of the Moderna vaccine.  Since October 2020 to present, she has had two event monitors placed.  One event monitor was 2 weeks in length, the other was 30 days in length.  She is a patient of cardiologist, Dr. She has also seen electrophysiologist, Dr. and internist Dr.   She has an appointment for a second opinion on 8/2/2021 with electrophysiologist Dr.  She has been treated for high cholesterol for the past 40 plus years.  She has been treated for hypertension for the past 40 plus years.    Starting with Covid-19 in October 2020, she has had the sensation of ?needles sticking up? which goes around the neck, up to the ears, and along each joint of her jaw.  She was placed on a blood thinner by Dr. around 6/2/2021.  Dr.  also has placed her on Diltiazem to treat her blood pressure issue. As of today, 7/6/21, the sensation is subsiding and is nothing like when she had Covid-19.
Soreness and itching at the injection site which went away with cold compress and BENADRYL.
6 year old pediatric patient received 0.3ml Adult COVID-19 Bivalent dose instead of 0.2ml Pediatric COVID-19 Bivalent dose. Parent were provided with CDC guidelines and recommendation on wrong dose COVID-19 Bivalent vaccine as well as guidance from infectious disease provider doctor and Allergy & Imms provider doctor. Parents aware to monitor child for the next 72-Hours for any adverse side effects to include increased lethargy, fever, or any life threatening symptoms; take child immediately to ER.
Syncope; Autonomic Dysfunction; Orthostatic Intolerence; Fatigue; Dizziness; Headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 31-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unspecified date in 2013, the pt experienced following vaccination syncope, orthostatic intolerance, dizziness, headache, fatigue, and autonomic dysfunction. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.   Upon internal review, the syncope was considered as a medically significant event.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007498: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007521: US-009507513-2301USA007594:
7 to 8 days after shot I have been getting an allergic reaction in the left arm (where I received the shot) to the left of the injection site and slightly below. It comes and goes but will flare up and become itchy at random times. There is small swelling in the itchy area but not a huge bump on arm, only slight risen and very red, work/ hot feeling in the area. Currently feeling this now 1/22/21 as I fill this form out but it is going away, again.
A non-serious spontaneous report of "is cold with chills is shaking" has been received from a consumer concerning an eight-year-old male, subsequent to Influenza A (H1N1) 2009, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received a single dose of Influenza A (H1N1) 2009, Intranasal on 16-Oct-2009. On an unknown date after receiving Influenza A (H1N1) 2009, Intranasal, the patient developed "is cold with chills and is shaking". The outcome of the events was not provided.
Abdominal pain began the morning of April 2nd, followed by a sharp increase in pain in the overnight hours of April 2-3. Appendix ruptured at approximately 3am April 3rd (88 hours post vaccine administration). Blood present in stool on April 6th (first bowel movement post-rupture).  Due to nausea and abdominal discomfort as possible side effect of vaccine, did not seek medical attention immediately. Was hospitalized on April 8th, discharged April 13th.  Second vaccine given May 18th. Abdominal pain followed on May 22nd and I was taken to the Emergency Room.
Started feeling aches all over 4 hours after shot. Twelve hours after shot developed 103 degree fever. Twenty hours after shot fever is 102 degrees along with symptoms of severe flu. Treating with Tylenol, Ibuprofen and fluids.
Information has been received from a physician concerning a 16 month old female with no pertinent medical history and no drug reactions/allergies, who on 26-NOV-2007 was vaccinated SC in the right thigh with a first 0.5 mL dose of Varivax (Oka/Merck) (lot number: 658523/1253U).  Suspect therapy included a first dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (lot number: 654687/1025F) (HSA) in the left thigh.  The physician mentioned that about a month after the patient received the vaccine, the patient was diagnosed with ataxia.  The patient was hospitalized for one day so that a "work up" could be performed prior to the diagnosis.  Lab diagnostic studies performed included an MRI that was negative and a spinal tap that showed a count of 10 white blood cells.  Other unspecified lab studies were performed.  No additional information was available.  Unspecified medical attention was sought.  The outcome was reported as recovering.  There was no product quality complaint.  Follow-up information received indicated that the patient became "shaky" about 4-6 weeks after immunization.  She was noted to have ataxia on 26-JAN-2008.  However, subsequent work-up revealed a ganglioneuroblastoma in her chest.  The patient was hospitalized for 4 days and required medical/surgical intervention.  The ataxia is therefore unrelated to vaccines.  Relevant diagnostic tests and laboratory data included an MRI of the chest that showed a ganglioneuroblastoma which was the cause of her ataxia.  There were no adverse events following prior vaccination.  There was no illness at the time of vaccination.  The outcome is reported as not recovered.  the ganglioneuroblastoma and ataxia were considered an other important medical events.  Additional information has been requested.
Approximately around 8:00 pm the same day as my injection I started to be in a fair amount of pain at the injection site (right shoulder) I took a bath still was in pain took Tylenol hoping it would take the edge off around 11:30 the pain started to increase so I put a heating pad on my arm . As the night progressed my shoulder pain intensified and then  I started to feel pain all over my by body mainly in the joints. It was very severe joint pain all over and especially in my right shoulder that I took another bath.  I couldn?t lay down or sleep I could barely walk around my bedroom but even that hurt so bad in my hips and knees. This feeling was very similar as if I were to having an lupus episode in my joints. Around 4 am on January 14th I finally took ibuprofen and eventually I was able to fall asleep. I later woke up around 9 am and thankfully pain free other than a mild shoulder pain where I got my vaccine.
My left armpit is extremely swollen and painful.; My left armpit is extremely swollen and painful.; I can barely move my arm because it starts to throbbing and pulsating; I can't sleep because I'm in pain; I can barely move my arm because it starts to throbbing and pulsating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2022 10:15 (Lot number: FM0698) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPIRONOLACTONE; ZYRTEK; CENTRUM WOMEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0180, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 10Jun2021, when the patient was 31 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0185, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 19May2021, when the patient was 31 years old, for Covid-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 05Mar2022 14:00, outcome "not recovered" and all described as "My left armpit is extremely swollen and painful."; MOBILITY DECREASED (non-serious), PAIN (non-serious) all with onset 05Mar2022 14:00, outcome "not recovered" and all described as "I can barely move my arm because it starts to throbbing and pulsating"; INSOMNIA (non-serious) with onset 05Mar2022 14:00, outcome "not recovered", described as "I can't sleep because I'm in pain". Therapeutic measures were taken as a result of axillary pain, pain. Therapeutic measures were not taken as a result of swelling, mobility decreased, insomnia.  Additional information: Reaction/event as reported by primary source included that the left armpit was extremely swollen and painful. It started the same day as the patient took the third dose of the vaccine. Patient could barely move her arm because it started to throbbing and pulsating. She can not sleep because she was in pain and can not even put on her clothes by herself. It was really scary and she does not know what to do. Was taking Tylenol for pain but can not say it was helping. Was worried about her lymph nodes and if it can get more serious since it was right next to her breast. She cannot wear a bra or do anything, and since she does not have insurance, she can not see a doctor about it. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device date was reported as 07Mar2022.  Follow-up attempts are completed. No further information is expected.
Left deltoid red swollen on 9-10-07 pt treated for cellutlitis with Keflex 500mg
Received dose #1 of Moderna on 12/31/2020  Day #1  - nothing  Day #2-3 - mild tenderness at injection site Day # 8 -  Left arm induration 6cm X 7cm i Around injection site: red, hot, tender with itching. Small central pustule at injection site surrounded by induration- pustule  then resolved . Accompanied by headache & sore throat.   Benadryl did not resolve left arm symptoms  Tylenol helped headache  Did not need to use Epi pen
9OCT91 7PM t103 R; 4AM 10-10 104F R 7AM; 10OCT91 t105F R; no other sx other than runny nose; pt was seen @ clinic w/ t105.3; no signs of illness other than diarrhea & runny nose; dx Bronchitis & pyrexia;
It was realized at the time the patient presented for her second covid 19 vaccine, that the patient was 17yo at the time of administration, rather than 18 yo or >.  CDC was contacted and since patient was 12-17 yrs of age, and Moderna was inadvertently administered as the first dose instead of Pfizer-Bio N Tech, it was indicated to administer Moderna as the second dose (as off-label use), and to report this incident to VAERS, as a vaccine administration error.   Since the provider who had ordered the vaccine in August was not in the office, the on-call provider was consulted with the information from CDC, and direction was given to administer the second Moderna vaccine.  Patient and parent were also made aware of this situation.
Severe hives, skin itching, and irritation started December 2, 2021.  Required steroid injection, oral steroid, benadryl and zyrtec to reduce symptoms. Symptoms are milder after 8 weeks but still require zyrtec and/or benadryl.
his death was weeks after getting the vaccine; pneumonia; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), 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 following information was reported: DEATH (death, medically significant), outcome "fatal", described as "his death was weeks after getting the vaccine"; PNEUMONIA (medically significant), outcome "unknown". The date and cause of death for the patient were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: his death was weeks after getting the vaccine