chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with (Oka/Merck) PROQUAD which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot # and expiration date unknown). No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
The patient described a rash that was warm to the touch, and spread from arm to neck and breast areas. She gets the flu shot every year and never had a reaction in the past, so she believes it may be due to Boostrix. She will be following up with her PCP tomorrow to have rash checked.
Patient stated that she went from being able to work to having to have help to do daily tasks. The first dose she went completely numb for about 30 minutes on her left side. She only took the second dose because of work. After receiving the vaccine she had a large lump/knot on her left arm and it is still there, very hard. She has been very weak. She has not recovered her strength and this has lead to her losing her job at the nursing home she worked at.
Swelling, at the site at 9pm fever of 102.0 at 2am gave Tylenol and Motrin now more red this AM but better now per mother.
Patient had NO adverse rxn... She rec'd one extra Shingrix dose in Sept 2019 outside protocol window. Therefore this VAERS was done. This patient had completed the 2 shot protocol in early 2018 and RPH hadn't realized that....No Hospitalization or Dr intervention needed.
Systemic: Lymph Node Swelling-Medium, Additional Details: Patient noticed uncomfortable feeling in right armpit area during the evening/night after receiving vaccine. In the morning, patient noticed a bump/swollen area under his right armpit. Patient reports that bump doesn't hurt, but is uncomfortable; reports that bump is soft to touch. Patient reports no other symptoms and has no other complaints. Pharmacist visually observed bump, looked like a swollen lymph node. Advised patient to seek care from PCP/ER if swelling doesn't resolve in 1-2 days.
Lupus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, 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: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Lupus".  Clinical course: The caller is trying to schedule an in-home booster shot from Pfizer for him and for his fiance. He mentioned that he took the first and second shots of the COVID-19 vaccine and has health problems; he has lupus. Gathered caller's concern/inquiry, Gathered callers Demographics (Unable to verify the name of the caller's name since were not allowed to spell out their name back), Privacy statement Provided, Provided FAQ response can you assist with scheduling my vaccine appointment, After referring to the local health department caller hung up. The caller has health issues, has lupus, and got the first and second shots of the COVID-19 vaccine. Medical inquiry was not forwarded.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300015124 same patient, same event, different dose of vaccine;
developed severe case of dermatitis on extremities and torso.  nothing changed in routines or environment.  doctor can't explain why it has occurred.  symptome are abating now
BREATHING COMPLICATIONS; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age. The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included: Patient was perfectly healthy with no issues at all and worked out regularly. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the patient experienced breathing complications, and was hospitalized (date unspecified). Patient was on medication for life. Number of days of hospitalization was not reported.  It was reported by consumer that, "My friend is now in an out of the hospital due to breathing complications and on medication for life just days after receiving the J and J vaccine. He is monitored regularly by a doctor. Sad because prior to the vaccine he was perfectly healthy with no issues at all and worked out regularly. Can barely do that now." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from breathing complications. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20221135402-Breathing complications. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Within 12 hours of shot, experienced uncommon fatigue, drowsiness. Within 24 hours of shot, began to itch and had a few whelps on my arms. Initially assumed it was a reaction to a mosquito or spider bite. A few hrs. later entire body covered in whelps with tremendous itching till I applied hydrocortisone cream and took BENADRYL. 48 hrs. after shot, whelps still severe.
Pain at injection site and under arm pain second day after 2nd vaccine, lymph node swelling and pain on fourth day after 2nd vaccine.
My adverse reaction was about 2-3 hours after I had the vaccine, I expected my arm to be sore but it steadily got more and more sore. It kept waking me up on that night 2/3. I tried not to lay on my left side and I was getting chills like you get when you get the flu, so that lasted for about 30 hours after I had my vaccine. And then about 2:30-3:00 in the afternoon all of the adverse symptoms/reactions I was having just stopped. The only other thing I want to say is that I wasn't hungry at all, i could taste and smell but I didn't want to eat anything. I had soup and everything else but I had no appetite.
Lip tingle; Tongue- back, Each side-felt full; Eye lids dropped; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 68-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand Pfizer, lot EK5730, expiry date not reported), intramuscular in the left arm on 21Dec2020 16:15 at single dose, for Covid-19 immunisation. Medical history included asthma. Prior to vaccination the patient was not diagnosed with COVID-19. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included liothyronine, levothyroxine sodium (LEVOXYL), ergocalciferol (VIT D) and fluticasone propionate (FLOVENT). The patient experienced lip tingle, tongue- back, each side-felt full, eye lids dropped on 21Dec2020 16:15. He went to professional office/clinic visit/Emergency room/department or urgent care. An unknown treatment was given to the patient. The outcome of events was recovered.
Pt has 10.5 cm x 8 cm area of erythema with 8 cm x 6.5 cm area induration with 3 cm diameter centrally of minor excoriation.  Pt complaints pf pruritus. Pt has no complaints of pain or has a fever.
The pt received Tdap and HPV (GARDASIL) #1 in her right upper arm at 1400 on 7/23/12. At the time the pt was in her normal state of good health. When the pt removed her uniform at 1700 she noted a red, flat, non-pruritic "rash" on her shoulders. She denied difficulty swallowing, difficulty breathing, swelling, pruritus, nausea, vomiting, abdominal pain or diarrhea. The pt presented to her PCM on 7/24/12 at 0915. The rash consisted of 5 marks/lesions on her right shoulder and 4 lesions/marks on her left shoulder. It was suggested that a tryptase level be drawn which was nml. When the pt presented to the clinic she had 4: 2-4mm long x 1-2mm wide linear red non-raised marks on the top of the left shoulder lateral to her bra strap. Additionally, she has 2: 10mm long x 1-2mm wide linear red non-raised marks; 2: 3-4 mm macules (red) and one 5mm V shaped red non-raised red mark on the top of the right shoulder. She denied use of any new shampoos, hair products, laundry detergent, soaps, body creams/lotions. The pt did report that she wore a new shirt (unlaundered) with a tank top and bra underneath on 7/23/12. She did not note that the shirt was irritating. She denied scratching her shoulders. The "marks" began to fade on 7/25/12 and gradually resolved by 7/30/12.
Dizziness, anxiety, nausea. BP 111/74 (pulse 73), 93% O2 sat. Stable.
tested positive on the PCR/Tested positive of the covid-19 virus after the both the doses; tested positive on the PCR/Tested positive of the covid-19 virus after the both the doses; sore arm; chills; couldn't sleep well/  couldn't sleep really well; felt feverish; fatigue; Injection site pain; Sleeplessness; This is a spontaneous report from a Contactable Consumer.   A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: FA6780), via an unspecified route of administration on 01Sep2021 age at vaccination was 61 years as DOSE 2, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine includes the patient received first dose of BNT162B2 Pfizer Covid 19 vaccine, Batch/Lot number: FA6780 on an unspecified date for COVID-19 immunization had side effect of sore arm. In Sep2021, the patient had sore arm, chills, couldn't sleep well/couldn't sleep really well, felt feverish, fatigue, injection site pain, and sleeplessness. On 03Sep2021, the patient tested positive on the PCR for the covid-19 virus after the both the doses. The reporter reported that, I have recently gotten vaccinated, my first dose a little over 3 weeks ago and my second dose Wednesday. On Wednesday night, I had a sore arm which is normal for me because I had it with the first one, but then I started with chills throughout the night. I couldn't sleep well, felt feverish. Around 5am, about 16 hours after injection, I took 1 Tylenol felt better almost immediately and said awesome I was just having side effects. To be safe, I went to go get tested around noon time the next feeling just fine back to myself, took another Tylenol as a precaution because I had the fatigue, the whole 9 yards. I felt fine yesterday for the rest of the day, I thought great my side effects are over, until I got a phone call this morning from the state of that said you tested positive on the PCR, you tested positive, but I'm feeling back to myself now, like okay. I went and got another PCR test that had someone else do it and that came back negative. I'm feeling just fine, oxygen at 99%, everything is normal about me, but I'm really concerned did I have covid. The lab data included oxygen saturation was 99% on an unspecified date in 2021, PCR test negative on an unspecified date in 2021, and PCR test positive on 03Sep2021. The treatment medication included TYLENOL for fever. Outcome of the events sore arm, chills, I couldn't sleep well/couldn't sleep really well, felt feverish, fatigue, injection site pain, and sleeplessness were recovered in 2021 and other events was unknown. Follow-up attempts are completed. No further information is expected.
pt had screaming episode lasting approx 3 hrs following 2nd vax; event occured in 1988;
Day of vaccine administration, patient had episode of going limp, eyes rolling back & difficulty breathing.  Patient w/fever 100.4 at the time.  Patient recovered after 5 minutes.  Patient was seen in clinic 8/26/09 & exam was normal.  Patient had repeat episode the same evening & seen in ER.  Referred to neurology.
Pt. received vaccination and less than a couple of minutes the patient was sitting in a chair and fell face first on the floor. She fainted and was not responsive when the pharmacist arrived to the scene. At that point the pt. had a pulse but lying face first on the floor, that is when the Epipen 0.3mg dose was injected in the right thigh. The pt. was at that point able to communicate and able to identify her name and date. App. 5 min later the paramedics took over the scene and the pt. sat up and started to feel better.
Patient woke up on saturday July 17,2004 with painful arm, red and swollen. Patient did not want to move the arm for anything. Low grade temp.No other symptom.
Pt vaccinated with DTP/OPV developed fever, rt leg pain 23AUG90; Rt thigh swollen & hot, temp 101.6; IV antibiotics & rechecked Follow-up 4SEP90 showed 3x4 CM cyst mass has resolved-never "pointed" or drained.
The night of the vaccine my entire arm from base of neck to hand was in excruciating pain.  Not the regular pain I experienced from shot #1.  Got up during the night to get some tylenol and became extremely dizzy and fell very suddenly on my back, almost losing consciousness.  When I saw my face shortly after I was extremely pale.  The following day I was very tired all day but less dizzy.  Arm was still unusually painful but mostly around injection site instead of the whole arm.  Two days after the shot I was mostly recovered, normal arm pain and very slight tiredness.
Moderna COVID-19 Vaccine EUA My mother got a nose bleed around 9pm after taking her medications that evening. The bleed was not significant and stoped fast. No medical help was sought.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 01-MAY-2015 was vaccinated with an improperly stored dose of GARDASIL (lot # K006960) (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Patient is 16 years old but was given the Moderna. She should have received Pfizer COVID-19 since she is less than 18 years old. Patient reports no adverse effects other than mild nausea.
Developed unexplained essential tremors shortly after vaccination, they were subtle at first. This was reported to the doctor several times. The doctors said it was probably caffeine or puberty causing them and did not record them in his file until 2019. Tremors continue today.
6/10/99 felt bad;6/11/99 T103.2;6/12/99 red blotches appeared;6/13/99 classic varicella pox;tx famvir & APAP;
Soreness at the vaccine site 1 day after administration, diffuse body aches and fever, chills and rigors overnight. Presented to ED on day 2 after administration with temp of 103 F, HR 122, complains of tingling,  cramping and spasming of fingers bilaterally.  Physicial exam significant for carpal spasm to fingers of bilateral hands.
Joint and muscle aches, headache, pain at site (right upper arm and arm pit) that evening into and through the 17th (Saturday).
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient concerned a 57 year old  male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, codeine, demerol, NSAIDS allergy, and bananas, strawberries, carrots allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, 1 in total administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-APR-2021, the patient had a dry cough. On 22-APR-2021, the patient started to feel sore all over. On 23-APR-2021 (Friday) night, patient had chills and fever of 101F and took Tylenol to relieve the fever. On 24-APR-2021, patient got a COVID test and it came back positive for COVID (coded suspected covid 19 infection and suspected clinical vaccination failure). On 26-APR-2021, the patient saw infectious disease specialist and received the monoclonal antibody treatment for COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid 19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210452164. This case is associated with product quality complaint (PQC) number 90000177846.; Sender's Comments: V0: 20210451939-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Reports she was exhausted and weak for a few days after the shot. on 4/20 she went to the ER to receive treatment for a blood clot in her right leg. Reports she had been having trouble with her leg for 5 days before going to the ER. She has started taking Xarelto. She went  for treatment. She was not admitted.
Bad headache; Bad muscle pain; Cramps; Fatigue; Low grade fever (~102 max); Diarrhoea; Feeling dehydrated; sensitive skin; This is a spontaneous report received from a contactable consumer. A 32-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 9:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and ADHD (attention deficit hyperactivity disorder). The patient was allergic to penicillin. Concomitant medications included amfetamine aspartate, amphetamine aspartate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and salbutamol (ALBUTEROL) for unknown indications. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, the patient experienced headache, myalgia, muscle spasm, fatigue, low grade fever (102 maximum) (unspecified unit), diarrhea, dehydration and sensitive skin. No treatment was received for the events. 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 headache, myalgia, muscle spasm, fatigue, low grade fever, diarrhea, dehydration and sensitive skin was recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
expired dose of FLUZONE QUADRIVALENT was administered inadvertently, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via physician via Agency (Reference number- 00877775) and transmitted to Sanofi on 30-Nov-2021.  This case involves a 29 year old female patient who was vaccinated with expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] inadvertently (Expired product administered).  The patient's medical history, medical treatment(s), past vaccination(s) and family history were not provided.  She had no other vaccines.   On 24-Nov-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE produced by Sanofi Pasteur (lot number: UT7058JA and expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency same day).  It was reported "Nurse reported that an expired dose of FLUZONE QUADRIVALENT was administered inadvertently to a patient by a medical assistant on 24NOV2021. The FLUZONE QUADRIVALENT expired on 30JUN2021. The caller would like to know if this is a valid dose and how to proceed. Product: FLUZONE QUARIVALENT (pre-filled syringe (PFS)). Caller stated that the patient did not have any adverse reactions and did not require Doctor or emergency room (ER) visit post administration"  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
I received my Pfizer Bivalent booster for COVID-19 on 10/21/2022. On the morning of 10/23/2022, I woke up feeling very fatigued. I had a throbbing headache, sore throat, weakness, and a feeling of being out of place. I was confused and disoriented and not sure about where I was. I still had an appetite, and I didn't lose my senses of taste or smell. I felt nauseous, though, so I didn't eat much. My smart watch alerted me that my heartrate was high, and this continued for about 7-8 hours. At its highest, my heartrate was 149, but it then went down to 120 and 104. For the most part, my breathing was normal. However, when I was in bed, I sometimes felt like I was gasping for air. Whenever I would get up to go to the bathroom, I could hear myself wheezing. I slept well that night, and when I woke up on the morning of 10/24/2022, I felt much better. It felt as if a storm had passed. Basically, the day went normally, though my watch alerted me at one point that day that my heartrate was 104. When I woke up this morning, I still felt a little under the weather, but I still feel much better than I did on Sunday, and I feel like I'm continually getting better.
Developed rash to face within 4 hours of receiving MMR injection. Following morning woke with swollen face/rash to face, stomach pains.
Patient's arm was feeling tight after the injection, The sleeve seemed to be tightening her arm and after the injection she felt all the blood rush down her arm and she stated the injection site came out a bit and had a little bump. She went to the observation area and was feeling faint and light headed. She was taken to a separate room and she became a little faint and was given some water and kept longer for observation.  After about an hour shes feeling much better and her color as returned and only feeling slightly light-headed.
Fully vaccinated, not boosted.  Asymptomatic COVID infection with inpatient hospital stay.
Patient had (2) doses of varicella, A Proquad (MMRV) and a varicella was given on the same day. No adverse reaction from extra vaccine given. Made follow up phone call mother on 5-14-19.
Patient explained that she woke up in the middle of the night to use the restroom and experienced complete muscle weakness. She could not get out of bed. Her leg and arms felt like mush. Lasted for some time before she could get out of bed and walk.
Worsening chest pain, ST segment elevations on EKG, elevated cardiac enzymes in acute MI range. Dx: acute myopericarditis
bumps and red rash around injection site on left arm, that spread around entire arm, about 4-6 inches wide, and bumps and itching inside the labia and on the labia of vagina.