chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller stated he has been taking Paxlovid since Sunday when he tested positive/ was vaccinated and had booster, still got Covid; Caller stated he has been taking Paxlovid since Sunday when he tested positive/ was vaccinated and had booster, still got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 21Aug2020 as dose 1, single (Lot number: 051732), on 11Sep2020 as dose 2, single (Lot number: 061878) and on 27Oct2021 as dose 3 (booster), single (Lot number: 541035) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Open heart surgery" (unspecified if ongoing), notes: Open heart surgery 4 and a half years ago; "Sleep disorder" (unspecified if ongoing); "liver problems" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22May2022, outcome "unknown" and all described as "Caller stated he has been taking Paxlovid since Sunday when he tested positive/ was vaccinated and had booster, still got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive, notes: Sunday when he tested positive; (24May2022) Positive, notes: He took 2 tests Sunday and took one yesterday that were positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: The patient was in the Pfizer trial for the vaccine and was one of the first people to get the Covid-19 vaccine and was still in the study. He also got the booster in the trial last Oct2021 and still, he had Covid. The patient stated he tested positive for Covid on Sunday (as reported). He notified the lab and the whole bit. They also had him call his doctors and they prescribed him Paxlovid and he thinks it's working. The patient stated he has been taking Paxlovid since Sunday when he tested positive. The patient further stated that he took the test. He took 2 tests Sunday and took one yesterday that were positive. Caller stated he had both doses from the trial, as well as the booster. The patient stated he was on a zillion different medications, he has got quite a few. The names of these medications were not provided.
Fluzone vaccine delivered 10/6/22. Resident tested positive for Covid 19 10/11/22 and was sent to hospital 10/12/22.  Hospital records show GBS (Guillain Barre Syndrome)
Pt received vaccine in the back of her arm (L). Pt complained of (L) arm pain during and 8 hrs later. Pt with swollen area the size of a grapefruit around injection site nd soreness and pain and swelling.
Pt noted an ugly looking rash, which she describes as bright red and a lengthwise oval that is about 2-3" long.  She notes that it may be slightly raised, but does not itch.   She noted her temperature is 100, but she is also getting over a cold.
Apparent cellulitis after 7-25-06 vaccination.  Received antibiotics.  3/21/08 Reviewed hospital medical records of 07/15/2006-07/27/2006. FINAL DX: prostate cancer. Records reveal patient experienced laparoscopic radial prostatectomy.  Received Pneumovax prior to d/c home.  Records also reveal patient was re-admitted 7/27/2006-08/01/2006. FINAL DX: cellulitis Patient experienced nausea, abdominal pain & fever of 101.8.  Returned to hospital on day of d/c s/p prostatectomy.  Developed swelling & erythema of LUE next day s/p pneumovax c/w cellulitis.  Tx w/IV antibiotics.  Progressed well & d/c to home on continued oral antibiotics.
This spontaneous report was received from a medical assistant via company representative who reported that an unspecified number of doses of ZOSTAVAX that my have been stored under conditions other than what is recommended in the prescribing information, may have been administered. No adverse effect reported. Additional information is not expected.
Information has been received from a physician concerning an adolescent patient (exact age not provided) who on an unspecified date was vaccinated with an "adolescent" 0.5 ml single dose of RECOMBIVAX HB. It was reported that about two to three days after vaccination the patient developed a 3 mm blister at the injection site that lasted for two weeks. It was noted that a 5/8 inch needle was used instead of a 1 inch needle. It was believed that the vaccine was administered subcutaneously instead of intramuscularly. Unspecified medical attention was sought. It was unspecified if lab studies were performed. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Gout flare up in right knee and right big toe; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 25Apr2021 at 09:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included gout. It was reported the patient had gout-no flares for over ten years. The patient had no known allergies to medications, food, or other products. The patient did not receive any concomitant medications within two weeks of vaccination The patient previously first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 09:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021 at 01:00, the patient experienced gout flare up in right knee and right big toe. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event Gout flare up in right knee and right big toe was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
24 hours, post vax, had itching in the injection site, then development of macular eczema-like lesions on trunk and arms.
Fever for 2 days Tmax 101F beginning 9 days after vaccine; rash 1 day later, maculopapular, with conjunctival injection c/w measles vaccination.
After the vaccine - three days after - 11th of Jan, I had nausea and tiredness and mild  headache. The next day, four days after, I had nausea, abdominal pain, diarrhea, slight fever and high blood sugar. I had severe fatigue and severe headache. I felt horrible. I wasn't vomiting. That lasted two days. I did miss one day of work.  In June 13th, I had got a sore throat. I had nasal congestion as well as sinus pain - face pain. On the 14th of June, that turned into nausea, fever, chills and that is when in to be seen. She did a chest x-ray. 14th, 15th and 16th, I missed work and I had a letter to go back on the 17th. I had to wear masks and goggles at work so I had a hard time breathing - I had to use an inhaler for two weeks (because I couldn't breathe) so it took my lungs a long time to get better.
Patient monitored for 35 minutes d/t patient c/o lightheadedness. Patient admitted to having similar reactions (nausea vomiting and lightheadedness) to past COVID 19 vaccines. nausea vomiting increased weakness, heart racing, and HTN with SBP in 150's.
At 920 pt fainted after receiving vaccines tdap and flu, pt was sitting on the exam table and fall down to the floor code assist was activated staff took over.
Patient presented with symptoms of syncope 2 minutes post Janssen Covid vaccine at approximately 12:41pm.  Paleness, sweating, complaints of extreme dizziness (7 out of 10).  Asked the patient to move to the ground to elevate feet, but was unable. instead lowered head and elevated feet. Pulse was weak, patient maintained consciousness throughout. Ice pack applied to head and BP/HR taken at 12:45pm (129/112, 42). By 12:50pm, the patient stated that he was beginning to feel better and the ice pack was giving him relief.  Supplied patient with a cold water and took BP/HR again  (100/71, 59).  By 12:55pm, patient's dizziness was completely resolved and BP/HR was 100/71, 65. Patient complained of a mild headache which would be normal after drastic change in BP/HR. Patient sat for another 10 minutes with 2 more BP's taken (1:00pm 110/84, 57 and 1:05pm 109/82, 59).  I then had the patient stand for 2 minutes to eliminate the possibility of dizziness with positional changes, to which he had no adverse reaction.  The patient was dismissed at 1:15pm to do some shopping in the store.  He was also instructed to receive any subsequent vaccines in a medical care setting.
28OCT92 3AM hands itchy, red, swollen, tingling; 6AM states hands were hard to close, arthritic; PM red feet up to ankles; 29OCT92 redness on bilateral arms, went to ER & started on DPH; 31OCT92 face splotchy red;
My experience with the vaccine has been the most brutal experience I can even imagine.   I went into anaphylaxis shock. I had sezuires. I feel confused. I feel weird. I don?t feel like my self. I had cpr done. My heart was racing one minute, to them not being able to find it. One minute I?m talking, the next I?m past over shaking and unresponsive. Once I?m finally responsive, I have no clue where I am. The walls are moving, the lights on the ceiling are going round and round in the hospital.... there?s no way a vaccine can make people feel like this right?   Luckily, I?m feeling better, not fully, but better. To be honest there was a moment where I was just accepting what it is. And I?ll deal with the consequences after.   Turns out, if you?ve ever had anaphylaxis shock in the past you can?t get the vaccine. I have had anaphylaxis shock to bee stings before. They knew this, I didn?t. I still got the vaccine. And now I wait to see if there?s any more consequences for choosing to do what I thought was right.
DTAP and IPV given at 11:30. Mom called at 15:15 complaining of son being lethargic and rash on his back and itching. Told to call MD at clinic. Called back at 16:30 to follow-up and states rash is gone and he is doing fine.
Pregnancy Information:  Normal pregnancy until 20 week ultrasound on June 29th, found that there was no amniotic fluid, although there had been fluid previously. Lost the pregnancy.
Patient was 17 years of age and was provided Moderna vaccine by error. Patient indicated that she was had no adverse reactions and was monitored for 30 minutes without side effects reported.
Patient received 1st dose of Pfizer, patient fell face down on the floor 5 minutes after receiving the vaccine. She complained of dizziness, crying and shaking. Neurological and skin assessment done - no injuries sustained, she was alert and oriented x 4, crying and anxious. Vitals were within normal limits, legs were elevated and assisted to sitting position when dizziness relieved. She was released stable to family members.
Localized edema and erythema at injection site within 24 hours. NSAID therapy, heat and ABX given. Signs of cellulitis began 7 days after injection. ABX at that time
felt dizzy, nauseated, and cold within 15 mins of vaccination.  BP 130/90, pulse ox 87. Felt better but 911 called and she was taken to Hospital ED Outcome : Peanut Propensity to adverse reactions. Syncope, unspecified syncope type
Dizziness 2 mins after vaccine administration Exam was normal Patient was taken to a station, vitals taken and stable. Water and snack was given. Patient rested and observed for 30mins. Patient stated he felt immediate improvement. Discharged to home
Rapid pulse, low blood pressure, heart palpitations, weakness, fatigue, back and shoulder pain, dizziness, jitteriness.
Vaccine was administered at another facility. Presents to our clinic for sore and blisters on had and redness at base of fingernails. Started 7-10 days post vaccine. Pernio-like reaction.
Regarding the vaccines:  With the exception of the first dose, all shots were Moderna and I had fever, headaches and flu-like symptoms for about 48 hours.   The latest event was 2 positive COVID tests and symptoms.
Roughly 2.5" square area on arm (below the injection site, not around) is red and warm to the touch.
headache; itchiness; arm pain; arm red; shivers; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced fever, headache, pruritus, pain in arm, erythema of extremities and shivers. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the headache, pruritus, pain in arm, erythema of extremities and shivers were unknown.   It was unknown if the reporter considered the fever, headache, pruritus, pain in arm, erythema of extremities and shivers to be related to Shingrix.  Additional details were provided as follows: The patient got a shingle shot about 2 days ago and she ran a high fever shivers and a very strong headache, her arm was very red and itched a lot. The patient asked what could she do to relieve the itchiness and doctor told her to go to the emergency room but she took Tylenol and her fever went down but the pain in her arm was bad and the itchiness was so bad.
Red itchy arm.. hardened area at the site of vaccination. Itchy throat 1 day following vaccination, dizziness right after vaccination.  Took Benadryl for 2 days.. now feeling better.
Injection 1 resulted in a large bruise at injection site. A few days later I noticed bruising other places on my arms and legs. No know incident had happened to cause the number of bruises. They continued to show up. After 3 weeks they are finally subsiding but some continue to show up.
Circulation felt impeded; middle finger turned purple; it happened in the right hand middle finger, got red, then swelled; it happened in the right hand middle finger, got red, then swelled; This is a spontaneous report from a contactable consumer via the Medical Information Team. A female patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first dose and 9 days later her middle finger turned purple. It lasted for 2 days and faded away. Last night, it started up again in one middle section in the middle segment of the middle finger. Circulation felt impeded, it happened in the right hand middle finger, got red, then swelled and then got purple. when she woke up, color came back and everything felt normal. The outcome of the events was recovered on an unspecified date. Information about Lot/Batch number has been requested.
pt found unresponsive by parents-ambulance called @ 0500-ambulance arrived 0512, CPR in porgress per family member-transported to hosp; DOA per ER MD was intubated & given EPI enroute;
Headaches aches fatigue since shot, headaches more severe at night, can?t sleep   Severe allergic reaction with trip to ER following excederin 6/5  Headaches continue trying Tylenol and imitrex
deathly sick; Initial information received on 21-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult patient of an unknown gender who had deathly sick after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, lot number; formulation, route, administration site, expiry date and strength not reported) for Flu.  On an unknown date the patient developed a non-serious deathly sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant details were provided. No treatment details were provided.
Patient developed severe neck pain with stiffness, radiating to shoulders bilaterally. Pain level 9/10 as per patient.  She took ibuprofen, acetaminophen - no relief.
Mother called and stated left arm started with redness and swelling Weds. after vaccination and on Friday she was taking her son out and would get him shoes (?). After MD visit he stated give Benadryl. 4/7/03 Pt OK , better now.
The day of vaccination: Chills, temperature and severe headache.  The next day: Blurred vision and dizziness for a few seconds. At 11 days: Blurred vision and dizziness for a few seconds
No adverse effects. Pt was dosed with pediatric (10 mcg) dose and subsequently dosed with an additional 20mcg injection to equate the 30mcg dose of Pfizer Covid 19 adult vaccine.
Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a healthcare provider. This case is linked to case 2018SA299778 same reporter. This case involves 81 years old patient who received vaccine FLUZONE HIGH DOSE (batch number, expiry date, dose, route and site of administration were not reported) on 26-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Expired vaccine used. It was reported that give a high dose flu vaccine on September 26, 2018 and it was discovered during charting that the shots were from 2017-2018 flu season. It was unknown if any adverse event was occurred. 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. Documents held by sender: none.
Presents for cough & SOB x2 wks.  Admit for asthma exacerbation w/COVID pneumonia (CXR shows no acute abnormality). Tx: O2 via NC, steroids, mag sulfate, albuterol, zinc. DC to home.
In minutes I had pain so bad I was hoping I would die. If I had a gun and no one to stop me I would have killed myself.
This spontaneous report as received from a pharmacist refers to an unspecified number of unspecified patients. On an unknown date the patients were vaccinated with does of a volume of 0.6 to 0.63 ml ZOSTAVAX vial 19400 PFU, lot #, expiration date and route unspecified. Product quality control (PQC) involved. No adverse effect reported. Additional information has been requested.
Itchy rash at the injection site; Itchy rash at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itchy rash at the injection site) and VACCINATION SITE RASH (Itchy rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (Itchy rash at the injection site) and VACCINATION SITE RASH (Itchy rash at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchy rash at the injection site) and VACCINATION SITE RASH (Itchy rash at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: The reporter's contact information was updated.
pt ran fever over 101 24hr p/vax;also c/o stomach ache;
Abdominal cramps and bloating starting approx 24 hours after vaccine lasting 1-2 days, fatigue for 2 days, deltoid soreness with movement for 1 week, tender left axillary adenopathy noted Monday Jan 4th.
4/15/2021 I received the first Pfizer Covid 19 shot. 4/16/021 woke to find red rash at injection site. 4/16/2021 at 10:30 am, left arm began to itch at injection site. No additional rash detected. At 6:00PM on 4/16/2021 I began to swell just under my left eye. By 10:00 pm both eyes and forehead had become swollen. Took two Bendadryl thinking that would help. By 8:00 am 4/17/2021 both eyes became nearly swollen shut and swelling had moved to upper lip. Went to ER. ER doctor on call prescribed a steroid shot and oral steroids to take starting the next day. Rx was for (3) 20mg prednisone 1x a day for 4 days. Sunday evening 4/18/2021 still had some swelling in face. Monday, minimal swelling in eye lids. I supplemented Cont'd:  I also took Benadryl every 5-6 hours around the clock for four days (from 4/17/2021 - 4/20/2021) which seemed to help minimize the swelling. I also had significant flushing (redness) in my face from 4/17/2021 - 4/21/2021.  On Wednesday 4/21/2021 I contacted my General Practitioner for a follow up appointment.  During that visit, he said that it would not be good for me to get any further Covid 19 shots.  I have canceled my appointment for the second shot.  At this time, I have not had any additional side effects but, I will be monitoring over the course of the next several months.
Myalgia, Fever, NauseaVomiting, fatigue Narrative:  onset with in 12 hours of above s/s
Pt was given booster shot ahead of time. Pt was to receive booster shot in June 2022. Pt didn't present adverse reaction to the vaccine 30 minutes after administration. Case was discussed with Dr. with no action needed at this time. Pt oriented to return to the clinic if symptoms occurs.
PT WAS LIGHT-HEADED WHILE SEATED, BLACKED OUT FOR A FEW SECONDS AND VOMITED 3 TIMES WITHIN 10 MINS. BP ~103/80  . EMT ARRIVE 20 MINUTES LATER AND PT WAS ALMOST RECOVERED BEFORE TAKEN AWAY.