chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   In or about March 2016, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the prophylaxis.  On an unspecified date, shortly after to the patient vaccination, the patient was caused to suffer shingles. As a direct and proximate result receipt of the zoster vaccine live (ZOSTAVAX) vaccine, patient had resulted in physical limitations not present prior to using the vaccine; Patient had also experience mental and emotional distress due to resulting physical limitations and seriousness of Plaintiffs' condition. The patient sustained severe and permanent personal injuries; Patient had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome of the event was unknown.  The reporter considered the events of shingles to be related to zoster vaccine live (ZOSTAVAX).
6 hours post - dizzy spells, headache, fatigue day 1 - day 6 - Nausea, vomiting, diarrhea, headache, fatigue, arm pain and redness, muscle aches day 7 - red ring around injection site and itchiness
I received the dose at 12:00pm Saturday and by midnight I was awoken with severe 9/10 pain to my left arm radiating up my left side of my kneck to my ear and down to the middle of my back. This follows Sunday morning with muscle aches, joint pain, headache and nausea. Continuous nausea occurs until vomiting starts sunday mid afternoon. This all continues until Tuesday morning when a Phenergan shot IM is able to be administered at urgent care where I return home and sleep for 24 hours. Tiredness and weakness continue until the morning of Saturday 16th where I wake up feeling "normal" in a sense.
Shingles breakout about a week after 1st vaccine. Dermatology confirmed; medication given and treatment plan started.
The evening on the day I got my 2nd shot I was feeling very restless for no reason and I barely got any sleep, about 4 hours. The next day my arm was sore along with my whole body. I just felt achy all over and super tired. The 2nd day after my shot I still felt very tired the whole day however by about 9:00 pm that night I felt just fine.  Today is the 3rd day since the shot and I have a mild headache and diarrhea.
This spontaneous case, initially received from other health professional (nurse) on 11-Oct-2018, concerns a 67-year-old, elderly male patient. The patient's historical condition included a significant fall and was under surgery on his knee and elbow. On 09-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 250798 and expiry date: 31-May-2019]. On 10-Oct-2018, 1 day after vaccination, the patient woke up and noticed a rash on his chest on the side, where he received the flu shot. On an unspecified date in Oct-2018, the patient went to the dermatologist, who gave him a fluocinonide topical cream. Eventually, the patient applied the fluocinonide cream on the rash and reported that cream had worked. On 11-Oct-2018, the patient had recovered from the event. The reporter assessed the case as non-serious.
Developed varicella-like rash (2 pox) 7 days after vaccine administration on 8/20/2020 Papulovesicular rash on (L) arm, (R) hand, otherwise well
ExtReme muscle pain. WoRst at Low back and buddocks. FaciaL muscle pain and uppeR body pain as well. FeveR and stomach pain. ExtReme symptoms lasted 24 to 36 hRouRs. DuRing second day weRe slightly mildeR. All symptoms gone by day five. Tylenol did not help the pain. I will not take the 2nd dose.
Moderna COVID?19 Vaccine EUA After getting the 2nd Moderna COVID shot, the patient was ok for about 10-11 days. Then, suddenly on March 25, he started showing high levels of dizziness and increasing blood pressure. We didn't think much of it and thought it was fatigue and asked him to rest. But, by April 2nd, his blod pressure was around 200/110. We rushed to ER. They conducted all the necessary tests and released him with his blood pressure holding around 170/100 asking him to go to a general practitioner. Then, on Monday we visited Dr. who recommended we wait for 2 weeks to see if the effects will dissipate to determine if it is neurological or if it is vaccine effect. It has been a very very slow dissipation of the side effects. He still has to walk very carefully and feels dizzy all the time. The impact has diminished about 20-25% in about 10 days but 6 weeks after his vaccine, he is still in trouble and is worried.
Sore arm for two days, mild general fatigue, but at  -37 hours post-vaccine, upper lip itched and swelled slightly. Went down after taking a Benadryl.
Bad headache; Washed out; Temperature of 99 degrees; A spontaneous report was received from a consumer, concerning a 82-years-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced bad headache, temperature of 99 degrees and washed out.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 17 Feb 2021, the patient received first of two planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection in left arm.  On 17 Feb 2021, after vaccination, the patient experienced symptoms of bad headache, temperature of 99 degrees and patient was washed out.  Action taken with mRNA-1273 in response to the events were unknown.   The outcome of the event's bad headache, temperature of 99 degrees and washed out were considered unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: 24 Feb 2021 (Pallavi Parab): The event body temperature increased was kept as listed since the temperature reached to 99 degree Celsius (kindly reassess).
Information has been received from a physician concerning a 10 year old female who on 22-MAY-2007 was vaccinated IM with 0.5 ml of the first dose of Gardasil.  Concomitant therapy included Varivax (MSD) and hepatitis A virus vaccine (unspecified).  On 22-MAY-2007 the patient experienced injection site redness, swelling and itching.  As of 23-MAY-2007, the patient had not recovered from her experience.  Medical attention was sought.  Additional information has been requested.
Pt received second Pfizer vaccination in series. She developed a Pulmonary Embolus 3/5/21, and was hospitalized for this as well as Acute Hypoxic respiratory Failure. It was initially attributed to hormone therapy that she has been taking for 40 years, and never had any issues with this. However, she was removed from the Hormonal therapy after this episode. She got her 3rd Pfizer booster 11/17/2021, and developed another PE 02/04/2022. and was hospitalized again.
Six days after the shot,  my are started to itch and a red area developed  4 inches by 3 inches.  I am not experiencing any pain. The red area itches on one side of the  red area.
The baby develops hives all over the body a few hours after the vaccinations were given. The child went to ER on 08/31/2005 where Benadryl P.O. was prescribed.
fever to 104 9 days p/vax;macular papular rash 11 days p/the vax;
-Redness at the site - vomiting/diarrhea RX; supportive care
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years 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 included: "Hypergammaglobulinaemia benign monoclonal" (unspecified if ongoing), notes: Other medical history: Mgus; "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: After testing negative on Paxloivid, tested positive on day 3 after my last dose; (unspecified date) Positive, notes: Treatment of COVID-19; (05Oct2022) Positive, notes: After testing negative on Paxloivid, tested positive on day 3 after my last dose. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association  the causal role of suspect  BNT162B2 cannot be excluded for reported events. Case will be reviewed on receipt of FU information.
Patient was receiving vaccine with vanishpoint syringe. When nurse was pushing down on the plunger to administer the vaccine, the contents squirted out of the side of the syringe and the patient did not receive any of the vaccine. Parents and nurse were confident that the patient did not receive any of the vaccine and gave another dose.
2/4/16 - Tdap given at approximately 1100. 2/5/16 - Sx onset at 1730. Body aches, swelling, redness at injection site. Skin felt "on fire". 2/8/16 - Cool compresses, Loratadine 10mg QD and Famotidine 20mg BID and topical steroid cream.
Vaccine GARDASIL given on 4/10/09. Pt reported on 4/28/09 that she had pain in neck on side and had difficulty swallowing and fever next day of vaccine, on 4/11/09.
Pt states he has had wheezing, dizziness, weakness with dry cough and fever. Pt has taken ibuprofen for fever and reports "aches, chills and sweats". Symptoms began within 12 hrs of vaccine.
01/14/2021-approximately 4pm, approximately 5 hrs. post vaccination, Ct started experiencing a 'vibration sensation' inside legs and hips. Ct was driving at the time, thought something was wrong with her car got out and realized it was her body. By 6pm she had 'internal tremors' throughout whole body. Described vibrations at bedtime as quite violent. Reported to Heath Department via V-safe. Was going to go to the ER but didn't, next morning, 9am, tremors started to subside and were gone within 24 hrs. of the vaccine.
Get ache muscles cold even shakes on a daily basis since for 6 or 7 weeks now, some days are not so severe and aspirin or Advil take care of symtoms easily
Pfizer-BioNTech COVID-19 Vaccine. Chills, headache, body aches, nausea, fatigue
no adverse event; Patient received the Moderna Bivalent booster as their second dose instead of the Monovalent dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Moderna Bivalent booster as their second dose instead of the Monovalent dose) and NO ADVERSE EVENT (no adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 27-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 27-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the Moderna Bivalent booster as their second dose instead of the Monovalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Moderna Bivalent booster as their second dose instead of the Monovalent dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the Moderna Bivalent booster as their second dose instead of the Monovalent dose).    No concomitant medications were reported.  No treatment medications were reported.
Patients mom called on 7/29/2008, and stated that the site where the injection was given ( RIGHT ARM) was red and swollen. I advised the patient and the mother to come in the office and have Dr. look at the area. Patient came into the office and saw Dr. Dr. documented in the chart, the following: Swelling, redness, warmth induration extending down from the injection site. Measured 7x10cm. No fever, no rash, No malaise, No LAD. To call back if it gets worse, LAD enlarged, fever greater than 101F, pain , redness increases, ect. Patinet will be called by myself this afternoon to see if the symptoms are getting better or worse.
I gave the patient the Flu shot and after about 5 minutes she came out of the room and said her tongue was numb. She went in to use the restroom and when she came out her tongue was now swollen. I grabbed the FNP and went and got an epi-pen and some Benadryl. The FNP gave the pt the Benadryl and gave it a few minutes to see if that would work so we wouldn't have to use the epi pen. After about 10 minutes after taking the Benadryl the swelling went down and the patient said her tongue no longer felt numb. The patient was cleared to leave after waiting a total of 15 minutes after taking the Benadryl.
Pt had tingling for 3 hours after the Trumenba vaccine in his L leg. Patient experienced tingling in R leg the following morning and he felt as if it was spreading to other body locations. Said it was a sensation that he has never felt before. Also reported chills and not feeling well. History of anxiety and experience anxiety associated with  discussing Guillain Bare Syndrome.
Information has been received from a physician concerning a 68 year old female who was vaccinated SC with 0.65 ml dose of Zostavax. On the day of vaccination, patient developed a "varicella like rash" at the injection site that was reported as "the size of softball". The patient recovered 1 week after vaccination and was reported the patient was "otherwise in good health". Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. Information has been received from a physician concerning a 68 year old female with allergies to "statins and muscle relaxants" and  history of hypertension and osteoarthritis who on 22-JAN-2007 was vaccinated SC in the left arm with 0.65 ml dose of ZOSTAVX (lot # 14067). There was no illness at the time of vaccination. On the day of vaccination, patient developed a "varicella like rash" at the injection site that was reported as "the size of softball". The patieny recovered 1 week after vaccination and was reported the patient was "otherwise in good health". Unspecified medical attention was sought. A product quality complaint was not involved. Additional information indicated that on 24-JAN-2007 the patient developed a rash at the injection site which was erythematous vesiculopapular rash resembling shingles. The patient was seen for a doctor's visit and clinical exam was performed. The patient recovered one week after vaccination/ No further information is expected.
Began with redness and induration at approx 8 PM on 2/26/2003. On 2/27/2003 induration was 4.5cm diameter on left bicep, pt with positive tenderness over injection sites X 2 left bicep. Gave Atarax 10/5 syrup one tsp by mouth in office. Apply warm compress prn.
A few hours after PENTACEL (DTAP/IPV/HIB) and PREVNAR (PCV 13) vaccine had tremor of arms, legs and seemed off balance, resolved in 24 hrs.
Narrative:  82 yo male with PMH OSA, HTN<s/p prostatectomy, HLP, CAD (MI 2002, PTCA 2002) reported bradycardia through a telephone triage call on 1/11/2021. Pt stated that he noted his pulse went down into the 40's x2 days, denied symptoms when pulse was in the 40s. Per notes, his pulse at the time of call was in the 80s, which was normal. Patient received Pfizer vaccine on 1/5/2021. Review of notes show that it is unknown if pt really had bradycardia from covid19 vaccine. Please see addendum on 1/11/2021, pt stated that he wasn't sure if the reading of pulse was correct when the reading said 40.
Pt reports increased bruising, specifically to the left lower extremity and papular, "sandpaper" rash to bilateral popliteal region, 2 days after vaccination.  Pt also reports pain to the upper right calf w/o swelling or warmth.
At 4:40pm received shot on April 1, 2021. On 8pm same day the sore arm and headache started. April 2, 2021 woke up with Sore arm, swollen lymph node in left armpit, dizziness, fever of 102 for 2+ days, sensitive skin, no appetite, burning hot, chills from the inside out, achy joints, nausea, fatigued, headache for 3 days. Sick until Sunday night 4/4/2021.
Information has been received from a physician via company representative referring to a 15 year old male patient. No medical history or concurrent conditions were reported. On 22-AUG-2016 the patient was vaccinated with his first dose of GARDASIL (lot# L043214, expiration date, dose and route unspecified). Concomitant therapies included MENVEO (unspecified if it was administered in the same arm as the GARDASIL). On an unknown date in August 2016, an unspecified time after receiving the GARDASIL, the patient developed syncope. The outcome of syncope was not provided. The causality between syncope and GARDASIL was not provided. Additional information has been requested.
On the 22nd, I was hiking with my wife and I couldn't catch my breath and I had to sit down and rest for a bit. And I was getting faint the day that  I got my vaccine when I was going up the stairs. On the 22nd, I went to Urgent care - they did a blood test and they sent me home. I had had a couple of blood tests before in the week. I decided to send them to my Urologist. And she told me to go to ER and that was on Monday, the 23rd. They admitted me and kept me for two days.  Kept me hydrated and gave me an IV of saline for two days. I got out on the 25th. The doctors are trying different levels of Calcitriol - to see what's best.
about 14 minutes into 15 minute post vaccination wait time, pt stated he was feeling dizzy and having blurred vision.  Gave pt water to drink and observed pt for another 15 mins; he said the dizziness got better but still slightly blurry vision. Suggested he follow up with primary MD if that did not resolve.
Chest pain, starting 3 days after.  EKG abnormal on stress test.  Inferolateral ST segment depression.  CAD ruled out.  Menstrual cycle abnormal.  Lost cycle February 2022 returning June 2022.  FSH was high 48.7 on 4/13/22 30.0 on 6/30/22 became closer to nomal 14.3 on 10/7/22.  MRI on pituitary gland normal.  Lactating prolactin level 90.8 (norm 4.8-23.3).  Loss of > 20 lbs from Dec 2022 to Nov 2023
Patient experienced acute respiratory distress syndrome. Onsite EMS was called vitals BP 110/72 HR 74. Patient refused evaluation or care and was released agianst medical advise.
Patient's sister reported patient was experiencing shortness of breath, hives, and severe migraines within an hour and a half of receiving the vaccine. Patient was admitted to the emergency room for treatment shortly after and was discharged that same evening. It should be noted that the patient had taken her initial dose of MACROBID during the period between receiving the vaccine and developing symptoms. The MACROBID was new for the patient. Upon followup the next day, the patient had recovered but was still experiencing some migraines, though not as severe.
Pain and swollen right arm where shot was given. Metal taste in mouth that has not gone away yet. Taste like a coin is in mouth. Started between 30- 1 hour after shot and still tasting it a day later
rash, high fever up to 104 x 6 days;loss of appetite, urinary tract infection, leg swollen, red, hot
Varivax 0.5ml administered SQ into the left arm on 7/24/07. Patient returned to clinic on 7/26/07 c/o sore arm and bruising. Medium sized reddened area measuring about 10 cm by 5cm noted over the vaccine site. Small dime sized bruising noted at the administration site. Encouraged benedryl orally, ice to the site, Ibuprofen for pain and elevation of the affected arm. 7/27/07 client returned to clinic, c/o urticaria on the site. No noticable change in the size of the reaction site. Site continued to be reddened. No blistering or drainage noted. Skin was warm to the touch. Encouraged patient to seek medical attention if reaction worsened over the weekend. 7/30/07 f/u phone call made, left message re: condition of reaction.
Nauseated; Arthritis aggravated; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis aggravated) and NAUSEA (Nauseated) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced ARTHRITIS (Arthritis aggravated). On an unknown date, the patient experienced NAUSEA (Nauseated). At the time of the report, ARTHRITIS (Arthritis aggravated) and NAUSEA (Nauseated) was resolving. Not Provided          No concomitant medications were reported No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporters causality for the event(s) of ARTHRITIS WORSENED was not provided. The reporters causality for the event(s) of NAUSEATED with HUMIRA(ADALIMUMAB) was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
A non-serious spontaneous report of administered expired FLUMIST was received from a health professional concerning an 20-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 13-Feb-2012. The patient inadvertently expired product on 16-Feb-2012. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 26-Mar-2012: The reporter stated that the patient did not experience any adverse events and the patient received FLUMIST very soon after it expired.
True vertigo - room spinning dizziness, perceived motion,  made worse with changes in head position.  Nausea and vomiting at extremes of vertiginous symptoms. Also  generalized fatigue noted.    No fever, chills, diaeresis, headache, hearing loss, loss of taste or smell, cough, or nasal congestion, muscle aches, body aches or myalgias.
Fever and vomiting <1 day after receiving vaccine. Rash, swelling, redness at injection site.
Syncope post vaccine. Patient taken too medic tent. No chest poison, no sob, no weakness of extremities. No facial droop. No bowel and bladder incontinence. No confusion the following syncope. Syncopal event lasted for a brief 2 to 3 seconds.