chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 01/09/2001 the patient was found to have herpes zoster. The vesicular lesions were distributed on the left side buttocks, down the left leg to the left toe in a dermatome pattern. Approximately 50 lesions were noted. Additional information has been requested. Per F/U 6/17/02: Information has been received from a physician concerning a 17 month old female pt with no known allergies and past medical history of hyperbilirubinemia and hypoglycemia, who on 8/1/00, was vaccinated with 1 dose of varicella. There was no concomitant medication. It was reported that within a 2 week, post vax period, the pt had "some fever, but no rash". On 1/9/01, the pt was found to have herpes zoster. The rash was reported to have lasted 2-3 weeks. The physician noted that the pt was a healthy female without any known immunosuppression and without any known exposure to wild-type virus. Preliminary results indicated that the specimen, which was from a vesicular lesion/scab crust, for this case was VZV positive. Additional info indicated that the vesicular specimen was VZV positive and the presence of Oka/vaccine VZV had been identified using PCR analysis. It was reported that the pt recovered completely from that episode. Upon F/U; it was reported that on 7/3/01, the pt developed a rash "first on back, also on face, chest, legs, etc., first as red bumps (then becoming vesicular". There were new lesions identified on 7/4/01, 7/5/01 and the physician questioned the presence of new lesions on 7/6/01, when he also noted that the "old" lesions were fading and again on 7/7/01. There were no other symptoms reported. The physician stated that the rash resembles possibly breakthrough varicella. There was no recognized exposure to chicken pox or shingles. Upon physician exam, the physician reported 40 scattered lesions, mostly papular, some micro-vesicular. There were no lesions identified on the mucous membranes. This was noted to be a possible immune deficiency. However, he indicated that if specimens reveal VZV, the pt might need an immune work-up. It was reported that "no treatment (was) necessary". On 12/17/01, it was reported that the possible breakthrough rash swab specimen, collected for PCR analysis, was inadequate to process. The specimen was negative for direct fluorescent antibody. There were reported to be the final results. Addtionla info has been requested.
I noticed a yellow goopy discharge on the belly button. I had that 2 nights in a row. When I squeezed it I would get a lot of puss coming out of it. It does not hurt but it is tender to the touch. I also had bloating and abdominal cramping. My physical therapist noticed I had a lot of inflammation and fluid on the lower left section of my rib and abdomen. The provider that I saw through virtual health said it was Umbilicitis and put me on antibiotics for a week. She told me to get evaluated by a provider in person once I am done with the antibiotics to see if I need a drainage.
Hospitalized for unresponsive hypoglycemia. Resp failure secondary to severe COVID 19 pneumonia needing BiPAP. Tested positive for covid 19. Large heel ulceration
Injection site turned red, welted, warm to touch approx 2" wide and remained very sensitive to touch for 48 hours.
fatigue; arm soreness; This is a spontaneous report received from a contactable consumer (patient). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247, expiry date was unknown), via an unspecified route of administration on right arm on 03Feb2021 11:30 AM at single dose for COVID-19 immunization, at workplace clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 03Feb2021, 18:00, the patient experienced fatigue, arm soreness. Patient was not given treatment for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Right after injection, site started itching with small rash, then the itching, swelling, pain, and rash has gotten worse. Signs of "Covid Arm".
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 4 (booster), single (Lot number: Gh9703) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications within 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 21Apr2023 to 25Apr2023.  No follow-up attempts are possible. No further information is expected.
Narrative: Patient hospitalized 7/27/21 after completion of COVID-19 vaccine series Feb 2021 for weakness, productive cough and shortness of breath after close contact with a positive COVID case at an event. Treated with dexamethasone and as needed oxygen. Discharged to home 8/9/21.
From telephone correspondence received on 10/22/02, it was reported that a 38 year old female was vaccinated with Fluzone, lot U0982AA, on 10/8/02. She developed a rash approximately 12 hours after vaccination. She denied any respiratory problems and was not seen by a physician. It was reported that the patient fully recovered. This case is closed.
Client received Immunization on 3/26/09 (DTAP and MMR). Mom states, "Started on TYLENOL and MOTRIN, but spiked temperature 104 on 3/28/09 2:00 p. Gave MOTRIN and took clothes off to cool client and temperature dropped within 30 min to 102, but Dad was holding client, when he started to seize, called EMS and took to ER - Mom notified Health Dept 3/30/09.
An adolescent female patient with exposure to rabies experienced back, shoulder, hip and chest pain after receiving RabAvert. The patient received rabies vaccine approximately 3-4 years ago. No past medical history or concomitant medication were know.   The patient complained of back, shoulder, hip and chest pain after receiving rabies vaccine. The same symptoms continue to persist for the patient. No further details were available at this time.  The events are considered possibly related to the RabAvert.
Vaccine at 2;00.Problem started at 4:30 with a sudden tickle sensation in left nostril.  Caused sneezing 8-10 times. Runny nose, eyes red with tears, phlegm required constant blowing of nose.  Stuffed cotton up left nostril and breathing through mouth gave some relief. It is now 8;15 and doing much better.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 24-AUG-2017, the patient was vaccinated with one dose of RECOMBIVAX HB 2.5/0.5 (unit unspecified) (route unspecified) from lot # N002914, expiration date: 04-NOV-2019 and one dose of VAQTA (strength, dose, and route unspecified) from lot# M036459, expiration date: 18-JAN-2018; for prophylaxis, that were improperly stored. No adverse effects reported. The vaccines were exposed to a temperature of 28.6 Fahrenheit (F) for a time frame of 115 minutes. Previous temperature excursion was 32F to 35 F for 225 minutes. The call was because of a data logger. No product quality complaint involved.
Large lump/knot on super bicep, huge swelling. Looks like another shoulder, knot is hard and mounted length wise onto bicep.
Pt stated that after she received the vaccine, her arm was sore; around two months after the second dose she slept on that arm and woke up experiencing pain in the muscle of the arm she received the shot. Pt stated that her shoulder did not hurt, just the muscle.  Pt stated the pain went away, but she still experiences intermittent pain in the muscle (left deltoid) where she received the vaccine.
PT COMPLAINED OF DIZZINES,S, NAUSEA, AND DECREASED BP..  EMS called and pt taken to ER
a 69 y.o. female presenting for follow-up of adverse reactions shingles vaccine.  She was initially given the 1st dosage of the shingles vaccine on 05/27/2022 and then the subsequent dose on 06/20/2022.  I spoke and confirmed with nursing that this was the case.  Patient developed side effects the same day as receiving the second dose of the vaccine including dizziness, body aches, tactile fever, weakness, fatigue, nausea, decreased appetite.  She subsequently developed a rash on her face described as blister-like around and in her mouth which was painful.  The rash has since resolved.
3 hrs after rcv'ng flu vax, hives devel on hands, arms and trunk. Shortly thereafter, hives became generalized. At ER rcv'd Benadryl. Sx resolved.
Guillain-Barre Syndrome; This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced guillain barre syndrome after receiving flu vaccine.
Pt  was nervous about the shot, but seemed ok immediately after it was administered.  He went to the chair to wait his 15 minutes with his mom.   A minute later, his mom was calling that he was having a reaction.  A technician called 911 while I went to check.  He passed out for just a moment and came to quickly.   His mom said he was ok but paramedics arrived within minutes and were checking him out.  His blood pressure was super low and they monitored him and took over.  They were gone within probably 10 minutes.
Began with chills, fever, headaches, body aches, sinus draining and cough.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-OCT-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 48, 1 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
I saw my doctor on 5/13/2022 for a wellness check as I turned 65 years old this past month. I was given the Pneumovax 23 vaccine and within several hours, while driving home. developed a very large, hard lump on my left upper arm. Later it was progressing down my arm to my elbow. I phoned my doctor who told me to immediately go to the emergency room, which I did. After several hours they released me thinking that it was simply an allergic reaction. It did not respond to Benadryl. The following morning it is continuing to progress and my left arm is nearly twice the size of my right arm. As instructed, I took Benadryl but it is having no impact and is not relieving the possible allergic reaction to the vaccine. I am reluctant to return to the emergency room and spend another $120. only to be told the same thing. I am 65 years old, single, with a disability and reside alone where I have no family. My closest friend is immunocompromised due to a kidney transplant so I do not want him exposed to any illnesses at the emergency room. Having worked all my life and traveled extensively, I have always been vaccinated, especially before traveling to another country. I have never had an adverse reaction to a vaccine. I am not am alarmist, however this, being quite out of the ordinary, is concerning. All of my vital signs both initially at my doctors appointment and in the emergency room were normal. My blood pressure. weight, and vitals are all normal. I do not drink or smoke and have no other contributing medical factors that would have caused this.
I took the bandage off and saw black and blue bruise; saw little blood on the bandage; A spontaneous report was received from a consumer concerning a 87-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events i took the bandage off and saw black and blue bruise, saw little blood on the bandage.  The patient's medical history was not provided. Concomitant medications reported were Lovastatin, Baby Aspirin for drug use for unknown indication.  On 13 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient took the bandage off and saw black and blue bruise (contusion) and saw little blood on the bandage (vaccination site discharge).  Treatment details included, mRNA-1273 mRNA-1273 Adverse Event Not Applicable.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
patient was given regular Fluzone QIV vaccine instead of the Fluzone High Dose with no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via agency (Reference number- 00318089) and transmitted to Sanofi on 15-Oct-2020  This case involves a 76 year old female patient who was vaccinated with a 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (batch number UJ477AA and expiration date 30-Jun-2021) via an intramuscular route in the left arm instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in error on 15-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any other vaccine concomitantly.  This was an actual medication error case due to wrong vaccine administered (latency: same day). Nurse Practitioner reporting a medication error described a consumer in error got the Fluzone Quadrivalent Standard dose and not the prescribed Fluzone Quadrivalent Standard High Dose. The patient was concerned she did not get the high dose. The nurse wanted to know if there were any exceptions about revaccination.  At the time of reporting, no adverse reported for the patient.  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.
Nausea, eye sight fluctuations, rash, headache, insomnia, tingling of hands & feet, Long bones in arms & legs are so sore they hurt when touching each other. Ear problems with loud noises. I now have 6 plugged arteries. A follow up report received 10/31/2001 adds: Pt's attorney instructed him to call VAERS in F/U to his previous report. Pt's symptoms persist in terms of difficulty focusing with his eyes, sensitivity to sound, pain in bones of arms and legs, and insomnia due to discomfort. No prescription or OTC medications have been effective. About 6 months ago he had 3 stents placed for the previously reported coronary artery occlusions. His cardiologist stated that pt's eye, ear and bone pain problems were not related to his cardiac problems. Pt's PMH is significant for coronary bypass surgery approx 1991 and treatment with Prednisone for 7-8 months due to symptoms of Lyme disease (fatigue, pain, bulls-eye rash) in 1991. Pt states his condition then was not diagnosed as Lyme disease and his blood tests were negative. However, the tests were unsophisticated at that time according to the pt and it is now presumed he indeed had Lyme disease. He states he fully recovered at that time. Currently he takes large amounts of vitamins and minerals and, "something for sleep which does not help past 1-2 hours".
Arm that got the shot became extremely sore after several hours. Couldn't move arm at all w/o getting extreme pain. Unable to undress or dress, etc. lasted about one week, *Pneumococcal.
Fever, chills, body aches, headache, plugged right ear, exhaustion, 3 x 5" redness at injection site, pain at injection site. This has been going on for 3 days -- I don't know when it will end. I have never had an adverse reaction to a shot before, except for a sore arm for a few days. I am a very healthy woman. This reaction has been a bizarre experience for me.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction under the left arm), INFLAMMATION (it got inflamed), MASS (had like a ball under the arm that was quite big, arm still has like a ball that never left, the size of half a ping pong ball, like something that fits your hand.) and PAIN IN EXTREMITY (pain in the arm at the time of the reaction) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-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 experienced VACCINATION COMPLICATION (reaction under the left arm), INFLAMMATION (it got inflamed), MASS (had like a ball under the arm that was quite big, arm still has like a ball that never left, the size of half a ping pong ball, like something that fits your hand) and PAIN IN EXTREMITY (pain in the arm at the time of the reaction). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (reaction under the left arm), INFLAMMATION (it got inflamed), MASS (had like a ball under the arm that was quite big, arm still has like a ball that never left, the size of half a ping pong ball, like something that fits your hand) and PAIN IN EXTREMITY (pain in the arm at the time of the reaction) outcome was unknown. No concomitant medications reported. Patient reported going to a medical center and received poor and bad medical attention.
Rash developed 3 days after shot given. Rash on legs/extremities.
no adverse event; incorrect product storage; This spontaneous report has been received from an office manager referring to an unknown age and gender patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 20-AUG-2021, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, route of administration and anatomical location were not provided; lot # U009260, expiration date reported as 19-SEP-2022, albumin status recombinant Human albumin (rHA)) for prophylaxis. The vaccine underwent temperature excursion of -10.7 degree Celsius for total 192 hours. It was reported that there were no previous temperature excursions. At the time of report, there was no adverse event (AE) reported.
Second dose not received in time window; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not received in time window) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not received in time window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not received in time window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.  Patient reported that there were no side effects with the first dose of the vaccine. The patient was originally scheduled for the second dose of the vaccine on 13-May-2021 but did not get it at that time and had not received that dose till the time of this report. No treatment medications were reported.
8/4/21: patient admitted. The patient presents with SOB. Pt states she went to her PCP three days ago and was prescribed Levaquin and diagnosed with bronchitis. Pt states she wasn't feeling well, and was having decreased appetite, SOB, wheezing, cough. Pt also states that she did have a fall and has pain to her right arm. Pt states the Levaquin is causing diarrhea and c/o nausea, fatigue The onset was 3  days ago.  tested positive for COVID-19 on 8/4/21.     8/9/21: discharged Note: patient previously administered Moderna COVID-19 vaccine in Feb.
The patient was administered an improperly stored dose of ROTATEQ; This spontaneous report as received from a registered nurse, and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.  On 19-MAY-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1660941 expiration date 12-FEB-2021, oral for prophylaxis.  The rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was exposed to a temperature excursion of 12.1°C during 16 hours 11 minutes called by data logger. There was not previous temperature excursions
Note*  I have no idea if it is related, and I'm not blaming the vaccine, but I think it's important that you have as much information as possible. I contracted shingles one week after getting the Second dose of the Pfizer vaccine.
She felt faint, and very weak. Had difficulty walking. She felt like she was cold. Her skin flushed.
This spontaneous report as received from a Medical Assistant refers to a 7 months old infant, gender not reported. On 17-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K004620, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
The employee received her second COVID-19 Vaccine at 0744.   At 820 she c/o dry mouth and a "funny feeling in her chest, but not pain."  The employee was brought into the observation room and given 25mg of PO Benadryl. Her VS were 65-18-128/79-98%.  Her lung sounds were clear.   At 0825 Dr was notified and he came to the clinic.  At 0831 the employee states that the chest feeling was improving, her lips and mouth were feeling better. 0910: 57-18-129/75-99% The employee states that she has had an allergic reaction to Versed and Haldol
Fever, Chills, Headache, Body Aches, Joints Ached, Run Down Feeling