chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented to clinic on 11/14/18 and parents stated he developed a diffuse rash 2 days prior (11/12/18, 4 days after receiving his 1 year old vaccinations). The rash was described as starting throughout the body but did worsen over the course of 2 days. Rash was pruritic. On exam the rash consisted of small flesh colored to erythematous papules throughout the chest, abdomen, back, arms, and legs - no oral involvement, no evidence of blistering lesions. Pt prescribed symptomatic care (cetirizine, hydrocortisone).
a rash on the back of her shoulders, from one to the other, painful, burning, not itchy; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (a rash on the back of her shoulders, from one to the other, painful, burning, not itchy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032LC0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included NABUMETONE (RELAFEN) and NABUMETONE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced RASH (a rash on the back of her shoulders, from one to the other, painful, burning, not itchy). On 24-Jan-2021, RASH (a rash on the back of her shoulders, from one to the other, painful, burning, not itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient take Solution of Witch-hazel and 3 Benadryl as a treatment medication
Initial report was received 03 January 2011 from a health care professional. An unidentified patient had received an injection of ADACEL (lot number, route, site and date of administration not reported) and two days later, the patient developed an abscess which required hospitalization and treatment for four days. The reporter did not have any further information at the time of the report and the patient's outcome was unknown. Documents held by sender: None.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown demographics. Patient's concurrent condition and relevant medical history was unknown. The nurse practitioner reported that the patient was vaccinated expired dose of PNEUMOVAX 23 (lot number: H013847 with expiry date of 15-MAR-2014) dose 1, 0.5 ml, intramuscular on 22-AUG-2014. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PNEUMOVAX 23 was not reported. Product quality issue was not involved. Additional information has been requested.
Pt c/c of feeling dizzy. Pt appeared to be passing out. Pt sat back on the chair and unable to respond to question and looked very pale and diaphoretic. Pt was moved to the cot and had her lay down. Few minutes pt felt better and able to say her name. EMT assessed the patient and felt much better
Client/participant had flu vaccine administered at 9:02 AM. First time flu vaccine administered and stayed with RN for 15 min (until 9:20 AM). At 9:50 AM, she reported her tongue felt thick and she had some drool episodes. She got "tunnel vision" looking at computer monitor. She reports history of hypertension but has not taken her BP medication nor seen a physician since last 2012. No signs of respiratory distress, speech is clear, no signs of rash. Tongue is not edematous. Refused ambulance and father took her to ER. #1 @ 950: 176/118, Pulse 98. #2 @ 955: 156/102, pulse 90. #3 @ 1005: 126/90, pulse 96. #4 @ 1015: 132/92, pulse 88. Very anxious before vaccine administration due to fear of needles.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 18-AUG-2015, the patient was vaccinated with a dose of improperly stored M-M-R II, lot # K024035, expiration date: 26-NOV-2016, (dose, dose number, route of administration and injection site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In March 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. On or about 01-JUL-2014, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Heart palpitations; Fatigue; Severe stomach cramping; High blood pressure; Cough; This is a spontaneous report from a contactable other HCP (patient). This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at single dose (lot number: EK5730) for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient said she had a list of reported side effects that she was having from the COVID Vaccine. The patient received COVID-19 vaccine on 23Dec2020 (not clarified), and since then she had been having symptoms. She had been to the doctor about it and she was currently going to treatment for it. But she had been experiencing heart palpitations, fatigue, severe stomach cramping, high blood pressure and cough. That was all she got. Outcome of all events was unknown.
This initial case was received from a consumer on 16 January 2014. Two cases of unidentified patients, who each experienced pertussis following administration of ADACEL, were reported by the same reporter. The other report is captured in case number 2014SA007169. An 13 year old female patient was vaccinated with ADACEL lot # U4308BA in May of 2012, date not specified. The route, site of administration and dose were not reported. On an unreported date the patient experience coughing lasting for past 4 weeks. Blood work for each patient was positive for pertussis on an unreported date. The reporter stated that they do not have any cultures. The patient's medical history and concomitant medications were not reported. The patient outcome was reported as not recovered. No further details were available at the time of this report. Documents held by sender: None.
Fully vaccinated, not booster.  COVID asymptomatic breakthrough infection with inpatient hospital stay for non medical reason
inadvertently administered a dose of Pentacel that had been exposed for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F with no adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 1 years old female patient who was diagnosed with inadvertently administered a dose of pentacel that had been exposed for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no adverse event after receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE for Prophylactic vaccination.  On 08-Feb-2023, the patient received suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine at dose of 0.5 ml at dose series 4 (strength, frequency, formulation, route, expiry date: unknown) (lot UJ682AAA) via intramuscular route in unknown administration site for prophylactic vaccination (immunization).  On 08-Feb-2023 the patient diagnosed with a non-serious inadvertently administered a dose of pentacel that had been exposed for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no adverse event (poor quality product administered) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.  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.
High fever (103) that did not respond to Tylenol for two days. Excessive vomiting that led to severe dehydration. Chills and sweating. Unusual menstrual bleeding right after vaccination.
neck and back muscle pain set in 1st hour,   fatigue set in over the course of the afternoon, constipation experienced the morning after the shot!
Feeling out of my head (6 days so far) dizzy(6 days so far), extreme fatigue (6 days so far) headache (intermittent) chills (intermittent), nausea, weakness (6 days), body and head feel like lead (6 days), chest pains (one day), abdominal pains (1 day), diarreah (1 day), blurred or double vision (two occasions), eyes burning (one occasion)
The Pfizer vaccine was kept in the refrigerator past the date of removal/expiration. We attempted to notify the patient about the expired dose given, however they were never reached because incorrect contact information was given.
Discovered that patient had gotten the COVID vaccine with a 5/8 subcutaneous syringe in the deltoid muscle.  Patient did not report any adverse events.
flu-like symptoms 24 hours s/p tetanus toxoid vaccination.   Did not seek medical attention but reported these symptoms when returning to clinic to have her PPD read 3 days later.  Had treated symptoms with ibuprofen and ice pack.  Complained of "feeling bad", feverish, headache, arm discomfort, warmth and erythema at site of injection.
it does hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: it does hurt). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient had the first vaccine, and it did hurt. The patient thought it would be worse if he/she got the disease.
Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 40-year-old male. Neither medical history nor concomitant medications were reported. On 25-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Information has been received from a health professional concerning a 12 month old male with no known medical history who on 27 Apr 2006 was vaccinated SC with a 0.5 ml dose of Varivax. Concomitant vaccination the same day included doses of MMR, DPT, Daptacel, Poliovirus vaccine. On 09 May 2006 the patient experienced an itchy rash all over his body with red elevated bumps. No fever was noted. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. No laboratory tests were performed. There was no product quality complaint involved. Additional information has been requested.
red arm; itchy arm; painful arm; swollen arm; arm blotch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red arm), PRURITUS (itchy arm), PAIN IN EXTREMITY (painful arm), PERIPHERAL SWELLING (swollen arm) and RASH MACULAR (arm blotch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ERYTHEMA (red arm), PRURITUS (itchy arm), PAIN IN EXTREMITY (painful arm), PERIPHERAL SWELLING (swollen arm) and RASH MACULAR (arm blotch). On 28-Feb-2021, PERIPHERAL SWELLING (swollen arm) and RASH MACULAR (arm blotch) had resolved. At the time of the report, ERYTHEMA (red arm), PRURITUS (itchy arm) and PAIN IN EXTREMITY (painful arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided. Treatment included Tylenol
The  covid vaccine was drawn 4/20 at 5pm before it was given and was administered the next day at 155pm on 4/21/21. The vaccine was pre-drawn using the aseptic technique and was kept in the refridgerator the whole time. Called the moderna to seek advise and was told by pharmacist that the second dose is not necessary and that the dose is still viable since it was kept in the refridgerator. Second dose will be given to pt on scheduled date.
Menveo reconstituted with sterile water; Menveo reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA730A, expiry date 30th September 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's comment: The pharmacist reported that the patient was administered the Menveo lyophilized portion, which had been reconstituted with sterile water.  The Vaccine administration facility was the same as primary reporter. The expiration date was Sep 2023 so used last day of month on form. The reporter consent to follow up via email. Additional Supportive Information: The patient was administered Menveo lyophilized portion reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
On Tuesday, 1/8/21, client came to facility Covid-19 vaccination POD for a Covid-19 vaccine booster. Client was vaccinated with Covid-19 Moderna booster dose (LOT #: 059H21A) at 2:00 PM in his left deltoid. Alerted vaccinator after vaccination that appointment could not be completed due to client being 17 years old. Per CDC guidelines, Moderna is only authorized for 18 and up. Vaccinator alerted Lead who elevated to Vaccine Operations Leads via text. Lead informed County MD via text who advised for Lead to explain to client situation and he was to be monitored for any adverse reactions. Client verbalized understanding. Client denied any underlying medical conditions or allergic reactions and was to be a 15 minute observation. Client was also educated by RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client experienced no adverse reaction while waiting in Observation Area and left vaccination site with a steady gait at approximately 2:25 PM.
Headache, Myalgia, CHILLS, FATIGUE, SORE THROAT, COUGH Narrative:
NauseaVomiting fatigue, fever 100.# F on evening of 2/5/2021 when she received 2nd Moderna COVID vaccine Narrative:
9-06-15 "Low fever" per grandmother. 9-07-15 T 104 degrees - sore throat - swollen gland - dr - family physician - dx "tonsillitis" - rx ZITHROMAX but wrote bronchitis on script. 9-08 to 9-10-15 T 102 degrees - rash torso, face blotchy - no sore throat GM D/C ZITHROMAX. Returned to dr (date unknown) rx amox 9-17-15 afebrile but rash continues.
I expected fever and tiredness but no where online or in person has anyone said anything about throat and lung pain. Ever since I woke up the next morning after receiving the vaccine my throat burns and my lungs ache with each breath I take. Hot beverages stop it for a short amount of time and ibuprofen (though it is child ibuprofen but I am not good at taking pills) worked at first and hasn't really since the first time. In theory my brother has also been experiencing this sort of pain but all he is saying in regards to it is that his chest hurts.
I received vaccine in left arm on 3/31/2021/ appointment  time 10:30 a.m.. Thursday 4:30 a.m. chills, slight temp of 99.7 which began to elevate more even after taking Tylenol to 103.2. Body aches and swollen Lymphnodes and weakness as well. Friday morning as I walked to my fridge to get a Gatorade and lost consciousness, later to find I was on my floor with no recollection as to how it happened. I just remember opening my bottle and nothing else after that. I'm not sure how long I was out. But when I came too and saw what had happened to me I had to really focus still being very weak to get back to my couch in my family room. Later that morning after I got up I decided I needed to rest that entire day. By Saturday morning  things were back to normal. However, I did call my PC and let her know what was going on. I made an appointment to see her April 9, 2021 @ 11:30 a.m. Waiting for blood work to return.
~24 hours after DTaP, generalized arm swelling down to wrist.  Was tense 3 days after shot, arm still swollen, but not red, not hot, no localized lump.
First dose on 11-Feb-22 and second dose on 4-Mar-21; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 11-Feb-22 and second dose on 4-Mar-21) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CEFALEXIN MONOHYDRATE (LEXIPRON) and ATORVASTATIN CALCIUM (LIPITOR) from 12-May-2022 to an unknown date for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, 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 experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 11-Feb-22 and second dose on 4-Mar-21). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022 at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 11-Feb-22 and second dose on 4-Mar-21) outcome was unknown.            The patient had no known allergies.  The indication for Paxlovid (treatment medication) was reported as Treatment of COVID-19.   This case was linked to MOD-2022-576716 (Patient Link).
History of Present Illness    Patient is a 38y/o F who presented to the ED with SOB and general malaise. PMHx significant for DM2, HTN, Obesity.  Diagnosed with COVID on 7/6/21. Symptom onset 7/5. Pt with difficulty communicating 2/2 current condition.  Endorses fevers/chills, SOB, CP, body aches, malaise, fatigue, HA, N/V. States she has also had chronic diarrhea. Unable to keep any PO down. Denies any bloody emesis/stools.  States this AM she called EMS as she was so weak, she did not think she could make another day. Hypoxemic on arrival requiring 2L. Titrated down to RA in ED.  Was fully vaccinated in December/January.
Missed second dose appointment; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose appointment) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose appointment). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose appointment) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.
Patient presented to the ED and was subsequently hospitalized for cellulitis of forearm within 6 weeks of receiving COVID vaccination.
During the 15min observation period, I felt flush for about a minute. I felt super hot, but it subsided. The biggest issue was the injection site. It was a huge, super hot, golf ball size welt on my arm. It spent two days growing bigger. The fourth day it began to feel better. I also had muscle stiffness, body and body aches lasting about 2-3 days.
dizziness, muscle weakness, blurred and sensitive vision, began around 48 hours after administration (approximately 9am on 4/8/21).  Active, healthy 15 yr old boy first complained about it during class today, 4/8/21.  Symptoms continued through soccer practice this evening and he has described his current status as "the same."
01/07/2016 (L) hand numbness in the morning. Continue to reoccur for 1 month. 2/8/2016 numbness to face/chest pain continued for 2 day. Went to ER on 10 of Feb. Admitted for 1 day (obs). No cardiac issues. Patient reports, MD said it is possible it was due to Hep B vaccine.