chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I did have some flu like symptoms the following day after the initial vaccine but then I also felt tremendous electric pain in my neck and shoulder on the side the shot was given to me (left upper arm). The pain has consistently gotten extremely bad. It feels like nerve pain. It does sometime dissipate but it's gotten progressively worse over the last 2.5 months to the point where I have had an X-ray of the neck and cervical spine and now I have an appointment to see a Neurologist.
Patient received FLUZONE HD Thursday 10/8/15 in the early afternoon. By Friday 10/9/15 in the evening, patient started to develop a rash on her left neck/top of left shoulder area. By Saturday 10/10/15, rash spread to front of chest and continued to spread to front torso area. Patient went to a clinic which prescribed her triamcinolone 0.1% cream. Patient stated that rash cleared up by Thurs 10/15/15.
When I caught COVID-19 I had a headache and a fever. The next few days I developed a hacking cough and a sore throat. I was prescribed paxlovid and cough medicine from my daughter-in-law who is a physician. On 7/27/2022 I started the 5 day course of paxlovid. My fever was gone on the first day. On the last couple of days I started to get better. I didn't lose my sense of taste or smell. The paxlovid left a horrible taste in my mouth from paxlovid.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  22-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, route of administration, anatomical location were not reported; lot number R021636 was confirmed to be valid, expiration date 12-MAY-2021) for prophylaxis. Administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. Data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report was received from a consumer (mother of the patient) and refers to a 11-year-old female patient. No information regarding the patient's medical history, concurrent conditions, concomitant therapies and the patient's allergies was provided. On 03-AUG-2016, the patient was vaccinated with first dose GARDASIL 9 injection for prophylaxis (strength, dose, route of administration, lot # and expiration date were not provided). On 27-OCT-2016, the the patient was vaccinated with second dose GARDASIL 9 injection for prophylaxis (strength, dose, route of administration, lot # and expiration date were not provided). At the time of the report, the patient had not received the third dose in the series, which was indicated in the prescribing information. No adverse event was reported. No product quality complaint was involved.
Massive headache, so bad I could not get out of bed. Fever of 102 that was gone the next day. Sore, tired, cranky. I still have a headache only I can function. It is a 4 today on a pain scale of 1 to 10. On April 1st it was so bad I could not get out of bed. I felt like my head was a giant toothache. I am not too sure about getting the second dose. I was truly frightened. I don't think I have ever felt that bad. Having kids was easier.
patient  passed out and fell down on the floor .  Patient was alert and oriented, no swelling of lips or tingling on tongue . We had called 911 they came and checked her vitals.
injection site pain both after First and second jab; This is a spontaneous report from a contactable consumer (patient). A 83-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration, administered in left arm on 02Feb2021 at 02:30 (at the age of 83years old) as a single dose for COVID-19 immunisation. Medical history included old age, BP, mild prediabetic, arthritis of knee. The patient did not have any allergies to medications, food, or other products. 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 concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took historical vaccine on first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown) in left arm on unknown date for covid-19 immunisation. On 04Feb2021 at 12:00 the patient reported that he did not get any adverse reaction except injection site pain both after first and second jab. Will I get antibodies after this shot considering my age is 83. It was unknown if the patient received any treatment for the events. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient received Pfizer COVID vaccine on 9/20/21 and 10/18/21. On 1/28/22, patient admitted to our inpatient facility (med/surg unit) for COVID19 pneumonia. Patient discharged home today (2/1/22) in stable condition.
Pt recvd 3 doses of Engerix-B & 30SEP91 it was determined that pt did not respond to the vax series;
Fever, chills, body aches, chest pain, shortness of breath,  pain at site of injection.
Hive size of 50 cent piece; Hive itched; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA and PRURITUS in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced URTICARIA and PRURITUS. At the time of the report, URTICARIA and PRURITUS outcome was unknown.        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.   The patient took Diphenhydramine and the hive went away.   This case was linked to MOD-2021-342798 (Patient Link).
Rash noticed on right leg (1/28/16) - three clusters of papulovesicular lesions in a dermatomal distribution on her right lower leg consistent with shingles.
Round, reddened, raised area on left deltoid approximately 50mm, warm to touch. Pt complaining of discomfort since 2/17/00. Pt is afebrile. Treated with Neosporin and saran wrap.
A physician reported that a female in her 60's received injections of Pnu-Imune 23 and influenza virus vaccine (1998-1999 formula) approx. 1 year ago. She developed constant aching at the site of Pnu-Imune 23 administration that still persists. She reports occasionally being able to palpate a circumscribed mass in the area; however, the physician is unable to confirm this. Follow-up information received from the reporting physician on 2/15/00, provided the vaccine provider and pt's address.
Swelling of fingers, multiple out breaks of lesions/sore on hands/arms/legs (recovering) hands cracked and bleed.
Administered Incorrect Vaccine COVID 19 Pfizer Primary Series instead of COVID 19 Pfizer Updated Booster Doses
Pt. woke with chills, fever to 101, given TYLENOL 500mg. Also complained of severe headache and photosensitivity. Seen 2-25-11 at clinic - tested for strep, flu (Negative tests) on 2-26-11 pt. could not sleep - complained of severe headache - taken to ER. Given morphine, CBC, pregnancy test done - neg. Resolved after sleeping most of day Sat. 2-26-11.
Found to have BOM, convuls trembling episode, fever over 100F to 104; Seen by hlth car provider; Dx BOM, rx Amoxicillin 250mg;
Small bruise appeared one day after injection, expanding to 3/4 inch diameter over several days and to 2 inch diameter after 6 days.
1 day p/vax pt devel inj site rxn w/cellulitis. This is 1 of 5 pt to exp rxn to lot #449-578.
This spontaneous report as received from a nurse refers to a 33 year old female patient. Relevant medical history and concomitant medication were not provided. On an unknown date, reported as a child, the patient was vaccinated with M-M-R II two dose series. On an unknown date the patient's rubella titers were drawn and found to be equivocal. The nurse asked if the patient could received the third dose. The outcome of rubella titer equivocal was unknown. The reporter causality was not provided. Additional information has been requested.
Severe headache, fatigue, copious thick nasal sinus mucous, new DOE with stair climbing causing some CP
None- vaccine given 11 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 11 days post expiry) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 11 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 11 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment drugs were reported  Patient did not experience any adverse event- vaccine given 6 days post expiry   This case was linked to MOD-2021-395985 (Patient Link).
Soreness  at the injection site and redness under the arm from armpit down to the elbow with a streaking appearance
Patient presented to the ER with a rash 3 days after receiving vaccines. He was diagnosed with acute urticaria. He was treated with Prednisone for 5 days & BENADRYL for 3 days.
Pneumothorax in my left lung. I was having chest pains and thought it was my heart. The harder I breathed the more pain I felt. I drove myself to the hospital 10/11/2021.
Patient reports she received 5 of the 6-shot vaccine series in 2002. After the 2nd or 3rd dose she began to develop aching in the muscles and joints. The symptoms continued and she evolved to experiencing pain in the upper and lower back, hips, SI joints, and neck, as well as fatigue interfering with functioning, and unrefreshing sleep. She reports she was evaluated by rheumatology in 2011 and diagnosed with fibromyalgia. In the course of this evaluation multiple other conditions were ruled out including autoimmune disease, ankylosing spondylitis, psoriatic arthritis (employee has psoriasis), and Ehlers Danlos syndrome (which is in her family history). Fibromyalgia syndrome continues today. Patient also meets the 2012 International case Definition for Chronic Fatigue Syndrome.
Patient walked outside after getting shots and passed out on ground. Girlfriend found him lying in parking space unconscious, easily aroused and got Health Department staff. Nurse went out an assessed patient B/P 142/88, P 88, Neuro checks completed and all within normal limits, patient alert and oriented to person, place, and time. Contusion noted back of head and left elbow.  Assisted to sit in truck in air conditioning, given water and candy. Patient reports felt sick on stomach and head hurt but just thought he was hungry due to not eating since early AM. RN advised patient to go to ER for further evaluation due to hitting head and concussion symptoms multiple times, patient refused. Girlfriend called back later to advise patient letting her take him to Hospital ER, for evaluation due to extreme headache and emesis.
Information has been received from a registered nurse referring to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II (lot # M008589, expiration date: 16-FEB-2018, therapy type: rHA; dose and route unknown) for prophylaxis. From 14-OCT-2016 to 06-DEC-2016, M-M-R II was stored under temperature between 32 Fahrenheit and 36 Fahrenheit for 135.5 hours. The M-M-R II was stored under temperature between 46 Fahrenheit and 77 Fahrenheit for totally 40.5 hours. Data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA005338: US-009507513-1702USA012145.
Myalgia; fever; chills; This case was reported by a physician via call center representative and described the occurrence of myalgia in an unknown number of adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia, fever and chills. On an unknown date, the outcome of the myalgia, fever and chills were unknown.   It was unknown if the reporter considered the myalgia, fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The physician reported that he had multiple patients that had received the Shingrix and had experienced common local reactions such as myalgia, fever and chills.  The physician asked if the patients received ibuprofin or tylenol afterwards? If these medications decrease the effectiveness of the vaccine?  No additional information provided. The reporter did not consent to follow-up. The physician would not provide patient identifiers.
I currently have severe rash over legs, arms and upper chest.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE UNMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced that currently having severe rash over legs, arms and upper chest. The patient reported that I received Pfizer Covid vaccines. I currently have severe rash over legs, arms and upper chest. Could this possibly be from vaccines and what is best course of treatment. I can send pictures if necessary. Only looking for advice. Seeking nothing else. The outcome of the events unknown.  Follow up (02May2021): This is a follow up spontaneous report from a Pfizer sponsored program   Follow up(05May2021): case number has been provided. No new information.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient was given .5 ml of Moderna Bivalent and should have received .25 ml as he is only 11 years and 8 months.
9 to 10 days post vaccine: Flu symptoms for 24 hrs, Fatigue the following day with headache and sinus discomfort. Monday the 29th, worked and arrived home feeling like I may have a sinus infection. Tuesday, no headache just extreme fatigue, left work early took a 2 hr nap and feel a bit better. Lower back discomfort during this time period, discomfort urinating. Feeling of constriction but no pain while peeing.
A little over 24hrs after receiving dose of PREVNAR 13 patient developed hives on lower extremities. This responded to diphenhydramine but recurred again 24hrs later.
Rash and hives over mouth, neck chest, belly, diaper area, arms, back. Swollen right ear.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 02-DEC-2015 the patient was vaccinated with VAQTA (lot # L002717, expiration date 02-JUN-2017, dose and route not reported), which was exposed to temperatures outside of the recommended temperature (incorrect product storage). No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Initial information has been received from a healthcare worker and follow-up information was received from a physician concerning a 46 year old female who on 31-OCT-2008 was vaccinated with a dose of PNEUMOVAX (lot # 657143/0380U) intramuscularly. The patient had skin reactions after administration of PNEUMOVAX. The patient developed redness and pain in the injection arm. She had sore area a few inches across. On 17-NOV-2008, the patient was in the office and had recovered. This is one of several reports received from the same source. Additional information has been requested.
September 6th I came down with COVID-19 I was extremely tired and stayed in bed for a few days. I went to a local urgent care to get PAXLOVID and after utilizing it I did start to improve, however, after completing the PAXLOVID, approximately four days later, my symptoms came back. My symptoms were worse and I had a new symptom of congestion the post PAXLOVID. Two weeks after symptoms improved the second time I noticed that I would get tired more easily and more frequently. I am feeling much more normal and back to my usual self.
Mild pain/discomfort in arm, close to the injection point; persistent.; Mild pain/discomfort in arm, close to the injection point; persistent.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Apr2021 at 15:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included bladder cancer remission and atrial flutter. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 14:00, the patient experienced mild pain/discomfort in arm, close to the injection point which was persistent. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild pain/discomfort in arm, close to the injection point was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 64 years old female patient who received 0.5 ml vaccine FLUZONE HIGH DOSE (lot UJ022AA) via unknown route in the left arm on 11-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitants were reported. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. No known reported symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Not injected in the deltoid muscle/ injected subcutaneously; Giant hard spot 3-4 inches; It is also hot; Fever; A spontaneous report  was received on 03 FEB 2021 from a nurse (50-year-old female), who was administered 2nd dose of Moderna's COVID-19 vaccine was not injected in the deltoid muscle but was injected subcutaneously. She had giant hard spot 3-4 inches, it is also hot, and had fever.  The patient's medical history includes high blood pressure and allergies to penicillin, codeine and raw shellfish. No relevant concomitant medications were reported.  On 02-FEB-2021, the patient received her 2nd dose of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection on left arm. She stated that, it was not given intramuscularly, but given subcutaneously (inappropriate route of vaccination). She had a giant hard spot 3-4 inches and it was hot. She also had fever. The treatment she took was Tylenol and ice.  Action taken with mRNA-1273 was not applicable as the patient received two doses of vaccine already.  The event, vaccine was not injected in the deltoid muscle but was injected subcutaneously was considered resolved on 02-FEB-2021 and outcome of the events giant hard spot 3-4 inches, hot spot, and fever were not provided at the time of report.; Reporter's Comments: This case concerns a 50-year-old female patient with medical history of allergies to penicillin, codeine and raw shellfish, who reported Incorrect route of product administration and experienced non-serious events of Vaccination site induration, Vaccination site warmth, and Pyrexia. The events occurred on the same date after 2nd dose of two planned doses of mRNA-1273, lot # unknown. Treatment details included Tylenol and ice. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Redness at the injection site after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site after second dose) 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 12-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 12-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site after second dose). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site after second dose) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications were reported. No treatment information was provided