chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccinator gave employee pfizer 3rd dose/booster when employee previously had completed dose of moderna.
Teleconf with pt. She called to report that she has a rash after taking the 2nd VIVOTIF tablet. She received her injectable vaccines on Tuesday Feb 22. She started the first VIVOTIF on Wednesday the 23rd without problem. She took the 2nd pill today, Friday Feb 25 at 6:00 a.m. About 3:30 she happened to look in the mirror and noticed a fine red, flat rash on both eyelids, spreading up to eyebrows but not on forehead. The rash is mildly itchy. She called us for advice. I advised her to stop taking the VIVOTIF and use careful food and water precautions on her trip. I advised her to take BENADRYL at bedtime if the rash and itching are still present. She should call 911 if any breathing difficulty occurs. Do not use cortisone that close to her eyes.
This was a vaccination error. The patient did not have a reaction but she came for her second Pfizer vaccine and was given the Moderna instead.
20OCT98 early AM for several days erythema rt forearm below inj site;sl swelling inner elbow area-sl pruritus redness & swelling by 23OCT98 denies discomfort;
Headache, Myalgia,  fatigued  Narrative:  Received 2nd covid vaccine on 2/22/21 at 3pm. Reports full body aches, headache, very fatigued. Has a "Dead Arm" happens every time gets a vaccine arm very sore able to move it, not swollen, no rash. Has taken ibuprofen this am at about 0800
Information has been received from a pharmacist referring to a newborns (numbered 186). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 12-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength  (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Adverse event: second Moderna vaccine scheduled 20 days after first. Pharmacy refused to schedule it on any other date or time.  I received my first Moderna vaccine from the Pharmacy on 2/24/21. Today, they contacted me to schedule a second vaccine on 3/16/21. That is only 20 days after my first vaccine. When I said I thought it needed to be 28 days, the woman I spoke with said there was new CDC guidance and it could be 21-42 days. I scheduled the appointment and then searched online. Everything I have read (CDC ) indicates the second Moderna vaccine should be scheduled no earlier than 24 days after the first.  I called the pharmacy back and said I saw nothing indicating that the Moderna second dose should be given any earlier than 24 days later. I asked if I could schedule my second vaccine the following week. She said no. I asked if this was the only option I would be given for the second vaccine and she said yes.
Patient was given Moderna vaccine after stating he forgot his card from the first dose. Then the patient found the copy in a picture and it indicated that he had received Pfizer NOT Moderna and had already been given the dose of Moderna today.
Pt developed a rash thought to be Shingles approx 3 weeks s/p Zostavax administration.  Pt treated with valacyclovir.
Long haul COVID symptoms; Long haul COVID symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  An adult female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Long haul COVID symptoms". Clinical course: The two female patients in their 30-40s were abnormally thin and they were both experiencing long haul covid symptoms after being vaccinated. The reporter stated that the patients were both so petite, they may need a child size dosage. Further stated the company should look into making doses based on weight and stated that a 90lb middle aged woman and a 190lb middle aged man probably need different size dosages. They both reacted negatively to the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201233450 same reporter/vaccine/event, different patients.;
Headache, Myalgia, NauseaVomiting, fatigue Narrative:
Mother called the office today to report that her son had a reaction after he received his vaccine on 8/31/22.  (See continuation Page) Mother called the office today to report that her son had a reaction after he received his vaccines of 8/31/22.  Mother recalls that approximately 36-48 hours after receiving vaccines, he started to develop large spots about the size of .$25 piece- with white/blanched area with red centers all over his trunk and face.   She said she then recalled that after his first Hep A vaccine- he had red rash (similar to rosacea) on his face and trunk. She gave him children's Benadryl- as she had done before.   When she checked in with her Pediatrician, his instructions were to continue  Benadryl and also to administer Pepcid for this.  He felt that the child has developed a "Stevens- Johnson Syndrome" from vaccine.  Mother also states that the child will now be exempt from ANY FURTHER VACCINES- and she will send us a copy of the Physician's Exemption form for his chart.   I did inform the mother that I would also complete an Adverse Reaction to Vaccine report regarding this.  Mother was agreeable to this.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 09:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 61 years, in right 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Dec2022) Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid Treatment start date 21Nov2022 to 25Nov2022.
Large 15cm x 17cm local painful whelp on the site of injection on the left arm
Pain all over the body; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Pain all over the body".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program.  A female patient received BNT162B2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache".  Additional Information: The patient's son-in-law reported that the patient experienced a headache after the first dose and wanted to know if the patient can take ibuprofen (ADVIL) or other medications.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. ON 18-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # M010478, expiration date 01-SEP-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
At time of vaccine administration and per the completed CDC pre-vaccination checklist, family states that patient had only 2 prior doses of Pfizer COVID-19 vaccine. After vaccine administration it was discovered that per our vaccine registry that patients record showed 3 prior doses (last dose on 1/9/22). Family is adamant that this vaccine dose was not received.
A physician reported the occurrence of an injection site reaction in a child of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date in May 2003, the subject received the fifth injection of Infanrix (lot DTPA572A2). Within one week post-immunization, the subject developed an injection site reaction characterized by swelling and redness. The reporter considered the injection site reaction to be probably related to Infanrix administration. As of 5/15/03, the outcome of the injection site reaction was unknown.
Myalgia, Fever, SkinRash, Rash, RASH TO BLE. RIGHT WORSE THAN LEFT. ITCHING 9/10, WARM. ENTIRE LEFT AND RIGHT LEG Narrative:  Day 4- bilateral lower extremities with raised, itchy rash, right greater than left. Employee applied lidocaine. Described itching unbearable from 9/10. Denies rash anywhere else. No sob, hives per report. Advise to follow up with primary care doctor.
1/7 vaccination Forty minutes later, I felt flushed light headed and I had difficulties swallowing my saliva. I went back to the nurse to be evaluated. My BP had gone up to 185 (50 points) / 100 (went up 20-30 points). Significant increase in both diastolic and systolic. Pulse went up to 115-116. I just felt light headed. They started me on O2 and gave me Benadryl shot. I was still having difficulty swallowing. Took me to the ER. They gave me the steroid shot, and I fell asleep for 60-90 minutes later.  *COVID + 4/2020
Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 006B21A) for COVID-19 vaccination.     No medical history.  The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMINS NOS, VITAMIN D NOS and CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm). At the time of the report, PAIN IN EXTREMITY (Pain in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's medical history was not provided.  The patient did not receive any treatment. Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060734:DOSE 2
I had a case of hives occurring on both legs above the knees, and lower trunk both front and back below breast line.; Hydrocortisone Cream to relieve the itching.; Soreness in shoulders; Day 1 through 4 I had soreness in shoulders, back and hip and knee joints.; Day 1 through 4 I had soreness in shoulders, back and hip and knee joints.; Day 1 through 4 I had soreness in shoulders, back and hip and knee joints.; There was a sense of a typical flu-like symptom but on days 4, 5 and 6; This is a spontaneous report from a contactable consumer, the patient. An 82-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 27Mar2021 at 17:00 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as to be confer with the patient's doctor. Concomitant medications included acetylsalicylic acid, ascorbic acid (ASPIRIN )80mg and ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE-A-DAY MEN'S VITAMIN) for unknown indication from an unknown date. The patient had no known 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 other vaccines within four weeks prior to the vaccination. On 27Mar2021, day 1 through 4 after the second dose the patient experienced soreness in shoulders, back and hip and knee joints. There was a sense of a typical flu-like symptom but on days 4, 5 and 6, On31Mar2021, the patient had a case of hives occurring on both legs above the knees and lower trunk both front and back below breast line. This was the first time, the patient ever had hives and self-medicated with a daily loratadine and hydrocortisone cream to relieve the itching. Early on day 6, it was over with no noticeable residual effects. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of hives, itching and included treatment with daily loratadine (MANUFACTURER UNKNOWN) and hydrocortisone (MANUFACTURER UNKNOWN) cream. The clinical outcome of the events soreness in shoulders, back and hip, knee joints and flu like symptoms were recovered day4 on 31Mar2021 and events hives and itching were recovered on day6 on 02Apr2021.   No follow-up attempts are needed. No further information is expected.
Fever 101.4, chills, severe body aches, fatigue, severe weakness, bad headache
Initially, there was a burning sensation, then a couple of hours later, it turned red at the injection site and swollen, just at the injection site. Then it proceeded to spread to my entire upper arm. It became red, hot and swollen, and it hurt, like there was a lot of pain. At that point, I took my temp, and I had a fever. My fever was 100.5, and to me, that's feverish. I took Tylenol and I had abdominal cramping at that point and I was not hungry, and that's how it's been Friday afternoon. My arm is still hot, red, painful and swollen, and I still have fever. On 7/23/23 I was on the phone with my doctor, so he knows about the reaction.
Rapid heartbeat; chest pain; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (Rapid heartbeat) and CHEST PAIN (chest pain) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016MZ0A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced TACHYCARDIA (Rapid heartbeat) and CHEST PAIN (chest pain). The patient was treated with VERAPAMIL for Adverse event, at an unspecified dose and frequency. In March 2021, TACHYCARDIA (Rapid heartbeat) and CHEST PAIN (chest pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab data includes blood tests with unknown results.  No relevant concomitant medications were reported.  Reporter stated that a month later, patient started having a rapid heartbeat and chest pain. He had A-Fib from before the vaccination, so she thought it was probably just A-fibrillation. There was no enlargement with the heart, and no issue with the lining of the heart, there was no diagnose of Myocarditis or Pericarditis. Chest pain and rapid heartbeat were the only symptoms reported by the caller.  Patient was not immunocompromised.
2nd dose almost 8 months after 1st dose; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on an unknown date 8 months prior to date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 31-May-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient asked if he/ she was protected. Additional Supportive Information: The patient received 2nd dose of Shingrix 8 months after 1st dose, later than the recommended standard schedule, which led to lengthening of the vaccination schedule. The follow-up would not possible as no contact details were available.
Received rotavirus Monday 11-3-2014 began having quite mucousey stools Thurs 11-6-14 and hemocult (+) stools in office Friday 11-7-14.
67 y.o. male with past medical history of asthma, prostate cancer, GERD, hyperlipidemia, hypertension who was admitted with chest tightness and sob was found to have b/l PE after moderna vaccine for COVID (3/26) second dose otherwise nothing different in his life and PE could have been caused by COVID 19 vaccine.
Redness at the injection site worsened; Hot at the injection site; Swelling at the injection site; Painful at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Painful at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site worsened) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Painful at the injection site). On 12-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site worsened). On 13-Jan-2021, VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Painful at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site worsened) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information and concomitant product were not reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. vaccination site pain, vaccination site swelling and vaccination site erythema are consistent with the product safety profile
fever, chills, headache, myalgias, fatigue, and nonproductive cough  HL.  IV fluid.   Advil; Tylenol
Information has been initially received from a registered nurse concerning a 1 year old grand daughter who on 07/06/2001 was vaccinated first dose in her thigh with varicella vaccine. Concomitant therapy included MMR vaccine, HIB conj-hep B vaccine. Other comcomitant therapy included Prevnar. On approx. 07/08/2001, 2-3 days post-vaccination, the pt developed a "knot" at the injection site on one of her thighs and a generalized body warmth; a fever. It was reported that the specific sites of injection for each vaccine was not known. The fever and the injection site knot on her thigh had resolved on the following day. It was noted that the child had been teething prior to her vaccination. On approx. 07/17/2001, the pt developed fine red rash-little dots on her chest which had resolved within a day. It was also reported by the registered nurse that her father who had asbestosis, emphysema, long term steroid therapy for treatment of his emphysema, and a history of being "susceptible to pneumoniae," chicken pox and shingles around his chest 'several years ago" also had experienced symptoms. On 07/16/2001, the child's grand father had developed blistering around the corner of his eye and forehead which was initially diagnosed as conjunctivitis. The blistering continued to worsen, and the pt returned to his physician who diagnosed shingles. The pt was treated for shingles with an unspecified medication. It was reported that the pt had scabbed lesions around the corner of his eye, forehead, and scalp. On follow-up, it was reported by the nurse that he was "feeling better" today. Upon review, this pt experience was considered to be a possible secondary transmission of herpes zoster. In follow-up, the registered nurse was interested in info on secondary transmission. The VZV ID Program was discussed with her. The reporting nurse stated that the pt had a number of scabs, and there were several in the pt's scalp area, which could be unroofed without risk of scarring. She stated that she would speak with her father to see if he would like to participate in the VZV ID Program. Additional info has been requested.
got the Modern and Pfizer shots; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (got the Modern and Pfizer shots) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (got the Modern and Pfizer shots). At the time of the report, PRODUCT ADMINISTRATION ERROR (got the Modern and Pfizer shots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.