chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine; 2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 IMMUNISATION (2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine), INTERCHANGE OF VACCINE PRODUCTS (2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (1st dose). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 IMMUNISATION (2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine), INTERCHANGE OF VACCINE PRODUCTS (2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, COVID-19 IMMUNISATION (2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine), INTERCHANGE OF VACCINE PRODUCTS (2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for COVID-19 IMMUNISATION (2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine) and INTERCHANGE OF VACCINE PRODUCTS (2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine).    It was unknown if patient was under any concomitant or regular medication. It was reported that the patient was administered second dose of Moderna COVID-19 Vaccine after a previous first dose of Pfizer vaccine. It was unknown if patient experienced any symptoms. It was unknown if any treatment was given.   This case was linked to MODERNATX, INC.-MOD-2022-616411 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2022-616411:Case crosslinked with MOD22-020043(Different patient)
did not receive the entire .5mL dose; syringe was leaking by the needles; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (did not receive the entire .5mL dose) and DEVICE CONNECTION ISSUE (syringe was leaking by the needles) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced UNDERDOSE (did not receive the entire .5mL dose) and DEVICE CONNECTION ISSUE (syringe was leaking by the needles). On 07-Apr-2021, UNDERDOSE (did not receive the entire .5mL dose) and DEVICE CONNECTION ISSUE (syringe was leaking by the needles) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received her second dose and it was discovered that the syringe was leaking by the needle tip. It was reported that the patient did not receive the entire 0.5mL dose.  No treatment medication provided  No concomitant medication list provided.  This report refers to a case of Underdose and Device connection issue for mRNA-1273, lot # unreported with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: No New information; Sender's Comments: This report refers to a case of Underdose and Device connection issue for mRNA-1273, lot # unreported with no associated AEs.
local site reaction was much better with the second dose; Asthma; This spontaneous case was reported by a physician and describes the occurrence of ASTHMA (Asthma) and LOCAL REACTION (local site reaction was much better with the second dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis since 15-Sep-1005, Breast cancer since 01-Mar-2006 and Depression since 01-Feb-2000. Concomitant products included ESCITALOPRAM for Depression, INTERFERON BETA-1A (REBIF) for Multiple sclerosis.   On 16-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021 at 2:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ASTHMA (Asthma). On an unknown date, the patient experienced LOCAL REACTION (local site reaction was much better with the second dose). At the time of the report, ASTHMA (Asthma) and LOCAL REACTION (local site reaction was much better with the second dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatments were reported.   This case was linked to MOD-2021-029847 (Patient Link).
Pain, itching, hot injection site by the next morning.  Pain shooting down arm from injection site by 2nd day.  Better and no sign of redness on day 5.  Day 8 pain, itching, redness at injection site.  Day 9 swollen injection site and pain, knot at site about the size of an egg.  Off and on pain  below the injection site and down to elbow still.  Taking ibuprofen and using heating pad on elbow.  Feels like nerve pain today.
Had increased joint swelling and pain over the period of late April-June. Was referred to rheumatology by my primary care doctor since i have a family history of rheumatoid arthritis.
dizziness; nausea; This is a spontaneous report from non-contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, mRNA-1273, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Not moderna, patient got first pfizer shot and had dizziness and nausea. The outcome of the events were unknown.  Additional information requested.
Product storage error; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  HCP said that 606 doses were given after expiration date. HCP said that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned.  On 08-Oct-2021, the vial was stored in the refrigerator and administered on same date. The vial did not undergo any temperature excursions and had no adverse event.
pt recv vax 29JUL96 & fever 103 w/in 24hr not relieved by APAP;seen MD on 30JUL96 & hosp;
She had nerve tingling; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (She had nerve tingling) and SINUSITIS (Sinus infection) 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 06-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (She had nerve tingling) and SINUSITIS (Sinus infection). The patient was treated with AZITHROMYCIN (Z-PAK) ongoing since an unknown date for Sinus infection, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (She had nerve tingling) had not resolved and SINUSITIS (Sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. Patient stated that the nerve tingling that is ongoing was at random.. The patient was due for the 2nd dose on Monday but cancelled due to sinus infection, said it was mandated to get the vaccine.
This spontaneous report was received from a medical assistant and refers to a 2 year old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 18-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
The patient developed chicken pox 12 days after receiving his second Covid-19 vaccine. He was vaccinated for varicella twice as a young child. Interestingly, his father developed shingles 15 days after his first Pfizer Covid-19 vaccine. The father developed shingles 20 days before my patient developed varicella.  The father had chicken pox as a child. My patient was not systemically ill and all of his lesions crusted over by day 9 of the illness. The rash was atypical in that he only had a few vesicles and none of the classic pustules seen with varicella. (I have been in practice for 40 years and have seen many cases of varicella, but none for a long time.)
This is a non serious spontaneous case from a nurse of a medication error. The reporter causality was not provided to Flumist. A nurse reported a series of medication errors. The nurse misunderstood the dosing instructions for FluMist and administered a double dose of vaccine to seven pt's . Prior to the administration of the vaccine she removed the dose divider clip thereby giving 0.50ml per nostril versus the prescribed dose of 0.25 ml per nostril. On 26Oct04, at 11:00 in the morning, the reporter gave a double dose of FluMist to a 47 year old female pt whose medical history was not reported. The reporter stated the pt had no adverse events. No further information is available.
Info has been received from a physician concerning a 12 month old male with a solitary kidney at birth and no allergies or drug reactions who on 5/18/05, was vaccinated, SC, with an 0.5 mL dose of MMRII (lot 648664/0992P). Concomitant vaccination on 5/18/05, included a dose of varicella virus vaccine live (lot 649281/0656P). There was no illness at the time of vaccination. Subsequently, on 6/8/05, the pt awoke with diffuse swelling of the left side of his face. There was no obvious lymph node swelling. It was also noted that the day prior, on 6/7/05, the pt was placed on therapy with prednisolone sodium phosphate (Orapred) for wheezing that was not related to the diffuse swelling. Unspecified medical attention was sought and no treatment was required. No diagnostic lab tests were performed. As of 6/8/05, the pt had not recovered. A product quality complaint was not involved. Follow-up info was received from the physician who reported that on 6/89/05, the pt had parotitis 18 days after vaccination with MMRII. The event lasted for 5 days and the pt recovered. No diagnostic lab tests were performed. No further info is expected.
Pain in arm; Shivering; Fever; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 at 09:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included telmisartan (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 14:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 21:00, the patient experienced pain in arm, shivering, fever and tiredness. 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 the events and included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in arm, shivering, fever and tiredness was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received the Moderna COVID-19 booster on 4/4/2022. On 7/19/2022, I took a home antigen test and got a positive result. I then decided to also have a PCR test done at a local pharmacy. The PCR test also yielded a positive result. During this time, I was asymptomatic, but on 7/21/2022, I had a fever, body aches, cough, and sore throat. I took the ADVIL multisymptom cold and flu medicine, which reduced the coughing, sneezing, sore throat, and fever. However, I still felt bad despite this. I also had extreme fatigue during this time. I contacted my doctor, and I was prescribed an albuterol inhaler, TESSALON PERLES, and PAXLOVID. A couple of days after I started the PAXLOVID, I began to feel better. The albuterol inhaler and TESSALON PERLES also helped me breathe better. As I continued to take the meds, I just gradually got better. I underwent another PCR test on 7/29/2022 and got another positive result. On 8/2/2022, I contacted HR at my workplace to ask them what the best course of action would be. I explained that I felt better, though I still had cough, congestion, and fatigue. They told me that I could return to work since it had been over 5 days since I had first tested positive. I was also told that I would have to wear a mask, though. I returned to my workplace on 8/5/2022. At that point, I still had extreme fatigue, cough, and congestion. I was then given the option to telecommute, so I just worked from home for a week afterwards. It took a couple of weeks for the cough and congestion to subside, but the fatigue lingered for another 2 months. During my bout of COVID-19, my rheumatoid arthritis also flared up, and I also developed psoriasis. At the time of this writing, I still have residual psoriasis on my hands and legs; it's much milder now than it was when I first got COVID-19, and presently it just takes the form of dry, peeling patches of skin. Before I got COVID-19, I had never had psoriasis before. Also, I still have some residual issues with the rheumatoid arthritis flare up. I still have joint pain and brain fog (mainly in the form of aphasia).
This is a spontaneous report from contactable other HCP via Pfizer Sales Representative. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 2 single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as dose 1 single for COVID-19 immunization. After the 2nd dose, the patient did not feel well the day after receiving the 2nd dose. She experienced minor body aches and chills on an unspecified date. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Information has been received from a female consumer who on an unknown date, was vaccinated with GARDASIL (lot # not reported).  Subsequently the patient experienced severe side effects.  The patient was told that the reason she had the side effects was because she sat down for 15 minutes after administration.  It was unspecified if the patient sought medical attention.  No further information is available.
AT 4:30 PM STARTED A RASH IN NECK AND ARMS. DR. EVALUATED THE PATIENT IN THE EMERGENCY ROOM AND GAVE HER BENADRYL 25 MG AND SOLUMEDROL 125 MG.
MMR was possible mixed with IPV form submitted per CDC recommendations No Reaction per client's parent.
Patient experienced syncope about 5 minutes following the administration of the vaccine. She was seated when it occured. She said she felt normal after a couple of minutes of remaining seated.
No adverse event; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medicine were reported. Age of the patient was 29 Year 4 Month NDC 80777027310 No treatment medicine were reported.
Mild muscle aches roughly 18 hours after injection followed by a medium pressure headache.; Mild muscle aches roughly 18 hours after injection followed by a medium pressure headache.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2023 at 12:45 as dose 4 (booster), single (Lot number: HF9275) at the age of 38 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunization. The following information was reported: MYALGIA (non-serious), HEADACHE (non-serious) all with onset 19Sep2023 at 06:30, outcome "recovered" and all described as "Mild muscle aches roughly 18 hours after injection followed by a medium pressure headache.". Therapeutic measures were not taken as a result of myalgia, headache.
pt recvd vax; fever since 22oct94; h/a; v; n; dizziness;
Arm had fever in it. Sore to the touch. Can't raise above head. Weak in the arm and still in pain.
Fully vaccinated, with 2 boosters last 12/20/21.  COVID breakthrough infection
Swelling and slight redness in the morning the next day after the shot, with time there selling got worse and it became more and more red, it also became very tender. The size of the swelling and redness progress. Saw doctor around 2 PM, patient was prescribed Hydroxyine HCL. The following day on 04/05/2014 still no change.
Information has been received from a registered nurse referring to a patient of  unknown age and gender. On 05-NOV-2015 the patient was vaccinated with improperly stored ZOSTAVAX (lot # L003216, expiration date 30-APR-2016, strength, dose and route were unknown). NO adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 01-JUL-2016 the patient received and improperly store dose of PROQUAD (lot # L040412, expiry date: 13-APR-2017) (incorrect product storage). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. 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 female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 05-MAR-2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-NOV-2015, the patient was treated at a clinic 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. Additional information has been requested.
MUSCLE WEAKNESS; SEVERE HEADACHE; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 120 pounds, and height was 165 centimeters. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug. the patient was not pregnant at the time of report.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced muscle weakness. On 27-APR-2021, the subject experienced severe headache. On 27-APR-2021, the subject experienced extreme fatigue. Laboratory data included: Pain scale (NR: not provided) 7/10 severe headache with a pain level. On 28-APR-2021, Laboratory data included: Pain scale (NR: not provided) 1/10 severe headache with a pain level drops. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headache, extreme fatigue, and muscle weakness. This report was non-serious.