chrisvoncsefalvay/vaers-outcomes huggingface dataset:
difficulty breathing /  winded / can't catch breath/waking up in the middle of the night feeling winded; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing /  winded / can't catch breath/waking up in the middle of the night feeling winded) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-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 DYSPNOEA (difficulty breathing /  winded / can't catch breath/waking up in the middle of the night feeling winded). At the time of the report, DYSPNOEA (difficulty breathing /  winded / can't catch breath/waking up in the middle of the night feeling winded) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No concomitant medications were reported.  Action taken with mRNA-1273 vaccine due to the event was not applicable.   This case was linked to MOD-2021-239099 (Patient Link).
pt devel fever, irritability & poor feeding p/vax; full sepsis w/u was done & all results were neg;
Initial and follow-up information has been received from a physician's office manager, pharmacist, and a registered nurse concerning a 58 year old female patient with a gastrointestinal illness, and allergies, who on 01-NOV-2007 at 08:00 was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 657145/1226U). Concomitant vaccination included influenza virus vaccine (unspecified) (Lot# U2466AA) administered in the left deltoid. The night before receiving pneumococcal 23v polysaccharide vaccine the patient experienced nausea and did not feel well in the morning. On 01-NOV-2007, the patient experienced faintness and sweating 5 hours after the injection. The patient experienced decreased food intake. It was reported that the faintness and decreased food intake were apparently related to the gastrointestinal illness. The patient visited the school district nurse. The patient recovered on 02-NOV-2007. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 6 months old patient of unknown gender. On 12-SEP-2016, the patient received improperly stored dose ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
Severe cold chill lasting over 24 hours.  Muscle aches all over. Cold sweat.
Monovalent Pfizer dose given in error instead of the Bivalent Booster
received /a dose of Infanrix that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-year-old female patient who received DTPa (Infanrix) (batch number j947T, expiry date 30th May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 2nd August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: On 2nd Aug 2021, the patient was administered Infanrix, which was expired on 30th May 2021. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up.
I was given the 1st Zoster Vaccine & the HD Flu shot in the same arm, as suggested by the pharmacist. I don't think it's a good idea to have the shingles vaccine at the same time as any other vaccine. I not only developed pain, redness & swelling but also a rash that reminded me a little of shingles. The only listed side effect I didn't experience was throwing up. My temperature went to 101.4 which was very high for me as my normal temperature is usually 96.6. I had some swelling of the tongue & felt very disoriented. I also experienced a severe stiff neck & was unable to turn my head for two days. It has taken almost ten days for all the side effects to dissipate. I will go back for the second shot in the two to six month window, but I won't be taking it with any other type of shot. I'm wondering if you've ever heard of people who have had Malaria not being able to have the Zoster Vaccine?
Rash on neck; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient 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 08Mar2021 at 16:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. The patients medical history included osteopenia. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN) and a multi-vitamin (MANUFACTURER UNKNOWN); both from unknown dates for unspecified indications. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 at 08:00, the patient experienced rash on neck. 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 rash on neck and included treatment with triamcinolone 0.1% Cream, prescribed by dermatologist. The clinical outcome of the event rash on neck was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a 52-year-old female patient who was referring to herself. The patient had no pertinent medical history and did not take any concomitant medications. The patient's concurrent conditions included allergy to morphine. On 14-MAY-2017, the patient was vaccinated with ZOSTAVAX, intravenously for shingles prevention. In May 2017 (reported as few hours after vaccination), the patient experienced redness, itchiness, warmth and swelling. The patient sought unspecified medical attention. There was no lab diagnostic studies performed and the patient did not received any treatment for an adverse events. At the time of the report, the events persisted. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected as there was no consent to contact the physician.
Pain at injection site, fever, body aches, nausea, headache, chills, frequent urination
Information has been received from an RN concerning a 34 year old female who on 5/17/99 was vaccinated with Hep-B vaccine recombinant. Concomitant therapy included Measles virus vaccine (MSD). On 5/20/99, the pt experienced dizziness and vertigo and was takne to the ER. She was dx'd with an allergic reaction and was hospitalized. Additional information has been requested. No further information is available.
Pain in arm - severe - 4 hrs later. Swelling - down to mid-arm. Redness - down to mid-arm - entire arm. Fever - 101. Weakness. Nurse states developed cellulitis: Allergy. Admitted to hospital - 2 day 1/2. Given IV antibiotics. Several blood tests.
No adverse event; Patient was administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired vaccine) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired vaccine).    No concomitant medications were reported.  It was reported that the date of the patient vaccine administration was not known, and it was also unknown whether patient took first, second or first and or second booster doses. The vaccine was expired on 01-Apr-2022 and vials were initially stored in the refrigerator on 07-Jun-2022, they had not undergone any temperature excursions.  It was reported that the dates of vaccine administration were 01-Apr-2022, 05-Apr-2022,06-Apr-2022, 08-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 09-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022.   No treatment medications were reported.   This case was linked to MOD-2022-589423 (Linked Report).; Sender's Comments:  MOD-2022-589423:Master case
This spontaneous report as received from a registered nurse refers to an unknown age and gender patient. Pertinent medical history, drug reactions or allergies were not reported. On 17-JUN-2013, the patient was vaccinated with an improperly stored dose of VARIVAX, (dose was not reported), lot # H009635, expiration date: 09-MAY-2014. Concomitant medication was not reported. The reporter stated that VARIVAX was improperly stored from 03-JUN-2013 to 21-JUN-2013, and the total amount of time that the doses were above the recommended storage range of -15 Celsius (C) was 187.5 hours. Though most of the temperatures recorded in that time period were below -10C, there were three occasions where a highest temperature of 0C was recorded. The three temperature excursions were: 1). 88.5 hours to as warm as 0C, 2). 7.5 hours t as warm as -6C, and 3). 88.5 hours to as warm as -8C. No adverse effect had been observed or reported. This is one of four cases linked to the same reporter (MARR# 1310USA010120, 1310USA010121 and 1310USA010122). Additional information has been requested.
5/1/2021 Vaccination  Within 10 minutes, I experienced glazed over look, rash, minor SOB. Feeling of needing to slow down but not struggling to breathe. They gave me Benadryl within 10 minutes and that seems to knock those symptoms away. They observed me for 45 minutes and I was better.
given expired drug on 10/1, but according to pfizer is stable till 10/19
Severe pain in the upper arm where the injection was made. Tylinol was taken to control the pain.
her husband tested positive for Covid after 1st dose; her husband tested positive for Covid after 1st dose; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer sponsored program. A male patient (husband) of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The Reporter husband tested positive for Covid after 1st dose. The patient tested positive for covid after first dose. Reporter and her husband would like to reschedule their 2nd dose of the vaccine. They wanted to cancel the schedule tomorrow (26Mar2021) as the patient tested covid-19 positive. Reporter would like to know as well what will be the effect if the 2nd dose is delayed. The patient underwent lab tests and procedures which included tested covid-19: positive The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Numbness, tingling, and pain in left foot then it proceeded up the leg, then into the groin area and by 3:00pm it all the way up the left side where I began having a shocking sensation and it unable to be touched and stopped just below the shoulder area.
Patient received the third dose of RECOMBIVAX HB 4 days early; No adverse effect reported; This spontaneous report has been received from a consumer referring to herself as a female patient of an unspecified age. The patient's pertinent medical history, concomitant medications, drug reactions or allergies were not provided.   On an unknown date, the patient started therapy with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (dose, formulation, vaccination scheme frequency, route of administration were not provided; lot number and expiration date were unknown by the reporter).   It was stated that on an unspecified date, the patient reported that she received the third dose of vaccine hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 4 days early (inappropriate schedule of product administration). No adverse effect was reported.  Follow up information has been received from the consumer on 16-NOV-2020.  The patient historical vaccine included an unspecified hepatitis B vaccine, which never worked and she was never immune.  The patient stated that she received six doses (reported as "shots") of an unspecified hepatitis B vaccine, but did not disclose which one it was. The reporter additionally stated that the doctor switched her to the hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, dose, route of administration, lot number and expiration date continued reported as unknown), and received three shots that worked for her. The patient also reported that later after nine shots of the unspecified hepatitis B vaccine and hepatitis b vaccine (recombinant) (RECOMBIVAX HB), she was finally immune to Hepatitis B.
Paresthesia Narrative:  Patient is a 38 MALE patient with no PMH who on 3/26/21 received his 1st dose of Moderna mRNA COVID-19 vaccine. He was observed for first 15 minutes post vaccine. During this time, he began reporting tingling sensation in hands, headache, and "blotchy" rash of upper and lower extremities. He presented to Urgent Care. Continued to endorse tingling in finger tips but HA and rash resolved. T 97.7 F, P 61, BP 133/90, RR 18, SpO2 98% on RA. On exam had no discrete rash identified but some erythema was noted. No oral or facial edema and lungs clear without wheezing. He was discharged with oral prednisone 60 mg (2 doses) to use only in case of delayed allergic symptoms. Per ID Consult-Patient did not have an immediate allergic reaction to the Moderna mRNA vaccine, rather he likely had a sympathetic reaction if symptoms flare. No additional information in patients chart beyond 3/27/21 addressing this issue.
Client passed out 5 minutes after administering the immunization and hit the back of her head. Client was trasported to hospital via ambulance.  Client also stated she was scared of needles.
Covid19 Bivalent vaccine lot# GP4345 had a 10 week expiry of 04/07/2023. Administered vaccine three days past due  BUD on 04/10/2023. We contact Pfizer on 04/18/2023 for Stability assessment: Stability data DOES SUPPORT. No need to re vaccinated.
Neck is noticeable larger; Swelling of supraclavicular lymph nodes; Axillary tenderness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Neck is noticeable larger), LYMPHADENOPATHY (Swelling of supraclavicular lymph nodes) and AXILLARY PAIN (Axillary tenderness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced AXILLARY PAIN (Axillary tenderness). On 06-Jan-2021, the patient experienced SWELLING (Neck is noticeable larger) and LYMPHADENOPATHY (Swelling of supraclavicular lymph nodes). On 04-Jan-2021, AXILLARY PAIN (Axillary tenderness) had resolved. At the time of the report, SWELLING (Neck is noticeable larger) and LYMPHADENOPATHY (Swelling of supraclavicular lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events paracetamol was reported.   Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
She got the first vaccine on 25Feb 2021, which was the Pfizer one and She got Moderna the second time; a week later, she got an email to come back for 2nd vaccine, she got second one; got very sick; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (She got the first vaccine on 25Feb 2021, which was the Pfizer one and She got Moderna the second time), MALAISE (got very sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a week later, she got an email to come back for 2nd vaccine, she got second one) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 25-Feb-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (She got the first vaccine on 25Feb 2021, which was the Pfizer one and She got Moderna the second time) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a week later, she got an email to come back for 2nd vaccine, she got second one). In March 2021, the patient experienced MALAISE (got very sick). On 05-Mar-2021, INTERCHANGE OF VACCINE PRODUCTS (She got the first vaccine on 25Feb 2021, which was the Pfizer one and She got Moderna the second time) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a week later, she got an email to come back for 2nd vaccine, she got second one) had resolved. At the time of the report, MALAISE (got very sick) outcome was unknown.            No concomitant information was reported. No treatment information was reported.
No additional AE/PQC reported; HCP calling to report an AE regarding the VAQTA and RECOMBIVAX HB vaccines. HCP reported that the patient was administered improperly stored vaccines of VAQTA and RECOMBIVAX HB. The operator of the devices are unknown. Permission was provided to cont; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, lot #X004814, expiration date: 10-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided); and  hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, unk, lot #W008704, expiration date: 18-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, the patient experienced No additional AE/PQC reported. On 10-JUL-2023, the patient experienced HCP calling to report an AE regarding the VAQTA and RECOMBIVAX HB vaccines. HCP reported that the patient was administered improperly stored vaccines of VAQTA and RECOMBIVAX HB. The operator of the devices are unknown. Permission was provided to contact the HCP. Case 02430905 filed. AE cases 02430937 and 02430938 filed. No additional AE/PQC reported.
Breakthrough case admission after 4 vaccines Moderna 2/25/21 Lot# 025L20A;  Moderna 3/25/21 Lot# 043L20A;  Moderna 12/8/21 Lot# 030H21B;  Moderna 6/13/22 Lot# 058A22-2A
no adverse event Expired dose of MMRV given. Called ,mother and will make repeat appointment to revaccinate. Merck stated considered vaccination viable, Doctor directed to repeat dose of obtain a MMR V titer
Light headed, blurred vision, foggy headed & felt medicated, balance off, weakness and dizzy. Started after woke up and progressed to the point of having to call husband home because of fall risk. Then fever came. Most concerning and alarming are the symptoms of vision change like smog in front of my eye sight, feeling weak, light headed and dizzy like walking on a rocking ship. Such a medicated feeling, this all progressed from between 7:30 am to about 10:30, had fever come 100.1 dizziness and weakness and vision gradually got better around 11:30. But when fever spiked again in the evening dizziness came back for a hour or more. Next day a milder episode of dizzy and that passed. These are the most concerning symptoms and Doctor advised I do not get second dose. I had many other symptoms and still have some.
The pt developed fever of 104.5 deg. F., lethargic, and red rash coving trunk of body. Pt taken to ER on 04/14/2002 at 17:22.
4/21. Day of injection: hot flash within 15min of injection. 2hrs later, had massive headache, was dizzy with fast movements. 4/22.  woke up to massive headache and chills (it was in the 80s outside and I was freezing. )  I rotated between tylenol and ibuprofen and slept the day away. 4/23.  Chills finally resolved. headache started to clear. Still dizzy with fast movements. Now arm  has a red raised area below injection sight, hard and HOT to the touch. Google said it's covid red arm??!!