chrisvoncsefalvay/vaers-outcomes huggingface dataset:
all three doses of the Pfizer COVID 19 Vaccine; if the vaccine could lower your testosterone/He did experience this as a side effect/He notes them to not be "low low" but are a "little low."; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunisation. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single  for COVID-19 immunisation and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient call to the facility and was very impatient and had all three doses of the Pfizer COVID 19 Vaccine. The patient wanted to know if the vaccine could lower your testosterone. On an unspecified date the patient experienced lower testosterone levels as a side effect. The patient questions if his lower testosterone levels could be because of the vaccine. The patient also stated that his son also experienced the same low testosterone and questions it possibly be due to them being out of shape or possibly not eating the right things. The patient stated that he was older, and he knows why the patient was lower. The patient had the 1st 2 shots and caught a mild case of COVID19 afterwards. The patient noted that COVID19 can lower testosterone and he is wondering if in the form of the medication to fight it off has the same stuff as COVID 19 to build immunity. The Patient stated that might lowers testosterone as COVID 19 can lower testosterone. On an unspecified date the patient underwent lab tests and procedures which included blood testosterone: little low and the patient noted the facility to not be low,low but are a little low. The clinical outcome of the events was unknown.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Itching and redness at injection site developed within a minute of administration;  ice was applied, and 50mg Benadryl IM was administered.  Vitals pre-benadryl  administration were 139/100; O2=99%; P=87.  Patient was observed 45 min.  Vitals 25 min after the vaccine  administration and prior to leaving the clinic were 137/93; O2=99%; P77
Swelling in rt arm on 11/20/21.  Swelling in arm pit on 11/28/21 warm to touch on shoulder. ER visit 11/28/21 @ Hospital.  Venous Doppler done 11/29/21 1000 am.  Positive subclavian vein Thrombosis.  Lovenox 70mg started at 3pm on 11/29/2+ BID FOR 3 DAYS.  Will start eliquis for 3 months  Off work for 7 days per Dr Note  Wearing compression sleeve for 3-5 days.
Client received vaccines on 04/04/2017 at our clinic in the afternoon. Client states that on 04/05/2017 while playing a video game at 10:00PM, a "loud sound" came through his headphones and he began to feel dizzy. Client stated that he ate food, which did not help the dizziness. No other symptoms reported. Client called our clinic on 04/06/2017 around 10:00AM to report his symptoms, since they had not resolved. Client instructed to not drive and seek medical care. Client referred to urgent care locations in his area that accept his insurance since he reports not having a PCP.
started to develop rash around the knee and the back of the knee, elbow / spread up the leg and hands; small red itchy bumps, not in clusters but close together; itchy bumps; rash spread up the leg and hands; swelling of lymph node; got really sick the whole day; wasn't well; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick the whole day), MALAISE (wasn't well), RASH (started to develop rash around the knee and the back of the knee, elbow / spread up the leg and hands), RASH ERYTHEMATOUS (small red itchy bumps, not in clusters but close together) and PRURITUS (itchy bumps) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced MALAISE (wasn't well). On an unknown date, the patient experienced ILLNESS (got really sick the whole day), RASH (started to develop rash around the knee and the back of the knee, elbow / spread up the leg and hands), RASH ERYTHEMATOUS (small red itchy bumps, not in clusters but close together), PRURITUS (itchy bumps), RASH (rash spread up the leg and hands) and SWELLING (swelling of lymph node). At the time of the report, ILLNESS (got really sick the whole day), MALAISE (wasn't well), RASH (started to develop rash around the knee and the back of the knee, elbow / spread up the leg and hands), RASH ERYTHEMATOUS (small red itchy bumps, not in clusters but close together), PRURITUS (itchy bumps) and SWELLING (swelling of lymph node) outcome was unknown and RASH (rash spread up the leg and hands) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-092541 (Patient Link).
After dose #1 (3/11/21) there was severe fatigue from around day 10 to day 17, resolved.  The main thing I want to report was at the #2 on 4/1/21.  I sat for the 15 minutes required after the injection and when stood up, felt like I was weaving trying to walk.  I thought this was orthostatic hypotension, as occasionally happens, and I left because there were no allergic reaction symptoms.   By the time I got to a store about 10 minutes later, trying to stand while waiting for service, it was difficult to stand due to feeling like I was dizzy and unsteady.  Later that night, was EXTREMELY dizzy getting out of bed and had to sit down every time tried to walk.  It was better by the next day.  To a lesser extent, I've continued to have this sense of weaving when walking or standing occasionally, but it has gotten better.  Occasionally trying to walk I still feel a bit ataxic.  No injection site soreness at all.  Otherwise felt fine, no flu-like symptoms.
Patient was given a third dose of Menactra. This third dose was given less than 5 months after his booster dose.
Fever over 103 -104 for 3 days, ice extremity and Ibuprofen for fever.
He was positive for COVID 19; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old male consumer received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration in left arm on 27Apr2021 at 14.00 as first single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any antipyretic drug around the date of vaccination. Product complaint was reported. The patient reported that he got first shot 27Apr2021 and he took a test on 03May2021 and he was positive for COVID 19. He only got the first dose, he goes for the second dose 14May2021, he says they did not give him a vaccine card. He did not know any lot number or expiration for the dose he received. The case was classified as serious. The outcome of event was unknown.   Information on the Lot/Batch number has been requested.
RASH ON HER BACK AND BELLY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced rash on her back and belly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash on her back and belly was not reported. This report was non-serious.
1.Headache the day of vaccination 2. Left deltoid and arm including left hand has sensation of being ice cold.. has persosted for 3 days so far
pain in rt arm extending from inj site & up into the neck;pain to the point that pt wouldn't allow the area to be touched;no swelling noted by mom;no redness noted by mom;
the pain is unbearable; she got shingles August 2022 she still has it!/suspected vaccination failure; she got shingles August 2022 she still has it!; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In AUG-2022, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: she got shingles August 2022 she still has it!/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: she got shingles August 2022 she still has it!). On an unknown date, the patient experienced pain (Verbatim: the pain is unbearable). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient's brother or sister via interactive digital media. The patient got the vaccine and got shingles and still had them. The reporter reported that the pain was unbearable. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
pt recvd vax; became stiff, eyes starring & breathing stopped; resuscitated by md; remained pale; heart rate & pulse nl;
Muscle aches, chills, shivering, sweating, fatigue within 12 -24 hours.  Hives on left arm 48 hours after vaccine was given.
10 minutes after giving booster dose of Moderna, patient complains of sudden on set of severe headache with nausea. vital signs stable, patient pale, blurred vision, rapid response called and patient taken to the Emergency department for further evaluation and workup.
Patient was administered with vaccine that was beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient had acute illness at the time of vaccination and up to one month before.     On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the age of patient was 22 years 8 months. No concomitant medications were reported It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions. Patient had reported no adverse reactions after the administration of vaccine. No treatment medication were reported. On 10-Jun-2022, the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code 80777-0273-99.
Information has been received from a female registered nurse concerning a 25 year old female patient with no known allergies and no reported medical history who on 22-OCT-2007 was vaccinated with Gardasil (Lot #658560/1062U) 0.5 ml intramuscularly in the right deltoid. There was no concomitant medication. On 22-OCT-2007, the same day after receiving the first injection, the patient developed nausea, vomiting and fever, on 23-OCT-2007 the patient notified the physician via telephone after the adverse symptoms were resolved. No treatment was rendered and no other information is available. Additional information has been requested.
Stomach cramps; Diarrhea; Nausea; Vomiting; Injection site pain in her right arm; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injecton, Lot number and expiry date were not reported) via an unspecified route of administration, administered in Arm Right on an unspecified date as single dose for covid-19 immunisation. Medical history included covid-19 from 2019. The patient's concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. On an unspecified date, the patient experienced stomach cramps, diarrhea, nausea, vomiting, injection site pain in her right arm. The patient reports taking a Tylenol to help her pain, pain has not subsided and she was felt heat moving in her body once the injection was given. Patient states that she gets tested frequently for COVID, and she's continued to test negative. Caller reports the symptoms she is feeling feels like when she had COVID in 2019, after she received the injection. The outcome of the events were unknown. Patient had questions: If she can take muscle relaxers or something for stomach pain, Is stomach pain associated with the vaccine, and can the vaccine make COIVD active again.  Follow-up attempts are completed. No further information is expected. Information about lot/batch number has been requested.
13 hour after,: severe body aches, not resolved w/ Tylenol, Ibuprophen 800 mg took the edge off only.  Nausea which increased to severe 36 hours after severe nausea, malaise lasted for 1 week.
patient called complaining of sharp pain in back and shortness of breath approximately 6 hours after receiving the first dose of Moderna COVID vaccine
Cellulitis - right arm 5cm x 5cm erythema plus warmth.  On Augmentin 400mg PO BID for 7 days.
Headache, backache, joint ache, stomach pain, exhaustion and chills for about 36 hours. Sore at injection site and below injection to about 3 inches below injection site for a week. 2 inch circular rash appeared 3 inches below injection site and remained for about one week. Note: had no side effect from the first SHINGRIX vaccine on 4/24/18.
Left arm was hot to the touch, swollen, and the redness approx 100mm x 80mm. Mother stated child had no temp and arm was not sore. Instructed mother to apply cold compress to left arm site, Prn. Instructed to give child Tylenol for fever and pain (per bottle instr.) prn. Instructed to buy OTC Benadryl for s/s. Instructed to call back if s/s persisted and become worse for RN assistance to see MD in local family care clinic or go to local ER. Mother verbalized and understood all instructions given. TC with Mother, ask how child was doing. Mother stated child was fine and that the redness was gone and the arm was hard about 1/2" around injection site.
administered with vaccine which underwent temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine which underwent temperature excursion) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine which underwent temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine which underwent temperature excursion) had resolved.        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.   No concomitant and treatment medication details were reported.  The reporter reports that they had a temperature excursion in their pharmacy involving 2 lot numbers:  Lot number(s) - 045C21A with the temperature excursion occurring on 20Oct2021-04Nov2021; 065F21A (09Nov2021-17Nov2021).  From lot number 045C21A, 3 booster doses were given on 27Oct2021; 3 booster doses and 1 regular dose on 28Oct2021; 3 booster doses and 1 regular dose on 29Oct2021; and 3 booster doses on 02Nov2021 From lot number O65F21A; 1 booster dose and 1 regular dose were given on 09Nov2021; 1 booster dose on 10Nov2021; 4 booster doses on 11Nov2021; 1 booster dose on 16Nov2021 and 1 booster dose on 17Nov2021.
UTI; This spontaneous case was reported by a patient and describes the occurrence of URINARY TRACT INFECTION (UTI) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient took Moderna vaccine and believes he had UTI. Patient took doctor's appointment and wanted to know if taking antibiotics they may prescribe him will interact with the vaccine or not. Treatment medication was provided.
Contracted COVID after being fully vaccinated and boosted. Fever, Shortness of Breath, Cough, anorexia, fevers.
Arm pain; J & J vaccine dose 1 and Moderna vaccine dose 2; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and INCORRECT DOSE ADMINISTERED (J & J vaccine dose 1 and Moderna vaccine dose 2) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain) and INCORRECT DOSE ADMINISTERED (J & J vaccine dose 1 and Moderna vaccine dose 2). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown and INCORRECT DOSE ADMINISTERED (J & J vaccine dose 1 and Moderna vaccine dose 2) 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 medications were reported
This was the patient's booster vaccine. The patient had Pfizer the 1st 2 doses.  Completed vaccine and asked patient to wait for 15 minutes.  Within about 2 minutes of receiving vaccine the patient returned to the counter stating he couldn't breath.  He was gasping and grabbing his throat.  He then stated he was going to pass out. At that time the patient received a dose of Epinephrine 0.3mg in his outer thigh and placed in a chair.  911 was called and the ambulance proceeded to take the patient to the hospital for follow-up.
This spontaneous report as received from a nurse refers to a 14-year-old female patient who weighed 224 lbs. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 21-SEP-2017, the patient was vaccinated with an adult dose of VAQTA injection, lot # N016805 with expiration date on 04-SEP-2018 (dose and route of administration were not reported). No adverse effects were reported. Follow up information has been received from a registered nurse on 02-NOV-2017 regarding a 14 year old (also reported as 15 year old) female patient. The patient's medical history included ADD (Attention deficit disorder). It was confirmed that the patient was vaccinated with an adult dose of VAQTA injection, lot # N016805 with expiration date: 04-SEP-2018, intramuscularly in left deltoid on 21-SEP-2017. Other suspect therapies included poliovirus vaccine inactivated (unspecified) (lot # N1A461M), given intramuscularly in right deltoid for prophylaxis. The patient was vaccinated at private doctor's office/hospital and the vaccine was purchased with public funds. It was also confirmed that the medication error was occurred during the preparation for administration.
Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (sulfa drugs), Penicillin allergy, Major depression, Anemia, Hiatal hernia and Insomnia. Concomitant products included BUPROPION for Depression, TRAZODONE for Insomnia.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 30-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported. Patient's race is black. Patient's height is 66.14 inches. Patient received the vaccine on 30th Aug 2021 at 08:45 am. This report refers to a case of Product storage error for mRNA-1273, lot # 014C21A  with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received: reporters information , patient's demographic, concurrent condition of the patient and concomitant medication were updated.; Sender's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # 014C21A  with no associated AEs.
Patient was in office for COVID vaccine. It was verified at check in and with nurse to be getting a Moderna  Booster vaccine. PT received Moderna and should not have d/t age. Guardian notified of event.
Nausea, diarrhea, low grade temp of 99.2. very sore arm.
RECEIVED FIRST DOSE IN OCTOBER, STILL EXPERIENCING ARM/SHOULDER DISCOMFORT