chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the first covax then 5 days after tested positive for the virus; received the first covax then 5 days after tested positive for the virus; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received a first dose of BNT162B2 (batch/Lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, she received the first covax then 5 days after tested positive for the virus. Further, she was asking what she should do about the second covax. The patient's laboratory investigation included she was tested (SARS-CoV-2 antibody test) as positive for virus on an unknown date. The outcome of the event was unknown at the time of the report.   Information on the lot/batch number has been requested.
2 days following Td vax pt devel rash & was taken to MD & put on the Medrol DOse pack along w/DPH; pt was given a Medrol Dose Pack on 31JAN95;
RIGHT LEG LOCAL REACTION - 2 INCHES AROUND; LEFT LEG LOCAL REACTION - 1 INCH AROUND; RED AND HOT; NO FEVER
Patient presents at the ER 1 hour after having Moderna COVID vaccine with chest tightness with shortness of air.  She was having wheezing and difficulty swallowing, but no rash. Alprazolam 0.25mg, Duoneb x2, prednisone 20mg, Epinephrine 1mg/ml IM, Patient leaves ER at 11:19am
Site: Pain at Injection Site-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: BP 103/65 Pulse 62-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: EMS was called but she went home with her mother and slept the rest of the day, she had a sore arm on Tuesday but was otherwise fine per mom.
BY 1PM/3HOURS AFTER VACCINE PT STARTED WITH A FEVER HIGHEST 103. SHE BEGAN VOMITING ALOT PER MOM AND WET LOOSE STOOLS. RASH ON NECK IS WORSE THAN IT WAS YESTERDAY AT TIME OF VACCINATION PER MOM BY PHONE. MOM TOOK PT TO ER LAST NIGHT.
Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked to case 2018SA183350, 2018SA201512, 2018SA201513, 2018SA201514. This case involves a four-years old patient (gender not reported) who received a IPOL from shipment which should be returned due to it being in transport a day longer than it should have, no adverse event. This is the case of actual medication error as the vaccine was administered to the patient, which was incorrectly stored. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On an unknown date, the patient received a dose 0.5 ml of suspect IPV, lot N1K92 via unknown route in unknown administration site on 12 Jun 2018. Caller reported that by the time they received notification that their IPOL shipment should be returned due to it being in transport a day longer than it should have, they had administered 5 doses to patients already. All of the patients were 4 years of age. It is unknown who administered each dose. There were no adverse reactions reported for any of the patients who received the doses. The doses were administered on June 8th, June 12th, June 13th, June 14th, June 18th and June 21st. Caller stated they were aware that the parents will have to be notified and the children will have to be re-vaccinated. Caller stated that she had already talked to someone about returning the shipment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
(L) deltoid with nonerythmeteous, slightly tender, slightly hardened area around vaccine area.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine experienced multiple warm excursions and was administered past it's expiry date), PRODUCT STORAGE ERROR (Vaccine was above 5F for a total of 20 reported hours and reached a max temperature of 19.4F (is true max, 75.2F was most likely battery change)) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine experienced multiple warm excursions and was administered past it's expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was above 5F for a total of 20 reported hours and reached a max temperature of 19.4F (is true max, 75.2F was most likely battery change)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine experienced multiple warm excursions and was administered past it's expiry date), PRODUCT STORAGE ERROR (Vaccine was above 5F for a total of 20 reported hours and reached a max temperature of 19.4F (is true max, 75.2F was most likely battery change)) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine experienced multiple warm excursions and was administered past it's expiry date) and PRODUCT STORAGE ERROR (Vaccine was above 5F for a total of 20 reported hours and reached a max temperature of 19.4F (is true max, 75.2F was most likely battery change)). Concomitant product use was not provided by the reporter. Moderna product was stored in the freezer (prior to moving to the fridge). Vaccine experienced multiple warm excursions and was administered past its expiry date. The vaccine was damaged out at the time of report. Lot 048L21A was delivered on 17-Mar-2022. Vaccine was moved to the fridge on 31-Jul-2022 and administered on 01-Aug-2022 and vial removed from fridge and punctured at 1:00pm. The vaccine was above 5F for a total of 20 reported hours and reached a max temperature of 19.4F (was true max, 75.2F was most likely battery change). The reporting interval changes on 07-Apr-2022 at 9:13am from a 5-minute reporting interval to a 15-minute reporting interval. There was missing freezer temperature data from 09-Jun-2022 to 18-Jul-2022. The sharp spike was most likely when the team changed the battery and placed the TempAlert device back in the freezer. When the data came back there were two warm excursions. Treatment information was not provided.
Fever, chills, headache, stomach pain, flu-like symptoms.  Completely out of commission for 36 hours.   Worst reaction to a vaccine I've ever had.  I am considering not getting the 2nd dose given this bad reactions.   Two other people in my family (53- year old  husband and 84-year old mother) also had exact same symptoms to Shingrix vaccines received the previous week.
None reported when client notified 11/10/11, 11/11/11 & 11/12/11.
Pt. explains feels like symptoms started on 10/30/16 light headed, no sleep, no appetite, arm numbness (left).
Immediately after having vaccines, patient had a seizure that lasted a few seconds. Dr. did a neurologic exam 5 minutes and 30 minutes after episode which was normal.
Patient states she is experiencing shortness of breath several hours after receiving the second dose of the Moderna Covid vaccine.
COVID breakthrough Case. I received my 1st booster shot on 11/30/2021 and my COVID symptoms started on 05/23/2022 at night around 6-7 PM it started with a nasal drainage and by the next mooning I was really off 05/24/2022 I had sore throat, runny nose, light headache, tired, exhausted, on 05/25/2022 fever, and chills. I tested  with a home COVID test on 05/25/2022 which came out to be positive. The same day I went to the urgent clinic they gave me a PCR test which was positive. They prescribe me with prednisone first and they knew I had asthma so my doctor later on gave me PAXLOVID for 5 days. I recovered completely.
Vaccine gave me the flu. Made me hot, flashy and lightheaded to the point I fainted.
Information has been received from a physician concerning a 12 year old male who on the day before the child's first birthday was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck).  The physician reported that the patient experienced a break through case of chickenpox on an unspecified date (greater than 50 lesions) and the patient was already given VARIVAX.  Medical attention was sought, the patient was seen by a physician.  The physician stated this patient had a more serious case of chickenpox.  At the time of the report the patient was recovering from the adverse event.  There was no product quality complaint.  Additional information has been requested.
Golf-ball sized lump. Tender to touch. Advised to apply heat and to take Ibuprofen. Advised to go to ER for any worsening symptoms or symptoms of anaphylactic reaction.
Information has been received from a medical assistant referring to a 60 year old patient of unknown gender. Concomitant therapy included sterile diluent (MERCK) (lot# M039641 with expiration date 16-JAN-2019). Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 25-OCT-2018, the patient was inadvertently received a dose of ZOSTAVAX (subcutaneous, lot # N020938, strength was not reported) for prophylaxis which expired on 31-JUL-2018. No adverse effects were reported.
Symptoms developed about 14 hours after vaccination. Low-grade fever (lasting 24 hrs), shakes/chills (lasting 3 hours), muscle aches (lasting 12 hours), nausea (lasting 7 hours). Vomited twice. Symptoms gradually disappeared, with all starting roughly about the same time.
Pain in both armpits; Nausea; Headache; Swollen painful lump in arm; Tingling for 24 hours in right arm; Nerve pain for 24 hours in right arm; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Apr2021 at 14:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included migraines, fibromyalgia, anxiety and depression. The patient had known allergies to penicillin, sulfa drugs, mango and pears. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN) and duloxetine hydrochloride (CYMBALTA); both for unspecified indications from unknown dates and unknown if ongoing. 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 18Mar2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 13Apr2021 at 00:00, the patient experienced nausea, headache within a few hours of vaccination, swollen painful lump in arm and tingling nerve pain for 24 hours in right arm. On 15Apr2021 after 2 days of vaccination, the patient experienced pain in both armpits which continued for at least 48 hours (at the time of reporting). The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as the result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, headache, swollen painful lump in arm, pain in both armpits was resolving at the time of this report. The clinical outcome of the event tingling nerve pain in the right arm was resolved on 14Apr2021, after a duration of 24 hours.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Things taste bad after the vaccine; Mouth feels like it's always dry now after vaccine; Milk tasted really sour after 2nd dose; Arm hurts after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Things taste bad after the vaccine), DRY MOUTH (Mouth feels like it's always dry now after vaccine), DYSGEUSIA (Milk tasted really sour after 2nd dose) and MYALGIA (Arm hurts after 2nd dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033b21a and 0dlbz1a) for COVID-19 vaccination.     The patient has no reported medical history.  Concurrent medical conditions included Rheumatoid arthritis.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-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 TASTE DISORDER (Things taste bad after the vaccine), DRY MOUTH (Mouth feels like it's always dry now after vaccine), DYSGEUSIA (Milk tasted really sour after 2nd dose) and MYALGIA (Arm hurts after 2nd dose). At the time of the report, TASTE DISORDER (Things taste bad after the vaccine), DRY MOUTH (Mouth feels like it's always dry now after vaccine) and MYALGIA (Arm hurts after 2nd dose) outcome was unknown and DYSGEUSIA (Milk tasted really sour after 2nd dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was provided.  No treatment medications information was provided.  Patient had RA which makes her feel fatigue.   This case was linked to MOD-2021-148126 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Additional details included event outcome and medical history.
Patient's mother signed her up for Moderna  COVID 19 vaccine. I administered Pfizer knowing that patients must be 18 to receive Moderna. In my haste I failed to notify patient's mother that she was receiving Pfizer instead of Moderna like her consent form requested.  I signed  COVID card reflecting that patient received Moderna but am certain that the patient received Pfizer. The mother of patient was notified of which vaccine patient actually received and provided with Pfizer Fact Sheet.
This case was reported by a healthcare professional and described the occurrence of anaphylactic reaction in a female subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received 2nd dose of HAVRIX (unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced anaphylactic reaction. The healthcare professional considered the event was life threatening. The subject was treated with BENADRYL. At the time of reporting the outcome of the event was unspecified.
Oct 2, I got chest pains and difficulty breathing, lasted for about 20 minutes then subsided, returned Oct 19, chest pain and breathing difficulty returned lasted long enough for me to go to ER.
pt stated lt arm became very red & sore for several days p/Td was treated w/ATB;
R upper arm with swelling, macular rash and tenderness.  Itch/pain.  Prescribed Benadryl pru, Motrin PO pru.
cramps in the left calf; strained left calf muscle while walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 16:00 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "treated high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: Q10; VIT D [COLECALCIFEROL]; VIT C; VIT B12. The following information was reported: MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "cramps in the left calf"; MUSCLE STRAIN (non-serious) with onset Mar2021, outcome "unknown", described as "strained left calf muscle while walking". Therapeutic measures were not taken as a result of muscle spasms, muscle strain. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known allergies to medications, food, or other products. The patient was also concomitantly taking unspecified multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sudden pain below the left chest.While having that symptom, feel pain when having a deep breath or a big smile.; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the left arm on 08Oct2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3184 [as reported] ) via an unspecified route of administration in the left arm on 17Sep2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. On an unknown date in Nov2021 at 09:00, the patient experienced sudden pain below the left chest. It was reported that while having that symptom, the patient feels felt pain when having a deep breath or a big smile. After 10-15 minutes, the symptom was gone. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sudden pain below the left chest while having that symptom, felt pain when having a deep breath or a big smile was not resolved at the time of this report.
Vaccine was not diluted. Reported to clinical supervisor and another employee in Quality. Clinical supervisor contact patient mother and interpretor, conversation held, patient mother, interpretor and told of vaccination administration. Told mother to watch for systemic side effects: pain, fever, fatigue. Patient advised if any questions to call clinic. Patient mother had no questions. Patient's mother was told to not repeat dose per quality. Patient's mother was told that VAERS could possibly contact patient's mother to see how patient is doing. Again asked if any questions. Mother had no questions. Told mother to call clinic if any concerns or questions. Routed to provider.
AGE-APPROPRIATE BIVALENT PFIZER WAS ADMINISTERED ONE DAY AFTER FDA ENDED AUTHORIZATION FOR USE.
Tetanus shot was in left arm. Tingling of left thumb and left pointer finger as well as significant loss of left tricep strength.
Patient started to feel hot 10 minutes after shot was administered. Then patient started to pass out 5 minutes thereafter. Patient was given a bottle of water and ice pack in order to cool down. Blood pressure was being monitored. After 15 minutes of adverse reaction occurred patient started to feel better. EMT's arrived and monitored patient before he was released 30 minutes after adverse reaction had started.
I developed COVID-19. My adverse event was not a result of the vaccine, just incidentally happened in the weeks after my booster
depression; haven't stopped crying; have no appetite; it feels like a tomb is sitting on my head; feels like you don't want to wake up, if you can even get to sleep; concerned; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 88 year-old female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER 1), when the patient was 88 years old, for COVID-19 immunisation. The following information was reported: DEPRESSION (non-serious), outcome "unknown", described as "depression"; CRYING (non-serious), outcome "unknown", described as "haven't stopped crying"; DECREASED APPETITE (non-serious), outcome "unknown", described as "have no appetite"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it feels like a tomb is sitting on my head"; SLEEP DISORDER (non-serious), outcome "unknown", described as "feels like you don't want to wake up, if you can even get to sleep"; ANXIETY (non-serious), outcome "unknown", described as "concerned". Additional information: she states that since receiving her second dose she has been suffering from depression and states "[I] haven't stopped crying, have no appetite", that it "feels like a tomb is sitting on my head", and "feels like you don't want to wake up if you can even get to sleep!".  She was concerned because it showed up after the second dose and she "didn't sign up for this". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv 1st & 2nd dose of vax  january & march of 1996 & subsequently lab evaluation revealed a lack of response.
adult patient received 0.25 ml doses of Fluzone Quadrivalent/no AE; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a office staff.  This case involves a 40 years old male patient who vaccinated with a 0.25 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot number: UT6647JA, expiry date: 30-Jun-2020) via unknown route in the left arm on an unspecified date on 28-AUG-2019 .  It is an actual medication error case due to vaccine underdose. It was reported that a 0.25 mL dose of vaccine FLUZONE was administered to a adult patient.  It was reported that Symptoms were none reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
5/2/13 - abnormally tired. 5/3/13 - Vomiting, diarrhea, loss of appetite, couldn't sleep.