chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    Concomitant medication list was not provided. It was reported that 196 patients received 0.25mL of Moderna COVID-19 vaccine, Bivalent. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up: added patient demographic details.
pt recvd vax & the following day exp soreness @ inject site & exp flu-like sx consisting of h/a, nausea, vomiting, fatigue, flushing & neck stiffness; sx persisted until 18JAN93; presented to MD & was advised not to received 3rd dose of vax
I've been running a fever of 103.4 and I have a really bad headache dizzy and light-headed and sick to my stomach
Client reports "legs and back gave out" while walking back to her room at the Assisted Living facility. Also reports she had a fever of 103F during the night. Feels better this morning. She did not seek medical treatment.
I have Covid arm.  Developed a lump over the next several days post vaccine, which got larger over time.  Didn't hurt too much unless I touched it.  Didn't stop me from doing anything I normally do, and I didn't pay much attention to it.  On Day 10 post vaccine, I happened to look at my arm in the mirror after a shower, and noticed a red circular rash at the injection site, about the circumference of a golf ball.  The lump underneath was very warm to the touch, and the spot was still sore if touched.  Kept watching daily.  On Day 12, it was the largest that it had been...the rash was 2 1/2 inches in diameter and still warm and sore.   Had soreness going up into my neck and down towards my elbow.  By Day 14, I noticed that the center of the area was returning to normal skin color, so the rash looked like a big red 'O' now.  Have taken Benadryl the last two nights, and it appears a lot lighter in color today (Day 15 post vaccine).  Lump is still there and still warm, but it seems that the worst is over.  The lump fills my cupped palm, but I can push on it pretty hard now without pain.
This case was reported by a consumer via call center representative and described the occurrence of tremor in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 14th March 2019, the patient received SHINGRIX. On 14th March 2019, less than a day after receiving SHINGRIX, the patient experienced tremor, chills, pain and feeling abnormal. On 15th March 2019, the patient experienced lethargy and headache. On 17th March 2019, the patient experienced chest pain. On 19th March 2019, the patient experienced neck swelling. On 15th March 2019, the outcome of the tremor, chills and pain were recovered/resolved. On an unknown date, the outcome of the feeling abnormal was unknown and the outcome of the lethargy and headache were not recovered/not resolved and the outcome of the chest pain and neck swelling were recovered/resolved. The reporter considered the tremor, chills, pain, feeling abnormal, lethargy, headache, chest pain and neck swelling to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient had never had any type of reaction to previous vaccines. The patient began shaking, having chills, hurting everywhere and having pulsating pain in different parts of her body on the night of the vaccination. The next morning (15th March 2019), the patient felt normal but lethargic and had a headache that started in the back of her head, then moved around to different parts of the head. She felt the same on Saturday (16th March 2019). On Sunday (17th March 2019), the patient started having chest pains and a really bad headache. The chest pain resolved but she slept until 1:30 yesterday and woke up with a bad headache. On 19th March 2019, the patient woke up with a slight headache but noticed her neck looked swollen at times but it came and went. At the time of this report, it looked normal. The patient provided the consent for follow up.
temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.  Reported stated that this vaccine was then placed in a different freezer which experienced a temperature excursion on 19NOV2021, reaching a maximum of 10.8°F for 5 hours and 31 minutes.
and have a question about a death being reported as possible link to COVID-19 vaccine; This is a spontaneous report from a contactable consumer. An unspecified age and gender patient received an unspecified dose of BNT162B2 via an unspecified route of administration on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unknown date, the patient experienced death and it was been reported as possible link to COVID-19 vaccine. The reporter stated that was reported a teen dead several days after gotten a vaccine. Since only Pfizer vaccine is available to teens and reporter wanted to know whether have a statement about this. The CDC was investigated any potential link. The outcome of event was fatal.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: and have a question about a death being reported as possible link to COVID-19 vaccine
Swelling, redness, pain, noticeable lump, itching just below the site of the injection that has been continuous since 5-17-21 to present
All the basics - pain in arm and shoulder; extreme fatigue; body aches and head ache; slight nausea; brain fog; and a rash over my chest and shoulders with a little on my back and face that itches and burns so that I couldn?t sleep and nothing would make it stop to the point where I went into urgent care
Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9 months old patient of unknown gender who received an expired dose of vaccine IPOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal Vaccine; TDAP; ACTHIB; and FLUZONE QUADRIVALENT. On 10-Jan-2019, the patient received a single 0.5 ml dose of suspect IPV (VERO), lot UI859AAA via unknown route in the right thigh. It was a case of actual medication error due to expired vaccine used. (expiry date: 09-Jan-2019). It was unknown whether adverse event occurred. 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.
he got positive in COVID-19; he got positive in COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he got positive in COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he got positive in COVID19 and was told to quarantine. Clinical course: Caller asked if taking Plavix would help him because he got positive in COVID-19 and was told to quarantine. He mentioned that his friends said that medicine will help people who have been tested positive and have taken the Pfizer COVID-19 vaccine.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report received from a patient concerned a 5 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, pre-diabetic, and shrimp allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 15:00 for covid-19 prophylaxis. Age at time of vaccination 42 years old. No concomitant medications were reported. On an unspecified date, the patient experienced drowsy at night, swelling in the right arm, and injection site area was still swollen and looks like lump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site area was still swollen and looks like lump, and swelling in the right arm, and the outcome of drowsy at night was not reported. This report was non-serious.
pt recvd vax 4JAN93 resulted in fever of 104, listlessness, achy all over, cried hard; went to ER checked over & told mom to cont fever control & comfort; returned to nl 48 hrs later;
vaccine booster; Patient got COVID-19 in December from her grandson. She tested positive; Patient got COVID-19 in December from her grandson. She tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.-  A 45 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 45 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ENTRESTO. Vaccination history included: Covid-19 vaccine (Manufacture: Unknown, dose number unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION, outcome "unknown", described as "vaccine booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Patient got COVID-19 in December from her grandson. She tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical courses: The patient tested positive but did not show any side effects besides a cough. She thought she was ill due to the COVID-19 Vaccine booster.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Raised with redness, no pain, no tenderness, no real swelling, but better now than this morning.
Patient states she experienced headache, ringing of ears, stiff neck, listlessness and fever the day after receiving vaccines.
Temp 102 for 12 hours. 5 "welts" for 3 days
Chest tightness, dizziness, hives/itching entire body.  Chest tightness ended about 12 hours later. Dizziness and hives/itching still persistent after 24 hours
Patient developed a red raised area around injection site. It itches, is about 1" x 3". It developed between an hour or two after injection. Patient waited a day before seeing the Dr. She prescribed Ibuprofen 800mg once-twice daily. At site of ZOSTAVAX admin.
Pt vaccinated on 7/8/05, and denied any possibility of being pregnant at that time, she subsequently was found to be pregnant with a LMP of early MAY 05.  Her pregnancy was confirmed 17 days s/p vaccination with Smallpox.  Pt has had no evidence of threatened ab, and is otherwise doing well.
arm soreness and a headache; arm soreness/arm hurt a little bit; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 22Apr2021 at 14:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had experienced arm soreness and a headache on Apr2021. The patient wants to know if he got any side effects, can he use ibuprofen for headaches or arm hurts at the injection site. It was also reported that the patient's friend said to take the ibuprofen and the patient's daughter said to take ibuprofen or paracetamol (TYLENOL). The patient was referred to health care professional (HCP) for treatment recommendations. The outcome of these events was unknown at the reporting time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient states that "ever since he got the Shingles shot, he has had Shingles". Complains of burning/painful rash.
This spontaneous report was received from a licensed practical nurse and refers to a 11-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 26-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccine 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. 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.
I developed shingles on the underside of my left breast. This is the second time...the first was a year and a half ago on my upper right arm. Fluid filled pustules, itchy, dull ache.
Moderna COVID-19 Vaccine EUA I started to have an increased heart rate and heart palpitations that lasted about a second/1.5 seconds on and off. The increased heart rate would persist for quite some time (an hour or two), and then would stop, and happen again on and off.  The heart palpitations would occur multiple times per day. This lasted for about three days from the start date of the adverse event. On that start date, I also had some muscle cramping in my left arm (arm of vaccine injection), and had soreness beginning around my lymph nodes in my left armpit (that radiated into my chest a bit)  which was enough to make me want to life my arm up so it wasn't pressing down on it. The soreness is mostly gone now, but still there. I also had what I believe is muscles in my chest (on the left side mainly) cramping, as I had some aching and brief sharp pains occurring mainly during the time I had heart palpitations and increased heart rate, but it was hard to tell. I still get an occasional heart palpitation (one or two per day), but it is much less frequent than before.
This is a spontaneous report from a contactable nurse. A patient of unknown age, gender and received single dose of PREVNAR 13 on an unknown date, for immunization. Relevant medical history and relevant concomitant medications were unknown. After vaccination on unknown date the patient had redness, swelling and discoloration of skin. Relevant laboratory data was unknown, last action taken with PREVNAR 13, therapeutic measure taken in response to the events and clinical outcome of the reported events were unknown at the time of report. Follow-up (06Jun2014): Follow-up attempts completed. No further information expected.
Patient received Moderna bivalent booster dose that had undergone a temperature excursion; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medications were reported.  The case was reported for 62 out of 77 adult patients who had received the vaccine as reported by the reporter.  It was reported that the vaccine was administered to 77 patients before it was known if the vaccine was ok to use after the excursion.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Next day had sore left arm 2 days after injection had mild nausea, mild fever and moderate headache 3 days woke with all symptoms gone except one new symptom - very red conjunctivitis - left eye red cornea
Heart palpitations started on July 7, 2021 and have persisted since. I went to the emergency room after visiting my primary care doctor?s office. I left with a heart monitor.
High fever>103 from 5-18 to 5-21, lymph nodes in neck very swollen, headache and arthritic pain in legs. Low fever from 5/15 to 5/17. Pt missed one week of school. Siblings did not get ill, therefore confirming this was reaction from vaccination.
Headache, body aches, low grade fever, fatigue, flu-like symptoms. Started with a headache and lethargic feeling day of shot. By 13 hours later, fever and chill with worsening headache woke me up.  Feel like I'm fighting the flu.
patient was worried; Rash began developing that night, FOUR DAYS AFTER the booster shot.; Came down with shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Came down with shingles), ANXIETY (patient was worried) and RASH (Rash began developing that night, FOUR DAYS AFTER the booster shot.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 004M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Chest pain, Shoulder pain and Back pain. Concurrent medical conditions included Hypertension (within past 2 years.) and High cholesterol (within past 2 years.). Concomitant products included ATORVASTATIN for Coronary artery disease, VALACICLOVIR and HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN + HIDROCLOROTIAZIDA) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced HERPES ZOSTER (Came down with shingles). On an unknown date, the patient experienced ANXIETY (patient was worried) and RASH (Rash began developing that night, FOUR DAYS AFTER the booster shot.). The patient was treated with METHYLPREDNISOLONE from 30-Oct-2021 to 01-Nov-2021 for Shingles, at a dose of 4 mg. At the time of the report, HERPES ZOSTER (Came down with shingles) had not resolved and ANXIETY (patient was worried) and RASH (Rash began developing that night, FOUR DAYS AFTER the booster shot.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HERPES ZOSTER (Came down with shingles) to be not related. No further causality assessments were provided for ANXIETY (patient was worried) and RASH (Rash began developing that night, FOUR DAYS AFTER the booster shot.).    Patient says the episode was unrelated to the vaccine because he started having pain under the shoulder, the back and under the chest area, prior to the vaccine. Patient went to the doctor and doctor said it was common to feel pain preceding the shingles rash. As patient was worried it might affect somehow the effectiveness of the vaccine and the immune response.   This case was linked to MOD-2021-372016 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received on 02-Nov-2021 is significant it has information related to Patient's demographics and event details updated. On 04-Nov-2021: non signi follow-up On 05-Nov-2021: Significant Follow up-Secondary Reporter added,Date of event and outcome of event updated, Medical History added.
very swollen lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (very swollen lip) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. V07M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced LIP SWELLING (very swollen lip). At the time of the report, LIP SWELLING (very swollen lip) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.