chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness has increased in size and area has become itchy; Redness around the injection site; Pain at the injection site; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain at the injection site / vaccination site pain, redness around the injection site / vaccination site erythema, redness has increased in size and area has become itchy / vaccination site pruritus.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, prior to the onset of the events, the patient received her dose of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient experienced pain at the injection site for the first 3 days, after receiving the vaccine. On 04 Jan 2021, Monday, the patient experienced redness around the injection site. On the same day, the patient stated the redness had increased in size and the area had become itchy.  Treatment details included topical cortisone cream and diphenhydramine.  Action taken with mRNA-1273 in response to the events was not reported.   The event, pain at the injection site, was resolved on 31 Dec 2020. The events, redness around the injection site and redness has increased in size and area has become itchy was not resolved; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
On wednesday I had body aches and chills ( I have fibromyalgia and arthritis so I thought it was due to these ailments) I went to therapy that morning . then i got worse chills and i had a fever of 102 that afternoon. tylenol helped but it came back. fatigue, headache, muscle pain, joint pain, nausea, sore throat, ears hurt, my sinuses hurt, my mouth and teeth and tongue hurt. I have a dry cough.
Client came for second dose of Moderna but reported the following symptoms with first dose:  Rapid heartbeat, change in vision, redness to face, spasms in back, feet, and jaw, difficulty speaking, dizziness with weakness, Icy left arm.
Patient received booster dose of Moderna around 1:15pm.  At 3:00pm she reported generalized itching in different locations not near the injection site, but no rash and no throat swelling or tightness.  I advised her to take some Benadryl and go to the ER if it worsens.  At around 6:00pm patient reported her blood pressure was very high and she seemed to be panicking. She also said that her lips might feel a little swollen.  I advised her to go to the ER for treatment.
Patient was fully vaccinated + booster with Pfizer (7/1/21, 7/21/21, and 10/21/21). Patient has had a cough, SOB, and myalgias since 12/12/21. Patient was admitted with COVID 12/22/21 and is currently hospitalized.
severe h/a 105PM 11NOV97 frontal h/a w/photophobia given Toradol;
After a few hours I know it is more common symptoms such as pain at the injection site, headache, fever, all over body soreness.   I also noticed short-term memory loss and mood changes from feeling of Happy and sad and angry from around 5:00 p.m. to 8:00 p.m.  and the feeling of complete uselessness and regretting getting the vaccine to the point I wanted to cry saying oh I made a mistake. Almost as if my body was trying to tell me this was a mistake.  Throughout the evening the all over muscle soreness and headache and fever seem to be getting worse I even woke up in the middle of night between 2:00 and 3:00 a.m. and took Tylenol PM to help go back to bed.   Started feeling better later in the afternoon on April 2nd. Almost if everything went away and back to normal.   I have noticed that I have been having more head pain (I normally have none) than normal since receiving the vaccine.
47 day old started crying turned limp 1 1/2hr post vax w/DTP/HIB  & HEP/OPV;
This spontaneous report as received from a medical assistant refers to an unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patient were vaccinated with a doses of improperly stored VARIVAX (Merck) (dose and route were not provided) lot # L023594, expiration date 26-JUN-2017. No adverse effects has been reported. Additional information has been requested.
child was given pediatric dose of Pfizer instead of the 12 and older dose 0.3 for second dose. No adverse reactions noted. Medical Director consulted per protocol,  No treatment needed. Would not need to repeat dosing based on the information from CDC guidelines  and medical decision information
Fever, Vomit, Malaise, Headache. 12/28/2007 MR received for DOS 12/78/2007 with Final Dx:  Fever of Unknown origin.  2' Dx: Abdominal pain.  Lymphadenopathy.  Pt admitted for w/u of FOU  x 1 month.  Pt developed injection site pain and muscle aches following flu shot.  Pt has developed diffuse body aches, abdominal pain, night sweats, malaise, nausea, vomiting and fatigue.  Pt has been seen multiple times and txd with multiple abx with persistant sx. 5 lb weight loss.  Pt also had 1 week of intermittant L-sided numbness of head, face, neck, chest, arm and fingers. PMH:  none. PE (+) for cervical lymph node swelling. Per consultant- "pt may have  mononucleosis picture".
Progressive and gradual pain at the neck; Sore arm; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Progressive and gradual pain at the neck), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced NECK PAIN (Progressive and gradual pain at the neck), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). At the time of the report, NECK PAIN (Progressive and gradual pain at the neck), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown.            This case was linked to MOD-2021-091001, MOD-2021-091001 (Patient Link).   Reporter did not allow further contact
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 17-MAY-2007, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 22-MAY-2009, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX lot # L029472 (06-AUG-2017) subcutaneously. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
red arm/little red; hot to touch; arm began to itch and break out; having some pain in the area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red arm/little red), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE PAIN (having some pain in the area) and INJECTION SITE PRURITUS (arm began to itch and break out) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (having some pain in the area). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red arm/little red), VACCINATION SITE WARMTH (hot to touch) and INJECTION SITE PRURITUS (arm began to itch and break out).   At the time of the report, VACCINATION SITE ERYTHEMA (red arm/little red), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE PAIN (having some pain in the area) and INJECTION SITE PRURITUS (arm began to itch and break out) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-021710 (Patient Link).
after patient's name, DOB, allergies, vital signs obtained, medications taken, whether she is a diabetic, and any known adverse reactions to immunizations had been completed the vaccine was administered in right upper arm.  Within a few minutes patient stated she felt whoozy.   nurse noticed patient becoming pale and fainted.  Blood sugar obtained at this time, It was 110.  Vitals obtained again.  Squad called to facility.  Patient refused to leave with squad personnel and left with a family member.
Pt presented to clinic for RZV #2 on 12/27/2022.  At this visit, pt reported developing "temperature issues" and fever (Tmax 103 degrees F) after receiving RZV #1 and PCV20 on 10/26/2022; states temperature went "from very high to low."  Pt reported that she was "gagging on water" after receiving these IZs on 10/26/2022.  Pt stated that she presented to the ED for evaluation after developing these sx.  Pt denies s/sx of anaphylaxis; states healthcare provider at ED thought it was a "strange reaction" to the vaccines.  Pt reported that she also followed-up with PCMP; states PCMP indicated safe for pt to receive RZV #2.  Given that no hx of anaphylaxis after RZV #1 (contraindication to vaccination per guidelines), RN administered RZV #2 on 12/27/2022.
Bilateral lower extremity weakness, difficulty walking, complaining of "heaviness" in legs. Decreased feeling in left lower extremity. Sent to ER for further evaluation.
got 1 shot in right arm. Next day 9/18/04, mom noticed was hard and swollen. The following day 9/19/04 it was red, hot and hard. The whole arm from elbow to shoulder and blisters. Went to med center 9/19/04: got antibiotics and a creme Benadryl. On 9/20/04, mom back to pediatrician. She told mom to stop antibiotics, but she continued 9/24/04. Still skin peeling, slightly hard.
Received a merk diluent  that was reconstituted with the Shingrix; Received a merk diluent  that was reconstituted with the Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 4M39A, expiry date 28th August 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-May-2022 Reporter's comments: Merck's diluent that was used to reconstitute MMR and varicella vaccines was reconstituted with the Shingrix and administered to the patient. No reactions were reported. The consent to follow up was given. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The Shingrix was reconstituted with Merck's diluent and administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022082842:Same Reporter
Patient complained of having feelings of weakness and chills shortly after receiving the vaccine. He did not report this reaction until after receiving the second dose on 1/14/19. He stated that he had the same reaction when he had received the first dose on 10/20/18. He stated that the weakness and chills started "a little while" after receiving the vaccine and lasted for about one day and then resolved.
At tie of injection extreme pain in arm where shot was given.  About 7 hrs after vaccination (10:00 pm), I got body aches, chills, fever, slight headache, and sore arm at injection site.  I took 1 Tylenol and went to bed.  The next day, I felt slightly achy and tired/ low energy all day.   By the 3rd day, felt ok, other than a sore arm.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 30-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # 0168AE, expiry date: 06-MAR-2013). Dose strength and route were not provided. No concomitant medications were reported. The nurse stated that the dose of ZOSTAVAX was expired. No adverse effects were reported. No further information was available. Additional information has been requested.
severe pain rt deltoid & arm; pain persists as of date of report but has diminished; pain aggravated by adduction rt arm across chest; vomited x 1 26OCT94;
Report 200101354-1 described pulled muscle in a pt who rec'd hepatitis B vaccine recombinant (Engerix-B) for prophylaxis of hepatitis B. This report was rec'd from the pt's mother and has not been verified by a physician or other HCP. Reportedly, the pt had no known allergies or medical history. Reportedly she rec'd no  concomitant medications. reportedly, the pt had never previously experienced a pulled or painful muscle. On 5/29/01, the pt rec'd her first R deltoid dose of Engerix-B. On 5/31/01, while running in the gym, the pt reportedly experienced a pulled muscle or pain (unknown if R or L leg). Reportedly, the pt's symptoms resolved in 24 hrs.
Quarter sized itchy swelling at injection site, one week after receiving shot. Not painful, just itchy.
Vaccine given in afternoon of 11/26/2001 left arm SQ. On 11/27/2001 the site became red and swollen. On 11/28/2001 pt reported the site continued to hurt and her feet were very sore and had blistered. She had 6 blisters on her right foot and 4 on her left in all. Was seen in ER on 11/28/2001.
A strong headache/like a migraine; Dizziness; Malaise; Flu-like symptoms; Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MALAISE (Malaise), INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills) and VACCINATION SITE PAIN (Sore arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced DIZZINESS (Dizziness), MALAISE (Malaise), INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills) and VACCINATION SITE PAIN (Sore arm). On 11-May-2021, the patient experienced HEADACHE (A strong headache/like a migraine). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 08-May-2021, DIZZINESS (Dizziness), MALAISE (Malaise), INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills) and VACCINATION SITE PAIN (Sore arm) had resolved. At the time of the report, HEADACHE (A strong headache/like a migraine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-123757 (Patient Link).
Breakthrough COVID-19 infection. Patient tested positive on SEPT 17 2021. Patient was fully vaccinated on MARCH 24 2021.
Bad cramps in the leg; Felt like legs are going to give out beneath her; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Bad cramps in the leg), ASTHENIA (Felt like legs are going to give out beneath her) and FATIGUE (Fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Bad cramps in the leg), ASTHENIA (Felt like legs are going to give out beneath her) and FATIGUE (Fatigue). At the time of the report, MUSCLE SPASMS (Bad cramps in the leg), ASTHENIA (Felt like legs are going to give out beneath her) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication was provided.
Ct. was due for her last Hep B. Given a Twinrix by mistake.
For both doses of the Pfizer COVID Vaccine (1st - April 7th, 2nd - April 28th), I developed a Urinary Tract Infection within 2 days of the vaccination. I was treated for the UTI caused by the first dose, and the infection had gone away prior to receiving the second dose of the vaccine, in which I then developed another Urinary Tract Infection following the second dose.
Feeling like she had a cold; Arm is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vape" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Feeling like she had a cold"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is sore".  Additional information: Reporter stated, she just had a concern, her teenager she got the COVID Vaccine and she was having normal side effects at this point, feeling like she had a cold and her arm was sore, that one thing that she was concerned about reading about teenagers having heart problem with the vaccine. It came to her mind one thing that she was to know if you at Pfizer (Incomprehensible voice) paying attention to she was not a therapist or, the main issue in this age group they have been using vape. They are vaping and it was like another epidemic problem. So she wanted to call you guys to check if you are considering vaping because a lot of time like her daughter has been using vape and that's been a concern for her because of her lung condition lots of problem in the vaping, they have heart condition too. So she just wanted to call you to talk about this if she was in the (Incomprehensible voice) of researchers because many people asked if they are taking any medication or if they have any health problem, that many parents do not know that their kids are using. And there was a lot of different chemicals in the vape not only we could see they have lots of other chemicals that could possibly be a reaction with all those other things that are there. So she was not sure exactly who to talk to but she thought it would be better to just contact Laboratory directly in mention about this.   Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Labored breathing, numbness, then tingling at left side of face, blurred vision left eye, stabbing pain left ear.
Patient developed elevated heart rate to 120 beats/minute, elevated blood pressure to 180/110, elevated fasting glucose readings to 250 (normally <150), psoriasis flare and profound fatigue. All of the above symptoms developed within 48 hours of administration of the 1st vaccine and have persisted, with some improvement, for up to 9 days.
felt pretty bad; just woke up with a facial rash; Rash on arm; achy; the arm got red , a slight redness; nauseas; very fatigue; cold,hot; felt lousy for 2 days; got a whole flush, cold, hot, nausea and it happened ten minutes later; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt lousy for 2 days), FLUSHING (got a whole flush, cold, hot, nausea and it happened ten minutes later), VACCINATION COMPLICATION (felt pretty bad), FEELING OF BODY TEMPERATURE CHANGE (cold,hot) and RASH (just woke up with a facial rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Mo medical history reported). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced LETHARGY (felt lousy for 2 days), FLUSHING (got a whole flush, cold, hot, nausea and it happened ten minutes later), FEELING OF BODY TEMPERATURE CHANGE (cold,hot), MYALGIA (achy), VACCINATION SITE ERYTHEMA (the arm got red , a slight redness), NAUSEA (nauseas) and FATIGUE (very fatigue). On an unknown date, the patient experienced VACCINATION COMPLICATION (felt pretty bad), RASH (just woke up with a facial rash) and VACCINATION SITE RASH (Rash on arm). At the time of the report, LETHARGY (felt lousy for 2 days), FLUSHING (got a whole flush, cold, hot, nausea and it happened ten minutes later), VACCINATION COMPLICATION (felt pretty bad), FEELING OF BODY TEMPERATURE CHANGE (cold,hot), MYALGIA (achy), NAUSEA (nauseas) and FATIGUE (very fatigue) was resolving and RASH (just woke up with a facial rash), VACCINATION SITE ERYTHEMA (the arm got red , a slight redness) and VACCINATION SITE RASH (Rash on arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included diphenhydramine, ibuprofen, paracetamol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.