chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 9:35am returned to Clinic c/o itching and burning. "Felt like area was on fire: Left upper deltoid area hot, dark red approximately 3 inch perimeter around injection site. Diphenhydramine oral suspension 25 mg administered. Ice pack to left deltoid. No difficulty breathing, soreness itching or tightness in throat. Talking without difficulty. BP 140/90 P. 76. Remained at clinic 10:51 pm direct observation. Notified PCP for further orders: Given 2nd dose Diphenhydramine 25 mg. Released to supervision.
Ringing in left ear, metallic taste - just after shot - 1-2 days after hand and foot inflammation and stiffness.
Cellulitis developed at injection site within 24h. Responded well to Keflex 500mg every 10 hours for 10 days.
Pressure like chest pain with rad to left shoulder onset 08 Nov while cleaning. No relief from ALKA SELTZER. Presented to ED on 12 Nov with inc pain worse with laying flat. Pos enzymes and BNP, pos EKG. Neg heart cath, + pericardial tamponade. DX myocarditis with pericardial effusion. Neg card hx. Was not ill prior to imz. Symptoms: CHEST PAIN, UNSPECIFIED, DYSPNEA, UNSPECIFIED.
high school reported pt is sick & vomiting a lot;they wanted to know if this was a rxn to one of the shots that pt got this morning;
The patient reported redness going down her left arm, about a foot in length.  It was itchy as well. It has gone down from the initial time, but it is still visible.  Patient says it is not bothersome
Really sick; Nauseous; stuck in bed all day; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really sick), NAUSEA (Nauseous) and BEDRIDDEN (stuck in bed all day) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SALICYLIC ACID (CREAM 91) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Really sick), NAUSEA (Nauseous) and BEDRIDDEN (stuck in bed all day). At the time of the report, ILLNESS (Really sick) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-149468 (Patient Link).
Flu shot left arm = no reaction. PNEUMOVAX right arm = 2/8/13 reported right side sore, then changed to right arm and feeling "bad".
Kind of did not feel right after the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Kind of did not feel right after the first vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Brain injury. Concurrent medical conditions included Allergy (Allergic to an injection during surgery about 50 years ago.) and Hypertension. Concomitant products included OXYCODONE for Pain, DICLOFENAC SODIUM, LOSARTAN POTASSIUM, AMLODIPINE, ATORVASTATIN and GABAPENTIN for an unknown indication, NAPROXEN.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION COMPLICATION (Kind of did not feel right after the first vaccine). On 13-Mar-2021, VACCINATION COMPLICATION (Kind of did not feel right after the first vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medication include Prenatal vitamin + iron Treatment information was not provided.   This case was linked to MOD-2021-281253 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Added, patient DOB and concomitant medication
Dizziness, vomiting, involuntary rapid movement side to side in both eyes.
Whole body moderate muscular weakness and fatigue beginning 18 hours after injection, increasing in severity to 36 hours after injection. Moderate to severe migraine beginning 24 hours increasing to 36 hours after injection.  Full recovery 42 hours after administration.
Whelps, redness, swelling at injection site. HA, body aches, flu-like symptoms.
My wife received her annual influenza immunization yesterday at pharmacy at approximately 11: 30 am 08/31/2020. She was immunized with AFLURIA PFS 2020-21 INJ 0.5ML manufactured by SEQIRUS administered intramuscularly in the deltoid area of her left arm. She noticed no adverse effects initially. At approximately 4:30 pm she developed a very uncomfortable fullness in her throat making it hard for her to swallow and drink. She described it as "like having a whole kiwi fruit stuck in her throat". I gave her two 25 mg. Benadryl (diphenhydramine) capsules orally. In about an hour the uncomfortable fullness began to decrease. By 10 pm the uncomfortable fullness was almost gone. The next morning she was back to normal. My wife experienced the same thing one year ago when she received her influenza immunization. The fullness last year was more severe following her receiving the "extra strength" vaccine. The vaccine she received this year was "regular strength". She is now afraid to receive any future influenza immunizations. I am also hesitant for her to receive any flu vaccine in the future.
After 32 days from receiving the COVID booster shot i had a stroke. booster given 12/15/2021 stroke 1/17/2022. Moderna lot #045J21A, 2nd booster shot given 3/2/23 Moderna lot #066H22A another stroke 4/7/2023.
Cellulitis left arm round 2cm x 2cm, hot, swollen, tender area at site of vaccine - IM Rocephin + PO Bactrim.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 45 years 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), SUSPECTED COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "COVID 19". The Seriousness was reported as Non-Serious. Therapeutic measures were taken as a result of suspected covid-19 which included Paxlovid from 18Apr2022 to 23Apr2022 via oral route.   Clinical Course: The events reported were Loss of sense of smell and taste starting Sunday 01May2022. Potential worsening of COVID symptoms after completion of Paxlovid (cough, fatigue).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
p/vax pt recv Pravachol for tx of hypercholesterolemia;10 day later pt devel toxic epidermal necrolysis;pt hosp;
Information has been received from a pharmacist concerning a 70 year old female with no known drug allergies, who on 18-JAN-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 669189/1389Z, expiration date 19-JAN-2012) subcutaneously. The pharmacist reported that on 20-JAN-2011 the patient developed a red, slightly raised, swollen, and warm area 2 inches in diameter at injection site after administration of ZOSTAVAX (Merck). The pharmacist stated that there might have been a localized rash as well. No labs/diagnostics studies were performed. At the time of reporting, the patient's red, slightly raised, swollen, and warm area 2 inches in diameter at injection site and a localized rash persisted. The patient was not given treatment. On an unspecified date, the patient sought medical attention by contacting the pharmacist. Follow-up information has been received from the pharmacist concerning the 70 year old (also reported as "71 year old") female patient with no illness at time of vaccination and no known allergies, who on 18-JAN-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 669189/1389Z, expiration date 19-JAN-2012) subcutaneously into her lower left arm. The pharmacist reported that on 20-JAN-2011 the patient developed a red, slightly raised, swollen, and warm area 2 inches in diameter at injection site, and localized rash at the injection site area. The patient had the visual inspection at injection area (results unknown). On 25-JAN-2011, the patient recovered from the events. No further information is available.
This spontaneous medically confirmed (initial receipt 01-Sep-2015) concerns a 29-year-old female patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) 0.5 mL once via intramuscular route of administration. No adverse reaction occurred after the administration. The outcome was reported as recovered. Reporter's outcome: The reporter assessed the event as non-serious and reported the term 'Medication error'. Additional information was received from the reporter on 01-Dec-2015: The reporter assessed the event as unrelated to AFLURIA.
Pt received shot on Thursday 2/9/18 and complained to doctor on Monday Feb 12, 2018 that his face was swollen/itching (per pt caregiver). Pt received MEDROL Dosepak on Feb. 15, 2018-no further report given.
MULTISYSTEM INFLAMMATORY SYNDROME; INFLAMMATORY SYNDROME; VASCULAR INFLAMMATION; PLATELET ACTIVATION; This spontaneous report received from a consumer and concerned multiple patients (4 patients) The patient's weight, height, and medical history were not reported. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry date: 24-AUG-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date a consumer called in with specific questions about lot number 1805031. The consumer stated that in the local area there were 4 patients who received this specific lot number and experienced symptoms of: inflammatory syndrome, vascular inflammation, multisystem inflammatory syndrome, platelet activation. This was not limited to women under 50 (2 women over 60, 1 man over 60 and 1 unknown).  The consumer was trying to rule out lack of training, injection injuries, or lot number number specifics. The consumer also mentioned that others were told to call in and report and mentioned there may be hundreds with same issue, not sure about lot number for the others (Found groups with issues, well over 2000 in one group, across Covid vaccines, at least several hundred that got Janssen). The groups were having issues post vaccine, severe harm had been done.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inflammatory syndrome, vascular inflammation, multisystem inflammatory syndrome and platelet activation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a consumer  concerned  multiple patients (4 patients:)-2  women, 1 man  over 60 years of age, and 1 patient of  unknown age and sex, who experienced symptoms of  inflammatory syndrome, vascular inflammation, multisystem inflammatory syndrome, platelet activation unspecified time after vaccination . No past medical history or concomitant medications were reported.  On an unspecified date a consumer called in with specific questions about lot number 1805031. The consumer stated that in the local area there were 4 patients who received this specific lot number and experienced symptoms of: inflammatory syndrome, vascular inflammation, multisystem inflammatory syndrome, platelet activation . The outcome of the events is not reported. At the time of the report no other information is available. Information is limited in this case. Multisystem inflammatory syndrome could represent background incidence of such events in the general population. Therefore, the relationship of multisystem inflammatory syndrome, to vaccination is considered unclassifiable due to insufficient information.
DIFFERENT SYMPTOMS EACH DAY FOR A WEEK; ARM WAS SORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced different symptoms each day for a week, and arm was sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm was sore and different symptoms each day for a week was not reported. This report was non-serious.
After the injection was given during the mid-day, at nighttime the symptoms began. The symptoms included chills, sweats, bodily fatigue, headache, nausea, electric-shock-like sensations throughout the entire body (being the most notable due to it being an odd symptom), tingling sensitive skin, and dizziness. These symptoms went on for a week and a half. The electric-shock-like sensations that occur in the entire body in forms of pulses would happen occasionally, some strands being hours apart and some being months apart. No known triggers as of right now cause these shocks. These shocks happen quickly (like a pulse) and  occur through the entire body, causing fatigue and bodily distress sometimes paired with sweating or dizziness as well as sensitive tingling skin. The shocks do not occur in a specific area of the body, but is body-wide. I was hospitalized on October 23rd, 2022 for these shock symptoms that only increased in intensity until it became so debilitating that it became a medical emergency. The symptoms apparent that hospital trip were sweats, chills, sensitive tingly skin, the shocks, fatigue, headache, nausea, and dizziness. There are no known triggers thus far. Throughout the past two and a half years, these electric shocks come in occasional strands, some strands being worse than others. No medical professionals have been able to deduce where these electric shocks come from or why they happen. No known treatment or preventatives keep these shocks at bay.
The weekend following my injection I started feeling weird palpitations in my chest, some soft fluttering, some hard beats. After doing a bit of research I chalked it up to potentially being gas but as it persisted and got worse at times I decided to go to the ER. The ER confirmed heart PVCs via EKG and conducted Xrays of my chest and did blood labs. I was told everything was fine and was discharged and told to follow up with my primary care physician. After following up with my primary provider she informed me to continue monitoring.
c/o pain & swelling in rt arm, neck & underarm;also pain in lower back & shoulders;states had temp but did not take;also bad h/a-unable t sleep on noc of vax;
The first symptoms I had a scratchy throat and in the evening. Later on that night or the next day I started coughing. My husband and I decided to test, and we were both positive for COVID-19. The heavy congestion set in on the fourth day I called the doctor I requested a prescription because I was having green discharge from my nose. I was given a 7-day medication which I can't recall. This medication didn't help but I did complete the medicine. I hardly ate through all this, and it lasted for about a week and a half.  My senses were so crazy one minute I could smell fine and the next minute I could smell nothing. I also isolated during this time period.
This spontaneous case was received from a 63 year old male consumer referring to himself. Medical history, concurrent conditions and concomitant medications were not provided.  He was allergic to penicillin. On an unspecified date, the patient received ZOSTAVAX at a pharmacy (dose, route and lot # not provided) because he did not want to get shingles. On 14-JUN-2017, he was diagnosed with shingles at an urgent care facility. The patient stated the shingles was not an immediate reaction. He received unspecified treatment. The outcome of the shingles was unknown. The patient requested reimbursement for the cost of the ZOSTAVAX and also threatened to get a lawyer and contact his local newspapers. Additional information is not expected as the patient did not provide consent to followup.
Information has been received from a registered nurse concerning a 9 month old infant who was vaccinated with the third dose of ROTATEQ (lot number, route and site not reported). No adverse effect was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Patient was given a 3rd booster (Janssen to start, followed by 2 moderna boosters, then received this fourth dose of moderna)
He said her first pregnancy was terminated around the same time frame and for similar medical reasons; This is a spontaneous report received from a contactable reporter (Pharmacist). A female patient (pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient was 21 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Bnt162b2 for COVID-19 immunization, notes: Dose 1. The following information was reported: ABORTION INDUCED (medically significant), outcome "unknown", described as "He said her first pregnancy was terminated around the same time frame and for similar medical reasons". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: diagnosed with Covid. Additional information: The Caller/Pharmacist has a patient who is pregnant of 21 weeks, and she has been diagnosed with Covid.  He confirmed that the patient received vaccines before being diagnosed with Covid and had severe side effects from Covid. He said her first pregnancy was terminated around the same time frame and for similar medical reasons.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, termination of pregnancy is considered an intercurrent medical condition associated with mentioned 'similar medical reasons' and unrelated to BNT162b2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Syncopal episode as pt was leaving practice. No tonic-clonic activity. Came to in under 1 minute.
ill for almost 3 days; Felt like I had the flu; enlarged lympnodes on side of body where the shot; This case was reported by a consumer via interactive digital media and described the occurrence of illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of rash (1st dose received on an unknown date and experienced rash, refer linked case US2022AMR083947).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced illness, influenza-like symptoms and enlargement of lymph nodes. On an unknown date, the outcome of the illness, influenza-like symptoms and enlargement of lymph nodes were recovered/resolved.   It was unknown if the reporter considered the illness, influenza-like symptoms and enlargement of lymph nodes to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR083947   Additional Information: GSK Receipt Date: 21-May-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The Shingles vaccine had a pretty high rate of side effects.  The patient was ill for almost 3 days  The patient felt like he/ she had the flu, enlarged lymph nodes on the side of body where he/ she had the shot.  Even with all that patient would do it all over again. Shingles was so much worse. Additional Supportive Information: Follow up would not be possible since no contact details were reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR083947:Same reporter
Patient received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) 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.     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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date).    It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No concomitant medication reported.  Total 190 patient received a vaccine past the beyond used by date with 9 different lots numbers.  No treatment medication reported.  This case pertains to the 37th patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE