chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) 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 ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case was for seventh patient of 9 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660845, US-MODERNATX, INC.-MOD-2022-666768, US-MODERNATX, INC.-MOD-2022-666748, US-MODERNATX, INC.-MOD-2022-666773, US-MODERNATX, INC.-MOD-2022-666772, US-MODERNATX, INC.-MOD-2022-666774 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660845:Patient 1 US-MODERNATX, INC.-MOD-2022-666748:Patient 3 US-MODERNATX, INC.-MOD-2022-666768:Patient 2 US-MODERNATX, INC.-MOD-2022-666773:Patient 6 US-MODERNATX, INC.-MOD-2022-666772:Patient 5 US-MODERNATX, INC.-MOD-2022-666774:Patient 8
Patient received a mixed series. Initially got Moderna, came in and was given Pfizer for a second dose. Client counseled and doing well after injection wait time.
About 8-10 min after adm, pt returned to pharmacy - stated hard to swallow, no other symptoms. Squad called, pt has not followed up with us.
Erythema and induration (R) upper extremity. Dtap given IM (R) deltoid and MMR given SQ (R) arm. Treatment: cold compresses, BENADRYL.
fever (100.7); headache; Pain in arm; swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), SWELLING (swollen), PYREXIA (fever (100.7)) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SIMVASTATIN, AMITRIPTYLINE, IRON, METOPROLOL, UBIDECARENONE (COQ), flexseed oil, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), CENTRUM SILVER +50, HCTZ and COLESEVELAM for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and SWELLING (swollen). On 20-Feb-2021, the patient experienced PYREXIA (fever (100.7)) and HEADACHE (headache). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm), SWELLING (swollen), PYREXIA (fever (100.7)) and HEADACHE (headache) outcome was unknown.            Treatment details included Baby Aspirin.  Action taken with mRNA-1273 is not applicable.
Approximately 6 to 8 minutes after receiving  the first dose of Pfizer COVID vaccine, patient became unresponsive for about 2-3 minutes.  While on the phone with 911, patient regained consciousness. I was informed to not provide medical treatment (no medication was administered). While waiting for paramedics, patient reported nausea and lightheadedness. Patient also appeared to be pale and was excessively sweating.   Emergency service arrived and evaluated the patient. Patient declined to go to the hospital.
lightheaded while working out; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246, expiry date: unknown), intramuscular on 10Jan2021 15:00 at single dose (Arm Left; either deltoid or bicep, he is assuming it was his deltoid it was high enough) for COVID-19 immunization (65 and over). Medical history included ongoing Allergic to penicillin (discovered when he was a child), Food allergy (discovered when he was a child, allergy is mainly shellfish), allergy-induced asthma (diagnosed as a child). The patient's concomitant medications were not reported. The patient did not have additional vaccines administered on same date of the Pfizer suspect and no prior vaccinations (within 4 weeks). Vaccination Facility Type: patient stated it was like a drive-in clinic in a field. The patient got vaccinated yesterday. He felt lightheaded while working out today on 11Jan2021 (about 9-9:30 a.m, unspecified). It was also reported that the lightheadedness only lasted 30-40 minutes. He verified he has recovered completely from it. The lightheadedness happened specifically when he started using weights. He clarified further it was when he was using the cable machine, working with weights/resistance. He wasn't when he was doing cardio or stretching or working on his core. It was when he was using his cable machine which would include weights and he had to stop. It was stated tht he is looking at the risks and side effects on the fact sheet and it didn't say anything about lightheadedness, so he thought maybe he should report it. It's not on the list, but he doesn't know if its from the vaccine. He also noticed while looking at the fact sheet, where it says signs of a severe reaction, one of the signs is dizziness and weakness. He doesn't know if what he experienced was the same thing. He thought it was lightheadedness but he may have felt dizziness. He doesn't know. To him, it was more lightheadedness, but it could have been dizziness. He had to stop working out. He asked what happens now, if they will look into this. He is scheduled to have his second shot on 31Jan2021. He knows a few people who experienced pain and extreme tiredness after getting the second vaccine. He declined to complete a report in regards to these people, stating he just heard 2 other individuals both said after getting the second shot, they were experiencing a lot of pain, didn't feel good. Felt may be 75% for one day, that's all he knows. He asked if he should get the second shot or wait to hear from anyone. He doesn't know if the lightheadedness is a result of getting the shot or something else. Patient states the only thing the card says is the product name and manufacturer. He sees Pfizer and then EL3246. He is not sure if the second digit is the letter "L" or the number 6. This is what is handwritten. He doesn't see anything else on the literature of the card. No further information was provided or obtained. The outcome of the event was recovered on 11Jan2021.  Information about lot/batch number has been requested.
Immediate metallic taste, flushing, sweating, itchiness.  Patient progressed to itching in throat and mouth, mild SOB, tachycardia, nausea, and rash over chest, abdomen, upper arms, and back over the next 30-60 minutes.  Treatment: Benadryl 50 mg PO, Zofran 4 mg PO, Loratidine 10 mg PO, ranitidine 150 mg PO.  Repeat doses of Benadryl, Zofran, and Loratidine given later that day.  Patient stated improved symptoms within a few hours. The facial redness and rash on chest persisted until the next morning.
On the 9th day after receiving the 2nd vaccine, my legs became very weak. By the 10th day, I could barely walk. It is now two weeks after the 2nd vaccine, and I can walk only about 700 steps at a time at a pace less than 2 mph. I previously could walk over 3 miles at 4 mph.  I've also had a low grade fever (99.4-99.6) off and on since the day after the vaccine.
Assoc. states developed chills, body aches and a fever of 99.8 approximately 4 hours after vaccine. Extreme pain then started in her left injectuion site, radiating down her arm to her fingers. On 12/28/2020 she reports extreme fatigue, chills and swetiness. 12/29/2020 she reports she had light headedness, fatigue and feeling like she might pass out. 12/31/2020 she awoke feeling " normal". No MD/ED visit. Took Ibuprofen on 12/28/2020 at 2100 and again on 12/29/2020 at 12:00.
I was diagnosed the first week of November, 2021 with double pneumonia, Dec 10, 2021 I was diagnosed with congestive heart failure, only 15% heart rate function. They told me a virus attacked my heart. I think the vaccine messed me up. I have been out of work ever since. I have been going to the doctor since November, have been hospitalized twice.
Extreme malaise, body soreness, and fatigue started around 24 hour after 11/22/21 vaccination. In the following 12-24  hours, patient developed alarming gross hematuria, resulting in a 11/24/21 ER assessment and treatment that seemingly resolved gross hematuria. Follow up appointments with family medicine and nephrology showed no apparent, physical issues with kidneys, but microscopic levels of hematuria and proteinuria had not yet resolved in the 4 weeks following vaccination.
06/16/2003: Had TD booster Left deltoid (0.5mL).  For few days after that she reports erythema and "bubble" at injection site (localized).  This resolved shortly after.  Since injection she has apparently had left deltoid pain described as deep aching and for past 2-3 weeks reports weakness.  Obj: Strength is appropriate.  Nontender left deltoid.  No infx or other problems noted to left upper extremity.  7 cm distal to right acromion the cirium was 3.5 cm left .
Information has been received from a registered nurse concerning a 14 year old male with no allergies and with Crohn's disease and who is immunocompromised as a result of taking 6 MP who on 15-MAR-1996 was vaccinated subcutaneous with a first dose of VARIVAX (Merck) and on 28-APR-2008 at 8:45AM was vaccinated subcutaneous in left triceps with the second dose of VARIVAX (Merck) (LOT# 660323/1973U) when the patient came in for routine physical examination. Concomitant therapy included 6 MP. On 29-APR-2008 the patient's father called the physician and stated that the patient became nauseated with abdominal pain and had swelling and tenderness at the injection site. The responsible physician called and spoke with another physician in infectious disease department who stated that the second dose of vaccine administration was fine. On 30-APR-2008 the patient felt better and less abdominal pain. His feeding was much improved. On 21-MAY-2008 the patient recovered from the symptoms. There was no product quality complaint. Additional information is not expected.
Moderate hematemesis - seen in ER 11/10/2013. Leukocytosis WBC 21.3 with 22 Segs, 64 L, ANC 4700, Hgb 14.2/Hct 39, Plts 215,000.
My son developed a wart on his knee that we haven't been able to get rid of.  It's been frozen off 4 times and the last time there were multiple in the same spot.
0.5 ml dose given (dose should have been 0.3 ml). No adverse reaction noted.
Information has been received from a physician concerning female with a history of herpes genitalis and varios sexually transmitted diseases who on 23-Jan-2007 was vaccinated with her first dose of Gardasil (lot# 653978/0955F) and on 27-Mar-2007 received her second dose of HPV (lot# 657006/0188U). Concomitant therapy included valacyclovir HCl (VALTREX) and famciclovir (FAMVIR). Subsequently the patient indicated that since receiving the vaccination she can not clear her outbreaks of genital herpes. The medication that usually clears a herpes outbreak is not working effectively. Unspecified medical attention was sought. The patient's outcome was not reported. No product quality complaint was involved. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a physician concerning a female, with a history of herpes genitalis and various sexually transmitted diseases, who on 21-Jan-2007 was vaccinated in the left deltoid with her first dose, 0.5ml, of GARDASIL (lot# 653978/0955F), and on 27-MAR-2007 received her second dose of GARDASIL (lot# 657006/0188U). Concomitant therapy included VALTREX and FAMVIR. Subsequently the patient indicated that since she received the first dose of GARDASIL, she could not clear her outbreaks of genital herpes. The medication that usually clears a herpes outbreak is not working effectively. Unspecified medical attention was sought. No product quality complaint was involved. At the time of this report, it was unknown if the patient had recovered from the herpes outbreak. No further information is expected.
chest pains starting a few days after vaccine received, along with shortness of breath. never had chest pain or shortness of breath before. this lasted two months before subsiding in severity, but these symptoms have returned periodically over the past year since I took vaccine. i have arythmia which also started after the vaccine, again never had this before.
The patient developed redness, warmth, and pain at the injection site on the same day it was administered. She was seen by her PCP two days later and given BENADRYL and Cephalexin. Was instructed to start Cephalexin if redness spreads. As of 4-27, the redness has migrated further down the arm, and Cephalexin was started.
Large raised, red swollen area on top of forehead that is hot to the touch, painful and causes headache, has not improved
Idle heart rate is between 100 ~ 120 bpm while rested for extended periods
Tinnitus on right started 29Dec2020 and has not subsided since.; This is a spontaneous report from a contactable Nurse (Patient). A non-pregnant adult (Age: 55; Unit: Unknown) female patient of an unspecified age received BNT162B2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection, Batch/Lot Number: El1284), via an unspecified route of administration, administered in left arm on 28Dec2020 at 13:00 as dose 1, single for COVID-19 immunisation in Hospital. Medical history included skin cancer and arthritis. Patient had no known allergies. Concomitant medication(s) included psyllium (PSYLLIUM [PLANTAGO AFRA]). Patient did not receive other vaccine in four weeks. Patient did not have Covid prior vaccination. On 29Dec2020 at 07:00 PM, patient experienced Tinnitus on right and has not subsided since. The event resulted in doctor or other healthcare professional office/clinic visit. The event was considered serious (disability or permanent damage). The patient underwent a lab test which included audiology exam: unknown results on an unspecified date. Patient not tested for Covid post vaccination. The treatment received included an audiology exam and still waiting for ENT. The outcome of the event was not recovered.; Sender's Comments: Based on the information in the case report, a possible causal relationship between Tinnitus and suspect product BNT162B2 cannot be excluded.  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.
After receiving MMR vaccine on September 17th,patient presented with a reddened, itchy rash on his arms and stomach on September 19th. Methylprednisolone was administered. On September 23rd, patient reported blistering rash on arms, legs, and abdomen. PCP referred to ED, where patient was diagnosed with poison ivy. Patient was given IV benadryl and prednisone and by 09/26/19, the rash was documented to have been improving. It is unclear if the initial presentation of rash was due to poison ivy as well.
Moderately sore upper arm (right arm). Used ibuprofen to minimize pain. Pain was moderate for the first few days, but low grade pain/soreness still persists nearly 3 weeks after shot, particularly when moving arm in certain positions.
Hives over my whole body, wheezing and chest contraction and tightness, very fast heart rate, dizziness, nausea and extreme weakness. Loss of appetite and mental confusion.
Case number PHEH2012US021091 is an initial spontaneous report received from a medical assistant on 24 Oct 2012. This case refers to three patients (age and gender not reported). These patients were vaccinated with MENVEO (batch number: not reported) intramuscularly on unspecified dates. Two patients were vaccinated two weeks before and other patient vaccinated about one month before the time of this report. All the three patients fainted following vaccination. No other information was available.
No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U010401, was verified to be a valid lot number with an expiration date reported and established as 01-APR-2023) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 20-AUG-2021, the patient was vaccinated with this improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000273:
53 year old female received injectable 10/27/2010. On the day of vaccination pt. experienced pain, redness, swelling, warmth, and itching at injection site. Swelling and redness reached a diameter of 6 inches. 48 hours after vaccination pt. visited family physician and was started on a 5 day course of Prednisone. Symptoms improved and resolved 8 days post vaccination.
More than 42 days after the first dose; Sore arm from the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 42 days after the first dose) and PAIN IN EXTREMITY (Sore arm from the first dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm from the first dose). On 15-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days after the first dose). On 15-May-2021, PRODUCT DOSE OMISSION ISSUE (More than 42 days after the first dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm from the first dose) had resolved.        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.   No concomitant medication details was reported. No treatment medication was provided.
stomach feels a little upset; arm was sore with a patchy area on it; arm was sore with a patchy area on it; Diarrhea; cramps; vomiting; nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of diarrhea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, for tolerance of 1st dose refer case, US2023AMR074135).   On 15-MAY-2023, the patient received the 2nd dose of Shingrix. In MAY-2023, less than a week after receiving Shingrix, the patient experienced diarrhea (Verbatim: Diarrhea), cramp (Verbatim: cramps), vomiting (Verbatim: vomiting) and nausea (Verbatim: nausea). On 17-MAY-2023, the patient experienced pain in arm (Verbatim: arm was sore with a patchy area on it) and patchy rash (Verbatim: arm was sore with a patchy area on it). On 22-MAY-2023, the patient experienced upset stomach (Verbatim: stomach feels a little upset). Rechallenge with Shingrix was positive. The outcome of the diarrhea, cramp, vomiting, nausea and upset stomach were unknown and the outcome of the pain in arm and patchy rash were not reported.   It was unknown if the reporter considered the diarrhea, cramp, vomiting, nausea, upset stomach, pain in arm and patchy rash to be related to Shingrix.  It was unknown if the company considered the diarrhea, cramp, vomiting, nausea, upset stomach, pain in arm and patchy rash to be related to Shingrix.   Linked case(s) involving the same patient:US2023AMR074135   Additional Information: GSK Receipt Date: 22-MAY-2023 The case was reported by the patient. The patient stated that on Wednesday her arm was sore with a patchy area on it. Then on Friday night into Saturday morning, she reported having diarrhea, cramps, nausea and vomiting. At the time of reporting, she reported her stomach felt a little upset.  The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR074135:Original Case : US2023072482
Patient reports itching in both arms and neck is not observed rash. Patient evaluated by Doctor and who ordered 10ml of BENADRYL by mouth and observed for 30 min. 110/80, 99%, 66p, 18 R. The mother of the patient was directed to report the event for the administration of the second dose.
Initial report received from a physician on 18 August 2010. A 65-year-old female patient had received an intramuscular left deltoid booster injection of DECAVAC (lot number U3073BA) on 17 August 2010. By 19:30 that night she had tightness in the right and left jaw that persists at 75 percent tightness. The patient was treated with BENADRYL with some improvement. It was reported the patient had no concurrent illnesses and no known allergies at the time of the vaccination. She had not received any other vaccinations within 4 weeks prior to 17 August 2010. The patient currently takes ARMOUR THYROID (indication not reported). At the time of this report, the patient had not recovered. Follow-up information was received from a health care professional on 12 November 2010. The patient has a past medical history of "hypothyroid". No further information was available at the time of the report. The patient's outcome was reported as recovered on 24 August 2010. Documents held by sender: None.
6/22/06: Patient received MMR, Varicella, PCV7 and HIB. 6/22/06: At 5 PM, noted bruising, redness, and warmth at left thigh. Patient fretful, hot reaction, bruising, redness and warmth at lateral left thigh radiating up to buttock and down to knee.