chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOWER BACK/KIDNEY PAIN; CHILLS (SEVERE, UNCONTROLLABLE SHAKING, COLD HANDS AND FEET); SORE ARM; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included panic attacks. The patient was previously treated with alprazolam for panic attacks.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced lower back/kidney pain. On 09-APR-2021, the subject experienced chills (severe, uncontrollable shaking, cold hands and feet). On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 109 F, and Body temperature decreased (NR: not provided) 102.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills (severe, uncontrollable shaking, cold hands and feet), nausea, lower back/kidney pain, sore arm, and fever. This report was non-serious.
Information has been received from a health department official concerning a child who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (site unknown). On 10/06/2001, it was reported that the child had lesions. The pt sought unspecified medical attention. FOLLOW UP information received from the health departmental official indicated that the child's was treated (unspecified) and no hospitalization was required. No further is available.
Hearbeats per minute soared to 112 (usually 60).  Still experiencing spikes of 80 to 110. Feels like panic attacks.  Dizziness, sometimes severe. Fell and had to go to the Emergency Room.  Left eye had very heavy bruising, and the blood took a long time to re-absorb. Broke an ocular bone.in the fall  Heat Sensitivity  Memory Loss
Day 1 s/p vaccine extreme fatigue & malaise/ mild headache and nausea/ aris/ needles fingers # 1,2,and 3. Day 2 symptoms decreased but still present. day 3 tired otherwise OK. Day 4 fine
Within hours after tetanus booster vaccine, all-over muscle pain/body aches, chills, sweating that lasted 3 days, weakness, blurred vision and numbness across face on day 4,  weakness and lightheadedness on day 5, then s/s resolved.
Per healthcare professional; pt recv 1 dose MMR vax & pt exp testicular swelling. No further info or details
5cm round area of erythema & induration;tx APAP for pain & DPH;
Received dose #2 of Pfizer vaccine on 1/14/2021.  On 3/18/2021 developed nasal congestion and cough.  Tested positive for COVID.
Knot on (L) thigh, dark color. Dx'd fat necrosis, 1 month after immunizations. Pt was referred to Pediatric Surgery.
This spontaneous report was received from a nurse practitioner referring to a 15 year old female patient who on 24-FEB-2011, was vaccinated with 1st dose of GARDASIL in the left deltoid (lot# 1498Y, expiration date, 06-OCT-2011). On 03-JUN-2013, was vaccinated with 2nd dose of GARDASIL in the right deltoid (lot# 1561Z, expiration date, 23-MAR-2013). No concomitant medication, pertinent medical history and drug reactions/allergies were reported. No laboratory test was performed. On 24-FEB-2011, after the first dose of GARDASIL the patient developed methicillin-resistant staphylococcal aureus (MRSA). Then on 03-JUN-2011, after second dose of GARDASIL the patient developed mononucleosis. The patient saw her unspecified primary care physician on an unspecified date. The patient was now concerned about receiving the third dose of GARDASIL. As of today, 06-MAY-2013, the patient had not received the third dose of GARDASIL and she did not have MRSA or mononucleosis. The relationship between MRSA and mononucleosis and GARDASIL vaccines was unknown. Additional information has been requested.
Watery diarrhea for 3 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Watery diarrhea for 3 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Watery diarrhea for 3 days). At the time of the report, DIARRHOEA (Watery diarrhea for 3 days) had resolved.            No concomitant medications reported.  Treatment information not reported.   Reporter did not allow further contact
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ASD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medications in 2 weeks.Patient received Covid-19 treatment from 15Feb2023 to 20Feb2023.Patient did not had known allergies.
I had every COVID-19 symptom there is. I had trouble breathing, flu like symptoms, and a horrible headache. I thought my heart was going to jump out of my chest. My smart watch was telling me to stop exercising and I was sitting in my recliner. I called the clinic to see what they suggested, and they told me to go to the emergency room. They gave me some fluids and sent me back home. They told me to see my primary care if it continued. I went to my primary care, and he prescribed prednisone to help me breath. I have had an irregular heartbeat for 2 weeks. It is getting a little better now, but if I stand up to put something in the cabinets, my heart will start racing.
given intramuscularly instead of subcutaneously with no reported adverse event; Initial information received on 15-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 27 years old male patient who had given YELLOW FEVER VACCINE [YF-VAX] intramuscularly instead of subcutaneously with no reported adverse event.  The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.  On 14-Nov-2022, the patient received an unknown dose of suspect YELLOW FEVER VACCINE once (strength, formulation lot number and expiry date was unknown) via intramuscular route in the left arm for Immunization.  On 14-Nov-2022 the patient developed a non-serious event of given intramuscularly instead of subcutaneously with no reported adverse event (product use issue)(Latency: same day) following the administration of YELLOW FEVER VACCINE.Reporter wants to know the implications in this situation.  Action taken : not applicable.  Outcome: Unknown  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 the 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.
The night of each injection, he complained of redness and itching to his face. No SOB; body rash, etc. Injection site was clear. The employee did not report reaction after 1st dose. When asked if any problems, he had denied any.
Sore throat; Swelling; This is a spontaneous report from a contactable consumer patient via the Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 27Feb2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Mar2021, the patient experienced sore throat and swelling. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
The adverse event was a slight tightening of the throat that lasted about 5-10 minutes then dissipated.  No further effects evident.
Pt was administered HPV versus MMRV.  Event was discovered right after administration and provider spoke with parent during visit.
kidney infection, acute renal failure, CHF, and diskitis following booster; requiring 5 day hospital admission, followed by 2 weeks in rehab facility, and 6 weeks of IV antibiotics. Also vaccine failure with Covid infection following booster.
pt experienced large area of erythema from injection site down to just above his elbow, lasting  about 3 days denies pain.
inadvertent administration of PENUMOVAX 23 to a 3 month old; inadvertent administration of PENUMOVAX 23 to a 3 month old; This spontaneous report was received from a medical assistant and refers to a 3-month-old patient of an unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 07-JAN-2021, the patient was inadvertently vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), lot # S022294 expiring on 26-MAR-2022, for prophylaxis (exact dose, route and site of administration were not reported, instead of pneumococcal 13v conj vaccine (CRM197)(PREVNAR 13). The reporter stated that the first dose of pneumococcal 13v conj vaccine (CRM197)(PREVNAR 13) was not administered. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T022294; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Initial report received from a health care professional on 04 May 2012 via MIS/VIS call. MIS/VIS reference number: 12-0271. A 38- year-old female patient whose medical history and concomitant medications not reported, received an intramuscular dose of ADACEL (batch number U4325AA) in her left deltoid on 02 May 2012. The patient was presented with induration, mild erythema and swelling at injection site which measured 4 inches. Patient also reported mild fever (100.8 degree C) this morning. The patient was being treated symptomatically for site reactions while low grade fever was reported to have subsided on the morning of report. At the time of report all events were reported as recovered. Documents held by sender: None.
Dental Infection; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Dental Infection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced TOOTH INFECTION (Dental Infection). At the time of the report, TOOTH INFECTION (Dental Infection) had not 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.   Treatment medication for the event included Antibiotics.
shrill crying for 5 hrs day p/DTP booster; tmax 104 both legs shaking, no limpness or sz;
chills, stomach ache, fatigue, muscle aches, sl dizziness-started 1 1/2 to days p/inj;lasted about 2 days;
Patient states her left arm is swollen down to hand (double the size of the right) and had cold sores breakout on lip
10pm temp of 99.3, nausea, headache, body aches, dizziness 5am temp 100.3, headache, dizziness
After several hours, extreme arm pain began. I was unable to move my arm without terrible pain for several days.   By the time I went to get my second dose (5/5/21), the arm pain STILL occurred. I got the second shot in the same arm.   My arm STILL hurts today (7/1/21) and I'm not sure what to do it about it. The pain is not as severe as the first month, but it is still painful and doesn't respond to traditional pain medications
Multiple Hospitalizations.  Over 40 cardiac events detected on my defibulator starting 72 hours after second shot and continuing to get worse.
patient received part of flu shot out of state/it ran down arm/not sure how much was administered/no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00319556) and transmitted to Sanofi on 16-Oct-2020.  This case involved a 4-years-old male patient who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiry date were unknown) via unknown route in unknown administration site for prophylactic vaccination on an unspecified date.  On 15-Oct-2020, the patient received part of flu shot out of state, which ran down arm and patient was not sure how much was administered. It was unknown how much of the vaccine was administered and how much was lost. Limited information available. The nurse stated that the first dose was given by a pharmacist, the mother called them yesterday about the partial dose and did not have any specifics.  It was also a case of vaccine underdose.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Painful injection sore shoulder pain got worse daily loss of range of motion aggravated fibromyalgia severe pain at night pain shoulder saw doctor several times shoulder inflammation physical therapy still painful hard to reach above my head
Pharmacist reported that a 2-4 mo old infant developed a fever of 104 post vax. Pt taken to ER where a diagnosis of otitis media was made. This is 1 of 5 pts from this facility who developed an adverse experience following receipt of Prevnar.
Patient had three seizures over week following the vaccine, after not having a seizure for 8 months.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
pt recv vax & 2hr post vax pt exp hives;pt self-medicated w/DPH & sx resolved;
TINGLING IN  LEFT CHEST; BLURRY; DIZZINESS; BRAIN FOG; PRESSURE AT TEMPLES; HEADACHES; FATIGUE; STRUGGLE AT WORK; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included concussion, and concurrent conditions included hypertension, and menopause.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. Concomitant medications included naproxen for hypertension. On 19-MAR-2021, the subject experienced struggle at work. On 19-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced headaches. On 20-MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced pressure at temples. On APR-2021, the subject experienced brain fog. On 08-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 15-APR-2021, the subject experienced tingling in left chest. On 15-APR-2021, the subject experienced blurry. On 15-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in left chest, blurry, and dizziness on APR-2021, had not recovered from headaches, and the outcome of chills, fatigue, pressure at temples, brain fog and struggle at work was not reported. This report was non-serious.
Rash on lower arms (left and right), and left side of body. Symptoms started 1 day after vaccination was given. No rash or redness at local injection site. No other systemic side effects.
I had my vaccination on 05/08/2023. On 05/10/2023 I started to have a hard time breathing walking up a hill. On 05/12/2023 I was walking every city block I had to stop and try to catch my breath. By this day my breathing had become very horrible with shortness of breath. I contacted my physician and was told to increase my asthma inhaler. I am still recovering on 05/16/2023.
The Pharmacist reported she received two dose of GARDASIL 9 that were not shaken or agitated, prior to administration.; It was a pre filled syringe and it was flicked; Circumstance or information capable of leading to medication error; No adverse effects; This spontaneous report was received from a pharmacist regarding herself of an unknown age. The patient's concurrent conditions, drug allergies, medical history and concomitant medications were not reported. Pharmacist reported that she received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) approximately 2 months ago in mid march 2019 and received second dose on 19-MAY-2019(0.5 ml/doses, route via intramuscular for prophylaxis. On an unknown date, she reported that she received 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) that were not shaken or agitated prior to administration(wrong technique in product usage process).  Pharmacist reported, after receiving the second dose, she confronted the unspecified pharmacist, who administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the unspecified pharmacist informed her that it was a pre filled syringe and it was 't flicked(product preparation issue, and circumstance or information capable of leading to medication error).No adverse effects were reported(no adverse event). No further information was provided. No PQC found.
Swelling left side of throat, weakness, low grade fever (99 deg), redness, swelling below site in injection, numbness left side of face.
About three hours after having the shingrix vaccination, I developed terrible diarrhea, nausea and chills. Diarrhea and chills have stopped.
temperature excursion; No other AE; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck) (VARIVAX) lot # U015845, expiration date 19-MAY-2023, 1 time dose (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 17 degree Fahrenheit (°F) for 30 minutes. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.
The next day after the vaccine, around 10pm, I got a covid arm. It was red and swollen. I developed a  2 inch scar line filled with blood and it was swollen. I also had flu like symptoms- mild fever, chills, body aches, diarrhea, severe fatigue and headaches. These symptoms lasted about a  1 and 1/2 weeks. Most of the symptoms resolved but I am still suffering from chills up to twice a day and can last upto 30 minutes. I called my doctor since I was concerned about the blood filled scar. I did a televisit and sent photos to my doctor and he did not know what it is. The blood filled scar continued and finally resolved after 2 months. I am now left with a 1 inch permanent scar that looks like a scratch. My doctor recommended that I go ahead and get the 2nd dose but to get the 2nd dose in the other arm.