chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt really hot; Tired; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 18Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient felt really hot and tired on an unspecified date after getting his second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Hives around mouth and ears on October 30. Responded well with Benadryl until November 7 when I broke out in hives over face , neck, scalp, ears, arms, sides, and upper legs.   Also experienced mild chest pain on that same day.
Sudden diphoresis, flush feeling in face, elevated BP, throat tightening and swelling.  Taken to ED for evaluation
pt grandma stated pt had warmth, swelling & c/o itching & pain of upper rt arm from shoulder half way down to elbow;pt had approx 20 red, raised bumps in this area;pt has a few red, raised bumps & warmth & swelling dec;
Pt received ZOSTAVAX vaccination on 8/8/11 and noticed rash approximately 1 week later, pt will speak with MD about possible treatment.
Started Wellbutrin 1/29/22 2/2/22 gyn appointment, received tetanus booster  2/3/2022 felt arm soreness and left sore, body aches, subjective fever 2/4/2022 had TXA 2/5/2022 had nasal allergies 2/6/2022 rash developed on left arm 2/7/2022 Monday whole arm was sore 2/8/2022 Tuesday upper chest and into right arm with hives 2/9/2022 with hives spreading to upper thighs States hives very itchy.  No shortness of breath, no lip swelling, no throat closure
Local rxn deltoid muscle w/soreness; cannot do any writing until 01NOV91;
side effects; Sore throat; Ringing in the ears; Diarrhea; rash for 7 days; Tiredness; Headache; Muscle pain; Chills; Fever over a hundred; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects), OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea) and RASH (rash for 7 days) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (symptoms were headache, ringing in the ears and diarrhea one time).    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects), OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), RASH (rash for 7 days), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever over a hundred) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (side effects), OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), RASH (rash for 7 days), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever over a hundred) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Fast heart rate/fast heart rate which comes and goes.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.   This case was linked to MOD-2021-348398 (Patient Link).
This spontaneous report as received from a physician refers to a 20 month old patient. On 21-AUG-2017, the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 21-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
Area (Right vast. lateral) red, swollen, hot to touch, hard. Area measured 9 cm x 12 cm.
One to 2 days post vaccination, the patient developed a rash on his stomach. No further information is available.
Information has been received from a 23 year old female patient with no pertinent medical history and sulfonamide allergy who on 06-NOV-2008 was vaccinated with the first dose of GARDASIL (lot number not reported). On 03-FEB-2009 the patient was vaccinated with the second dose of GARDASIL (lot number not reported). Concomitant therapy included NEXIUM. On 06-NOV-2008 the patient was submitted to hospital because she was dehydrated after a fight. A urinalysis was performed and stool sample was collected for dehydration (results not provided). At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Vaccine given at 5:50om. Itching started about 6:25pm and continued to get worse over the course of the evening. No rash ever appeared but was flush in the face. Morning hours came with flu like symptoms and more itching. Have had fever and chills off and on all day. Have been taking Benadryl to help with itching.
Fever, in the afternoon. Treatment with Tylenol. Fever continued for two more days. On 8/1/2011 at 8:15pm she had a febrile seizure when fever reached above 104 degrees, and was rushed to ER by rescue. Treated around the clock with Tylenol and Motrin but spiked another high fever that night. On 8/4/11 rash developed all over body. Fever was still present. On 8/8/11 rash finally cleared completely and fevers were gone completely.
No additional AE; RECOMBIVAX HB was administered after the expiry date; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 04-JAN-2023, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) pre-filled syringe, lot #U019135, expiration date: 22-NOV-2022 (strength, dose, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis (expired product administered). No adverse event was reported.
3 red bumps around my mouth; it is an acne break out; feeling extremely fatigued and slept most of the day; feeling extremely fatigued and slept most of the day; This is a spontaneous report from a contactable consumer (patient). A 36-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0181), via an unspecified route of administration, on 25Jun2021 at 05:45 PM (at the age of 36-year-old), as dose 1, single for COVID-19 immunization. Patient's medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing. Patient's had allergies to red and purple tattoo ink. Concomitant medications included lynestrenol taken for an unspecified indication, start and stop date were not reported. On 27Jun2021 (day 3) the patient experienced feeling extremely fatigued and slept most of the day, on 02Jul2021 (day 8) 3 red bumps around my mouth, On day 13 the red bumps spread all over my face, it is an acne. On 16Jun2021 the patient underwent lab tests and procedures which included sars-cov-2 test and the result was negative. Patient was received Antihistimine and topical ointment treatment. Outcome of all events were not recovered.   Follow-up attempts are completed. No further information is expected.
Pain on the left abdomin, sore ribs deep pain, 4 days later blisters break out on skin in this area. Looks like a full case of Shingles.
tired; body aches; chills; cold; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. This consumer reported similar events for two patients. This is the first of two reports.  A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. He mentioned that a family member developed Guillain Barre's syndrome after the Flu vaccine, about 30 years ago. The patient reported that he had "no problem" after receiving the first dose of the COVID-19 vaccine, but felt a "little tired and achy, with chills " after the second dose on an unspecified date. He also feels like he has a cold with body aches on an unspecified date. He then asked if it is okay to take Tylenol or Advil after the vaccination, while also referencing the information he read on the matter. The outcome of events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082243 same reporter and drug, similar event, different patient
Information has been received from a pharmacist concerning a 27 year old female with no known allergies who on 18 May 2006 was vaccinated with a dose of MMRII, there was no concomitant medication. At the time of the report the patient was "approximately three months pregnant", it was reported that the patient became pregnant at the end of April or early May 2006 with her last menstrual period being on 01 may 2006. Unspecified medical attention was sought. It was reported that the patient was not experiencing any problems. there was no product quality complaint involved. Additional information received from the patient indicated she was not aware of her pregnancy at the time of vaccination. "A couple weeks" after vaccination she developed a rash all over her body.  She was treated with steroids, which did not work and was then placed on stronger steroids. Subsequently the rash "cleared up". On an unspecified date the patient date the patient sought medical attention about things "being off in her body". A urine HCG pregnancy test was performed, and positive. She was unaware of her pregnancy until that time. Additional information is not available.
I had fever, muscle aches, chills, nausea, vomiting for 01-21-2021. on 01-22-2021, experienced body aches and a headaches and my left arm became quite swollen. On 01-23-2021, I spoke to a doctor through a telemedicine about my left arm swollenness. My symptoms had gone down b Saturday. My left arm was also hot to the touch, quite red and irritated. My symptoms went away within a week.
Really sore arm in upper left arm (injection site). Experienced pain to the point that she could not lie on left side or have full movement of left arm.
Redness and induration at injection site not related to Cellulitis 1-2 days after injection. Resolved. The patient is a 69 year old female who presents with a complaint of "Arm pain". Note for "Arm pain": Pt. is here due to redness and swelling in her left bicep. Red, warm, swelling, painful. Has gotten better, first noticed Wednesday and received Flu shot in the same arm on the 27th. Wondering if it could be from the flu shot or a blood clot. Tender left arm - with redness the next 2 days. Last night - went to strength training - suggested. Better today - wasn't able to sleep on the arm the last two night but was last night. Redness better too.
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a 16-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 04-Dec-2011. On 06-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
11/16/2021, 4/1/2021, 3/11/2021 Pfizer vaccination. Asymptomatic COVID positive hospital admission 12/14/21.
NO ADVERSE REACTION NOTED  RECEIVED ADACEL ON 4-11-06 FROM ANOTHER FACILITY WITHOUT OUR KNOWLEDGE AND THEN RECEIVED AGAIN ON 8-5-06.
Patient c/o pain at injection site then passed out approximately 5 minutes later. After rest/monitoring approximately 1 hour released in good condition. No adverse Rx at IM site. Vitals WNL. Patient fatigued, N/V, pale.
Per mother 1 week s/p vaccine received left leg with pinpoint swelling that increased in size and became erythematous. To ED told would resolve. Now 1 weeks later 2/10/10 left outer upper thigh with approx 1 cm area splotchy erythema and induration, no dk, no tender, no increased warmth today as above.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 10/20/2021. PATIENT FULLY VACCINATED ON 02/24/2021.
This spontaneous report was received from a registered nurse and refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 11-OCT-2016. On 12-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M023931 with expiration date of 09-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 63 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
Patient received a Moderna Bivalent booster dose instead of a Moderna (Red Cap) dose for her 1st immunization. This was her very first covid vaccine.   She is not having any major symptoms. She only has a sore arm.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 29-MAY-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot number K021487 (dose and route were not reported) and a dose of improperly stored MMR II lot number reported as 014833 (dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. Lot number 014833 is not valid lot number for MMR II. This is the one of the several reports from the same reporter source. Additional information has been requested.
Pneumococcal vaccine (along with flu vaccine) administered 10/11/05. On second day (10/12), fever began(reaching 102.6 F on 10/13-14). Beginning late 10/11, experienced redness, heat and pain in arm where administered. Arm pain and sensitivity disrupted/prevented sleep. Fever did not subside with self administered dosage of two ibuprofin pills (2 * 200mg) @ 4 hrs. Visited MD on fourth day (10/14). Dr. diagnosed bacterial infection in left (Pneumovax) arm. On doctor's prescription, took Cefzil antibiotic (500 mg twice a day) and, upon increasing ibuprofin dosage to 4 * 200 mg @ 8 hrs, fever began to subside. Total duration before relief: fever began second day, ended on fifth or sixth day (10/15-16). Arm swelling, pain and sensitivity persisted to seventh or eighth day (10/17-18).
She says her work made her get a COVID test on Sunday March 21st that was positive; Headache; stuffy nose; wet sore throat; she realized her symptoms were more like allergies; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age was administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown,), via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient got her first dose of the Pfizer COVID-19 vaccine on March 11th, then on Saturday March 20th she started having some symptoms that were not necessarily COVID, like a headache, stuffy nose, and a wet sore throat. Her work made her get a COVID test on Sunday March 21st that was positive. She was tested again on Thursday March 25th and she tested negative, and she realized her symptoms were more like allergies. She knows when she got a PCR test that there was a small trace of genetic material and the vaccine was a spike protein which was defined as genetic material. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
About 1 to 2 hours after injection I experienced severe joint pain in my left knee ( and some milder pain in rt knee).   and hands to the point I could not weight bear.  Had done nothing that day to cause this pain and swelling.  I do have  rheumatoid arthritis in left knee and fingers but  it is mild.  I self treated with ice and Aleve which helped.  Symptoms got better but we?re still painful 5 days later.   The injection site became red with rash and itchy after 2 days.  Had experienced this with other  Covid vaccines but not this severe joint inflammation and pain.
vaccine reaction; A spontaneous report was received from a healthcare professional concerning a patient of an unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced vaccine reaction. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event is considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Patient received a dose of IPOL that was no longer viable due to a temperature excursion with on reported AE; Initial information received on 18-Jan-2023 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 16-year-old female patient who experienced patient received a dose of ipol that was no longer viable due to a temperature excursion with on reported adverse event (AE) while receiving vaccine IPV (VERO) [IMOVAX POLIO].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included Hepatitis B Vaccine, Hepatitis A Vaccine, meningococcal vaccine measles vaccine, mumps vaccine, rubella vaccine (MMR), varicella zoster vaccine (Varicella Vaccine) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) all for prophylactic vaccination (Immunisation).  On 03-Jan-2023, the patient received suspect IPV (VERO) at a dose of 0.5 ml once (lot U1A451M, expiry date: 20-Feb-2023) via unknown route in the right deltoid for Immunization.  On 03-Jan-2023 the patient received a dose of ipol that was no longer viable due to a temperature excursion with on reported ae (poor quality product administered)  same day following the administration of IPV (VERO).  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 guidelines. 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.
Flu like symptoms; Injection site bleeding.; Warmth at the site of the injection on left arm; Body aches/Muscle pains; Chills; Joint pains; Fatigue; Pain at the site of the injection on left arm; Redness at the site of the injection on left arm; Swelling at the site of the injection on left arm; Itching at the site of the injection on left arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE HAEMORRHAGE (Injection site bleeding.), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), MYALGIA (Body aches/Muscle pains) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE HAEMORRHAGE (Injection site bleeding.), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), MYALGIA (Body aches/Muscle pains), CHILLS (Chills), ARTHRALGIA (Joint pains), FATIGUE (Fatigue), VACCINATION SITE PAIN (Pain at the site of the injection on left arm), VACCINATION SITE ERYTHEMA (Redness at the site of the injection on left arm), VACCINATION SITE SWELLING (Swelling at the site of the injection on left arm) and VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE HAEMORRHAGE (Injection site bleeding.), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), MYALGIA (Body aches/Muscle pains), CHILLS (Chills), ARTHRALGIA (Joint pains), FATIGUE (Fatigue), VACCINATION SITE PAIN (Pain at the site of the injection on left arm), VACCINATION SITE ERYTHEMA (Redness at the site of the injection on left arm), VACCINATION SITE SWELLING (Swelling at the site of the injection on left arm) and VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant and treatment medications were provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2021: No specific follow-up information recorded.