chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lower back pain; hip pain; burning; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), ARTHRALGIA (hip pain) and BURNING SENSATION (burning) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced BACK PAIN (lower back pain), ARTHRALGIA (hip pain) and BURNING SENSATION (burning). The patient was treated with IBUPROFEN at a dose of 800 mg, 1 tablet. On 06-Jan-2021, BACK PAIN (lower back pain), ARTHRALGIA (hip pain) and BURNING SENSATION (burning) 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 medications were reported.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
fever (to touch, no thermometer) 2MAY95 PM; red, raised rash 3MAY95 Am;
A LOT OF BODY ACHES; CHILLS; TIRED; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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, start therapy date were not reported 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 a lot of body aches, chills, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a lot of body aches, tired and chills was not reported. This report was non-serious. This case, from the same reporter is linked to 20211055339.
2nd Dose given before scheduled appointment. Dose give 13 days after 1st dose.
she had blood clots in her lungs; severe back pain; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 06Oct2021 (Batch/Lot number was not reported) (at the age of 80 years old) as dose 3 (booster), single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 for COVID-19 immunisation, the first dose was on 03Feb2021 at 10:30 and the second dose was on 24Feb2021. On 14Oct2021, the patient experienced she had blood clots in her lungs and severe back pain. She was experiencing severe back pain and went to her doctor. A CT scan was performed, showing that she had blood clots in her lungs. Event resulted in Doctor or other healthcare professional office/clinic visit. The treatment included medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 21-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. On unknown dates, the PNEUMOVAX had temperature excursions for 72 hours with lowest recorded temperature 28F (-2.2 Celsius) and 40 hours with highest recorded temperature 47 F (8.3 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Onset of acute myalgia in shoulders, back, pelvic girdle and thighs 3 days post injection.
Patient received Moderna for his first Covid vaccine dose, scheduled 21 days after for his second dose and was given Pfizer. Patient was observed for a little over 20 minutes even the the required is 15 min and had no reactions. Patient was made aware of the situation before being discharged.
w/in a couple of hrs p/vax pt exp irritability, fever, & high pitched crying;
Stroke with no findings.  Couldn't diagnose cause or location of stroke.   Had 4 CT scans, MRI, TEE, sonogram of heart,  carotid and legs.  No clots were found
Pt participated in health screening, flu vaccination. While being counseled and soon after vaccination, pt became "dizzy". She was pale, cool & clammy. VS 70/40 BP P 76. Pt conscious & obeyed verbal commands. Pt had donated plasma in AM & drank little since pt left. Cool compress to head & neck. Remained conscious & oriented.
This report was received from Pfizer Inc and was assigned a manufacturer report number (2016118776) for PREVNAR 13. It was reported by a physician referring to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On 17-AUG-2015, the patient was vaccinated with PREVNAR 13. On 07-FEB-2016, the patient was vaccinated with PNEUMOVAX 23 (anatomical location, dose number, lot number and expiration date were not reported). The patient's concomitant medications were not reported. This is one of two cases from the same reporter. (1603USA010586). Additional information has been requested.
Around 4/8/21 was feeling as if a muscle was pulled in my back, sciatic nerve Went to my PCP on 4/15/21 Was diagnosed with shingles on 4/16/21
Severe tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Severe tinnitus) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 047A21A) for COVID-19 vaccination.     The patient's past medical history included Tinnitus.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced TINNITUS (Severe tinnitus). At the time of the report, TINNITUS (Severe tinnitus) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided
GASTROFLEX, DIARRHEA, GAS, PAIN IN CHEST (UPPER STOMACH REGION), PRESCRIBER PRESCRIBED ACIPHEX
I went got the shot and I waited 20 minutes because I wanted to make sure I didn't have any problems. The next morning I woke up my face was itching like crazy, and red. I was nauseous. I was "queasy" to my stomach. My left arm it was hot and red. It looked like it spreading. It was 4 fingers down from my shoulder where the shot was put in. I spoke with my Pharmacy on the 13th and the pharmacist told me to use my Flonase and to take Tylenol or Ibuprofen.   She told me if my breathing or anything got worse to go to the ER ( I have SOB due to Alpha-1).  I did speak with my Doctor's office as well and they told me the same thing if I got worse to go to the ER. The 14th I still felt nauseous, queasy, and my arm was still sore but the itching had improved. I took more of my allergy  medication and  by the 15th I was fine.
ON DAY OF VACCINATION THERE WAS A LUMP AT THE THE INJECTION SITE WHICH WAS ACCOMPANIED BY BURNING, ITCHING, AND PAIN.  EIGHT DAYS LATER SWELLING AND PAIN BEGAN.  NINE DAYS LATER A RASH SPREAD TO THE ELBOW AND UNDERARM AREA.  TEN DAYS LATER THE SWELLING BEGAN GOING DOWN.
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 68-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 at 13:15 as dose number unknown, single (Lot number: FE3590) at the age of 67 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient not received other medication in 2weeks. Received treatment for COVID-19 with Anti-viral start date 02Jul2022 and stop date 06Jul2022. The patient had no known allergies.
Pain and swelling at injection site, chills lasting more than 8 hours, headache, muscle soreness, dizziness.
Information has been received from a nurse practitioner concerning a female patient with migraine with aura who on 11-SEP-2009, was vaccinated with the first dose of GARDASIL. The nurse stated that on 14-SEP-2009, the patient reported weakness throughout her body after receiving her first dose of HPV vaccine. On 02-OCT-2009, the patient reported a headache which had lasted a week as well as tightness in her chest under her left breast and pain reaching to her scalp. On 04-OCT-2009, the patient reported tightness in her chest and a burning sensation in her scalp. On 05-OCT-2009, the patient reported occasional chest pain. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow-up information was received from the nurse practitioner who reported that the 26 year old female patient with seasonal allergies and no known drug allergies was vaccinated on 11-SEP-2009 with the dose of GARDASIL (lot#0250X). No other vaccines were given on the same date. Concomitant therapy included ZYRTEC. The nurse reported that the events were not disabling and did not require treatment. At the time of the report, the patient's present status was unknown. Follow up information was received from the nurse practitioner who reported that the patient was vaccinated with a dose of GARDASIL intramuscularly into the left deltoid. On 11-SEP-2009, the day the patient received the GARDASIL she experienced weakness which continued for two days. She felt better on 14-SEP-2009. On 05-OCT-2009 the patient experienced headache for one week. On an unknown date the patient experienced burning in her chest muscles. At the time of this report, the outcome of the patient was unknown. Follow up information has been received from the nurse practitioner who indicated that the patient had migraines at the time of vaccination and her outcome was unknown. No further information is available.
This spontaneous report as received from a Registered nurse via a company representative refers to a male patient in early 20's. On an unknown date in December 2014 (reported as "sometime last week"), the patient was vaccinated with GARDASIL 9 (lot#, strength and frequency unknown), 0.5 ml, intramuscular. The patient fainted shortly after being vaccinated with GARDASIL 9. The patient did not seek medical attention and no treatment was given for the event. The outcome of the event was unknown. This is one of the two reported received form the same reporter. Additional information has been requested.
Frequent urination has resulted from the shot.  The first night I got up six times to urinate.  The second night it was three times.  The third night three times, and every night since then I have to get up two to four times in the night to urinate.  Previous to the shot I occasionally would wake up and have to use the bathroom, but usually could sleep all night without getting up.  It is almost like a diabetic that must urinate right after drinking liquid.
Within a very short amount of time, patient reported feeling dizzy with palpitation. Her hands were shaking, and she felt like her blood pressure was decreasing.  We are a pharmacy inside a hospital, so we called for help.  A dozen healthcare professionals (doctors and nurses) rushed to come get her.
Macular rash from head to toe, Pharyngitis(neg strep), afebrile.
sx started about 2 hrs p/vax highest t105.2, sl swelling, warmth @ inject site, was restless all noc, sensitive to light, hallucinations, abn high pitched cry lasting more than 3 hrs;
4pm severe peri orbital eye pain and severe headache  4:30p Severe ear pain  with light sensitivity 9pm fever, severe chills,with excessive uncontrollable shakes that appeared to look like a convulsion, uncontrollable teeth chattering, hot flashes, diaphoretic , elevated blood pressure and teeth nerve pain, severe body aches and lasting muscle soreness
been very thirsty; headache; left arm is very sore like if had been punched several times; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3248), via an unspecified route of administration in the left arm on 24Mar2021 at 15:15 (at the age of 35-years old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 35-years old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 15:30, after receiving the vaccine, the patient had a headache shortly afterwards that lasted a few hours. Her left arm was very sore like if had been punched several times. The patient had been very thirsty. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events headache, left arm is very sore like if had been punched several times and been very thirsty. The clinical outcomes of the events headache, left arm is very sore like if had been punched several times and been very thirsty were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
2 min after receiving my 2nd dose I. Started feeling dizzy, tightness in my chest my heart was beating to fast and last thing I remember was telling one of the nurses that I felt very dizzy and fainted after that. I was given epinephrine X2 twice and Oxygen.
Brain encephalopathy; This spontaneous report was received from a consumer (daughter) concerning an 89 year-old female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed  brain encephalopathy (encephalopathy).  The patient's medical history included aortic aneurysm (untreated), esophageal hernia (repaired), rectal cancer and uterine cancer. Concomitant medications included lisinopril, furosemide, sertraline, levothyroxine and FDgard.  On 21-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number: 032L20A). On 17-Feb-2021, the patient received their second dose of mRNA-1273 (Batch/Lot # 006M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 08-Feb-2021, 13 days after first vaccination, the family started to notice small balance changes, slight fine motor coordination changes (handwriting, etc.) and a little forgetfulness. They chalked it up to her being an 89 year-old. On 17-Feb-2021, the patient was administered her second dose of the vaccine. On an unknown date, the patient was unable to stand without assistance, leans backwards when trying to stand, has developed a spastic tremor bilaterally in her arms and her cognition is completely altered. She is experiencing hallucinations, memory loss, can follow some directions and her speech is clear, but inappropriate. Her hand writing was concise and clear prior to vaccine, but later became illegible; missing entries with no spatial awareness. On an unknown date, she was hospitalized. On 06-Mar-2021 and 07-Mar-2021 a CT (computed tomography) of brain, CT of neck, multiple urinalysis and multiple blood labs were performed. On 07-Mar-2021, the patient could not identify immediate family members in a photo. On 8-Mar-2021, short EEG (electroencephalogram), brain CTs with and without contrast, neurological consultation, speech consultation, psychological evaluation, lumbar puncture and MRI (magnetic resonance imaging) were performed. Results are pending. She has been diagnosed with brain encephalopathy, probably caused by molecular mimicry in response to the vaccine. She is being treated, but treatment information was not provided. The patient's daughter reports that prior to the vaccination, her mother was fully independent, living alone, mobile and with excellent cognitive function.    Action taken with the drug in response to the event is not applicable.  The outcome for the event, brain encephalopathy, was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient reports ongoing arm tenderness after both  injections 7/17/19 & 9/18/19 to the point where  he was unable to push himself up with arms.  Patient states duration lasted up to 7 months.
Devel fever 103 AX 18SEP91, cried constantly unconsolable; Seen by MD 19SEP, 20SEP, & 21SEP91; dx w/ear infect; 21SEP felt inc temp & crying was from DTP (mom reports MD said this);
Left arm swollen and red with erythema and warmth around injection site. Afebrile. Given Rx for Keflex and Benadryl after being seen by clinic on 09/09/05. Pt was to return on 09/12/05 but did not keep appt, unable to contact parent by phone until 9/16/05, parents not home but 14 yr old sibling reports child had no more swelling or pain.
Left leg warm, red, swollen knee to groin, right about 3cm diameter at site as of 4/17/08 245 pm (returned)
arm swollen and hard; arm pain; molars hurt; feeling like a full cement truck ran over me; sleeping all day; chills; fever (101.2); This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swollen and hard), PAIN IN EXTREMITY (arm pain), TOOTHACHE (molars hurt), FEELING ABNORMAL (feeling like a full cement truck ran over me) and SOMNOLENCE (sleeping all day) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swollen and hard), PAIN IN EXTREMITY (arm pain), TOOTHACHE (molars hurt), FEELING ABNORMAL (feeling like a full cement truck ran over me), SOMNOLENCE (sleeping all day), CHILLS (chills) and PYREXIA (fever (101.2)). At the time of the report, PERIPHERAL SWELLING (arm swollen and hard), PAIN IN EXTREMITY (arm pain), TOOTHACHE (molars hurt), FEELING ABNORMAL (feeling like a full cement truck ran over me), SOMNOLENCE (sleeping all day), CHILLS (chills) and PYREXIA (fever (101.2)) outcome was unknown.            There was no concomitant list.  Treatment included water and 7-up.
Red (covid) arm; Feels weak; Low-grade fever (100 F); Headache; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red (covid) arm), ASTHENIA (Feels weak), PYREXIA (Low-grade fever (100 F)), HEADACHE (Headache) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 002A21A) 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 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced ERYTHEMA (Red (covid) arm), ASTHENIA (Feels weak), PYREXIA (Low-grade fever (100 F)), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, ERYTHEMA (Red (covid) arm), ASTHENIA (Feels weak), PYREXIA (Low-grade fever (100 F)), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown. Not Provided          No concomitant medications were provided.  Treatment for the event included paracetamol (Tylenol)  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.
Day 2- fever and malaise leading to Jaundice on day 5. Patient is still undergoing treatment/support.
This spontaneous report was received from Registered Nurse regarding to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to previous temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received form the same reporter. Additional information had been requested.