chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Achy all over her body; Extremely sore arm; Chills; Dull headache; Muscle ache; Has 98.7°F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy all over her body), PAIN IN EXTREMITY (Extremely sore arm), CHILLS (Chills), HEADACHE (Dull headache) and MYALGIA (Muscle ache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20 and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (Achy all over her body), PAIN IN EXTREMITY (Extremely sore arm), HEADACHE (Dull headache), MYALGIA (Muscle ache) and PYREXIA (Has 98.7°F). 03-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, PAIN (Achy all over her body), PAIN IN EXTREMITY (Extremely sore arm), CHILLS (Chills), HEADACHE (Dull headache), MYALGIA (Muscle ache) and PYREXIA (Has 98.7°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Pyrexia: 98.7°f (High) 98.7°F.         No treatment information was provided. No relevant concomitant medications reported
First symptom: soreness at injection site followed by general muscular soreness and aching throughout the body. Next day: extreme muscular soreness and aching all over the body, including abdominal muscles, shoulder and back muscles. No headache or other symptoms, just the soreness and aching. Felt cold and some chills until bedtime. Slept pretty well for 5-6 hours, but woke to same intensity of soreness and aching. Took two ibuprofen and felt some relief in about one hour. No loss of diet or nausea. After and late evening nap, retired to bed and slept well for 5 hours (somewhat typical for me), but awoke with recurrence of soreness and aching all over. Took two ibuprofen at breakfast and felt good relief after and hour. By 2PM the soreness and aching returned and concentrated in my shoulders. Really hurt for awhile.
Chills, muscle and lymph site aches, neck pain and headache, nausea
Pt had episode of syncope lasting 3-4 seconds after administration of vaccines. No seizure or respiratory distress observed. Pt rested on the exam table and was given coke to drink. He reported to be doing well after 15 minutes.
Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  The vial did not undergo any temperature excursions Total of 168 doses were given from LOT 048C21A It was reported that the date vial initially stored in refrigerator was unknown  Treatment medication was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non Significant  follow up was received
Injection site pain. Muscle pain. Joint pain. Chills. Headache.  Eyes pain
Patient's father reported patient had swelling of left arm localized around injection day after immunization. Swelling progressed to the middle of forearm the next day. Therefore father took patient to ER. Received TYLENOL for fever and supportive care (cold compresses). PE: Left arm: warmth, erythema, swelling of left upper arm extending from shoulder to midline of forearm. No neurovascular compromise. Able to move left arm in all directions without any restrictions.
Unexplained itchy red rash that started behind ears; has moved to chest and back. Denies shortness of breath, dyspnea, tongue or lip swelling. Took one night's worth of Benadryl without noticeable effects. Pt was advised to continue antihistamine of choice x 7 days along with Zantac 150 mg bid x 7 days, and cortisone cream per package instructions. Return for f/u 48-72 if symptoms worsen, or sooner.
Information has been received from the mother of a 16 month old daughter with no medical history and no allergies who in late June 1999 was vaccinated with MMR. There was no concomitant medication. The pt's mother reported, that on approximately 04-JUL-1999 the pt stopped breathing, turned blue, had a high fever and rash approximately one week after the pt was vaccinated. the pt's mother sought unspecified medical attention for her daughter. Subsequently, the pt recovered. The pt's mother considered stopped breathing, turned blue, high fever and rash to be immediately life threatening. Upon internal review it was considered that stopped breathing was an other important medical event (OMIC). Additional information has been requested.
1st vaccine 1/18/21; 2nd dose 2/8/21; seen at ICC 2/20/21 for RLQ abdominal pain onset 2/18/21.
Patient c/o rash and pruritus to anterior aspect of neck area, face, back of scalp area, chest and bilateral knees. Face flushed with flat red rash to neck  Received Benadryl 50 mg PO
Brain fog next day, loss of taste and smell48 hours post vax lasted 18 hours
Information has been received from a nurse for the Pregnancy Registry for GARDASIL concerning an 18 year old female who on 13-DEC-2007 was intramuscularly vaccinated with her first dose of GARDASIL (lot # 658554/0928U) and later found out she was pregnant.  On 27-Dec-2007, the patient sought unspecified medical treatment with an office visit.  A pregnancy test was performed and determined she was about 5-6 weeks pregnant (LMP approximately 11/17/07).  No adverse events were reported.  Follow-up information was received on 03-NOV-2008 from a physician indicating that the patient is a female with 0 previous pregnancies.  The patient had no significant past medical history or concurrent medical conditions.  In early January 2008, 7-8 weeks from her LMP, the patient had an spontaneous abortion.  The products of conception were not examined.  It was unknown if the fetus was normal.  Upon internal review, the spontaneous abortion was determined to be an other important medical event.  Additional information has been requested.
Large redness left arm/chest and myalgria, nausea, jaw pain, short of breath
woke up in the morning around 8am , went to the restroom thinking I had to have a bowel movement, I notice large amounts of blood on my inner thigh and then notice it in the toilet.  I try to pinpoint where it's coming from and it's coming from my scrotum.  I applied pressure to stop the bleeding, any previous injuries I've had usually 5-10 min hold does the trick, but this did not stop after about 25-30 min of applying pressure.  The bleeding stopped but felt a dull pain coming from that area.  I went to the emergency room around noon that day to have it looked at it and provide some sort of information as to what was happening to me.  They stated it was a hematoma which is normal, but I have never experienced one in the past and did not have any symptoms of this until after the vaccine.
This spontaneous report was received from a Licensed Practical Nurse and refers to a 4 month old male patient who did not have concomitant medication, pertinent medical history, drug reactions or allergies.  15-AUG-2018 4 pm, the patient was vaccinated with a dose of ROTATEQ orally, lot # R003111 with expiration date of 12-SEP-2019, for prophylaxis (strength was not reported), with a dose of PEDIARIX lot # 9A2KC with expiration date of 03-JUL-2020), with a dose of PREVNAR 13 lot # T94424, with expiration date of 31-MAR-2020 and a dose of ACTHIB  lot # UI902AAA with expiration date of -14-SEP-2019). The reporter referred that, on the same date at 7 pm, the patient's parents returned to the office with the patient due to his lips being very pink in color (lip erythema) and swollen, the physician evaluated the infant and documented lip swelling had decreased, no respiratory issues and ordered unspecified  diphenhydramine (BENADRYL) 12.5 mg/5 ml, 1/2 teaspoon once every 8 hours, with phone follow up in 48 hours. No lab diagnostics were performed. No intervention to prevent serious criteria, or hospitalization was needed, no life threatening event or disability occurred. The outcome of lip erythema and lip swelling was reported as resolving. The causality assessment between lip erythema and lip swelling with the suspect therapies was not reported.
Initial report received on 05 November 2007 from a health care provider. An eight-year-old male patient, with no illness at the time of vaccination, had received a right arm, intramuscular injection of Fluzone SV 2007-2008, lot number U2499AA, on 03 November 2007. Within 24 hours post-vaccination, the patient experienced erythema, pain, blisters, and a feeling of "hot." The affected area was from the top of the arm to below the elbow. The specific arm affected was not reported. The patient was subsequently diagnosed with cellulitis and admitted to the hospital for 24 hours. Treatment included vancomycin and steroids. Per the reporter, the events had almost resolved.
pt discovered chickenpox disease w/diffuse vesiculopapular lesions 2 days p/being exposed to chickenpox & 7wk p/vax;
This spontaneous report as received from a female patient of unknown age refers to herself. On 28-SEP-2013 (sometime towards the end of September 2013, possibly the 28th of September) the patient was vaccinated with a dose of VARIVAX (merck), (lot#, dose, route, strength and indication not reported). On 13-OCT-2013, the patient discovered that she had conceived. No adverse event (AE) reported. The patient's date of last menstrual period was on 29-SEP-2013, and the estimated delivery date would be on 06-JUL-2014. Additional information has been requested.
Pt recv vax on 3/9/99; 15 min post vax pt exp hives over body; tx=Benadryl & Solucortef
This spontaneous report was received registered nurse regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored M-M-R II (lot # L040960, expiry date 16-OCT-2017) dosing details and route unknown. Concomitant medications were not reported. The vaccines were subjected to temperature excursion of 10.5 degree C for a time frame of 2 hours and 33 minutes. It was reported that there was no previous temperature excursions. No other symptoms reported. Product quality complaint (PQC) was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
Marked swelling, erythema involving the entire arm and onto the chest. Blistering at the site of the injection.
Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 32°F; Dose administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 32°F) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:21 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 32°F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 32°F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 69.98.  No concomitant medication was reported by reporter.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vial was moved to fridge on 23-Mar-2021 and moved to clinic on 31-Mar-2021 Vial was punctured right before administration. Vial best before use date was 22-Apr-2021. Vial was undergone temperature excursion on 08:00 AM with 32 degree Fahrenheit.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Just after my first booster in February I had a normal period and it was 7 days. It is normally 19-21 days in between. In March it was 28 days since last period. In April it was 13 days since last one and then I had a second cycle that lasted 7 days. In May it was 18 days since last one. In May I had blood work because of the issue with so many menstrual cycles. My thyroid numbers were under active. I had a biopsy in May and and the spotting began due to the biopsy and then I started my period and it was heavy at times. My biopsy was normal. Blood work was all normal except for thyroid numbers.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about concurrent conditions, concomitant medications, medical history and drug reactions was not provided. On 12-OCT-2018, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # R007722, expiration date 10-MAR-2020; route was unknown) for prophylaxis (Incorrect product storage). The temperature excursion was at 26 degrees Celsius or warmer for 2 hours. There was no previous temperature excursion. Data logger was not involved. No adverse effect was reported.
Injection site redness; Injection site swelling; felt like he had the flu; Wrong Route of Administration; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 17th August 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 18th August 2019, the patient experienced influenza like illness. On an unknown date, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site swelling, influenza like illness and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and influenza like illness to be related to Shingrix.  Additional information received were as follows: The caller was physician and also the patient. The patient received Shingrix on left arm this past weekend of the reporting date at a local pharmacy. The patient stated that he was given the injection subcutaneously in her left arm just above the elbow toward the back of the arm, which led to inappropriate route of vaccine administration. The patient did not had the paperwork from the pharmacy. Less than a day after receiving Shingrix, the patient noted that he experienced slight swelling and redness at the injection site. The patient reported that the day after his injection, he felt like he had the flu. The patient called on the reporting date inquiring about the efficacy of the vaccine given subcutaneously. This was related to patient. The caller was warm thanked to MIS.
get these purple bumps all over your body; itching; pain; she was dealing with it through tears; This is a spontaneous report received from a contactable consumer. This consumer reported for a Female patient (Daughter in Law). This is the second case out of 3 split cases.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Provided) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, My daughter in law has an auto immune condition, and after she took the shot, the vaccine (Pfizer COVID 19 Vaccine) she has met the worst case ever as I complaint this which was that where you get these purple bumps all over your body. So, I just wanted to report that, she was dealing with it through tears and pain and itching. But I really would recommend that something needs to be said prior to getting that shot. If you have an auto-immune condition that really needs to be truly discussed with their doctor because anyone with the auto-immune condition is sounds like to me they are having some trouble. It is just breaking in my heart (general sentence) So, I just wanted to report that, it is horrible. Reporter further stated, What strange was, I have met two other people that have developed the same condition So, anyway I really think a warning or just say you know kind of deal. You know, something that the person administrating the vaccine could share. But anyway, you know just like they should not take the Flu Vaccine So, it is the way that the body responding to some kind of, chemical in the vaccine (not appropriately clarified hence not captured as event). But anyway, I just wanted to report that. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101050810 same report/drug/AE, different patients;US-PFIZER INC-202101050518 same report/drug/AE, different patients
Family of 4 walk- ins for vaccines. Patient's paperwork was done but the families were not. Patient wanted to go 1st. Pharmacist took patient paperwork into the room but the card was with the families.  Pharmacist thought it was 1st dose and explained the vaccine as if it was first dose. Booster was given. Patient's mother has not reported any adverse side effects  or discomfort.
Patient reported rash, severe pain, and swelling at injection site. She said that she was unable to sleep and missed appointments due to the severity of the pain.
This spontaneous report was received from a physician refers to multiple unspecified patients of an unknown age. The patients' pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L048236 and expiry date 31-MAR-2018). Temperature excursion occurred at 46.8 F for 10 hours. No adverse events were reported. This is one of several reports received from same reporter. Additional information has been requested.
Flu symptoms with nausea and headache within 24 hours.  Hard lumps on right side of upper skull as of today with more flu symptoms.
This spontaneous report has been received from a female patient of unknown age referring to herself. Information about concurrent condition, medical history or concomitant therapy was not reported. On approximately 08-NOV-2016 the patient was vaccinated with ZOSTAVAX (injection, dose, frequency, route and lot# not reported). On 15-NOV-2016 the patient was experiencing redness and itching at the site of where the ZOSTAVAX vaccine was given. It was unknown if the patient sought any medical attention. The outcome of the event was unknown. The causality was not reported. Additional information is not expected.
Tingling in right arm from shoulders to fingers. Jerking of right arm also noted.  Arm slightly reddened and swollen at injection site.  Little feeling in tips of fingers of right hand. School district medical advisor contacted and Benadryl was ordered and given.  Child was brought home and later that evening another dose of Benedryl was given and child was sleepy. Slept well that night and woke the next morning and felt good and tingling and jerkiness in right arm was gone.
Left axillary lymphadenopathy. Tender. Gradually improved over 10-14 days. Still single enlarged but non-tender mobile lymph node on date of report (1/21/2021)
Vaccinator taking care of the patient. During initial screening she reported that she had an allergic reaction 16 hours after getting her Pfizer Monovalent COVID-19 booster shot in August of 2022, so her doctor recoment to switch for Moderna bivaleon. We let patient to wait for 30 minutes rather than 15 minutes. Vaccinator was check on pt. after 10 min, she was fine. Approximately 20 minutes she walked back to my table saying that she felt itchy on the side of her neck but denied any other complaints at the time. We get epi pen kit in case and we contacted 911. We checking her VS:HR 90, BP140/70, RR20,she did not have swelling in her face/tongue, uticaria, a hoarse voice, stridor, respiratory reaction.
Joint pain in hands, wrist, shoulders and hips. Along with swelling of the joints.
Information has been received from a public health nurse concerning a 7 year old female with no pertinent medical history and no known allergies who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live and subsequently experienced swelling of the body and difficulty breathing. medical attention was sought and the patient recovered. No product quality complaint was involved. Additional information has been requested.