chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Extreme fatigue"; HEADACHE (non-serious), outcome "unknown", described as "headache". Additional information: The patient's age was reported "44" (unit not specified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 12th February 2019, the patient received SHINGRIX. On 20th February 2019, 8 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had 4 small spots on her stomach near her bra line that the urgent care has identified as a Shingles outbreak.
Information has been received from a Registered Nurse concerning an 11 year old patient who on 10-NOV-2010 was vaccinated IM with 0.5 ml of a dose of possibly PEDVAXHIB (OMPC) (Lot # not reported) in error instead of MENACTRA. The nurse mentioned a staff member drew up PEDVAXHIB (OMPC) into a syringe because the staff member thought it was MENACTRA because the staff member thought the label said meningococcal derivative. The staff member then drew up TDAP in another syringe. The staff member gave one of the syringes to a patient and then realized PEDVAXHIB (OMPC) was drawn up instead of MENACTRA and did not give the other vaccine in the syringe. Both of the syringes looked the same and it was unknown which vaccine the patient received. Patient was not experiencing any known symptoms. Additional information has been requested.
I had my 1st Covid Moderna vaccination on 2/21/2021 on the left arm. It felt like a flu-shot and  I had mild fatigue, soreness of my arm and my sleep was not deep for 2 nights. After that, I was feeling fine.  However, 10 days after the vaccination, I had like a weld type of rash of 2.5 inches in diameter on the injection site.. It was warm and little itchy when touched. Following, some rashes formed in my left inner thigh and small rash on my chest. It took 3-5 days before the rashes went away. The rashes on the thigh were scattered and fine, and they were not  painful and neither was my injection site.  Putting cold compress on the injection site helped tremendously and staying away from hot shower helped the rashes stayed at bay.
brown faded circle at injection site; minor itching; 1.5in redness at site of injection; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE DISCOLOURATION (brown faded circle at injection site), PRURITUS (minor itching) and VACCINATION SITE ERYTHEMA (1.5in redness at site of injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (patient is scheduled to have Breast cancer surgery next month.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PRURITUS (minor itching) and VACCINATION SITE ERYTHEMA (1.5in redness at site of injection). On 18-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (brown faded circle at injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (brown faded circle at injection site) and VACCINATION SITE ERYTHEMA (1.5in redness at site of injection) outcome was unknown and PRURITUS (minor itching) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt complained of pain up neck, in excruciating pain, nausea, couldn't move arm - went to ER and got x-rays taken, pain meds & a sling .
Developed large, raised hives all over my body approximately 3 days after receiving my second dose of the Pfizer vaccine, no other signs or symptoms were present.  I had not been exposed to anything new or different in the days following the vaccine.  I attempted to treat by taking benadryl before bed, without relief.  The hives had actually worsened over night.  Took my normal dose of loratadine and another dose of benadryl the next morning.  After 6 hours without improvement, called telehealth and was prescribed a medrol dose pack and instructed to take zyrtec, in addition to my normal allergy medicine for 3 days.  Started the zyrtec and medrol dose pack later that day, as well as another dose of benadryl that night.  When I awoke the following day, the hives were not as welted, and were beginning to resolve.  It took an additional 2 days for the hives to resolve completely.
I am also a Physician Assistant, and I have a knowledge base that has helped me take care of myself. Within 9 hours of 2nd vaccination dose, I had the following symptoms: Grade 4 fever of 104.1 Severe rigors Tachycardia at 140-145 (sustained for over 24 hours) Severe tremors Grade 3 headache (worst headache of my life) Severe myalgias Nausea Vomiting Dehydration  All of the symptoms were sustained for approximately 36 hours.  Nausea, vomiting, and headache sustained for approximately 48 hours. When I was able, I took 800mg of ibuprofen alternating with 700mg of acetaminophen Q4 hours.  I happen to have a mediport (because of CF), and I happen to have port supplies and a 300ml bag of normal saline for IV infusion.  After approximately  52 hours, I had urinated only once.  I accessed my port at home and infused myself with the 300ml bag of saline.  I continued to have vomiting. After about 54 hours, I did urinate.  It was very dark yellow/light brown. I believe that I was probably in acute renal failure secondary to dehydration caused by profuse sweating and vomiting. I should have gone to the ER, but I did not even have the ability to find, much less use, my phone during the peak of my symptoms.
I got my 1st Moderna shot on the morning of Thurs March 25th. Initially, there was just pain at the injection site which went away after a day or two. On Sun April 4th around 330pm, I noticed a red itchy area had formed around the injection site and spread throughout my arm. Today is April 8th and the rash, that I now know is called "Covid Arm", is still here, slightly painful to the touch, and itchy. I began taking Benadryl allergy yesterday, Apr 7th. I am scheduled to get my 2nd dose on Apr 22nd.
Tdap booster received 8/5/23. The following day around mid afternoon, left shoulder joint became very painful, arm weakness, limited range of motion. Unable to perform acts of daily living. On 8/8/23 I contacted my primary care to be seen in the office due to pain. They would not see me, but instead prescribed prednisone which they sent to my pharmacy. 8/12/23- still have limited range of motion and joint pain and a burning sensation
a week after I got covid/tested positive for Covid; This is a spontaneous report from a Pfizer . A contactable consumer (patient) reported that a male patient of an unspecified age (age: 50, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got his first shot on 01Mar2021 and a week after, he got covid/ tested positive for Covid in Mar2021. He went out of quarantine this last Thursday (as reported) and he went today to get his second dose and they weren't sure what to do about his second dose and they rescheduled his second dose to 30 days from the day he got out of quarantine which was 17Apr2021 and they told him to contact you for further guidance.  He was wondering if that was the right thing to do and wondering if he will need to start over with the 1st dose when he was vaccinated. Outcome of event was unknown.  Information about lot/batch number has been requested.
pt recvd vax; slept & was difficult to arouse for 14 hrs following vax; mom states pt "acted drunk; could not keep head up;
A little bit of a headache all week; recurrent fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (A little bit of a headache all week) and PYREXIA (recurrent fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included ENALAPRIL for Blood pressure high, SIMVASTATIN for Cholesterol, ESTRADIOL;PROGESTERONE for Menopause, VITAMIN B12 NOS, CALCIUM and COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE] for an unknown indication.   On 23-Apr-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) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced HEADACHE (A little bit of a headache all week) and PYREXIA (recurrent fever). The patient was treated with IBUPROFEN for Fever and Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (A little bit of a headache all week) outcome was unknown and PYREXIA (recurrent fever) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 30-May-2021: Email
Dizziness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 75 milligram. In 2021, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Fatigue). In 2021, DIZZINESS (Dizziness) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had fatigue and dizziness after taking the first dose.  No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a registered nurse in a doctor's office concerning a 6 year old white male with no allergies or medical history who on 11-JUL-2001 was vaccinated in the left arm with a first 0.5 mL dose of Varivax (lot # 638243/0557L). There was no concomitant medication and there was no illness at the time of vaccination. On 07-JUL-2006 the patient experienced 20 to 30 lesions. The patient sought unspecified medical attention. No diagnostic laboratory tests were performed. As of 10-JUL-2006 the patient's 20 to 30 lesions persisted. It was noted that the patient had no adverse events following prior vaccination. Follow-up information was received from the registered nurse who reported that on 07-JUL-2006 the patient had approximately 30 lesions on his face, neck, ears, chest, trunk and buttocks. Symptomatic care was provided. No further information is expected.
One minute after receiving vaccine, patient lost consciousness and fell forward onto the ground. She regained consciousness after 5 seconds. Her forehead was bleeding due to impact with the ground. Paramedics arrived on scene within 10 minutes to assess patient.
Right side trap muscle in upper back spasmd and locked into a flex. Keeps pulling vertebrae and ribs out of place.  Severe excruciating pain. I've been seen by 3 chiropractors , no one can explain why this happened other than from the vaccine, and no one can fix it.
The next day, post vax, the pt began vomiting after eating. Around mid-afternoon on 5/26/01, he also had a low-grade fever of 100F. Symptoms subsided the next day, on 5/27/01.
At 18 min after vaccine with COVID dose one, patient complained of rash at injection on the upper chest and anterior neck.  5 cc of Benadryl was given. pt had some dry throat but rash and redness resolved within 5 min and she had no further symptoms. released at 40 minutes after observation.
Patient was administered a covid vaccine on 3/19/23 that was dated to expired on 03/14/2023. Pfizer and CDC was contacted and per Pfizer the vaccine stability data supports the storage between 2 to 8 . C for up to 75 days (ON  OR BEFORE 3/19/23). No adverse event was reported from the patient.
I95.9 HYPOTENSION 4/26/2023 SYNCOPE R09.02 HYPOXIA 4/26/2023 SYNCOPE
Patient fainted while standing, hit head on chair and/or floor. No LOC, but patient confused, retrograde amnesia of event. Concussion from fall.
I noticed a rash on my upper chest to my neck, more on left than right. Noticed it morning of 3/5 . It was more pronounced by morning 3/6. No pain or discomfort. Would describe it as mild with lots of irregular shaped spots smaller than a dime.
Cannot get the 2nd dose; Brusing; Allergic reaction,Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Brusing), PRODUCT DOSE OMISSION ISSUE (Cannot get the 2nd dose) and HYPERSENSITIVITY (Allergic reaction,Hypersensitivity reaction) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction,Hypersensitivity reaction). On 21-Apr-2021, the patient experienced CONTUSION (Brusing). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Cannot get the 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency. On 20-Apr-2021, HYPERSENSITIVITY (Allergic reaction,Hypersensitivity reaction) had resolved. At the time of the report, CONTUSION (Brusing) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Cannot get the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Patient visited ER on 19-Apr-2021.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Reporter details, Patient demographics, suspect details, treatment medication and events were updated
Rash with hives on both arms and legs....parts of neck and top of shoulders.   Dr prescribed Prednisone, Cetirizine, and Cimetidine
Itching all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (Patient on chemo since NOV2020.) in November 2020. Concurrent medical conditions included Hearing impaired (Hard of hearing).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching all over the body). At the time of the report, PRURITUS (Itching all over the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-053350 (Patient Link).
patient called the day after receiving her Shingrix vaccination reporting swelling, redness and "welts" near the injection site and surrounding area. I recommended she take benadryl, ibuprofen, and ice the area. If she did not see improvement in 2 days, I encouraged her to follow up with her PCP.
vaccine  site pain   within a day radiated to neck and shoulder pain     progressed  with extreme pain  and still experiencing    sought help at physician office   put on prednisone  and taking tylenol for pain
Hives on face, ears, arms &hands-onset approximately 24 hours after vaccines given.  Evaluated by MD-He does not think reaction due to vaccines.  Treated with Zyrtec and symptoms cleared
Patient was at check out with mom, told mom stomach hurt then had syncopal episode-aroused after 3-5 seconds then got up. No incontinence, no disorientation.
rash at the injection site; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient. A female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 2021, outcome "recovered" (2021), described as "rash at the injection site".  Additional information: The patient had a rash at the injection site for the last 4 days and would like to know if she needs to seek medical attention.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pharmacy called mom and informed her that they had given the child double of the dosage for her age. She was suppose to rcv 10 and rcvd 20
Seen at ER on 7/15/01 with complaints of rash on abdomen, chest, carms. Received IPV, MMR, Prevnar on 7/13/01. No other significant symptoms. Received Benadryl and Prelone in ER with marked relief of symptoms. Did not report to PCP until 15 months well baby exam. Follow up: notes exist in chart; reporter no longer with practice.  Prescription not known. Site reaction not known.
pt recv vax & on 7NOV95 pt devel herpes zoster;had zoster on abd & back;No further details were provided;
received call from patient thurs Oct 14th notifying us of her concerns and side effects she was experiencing. started noticing side effects about 7 hours after receiving vax then throughout the night. She is currently taking ibuprofen Q4 hours to keep pain/discomfort at bay. things she described feeling include: ovaries feel like they are on fire/feel like bowling balls, fever, migraines, major soreness, extremely short of breath, parts of body going numb, had a hard time getting from her bedroom to the bathroomf or 2 days, 17 hours of spasms-abdomen, upper and lower back, legs, feet cramping "contraction-like".  She is making it through the day with the ibuprofen. 10/18 she left a message stating she saw her doctor and was told because of her endometriosis and PCOS that her body is essentially taking longer to absorb the vaccine. an EKG was done which she says shows left side of her heart has a little bit of inflammation which could be contributing to her pain and breathing difficulty. Patient states she is having "bleeding" and is not supposed to be and has not had this while on Mirena in the past. She is experiencing intense ovary pain and in lower back and still hard to breathe and taking shallow breaths and then body triggers her to take deep breaths. Having hot flashes "not because of endometriosis. I had this all under control before the vaccine"she stated.  She also reported that she is still experiencing the same symptoms that she had the previous weeks.  She says she did have covid19 1 year ago.  She has a log of what she has experienced by the hour.
Information has been received from a nurse concerning a female who in 2002 was vaccinated with one dose of VARIVAX (Merck). The patient's mother reported to the nurse that subsequently her daughter developed "a few red bumps on her buttocks". The nurse did not examine the patient. The patient's outcome was not reported. The nurse also reported that the patient's brother developed widespread red lesions after receiving one dose of VARIVAX (Merck) in 2006. (Refer to WAES # 0803USA04509.) No further information is available.
At the injection site, it is red, splotchy. The skin is hot and hard. Arm and into the neck is sore and stiff. It started this morning and is ongoing.
Pt sustained a CVA. Pt was hospitalized and discharged home with left sided hemiparesis and inability to swallow.
Patient complained she felt sore at the site of injection and then her arm was swollen up and became redness at the site of injection. The swelling moves downward to her elbow. Her arm still gets swollen up and redness after 3 days.
TONGUE SWELLING AND TINGLING, THIS HAPPENED ON THE FIRST DOSE AS WELL, CARRIES EPI PEN FOR UNKNOWN ALLERGY. NO OTHER S/S VSS NO SOB OR CHEST PAIN . MEDICAL DOCTOR ON SITE NO TRANSPORT TO HOSPITAL NECESSARY ADVISED TO CONSULT WITH ALLERGIST MONITORED X30 MIN.
Patient received expired dose on 24-SEP-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose on 24-SEP-2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose on 24-SEP-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose on 24-SEP-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-531880 (Patient Link).
Parent called now 03/23/2016 7:30 pm stating baby has continuous crying after vaccines were administered. I explained to parent that child might need to go to ER if not feeding properly because of continuous crying. I also explained that continuous crying is a reason to avoid vaccine for DTAP in the future.
Unable to walk, unable to eat, speech minimal. Extremely lethargic. Three days. Reactions started approximately 5 to 6 hours after shot.