chrisvoncsefalvay/vaers-outcomes huggingface dataset:
malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; muscle pain; nausea; dizziness; swollen entire left arm injection arm; joint pain; kidney pain; unable to think clearly; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 13Jan2021 12:00 PM at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020, 05:00 PM at a single dose on left arm for COVID-19 immunization and experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes. The patient experienced malaise, feeling of severe unwell, migraine and neck pain, heart racing, blurry vision, muscle spasms, muscle pain, nausea, dizziness swollen entire left arm injection arm, joint pain, kidney pain, unable to think clearly on 14Jan2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain and nausea. The outcome of the events was recovering. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
Fever 101-103.4 / fever chills every day for 6 days.  Neck pain with swollen neck lymph nodes x 9 days, Ringing in ears interrupted sleep for 1 month, had decreased some although continues to this day.  Malays for 2 weeks.  Vomiting for the first 4 days.
3 sets of hives over 36 hours - would swell down with Pepcid & Benadryl, also took Zyrtec. Had to go to Urgent Care.
One day post vax, the pt developed redness on her chin, cheeks, and forehead.  the reporter indicated the child was afebrile. A copy of this report has been forwarded to Aventis Pasteur.
pt states the next day after receiving the vax her right shoulder swollen and it started itching badly.  She called her pharmacist and he told her to use hydrocortisone and she used Benadryl as well.  On the fourth day the itching moved from her right arm to her left arm which lasted for 2 days then moved to her right upper chest which lasted a couple of days before subsiding.  Pt has not contacted her PCP at this time.
5 days of twitching that was as frequent as 6x/d for 10 min, resolved to 1 episode of 1 twitch on the last day, no fever;
Within 5 minutes of shot the nerve endings began firing off at high levels; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 14:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included pain management, amputation of 4th metacarpal left hand and repositioning of 5th metacarpal into 4th position, chronic ongoing pain from neuromas since Nov1999 when original traumatic injury occurred, the past pain has been addressed with surgery and stellate ganglion nerve blocks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication. The patient previously received pregabalin (LYRICA), rare occasions small doses of 7.5 mg loratadine (LORATAB) combined with meloxicam (MOBIC) for pain from unknown date and pain was currently managed with occasional doses of 600mg paracetamol (TYLENOL). The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that the patient had a modified left hand, 4th metacarpal removed and 5th metacarpal placed into 4th metacarpal position and had multiple neuromas in hand. On 11Mar2021 at 14:50, within 5 minutes of shot, the patient had nerve endings firing off at high levels, he had learned pain management over the years, but when not expecting the vaccine to be a trigger it was a bit concerning. The patient considered this as a minor event, but for others who did not have good pain management in place for neuroma pain this could be debilitating pain levels. It had been 15 hours after receiving first shot and pain levels are at a 7 - 8 still. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event within 5 minutes of the shot the nerve endings began firing off at high levels was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Starting Sunday after vaccine, patient started experiencing gut pain and immediately started a liquid diet. In spite of that it progressed. By Tuesday she was not able to walk upright. She went to urgent care and was sent immediately to ER for a CT to r/o possible perforation. Dx was Severe diverticulitis flare requiring antiemetic, pain medication, CT scan at ER antibiotics. She has had flares in the past, but it?s always due to diet and mild. This time she had been compliant with her diet for weeks or months.
I got hives two weeks after the first dose of the vaccine. It was mostly on my front torso and my back. A portion on my thighs and my arms. I used Hydrocortisone cream for the itchy.  The hives were very itchy seven out of ten. They lasted two days before the hives started to get better. There are still some that are visible after ten weeks. I got the second dose and had no reaction.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/17/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient reports that arm was red and swollen after vaccine...that eventually resolved except for small bruise but was still feeling arm discomfort a month out. advised patient to follow up with md and circle back to us with any additional concerns. patient not upset.
Case number PHEH2013US017649 is an initial spontaneous report received from a nurse on 16 AUG 2013. This report refers to an 18-years-old male patient. His medical history and concomitant medications were not reported. It was reported that on 13 AUG 2013, he received only an intramuscular dose of MenCYW-135 liquid component of MENVEO (batch number: X12092) without being reconstituted with MenA lyophilized conjugate. No adverse event was reported following the maladministration.
At the time I thought the patient was in the age range to get the kinrix as they wanted a combined injection and she was very behind on her immunizations.  She tolerated it well.    When I realized she was 7 we called the Health Department and they said it should be ok and will not need to be repeated but I should make out this report.  There were no problems with the injection and patient did well. MA
psoriasis; It was totally dry skin on his legs/ It kept getting worse and worse and worse; After the second shot, he broke out in rash on his legs up to his knees/got worse on my 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (After the second shot, he broke out in rash on his legs up to his knees/got worse on my 2nd shot), DRY SKIN (It was totally dry skin on his legs/ It kept getting worse and worse and worse) and PSORIASIS (psoriasis) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A,) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (open heart surgery over 20 years ago). Concurrent medical conditions included Penicillin allergy, Drug allergy (allergy to anything that has statin in it) and Allergy to chemicals (Allergy to anything with sulfur in it).    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced RASH (After the second shot, he broke out in rash on his legs up to his knees/got worse on my 2nd shot). On an unknown date, the patient experienced DRY SKIN (It was totally dry skin on his legs/ It kept getting worse and worse and worse) and PSORIASIS (psoriasis). The patient was treated with BETAMETHASONE DIPROPIONATE for Adverse event, at a dose of ointment 0.05% and MOMETASONE FUROATE for Adverse event, at a dose of ointment 0.1%. At the time of the report, RASH (After the second shot, he broke out in rash on his legs up to his knees/got worse on my 2nd shot), DRY SKIN (It was totally dry skin on his legs/ It kept getting worse and worse and worse) and PSORIASIS (psoriasis) 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 patient wants to know if anyone else in the world has experienced anything like this. The patient wants to know if there is an antidote. He states there are injections for psoriasis, but they cost seven to eight thousand dollars. He can't afford that.   This case was linked to MOD-2021-407399 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2021: Non significant follow up appended
Stinging at time of injection. Swelling and muscular pain for 3 days post vaccination.
On day 6-7 of receiving vaccine, lower extremities had decreased sensation.  Unable to walk.  Visit to PCP that week.  On Friday evening, went to ER.  Admitted due to decreased sensation in LE.  Lumbar Puncture completed and revealed positive protein in CSF.  This resulted in verbal diagnosis of Guillian Barre.  However, discharge diagnosis on discharge summary reflects decreased sensation.  As of today 6/15/21, i continue to have difficulty walking and significant decrease in feeling/sensation in lower extremities bilaterally.  I continue to follow up with my PCP and my Neurologist.
Headache, Sedation,  upset stomach, elevated BP, arm  numbness/tingling/cold  Narrative:
Information has been received from a registered nurse concerning a 9-year-old male, who was vaccinated in the leg with a dose of hepatitis A virus vaccine inactivated. Suspect vaccinations included a dose of varicella virus vaccine live (Oka/Merck) (MSD). It was reported that the patient developed cellulitis and swelling in the leg which the vaccines were administered. He could not put weight on the effected leg. He was treated with steroids and diphenhydramine hydrochloride (BENADRYL) and fully recovered. No product quality complaint was involved. This information is one of several reports from the same source. Additional information has been requested.
Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.
after about 10-15 minutes patient started to experience dizziness and feeling hot and little sweating. Sweating and feeling hot went away after 15 minutes but patient still complained about dizziness. I reached out to the patient at about 6:45pm to check on her and said she contacted the doctor and doctor advised to keep eye on her sugar since she is diabetic., the dizziness should go away in the next day. if not to call office and make appointment.
Irregular period; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in May2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unknown date in 2021, the patient experienced irregular period. The clinical outcome of the event irregular period was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Taking Paxlovid for COVID virus; Taking Paxlovid for COVID virus; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Taking Paxlovid for COVID virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: The patient reported that she and her husband were on Paxlovid. She reported that all her shots were from Pfizer, her booster and everything. She did a home test on an unspecified date and it was negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Seen at emerg. rm 8/16/10 - Rash. Dx; Chicken pox - 75 pox initially - developed into 300 to 400 lesions. 1st patient I had that developed varicella after 2 doses of VARIVAX. Date of vaccine 3/24/05 and 2/28/08.
Facial swelling where I had fillers. Filler was placed about 6-8 months ago  A lot of edema under eyes and around chin-jawline  All of the areas where I had had filler placed is extremely swollen, sore and hot to the touch
Patient came in on November 15th, 2018 and stated that his arm is still sore from May when he got the shot. His PCP recommended that he come to the pharmacy for us to complete the form. Since receiving the shot, he also started chemotherapy.
I started with allergies that progressed to congestion and nasal drainage. Those both continued to get worse. My breathing became extremely labored. I had a video visit on November 30th, a telephone visit on December 2nd, an office visit on December 10th, a video visit on December 17th, and a follow-up visit on December 21st and 22nd. I'm scheduled for a follow up on January 5, 2022. I'm scheduled to see a Pulmonologist next month. My doctor diagnosed me with Covid and Pneumonia. I was prescribed Albuterol 90mcg, Budesonide 180mcg 1xday, Robitussin ac 100-10mg/5mL 1xday, Levofloxacin 500mg 1xday, and Prednisone 20mg 1xday.
Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. On 28-AUG-2015 the patients were administered an unspecified number of improperly stored doses of VARIVAX (Merck) (lot # L016123, expiration date 06-MAY-2017) (dose and route were not reported). There was no concomitant medication reported. No adverse effect was reported. Additional information has been requested.
THE MONOVALENT COVID #1 WAS ORDERED BUT THE BIVALENT 5-11 Y/O WAS GIVEN BVY ACCIDENT INSTEAD. Patient returned on 10/27 (3 days later) with complaint of cough and runny nose.
Vial was initially stored in the refrigerator on 5-Mar-2022, expired on 08-Apr-2022 and administrated to the patient on 14-Apr-2022; Vial was initially stored in the refrigerator on 5-Mar-2022, expired on 08-Apr-2022 and administrated to the patient on 14-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the refrigerator on 5-Mar-2022, expired on 08-Apr-2022 and administrated to the patient on 14-Apr-2022) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 5-Mar-2022, expired on 08-Apr-2022 and administrated to the patient on 14-Apr-2022) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the refrigerator on 5-Mar-2022, expired on 08-Apr-2022 and administrated to the patient on 14-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 5-Mar-2022, expired on 08-Apr-2022 and administrated to the patient on 14-Apr-2022). On 14-Apr-2022, EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the refrigerator on 5-Mar-2022, expired on 08-Apr-2022 and administrated to the patient on 14-Apr-2022) outcome was unknown. At the time of the report, PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 5-Mar-2022, expired on 08-Apr-2022 and administrated to the patient on 14-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that on the 14 Apr 2022 a 6 days old vaccine that expired on the 08 Apr 2022 was given to patient who was receiving their first booster of the Moderna covid19 vaccine.  Date the vial was initially stored in the refrigerator was 05 Mar 2022 and they stayed in the refrigerator until the 14 Apr 2022.  It was reported that the patient had never had COVID positive test nor diagnosis.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2022: Patient's demographics details and new event added.
Booster Dose; Rheumatoid arthritis flare ups in hips; Bruise on both sided of the hip bone; Sore spot on left arm below the elbow; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4193509-00.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Feb2021 (Batch/Lot number: unknown) as dose 1, single, (at age 56 years), intramuscular, administration date 06Mar2021 (Batch/Lot number: unknown) as dose 2, single (at age 56 years), and intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "Booster Dose"; RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "not recovered", described as "Rheumatoid arthritis flare ups in hips"; BONE CONTUSION (non-serious) with onset 2021, outcome "unknown", described as "Bruise on both sided of the hip bone"; PAIN OF SKIN (non-serious) with onset 2021, outcome "not recovered", described as "Sore spot on left arm below the elbow". The action taken for adalimumab was unknown.  The reporter's causality for the event(s) with (HUMIRA) Adalimumab of 'Bruise on both sides of the hip bone, Rheumatoid Arthritis Flare ups in Hips and sore on left arm below the elbow' was not provided. The reporter's causality for the event(s) with PFIZER BIONTECH COVID-19 VACCINE of 'Bruise on both sides of the hip bone, Rheumatoid Arthritis Flare ups in Hips and sore on left arm below the elbow' was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event IMMUNISATION, RHEUMATOID ARTHRITIS, BONE CONTUSION, PAIN OF SKIN and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
0845) arrived at clinic eating peanut butter and jelly sandwich. 0901) vaccines given. 0913) to check out desk. No reactions noted: 1015) clinic called to eye clinic by their staff. Pt awake, alert. Hives/rash to face, torso, legs, itchy. No wheeze or resp concerns. 1030) BENADRYL 15 mg given PO. 1105) Reassess - rash/hives have decreased. No itching. Pt awake, alert, interactive. Mother reports pt has eaten peanut butter for 3 years with no reaction.
Black & Blue...at the injection site; red spots at inject site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Black & Blue...at the injection site) and VACCINATION SITE ERYTHEMA (red spots at inject site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Black & Blue...at the injection site) and VACCINATION SITE ERYTHEMA (red spots at inject site). At the time of the report, VACCINATION SITE BRUISING (Black & Blue..at the injection site) and VACCINATION SITE ERYTHEMA (red spots at inject site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Treatment of events was reported as none.