chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling, like a little bubble on the middle knuckle of the index finger of Left hand/ pointer on left hand pointer finger the index finger is swollen; This is a spontaneous report received from a contactable male consumer (Patient). A 67-year-old male patient received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Mrna Vaccine; Solution for injection; Lot Number: Unknown), via an unspecified route of administration, administered in left arm as dose 1, single on 11Mar2021 between 11:30 AM and 12:30 PM (at the age of 67-year-old) for covid-19 immunisation. Medical history included prostate cancer from 2014 (back in 2014 and 2015), blood cholesterol, acid reflux, pain in rigidity knee and glaucoma, Surviving cancer patient. Concomitant medications included ongoing atorvastatin (ATORVASTATIN) for blood cholesterol (been taking the last couple of years); ongoing pantoprazole sodium sesquihydrate (PANTAZOLE) for gastrooesophageal reflux disease (been taking the last couple of years or so longer); ongoing ibuprofen, diphenhydramine citrate (IBUPROFEN, DIPHENHYDRAMINE CITRATE) for arthralgia (he was supposed to take this almost every day for the past 3 or 4 years), ongoing latanoprost (LATANOPROST) for glaucoma (took for years), sulatildemalol for glaucoma (took for years) and Bremonizol for glaucoma (took for years) all from an unspecified start date and ongoing. The patient had not received any other vaccines prior to the COVID vaccine within 4 weeks. No adverse events reported following prior vaccinations. Patient was a 67-year-old male who received the first dose of the Pfizer BioNtech Covid 19 vaccine on 11Mar2021. The next day 12Mar2021 swelling, like a little bubble on the middle knuckle of the pointer on left hand pointer finger the index finger and was still there. Patient thought it would go down and had been a week and a few days. He wanted to know if this could be a side effect from the shot since he had nothing from before receiving the shot. He stated the swelling has not went down. It hasn't gotten bigger or smaller and it doesn't hurt. He was scheduled to receive the second dose on 01Apr2021. The adverse event did not result in any emergency Room or physician office. He stated he just takes regular medications that he has been taking before and after shot. He stated they assured him it would not be a problem so he has been taking them before and after the vaccine. He stated but he has not taken medication for the adverse event. He stated he wished he was at home so he could provide all the information of the medications. At the time of this report, the outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a doctor of pharmacy via a company representative concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number and expiry date were reported as H016283 and 21-FEB-2014 respectively, dose unspecified), intramuscularly in the arm. No concomitant therapy was reported. On an unknown date, the patient experienced throbbing pain from the deltoid region down to their finger tips. On an unknown date, the patient experienced redness at the injection site and was seen in an unspecified emergency department. The patient sought medical attention (came back to the pharmacy to review the reaction). The patient took over the counter medications for the pain. It was unspecified if any lab tests were performed. The outcome of throbbing pain from the deltoid region down to their finger tips was reports as resolved (date unspecified). The outcome of redness at the injection site was unknown. The reporter contacted the other 7 patients who had also been vaccinated from this lot number and expiration date and no other reactions were reported. The relatedness for throbbing pain from the deltoid region down to their finger tips and redness at the injection site was unknown for PNEUMOVAX 23. This is one of the two reports from the same source. Additional information has been requested.
Headache, Myalgia, FATIGUE/CHILLS Narrative:   Other Relevant History:
Patient experienced sweating and felt faint about 2 minutes after injection. Look like she was going to faint. She was given some water and  patient recovered and went home.
chills, fatigue, body aches, massive headache; symptoms came in about 14 hour after injection and lasted 24 hours total. took one Tylenol for the headache and slept most of Saturday. on 2/18/2021 while at work I experienced tinnitus of the left ear. I had no prior experience with that. I was experiencing echoing when I answered the company phone and had difficulty distinguishing the clients question from the echo of my response and his question.
Patient was given an expired vaccine that was left out from the day before. He has reported no side effects.
Dry mouth, off the chart, feels like cannot get enough water, feels like she has to drink every 2 seconds; Dry mouth, off the chart, feels like cannot get enough water, feels like she has to drink every 2 seconds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she donated blood" (unspecified if ongoing), notes: prior to the second booster, she donated blood at the (Institution name withheld). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: DRY MOUTH (non-serious), THIRST (non-serious), outcome "unknown" and all described as "Dry mouth, off the chart, feels like cannot get enough water, feels like she has to drink every 2 seconds". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient got the second booster. Prior to the second booster, she donated blood at the (Institution name withheld) and was tested for antibodies after the first booster, but before the second booster. The patient was reactive plus, which means that she has very high levels of antibodies in her blood from the vaccines. After the second booster, she has experienced dry mouth, which feels off the chart, and she feels like she cannot get enough water, and feels like she has to drink every 2 seconds. The patient stated that she should not have gotten the second booster. Her doctor did not know what was going on and she thought it could be a side effect. She asked when this going will stop. She could refer herself to her own doctor. Her doctor did not help her. Pfizer could not advise people to get a second booster if people are going to have side effects. Caller states that she is going to call the CDC and go on Twitter to alert people to these issues and that Pfizer has no idea what was going on.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
from 2:00am on march 11th till approx. 2:00am on march 12th  i had the following symptoms:    fever of 99. to 100.8 .    chills.                 body aches.   nauseous.   tired.
Uncontrollable weight gain, periods lasting 2 weeks with golf ball size clotting for 10 months until hysterectomy needed. Ultrasounds, biopsy?s, mri, CT scan, and medication found no cause. Vaccine was right before period and period was regular and normal for years before vaccine.
Involuntary eye twitching; Pressure in ear left side; Pressure inside the head; Terrible headache; Arm soreness injection site; Nausea; Runny nose; Loss audition; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), HYPOACUSIS (Loss audition), BLEPHAROSPASM (Involuntary eye twitching), EAR DISCOMFORT (Pressure in ear left side) and HEAD DISCOMFORT (Pressure inside the head) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (Four strokes.). Concurrent medical conditions included Cancer (Four times cancer patient.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness injection site). On 10-Jan-2021, the patient experienced HEADACHE (Terrible headache). On 11-Jan-2021, the patient experienced HEAD DISCOMFORT (Pressure inside the head). On 12-Jan-2021, the patient experienced BLEPHAROSPASM (Involuntary eye twitching) and EAR DISCOMFORT (Pressure in ear left side). In January 2021, the patient experienced RHINORRHOEA (Runny nose), HYPOACUSIS (Loss audition) and NAUSEA (Nausea). On 12-Jan-2021, HEADACHE (Terrible headache) had resolved. At the time of the report, RHINORRHOEA (Runny nose), HYPOACUSIS (Loss audition), BLEPHAROSPASM (Involuntary eye twitching), EAR DISCOMFORT (Pressure in ear left side), HEAD DISCOMFORT (Pressure inside the head), VACCINATION SITE PAIN (Arm soreness injection site) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: follow up received on 19-Jan-2021 included patient history and Events; Sender's Comments: Based on the current available information and  temporal / possible temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.  This case concerns a 67 year old female subject who experienced the unexpected non-serious events of head discomfort, ear discomfort, hypoacusis, and pain in extremity, and expected non-serious event of headache.  The events of head discomfort, ear discomfort, hypoacusis, pain in extremity and headache occurred 3, 4, 10, 1 and 3 days respectively after the first dose of the study medication.  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.
Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019BA1A) for COVID-19 vaccination.     Concomitant products included METFORMIN, CARVEDILOL, HYDRALAZINE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced ASTHENIA (Weakness). At the time of the report, ASTHENIA (Weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
FEELING LIKE HE WAS HIT BY A TRUCK; SORE THROAT; BODY ACHES; HEADACHE; FEVER; This spontaneous report received from a parent 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: Unk) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced feeling like he was hit by a truck. On SEP-2021, the patient experienced sore throat. On SEP-2021, the patient experienced body aches. On SEP-2021, the patient experienced headache. On SEP-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling like he was hit by a truck, sore throat, headache, fever and body aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210936091.
This spontaneous report was received from a physician via field representative referring to a 2-month old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ROTATEQ first dose (strength, dose, lot # and expiry date were not reported) orally to prevent rotavirus. On an unknown date (2 days after ROTATEQ administration), the patient was hospitalized due to rotavirus and dehydration. The patient's stool test was performed, and the result revealed as positive for rotavirus in the hospital. The physician reported that the patient was admitted to the hospital for 2 days. It was unknown if any treatment was received. On an unknown date, 2 more doses of ROTATEQ was administered when the patient was 4-month old and 6-month old with no issues respectively. On an unknown date, the outcome of rotavirus and dehydration was recovered/resolved. Causality assessment was not provided for the events. There was no product quality complaint (PQC) involved.
Pt's arm was red & swollen. Pt states it was also itchy and that he had been scratching it. Pt received MENACTRA & Tdap on (L) arm. Dr looked at it and stated it was a local reaction. No treatment given.
LEFT UPPER ARM WITH 3 1/2 BY 2 INCH AREA OF ERYTHEMA AND SWELLING.
Deathly ill; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   Previously administered products included Meningococcal B vaccine with an associated reaction of ill-defined disorder (received 1st dose on an unknown date. For the tolerance of 1st dose, refer linked case US2020AMR119696).   On an unknown date, the patient received the 2nd dose of Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced unwell (serious criteria life threatening). Rechallenge with Meningococcal B vaccine was positive. On an unknown date, the outcome of the unwell was unknown.   It was unknown if the reporter considered the unwell to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Meningococcal B vaccine, the patient got deathly ill.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR119696:same patient, 1st dose
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). Concomitant medications in 2 weeks included: AZELASTINE; FLONASE [FLUTICASONE PROPIONATE]; LEVOTHYROXINE; MONTELUKAST; QVAR REDIHALER; RALOXIFENE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (05Jul2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included COVID 19 anti-vial treatment, brand-Pfizer, from 17Jun2022 to 21Jun2022. Covid rebound on 25Jun2022 and patient experienced headache, sore throat, chest congestion. COVID recovered on 05Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
I felt very fatigue, sniffy nose, body felt warmer, very winded, body aches, chills, sore arm.
Patient admitted to hospital with paralysis below the neck. History of GARDASIL vaccination; Last dose 04/17/2008. No definite diagnosis. Described as either Traverse Myelitis or Spinal cord infarction.
Itching on trunk, arms and legs with severe rash over the course of several days Moisturizer, Benadryl, Pepcid, triamciclinone cream.
73 y/o man who developed a somewhat odd constellation of symptoms.  After his first covid-19 vaccine shot, he developed mild left chest pain which gradually improved but never quite resolved.  He tolerated the 2nd shot better, but subsequently developed weakness in the left hand.  Interestingly, about 2 weeks later, he had much more significant left upper chest and scapular pain which prompted him to go to the ER.  PE and thoracic aortic dissections were ruled out.  That pain gradually improved, but never quite resolved completely.  His weakness is somewhat diffuse and involves at least 3 different nerves (median, ulnar, radial) as well as 3 different myotomes.  His sensory deficits also involve multiple dermatomes in LUE.  Clinically, this presentation, albeit a little atypical, is most consistent with a brachial plexopathy.  As he did not have any other viral illness and only inflammatory issue was the vaccination, I think that this occurred most likely as a sequelae of the covid-19 vaccine.  I offered him two more confirmatory tests to include more extensive EMG/NCS as well as dedicated MRI brachial plexus wo/w.  For now, he declined these studies.  Steroids are not really warranted anymore as the acute inflammatory phase already passed.
arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    The patient's past medical history included Seizures (The morning after surgery she had seizure.) in 2020, Ureteral disorder, Weight gain, Postoperative complication, Migraine, Tingling, Ureteric rupture (The patient experienced collapsed ureter tube/artery laying across kidney/caused from  gainig weight/morning after surgery had seizures.) in 2020, Head pain (She had searing pain down left side of head), Numbness, Pain (She had overexertion which caused pain) and Surgery (Patient experienced kidney surgery due to collapsed ureter tube, artery laying across it which was due to gaining weight.) in 2020.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In June 2021, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  After receiving first dose of Moderna Covid vaccine patient's arm was sore. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event pain in extremity was not provided with HUMIRA(ADALIMUMAB).  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.   This case was linked to MOD-2021-624027 (Patient Link).
Approximately 5 minutes after vaccination was administered patient has numbness and tingling in both hands in addition to nausea and dizziness. We gave him 50 mg of diphenhydramine with his mother's permission. By 10-15 minutes after the vaccination he was feeling much better and the numbness had gone away.
patient stated starting the evening she got Fluzone HD she experienced arm pain behind her left shoulder. She states it comes and goes but especially if reaching for something or lifting. As of 11/29/20 no pain just achey but not totally gone
This spontaneous report was received from a pharmacist concerning an unspecified number of patient who on unknown dates were vaccinated with a dose of live ZOSTAVAX (route, lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patients had experienced responses to live ZOSTAVAX such as local reaction to live ZOSTAVAX at the injection site. This reaction included redness, itching, warmth and swelling. No treatment information was provided. At the time of the report, the patients outcome was not provided. This is one of several reports received from the same source (other MAARS number 1301USA010850). Additional information has been requested.