chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arthritis in both hands got worse/arthritis to right heel part of foot got worse/worsening arthritis in her hands and right heel/arthritis in her hands also got completely worse; This is a spontaneous report from a contactable consumer, the patient's husband. A 66-years-old female patient second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534, Expiration Date: 30Jun2021) via an unspecified route of administration on 21Mar2021 (at the age of 65 years) as dose 2, single for covid-19 immunization. Medical history included ongoing arthritis. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198, expiration date was not reported), via an unspecified route of administration, administered in left arm on 01Mar2021 (at the age of 65 years) as dose1, single for covid-19 immunization. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced worsening of arthritis in both hands and to the right heel part of foot. It was reported that, arthritis was moderate to severe after getting both doses of vaccine. Therapeutic measures were taken as a result of event and patient took treatment with aspirin (TYLENOL) or arthritis pain relief (lot number 0LR0554, expiration date Aug2022), over the counter medications, which did not help her at all. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a certified medical assistant via company representative concerning a 12 year old male patient. On unspecified dates the patient was vaccinated with the first and second doses of GARDASIL, dose route and frequency unknown. On 14-JUN-2016, the patient received third dose (GARDASIL 9) lot # M005714, intramuscularly. Immediately after administration of GARDASIL 9, the patient stated that his throat felt funny. The reporter confirmed that it was not an anaphylactic reaction. The patient was monitored for 10 minutes in the reporter's office and the reaction resolved, the patient recovered (14-JUN-2016). The reporter did not assess the causality of the event with GARDASIL 9 and GARDASIL. Additional information has been requested.
My blood pressure was a little elevated, high for me / elevated blood pressure; Arm sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FL3246, expiry date not reported), via an unspecified route of administration in the left arm on 23Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing thyroid disorder. Concomitant medication included hctz. The patient experienced that her blood pressure was a little elevated, high for her/elevated blood pressure on an unspecified date. On 25Jan2021, the patient experienced arm sore. The patient underwent lab tests and procedures which included blood pressure measurement: 160/88 on an unspecified date, blood pressure measurement: normal (reported as normally around 130, 135, 138, normally runs 140/35-38), heart rate: 85 on an unspecified date, laboratory test: unknown result on an unspecified date. Clinical outcome of arm sore was recovering, while for blood pressure increased was unknown.
vial was stored in the refrigerator in-between use; No adverse event; vial was punctured at approximately 9:00 AM on 23-Jan-2023, and the dose was given on 24-Jan-2023 at approximately at 8:00 AM.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vial was stored in the refrigerator in-between use), EXPIRED PRODUCT ADMINISTERED (vial was punctured at approximately 9:00 AM on 23-Jan-2023, and the dose was given on 24-Jan-2023 at approximately at 8:00 AM.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023 at 8:00 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jan-2023 at 8:00 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (vial was punctured at approximately 9:00 AM on 23-Jan-2023, and the dose was given on 24-Jan-2023 at approximately at 8:00 AM.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was stored in the refrigerator in-between use) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (vial was stored in the refrigerator in-between use), EXPIRED PRODUCT ADMINISTERED (vial was punctured at approximately 9:00 AM on 23-Jan-2023, and the dose was given on 24-Jan-2023 at approximately at 8:00 AM.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (vial was stored in the refrigerator in-between use) and EXPIRED PRODUCT ADMINISTERED (vial was punctured at approximately 9:00 AM on 23-Jan-2023, and the dose was given on 24-Jan-2023 at approximately at 8:00 AM.).    No relevant concomitant medications were reported.   Refrigerator expiration date was reported 02-Mar-2023. The vial was punctured at approximately 9:00 AM on 23-Jan-2023, and the dose was given on 24-Jan-2023 at approximately at 8:00 AM. The vial was stored in the refrigerator in-between use.   No treatment information was provided.
Dose administered >12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Oct-2021 at 1:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported. The vial was initially stored in the refrigerator on 02-Oct-2021.It was first punctured on 04-Oct-2021 at 8:30 am. The vial was stored at room temperature post puncture. It didn't undergo any temperature excursions. It was left at room temperature for 28 cumulative hours.
Red at injection site along with deep blue vein - x6 days. Vein x1 day. Did get very hot with bruising. Subsequently, she had reported new onset of a superficial varicose vein across the upper part of her shoulder and chest.  She reported that this was new since the vaccine.
arm went numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (arm went numb) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (arm went numb). At the time of the report, HYPOAESTHESIA (arm went numb) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Patient's arm went numb for 5-10 minutes after the first dose of vaccine.  No concomitant medications were reported. Treatment information was not provided.
Patient lost consciousness and seized, HCP in room, assisted with repositioning, cool cloth, regained consciousness within approx 45 seconds,with no residual effects. Remained in office for 20 minutes post-recovery. Provider completed a brief neuro exam WNL.
p/ pt recv vax pt devel a breakthrough varicella rash w/greater than 50 lesions. also exp low grade temp
LEFT ARM WELT, ITCHY, RED SKIN LESION, HIVES, RAISED, WARM. PATIENT DENIES ANY THROAT SWELLING.
Warm feeling; dizziness; shortness of breath; nausea; This is a spontaneous report from a contactable Nurse. This 37-year-old Female Nurse (Patient) reported for herself that:  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Jun2021 16:00 (Lot number: EW0179) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Gastritis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; SPIRONOLACTONE; MULTIVITAMINS [VITAMINS NOS]. The following information was reported: FEELING HOT (non-serious) with onset 27Jun2021 16:15, outcome "recovered" (2021), described as "Warm feeling"; DIZZINESS (non-serious) with onset 27Jun2021 16:15, outcome "recovered" (2021), described as "dizziness"; DYSPNOEA (non-serious) with onset 27Jun2021 16:15, outcome "recovered" (2021), described as "shortness of breath"; NAUSEA (non-serious) with onset 27Jun2021 16:15, outcome "recovered" (2021), described as "nausea". Therapeutic measures were not taken as a result of feeling hot, dizziness, dyspnoea, nausea.  Additional information: Patient did not had covid prior vaccination or tested for covid post vaccination. Patient did not had any other vaccine in four weeks.  Follow-up (10Sep2021): Follow-up attempts are completed. No further information is expected.
Taken vaccine shot in right arm, time shot given could feel sting pain. 3 hrs later my right arm could not lift arm, could not hold keys or anything in right hand.
Information has been received from a physician concerning a college student who was vaccinated with one complete series RECOMBIVAX HB (dates and Lot# unknown). Subsequently, the patient had low anti-HBs titer. It was unspecified if the patient had sought medical attention. At the time of the report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Left deltoid hurt when injection started. Left deltoid is still very painful when touched or bumped with casual contact. Even with a TdAP injection at the same site, my muscle has not been so sore.
Initial report was received from a patient on 29 September 2011. An 85-year-old female patient had received an Intramuscular (IM) injection of FLUZONE HIGH-DOSE (lot number not reported) in left deltoid on 27 September 2011. On the same day of the injection, the patient developed chills, headache and runny nose, no vomiting and no diarrhea. The patient also stated that she had yellow pus draining from the injection site but it was a very small amount. No further information was available at the time of the report. The patient outcome was reported as all symptoms resolved. Documents held by sender: none.
Soreness injection site Headache Prickly sensation of skin Weakness/fatigue Stomach pain/nausea/ loss of appetite
Immediately upon injection entire left arm ached severely; day later, upper left arm was swollen and red from injection site to elbow. Pain and discomfort has continued with some improvement. But still have limited mobility of shoulder.
pt had a simple febrile seizure episode approx 12 hrs p/receiving the 3rd dose of vax in pvt MD office;
This spontaneous report was received from a consumer refers to her pediatric of unknown age. She reported that her daughter developed extreme depression, anxiety, panic attack, celiac disease, joint pain, and muscle pain since the GARDASIL (lot# unspecified), route, dose and location unspecified was given 7 years ago (approximately in August 2006). The reporter was experiencing these long term side effects from her GARDASIL. Additional information is not expected.
No adverse effect; received improperly stored vaccine; This spontaneous report was received from a nurse concerning a 4-year-old male patient. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not reported. On 14-NOV-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # S012470 with expiration date 20-OCT-2020 (strength, dose, schedule, anatomical location and route of administration were not reported) for prophylaxis, which was used with the sterile diluent. No adverse effects were reported. No additional information was provided. The storage temperatures of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were reported as between 6 to 14 (°F) (7.2 F) for a time frame of 1 hour and 10 minutes. There was no previous temperature excursion. There was an involvement of data logger. No product quality complaints (PQC) were involved.
Shortness of breath, chest pain unrelieved by nitroglycerin, fever. She went to hospital by ambulance where they did a full workup and couldn't find any reason except the vaccine for her symptoms.
8/18/05 developed some spots, low grade temp 18th/19th, then 8/22 bad croupy cough/wheezing, seen in office 8/23 macular papular lesions trunk/face with croup. Decadron 0.5mg/5ml. 1.5tsp bid x 3 days, MMR reaction.
FACE FELT TINGLING AND NUMB. TONGUE AND THROAT FELT FUNNY. GAVE 25MG BENADRYL. THEN PT STATED SHE HAD RECEIVED STEROID SHOT AND HAD MISSED HER BLOOD PRESSURE MEDICATION. SHE WAS GIVEN CARTIA 24OMG HER USUAL DOSE OF BLOOD PRESSURE MEDICATION.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling on her arms and legs"; ALOPECIA (non-serious), MADAROSIS (non-serious), outcome "unknown" and all described as "her hair was falling out as well as her eyelashes and eyebrows". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age atypical shingles outbreak. Facial, with pain in ears, eyes, and teeth
Sudden complete hearing loss in left ear. Loss of balance, vertigo, tinnitus, nausea.
Fever, chills, body aches, headache, skin hurts. Took ibuprofen, barely lessened fever from 102 to 101.
pt recv vax 11AUG95 & 8APR97 pt devel between 10 & 20 lesions & papules;pt also exp a low grade temp & achiness;pt recovered from sx by 11APR97;
At 11pm that evening headache (worst ever in my life), joint pain in hands, hips, knees, muscular pain in thighs and lower back, lasting about 6 hours. Diminished gradually over the next 4 hours. Fatigue ongoing.
Suspected vaccination failure; shingles shot was more unpleasant/felt slight soreness; Shingles; shingles shot was more unpleasant/felt slight soreness; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and injection site discomfort. On an unknown date, the outcome of the vaccination failure and injection site discomfort were unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and injection site discomfort to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient stated that he/she weigh a lot and so might not feel pain as much as if he/she would have been lighter. The patient stated that the shingles shot was more unpleasant than either Pfizer vaccination. The patient felt slight soreness with shingles for a day.  The patient reported that the MMR booster and the tetanus booster were not noticed by him or her now. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided
Information has been received from a 66-year-old female with asthma and "can not take anti-inflammatories" who on 22-FEB-2008 was vaccinated in the arm with her first dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. On 25-FEB-2008, the patient experienced a severe migraine. The patient did not seek medical attention and no diagnostic labs were performed. At the time of the report the patient's status was recovering. A product quality complaint was not involved. No further information is available.
Raised and Soreness at the injection site for a couple of days. Patient usually not with this reaction following vaccines. In addition, approximately 12 hours after the injection, the patient experienced severe rigors and shivering waking her from sleep. The reaction was so severe that she was unable to go back to sleep. This lasted for at least 8 hours. This was then followed by severe fatigue, myalgia, arthralgia, and nausea. She was unable drive, pay attention, or eat until later that evening. She was so fatigued that she had to miss a day of work.
Approximately half way through administration, preassembled needle detached from syringe causing the patient to receive a partial dose of the vaccine.  Patient was screened by an RN and evaluated by a physician on site. Infectious disease was consulted and advised the patient should not receive a full dose at this time but should be scheduled to return for the 2nd dose in 28 days.
Chest pain/chest pain started 6 hours after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain/chest pain started 6 hours after vaccine) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     Concomitant products included TRAZODONE, LAMOTRIGINE and CITALOPRAM for an unknown indication.    On 01-Sep-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 CHEST PAIN (Chest pain/chest pain started 6 hours after vaccine). At the time of the report, CHEST PAIN (Chest pain/chest pain started 6 hours after vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications reported.
after 1st injection i had metallic taste in mouth; This is a spontaneous report from a contactable consumer (patient).   A 34-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Aug2021 (Batch/Lot Number: EW 0181) as single dose (at the age of 34) for covid-19 immunisation. No other vaccine in four weeks. No Covid prior or post vaccination. No known allergies. Medical history included attention deficit hyperactivity disorder, obsessive-compulsive disorder, gastrooesophageal reflux disease. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), omeprazole. The patient experienced after 1st injection 'I had metallic taste in mouth lasting three to 4 weeks' on an unspecified date. The outcome was not recovered. The patient underwent lab tests and procedures which included laboratory test: unknown results.   Patient underwent multiple doctor visits and lab work  No follow-up attempts are needed. No further information is expected.
Fever 101.8, fussy, coughing all night, runny nose, sneezing, redness at injection site.
can barely walk; Feels like its on fire; Back was bothering him; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back was bothering him), GAIT DISTURBANCE (can barely walk) and FEELING ABNORMAL (Feels like its on fire) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced BACK PAIN (Back was bothering him). On 09-Apr-2021, the patient experienced GAIT DISTURBANCE (can barely walk) and FEELING ABNORMAL (Feels like its on fire). At the time of the report, BACK PAIN (Back was bothering him) outcome was unknown and GAIT DISTURBANCE (can barely walk) and FEELING ABNORMAL (Feels like its on fire) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided.
Heart felt funny, light headed, 15 second tonic posturing where sustained contraction of muscles in the legs and arms occurred, loss of vision, unable to sit up.
lung drained after open heart surgery; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LUNG DISORDER (lung drained after open heart surgery) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (Patient had open heart surgery earlier this year.).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced LUNG DISORDER (lung drained after open heart surgery). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, LUNG DISORDER (lung drained after open heart surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment included prednisone.   Reporter did not allow further contact
Redness, swelling and pain from injection site all the way down to lower arm (left arm).
Fast heart beat, chest tightness and pain, dizziness and weakness 2hours after got shot  Chills, muscle and join pain, headache the second day