chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 915AM 30APR98 & 930AM an approx 20mm local rxn @ inj site was noted;ice was applied to site;1015AM child back to nurse w/c/o SOB, wheezing, sweating & whole arm swollen down to the wrist;epi given;BP 100/60;
Inflammation of digestive tract - esophagus, stomach, small intestine and colon. Started after the third shot. Have been sick since. Lost 20 pounds. Still trying to figure out how to get this to stop.
Experienced lymphadenopathy in both axilla 2 days after injection. Muscle aches as well as muscle fatigue and sluggishness. Was seen by a local doctor and was told to monitor my symptoms and report back if anything became worse.
pt devel low grade fever approx 24 hrs p/vax given; fever progressed to 104 w/flu like sx diarrhea, nausea, backache; still t99;
Tachycardia Heart rate 128, shortness of breath, chest-tightness, muscle weakness, trembling, low grade temp 99.9F abdominal cramping, diarrhea x3, facial flushing x3
Patient received Janssen COVID vaccine. After vaccine was administered it was identified that patient was 16 years old and did not meet EUA age requirements. No adverse reactions were noted.
10 patients received doses from 1 vial after spending more than 30 days on the refrigerator//Patient7: Second Dose-Vaccine administered BUD (on day 32); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients received doses from 1 vial after spending more than 30 days on the refrigerator//Patient7: Second Dose-Vaccine administered BUD (on day 32)) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients received doses from 1 vial after spending more than 30 days on the refrigerator//Patient7: Second Dose-Vaccine administered BUD (on day 32)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients received doses from 1 vial after spending more than 30 days on the refrigerator//Patient7: Second Dose-Vaccine administered BUD (on day 32)) 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 assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Followup received and added patient demographics. On 10-Aug-2021: Follow up received and  Vaccine information updated.
Severe inflammation everywhere.  Bed ridden for weeks.  Muscle rigidity, muscle, bone and joint pain, severe sinus inflammation in face, severe neck pain (left especially) burning in arms, hands, feet and legs, severe pain, stomach upset, diarrhea, long Covid symptoms worsened.  Still in severe pain after 6 weeks!!
12 hours after vaccine, general feeling of malaise, weakness. Progressed over next 12 hours to headache, neck ache, myalgia ( generalized ) and general feeling unweel
Intermittent fevers and headaches/head pressure that have continued for 6 days post vaccination.   Side effects of muscle aches/chills subsided after 48 hours. Fever was less than 100F after 48 hours, so I returned to work per protocol. Was taking Tylenol and Ibuprofen.    3rd day: afebrile but headache remained. Taking Tylenol and Ibuprofen to help manage.   4th day: intermittent fevers throughout day (no higher than 100.3F). headache continues.   5th day: afebrile in the morning, but as day progressed headache began to get worse and I eventually spiked a low grade fever as high as 101.5F that afternoon. I was excused from work per protocol and receiving care/evaluation from occupational heath and infectious disease for return to work purposes. Still taking Tylenol and Ibuprofen which were helping the fevers stay between 99F but not helping the headaches.   6th day: Taking Tylenol and Ibuprofen around the clock. Fevers have ranged from 98.9-100.8F so far. Headache still remains.
received 1stdose in 2018, 2nd dose this past weekend; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   In December 2021, the patient received the 2nd dose of Shingrix. In December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The reporter was the concerned patient. The patient received her second dose this past weekend of reporting day in December 2021, which led to lengthening of vaccination schedule. The patient had nothing else to report.
This spontaneous report was received from a Nurse refers to a female patient of unknown age. On 14-SEP-2012, the patient was vaccinated with first dose of GARDASIL (0.5 ml) intramuscular. The nurse reported that on 03-JUN-2013, the patient was currently in the office to receive her second dose of GARDASIL. No adverse effect reported. No further information was provided. Additional information has been requested.
itchy; swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), PERIPHERAL SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D25A21A) for COVID-19 vaccination.     Concomitant products included CIMETIDINE (TAGAMET [CIMETIDINE]) for Acid reflux (oesophageal), VITAMINS NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRURITUS (itchy), PERIPHERAL SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red). The patient was treated with HYDROCORTISONE (topical) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy), PERIPHERAL SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history information was reported.
Pt developed an allergic reaction characterized by fever, dizziness, some shakes, malaise, pain and swelling in her arm. Pt recovered without treatment.
pt recv vax 12JUN96 & pt exp a varicella rash @ inj site;no further details were provided;
This spontaneous report was received from a healthcare worker and refers to a 7 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was not provided) lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effects were reported. Additional information has been requested.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 16-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-250494 (Patient Link).
Psoriatic arthritis; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4486835-00.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 06Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1159488), oral for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "Psoriatic arthritis". The action taken for upadacitinib was unknown.  Clinical course: It was reported that on an unknown date, the patient experienced psoriatic arthritis was not improving. Patient felt that her psoriatic arthritis should be more improved but physician stated to give Rinvoq more time. Unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality for the event of psoriatic arthritis with BNT162b2 was Possible.   The reporter's causality for the event of psoriatic arthritis not improving with Rinvoq (Upadacitinib) was not related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported   event and the suspect drug 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 RAs, Ethics Committees, and Investigators, as appropriate.
Lost consciousness, Either a siesure or passed out. Cadiac events - Varied and Rapid Heart rate, Low Potassium and Low Magnesium
Non-localized hives for 4 days (so far). Itchiness and redness with no other adverse effects. Treating with 20mg Zyrtec (cetirizine) daily.
Shortly after taking the vaccine as patient was standing at the checkout window with mom and started to feel dizzy. Got patient into a room adjacent to the check out window and propped her feet up. Placed cool cloths and a fan on her. Checked BP @ 2:02 pm BP- 99/56 P-85 and @2:05pm - BP -105/65 P-83. Gave patient a soda to drink and peanut butter crackers. Patient began to feel better after 10 mins. Advised mom to wait an additional 15 mins in the lobby before leaving.
First dose of Engerix-B a month ago / Dose of Twinrix on Dec 2nd, 2020 instead of a second dose of Engerix-b; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 59-year-old female patient who received HAB (Twinrix) (batch number 9355D, expiry date 14th March 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HBV (Engerix B).   On 22nd December 2020, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 22nd December 2020, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported, however it could be 58 or 59 years. The patient received the first dose of Engerix-B a month ago from the reporting date and then received a dose of Twinrix vaccine instead of a second dose of Engerix B vaccine, which led to wrong vaccine administered for Hepatitis A antigen. The reporter consented to follow-up, however health care professional declined to provide address.
This spontaneous report as received from a pharmacist refers to a 26 year old (also reported as 25 year old) female patient who was anemic. The patient had no known drug allergies (NKDA). The patient's medical history included anxiety, bipolar disorder, substance abuse and hepatitis C. The patient was not ill at the time of vaccination. On an unknown date, the patient received a first dose of GARDASIL (dose, route, lot# and expiration date were not reported). On 08-AUG-2015 at 17:28, the patient was vaccinated with an expired dose of GARDASIL (second dose, intramuscularly (IM) in the left arm, lot # H020002 with expiry date: 08-AUG-2015). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
After receiving my flu shot, I had normal pain at the injection shot. Although the pain never stopped and continued to increase drastically, to the point of not being capable of using my left arm.  I can not lift my arm without having severe pain. The pain began in my left shoulder and has progressively moved done my arm to my elbow and then to my wrist. The pain is excruciating and has not subsided. I need help showering, washing/styling my hair and getting dressed. Went to emergency room 12/01/13, pain started shooting from my left arm across the front and back of my chest.
w/in 2-3 mins arm became very itchy & red; no systemic reaction; over the next day devel flu-like sx w/local reaction characterized by induration, red & hot to touch; had vax last yr;
Confirmed breakthrough case  COVID-19 (Moderna) 1 01/14/2021 Moderna 026L20A   COVID-19 (Moderna) 2 02/09/2021 Moderna 007M20A   COVID-19 (Moderna) 3 10/29/2021 Moderna 076C21A
I was administered FLUVIRIN and ZOSTAVAX vaccines on Friday, September 22, 2017 about 3:50 pm. I had no reactions until Sunday, September 24, 2017. I got up at 6:30 am on Sunday feeling and moving fine. I sat down at 7:30 am and was not able to stand due to severe 8/10 sharp pain in lower back. Two 50-cent-sized muscle knots were found over both sacroiliac joints. The spasms and pain were unresponsive to ibuprofen 600-mg every 8 hours and ice packs for 2 days. Went to PCP and given Toradol and tizanidine for some relief. Knots and pain resolved slowly over 1 week. No history of any muscular activity to cause muscle spasms nor a history of previous back spasms at these locations. Noted other individuals online complaining of severe lower back muscle spasms from influenza vaccine. I wanted to note that this event has happened to me as well.
Pt had tongue swelling 30 minutes after injections, took benadryl and symptoms resolved 24 hours.  Currently seeing allergist for environmental allergies, has been cleared to get 2nd dose moderna by allergist.
About 12 days after the vaccine, I woke up in the middle of the night with sharp pain in my chest.  Since then I have had heaviness in my chest and other symptoms like difficulty breathing while walking or talking, etc.  I was otherwise previously healthy -- non-smoker, drink very occasionally, mostly vegetarian, light on sugar consumption, daily exercise.  I went to the doctor and then the ER at a local hospital on April 28.  They found fluid and possible inflammation around the hearth along with very high blood pressure.  Since then I have had medication for inflammation and high BP.  They are still doing tests to figure out what is wrong with me.
injection site was itchy; injection site was hard; injection site was peeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received bnt162b2 (BNT162B2), on 21Oct2022 as dose 5 (booster), single (Lot number: 3014584) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "She had an accident", start date: 2015 (unspecified if ongoing); "torn rotator cuff", start date: 2015 (unspecified if ongoing); "contusion", start date: 2015 (unspecified if ongoing); "concussions", start date: 2015 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (First dose, Lot: EL0149, injection in arm), administration date: 05Jan2021, when the patient was 51-year-old, for COVID-19 immunization, reaction(s): "injection site was itchy", "injection site was hard", "injection site was peeling"; bnt162b2 (Second dose, Lot: PAA156051), administration date: 27Jan2021, when the patient was 51-year-old, for COVID-19 immunization, reaction(s): "injection site was itchy", "injection site was hard", "injection site was peeling"; bnt162b2 (Third dose, Lot: EL0140), administration date: 06Jun2021, when the patient was 51-year-old, for COVID-19 immunization, reaction(s): "injection site was itchy", "injection site was hard", "injection site was peeling"; bnt162b2 (Fourth dose, Lot: EL3249), administration date: 26Jan2022, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "injection site was itchy", "injection site was hard", "injection site was peeling". The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "recovered", described as "injection site was itchy"; VACCINATION SITE INDURATION (non-serious), outcome "recovered", described as "injection site was hard"; VACCINATION SITE EXFOLIATION (non-serious), outcome "recovered", described as "injection site was peeling". Therapeutic measures were taken as a result of vaccination site pruritus, vaccination site induration, vaccination site exfoliation.  Additional information: She had an accident and had a torn rotator cuff and she was getting different injections. When attempting to clarify what type of accident, states she was in an ice storm and had concussions and contusions, this occurred in 2015. Once get it people have been lying and go back and go in the crowd. She is hoping that they did not write down the flu shot on this vaccination card. She was given a flu shot and covid booster shot on the same date. Flu shot and covid shot were given in opposite arms. Unknown which dose she was referring to where she was given flu shot on the same date.  Reports she took all of the Pfizer covid vaccines including the booster. States that when the injection site was healing it was itchy, hard, and she took a Tylenol. Thinks it was after all the covid vaccine doses she was given, where the injection site was itchy, hard, and peeling.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300299879 same patient/product/AE, different dose number;
SYRINGE OF THE 1ST INJECTION (LEFT DELTOID) WAS CRACKED CAUSING IT TO LEAK. PATIENT RECEIVED LESS THAN 0.25ML OF DOSE. UPON MANUFACTURER RECOMMENDATION, A FULL DOSE WAS GIVEN IN THE OPOSITE DELTOID (RIGHT) WITH PATIENT INFORMED CONSENT.
This spontaneous report was received from a nurse practitioner concerning to 11 patients of unknown age and gender. No medical history or concurrent conditions were reported. In March 2015, the patients were vaccinated with improperly stored GARDASIL (dose, strength, dose number, route of administration and lot number were not provided). No co-suspect or concomitant therapies were reported. Previous to administration, on an unspecified date, the vaccines were exposed to temperatures to 14.0 C for 4 hours and 30 minutes. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
10/27/15 - immunized 11/14/15 / 11/17/15 - hospital admission > severe diarrhea/dehydration.
experienced joint pain (worse in her hands and fingers than anywhere else, she will have it in her knees, but hands and fingers are the worst ones); This is a spontaneous report from a contactable consumer or other non hcp. This report received from a Pfizer sponsored program.   A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration, administered in left arm, on 08Apr2021 (at the age of 30-year-old) as dose 1, single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included flu vaccine, via an unspecified route of administration, on unspecified date in Oct2021, for immunization. The patient not received additional vaccines administered on same date of the Pfizer suspect. The patient not received prior vaccination within four weeks. The patient stated, she received the first dose of the Pfizer COVID-19 vaccine on 08Apr2021 and afterwards she experienced joint pain and she will not be getting the second dose. The patient stated, her doctor told her to call to see if the joint pain will go away and if this is a normal side effect from the vaccine. The patient asked, if there are other people that have reported joint pain as a side effect that has lasted for months or if there is any data regarding this. The patient clarified, she decided she is not getting the second dose, the doctor said to call to see if joint pain goes away ever and if this is normal, the doctor did not know what to do, the doctor wanted bloodwork, which she had done, and the bloodwork was normal, the doctor was unsure what to do. The patient stated, joint pain was a day or two after the vaccine, she got it on 08Apr2021. The outcome varies, it was bad for a while, then she thought it was better, but it comes back again. It seems to be worse in her hands and fingers than anywhere else, she will have it in her knees, but hands and fingers are the worst ones. The outcome of the event joint pain (worse in her hands and fingers than anywhere else, she will have it in her knees, but hands and fingers are the worst ones) was unknown.  No follow-up attempts are needed. No further information is expected.
Atypical Chest pain Pleuritic Chest pain Pt presents with pleuritic chest pain in context of recent RT treatment CTA negative, initial trop neg, initial EKG w/out signs of acute ischemia Repeat EKG (11/14) showing diffuse ST elevations D/W on call cardiology (see significant event note)  Lexiscan without signs of ischemia> current concern for Pericarditis  No viral prodrome, did receive COVID booster a couple days ago (unsure if re;ated at this point) Will start course of NSAID/PPI + prednisone taper, (drug interaction between colchicine and coreg) Cycle trop> neg, recent TTE performed no sig WMA, CTA with trace pericardial effusion Cardiology/ PCP follow up consults placed
7/9/2022 Very mild sore throat was noticed.  7/11 Sore throat got worse and prompted me to test using an At home COVID 19 Test which was negative.   Fever peaked at101. 7/12  At home COVID 19 Test, positive.  Telemedicine with Doctor.  Doctor prescribed brompheniramine pseudoephedrine and azithromycin.   Symptoms have improved up to time of reporting.
Patient received Pfizer Covid-19 vaccine gray cap for ages 12 and up, patient is currently age 11. No symptoms noted at time of administration.