chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness of arm that won´t go away; A spontaneous report was received from a nurse concerning a 27-years old, female patient who experienced the event injection site erythema.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included Topamax.   On 26 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039k20a) via unknown route for prophylaxis of COVID-19 infection.  On 26 Dec 2020, the patient experienced redness on her arm that she got the first dose of vaccine. She reported that the size of the reaction remains the same and that isn't going away.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not unknown.  The outcome of the event injection site erythema was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
forcing out/stumbling over words as I struggle to stay awake; profound fatigue; forcing out/stumbling over words as I struggle to stay awake; Limbs are heavy; This is a spontaneous report from a non-contactable other healthcare professional (patient). This 30-year-old female patient received the second dose of BNT162B2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 01Mar2021 09:00 AM on the left arm for COVID-19 immunization. The vaccine was administered at a Health Clinic. She did not receive any other vaccines in four weeks prior to receiving BNT162B2. The patient had no COVID prior to vaccination. The patient was not pregnant. Medical history included depression and had unspecified known allergies (known allergies: Yes). Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (BNT162B2, lot number and expiry date were not reported), on 08Feb2021 09:30 AM on the left arm for COVID-19 immunization at the age of 30-years-old. On 02Mar2021 12:00 PM, the patient experienced profound fatigue; feel like I forcing out/stumbling over words as I struggle to stay awake. Limbs are heavy. No corrective treatment was received. Outcome of the events was not recovered. The patient has not been covid tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Got a headache both days the shots were given to me.  My next cycle of menstruation after the 2nd dose of the vaccine I got a huge headache that won't go away, its been 8 weeks that I've had it. Migraine headache without aura. I'm very very sensitive to light.  Exercise makes it worse and stress makes it worse but nothing makes it go away.
Left Shoulder and Arm pain, Painful, swollen, red vein in upper left arm
Patient given 0.2 mL dose of gray cap Pfizer Bivalent for 12years and older. Patients did not exhibit any adverse symptoms. Patient had no complaints prior to leaving post vaccinations area.
Two days, 1/29 ,after shot, vomiting and fatigue,  emergency room visit on 1/31 , additional ER visit on 2/01.  Continual slight stomach upset but general fatigue and weakness still prevalent.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: 059E21A) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. The patient started treatment for COVID-19 on 05Jun2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200874401 Same patient, different product and event;
15OCT injection-pain muscle ache; 20OCT itching both legs starting @ groin working down; welts; red spots; redness;
This spontaneous report was received from a 62 year old female patient, reporting on herself. The patient's pertinent medical history included breast cancer and knee replacement. It was reported that the patient had no drug reactions or allergies. On 29-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 one shot, (lot #, expiration date, exact dose and route of administration were not reported). Concomitant therapies included influenza virus vaccine (unspecified) (reported as unspecified flu shot). On approximately 06-OCT-2015 (reported as about one week after receiving PNEUMOVAX 23), the patient developed hives. She sought medical attention, had an office visit and an unspecified steroid shot was given for the adverse event. No lab diagnostic studies were performed. No PQC (product quality complaint) was involved. The outcome of the event was reported as not recovered. At the time of report the patient continued to experience hives. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Pt. given DTaP instead of Tdap. No adverse reaction reported. RN tried to contact parents with info, but no answer. Family was traveling.
bursitis and arthritis; bursitis and arthritis; it got worse with pain from his shoulder down to his fingers; his elbow swelled up; discomfort in his arm; This is a spontaneous report from a contactable consumer or other non-health care professional. An 82-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: Not Reported, Expiry Date: Not Reported) via an unspecified route of administration on 04Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: Not Reported, Expiry Date: Not Reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date in feb2021 that is two weeks after vaccination, the patient experienced, some discomfort in his arm Later on an unspecified date it got worse with pain from his shoulder down to his fingers, his elbow swelled up and he couldn't put pressure on it. He had seen the doctor and had x-rays and they said he has bursitis and arthritis on an unspecified date. He was placed on Steroids and then the following week they gave him an injection in his shoulder, but he is still having some problems with it. The patient underwent lab tests and procedures which included x-ray has bursitis and arthritis on an unspecified date. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
dtp acell IM was given 11-5-03 and started getting red and swollen about 20 hours after the injection.the erythema and swelling rapididly increased and child was seen about 40 hours later in the pediatric office . child had a significant swelling from the shoulder to the proximal aspect  othe forearm with striking hot erythema and unable to flex the elbow . child had a small crusty lesion in the injection , right deltoid area of the right arm. With the consultation of the pediatric infectious disease,  child was admitted to the peditric ward and systemic antibiotic was initiatd.. Nafcilin 200 mg/kg/day and warm compressess every 2 hours .  child clinical condition improved by 50 % in the next 24 hours, by 75 % in the next 48 hours and by  90 % when about 72 hours of antibiotic, including the decreased of swelling and erythema that was in one point from the top of the shoulder to the mid aspect of the right forearm... child was discharge on augmentin , orally, bid.
Rt. arm (DTap) was swollen with indurated from the shoulder to elbow - given BENADRYL x ice pack.
preseptal cellulitis/facial cellulitis; flu likesyndrome; This case was reported by a physician via call center representative and described the occurrence of preseptal cellulitis in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 2 weeks after receiving Shingrix and an unknown time after starting Augmentin, the patient experienced preseptal cellulitis (serious criteria GSK medically significant) and influenza-like symptoms. The patient was treated with amoxicillin sodium, potassium clavulanate (Augmentin) and sulfamethoxazole + trimethoprim (Bactrim). In January 2020, the outcome of the preseptal cellulitis and influenza-like symptoms were recovered/resolved.   The reporter considered the preseptal cellulitis and influenza-like symptoms to be almost certainly related to Shingrix.  Additional details were provided as follows: The patient experienced typical moderate flu like symptom within first day (24 to 48 hrs) of receiving Shingrix. The patient developed left facial cellulitis, treated some 5 to10 days after vaccination. The patient treated successfully with combination of PO Bactrim and Augmentin for 10 Days. The patient never suffered preseptal cellulitis before. The patient recovered and hesitantly agreed to a second dose. For tolerance of 2nd dose please refer case US2021AMR032306.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR032306:Same reporter
little pain where we got the shot; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients (Himself and His Wife) This is the 2nd of 2 reports. This consumer (Husband) reported that a 68-year-old female patient (Wife) received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number; was not reported), via an unspecified route of administration on 21Feb2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient concomitant medications were not reported. The patient experienced a little pain where she got the shot on the next day (22Feb2021), but it was fine. The patient got an appointment reminder for the second dose on 26Mar2021 which was beyond the 3 weeks period. It should be 14Mar2021. The patient inquired about the change in appointment. The patient did not have any adverse events to report. The patient reported that they will try to get it change to the 14Mar2021 but if not then maybe they will have to keep it for the 26Mar2021. The outcome of the event (little pain where we got the shot) was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021246838 same reporter, drug, event/different patients
Arm still red, lump hot to touch; Arm still red, lump hot to touch; Arm still red, lump hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm still red, lump hot to touch), LIMB MASS (Arm still red, lump hot to touch) and FEELING HOT (Arm still red, lump hot to touch) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ERYTHEMA (Arm still red, lump hot to touch), LIMB MASS (Arm still red, lump hot to touch) and FEELING HOT (Arm still red, lump hot to touch). At the time of the report, ERYTHEMA (Arm still red, lump hot to touch), LIMB MASS (Arm still red, lump hot to touch) and FEELING HOT (Arm still red, lump hot to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Patient stated it has now been ten days since she got the vaccine.  Treatment information was not provided by the reporter.
She reports testing positive for the covid 19 virus last Friday; She reports testing positive for the covid 19 virus last Friday; This is a spontaneous case received from a contactable consumer (patient). A 49-year-old female patient received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, lot number were not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient reported of testing positive for the COVID-19 virus last Friday. She was supposed to get her second dose of the vaccination series today however said that she had heard two different things if she could get it or not. Caller reports that she was going to get tested again tomorrow and Monday will be her 10 days of quarantine. The patient underwent lab test which included COVID-19 virus test and was tested positive on 03Sep2021. The outcome of the events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (did not feel good at all) and rash (broke-out in rash) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced feeling abnormal (did not feel good at all) and rash (broke-out in rash). At the time of the report, feeling abnormal (did not feel good at all) and rash (broke-out in rash) outcome: unknown.  No concomitant medication or treatment medication reported. This case linked to MOD-2022-550512 (patient link).
PFIZER 1st shot: February 2021  PFIZER 2nd shot:  March 2021  PFIZER Booster: 12/29/21  Headache/Brain Fog; Couldn't focus and unable to remember names x 1 day (1/2) Nauseous, Dizzy and shooting nerve pains in both arm and legs (1/3 & 1/4) Horrible, very vivid, weird dreams (very scary) (1/3) Very tired, however, unable to fall asleep (1/3) Difficulty swallowing (1/3) Right ear ringing (loud) (1/3 to present) Drowsy, vertigo (1/2 to present)
I felt very faint and lightheaded. I was also extremely nauseous and had diarrhea.
3-8 hrs of screaming & crying/fussy x 24 hrs; induration of lt thigh x 24 hrs; temp to 101;
11Jul90 pt vax w/ hepta B;  20Sep90 HBsAB showed titer of 0.9RU.
This spontaneous report has been received from a registered nurse, referring to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, and drug reactions or allergies, if any, were not provided. On an unspecified date in May 2015 (reported as "3 years ago"), the patient was vaccinated with the first dose of PNEUMOVAX 23, one dosage form, for prophylaxis (frequency, route and anatomical location of administration were not provided; lot number and expiration date were unknown by the nurse). Three years after the patient received the first dose of PNEUMOVAX 23, on 31-MAY-2018, the patient was vaccinated with the second dose of PNEUMOVAX23, one dosage form, for prophylaxis (frequency, route and anatomical location of administration were not provided; lot number R009162, expiration date 06-JAN-2020). No adverse effects or product quality complains were reported. Further information was not provided.
Lung cancer developed in early 50's. He did not smoke. Died of cancer treatment. Suspect connection to Rhesus polio vaccine
Awoke early morning with shallow breathing, fever of 102 degrees & rapid heart beat.  After nursing, breathing remained shallow & heartbeat became faint - patient eventually fell asleep.  Follow-up visit to pediatrician's office.
At injection site (Right outer thigh) welt measured 2cm x 2.5cm with surrounding area red measuring 4cm x 4cm immediately after injection of varicella vaccine SQ. Dr notified. Instructed to given BENADRYL, monitor for fever & changes. 01/06/2012 - no further s/sx: cleared up.
get very sick every year; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involved a patient with unknown demographics who get very sick every year (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported that he/she get very sick every year (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown, at the time of reporting.  There will be no information available on the batch number for this case.
20 days p/ vax pt devel generalized rash w/13 lesions, 26sept devel low grade fever & bumps on the arms & legs, 27sept exp diarrhea, also exp runny nose & irritability. MD believed the generalized rash was bug bites
administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were 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. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Original Case : US2021223559 US-GLAXOSMITHKLINE-US2021223559:Same reporter
Sore left armpit; swollen left arm; This spontaneous case was reported by a pharmacist and describes the occurrence of AXILLARY PAIN (Sore left armpit) and VACCINATION SITE SWELLING (swollen left arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced AXILLARY PAIN (Sore left armpit) and VACCINATION SITE SWELLING (swollen left arm). At the time of the report, AXILLARY PAIN (Sore left armpit) and VACCINATION SITE SWELLING (swollen left arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication  was reported.  No treatment medication was reported.
(R) upper arm erythema/warmth (17 x 16 cm) fever, muscle pains, nausea, fatigue. dizziness. Sx started evening of day of administration. Pt placed on steroid (MEDROL dose pack) 3-1-15 and BACTRIM.
This case was received from a health professional on 25 July 2007.  A 12-year-old patient with no known medical history received an intramuscular right deltoid injection of Menactra (lot number U2327AA) and an intramuscular left deltoid injection of Varivax (Merck, lot number 0674U) on 11 July 2007.  On 13 July 2007, two days after vaccination, the patient developed a temperature of 101 degrees Fahrenheit, chills, sore throat, malaise, vomiting, and neck pain.  The patient was seen in the doctor's office on 16 July 2007, at which time a strep test was negative.  Treatment included fluids and rest, and the events resolved after 48 hours.  Follow-up information received on 20 August 2007 from a health care professional.  The case was reviewed, and there was no additional information at this time. The reporter in this case is the same as in case 2007-02626.
Unknown adverse event; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, less than 4 months after receiving Kinrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Kinrix.  Additional details were provided as follows: The age at vaccination was not reported. The purchaser on the line stating there are physicians from the pediatric Unit reporting adverse reactions to specific lot numbers for the product.  The patient had injection site reactions to Kinrix.  The reporter consented to follow up. The reporter did not have any further details for the patient. The PQC Form was considered an adverse event only.  No product complaint was reported. This case linked with US2019145738, reported by same reporter.
pt had a poss allerg react to flu vax in early DEC; relatives recall the day following vax pt was sick & throwing up; 2 days later ached all over & had diarrhea & then devel rash five to seven days later; rash turned more hive-like splotchy
Broke out in hives the next day. Family physician determined it was a chicken pox like reaction. Joints hurt.
Red raised rash at injection site (RA) and red rash on left leg at calf. Patient took BENADRYL for itch.
Neck pain; A spontaneous report was received from a 24-year-old female male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced neck pain.   The patient's medical history was not provided. Concomitant medications were not reported.  On 03 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026C20A) intramuscularly in arm for prophylaxis of COVID-19 infection.  On 04 Jan 2021, 24 hours post dose, the patient experienced neck pain. She described the pain as off and on for past four days.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event neck pain was unknown.; Reporter's Comments: This case concerns a 24-year-old female who experienced NS unexpected event of neck pain. Event onset occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.