chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Medical Assistant via Field Employee refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX Single dose (route, dose and lot # were unknown). Without any concomitant vaccination. On an unknown date the patient experienced extreme swelling of the arm, which lasted for an unspecified period of time. The patient was recovered within an unspecified period of time, without any intervention. The patient sought medical attention via contacting physician. This is one of two reports from the same reporter. Additional information is not expected.
she unknowingly had Covid infection/tested positive for Covid/chills, headache and coughing; she unknowingly had Covid infection/tested positive for Covid/chills, headache and coughing; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Covid 19 vaccine on an unknown date, but she unknowingly had Covid infection on an unknown date. On the second day, she had chills, headache and coughing, and her symptoms got worst on the third day. They took her to urgent care and it turned out it was not related to the vaccine, she tested positive for Covid (date unspecified) and they gave her a Bam infusion. She was recovered now, she tested negative on an unknown date, but reporter wanted to know if patient can get the second dose, that patient have scheduled for 26Mar2021. The outcome of the event was recovered on an unspecified date.   Information on about lot/batch number has been requested.
vaccination site pain; Dizziness; Fever; cough; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain), COUGH (cough), DIZZINESS (Dizziness) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced COUGH (cough) and PYREXIA (Fever). On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain) and DIZZINESS (Dizziness). At the time of the report, VACCINATION SITE PAIN (vaccination site pain), COUGH (cough), DIZZINESS (Dizziness) and PYREXIA (Fever) outcome was unknown.        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.   concomitant medication were not provided   This case was linked to MODERNATX, INC.-MOD-2021-109993 (E2B Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2021-109993:Wife case
expired Daptacel vaccine that was administered, NO AE; Initial information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 18 months old female patient who was vaccinated with expired 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5366BA and expiry date: 07-Feb-2020) via intramuscular route in the left thigh on 12-FEB-2020 for Prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE).  It was actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a medical assistant concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of RECOMBIVAX HB lots # L048208 and L048849 with expiration dates 15-SEP-2017 and 04-FEB-2018 respectively, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. The medical assistant reported that the vaccine was exposed to a temperature of 51F for 1 hour and 30 minutes and then was also exposed to a temperature of 48F during an hour and that this information was obtained with a digital data logger. Finally, no product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as no consent for follow up was given.
55 minutes (12:00pm) after receiving 1st dose of Moderna COVID-19 vaccine resident was shaky all over.  States he's had panic attacks but it "doesn't feel like that".  Denies chest pain.  Denies shortness of breath.  Visibly shaking.  Facial   Hx of diabetes and had just finished lunch.  Blood sugar 189.  02= 98% on room air, BP 140/70  Pulse 106.  At 12:07 complains that tongue feels numb and throat feels tight.  12:08 pm, Epi-pen administered to left outer thigh.  12:16pm  states he's feeling better.  Shaking has subsided.  Tongue numbness almost gone.   12:31pm T= 98.3  02 = 98%   P=80   BP= 114/72
Pt was given DTaP L upper thigh - local edema, erythema - mom had a severe respiratory reaction as a baby.
I had a little red rash and along in my arm; a little swollen and it hurts; a little red rash and along in my arm and heat; a little swollen and it hurts; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Dec2022 as dose number unknown (booster), single (Lot number: GJ6739) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high; "High cholesterol" (unspecified if ongoing), notes: High cholesterol; "GERD" (unspecified if ongoing), notes: GERD; "Type 2 diabetic" (unspecified if ongoing), notes: Type 2 diabetic; "vision problems" (unspecified if ongoing), notes: Avastin shots for in my right eye; "little mini stroke", start date: Dec2013 (unspecified if ongoing). Concomitant medication(s) included: METFORMIN ER oral; OZEMPIC taken for diabetes mellitus; GLIPIZIDE; LIVALO taken for blood cholesterol abnormal; EZETIMIBE oral; BABY ASPIRIN; VITAMIN D 2000; PEPCID [FAMOTIDINE] taken for gastrooesophageal reflux disease. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Unknown manufacturer), for Covid-19 immunization. The following information was reported: RASH (non-serious) with onset Dec2022, outcome "not recovered", described as "I had a little red rash and along in my arm"; FEELING HOT (non-serious) with onset Dec2022, outcome "not recovered", described as "a little red rash and along in my arm and heat"; PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Dec2022, outcome "not recovered" and all described as "a little swollen and it hurts". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, pain in extremity, feeling hot, peripheral swelling. Additional Information:  Treatment: Consumer stated that When she first got home I took Tylenol and she put ice pack on it for the first 2 days, and then the last 2 days, she have aloe Vera cream in my refrigerator and she have been putting refrigerated aloe Vera cream on it and it seems to help. Consumer stated that Monday I had my A1C check and it was 7.5." (Further the result was not clarified hence, not captured in tab)
Third dose was given on day 0, 7 and 14; Case reference number US-BN-2021-002269 is a spontaneous case report initially received from a health professional via Agency (reference number: USBAV21-0467) on 10-Sep-2021 and concerns a male patient of an unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided), at a dose reported as one vaccine per dose, via unknown route or site of administration and for pre-exposure immunisation.   On an unspecified date, also reported as on a day seven, the patient was vaccinated with the second dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided), at a dose reported as one vaccine per dose, via unknown route or site of administration, for pre-exposure immunisation.   On an unspecified date, also reported as on a day 14, the patient was vaccinated with the third dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided), at a dose reported as one vaccine per dose, via unknown route or site of administration, for pre-exposure immunisation. The reporter stated that it was an accelerated dosing (explicitly codes as Inappropriate schedule of vaccine administered').  The reporter asked if the patient was going to get an adequate response duo to changed vaccination schedule.  It was not reported if the patient experienced any adverse event due to RabAvert.  The reporter assessed the event as non-serious and not related to RabAvert vaccine.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient was vaccinated with the third dose of RabAvert, for pre-exposure immunisation, on Day 14, which is considered inappropriate schedule of product administration. No associated adverse events were reported. Inappropriate schedule of product administration is not related to the suspect product, but to a human action. This case is considered non-serious.; Sender's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient was vaccinated with the third dose of RabAvert, for pre-exposure immunisation, on Day 14, which is considered inappropriate schedule of product administration. No associated adverse events were reported. Inappropriate schedule of product administration is not related to the suspect product, but to a human action. This case is considered non-serious.
father reported that patient's DOB was 5/17/09 and was 12 years old on VAR questionnaire. When processing rx after administration, a duplicate patient record came up with a different DOB of 5/27/09 which would make pt 11. Upon calling parents, we verified that pt's DOB was 5/27/09 and he wouldn't be twelve for another 7 days after first dose administration.
Second Moderna COVID 19 taken 2/5/21 at Hospital with no adverse reaction. I took Dupixent injection myself on 2/8/21. That night my face and ear lobes started to burn and turn very red and swollen. I took Benadryl 25mg and called Dr. She said probably an interaction.
Exposed to COVID; This spontaneous case was reported by a non-health professional and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to COVID). On 13-Jan-2021, EXPOSURE TO SARS-COV-2 (Exposed to COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact; Sender's Comments: This case is under consideration for deletion.
?COVID Arm? - large swelling under the skin at the shot site with blotchy, itchy red rash
Information has been received form a 65 year old female consumer with osteoporosis and cholesterol and no drug reactions or allergies, who "in October or November 2010", was vaccinated with a dose of ZOSTAVAX (Lot # not reported). Concomitant therapy included alendronate sodium (MSD), simvastatin (manufacturer unknown) and trazodone HCl. The consumer reported that she was administered ZOSTAVAX on Monday and by Wednesday she developed a rash which her physician said was shingles. The consumer noted that the rash was on her back, sides and chest and was extremely painful for about a month and a half. The consumer noted she still had a rash in those places but it was not painful, it just looked bad. There were no longer any open lesions. It was reported that the consumer had received an unspecified treatment for the adverse events. The consumer sought unspecified medical attention. At the time of the report, the consumer was recovering. Follow up information has been received from a physician concerning the retired patient with no illness at time of vaccination and a history of chicken pox and herpes zoster several years ago, who on 13-OCT-2010 was vaccinated with the first dose of PNEUMOVAX (Lot # 667912/0933Z) IM in the left arm and on 25-OCT-2010 was vaccinated with the first dose of ZOSTAVAX (Lot # 665430/17649Y). The physician reported that on 02-NOV-2010 the patient developed a rash from the right nipple line to the thoracic spine with several congregation of vesicles on an erythematous base. The patient had not recent exposure to chickenpox or herpes zoster. There was not a direct fluorescent antibody done. There was not specimen collected for PCR. There was not photo taken. At the time of the report, the patient had recovered. No further information is available.
Around 1:00pm, a few hours after getting the vaccine in my left shoulder, my left shoulder was extremely sore for about 24 hours. Also I experienced a sore throat around 7:00pm and that lasted overnight and into the morning and then went away during the day.
Ten days, post vax, the pt experienced a rash and low-grade fever. The reporting physician noted "rash is not a measles or rubella rash, think it's just a mild reaction to the vaccination." Additional information has been requested.
Reports migranes on daily basis since vaccine administered and neck pain on the back side. Reports headaches will come and go.  Has been taking Tylenol and ibuprofen. Hx of migranes but has been absent for 5 years.
AT THE END OF THE WAITING PERIOD, PATIENT BECAME PALE, VERY DIZZY AND FAINT, ALONG WITH HEAVY SWEATING.
Fatigue a couple hours after vaccine, I took Acetaminophen  1g at ~8pm High fever (my guess is ~103F) and shivering overnight. At least a few hours, I wasn?t conscious enough to get up and take my temperature nor more medicine. In the morning fever was down to 100F and shivering was gone, I felt a lot better comparatively. Took another 1g Acetaminophen.  Intense fatigue and  98.6F temperature until aprox 24h after the vaccine. I had some chills in the evening, but very mild. Note: I had diagnosed COVID19 last week of October 2020. Then I had 100F fever for 2 days and cold like symptoms starting on day 3 for about 5 days.
The 2nd Covid shot had more side effects.  Moderate headache, chills, body aches and joint pain.  This lasted about 24-48 hours.
fever 103, sore throat & h/a; seen in ER 22JUL95 & given ATB; ER MD told pt's mom that shot was given too fast & should not have recv adult dose
Breakthrough covid case. Had cohabitants that are positive. Tested positive 5/30/21
Initially, loss of sensation of touch; progression to severe hand, forearm pain; developent of involuntary muscle spasms; falls associated with and without headache; neurological decline; hospitalized 5 days; treated with 5 days IVIG; symptom management with medications; persistent mobility and balance problems.
Information has been received from a physician concerning a female who in approximately 2008 ("about 1 year ago") was vaccinated with GARDASIL 0.5 mL. After getting GARDASIL the patient experienced stopped menstruating for a period of time and then went back to normal. Additional information has been requested.
pt recv vax 27AUG97 & 3 days later on 30AUG97 pt was found in a coma w/blue fingers;pt hosp & d/c summary is not available;tx currently unk;pt is in a coma & current status of event is unresolved;
Immediately following administration of  vaccines, localized swelling/slight bruising of injection site area noticed on Right Thigh where Pediarix was administered to the patient. This nurse informed provider who assessed the location and the patient. She informed mother of appropriate return precautions and is prescribing  Benadryl to be administered if needed according to provider instructions.
I had a fever yesterday, bad cough, fatigue, sinus infection, joint pain; muscle ache; sore throat and I've taken TYLENOL for pain and fever.
About 1 year after receiving ZOSTAVAX vaccination I began getting joint pain and tendon weakness, also ligament damage. My Dr. said or blamed my age, I told him there was 100% change in the last year, he said this was normal. I said people don't get vaccination till they are over 60 years old which hides the side effects of the vaccination as old age. Please look into this, it's a hidden adverse reactions to this vaccination ZOSTAVAX.
Patient develop generalized tonic clonic seizure of both upper and lower limbs associated eye rolling and post-ictal phase. Patient had a seizure for 20 minutes requiring ativan x2 and keppra x1 to abort the seizure.
atient was in for 2nd covid-19 (Pfizer lot was EW0167, exp 8/31/2021):  It was her and her brother receiving the vaccine. Brother went first and was fine. She was second. After receiving the vaccine (~30-60sec) she appeared to lose conciseness (not sure if complete or partial) she said she didn't remember all of it, but it was more like a dream. During that she had some twitches/spams (involving circular motions with her arms and leg, leg extended and then retracted, but her head rolled back). Upon coming out/waking she appeared sensitive to light and was nauseous. Left her in the room with her mom to get an ice pack, water, paper towel. Total episode lasted less than a minute, but took about 10-15 minutes (estimate, unsure of full time spent) before she felt good enough to use a wheelchair and get in her mom's car to drive home.
Difficulty Swallowing, Throat Tightness-Mild, and Tingling (specify: facial area, extemities)-Mild. The patient complained for tingling in lips and difficultly swallowing/feeling of lumps in throat. Patient was administered epi-pen and observed for 40minutes after epi-pen. Patient felt fine after and went home. Patient was contacted about 2 hours later and she said she was feeling fine.
loose bowel situation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunization.  The following information was reported: DIARRHOEA (non-serious) with onset Dec2022, outcome "not recovered", described as "loose bowel situation".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
patient lost the ability to walk due to lack of control and loss of sensation in bilateral lower extremities.  First occurred 1 week post dose 2 of the Moderna Vaccine.
Trouble sleeping, anxiety, itching skin but mostly on calves,  little bumps on lower legs that itched, swollen feet and ankles,  ringing in ears, joint pain, fatigue.  Week following shot had dr appointment.  Blood pressure was 200 over 90.  Started immediately on a blood pressure medication.   It took a month to bring it down to 130 over 80.  Started on anti-histamine twice a day.  Started on  pregabalin and vitamin d.  Started methotrexate.   When swelling didnt go down in my feet we started low dose prednisone.
Cheek swelling that was reported into midline into jaw started approximately one hour before report.  Instructed to take Benadryl stat and go to ER if symptoms progressed.  Consulted MD and immediately returned call to pt recommending Benadryl 50mg every 6-8 nhrs for 48hrs with need to be seen at ER if tongue swelling, cough or SOB occur.  Called back to pt at 5:30pm and left message with mother returning call at 6pm stating they had been seen at ER after swelling spread to other cheek and were sent home with same recommendation for oral Benadryl.
Patient states she had redness and swelling at the injection site for approximately 2-3 weeks following 1st injection of Shingrix. Today she presents and states injection site still very painful but no redness or swelling noted.
Soreness in arm, immediately. During the night had chills and aches. Fever is early AM of 100.5F. On 5/11/01, continued with dizziness, achiness and fever. On 5/12/01, recovered.
Swollen L-Arm with mild fever, DX cellulitis per NP. Treated with Keflex 250/5 TID x 7 days.
This case concerned a male patient, age nor reported. The patient had received the first dose of rabies vaccine on 11/14/2005. The patient received a typhoid vaccine, batch number and manufacturer not reported on an unknown date. The patient also received a hepatitis B vaccine, Engerix B, batch number not reported and a meningococcal GP C conjugate, batch number and manufacturer not reported on an unknown date. On 11/21/2005, the patient received the second dose of rabies vaccine, Rabipur, batch number not reported. On 11/29/2005, the patient received the first dose of a Cholera vaccine, Dukoral, batch number not reported. On an unknown date, but following the vaccination, the patient experienced appendicitis and was hospitalized. the patient was not able to received the second dose of Dukoral or the third dose of Rabipur. Details of any corrective treatment have not been provided. It is not known if the patient has recovered at the time of reporting. Both the reporter and MRHA considered this to be a serious reaction (OMIC). No more information is expected, this case is closed.
Pt devel sz; Taken to Hosp seen by MD; Pt had sz 1 yr prior to this event; Not related to immun; On Phenobarbitol;
pt recv vax & devel a flare splotchy red rash @ inj site;the next day rash disappeared;