chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left upper arm pain, redness, and swelling with progression down to elbow and underside of upper arm.
ACHES; SORE ARM; SLIGHT CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 10-APR-2021, the subject experienced aches. On 10-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced slight chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, slight chills and aches was not reported. This report was non-serious.
Premature Ventricular Contractions,  Tachycardia.  Has lasted 4 weeks.
Raised swolen area at injection site approx inch diameter. Lymph node swelling and itching in armpit of same arm.  Patient indicated a need for additional sleep the following day.  Patient is unsure of the the brand of vaccine.  Patient is only 2 days into the vaccine.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 6th March 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain. On 7th March 2019, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovering/resolving. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX in the left arm and experienced arm pain at the injection site the day after. A day before the date of reporting, the patient also noticed redness at the area the size of a grape, not raised just the circle size of a grape. After showering at the date of reporting, the redness grew to the size of an apple again not swollen. It was located below where the injection was given. The patient consented to follow up. This case was linked with US2019043026, reported by the same reporter.
a few drops dripped out between the needle and the syringe; it was like four drops that ran down the patient's arm with no reported adverse event; Initial information was received on 21-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 24 years old female patient who experienced a few drops dripped out between the needle and the syringe; it was like four drops that ran down the patient's arm with no reported adverse event after receiving rabies (hdc) vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect rabies (hdc) vaccine(Powder and solvent for suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event of a few drops dripped out between the needle and the syringe; it was like four drops that ran down the patient's arm with no reported adverse event (accidental exposure to product) (unknown latency) following the administration of rabies (hdc) vaccine.  No lab data reported.  Action taken with rabies vaccine (Imovax Rabies) was not applicable.  At time of reporting, the outcome was Unknown for the event a few drops dripped out between the needle and the syringe; it was like four drops that ran down the patient's arm with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
sores inside her mouth and tongue; sores inside her mouth and tongue; sore throat; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included autoimmune disease. The patient's concomitant medications were not reported. The patient previously took two shots of cortisone last Wednesday. On an unspecified date, patient stated that she has sores inside her mouth and tongue and a sore throat. Patient further wanted to know that cortisone could reduce the effectiveness of the vaccine? The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
two hours after vaccination I experienced injection site felt like it was hit with a bat, tired, dizzy, headache, muscles and joint pain every where like I had the flu, chills, nausea, face and throat swollen and knots on throat, my mouth had sores on my gums, I had a cough and had to take medication for that, sore throat, my fever was up and down.
Pt recvd Hep B (Recomb) on 15MAY91 & on 16MAY91 lab eval revealed abnl liver function tests; Hep B & Hep C panel were neg; 14JUN91 pt recvd 2nd dose of Hep B vax & exp no rxn;
When I first got the shot, 25 minutes later it felt like my left hand wanted to cramp up. That lasted about 3 hours. The. The soreness around the injection started and never went away. Then I could not go to sleep that night, the soreness feeling got more intense. I won?t at 5 trying to get ready but the more I moved my arm the soreness got worse and it started to burn.
Wrist became inflammed and in pain, dr said flare of carpal tunnel now in both wrists, but worse on left arm; Joint pain in arm and shoulder-left side; Injection site soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARPAL TUNNEL SYNDROME (Wrist became inflammed and in pain, dr said flare of carpal tunnel now in both wrists, but worse on left arm), INJECTION SITE PAIN (Injection site soreness) and ARTHRALGIA (joint pain in arm and shoulder-left side) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE PAIN (Injection site soreness). On an unknown date, the patient experienced CARPAL TUNNEL SYNDROME (Wrist became inflammed and in pain, dr said flare of carpal tunnel now in both wrists, but worse on left arm) and ARTHRALGIA (joint pain in arm and shoulder-left side). At the time of the report, CARPAL TUNNEL SYNDROME (Wrist became inflammed and in pain, dr said flare of carpal tunnel now in both wrists, but worse on left arm), INJECTION SITE PAIN (Injection site soreness) and ARTHRALGIA (joint pain in arm and shoulder-left side) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used included blood thinner. The week following vaccination, the patient wrists became inflamed and in pain. Their doctor said it was flare up of carpal tunnel, which is now in both wrists, but worse in the left arm. Treatment for the events included ice. No prescription medications were provided. The patient has recovered with no problems.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up information was received and processed the same time as initial report. Follow-up information from the patient indicated they recovered.
Can not move the arm; Itchy arm; Red arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move the arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE SWELLING (Swollen arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move the arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE SWELLING (Swollen arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move the arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 7 months old male patient who received 0.5 ml third dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE (Liquid: lot: UJ100AB, Expiry date Jun-2020) via unknown route in the left thigh on 13-Feb-2019. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that the patient was administered with just the diluent-DTAP IPV portion and the lyophilized powdered-ACTHIB portion was not administered. No side effects reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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. Documents held by sender: none.
This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. This Pharmacist reported similar events for 3 patients. This is 2nd of three reports. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness, swollen and feels warm at the injection site after pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) administration. The outcome of the events was recovered on an unspecified date. Information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018424190 same reporter, event and suspect drug; different patient; US-PFIZER INC-2018424204 same reporter, event and suspect drug; different patient.
red and swollen arm at injection site; red and swollen arm at injection site; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE ERYTHEMA (red and swollen arm at injection site) and VACCINATION SITE SWELLING (red and swollen arm at injection site) in a 101-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red and swollen arm at injection site) and VACCINATION SITE SWELLING (red and swollen arm at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red and swollen arm at injection site) and VACCINATION SITE SWELLING (red and swollen arm at injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included hot compress and elevate.  Upon in internal review on 21 May 2021, the age was corrected to an unknown age.
Began vomiting & running a fever approx 9 hrs p/receiving vax; Seen by MD dx of probable gastroenteritis;
itchiness body wide; headache; tingling in mouth and face; tingling in mouth and face; swollen face; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 09Mar2021 13:00 (Lot Number: EN6207) (at the age of 52-years-old) as 1st Dose, single dose for covid-19 immunization. Medical history included PFO/ASD (Atrial Septic Defect) , TIA (transient ischaemic attack), asthma, high BP (blood pressure),  diabetic and obesity. Patient has known allergies in cinnamon, cloves, allspice, adhesives, mold and pollens. The patient was not pregnant and did not have COVID prior to vaccination. Concomitant medications included BP medication, zolpidem and cholesterol medication. The patient did not receive other vaccine in four weeks. The patient experienced itchiness body wide, headache, tingling in mouth and face and swollen face even after taking 2 BENADRYL on 09Mar2021 at 13:15. The patient was not tested for COVID post vaccination. The outcome of events  was recovering.  No follow-up attempts are possible. No further information is expected.
they are past due for dose two / they received dose one / in August on 2019 / they have not received dose two; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The consumer declined to provide demographics, lot number, or expiration date. The reporter did not consented to follow up  No additional details to report. This case has been linked with case US2021147629, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021147629:Same reporter
Stroke from a blood clot that went to the left side of my brain causing the right side of my body to be numb , weak and to lose a range of motion. Event date: 3/24/2021; hospitalized 3/24/21, 3/25/21, and 3/26/21.
Vomiting; Constipation; This is a spontaneous report from a contactable consumer or other non hcp.     A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown), via an unspecified route of administration, on an unknown date in Mar2021 (at the age of 74- years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. It was unknown if the patient had allergies to medications, food, or other products. It was unknown if the patient received any other vaccines within 4 weeks prior to COVID vaccine. It was unknown if the patient took any other medications within 2 weeks of vaccination.  The patient's concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination. It was unknown if the patient was tested positive for COVID-19, since having the vaccine. It was unknown if the patient receives any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown is any other medications patient received within 2 weeks of vaccination. The patient experienced vomiting and constipation on an unknown date in Mar2021. It was reported that she was quite healthy and active so these issues were not normal for her. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Patient said that she had several issues. Vomiting & constipation were the primary issues that I remember. She's a retired nurse, quite healthy and active so these issues are not normal for her. She is okay with you contacting her for more information. The treatment received for the vomiting and constipation was unknown. The clinical outcomes of the vomiting and constipation were recovered on unknown date in Mar2021.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's Country captured as "country name". Final sentence "Information about lot/batch number cannot be obtained. No further information is expected." updated as "No follow-up attempts are needed; information about lot/batch number cannot be obtained." Initial information need review.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient contracted COVID after being fully vaccinated, no booster Weakness, body aches, dizziness, chills, congestion, headache, hypoxic, fatigue.
pt recv vax 16DEC96 & 7JAN97 pt devel fatigue & a sore throat w/no cough;the fatigue resolved on 24MAR97;A red macular rash devel on the trunk & extremities & resolved;pt also devel a h/a intermittently;
Pt. came back about 3 hours after vaccination complaining of redness warmth to touch and swollen area at site. Pt went to see nurse in clinic on site and Dr. who both confirmed allergic rxn. She took BENADRYL for the rxn.
Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case is linked to 2019SA035905 and 2019SA037139 (same reporter). This case involves a female patient (age not reported) who was vaccinated a dose of ADACEL lot U5980DA via unknown route in unknown administration site on 02-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to incorrect product storage and deteriorated drug administered. It was reported that the patient was vaccinated which was not viable and had a temperature excursion on 19-Nov-2018 at 32 F. It was unknown whether the patient had any harm or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. List of documents held by sender: none.
Pt developed a red, hot patch about the size of 2"x3" on the right arm. Stated a little pain but no fever. Pt stated it occurred the night that the shot was given.
Severe, Symptomatic Aortic Stenosis. Hospital admission. This visit is within 6 weeks of rece3iving the COVID vaccine.
She had allergy in her whole body like a rash and then she had hive she also got hiverash all over her whole body even her face from head to toe; She had allergy in her whole body like a rash and then she had hive she also got hive; Bad itch; She had allergy in her whole body like a rash and then she had hive she also got hive; Dizziness; Headache; Vomit; Diarrhea; Got a fever 104, 105; Tiredness; This is a spontaneous report from a contactable consumer (patient's husband) or other non hcp. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: 301308A via an unspecified route of administration on 15Sep2021 (at the age of 43-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FC3183 via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunisation. On an unknown date in Sep2021, the patient had a bad reaction, the patient had allergy in her whole body like a rash and then she had hive she also got hive rash all over her whole body even her face from head to toe, bad itch, dizziness, headache, vomit, diarrhea, got a fever 104, 105, tiredness. So we took her to the hospital (further clarification unknown). They kept on trying to put different medication they put on steroids (unspecified medications) but it made it worse like she got hives all over again after they put, she got hives worse like it was itching her whole body she was in bad itch. She had rash all over her whole body even her face from head to toe. She was scared you know because every time they put a medication so they would also put Benadryl and this Benadryl seem like it helped with allergy with rash a little bit but then it would come back a little bit after it relived a little bit itching then the rash come out again. They put some other medication (unspecified medication) and she broke out again she got hives again and rash. She was there for 4 days like that. The reporter added that the patient was in hospital from 16Sep2021 to 19Sep2021. The patient underwent lab tests and procedures which included blood test: unknown results on Sep2021, body temperature: 104, 105 on Sep2021 Fever. Therapeutic measures were taken as a result of adverse events. The patient received treatment with Benadryl and an unspecified medication. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Pt recvd vax & 54 hrs p/vax exp dizziness with changes in position; pt was seen by MD; pt indicated that recovered spontaneously 1 wk p/onset of sx;
Patient reported to clinic on 8-17-07 at 14:10 PM complaining of swelling to penis, rash on suprapubic area nd face. Patient is able to urinate.
Client's arm was sore and achey 2 hours after immunization.  By 6:00 p.m., she couldn't lift her arm up.  She had to use teh other arm to lift her left arm.  She had fever of 100.8 F, used cold packs and took ibuprofen.  Had the problem for 3 days and couldn't work.  Had to cut her sleeve off left arm.