chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After vaccination, the patient explained that she had already received both doses of the Shingrix vaccine so she was mistakenly given a third dose on 6-3-23.  The patient thought that she needed to get the pneumonia and shingles vaccine on a yearly basis like the flu vaccine so she had scheduled the appt for the pneumonia and shingles vaccine for 6-3-23.  The pneumonia vaccine was not administered to the patient and was discarded by the pharmacist immediately after the pharmacist was informed by the patient.
Patient received shot on 10-20-15 and returned to the pharmacy with a bruise, yellow at the top and purple down her arm, below the injection site. Patient states arm is sore and itchy.
This is a spontaneous report from a contactable consumer. This 45-year-old female patient (consumer) reported for herself that she received first dose of bnt162b2 (Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in upper left arm on 12Nov2021 at 14:15 (at the age of 45 years) as dose 1, single for covid-19 immunisation. Pregnancy at time of Vaccination: No. Medical history included ongoing rheumatoid arthritis in 1997. No known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. There were no concomitant medications. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Facility type vaccine: other Mobile clinic bus. On 12Nov2021 at 19:00, she had muscle and back pain the evening of vaccine and had chest pain. Thought it was a pinched nerve but continued into the next two days and two days after she still had chest pain making it hard to take a deep breathe and then had rapid heart rate. She went to emergency room//department or urgent care (ER) on 14Nov2021. On an unspecified date in 2021, patient experienced internal inflammation. No hospitalization was prolonged. The events were non-serious. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included blood test: unknown on 12Nov2021. The patient received medication which included medicine for internal inflammation, blood work. The outcome of event internal inflammation was unknown while the outcome of other events was recovering. Device timestamp: 15Nov2021.The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up. The patient experienced muscle and back pain (myalgia) (non-serious) on 12Nov2021 19:00 with outcome of recovering , muscle and back pain (back pain) (non-serious) on 12Nov2021 19:00 with outcome of recovering , chest pain (chest pain) (non-serious) on 12Nov2021 19:00 with outcome of recovering , thought it was a pinched nerve (nerve compression) (non-serious) on 12Nov2021 19:00 with outcome of recovering , hard to take a deep breathe (dyspnoea) (non-serious) on 12Nov2021 19:00 with outcome of recovering , had rapid heart rate (heart rate increased) (non-serious) on 12Nov2021 19:00 with outcome of recovering , medical internal inflammation (inflammation) (non-serious) on an unspecified date with outcome of unknown. The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of muscle and back pain (myalgia), muscle and back pain (back pain), chest pain (chest pain), thought it was a pinched nerve (nerve compression), hard to take a deep breathe (dyspnoea) , had rapid heart rate (heart rate increased). The events were non-serious.
Flue like symptom of body aches and low grade temporary abt 36 hours;; Swollen glands left arm pit and into breast tissue - can physically locate and feel swollen glands.; "I"feel pain it they are touched or pressed by clothing.; Flue like symptom of body aches and low grade temporary abt 36 hours; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old female patient received BNT162b2 (PFIZEWR BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 01Mar2021 at 13:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The medical history included hashimoto's disease and morbid obesity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included loratadine(CLARITIN), levothyroxine sodium (SYNTHROID) and cyanocobalamin (B-12), all from unknown dates for unknown indications and unknown if ongoing. On 01Mar2021 at 16:30, the patient experienced flu like symptom of body aches and low grade temperature about 36 hours and swollen glands left armpit and into breast tissue. It can physically locate and felt the swollen glands. The patient felt pain when they are touched or pressed by clothing. The adverse events did not result in doctor or other health care professional office/clinic visit and emergency room or department/ urgent care. Therapeutic measures were not taken as the result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu like symptom of body aches, low grade temperature, swollen glands left armpit and into breast tissue and felt pain when they are touched or pressed by clothing was not recovered at the time of this report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax on 28JAN93 pt exp rubella like sx manifested by inc achiness, backache, swelling of glands in both upper cervical regions, maculopapular erythematous rash; No further details were provided;
As per daughter, client developed heavy phlegm, cough and frequent fevers of 99.6 degrees. On December 8, 2016 he was taken to MD because he was very weak and had difficulty walking. As per daughter client continues to be ill with all previously mentioned symptoms.
Left arm became inflammed red and hot to touch.  Arm was extremely painfull when lifted or during slight movement. These symptoms became worse as time went on.  Patient called the CDC info line and was instructed to seek medical attention.  Patient went to her physician and was diagnosed with Cellulitis.  She was perscribed Doxycycline Hyclate 100 mgs.
Medication Error Only: I had not noted the complete Hep B series on the out-of-state immunization record prior to administering the Heplisav dose and discovered the error when re-reviewing the record to enter as history.
Shortness of Breath Hives Swollen Tongue Treated at ER.  Received IV Benadryl and Solu-Medrol
expired ActHib was given with no adverse event; Initial information received on 30-Mar-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves patient of unknown age and demography to whom an expired HIB (PRP/T) VACCINE [ACT-HIB] (lot number and expiration date not reported) was given via unknown route in unknown administration site for prophylactic vaccination on an unknown date.   The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  It was a case of actual medication error due to expired vaccine used (same day latency).  Pediatrician asks for appropriate follow-up after expired vaccine was given and also asked what would be adverse reactions to monitor for.    It was not reported whether the patient had any adverse event.  No further information available at the time of report and health care professional stated they will be reporting it later.  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.  There will be no information available on batch number for this case.
I did not administer vaccine, patient did not provide information during brief hospital stay.  Our database does confirm he received vaccine from source on 08/16/2021.
20 or so pox on trunk and thighs. A couple on arms. First ones to appear have broken open and scabbed over. No s/s itching. No treatment at this time.
Pain all over body, aches, nauseous for 2 days, arm where shot was injected was painful for two days and could barely move it. Headache, stiff neck and high fever that lasted a day. Fatigue lasting into 3rd day of getting shot.
HCP reported an 18 YO female received a third dose of Bexsero; This non-serious case was reported by a physician via sales rep and described the occurrence of extra dose administered in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 1st of Bexsero on an unknown date) and Bexsero (received 2nd of Bexsero on an unknown date).   On an unknown date, the patient received the 3rd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: HCP reported an 18 YO female received a third dose of Bexsero). The outcome of the extra dose 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 Information: GSK Receipt Date: 21-OCT-2023 The healthcare profession (Physician) reported an patient received a third dose of Bexsero which led to Extra dose administered. The reporter consented to follow up.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 10-JUL-2013 the patient was vaccinated with MMR II (lot number reported as H017927, expiry date 14-SEP-2014) that reporter could not support with their temperature stability. No adverse effects reported. It was unspecified if the patient had sought medical attention. This is one of several reports from same source. Additional information has been requested.
First injection was given at mom's request on 9/15/2021. Second dose given 10/13/2021.
Itchiness on b/l legs- 50mg IM benadryl given in R arm, vitals taken: 99%O2, HR 93, Temp 37.1, BP 136/85. Pt monitored for 1 hour. Pt denies rash.
Hives and welts all over my body for 3 days. Took allergy Benadryl with Tylenol. I've had flu vaccine for the past 7 years and this was my first adverse reaction.
Developed knots on several fingers  - left hand Developed severe pain in middle finger left hand - still in pain after more than a week. Waiting to hear from primary care physician concerning appt to investigate the issue
pain in right thumb; pain in index finger joint; pain in wrist; pain and stiffness in my right thumb; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 11Feb2021 (Batch/Lot Number: EM9809) as single dose for covid-19 immunisation. Medical history included hypertension, goitre , anxiety and "Known allergies: Blackened Seasoning". Patient did not have Covid prior to vaccinationand was not tested post vaccination. Concomitant medication(s) included hydrochlorothiazide/triamterene (TRIAMTERENE & HCTZ) taken for an unspecified indication, start and stop date were not reported; diltiazem hydrochloride (DALTAZEN) taken for an unspecified indication, start and stop date were not reported; buspirone taken for an unspecified indication, start and stop date were not reported.  On 16Feb2021 07:00, patient experienced pain in right thumb, pain in index finger joint, pain in wrist, pain and stiffness in my right thumb. Therapeutic measures were taken as a result of the event included: Quick fit Wrist/Forearm UNIV, RTbrace and Ibuprofen. Outcome of events was not recovered.   No follow up attempts are Possible. No further information is expected.
patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion).    No concomitant products reported.  It was reported that patient received the dose of Moderna vaccine post excursion.  No treatment products reported.   This case contains information for the 7th of 19 patients reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:pt 1 of 19 (master case)
Patient woke with enlarged leg, left thigh. Parents started factor right away. Called the office later to see what to do. Dr recommended ER. went to ER next day 12/19/09. Had ultra sound of leg, appeared injection went into muscle. Started on antibiotic to prevent cellulitis.
Starting 07/01/2022, I started getting a sore throat, chills, pain around the rib cage, fever and coughing up phlegm. On 07/02/2022, I kept feeling worse and continued to cough up more phlegm. On 07/03/2022, I went to urgent care and they tested me for COVID-19 which came back positive. I took everything I wasn't supposed to on Saturday to try to open up my throat because I was concerned (prednisone, doxy etc which is what I normally take when I have asthma/breathing issues) and the urgent care told me I shouldn't have. The urgent care called me in a rescue inhaler of albuterol and a new prescription for cough medicine. This is what I have been using every 6 hours. I am not doing to great but am okay as long as I don't cough. I'm still taking extra strength tylenol due to having a fever.
terrific headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "terrific headache".  Additional information: Patient had the new shot and had a terrific headache. Patient was asking if she can take tylenol.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received vaccinations. As he was exiting the store he fainted and stumbled.  Per father he caught him before he fell to the ground.  Someone at front of store called 911. Paramedics arrived and provided care.  Patient recovered and father refused any further assistance from paramedics.  Contacted patient's physician and informed them of event.  Also recommended to patient's father that they follow up with primary care physician.
Patient reported left bicep was tender, red, slightly swollen, and warm to the touch approximately 7:00pm. The swelling and soreness has worsened over the last 48 hours. She tried TYLENOL for the pain and ice for the swelling. I advised her to seek medical care due to worsening symptoms.
Patient received Pneumovax (23 valent to left arm).  Lot # 0676M, 0.50cc 10/22/2003.  Patient developed arm pain and swelling.
24 hrs. after injection I had aches without a fever. That next am (4-6am)I had a low grade fever which was relieved with Tylenol. I continued to have aches again the next day-48 hrs. after injection. I noticed a red raised rash on my right arm from my axilla to wrist that was itchy intermittently. By the next day the rash remained(after treatment with Benadyl)and spread only to one small area on my abdomen-the right side. I recieved the injection in my right arm. The aches were gone by 72 hrs. Rash continues but has not changed in definition.
The pt experienced localized redness and induration x 2 days. No fever and no limpness noticed.
Pharmacist called to report that they gave a vaccine to two patients that was past the 12hr window; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist called to report that they gave a vaccine to two patients that was past the 12hr window) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist called to report that they gave a vaccine to two patients that was past the 12hr window). On 21-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Pharmacist called to report that they gave a vaccine to two patients that was past the 12hr window) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow up received and contains No New Information. On 25-Aug-2021: Follow up received added patient demographics (patient race), Second dose details(Route and site of administration).
A day later around red bump appeared.; A day later around red bump appeared.; Shot was given to me in wrong location down low on fatty part of my arm and nowhere near the deltoid muscle.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Mar2021 at 17:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Mar2021 at 17:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 29Mar2021 at 17:45, the patient reported that the shot was given in wrong location down low on fatty part of the arm and nowhere near the deltoid muscle and on 30Mar2021 at 10:00, a day later around red bump appeared. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event around red bump appeared was unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-MAR-2016 the patient was vaccinated with an improperly stored dose of VAQTA 10Pk 50U/1ml (lot # L017757, expiration date 08-APR-2018, dose and route were unspecified. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second timer was 360 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been received.
Vertigo occurring 10 days after each injection; This is a spontaneous report from a contactable consumer (herself). A 70-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left on 16Feb2021 at 14:45 as single dose for covid-19 immunisation. Patient did not take other medication in four week. The patient medical history and concomitant medication(s) included alirocumab (PRALUENT), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). Historical Vaccine included first dose of bnt162b2. On an unspecified date, the patient had vertigo occurring 10 days after each injection. Patient took other medications in two weeks was included praluent, BREO, allergy medications and vitamins. The outcome of the event was recovering.  Information about lot/batch number has been requested.
This spontaneous report as received from a pharmacist refers to a 71 year old female patient with depression, high cholesterol and TYLENOL allergy. On 03-SEP-2013 the patient was vaccinated with a first dose of ZOSTAVAX lot # H021712 exp date 06-MAR-2014, subcutaneous (dose not reported) to prevent shingles. Concomitant therapies included CELEXA and simvastatin (manufacturer unknown). In an approximately September 2013 (reported as soon after this) the patient experienced bruising at the site of injection. The outcome of bruising at the site of injection was reported as recovered on 21-SEP-2013. The patient's event was not treated. The patient sought medical attention: went to pharmacist. No lab diagnostics studies were performed. Relatedness between the patient's event and ZOSTAVAX was not reported. Additional information has been requested.
Rash and swelling on upper arm under the injection site. Started on 11/2 and continued up to mid-day 11/3 at time of notification. Patient had not taken anything for the condition at time of notification.
Joint pain and swelling primarily in both shoulders and hands. Nearly 60 days later the joint pain and swelling has settled into both hands. The resulting adverse effects are slight joint pain, loss of dexterity and flexibility, and swelling in all fingers.