chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an unspecified number of unspecified patients received a dose of improperly stored PEDVAX HIB or ROTATEQ; No additional adverse effect reported; This spontaneous report was received from a medical assistant referring to unspecified number of unspecified patients of unknown age and gender. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.   On unknown dates, the patients were vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # r036178, expiration date 09-OCT-2021; vaccine dosage detail and route of administration were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # r029818, expiration date 09-JUL-2020; vaccine dosage detail and route of administration were not reported) for prophylaxis (product storage error). Current temperature excursion was above 47 Fahrenheit degrees (56.8 Fahrenheit degrees) for 2 hours and 15 minutes. Previous temperature excursion was above 47 Fahrenheit degrees (51.4 Fahrenheit degrees) for 1 hours and 45 minutes. No additional adverse effect reported (no adverse event). Data logger was involved.  This is a non-valid case as no identifiable patient.
Mild injection site pain; muscle and joint pain; muscle and joint pain; fatigue; severe diarrhea; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm Left on 26Feb2021 10:30 (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, high blood Pressure ,neoplasm malignant and depression. Known allergies included shellfish. Concomitant medication included acarbose taken for an unspecified indication, glipizide taken for an unspecified indication, lisinopril taken for an unspecified indication, metformin taken for an unspecified indication, metoprolol taken for an unspecified indication. On 27Feb2021 12.00 am the patient experienced mild injection site pain, muscle and joint pain , muscle and joint pain, fatigue and severe diarrhea. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There was no treatment received for the adverse events. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
My COVID-19 symptoms started on 03/05/2023 in the morning. I had a very runny nose, cough, slight sore throat, slight fever, chills. I went to an urgent care clinic where they did COVID-19 test which was positive. The PA prescribe me Paxlovid. I stopped taking the medication on the 3rd day because my symptoms especially cough got worse. I went to my doctor because of my symptoms but she didn't prescribe me any medication. It just went away . I still have cough and it might stay for few weeks or months. On 03/13/2023 i had a rebound case of COVID-19 with cough and runny nose. It lasted till 03/13/2023-03/24/2023. It went away by itself.
felt like throat was closing; This is a spontaneous report from a non-contactable pharmacist. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route administered in right arm on 30Mar2021 (Batch/Lot Number: er8727) at the age of 63 years, as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if patient had COVID prior to vaccination. The patient stated she felt like throat was closing on an unspecified date. Dexamethasone was administered and symptoms resolved. Outcome of the event was recovered on an unspecified date. It was unknown if patient was tested for COVID post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported event Throat tightness and suspect drug BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Received Expired Dose of Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Booster) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   Reporter did not allow further contact
Patient reported sore arm that lasted almost 3 weeks. Soreness has been improving but still present when he reported. Pt also reported episodes of dizziness and flu like symptoms after the shots. Patient was advised to continue monitoring if symptoms did not improve, pt would call MD.
0.25ml booster Moderna shot was given instead of the second dose 0.50ml that the client actually needed. The client was  contacted  and informed of error. Information on this was emailed and the recommendation was if another 0.25 could be given today, it would be ok to count as 0.50 2nd dose.  If not able to be given today then 0.50 would have to be given.   The client was notified and  agreed  to get another 0.25ml which was done at her convenience at her home at appx 1pm 0.25ml Mderna was administered at the client's home on the same arm as her request. The vaccine was  drawn from the same vial as the previous vaccine.
Information has been received from a 39 year old female nurse with previous "reactions to multiple vaccines" who on 18-DEC-2007 was vaccinated with a fifth dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The patient reported that after receiving her fifth dose of measles virus vaccine live (enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) because she did not have a titer, she experienced redness at the injection site and her right upper deltoid was swollen the size of a baseball. The experience occurred within 24 hours of vaccination. Unspecified medical attention was sought. The patient was given antibiotics and BENADRYL. The patient reported that she had an "allergic reaction with previous injections." The outcome was reported as improved but not total resolved, recovering. No lot number was provided. There was no product quality complaint. In follow-up information from a physician, it was reported that the 39 year old patient with a penicillin allergy experienced severe cellulitis, which required an emergency room/doctor visit. The patient subsequently recovered. There was no illness at the time of vaccination. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/30/2008.  Information has been received from a 39 year old female nurse with previous "reaction to multiple vaccines" who on 20-DEC-2007 at 12:30 PM (also reported as 18-DEC-2007) was vaccinated SC with a fifth (also reported as second) dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus live (Wistar RA 27/3) (rHA) (Lot # 657138/0865U).  There was no illness at the time of vaccination.  The patient reported that after receiving her fifth dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar PA 27/3) because she did not have a titer, she experienced redness at the injection site and her right upper deltoid was swollen the size of a baseball.  The experienced occurred within 24 hours of vaccination.  Unspecified medical attention was sought.  The patient was given antibiotics and BENADRYL.  The patient reported that she had an "allergic reaction with previous injections".  The outcome was reported as improved but not totally resolved, recovering.  No lot number was provided.  There was no product quality complaint.  In follow-up information from a physician.  It was reported that the 39 year old white patient with a penicillin allergy experienced severe cellulitits, which required an emergency room/doctor visit.  The patient subsequently recovered.  There was no illness at the time of vaccination.  Follow up information indicated that on 20-DEC-2008, the patient experienced swelling and tenderness at the injection site.  Severe cellulitis was noted.  ROCEPHEN was adminstered IM to treat, along with CEPHALEXIN oral.  The patient recovered.  No additional information is expected.
I developed a headache 30 minutes after receiving the vaccine. I had a headache every day following that for 8 consecutive days. Of moderate intensity.  Advil helped, but did not alleviate.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L012042, expiration date 18-NOV-2016; lot # L003227, expiration date 13-OCT-2016; prefilled syringe lot # L003189, expiration date 23-JUN-2016; dose and route unknown). No adverse events were reported. Additional information is not expected because there's no consent for follow up.
Patient received first dose of Pfizer vaccine and reported lip tingling and numbness as well as "a funny feeling in his stomach" and light headedness. individual was taken to private stretcher area. Vital signs stable: BP 145/88, HR 64, RR 18, O2 Sat 100%. Observation continued for 30 additional minutes and symptoms resolved. No medications provided. Patient reports allergies and brought epi pen with him.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) (dose, route and lot number unknown). On an unknown date the patient experienced injection site reactions following the administration of ZOSTAVAX. The patient developed redness, warmth, swelling and pruritus. The outcome of the events was unknown. The patient had sought medical attention via office visit. Nurse was offered the VZVIP packet, which she declined. This is one of the two reports from the same reporter. Additional information has been requested.
Dizziness/lightheadedness; pallor; shaking; headache; vomiting; ringing in ears; shortness of breath; tachycardia; This is a spontaneous report from a contactable consumer (patient's parent). A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: Solution for injection, Lot number: EW0196, Expiration date: Unknown), via an unspecified route of administration in Left arm on 25Jun2021 at 12:00 as dose 1, single (at the age of 15-years-old) for COVID-19 immunization. The patient was diagnosed with COVID-19 prior vaccination. Since the vaccination, patient was not tested for COVID-19. There were no known allergies. The patient received no other medications in two weeks of vaccination. The patient received no other vaccine in four weeks of vaccination. The patient's medical history and concomitant medications were none. On 26Jun2021, at 01:00, the patient experienced dizziness/lightheadedness, pallor, shaking, headache, vomiting, ringing in ears, shortness of breath and tachycardia. The patient didn't receive any treatment for the events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
very large and tender lump the lump is still there I got a dark spot in the middle of the lump. The lump is very sore and very painful I am going to see the doctor next week.
Patient came in yesterday and related that she has had a positive pregnancy test at her PCP's office on 02.24.2016. LMP 01.08.2016. I gave her MMR at her appointment on 01.22.2016 as she stated that she was not pregnant at that time. I had given her instructions to be careful to not get pregnant in the next 28 days. Patient came in yesterday with family for additional vaccines and reported that she is currently pregnant.  She was not ill subsequent to the MMR injection and has felt fine except a brief decrease in blood pressure in the last one week, probably related to the nausea during early pregnancy. She did have this concern for 7 months in the previous pregnancy. Reassurance given that the MMR has not been directly linked with birth defects and is a theoretical risk concern. Additionally, it is less likely for problems due to the earliness of pregnancy and the set up of implantation. However, I recommended that she contact her PCP and explain that she did receive the vaccine on 01.22.2016. VAERS report done.
Information has been received from a physician's assistant concerning a 12 month old female with no known allergies and no prior medical history who on 10/21/02 at 10:00 was vaccinated with a dose of MMR II (640156/0978L). Concomitant therapy included a dose of varicella virus vaccine live administered in the right leg (638165/0158L). There was no illness at the time of vaccination. On 11/3/02, the pt presented to a physician's office with a maculopapular rash from head to toe (previously reported as "rash covered on face, extremities, and trunk"), low grade fever, runny nose, congestion and cough. In 2002, the pt had Rubeola IgM/IgG testing (results not reported). Subsequently in 2002, the pt recovered. The pt sought unspecified medical attention. Additional info is not expected.
hives on my stomach, side, arms, thighs; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old adult female patient received her unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 11Mar2021 at 11:15 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. The patients medical history was not reported. The patient had allergies to various antibiotics, shellfish, bees, honey & other medicine additives. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 16Mar2021, the patient experienced hives 4-5 days later, on stomach, side, arms & thighs. The patient received benadryl & prednisone for the adverse events. The clinical outcome of the events hives on stomach, side, arms & thighs were not recovered at the time of this report.    Information about lot/batch number cannot be obtained. No further information is expected.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Additional Details: Patient states after receiving vaccine she noticed rash around the vaccine site shortly after. She then reported to the hospital, where she was diagnosed and treated for cellulitis.
I had symptoms start on 12-22-2021 symptoms 5 days total. Headache, fatigue, 1 day little cough, 1 day runny nose. symptoms come and go. I then got a sinus infection one week after symptoms of Covid ended. Z-pack was prescribed
Information has been received from a certified medical assistant referring to an adult patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On 28-JAN-2016 the patient inadvertently received an expired dose of PROQUAD (Merck) injection (dose, frequency and route unspecified, lot # K009892, Expiration Date 11-JAN-2016) (expired product administered). No adverse effects were reported. This was outside the labeled recommendations in the PROQUAD (Merck) prescribing information. Additional information has been requested.
This spontaneous report was received from a consumer via Corporate Twitter. The reported tweeted an article. This report refers to a 949 patients of unknown age and gender. On unknown dates, the patients were vaccinated with GARDASIL (dose, route, lot # and expiration date were not provided). On unknown dates, the patients experienced an unspecified disability. At the time of this report, the outcome was unknown. The reporter considered the event as disabled. This is one of several reports received from the same reporter. Additional information is not expected as reporter details were not provided.
This spontaneous report as received from a nurse refers to multiple patients of unknown demographics. The reporter stated that the patients received improperly stored PNEUMOVAX 23 (lot number/expiry date unknown)on unknown dates (incorrect product storage). No adverse effects reported. The outcome was unknown. Excursion information for the vaccine: High temperature: 30 Minutes at 11.2 degree Celsius. Lowest temperature cumulative: 3 Hours and 17 minutes at 0.4 degree Celsius. It was confirmed that the vaccines that were incorrectly stored were administered. There were no previous temperature excursions. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sharp throbbing pain on the left side of my back. Running from my ribs down to my lower back. No recent back injury.  Went to my chiropractor to be adjusted. He mentioned that it could be a reactions to the vaccine. I went home and took one Benadryl. The pain subsided. Took a muscle relaxer that night and some Advil.
Several red spots on chest and stomach, itchy for about a week. Doctors concluded that I had a mild case of chicken pox.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Headache-Medium
On 05/07/2021, patient's wife, called the  nurse who administered the vaccine in the home,  to report the following:  - On Wednesday, 05/05/21,  patient awoke from a full night's sleep, he reported to his wife, he was not able to move his legs. The wife reported she was able to get dressed and assisted him to a power chair he uses regularly. - She reported that at 9:00 am or so she left her husband alone to get blood work and returned home within 20-30 minutes to find her husband half in and half out of the chair. She believed he "slipped out of the chair."  - She reported she could not get him up, he was still unable to use his legs. She contacted 911, EMS arrived within minutes and transported patient to Hospital. - Patient remained in the hospital until 05/09/21 when he was transferred to other facility for rehab.  - Patients' wife reported to me on Saturday, 05/08 that prior to the Moderna 2nd dose vaccine, patient was able to walk
LEFT ARM INJECTION SITE PAIN; This spontaneous report received from a patient concerned an adult male. 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, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on left deltoid muscle on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced left arm injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left arm injection site pain on 16-MAR-2021. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Crying x 3 hrs; referred to MD; Lortab liq. prescribed for pain;
burning bump in her left arm where she got the vaccine; fever of 100.7; muscle pain; nausea; can't control her head; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (burning bump in her left arm where she got the vaccine), PYREXIA (fever of 100.7), MYALGIA (muscle pain), NAUSEA (nausea) and HEADACHE (can't control her head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00AC21A and 8016B21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Watering eyes.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE PAIN (burning bump in her left arm where she got the vaccine), PYREXIA (fever of 100.7), MYALGIA (muscle pain), NAUSEA (nausea) and HEADACHE (can't control her head). At the time of the report, VACCINATION SITE PAIN (burning bump in her left arm where she got the vaccine), PYREXIA (fever of 100.7), MYALGIA (muscle pain), NAUSEA (nausea) and HEADACHE (can't control her head) outcome was unknown.            The caller had her second dose yesterday. She noticed a burning red bump in her left arm where she got the vaccine. she also has fever of 100.7, muscle pain, nausea, and can't control her head.  After the first dose she also had fever of 103.8 degrees, nausea, and vomiting for 3 days. She also notified us that she is immunocompromised and is on immunosuppressants. She also took Zyrtec because she has watery eyes. The first dose lot number 8016B21A and the lot number for the second dose is 00AC21A. The caller is okay with safety department reaching out via phone.
a patient received IPOL intradermally instead of Tubersol as intended, no AE; Initial information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 49 years old male patient who received 0.1 mL dose of vaccine IPV (VERO) [IPOL] lot P1A171M via intradermal route in the left arm on 26-Aug-2019 instead of TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  no other vaccines received.  It was a case of actual medication error due to wrong vaccine administered. Medical assistant stated that a vial of IPOL was in a bin with Tubersol and administered interdermally to the patient instead of Tubersol.  It was unknown whether the patient had any 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 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.  Documents held by sender: none.