chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US024821, is an initial spontaneous report received from a health care professional on 23 Nov 2015. This report refers to a 54-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) multi dose vial (MDV) into right deltoid intramuscularly at a dose of 0.5 ml on 23 Nov 2015 at 11:05 am. It was reported that the vaccine administered was out of temperature range at 46.8 degree Fahrenheit for 24 hours. The case was reported as non-serious. No adverse events were reported following the maladministration. Follow up information was received from a health care professional on 21 Jan 2016. Added batch number and patient weight and time of vaccination and site of vaccination and vaccine tolerated in past.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient's initials and date of birth were unknown. The patient experienced severe pain and redness at injection site. The reporter agreed to follow up from GlaxoSmithKline. This case was linked to the case US2018GSK169612, reported by the same reporter.
hives about 24 hours after flu shot no local reaction. Hives lasted several days, has not had eggs yet. RX Benadryl, No SOB or angio edema, no prednisone needed.
right leg is tight down near calf; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, NDC number and Expiry date are not provided), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that he had a schedule on 30May2021 for second dose appointment and did not expect them to be open and assumed they were closed. Stated technically speaking, he missed the second dose appointment. He also mentioned, was there any possibility that there would be a blood clot once he got the vaccine. He got it because he had to go to the doctor for something else and they scheduled him the appointment, he went over there and waited, waited, waited, and got an appointment, he got a paper and they said come back for second dose in 14 days. He stated that right leg right now was tight down near calf on an unspecified date in 2021 and he was noticing the last couple of days and said why was it so tight and that's all he was asking about. The outcome of the event was unknown.  Information on Lot/Batch number was not available. Additional information has been requested.
Patient developed tongue swelling after 30 min evaluation post vaccine. Patient returned back to the hospital and was observed for an additional 15 minutes. The patient self-medication with oral benadryl and zyrtec prior to return to the hospital.
her deltoid where the injection was given had developed redness, hardness and swelling; her deltoid where the injection was given had developed redness, hardness and swelling; her deltoid where the injection was given had developed redness, hardness and swelling; soreness at the injection site; This spontaneous report was received from a nurse via company representative referring to a female patient of unknown age.  The patient's pertinent medical history, drug reaction or allergies, concurrent conditions and concomitant therapies were unknown by the reporter.  On an unspecified date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) once intramuscularly in the deltoid region for prophylaxis (vaccination scheme, lot number and expiration date were unknown by the reporter).   Immediately after she received the dose, the patient complained of soreness at the injection site (vaccination site pain). Approximately two weeks after she received the dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), the patient's deltoid where the injection was given had developed redness (vaccination site erythema), hardness (vaccination site induration) and swelling (vaccination site swelling). It was unknown if the patient sought medical attention, underwent laboratory diagnosis or studies, or if treatment was given for the events. The outcome of the events was unknown.  The causality assessment between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the events was not reported.
soreness; arm pain; This is a spontaneous report from a contactable consumer or other non hcp (patients mother). A 37-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 20Mar2021 at 14:30 (at the age of 37-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the covid vaccination. It was reported that after first dose on 20Mar2021, reporter stated that the patient had just soreness and arm pain on an unspecified date. The patient is a self-employed, owner/operator with a transporter that he drives for, he transports automobiles. The patient did not require emergency room or physician Office as result of events. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EW0170), via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 (at the age of: 37-years-old) as dose 2, single for covid-19 immunisation. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Had Menactra on 4/2/08. Broke out in hives AM of 4-4-08. At one point had some shortness of Breath - has resolved.
About 5 months after dose 4 vaccine, I had a low heart rate. I went to my primary care doctor's office and saw the physicians assistant. She ordered a Holter monitor and I wore it for 48 hours. After wearing it, I went to see a cardiac specialist last week. He told me I had skipped beats and about 1200 episodes in 48 hours. He scheduled a stress test that will be on October 12, 2022 and he wants me to get a carotid artery ultrasound and that is still to be scheduled. I have a follow up visit with my primary care doctor on 10-4-2022.
On 07/07/2021 a lot of fatigue and disoriented, on 07/08/2021 lymph nodes all down my neck, and above the right collar bone were swollen, lasted for about 9 days. After the second dose my lymph nodes in my arm pits swollen up-dates unknown/lasted only about 3-4 days. On July 25th I had a period for 12 days and then stopped for 3 days and then again for 8 days ending 08/18/2021 then on 09/05/2021 which started early.
8 hrs p/inject devel 4"x3" red square around inject site which was itchy; also itchy around eyes, hives; local reaction on arm disappeared; 1st reaction in 200 doses;
Information has been received from a medical assistant concerning an 86 year old male with unspecified drug reactions / allergies and medical history who in September 2007 was vaccinated with ZOSTAVAX (Merck) (dose, route, lot number unspecified). The medical assistant reported the patient was diagnosed on 11-May-2009 with shingles. The patient developed red lesions, with a distribution from under the left axilla and extending into the left axilla, on 7-May-2009. The medical assistant stated the physician prescribed an unspecified therapy. The outcome of the patient was not recovered. The patient sought medical attention by office. Additional information has been requested.
Rash started about 10 days after vaccine. Started close to the injection site and traveled down down arm.  It did resolve after a few days.  Also had same event after the 2nd dose given on 7/20, only it happened within 2 days.
Patient is a 6-year-old female who came to the clinic with mother to receive a 2nd dose vaccine of the Pfizer 5-12yo dose. On 09/29/2022, patient received 2nd dose was Pfizer of 6month-4yo dose (lower dose). This resulted in the patient receiving a lower dose vaccine instead of the age-appropriate vaccine.  Per mother, no symptoms or adverse reactions have been noted. Mother was notified that her daughter received a smaller dose of the vaccine and that no harm is released to this much lower dose that she received, but protection may be inadequate without recording the supplemental dose. Per our Chief Medical Officer, mom was instructed to come back at 8 weeks and get a repeat 2nd dose (correct age dose). Mother understood message and had no further questions and or concerns.
Discovered 6/13/22, that patient above had received a vaccination that expired 5/20/2022. The date of vaccination was 5/27/2022.
Soreness in the arm at sight.  Tumors started coming back daily in his stomach, sides and back outside the rib cage.  Looked like big hard masses.  Cancer was in remission for about 6 months and aggressively came back after taking the 2cnd vaccine.
Extremely itchy; light rash down the arm; This is a spontaneous report from a contactable consumer, the patient. A 33-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: tn6208) via an unspecified route of administration in right arm on 09Mar2021 at 18:00 (at the age of 33-years) as a single dose for COVID-19 Immunisation. Medical history included inflammatory arthritis. The patient was allergic to penicillin, sulfa, Vicodin and zofran. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 09Mar2021, a few hours after vaccination, the patient experienced a light rash down the arm in which she got her shot in as well. When the patient woke up the next day, the rash on her arm had faded but her hand was worse and it was extremely itchy. Now, it was all over her neck and it was extremely itchy. The patient still had the rash and it had been 13 days. It was not responding to Benadryl anti-itch cream. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event rash was resolving whereas itchy was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Daughter called to report extreme fatigue, concerned that patient was so tired that he did not eat or drink much today and felt it was out of the normal expected fatigue.
6 days after 2nd Covid-19 vaccine given on 3/13/21 she had sudden onset of dizziness & double vision that has not resolved. Multiple diagnostic test have been done to determine the cause of her dizziness but no diagnosis has yet been determined. She is being referred to a Neuro Ophthalmologist for further evaluation.
Pt. Very nauseated & extremely anxious. allergy to Pineapple. H2O given & helped w/nausea then face states to feel warm and flushed then c/I "Funny" feeling in her throat. CODE GREEN called-paramedics arrived to assess.
Raised itchy rash on upper right arm. Primary Dr. ordered ZOSTAVAX, PREVNAR - protocol Dr.
Muscle pain and joint paint started 3 days after first dose. Joint pain in ankles and top of foot are so bad; Muscle pain and joint paint started 3 days after first dose. Joint pain in ankles and top of foot are so bad; Muscle pain and joint paint started 3 days after first dose. Joint pain in ankles and top of foot are so bad I had to seek medical attention and can barley walk unless on medication.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW016) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced muscle pain and joint paint that started on 15Apr2021, 3 days after first dose. Joint pain in ankles and top of foot were so bad. The patient had to seek medical attention and could barely walk unless on medication. The patient was over a week out from first dose and the pain was worse each day. The patient had got X- ray done on the same day and no blood clots or issues were found on X-rays. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain and joint paint that started 3 days after first dose; joint pain in ankles and top of foot were so bad; the patient had to seek medical attention and could barely walk unless on medication was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Vertigo; Very thirsty; Tired; This is a spontaneous report received from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration and anatomical site on 05Mar2021 at 12:15 (at the age of 69-years-old), as single dose for COVID-19 immunisation. The patient medical history included benign paroxysmal positional vertigo (BPPV), Persistent Postural-Perceptual Dizziness (3PD) and osteoporosis. The patient had no allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Past drug history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the left arm on 12Feb2021 at 12:15 (at the age of 69-year-old), as single dose for COVID-19 immunisation. Concomitant medications included loratadine 10 mg (MANUFACTURER UNKNOWN) and vitamin D 2000 IU (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Mar2021 at 06:00, the patient woke up with intense vertigo and could not raise her head without the sensation of spinning. Her husband had to help her to the bathroom, then to a chair. It was reported that the spinning stopped but it would start again if patient move her head left or right. The patient was very thirsty. It decreased over 2 hours, and then she was just a little tired. The patient received treatment for the events. The clinical outcome of event vertigo was resolved in Mar2021, very thirsty was resolving and for tired was unknown. No follow-up attempts are possible. No further information is expected.
7 days post vax, pt experienced 1 lesion and now has 7, mostly on leg and back.
aching; temp of 101.9 / fever; rash; blisters on his forehead; shivering; This case was reported by a consumer via call center representative and described the occurrence of pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bladder disorder. Concomitant products included COVID 19 VACCINE.   In March 2021, the patient received the 1st dose of Shingrix (intramuscular). In March 2021, less than a day after receiving Shingrix, the patient experienced pain, fever, rash, blister and shivering. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain, fever, rash, blister and shivering were recovered/resolved.   It was unknown if the reporter considered the pain, fever, rash, blister and shivering to be related to Shingrix.  Additional details were provided as follows: The patient had pre-existing conditions of bladder disorder. The concomitant medication included CBC drug for bladder disorder, COVID-19 vaccine for COVID-19 prophylaxis. The patient reported that he was vaccinated with Shingrix approximately two weeks ago. On the same day the patient experienced shivering, aching, rash and fever blisters on his forehead. The temperature was recorded on the same and found to be 101.9 degree F.  The patient took Tylenol for temperature as treatment medication. The reporter did not consent to follow up.
After my first dose of Moderna vaccine on 12/31/2020 on my left arm, I had slight dizziness 1 hour after injection and last for 2 hours . I developed swelling and tenderness of lymph node  under my left arm pit on 01/11/21 and I also found lump on my left breast  at 1 o'clock position on the same day. The lump grow from 0.5 cm to 1 cm within a week. Today 01/22/21, the lump is enlarge to almost 2-3 cm diameter.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported.  It was reported that, first dose of vaccine was administered after 1 days from first puncture.  Treatment information was not reported   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non significant follow up
fever; nausea; sore arm; This is a spontaneous report from contactable consumer. This consumer reported similar events for 02 patients. This report is for 2nd report of 02 patient. This consumer reported for a male patient (husband) that: A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included COVID-19 infection on an unspecified date in Dec2020 (Reporter and her husband were diagnosed with COVID-19 infection) and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, patient experienced fever, Nausea and sore arm. Consumer reported that she and her husband were administered with the first dose of the Pfizer's COVID-19 vaccine on Saturday, and they developed side effects after the administration of the vaccine. The Consumer reports that she and her husband were diagnosed with COVID-19 infection on Dec2020 and the symptoms are similar to the infection. Outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.; Sender's Comments: Linked Report(s) : 2021344898 Same reporter/drug, different patient/same event
Information has been received from a mother, for the Pregnancy Registry for GARDASIL, concerning her daughter, a 17 year old female with a history of antibiotic therapy and no known drug reactions/allergies, who on 22-APR-2008 was vaccinated (route unknown) with a 0.5 mL first dose of GARDASIL (Lot # unknown). Concomitant therapy included (BACTRIM, also reported as "Bectrum"). The mother reported the pregnancy for her daughter. The patient was administered with the first dose on 22-APR-2008 and as of 3-May-2008 she is 5 weeks pregnant (LMP "March 2008"). The lot # is not provided. No AE involved. A blood test was performed. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information was received from the nurse who indicated that on approximately 23-DEC-2008 the patient had an induction of labor after she came into the office with some contractions and elevated blood pressure (bp). During the induction the patient "quit dilating" and at 38 +2/7 weeks had a Cesarean section. On 23-DEC-2008 the patient delivered a normal baby, with Apgars values of 8 and 9 at 1 and 5 minutes respectively and only required a bulb syringe suctioning, "but no further resuscitation", the nurse also reported "everything looked good" with the baby. The patient also had a postpartum hemorrhage, and was transfused two units of packed red blood cells. Post-operatively the diagnosis was pre-eclampsia and chorioamnionitis. She also received antibiotics (unspecified) for the chorioamnionitis. The nurse also reported that the baby had a sepsis workup due to the mother's chorioamnionitis, but he was asymptomatic and all of his laboratory tests were normal also. The baby was discharged home with his mother on 26-DEC-2008. At the time of the report, the outcome of the patient was unknown. Upon internal review pre-eclampsia, chorioamnionitis and patient quit dilating and having a C section were considered as other important medical event. Additional information is not expected.
Patient was in observation after a 1 dose vaccination of Pfizer when she complained to incident staff that she was feeling dizzy and light headed.  Refer to  Medic Unit's patient care report for further information.  Patient refused transport and signed documents required to document the AMA/Release.
This is a spontaneous report from a contactable physician. A patient (sex and age unknown) was administered a dose of PREVNAR 13 on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day were unknown. Vaccines taken within the last four weeks were unknown. On an unknown date at unknown time after vaccination, the patient was diagnosed with Parsonage-Turner Syndrome and experienced unspecified irritation. Relevant lab data was unknown. At the time of the report the clinical outcome of the events were unknown. Company Clinical Evaluation comment: Based on the information provided in the case, this individual report would seem to modify the benefit/risk profile of PREVNAR 13.