chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other AE.; The customer said the patient will come back "soon" to receive the 3rd dose of GARDASIL 9, but the dose was not given yesterday as scheduled.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On an unknown dates, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (formulation, exact dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported).  On 02-JUN-2021 (reported as "yesterday"), the patient was supposed to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), but the dose was not given as scheduled because just received the COVID 19 vaccine 1 week ago, so the patient said that would come back "soon" to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). No other adverse events were reported.
Injection site erythema; injection site swelling.  Information has been received from a physician concerning a female who on 05 JUL 2007 or  JUL 2007 was vaccinated sc with a first single dose of zoster vaccine live (Oka/Merck).  This patient was receiving unspecified concomitant therapy.  Over the weekend of 07 JUL 2007 to 08 JUL 2007 the patient developed redness and swelling at the injection site.  The patient visited the physician's office for follow up and was treated with fexofenadine HCL (ALLEGRA) and a methylprednisolone dose pack (MEDROL).  On an unspecified date the patient recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
After the first vaccination shot (late April 2021), my menstrual cycle was fourteen days early. After the second vaccination shot, my menstrual cycle was later than usual, arriving at about Day 31 of my cycle. My cycle is typically 26 days long. The menstruation after my second shot was exceedingly heavy and painful - I had terrible cramps, worse than normal fatigue, and very heavy bleeding. The menstruation lasted longer than normal for me (about eight days), and it was followed by a few days of spotting, which is also unusual for me. In addition to these changes in my cycle, I experienced worse than normal migraines throughout the month of June, both during menstruation and during ovulation. I typically get migraines about once or twice a month, and I was getting migraines about 3-4 times a week throughout June.
PT CAME IN TODAY AND SAID THEY CANNOT LIFT THERE LEFT ARM AFTER THE IMMUNIZATION OF PNEUMOVAX. PT HAS HAD PLENTY OF VACCINES BEFORE SUCH AS PREVNAR, FLU AND SHINGLES AND HAS NEVER REACTED LIKE THIS BEFORE. HE HAS LIMITED MOVEMENT OF HIS LEFT ARM.
Arm tenderness; Runny nose; Cough; Anaphylactic reaction; A spontaneous report was received from a 63-year-old male who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, arm tenderness, runny nose and cough.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:011(J/5)20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Jan 2021, patient started to experienced cough which got progressively worse, runny nose and his heart started racing. He could not swallow water, his airway was shutting down, and he stated that it was an anaphylactic reaction. Patient also felt exhausted with arm tenderness and pronounced discomfort. Treatment for the events were not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, anaphylactic reaction, arm tenderness, runny nose and cough was unknown.; Reporter's Comments: This case concerns a 63-year-old, male patient, who experienced a serious unexpected event of anaphylactic reaction, and non-serious unexpected event of cough, and rhinorrhea, and a non-serious expected event of pain in extremity. The events occurred 1 day (same day) after first dose of mRNA-1273, lot # 011(J/5)20A. No treatment was administered. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
For two days after the injection, I was extremely tired. About one day after the injection I began urinating every hour to two hours.
I experienced a breakthrough case of COVID-19 with atrial fibrillation and very rapid heartbeat.
seizure; speech became limited; had a high fever; This spontaneous report was received from a patient's mother and refers to a 5-year-old female patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies.  On an unspecified date in 2015, the patient received the first dose (reported as vaccinated once) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (reported as MMR) subcutaneously (site of administration, lot # and expiration date were not provided) reconstituted with a sterile diluent (STERILE DILUENT) subcutaneously (dose, frequency, lot # and expiration date were not provided), both for prophylaxis (reported as measles, mumps and rubella). On an unspecified date in 2015 (reported as 7 days after receiving the vaccine), the patient experienced a seizure. Additionally, on an unspecified date in 2015, the patient's speech became limited and she had a high fever. The patient received ibuprofen (MOTRIN) as a treatment. There were no lab diagnostics performed. The patient sought medical attention and was seen by a pediatrician. The patient was not hospitalized and recovered from the events on an unspecified date in 2015.   The causality assessment between the events and the suspected therapies was not provided.   Upon internal review the event of seizure was considered to be medically significant.
About a week and a half after vaccine I developed asthmatic symptoms unlike symptoms I have had before. I hadn't used any of my asthma medications since December 2019. Went to see the asthma specialist and got medications on Jan 4th. Received steroid shots and prescribed steroid pack and nebulizer. Symptoms began improving and cleared completely in about 2 weeks.
A report has been received from a Health Professional concerning a patient, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 24-Oct-2014. The patient experienced two patients experienced rash 24 hours after receiving FLUMIST, one had rash on the face, the other on the trunk. The outcome of the event of two patients experienced rash 24 hours after receiving FLUMIST, one had rash on the face, the other on the trunk is unknown. The report was considered to be non-serious.
R09.02 HYPOXIA 4/19/2023 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD)
After vaccination, he had PVCs for the remainder of the day, through the next 12 hours before complete resolution.
Information was received from a Registered Nurse who stated that the refrigerator temperature rose to 16C time of excursion 67 hours (worse case), affecting PNEUMOVAX (dose, duration and site not reported) "(not supported)". The reporter stated that vaccines had experienced a previous temperature excursion of 14C for 12 hours. Temperature ranged and time frame: 16C for 67 hours and 14C for 12 hours. This is one of several reports received from the same reporter. Additional information is not expected because the registered nurse stated she did not want to receive any further follow up letters.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical information: Question: Caller was a patient also calling on behalf of her husband. Both have completed the 5-day treatment of Paxlovid and they were planning to get the second booster dose of Pfizer-BioNTech COVID-19 Vaccine this month (June). She wanted to know if they should wait some time after completing the Paxlovid treatment and before receiving the dose of the vaccine. There is no specific information on the timing of vaccination after the Paxlovid treatment. However, there is information about getting a dose of the vaccine after a diagnosis of COVID-19 infection. Caller also wanted to know if we had information about the COVID-19 rebound effect after the Paxlovid treatment. Pfizer cannot assess causality between the Paxlovid treatment and the COVID-19 rebound effect yet. At this time, there is no information regarding this topic described in the Prescribing Information or other resources from Pfizer. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12 months old patient received a dose of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The medical assistant reported that, 12 months old male patient who received a dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
It was reported that a pt (1 of 3) received a Tripedia vaccination, date not specified. Reportedly 24-48 hours after vaccination the pt developed a local reaction of swelling, redness and erythema at the injection site. Further info is requested. From additional correspondence received on 5/7/01, it was reported that the pt recovered from this experience. Additional pt, vaccine, vaccine administrator and responsible physician info was also provided. From mailed correspondence received on 6/19/01, it was reported, "Reviewed, no additional info at this time." This case is closed.
Pt stated he felt nervous and  Dizzy approximately 10  min post vaccination.  Assisted to gurney VS 90/50-81-100%.  Requested and consumed water and juice and rested for 10 min stated he felt better and would like to walk home. Ambulated out of clinic with steady gait, stating he was feeling better.
I received flu vaccine and ADACEL on 9/30/09 - Left deltoid - ADACEL - Rt deltoid - Flu. Lf arm developed a large bump approx. 30mm induration and pain. Few days later I felt pain from injection site down to finger tips w/numbness, tingling, weakness, heaviness. Left leg started to tingle with warm feeling LUE and LLE still tingling w/pain LUE worse. 12/09/09 PCP records received for DOS 9/30/09-11/16/09.  Vaccinated on 9/30/09 and presents with persistent induration at injection site and numbness and tingling in arm and leg. On 11/16/09 had neuro consult for left upper and lower extremity numbness and tingling which has improved but remains.  DX: Vaccine adverse reaction Will have NCS
This case was reported by a pharmacist via call center representative and described the occurrence of laceration in a adult male patient who was preparing SHINGRIX (batch number 539A2, expiry date 30th March 2020) for administration of the patient for prophylaxis. In September 2018, the patient received SHINGRIX. In September 2018, immediately after receiving SHINGRIX, the patient experienced laceration. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the laceration was recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the laceration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. Lot number for adjuvant suspension was unknown. Issue was reported as the base of the vial of the adjuvant suspension was cracked and missing pieces. The reporter's index finger of his right hand was cut when he reached into the carton to pull out the vial and filed related adverse event. The cut has resolved and this occurred approximately three weeks ago. The damage was noted at the time the product was being prepared for administration. The product was not administered to a consumer. The blister tray and or carton were not damaged. No evidence of leakage noted in the carton. No glass pieces were in the vial or in the carton. There were holes of glass pieces missing from the base of the vial. The product was stored on the bottom shelf of the refrigerator. There was no product left in the vial. The package was in good condition upon receipt. The pharmacist threw the vial in the Sharps container after he cut his finger on the vial. The product was not available for return and no picture of the suspect product was available to be emailed. The pharmacist requested to provide credit for one dose of the SHINGRIX.
This spontaneous report as received from a licensed practical nurse refers to a 57 years old female patient with hypothyroidism, allergy to penicillin and allergy to NASONEX. The patients medical history included mitral valve disorder, bilateral cataracts and hypotension. On 02-FEB-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot # 671139/1265AA, expiry date 05-NOV-2012 and dose was not reported) subcutaneously. Concomitant therapies included verapamil, triamterene, hydrochlorothiazide, levothyroxine sodium, calcium (unspecified) vitamin d and vitamins (unspecified) (reported as multivitamin). Approximately on 16-FEB-2012 (reported as 2 weeks after vaccination) the patient experienced rash all over the face. Following vaccination approximately on an unknown date in July 2012, the patient developed elevated hepatic enzymes (ast and alt) and elevated bilirubin levels. The nurse reported that the patient went to an unspecified eye doctor for the treatment of the rash (treatment details were unspecified). The duration and the type of the rash was not specified. The patient had reported about the rash on 07-MAR-2013 during the routine office visit. On an unknown date, unspecified blood test was performed. On an unknown date, the patient recovered from rash all over the face. on an unknown date in September 2012, the event elevated hepatic enzymes (ast and alt) was reported as recovered/resolved. The outcome of elevated bilirubin levels was reported as not recovered/not resolved at the time of this report. Additional information has been requested.
Initial report was received from a health care professional on 05 October 2011. An 85-year-old female patient received an intramuscular injection of FLUZONE HIGH-DOSE; lot number UH436A on 10 October 2011. On an unspecified date following the vaccination, the patient experienced a swollen arm. Concomitant medications included baby aspirin, SYNTHROID, omeprazole, simvastatin and vitamin D. Allergies to medications include doxycycline, erythromycin, LEXAPRO, BIAXIN, CIPRO and sulfa. No further information was available at the time of the report. Outcome was not reported. Follow-up information was received from a healthcare professional on 25 January 2012. The patient outcome was reported as recovered/resolved. Follow-up information was received on 26 March 2012 form a health care professional. The patient with an extensive past medical history including severe osteoarthritis of the knees had received on 01 October 2011 (previously reported as 10 October 2011) a left deltoid injection of FLUZONE HIGH-DOSE; lot number UH436AB (previously reported as UH436A) and two days later, experienced left arm swelling. The patient was advised by her physician to use ice and BENADRYL which she did for "several days". The patient presented to a clinic three weeks later stating she felt her left arm continued to be swollen. The patient also reported left leg and foot swelling but did not know how long she had it but reported "maybe one week". The patient reported the foot was painful and she had left knee pain. A physical exam revealed the left arm with no redness, no warmth and "maybe slight generalized edema (comparing arm size to right), but no pitting edema". The arm was neurovascularly (NV) intact and "NT". The left leg had "maybe slight generalized edema (comparing to right), but minimal pitting at distal leg. No foot edema. The left foot was slightly warmer than the right. Leg was neurovascularly (NV) intact with no calf tenderness. An ultrasound of the arm was negative. An ultrasound of the left leg revealed no DVT but showed a Baker's cyst which "may be causing the mild lower extremity edema. Treatment included TYLENOL. No further information was available at the time of the report. The patient's outcome was not reported (previously reported as recovered). Documents held by sender: none.
This spontaneous report was received from a nurse regarding an unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reaction/allergies were not reported. On 01-OCT-2018, the patient was administered an expired dose of RECOMBIVAX HB lot # N002922 and 30-SEP-2018 expiration date for prophylaxis (strength, frequency and route of administration were not reported). No adverse effects reported.
Pt describes axillary gland swelling and chills that started the evening of vaccination.  The lymphadenopathy persisted into the next day.
caller was rushed to the emergency room and was tested positive for COVID-19; caller was rushed to the emergency room and was tested positive for COVID-19; caller became symptomatic and experienced headaches; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first dose on 18Dec2020 and is scheduled for the second dose today, 09Jan2021. However, on 24Dec2020, she became symptomatic and experienced headaches. On Saturday, she was rushed to the emergency room and was tested positive for COVID-19. Her physician told her that she could get the COVID-19 vaccine if she has no symptoms anymore. She wanted to know the guidance per Pfizer. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 09Jan2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Case number PHEH2014US018186 is an initial spontaneous report received from a consumer on 09 SEP 2014. This report refers to a female patient whose age was not reported. She was not allergic to eggs. Her concomitant medications were not reported. Her vaccination history included influenza vaccines twice without any reaction. She had seasonal influenza vaccine (manufacturer and batch number: not reported) 5 years ago following which she had arm swelling (see related case number: PHEH2014US018187). She was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on 04 SEP 2014. She stated that she had extreme  fatigue and also high blood pressure since vaccination. She reported that she was tired around 8:30 PM and woke up around 5 AM and her sleep pattern was disturbed. Her blood pressure went up 10 points after receiving FLUCELVAX. She stated that she was worried and that her blood pressure was elevated due to anxiety. Her physician asked her to stay away from flu vaccines due to the reaction occurred 5 years ago and thought she received double dosage at that time. She stated that she also got muscle spasm in her leg since receiving FLUCELVAX on 04 SEP 2014, but it has quieted down. She had pain on an unknown date and took steroid injection for treatment following which she had temporary blood pressure increase. The events outcome was unknown. The seriousness and causality were not reported.
Felt my right leg the blood 'pulsating' through the femoral artery region for several seconds.  This occurred approx 5 to 6 times throughout the day only when I sat or drove my car (note I was working after I had this vaccination).  This stopped at approx. 3pm.
I reported all symptoms through the  program following vaccination daily, i was just able to find this form to send in to CDC.   Left side of the body, itching and burning; Lightheaded (Persisting: 4 days) Ongoing adverse events from date of vaccination to present occurring on a daily basis:  Blurred Vision, Light Sensitivity, Migraine & occasional SOB during activities that previously did not cause SOB.
Chills, fatigue, rash all over my abdomen, sore arm(injections site)
Narrative:  78yo patient died on 9/30/2021 at non agency hospital with hx of CAD/chronic ischemic heart disease with LVEF 51%, chronic Afib on rivaroxaban, GERD, hypothyroidism, T2DM, HTN, and HLD & recent hypotensive episodes. Pt had received covid vaccines at agency on 3/10/2021 & 2/16/2021. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
painful 3" redness & swelling x 4 days of deltoid;not seen day MD @ time of rxn;
About 9PM that night, I had a severe headache. So I laid down and a few hours later, I had a 101 temperature. I took Tylenol and tried to rest. Later that night, I started shaking real bad. I checked my temperature and it was 104. I called ER and was told to come into the ER. I was kept overnight. I had severe muscle pain and my skin was very sensitive to touch, so I went back to the ER and was given muscle relaxer to the calm the pain.
2 days post-injection: 3 inch diameter rash, one or two hives, itchiness all over upper body
- Pain & bruised at injection site - high fever - Paleness, Weak, dizzy - Sore throat, ear ache, sore eyes - chills 3 days MOTRIN & TYLENOT given
Patient admitted as inpatient on 10/10 due to acute respiratory failure with hypoxia. Patient was tested for COVID-19 and was positive on 10/10.
At 9:00 started having aches, chills and slight fever. But middle of the night same but chills increased. Got up to use the bathroom and get some fluids in me to bring down fever. I passed out in the bathroom (this has never happened to me before). Once I came to I could not get my balance back to bed and started vomiting and fell to the floor. Continued to run fever and chills throughout evening.