chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after the second dose of Shingrix had tachycardia; This case was reported by a other health professional via sales rep and described the occurrence of tachycardia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tachycardia. On an unknown date, the outcome of the tachycardia was unknown.   It was unknown if the reporter considered the tachycardia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter consented to follow up. Patient's identifiers, lot number, expiration date and vaccination date were not provided.
The patient's daughter reports that the patient moved into nursing home on August 2nd, 2021 and had to quarantine for 10 days. The patient received the Pfizer vaccine on August 12, 2021. The daughter reports that her mom stated she was starting to feel sick a few days after, stating "I think the shot made me sick". Daughter states over the next few days the patient was getting increasingly confused. By August 16th, 2021 the patient was extremely confused. The daughter reports the patient stripped down naked and was not making sense at the nursing home. The patient was transferred to Medical Center and remained confused for several days.
Two  days later (Wednesday, May 19) I woke up and realized that my herpetic whitlow (herpes virus trapped in the middle finger of my right hand) was flaring. I have not had an outbreak in almost two year, and s this outbreak has been exceedingly painful, similar to earlier outbreaks, accompanied by nerve pain in various parts of my body, swollen lymph nodes, and large ulcers on my finger. I began a course of valacyclovir immediately after calling urgent care.   (The day I received the vaccine, I remained in the monitoring area for an additional 15 minutes due to severe dizziness. My cheeks were flushed for several hours, and I experience severe dizziness and shaking (similar in feeling to a blood sugar dip) five hours after receiving the vaccine.)
experiencing cold or like a severe allergy; experiencing cold or like a severe allergy; her head stuck up; nose is running; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), HYPERSENSITIVITY (non-serious), outcome "unknown" and all described as "experiencing cold or like a severe allergy"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "her head stuck up"; RHINORRHOEA (non-serious), outcome "unknown", described as "nose is running".  Additional information: Caller mentioned that she already received the first dose 2 weeks ago and is due for the second dose tomorrow. Caller is asking if she needs to reschedule the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient called around 1130am to report that she was experiencing nausea, left sided weakness/numbness and racing heart. Advised patient to seek ER treatment.
Nausea after the first dose in late June.  Vomiting after second dose in October.
exposed to the covid virus and tested positive/started having symptoms; This is a spontaneous report from a contactable consumer reporting same the same event under the same suspect product for 3 patients (this is for the reporter's son). This is one of 3 reports. A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 27Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown at a pharmacy. Medical history included autistic and patient was unknowingly exposed to the COVID virus  from an unknown date. The patient's concomitant medications were not reported. The patient was unknowingly exposed to the COVID virus and tested positive on 01Mar2021 and started having symptoms that day which includes sweating from his head, fever, and cough. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Mar2021 Positive. Reporter asked if they should receive the second vaccine or start again. They were told after 90 days, they had to start over again. The patient received the antibody infusion for the virus from reporter's mother in law on the 24th. Outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021354303 same reporter, suspect drug, same adverse event; different patient.
pain in the arm; typical soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) and VACCINATION SITE PAIN (typical soreness at the injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm) and VACCINATION SITE PAIN (typical soreness at the injection site). On 09-Jan-2021, PAIN IN EXTREMITY (pain in the arm) and VACCINATION SITE PAIN (typical soreness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took ibuprofen 200mg on second night to help with the symptoms
Day one of second Shingrix shot same as first dose per patient (low energy & chills). On second day, felt tongue swollen. It resolved without medication
Extreme chills with four degrees of fever with low blood pressure. My heart was beating very fast...much faster than normal and my heart and lungs felt like they were in an oven cooking. Then I was feeling achy and my other insides felt warm and ackey. The tops of both of my arms became red like I had been in the sun which lasted for days. I was also short of breath. I told my son the next day that if he left, when he came back, I might be dead. I stayed in bed. My oxygen level we t down a bit. I finally took some aspirin and some Tylenol. Five days later I felt better but I feel like I will not get vaccines any longer after that and I may have had some sort of heart inflamation. I am sorry that I did the moderna vaccine. I will be telling my doctors a out this. We will be seeing if my body is damaged. The scariest part was the fast heart beat and it feeling hurtful and hot in my chest. You knew something was happening. I had also felt my heart squeezing on the tenth and eleventh day on the first shot.
No adverse event; Expired vaccine used; This spontaneous report was received from a nurse prescriber, and refers to a 2 month old patient of unknown gender. No information was reported regarding the patient's medical history, concurrent conditions or concomtiant medications.  On 31-JAN-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # T028130, per oral for prophylaxis. The vaccine expired on 28-JAN-2022. The product had no prior temperature excursions. No adverse events were reported.
This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients (demographics unknown). On an unknown date, the patients were administered with VAQTA (dose, lot number, expiration date and route not provided), which underwent a temperature excursion. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (therapy type: Digital data logger; lot # L028082, expiry date: 18-SEP-2017, lot # L027282, expiry date: 21-SEP-2017). Healthcare worker stated that the vaccine underwent a temperature excursion at 49.5 degree Fahrenheit for 186 hours. There were no previous temperature excursions. Healthcare worker confirmed that the vaccine was administered on unspecified dates before their expiration date. No adverse effects were reported. This is one of the six reports received from the same reporter. Additional information has been requested.
mini transient ischemic attack / mini stroke; mini transient ischemic attack / mini stroke; Confusion; could not remember things; This case was reported by a consumer via call center representative and described the occurrence of transient ischemic attack in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included TIA (transient ischemic attack) and stroke.  On 7th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 8th March 2020, 1 days after receiving Shingrix, the patient experienced transient ischemic attack (serious criteria GSK medically significant), stroke (serious criteria GSK medically significant), confusion and memory disturbance. On 8th March 2020, the outcome of the transient ischemic attack, stroke, confusion and memory disturbance were recovered/resolved.   It was unknown if the reporter considered the transient ischemic attack, stroke, confusion and memory disturbance to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported the case. The patient received Shingrix in left arm. On the next day, in morning, the patient experienced confusion and could not remember things. This lasted for about 5 hours and then he recovered. The reporter thought, this was a mini transient ischemic attack, a mini stroke that the patient had. The reporter did not consent to follow-up. No other details were provided.
Patient stated a bubble measuring about an inch and a half at the injection site after administration, arm soreness for a couple weeks, bruised, and feels numbness down her arm
reaction too much severe, Gillian Barry Syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Prednisone and Antibiotics (2 speculums).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got shingles already and he/she knew the symptoms and to get in to doctor within 1 day.  The patient received Prednisone and 2 speculums of antibiotics which knocked the shingles down before weeping stage and nerve damage. After receiving Shingrix, the patient experienced Guillain Barre syndrome. The patient stated that, his/her reaction to Shingrix dose 1 was much too severe to repeat with 2nd dose with chances of more severe Guillain Barre Syndrome reaction which was worse than shingles. The patient had built up a bit of immunity because having had shingles already, plus 1 dose of Shingrix, was better than nothing, and stated get into doctors at first sign of infection. The patient's doctor stated that, shingles caught early was very treatable whereas Guillain Barre syndrome could put in hospital for weeks, sick for a year or two like his/her friend, and high chance of permanent nerve or muscle damage. The patient was that close and stated not worth chancing with 2nd dose of Shingrix. The follow-up would not possible as no contact details were available.
No reaction - VAERS done due to wrong age group. Date of vaccination applies, no reaction just incorrect vaccine given.
By the evening of Day 2, swelling and soreness on tongue developed.; By the evening of Day 2, swelling and soreness on tongue developed.; In addition an odd taste is left in mouth.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the arm left on 02May2021 at 12:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The medical history was reported as none. The patient's known allergies were reported as none. 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 atomoxetine (MANUFACTURER UNKNOWN), dexmethylphenidate (MANUFACTURER UNKNOWN) and levonorgestrel (NORTREL), all for unknown indications from unknown dates and unknown if ongoing.  On 03May2021 at 16:00, by the evening of day 2,the patient developed swelling and soreness on tongue, in addition to that an odd taste was left in mouth. The patient reported that she was on day 3 and the swelling of tongue had caused her the need to took BENADRYL in addition to acetaminophen. She stated that her husband was having no other side effects in comparison to hers. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events swelling and soreness on tongue and included treatment with diphenhydramine hydrochloride (BENADRYL) and acetaminophen (MANUFACTURERE UNKNOWN). The patient did not receive any treatment for the event odd taste in mouth. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling and soreness on tongue and an odd taste was left in mouth were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-MAR-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications such as varicella pneumonia. The patient was treated by a physician at a medical office for a blistering vesicular outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events were considered to be not recovered. Varicella pneumonia were considered to be medically significant. Additional information has been requested.
refusing to bear weight onset 10 days after immunization. Seen by orthopedics 12 days after shot. Xrays negative. CRP<0.5. ESR 1 WBC 4.7.  Rx Ibuprofen. Follow up 19 days after immunization and symptoms resolved
This spontaneous report as received from a registered nurse refers to a currently 5 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-JUN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD recombinant Human albumin (rHA) or human serum albumin (HSA) of lot # N015623 with an expiry date of 15-NOV-2018 (Strength, frequency, route and anatomical location were not reported) for prophylaxis. On 03-APR-2018, a 11 minute temperature excursion of -13.3 degrees Celsius occurred as advised by the nurse. All other temperatures were in range and average temperatures remained stable. The vaccine was in the freezer at the time of excursion. The nurse advised that this was a "supported temperature excursion" since it was between -10 and -14 (Units unspecified) for a period of 11 minutes and that the supply could remain in stock and was viable. No previous temperature excursion occurred. No adverse vaccine reactions were reported. The call was because of a data logger. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter.
The vaccine was received through hospital at Community Health. Pt states that after he got his first Pfizer COVID shot 2 weeks ago he began having excessive fatigue, it got better after a week but pt states still "extremely tired". Pt states that he also had a rash develop the day after the vaccine and it was on his chest and back initially but has spread all over his body. The rash is not pruritic but is very tender to touch. Pt states increase amount of migraines, almost daily. Aleve helps the HAs. He had migraines years ago but they had virtually resolved. He also reports intermittent joint pain in the last few days and some central chest discomfort with deep breaths. He has a hx of chronic IBS like bowel issues after experiencing an infection abroad that took 4 rounds of antibiotics to treat. Treatment: 5 day course of Prednisone 20 mg BID. Tylenol 100 mg TID for aches and HAs. Follow up with PCP.
PATIENT FAINTED ABOUT 10-15 MINUTES AFTER RECEIVING HER FIRST DOSE OF THE MODERNA VACCINE
I got sick twice. On 03/24/2021 and 04/25/2021. I got sick the day I took the J & J vaccine on March 24th with 104.1* fever, chills, headache, body aches and weakness.  I was sick the entire day on the 25th and came out of it on the 26th. I got sick again on April 26th with fever and weakness 100.8*. It started around 11:45 PM. I was sick the entire day on the 26th and came out of it on the 27th.
39 yo vaccinated on 4/21/03 who sought care at the health clinic on 5/7/03 with c/o myalgia, headache, and fatigue which began on 5/5/03.  He was examined by the health clinic MD and discharged.
Employee within 15 minutes of receiving vaccine experienced redness in arm with hives over entire body, then throat and chest tightening
Patient states had increased temp and vomiting, swelling and redness on 10/01/2004, after receiving vaccines.  Arm painful, red and swollen for 2 days. States still taking tylenol #2 tabs every 6 hours.  Arm redness decreased and not as swollen.  Will observe.
Information has been received from a consumer, who was allergic to dairy, with no previous medical history reported, who on 16-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Merck) 0.65mL. Concomitant therapy included montelukast sodium (MSD). On 17-JUN-2008, the patient experienced dizziness and an upset stomach. No lot number was provided, at the time of the report, the patient had not recovered. The patient did not seek medical attention. There was no product quality complaint. Additional information has been requested.
right sided facial swelling, throat clearing;   1st vaccine - facial swelling 9 hrs after vaccine;  resolved with zyrtec.
Administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions.  Vaccine manufacture date of expiry reported was 09-Nov-2021.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up document included no new information.
30 mintes post tetamus immunization donor had mild nausea for 2 minutes, no treatment, no problem after.
Information has been received from a physician concerning a 19 year old female patient who was vaccinated with a dose of VARIVAX (Merck) (manufacturer unknown) overseas. The physician reported that the patient had subotimum titers after receiving VARIVAX (Merck), and needed a booster for college. The patient sought unspecified medical attention. Additional information has been requested.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: continued complaint of hard lump at injection site-Medium, Systemic: Joint Pain-Mild
About 5 minutes after vaccination, patient reported tongue swelling and lightheadedness.  Patient was closely monitored and tongue swelling resolved quickly.  Patient also developed hives on face and was given 25mg Benadryl orally.  Tachycardia was monitored and patient remained in clinic for 1 hour until symptoms resolved and she could demonstrate a steady gait to walk back to her car.  No additional treatment provided.
Pt received first Moderna dose 12/04/2021 and accidently received bivalent dose instead of second dose in series.  Pt states that she feels unwell / weak; stating that the booster should not make her feel this unwell. She spoke with her friends and no they did not feel under the weather with the booster. Pt states she feels unwell because she did not receive the second dose of the primary series first.
Pt recvd vax 6NOV92 & on 22NOV92 devel numbness in lt hand & lt upper-arm; pt was seen by MD 27NOV92 & by that time the sx had diminished;
Experienced fever of 104.2; 103.5; 101.3 with headaches and weakness.