chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took Vivotif for 4 days in a row; Spontaneous report received on 24FEB2020.  Based on the information obtained from a consumer, two individual case safety reports PVX2020-401 (20000166SP; wife) and PVX2020-403 (20000167SP; husband) were created and cross-linked in the database.  This case described a female consumer who "took Vivotif for 4 days in a row" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif capsule for prevention of typhoid. The consumer took four doses of Vivotif every day from 19FEB2020 to 22FEB2020. Action taken with Vivotif with respect to reported event was not applicable. The outcome of the event was unknown.  Concomitant medications included paroxetine, metformin, omeprazole, atorvastatin for an unknown indication.  Company Comment: A consumer took Vivotif for four days in a row ( Inappropriate schedule of product administration) instead of taking it every other day. Considering the nature of the event, the causality of  Inappropriate schedule of product administration is assessed as not applicable with Vivotif.; Sender's Comments: A consumer took Vivotif for four days in a row ( Inappropriate schedule of product administration) instead of taking it every other day. Considering the nature of the event, the causality of  Inappropriate schedule of product administration is assessed as not applicable with Vivotif.
Severe abdominal pain for days.  Went to emergency room and had CT Scan and blood tests.  Was admitted to hospital with pancreatitis and stayed for two days on an IV and pain medicaiton.
2/12/2021 woke up with sore arm and back. 2/13/2021 woke up with headache around 1am. Headache and nausea all morning. Mid-late afternoon started having seizures. Admitted to Hospital 2/15/2021 expired. Reported per wife on 2/25/2021.
Pt presented to the clinic for his second dose of the Pfizer monovalent 6m-4yr series. Unfortunately, the medical assistant did not dilute the vial prior to administration. A dose of 0.2 ml was drawn up from the vial without being diluted with sodium chloride first. The patient's family has been notified and advised to monitor for any signs/symptoms of an adverse reaction.
Mother reported today 1/9/19, that patient was extremely fussy, inconsolable and had regressions in all aspects for weeks following his 2 month vaccines that were given on 11/12/18. Mother could not provide distinctive information or exact dates of symptoms. Patient was not evaluated at any office or clinic for these symptoms.
Information has been received from a healthcare worker refers to a 61 year old female patient. The patient's medical history included shingles in 2014. on 07-MAR-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot# L035505 with expiration date 16-DEC-2016, 0.65 ml/once, subcutaneous) for vaccination. Concomitant drugs included multiple unspecified medications. On the same day the patient started experiencing redness at the injection site, the area was mildly warm to the touch with swelling measuring 3 centimeters in diameter. The patient was seen in the office by the physician on 08-MAR-2016. No treatment was given for the events. No lab tests were performed. Outcome of the events was reported as recovering. This is one of several reports received from the same reporter. Additional information has been requested.
Bruise was next day, swelling started 9/15/09 and has gotten worse 9/16/09, red, hard, measuring 3 1/2 length 4" wide, tiredness, fussy.
MILD HYPERMETABOLIC ACTIVITY IN A LEFT LYMPH NODE POST COVID VACCINE IN HER LEFT DELTOID. THIS WAS NOTED ATT IME OF ADMIT TO HOSPITAL FOR OTHER REASONS.   DOSE 1 OF MODERNA ADMINISTERED 3/5/2021 RIGHT ARM.
Approximate 17 hours post vaccine (vaccinated at 3PM Sat, beginning at 7AM Sun), began experiencing:  - Severe joint pain, unable to move  - Severe headache, the worst I have ever experienced  - Severe right eye pain, not relieved by any form of eye drop  - "Pulsations" in my head, severe  - Moderate nausea   - Chills  The best summary I can give is that this was the worst headache I have ever experienced, and it felt as if my head was going to explode. These symptoms were totally debilitating and I could not even get out of bed, much less work or conduct normal activities.  Symptoms persisted for approximately 30 hrs before rapidly decreasing in intensity.
UTI  - Treated w 7-day course of Ciprofloxacin -resolved
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Physician).  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 71 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Stage 1 breast cancer" (unspecified if ongoing). Concomitant medications included: CELEBREX oral, start date: Jan2020; CRESTOR oral, start date: Jan2020, stop date: 03Feb2023; DIOVAN oral, start date: Jan2020. Past drug history included: Clindamycin, reaction: "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Feb2023) Negative, notes: tested negative after day 5 Paxlovid; (10Feb2023) Positive, notes: symptoms began 3 days after last Paxlovid. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 03Feb2023 to 07Feb2023. Clinical course: The patient experienced rebound COVID with symptoms worse than the initial episode. Loss of taste was with rebound only. Low grade fever with no breathing issues but significant URI symptoms. Symptoms began 3 days after the last Paxlovid with positive home test. Had tested negative after day 5 of Paxlovid. Symptoms were persisting at the time of day 8.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) to the drug ineffective (LOE) and COVID-19 cannot be ruled out.
High fever (102 to 104) even with redness and swelling at injection site, diarrhea.
Injected 3/11/21 and felt fine. On 3/12, had nausea, vomiting, and severe headache. On 3/15/21, patient is mostly fine with a slight headache.
Redness, swelling, rash, fever, pain, muscle aches, body aches, headache.
Fever between 100 and 101, Chills, Headache, body aches, tiredness lasting 24 hours, took Tylenol 500 mg
Headache, Nausea, Diarrhea, Fatigue, lasted 4 days, just let it run its course.
Patient received dose 1 of the Pfizer COVID vaccine (lot EW0191) at 1400. At 1425, patient and her mother approached RN reporting visible tremors in her left thumb, the same side that she received the vaccine. The Paramedic approached to assess and take vital signs. PHN brought over juice and goldfish. Vital signs: blood pressure 126/88, pulse 88, respirations 16, O2 96%. Patient reported she ate a meal before arrival at the vaccine site but only drank approximately 8oz of water at breakfast in the morning. Patient denied swelling, pain, numbness. PHN noted no swelling in the face. Patient maintained full range of motion of left arm and hand. PHN encouraged patient to follow up with provider and when to call 911. PHN offered Benadryl but patient declined. Patient reported an allergy to amoxicillin, medical condition includes PCOS, and medications include vitamin D and birth control pill. PHN encouraged patient to stay for 30 minutes from onset of symptoms. Patient drank juice and ate goldfish. At 1440, vital signs: respirations 16, blood pressure 132/84, pulse 84. Patient reported a decrease in symptoms. At 1445, patient left walking with steady gait, against medical advice.
Patient complained of pain and limited range of motion of the left arm ever since the flu shot was administered on 09/15/2012.
I had my 2nd Shingles vaccine on Thursday 11/21/19 and at first it just really hurt, but then I had some bad side effects from it. The brochure advised that I should inform you, so I'm letting you know. My shoulder was very red and a bit swollen, very painful, tylenol and aleve helped a bit, but I also got a bad headache and felt very weak and sick. This lasted for 2 days, then slowly improved. Now, 4 days out, my arm is slightly sore and I'm finally feeling back to normal. The injection site also itched a bit, but nothing major.
Within minutes of taking the Pfizer vaccine I broke out in hives.  My lips started tingling and slightly swelling.  I waited for 30 mins and EMT said it was safe for me to leave because it wasn't causing breathing issues.  I took Benadryl when I got home and hives lasted 24 hours.
mild urticarial rash trunk and neck at 11:00 AM day following vaccine. No wheezing and no rection at injection site
Information has been received from a physician concerning an 18 month old male who was vaccinated with a dose of MMR II. After receiving the vaccine, the patient had a fever and was lethargic for 3 days. The physician now thinks the patient may be showing signs of autism. Unspecified medical attention was sought. There was no product quality complaint. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
Received his first dose of Pfizer (LOT#: FF8839 Exp: 12/2021) at 1505 on 11/01/21. PHN was alerted by EMT. PHN arrived on scene at 1518. EMT stated that patient's mom alerted EMT that her son was complaining about some tingling on his right forearm in one specific region. Patient stated that the tingling was not radiating towards the hand or up towards the rest of his arm or shoulder. Patient stated he received his COVID vaccine in the left arm. Patient was moved to anti-gravity chair. Patient was able to walk on his own to anti-gravity chair. EMT took patient's vital signs at 1321. BP: 132/78, HR: 115, O2: 99%. RN asked patient how he was doing and he said he felt fine and the tingling in his arm had gone away. RN asked patient how much longer he had in observation. Patient stated that he had finished his 15 minutes. RN educated patient and mom on adverse effects of COVID vaccine and when to seek EMS, urgent care or ED. Patient and patient's mom verbalized understanding. Patient left vaccination site unassisted with a steady gait with his mom at 1522.
Lips swelled so badly, they cracked and scabbed and took about 2-1/2 weeks for the new skin to grow. Taste was affected for the same time period, everything tasted awful, if I could taste it at all. Inside of mouth felt "astringent" for several weeks, as if had been drinking cranberry juice.
Tingling and numb tongue and lips; Tingling and numb tongue and lips; loss of sensation to my right entire side from the back of my head, face and down to my right foot, which included my back scapular region and both right extremities; sore tender lymph nodes under right arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 08Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included COVID-19 prior vaccination. Concomitant medication included levothyroxine. The patient previously took essential oils and experienced known allergies. The patient experienced tingling and numb tongue and lips, loss of sensation to her right entire side from the back of her head, face and down to her right foot, which included her back scapular region and both right extremities. Also, sore tender lymph nodes under right arm. All events started from 08Jan2021. This has been going on for 4 days as of 12Jan2021. No other vaccine in four weeks. Covid test done post vaccination: nasal swab on 12Jan2021, pending result. The outcome of the events was unknown.   Information about lot/batch number has been requested.
pt transferred from Medical Center; found to be positive for COVID; pt has a large intracranial hemorrhage and midline shift; uncal herniation; left sided paralysis, concern for a stroke; vomiting; intubated prior to transfer; neurology consulted and recommended comfort care to family; pt made comfort care, extubated, and he passed away in the hospital
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; needs to wait 90 days before getting the second dose; This is a spontaneous report from a sponsored program, A non-contactable consumer reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced positive COVID-19 test with symptoms. It was further reported that the patient was sick after receiving her first dose and when at the hospital, she was tested for COVID-19 and it came back positive. The reporter asked about re-scheduling the second appointment for the patient and also stated that she spoke to the doctor and was advised that the individual needed to wait 90 days before getting the second dose. The outcome of the event "positive COVID-19 test with symptoms" was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
Myalgia, Arthralgia, NauseaVomiting,  Chills Narrative: No additional details
3-4 hrs post vaccination fever 100-101 F. Parent gave alternating doses TYLENOL and Ibuprofen q6hr. But fever persisted episodically through Thurs 4/15/10 7pm. 7pm 4/15/10 fever spiked to 104.9F. Parents prepared to take child to Emergency Room (100 miles away). Parents did tepid bath, child limp, staring into space. When takes every bath shaking uncontrollably for several seconds. Fever came down to about 101-102F and gradually decreased to normal temperatures by AM Sat. 4/16/10 then developed runny nose / green nasal discharge.
10/24/22 obvious left sided weakness, numbness, tingling sensation of left face, arm, torso, leg. 11/11 numbness tingling weakness presents bilaterally over all body, now with muscle cramps and pains in all extremities. Weakness in all extremities. No one knows what this is, my primary is at a loss. SOMEONE PLEASE HELP ME!
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild
Neuropathy in both feet; Loss of smell and taste; Loss of smell and taste; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 28Sep2021 as dose 2, single (Lot number: 30145ba) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VENLAFAXINE; LAMOTRIGINE; DEXTROAMPHETAMINE [DEXAMFETAMINE]. Vaccination history included: bnt162b2 (Dose Number: 1, Batch/Lot No: fc3180, Location of injection: Arm Left), administration date: 11Aug2021, when the patient was 48-year-old, for COVID-19 Immunization. No other vaccine in four weeks. The patient had no known allergy.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Sep2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; ANOSMIA (disability), DYSGEUSIA (disability) all with onset Feb2022, outcome "recovering" and all described as "Loss of smell and taste"; NEUROPATHY PERIPHERAL (disability, medically significant) with onset Feb2022, outcome "recovering", described as "Neuropathy in both feet". The events "neuropathy in both feet" and "loss of smell and taste" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive. Therapeutic measures were taken as a result of neuropathy peripheral, anosmia, dysgeusia. Laser therapy for neuropathy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300310745 same patient, different dose number, different event;
Patient began snorting and flaring her nostrils while breathing about 1 1/2 hours after vaccine, nurses assured us it was normal.  Jaundice and lethargy  began to set in around the same time and again we were told it was common and to have her checked by the peds the next day if it was worse.  We were discharged to home where she continued to display above symptoms.  around 3:45 am on 01/18/2002 she stopped breathing, CPR was performed by her father and then the paramedics arrived, she was taken by ambulance to hospital ER where she was pronounced dead at 4:31 a.m.
Soreness at the site of injection; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number unknown) in the workplace clinic, via an unspecified route of administration on 22Jan2021 at 10:30 on the left arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced soreness at the site of injection during 12-24 hours post administration on 22Jan2021 at 22:00. The outcome of the event was recovered.  The patient did not receive treatment for the event. The event was reported as non-serious.   Information on the lot/batch number has been requested.
Kept falling after vaccination; had penicillin shot after vaccination to try to kill virus. Had incision to drain penicillin.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: I told parents and pt to have pt to sit for 15 mins after the injection incase of any dizziness/fainting incident. Parent and pt understood. I went to check on mom's 2nd shingrix date, then i heard a crash on aisle 17 at counseling window aisle. Dad coming running to window and yelled my son went down; he fainted.  I ran out to check on situation.  Dad said son fell on a shelf and cut the area around his earlobe. The son apparently got up from chair and walked down the aisle and fell. ~5min
Least amount of being sick; Received expired 2nd booster dose,"a few days expired"; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Least amount of being sick) and EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose,"a few days expired") in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2a, 028A21A and 027A21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: FLU (Intramuscular) in October 2021. Past adverse reactions to the above products included No adverse event with FLU. Concurrent medical conditions included Sulfonamide allergy, Allergic reaction to bee sting and High cholesterol. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 01-Apr-2022, the patient experienced ILLNESS (Least amount of being sick) and EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose,"a few days expired"). At the time of the report, ILLNESS (Least amount of being sick) and EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose,"a few days expired") outcome was unknown.            After receiving the second booster dose on 01-Apr-2022, patient reported the "least amount of being sick" compared to the other three Moderna injections.  The adverse event did not cause the patient to seek medical care. The patient did not experienced a similar event in the past.  No treatment information was provided.   This case was linked to MOD-2022-537576, MOD-2022-537582, MOD-2022-537584 (Patient Link).
This is a spontaneous report from a contactable pharmacist via a Pfizer-sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever and headache after receiving the suspected vaccine on an unspecified date. Outcome of the events, fever and headache was unknown. Information on batch number has been requested.
hives on her torso; Itching; Painful arm/ sore arm; This non-serious case was reported by a consumer via patient support programs and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 12-SEP-2023, the patient received Shingrix and Arexvy. On 12-SEP-2023, less than a day after receiving Shingrix and Arexvy, the patient experienced hives (Verbatim: hives on her torso), pruritus (Verbatim: Itching) and pain in arm (Verbatim: Painful arm/ sore arm).  The outcome of the hives, pruritus and pain in arm were not resolved.   It was unknown if the reporter considered the hives, pruritus and pain in arm to be related to Shingrix and Arexvy.     It was unknown if the company considered the hives, pruritus and pain in arm to be related to Shingrix and Arexvy.   Additional Information: GSK receipt date: 04-OCT-2023 This report was submitted via the online direct entry reporting system.  The patient called in complaining of a sore arm, hives on her torso, and itching.  She stated it had been about 30 days since she received both her second dose of Shingrix and the Arexvy shot.                                 Reason for no Batch or Lot number of Arexvy was unwilling to provide. The reporter consented to follow up.