chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OFF LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 17 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patient experienced off label use. On 20-SEP-2021, the patient experienced vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to patient of inappropriate age was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217833, 20211218297, 20211218548 and 20211218731.
Arm went numb within and hr.  Resulted in multiple neurological symptoms .  Face numbness, leg weakness and numbness.
Information has been received from a 34 year old female who was accidentally exposed to VARIVAX (Oka/Merck).   Concomitant therapy included allergy medication as needed.  The patient reported that while her 6 year old daughter was receiving the booster dose of VARIVAX some of the liquid splashed in both of her eyes.  She sought medical attention in the physician's office.  When she returned home and about 1 hour and 45 minutes after the splash into her eyes she was able to remove her contact lenses and flushed her eyes with water.  He eyes had mild burning before and after flushing.  At the time of the report her eyes felt a little irritated, and she was considered to be recovering.  Additional information has been requested.  Associated WAES#0805USA02974.
Vaccination was administered very high & toward the back of my left shoulder. It was sore as expected. ~ 2nd day after 1st vax, I developed pain more in front, like joint pain instead of soft tissue.  As the ?normal? shoulder pain diminished, this new pain remained.  It was aggravated by the 2nd shot. Again, typical soreness at injection site with joint pain in the shoulder. The joint pain has diminished but has not disappeared. I suspect that the pharmacist who administered the shot somehow involved the shoulder joint by injecting too high & too far back. It?s a minor annoyance, not debilitating.
They fell sick and tested positive for Covid 19; They fell sick and tested positive for Covid 19; This is a spontaneous report from a contactable pharmacist. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unspecified date in Feb2021, as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. Relevant medical history and concomitant medication were not provided. On an unspecified date in Feb2021 after receiving the first dose, the patient fell sick and tested positive for Covid 19 and missed the second dose. They came into the pharmacy to get the second dose of the vaccine. The outcome of the event fell sick and tested positive for Covid 19 was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Fever of 102 that lasted for 18 hours and extreme soreness at injection site that lasted for 2-3 days.
Swelling, muscle spasms, fever, itching, stomach pains, confusion, dizziness.
Information was received on 20-FEB-2017 from a pharmacist, who reported unspecified patient received PNEUMOVAX 23 (lot # M036728, expiration date 20-MAY-2018) intramuscularly on 17-FEB-2017. The pharmacist reported that "PNEUMOVAX 23 was diluted with about 0.7 milliliter sterile water." No side effects were reported. No further information was available. Additional information is not expected.
Pt was given Zoster vaccine instead of Varicella. Pt reported no adverse events.
She presented with chest congestion, cough, n/v/abd pain and covid + on 8-9-22.  She was admitted 8-8-22 ;  treated with remdesivir , BARICI, DEXA,  zosyn, vanco and merrem during her hosp stay which is from 8-8-22 to 9-21-22 at which time she  transferred to  facility.   She had anorexia, dysphagia  requiring Peg tube for nutrition .    Had a code blue 8-21-22 and had right sided pneumothorax with chest tube emergency placement.  Required intubation.  Made DNR 8-22-22 .     on 12-31-22 she was brought to ER in full cardiac arrest from a long term care facility .   ACLS was performed but she expired 12-31-22.   Had peg tube as well as long term trach.  Felt she likely passed from long term covid complications .
This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 20-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012635 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) and CHEST DISCOMFORT (fluttering in the chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpitations) and CHEST DISCOMFORT (fluttering in the chest). At the time of the report, PALPITATIONS (heart palpitations) and CHEST DISCOMFORT (fluttering in the chest) had resolved. Concomitant medications were not reported. Treatment medications were not reported. These symptoms were on and off and they had lasted for the last two months. These symptoms appear after she drinks caffeine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EWO162), in right arm and on 29Apr2021 as dose 2, single (Lot number: ER8731) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro", notes: known allergies: Cipro. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: indication Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took anti viral treatment Paxlovid on 30Jun2022 and stopped on 05Jul2022. Patient took other medications in 2 weeks.
tested for COVID-19 via PCR on 20Oct2021 and results Positive 21Oct2021.; tested for COVID-19 via PCR on 20Oct2021 and results Positive 21Oct2021.; This is a spontaneous report from a contactable other hcp. A 38-year-old female patient (Age at vaccination 38-years) received BNT162B2 (BNT162B2), dose 3 intramuscular on 31Aug2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE and first dose intramuscular, administered in Arm Left on 23Feb2021 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE and second dose intramuscular, administered in Arm Right on 16Mar2021 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested for covid-19 via pcr on 20Oct2021 and results positive 21Oct2021. Treatment for the events was reported as Unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Oct2021 (Nasal Swab). The outcome of the events was recovering.   The lot number for the vaccine (booster dose) [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on available information a contributory  role of  BNT162B2 to the reported events cannot  be totally excluded.  Case will be reassessed if additional information is received.
Returned to clinic approx. 15 minutes after receiving IM flu shot - c/o paleness, mild dizziness, mild nausea and sweating. No respiratory or skin complaints. VSS -> seated, provided H2O & 25 mg p.o. BENADRYL. No further symptoms or complaints after 15 min. Monitored VS Q5min x3, then at 35 minutes s/p episode. All WNL discharged from clinic with flu instructions.
Pt recvd 1 dose of Engerix-B & w/in 24 hrs exp edema of the hands; w/in 2 wks devel desquamation of the hands; seen by MD on 10JUL92;
The report had been received from a physician. The report concerns a patient of unknown age and gender. Concomitant product, concurrent disease and medical history were not reported. The patient received nasal FLUMIST (intranasal) 0.2 millilitres, unknown for influenza. The patient experienced urticarial started several days after FLUMIST administration. The outcome of the event of urticarial was unknown. The event was considered to be non-serious by the company physician.
chills; fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported, expiry Date: Not Provided) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported, expiry date: not provided) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date, it was reported that the patient had the second shot and had chills and a fever and the next day, nothing. Outcome of event was recovered in 2021.  The lot number for the vaccine, [BNT162B2], was not provided. Follow up attempts are completed. No further information was expected.
Information has been received through the Merck Pregnancy Registry from a healthcare worker concerning a female (age not reported) who on 02-JUL-2007 was vaccinated with a dose of GARDASIL (lot 657737/0522U).  On 15-APR-2008 the patient was vaccinated IM with the second 0.5 mL dose of GARDASIL (lot 657737/0522U).  Concomitant therapy included CLARITIN 10 mg PO q am.  At the time of the second vaccination the patient was pregnant.  The pregnancy was confirmed via a "pregnancy bloodwork."  No adverse events were reported.  The LMP was reported to be on 08-APR-2008.  Follow up information indicated that on 12-JAN-2009 the 18 year old female patient delivered a baby by cesarean section (no details provided).  The baby's weight was 8 pounds and 2 ounces with normal neonatal course.  It was 39 weeks from last menstrual period.  There were no past medical history and concurrent medical conditions.  Upon internal review, the patient's delivery via cesarean section was considered an other important medical event.  Additional information has been requested.
It started with rash coming out on my left arm all the way down to my hand has spread to my right arm under my neck and chest on my ankles behind my legs Red bumpy itchy red marks the rash has not gone away The rash appears every day does not gone away and my next shot is due on May 7, 2021
Pt feeling flushed, lump in throat/sore throat, arm pain. Within 15 minutes of onset of symptoms pt started with hives on bilateral arms, sore throat, headache. Vital signs were taken multiple times. Pt was given water, sat down, and given 20mL/50mg PO Benadryl. Within 15-20 minutes of administration of Benadryl patient's symptoms aside from hives and flushed cheeks completely resolved.
On day 8 after the shot I woke up with my left arm itching terribly .  I looked in mirror and there was a red round patch around the injection site. I hadn't had any any symptoms prior to this except for a sore arm..  The itching and redness was bad for about 3 days or so  then  subsided.
Migrating numbness and tingling in both arms and legs, (4 months, still present). Insomnia (4 months, still present). Muscle twitching all around my body. (4 months, still present). Fasciculations especially in both calves, constant (3 months, still present). Acid reflux (without heartburn, but reflux in my esophagus, 1 month, still present). Difficulty swallowing (1 month). Cramping or discoordination in hands (4 months, still present). Anxiety (4 months, still present).
Covid Arm Large red spot near injection site. Sore arm.  Warm to touch. Body aches, head ache, and fatigue.
PATIENT DROPPED BY THE PHARMACY (11/21/18) TO REPORT A REACTION SHE WAS HAVING TO THE FLUZONE QUAD SHOT THAT SHE RECEIVED AT OUR PHARMACY ON MONDAY 11/19/18. SHE SHOWED THE AVAILABLE PHARMACIST HER LEFT ARM. SHE HAD REDNESS ABOUT THE SIZE OF THE PALM OF A HAND ON HER ARM. SHE CONFIRMED IT WAS GROWING IN SIZE, SORE, AND HOT TO THE TOUCH. SHE WAS ADVISED TO BE SEEN BY AN MD, NP, OR PA TO ASSESS TO SEE IF SHE COULD BE DEVELOPING CELLULITIS. THE PHARMACIST CALLED HER LATER IN THE EVENING. SHE DECIDED NOT TO GO TO A CLINIC. SHE WAS AT HOME AND GOING TO USE ICE ON THE SITE. SHE WAS ALSO ADVISED TO TAKE BENADRYL THAT NIGHT. SHE WAS ADVISED TO GO BE SEEN IF THE SITE GROWS, SHE GETS NAUSEOUS, OR GETS A FEVER. THE ADMINISTERING PHARMACIST FOLLOWED UP WITH THE PATIENT THE FOLLOWING MONDAY, 11/26/18. THE PATIENT STATED ALL REDNESS, SWELLING, AND PAIN WAS GONE AND HER ARM WAS BACK TO NORMAL. SHE NEVER WENT TO A DOCTOR OR URGENT CARE. SHE ICED THE AREA SEVERAL TIMES THROUGHOUT THE DAY AND TOOK BENADRYL. SHE NOTED IT TOOK ABOUT 5-6 DAYS FOR HER ARM TO BE BACK COMPLETELY NORMAL. PATIENT WAS APPRECIATIVE OF OUR CALLS AND THANKFUL FOR OUR CONCERN.
MOTHER CALLED AM OF 06/08/19 STATED CHILD STARTED WITH RASH ON LEGS LATE IN THE EVENING OF 06/07/19, NO FEVER BUT IRRITABLE. CHILD WOKE AT ABOUT 11 AM 06/08/19 RASH WAS ALL OVER CHILD. CHILD WAS STILL IRRITABLE RASH ON ARMS, LEGS, ABDOMEN AND BACK WAS VERY ITCHY. ENCOURAGE MOTHER TO TAKE CHILD TO PCP. MOTHER NOTIFIED CLINIC AFTER SEEING PCP, APN DIAGNOSED CHILD WITH ADVERSE REACTION TO DTAPACEL PER MOTHER.
During cardiac workup for unrelated symptoms, low normal/borderline decreased heart function seen on echo (LVEF 50.7%).  Began treatment with diltiazem.  Began noticing SOB with mild exertion (walking <100 yards) and heartrate stayed above 100bpm despite medication.  Mildly elevated blood pressure.  Followup cardiac MRI performed 7/6 corroborated echo findings (LVEF 52%) and showed patchy areas of subacute pericarditis and myocarditis inflammation with changes to tissue noticed.  Visited urgent care with pericardial chest pain 7/21, received indocin as short term replacement for nabumetone NSAID treatment.  Currently waiting on stress test scheduled for 9/16.
Patient received incorrect dose of Covid 19 Pfizer Booster.  No adverse signs or symptoms demonstrated during 15 minutes observation period.  We plan to decrease the risk of incidence through additional inservicing of clinical staff  on the appropriate preparation of all Covid-19 vaccine.  The plan will include re-education on our color coding system and implementation of a vaccine preparation verification system.
Two days after the vaccination I felt a pinching pain in my lower right abdomen . It felt a little like a kidney infection.
Patient was seen at offsite UNM-Gallup COVID vaccine event today 4/8/21. At ~1305, provider was asked  to assess this 35yo who had received her 2nd dose of Pfizer COVID vaccine at 1247, with complaint of itchy rash to neck and throat "tightening." She has a hx of multiple drug allergies and is on multiple medications as below for seizure disorder and other comorbidities. She had reported a hives rash after her first  dose of COVID vaccine 3wks ago. As such, she had taken 50mg benadryl at ~1200 today to attempt to prevent a reaction. On limited evaluation, her oral airway was clear without obvious angioedema. She did have hives to her neck and was quite pruritic. Her lungs were clear and she was moving air without wheeze. She began slurring her speech and seemed confused, which her family member reported is how she becomes before seizures.  With concern for anaphylaxis, gave a dose of 0.3mg IM epinephrine.  EMS was called to transfer patient to ED. Dose epi given at 1320, with almost immediate improvement in hives, pruritus and notable improvement in mentation and slurring of speech. EMS arrived at ~1325, patient found to have HR 106, BP 180/84 after epi. She was transferred in stable but acute condition.
At 8pm, about four hours after getting the vaccine I had sudden fever with severe chills and muscle cramps. My hips and lower back muscles cramped so quickly I couldnt walk.  Severe headache with eye pain, light sensitivity and nausea.  I woke up early the next day to severe nausea and vomiting, migraine, muscle and joint pain.  My fever was normal by 4pm, but migraine, muscle and joint pain and nausea still bad. I could not leave bed for entire day.
dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (dose administered after vial appeared to have frost-like ring at the bottom after drawing up 5) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not provided.  The treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-095200, US-MODERNATX, INC.-MOD-2021-095384, US-MODERNATX, INC.-MOD-2021-095302, US-MODERNATX, INC.-MOD-2021-095633 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095200:Crosslinked case US-MODERNATX, INC.-MOD-2021-095384: US-MODERNATX, INC.-MOD-2021-095302: US-MODERNATX, INC.-MOD-2021-095633:
BONES HURTING SEVERELY ALL OVER THE HIPS KNEES ANKLES RIBS ARMS AND BACK; TINGLING IN RIGHT ARM; NUMBNESS IN RIGHT ARM; BODY ACHES LIKE THE FLU; LIPS TINGLING BUT NOT SWOLLEN  HAPPENED ONLY ONCE FOR HALF HOUR; SQUEEZING LIKE PRESSURE ON RIGHT ARM FELT LIKE RUBBER AROUND BANDS ARMS AND BLOCKING CIRCULATION; JOINT PAIN; HEADACHE ON RIGHT TOP SIDE OF HEAD; FEVER TEMP HIGHEST 104.1F TO  RANGE OF 102F; MUSCLE PAIN; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient not tested positive for covid, not aware that has had covid before, ended up in emergency room last fall due to non covid virus. The patient experienced got sick like in vomiting when treated with hydromorphone hydrochloride, and morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced bones hurting severely all over the hips knees ankles ribs arms and back. On 15-JUN-2021, the subject experienced tingling in right arm. On 15-JUN-2021, the subject experienced numbness in right arm. On 15-JUN-2021, the subject experienced body aches like the flu. On 15-JUN-2021, the subject experienced lips tingling but not swollen happened only once for half hour. On 15-JUN-2021, the subject experienced squeezing like pressure on right arm felt like rubber around bands arms and blocking circulation. On 15-JUN-2021, the subject experienced joint pain. On 15-JUN-2021, the subject experienced headache on right top side of head. On 15-JUN-2021, the subject experienced fever temp highest 104.1f to range of 102f. On 15-JUN-2021, the subject experienced muscle pain. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lips tingling but not swollen happened only once for half hour on 15-JUN-2021, and was recovering from tingling in right arm, squeezing like pressure on right arm felt like rubber around bands arms and blocking circulation, numbness in right arm, fever temp highest 104.1f to range of 102f, body aches like the flu, headache on right top side of head, muscle pain, joint pain, and bones hurting severely all over the hips knees ankles ribs arms and back. This report was non-serious.
Extreme pain for a period of 30 days, could not sleep for more than 5 to 7 minutes for the first ten days due to sharp pain in my back every 5-7 minutes
Bad muscle soreness at injection site, chills, general muscle soreness throughout body, fatigue, exaggerated joint soreness in arthritic joints. Somewhat like flu symptoms but without fever or upper respiratory issues.
Received 2nd Moderna shot on Thu 3/4 and on Saturday 3/6 had raised red rash on my right arm where I got the shot with extreme itching from around the shot site to about 3 inches above elbow covering the width of my front upper arm plus extremely  sore arm. Also extremely achy on my right side, shoulder blade all the way down my back which lasted till Tues 3/9.. Some dizziness and occasional nausea feeling through Sunday 3/7 . It's March 10th, 6 days after and the red rash mark is still there though lighter in color and not raised with just light itchiness. No other side effects now.
PATIENT HAD LOCALIZED REACTION REDNESS AND SWELLING, WARM TO THE TOUCH AND HARD TO THE TOUCH.