chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Boostrix instead of Kinrix; 4 year old female kid received by error Boostrix instead of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number J7749, expiry date 03-NOV-2024) for prophylaxis.   Previously administered products included Dtap (previously patient had 4 Dtap the last one was taken 1 year and 8 months ago).   On 04-AUG-2023, the patient received Boostrix. On 04-AUG-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix instead of Kinrix) and inappropriate age at vaccine administration (Verbatim: 4 year old female kid received by error Boostrix instead of Kinrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 08-AUG-2023 The patient received Boostrix instead of Kinrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.            The reporter consented to follow up via email.
I had low grade fever body ache, chills, extreme fatigue, congestion, and cough.
3 days after shot - tingling in left hand and left foot - CIDP symptoms or maybe a pinched nerve
admitted to hosp 29JAN93 w/severe h/a, nausea, photophobia; recvd Engerix-B inject on 22JAN93; myalgias; 23JAN93;
I tested positive for COVID-19 on September 12, 2022. The day of the adverse event was October 4, 2022. That day, I had a migraine. I took Ibuprofen. Fifteen minutes later, I had a Grand Mal Seizure in my home. I was not injured because my husband caught me. He called 911, and they took me to the Emergency Room to be seen. They did a CT scan which was clear. They also did blood work. The blood work showed I was very low in Potassium, Calcium, and Magnesium. They gave me Potassium, Calcium, and Magnesium through an IV. They recommended I see a Neurologist and an Allergy Doctor as I was taking Sudafed at the time of the adverse event. I saw the Neurologist and was asked to do an MRI with contrast of my head. They also did a Sleep Deprived EEG. They wanted to see if they could start another seizure to diagnose epilepsy. I didn't have a seizure, but I haven't gotten results for either yet. They Allergy Specialist asked me to stop taking Sudafed but didn't think it was the cause of the low electrolyte levels. She sent me to a Kidney Specialist instead. The Kidney Specialist ran blood tests and urine samples.  Additionally, she sent me to get an ultrasound of my kidney and bladder. I do not have the results yet. She also ordered an EKG. That is where we?re at today.
Description: 2/3/05- received SPV (3 pokes, left upper arm) along with flu vaccine (right upper arm)- states was "getting over a cold" (only sx= nasal congestion- sx resolved within next two days). 2/8/05- noticed sudden sharp ("knife-stabbing") pain that ran down "left side of my head down to my left jaw"- no aggravating or alleviating factors- sx lasts "few seconds"- occurs "every minute"- no meds taken for sxs- no other systemic complaints. 2/9/05- states started to notice left side of her lips and chin "numb and swollen". 2/10/05- seen by PA this am- pt's Case Manager contacted by this PA-brain CT and neuro consultation recommended by pt's Case Manager. Patient contacted by her Case Manager- denies any changes in above frequency of sxs- states left side head pain "now spread to my right side"- no change in pain intensity- pain not interfering with quality of life- no meds taken for her sxs- denies f/c, malaise, fatigue, upper respiratory sxs, n/v, tinnitus, photophobia, impaired vision, paresthesia, weakness, tremors, dizziness, lightheadedness or recent change in mood/mental clarity- no h/o ha, seizures or any other neuro problems/disorders- denies any recent h/o head trauma- denies any FH of autoimmune disorders/problems- states has had no problems with flu vaccines in the past. Feb 05 attempts made to contact pt. via phone for updates- no response. 2/22/05 received updated info from pt. via mail- states was treated with ZOVIRAX 5x/d for 10ds for BELL's palsy and states lyme disease titer was positive- states is currently being treated with Doxycycline BID x30ds. 3/22/05- medical records received. According to pt's medical records, this patient has successfully been treated for BELL's palsy which appeared five days after receiving her SPV and flu vaccine (2/3/05). Her last visit (3/18/05) to healthcare practitioner indicates that her "facial numbness resolved after 2 wks (2/22/05), reports ha resolved, no vision change reported, denies any changes in CNS, no joint pain"- repeat lyme titer ordered.
After receiving Janssen Vaccine patient's BP dropped to 70/42. Patient was laid down in a supine position. BP increased to 98/62 and patient was sat back up. BP continued to remain stable at 110/60. Nurse then noticed a fine rash on limbs and trunk. Benadryl was administered and BP dropped again to 72/56. patient was laid back down in a supine position and BP increased to 118/72. Patient was transported to the hospital via EMS and was given prednisone and discharged home.
I am not sure if this would be considered a side effect or allergic reaction, however I am concerned as I broke out in hives all over my legs and ankles. My left leg also became slightly swollen. This event occurred 4 days after the first dose. Benadryl helps to relieve the symptoms.
Upper arm injection site swollen to size of small apple. Malaise (body aches). Diarrhea.
Morning of 24Sep2022 left armpit lymph node is swollen; collarbone neck area is sore; By 9:30pm on 23Sep2022, the entire left arm became sore and tingling; By 9:30pm on 23Sep2022, the entire left arm became sore and tingling; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Sep2022 at 08:15 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bipolar" (unspecified if ongoing), notes: Other medical history: Bipolar, ADHD, PTSD; "PTSD" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ambien, reaction(s): "Known allergy:ambien", notes: Known allergies: Ambien. The following information was reported: PAIN IN EXTREMITY (non-serious), PARAESTHESIA (non-serious) all with onset 23Sep2022 at 21:30, outcome "not recovered" and all described as "By 9:30pm on 23Sep2022, the entire left arm became sore and tingling"; LYMPHADENOPATHY (non-serious) with onset 24Sep2022, outcome "not recovered", described as "Morning of 24Sep2022 left armpit lymph node is swollen"; NECK PAIN (non-serious) with onset 24Sep2022, outcome "not recovered", described as "collarbone neck area is sore". Therapeutic measures were not taken as a result of pain in extremity, paraesthesia, lymphadenopathy, neck pain.  Additional information:There was no other medication in four weeks. By 9:30pm on 23Sep2022, the entire left arm became sore and tingling. Morning of 24Sep2022 left armpit lymph node is swollen, collarbone neck area was sore. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had serve abdominal pain with excessive vomiting and  diarrhea. This happened 4 hours after receiving the vaccine. This lasted for about 48 hours and I also experienced a loss of conscious. I had some difficult recovering.
Information has been received from a physician concerning a patient who on an unspecified date, was vaccinated with ZOSTAVAX (Merck). The physician reported that on an unspecified date, the patient developed Guillain Barre Syndrome after received ZOSTAVAX (Merck). At the time of the report, the patient outcome was unknown. Upon internal review, Guillain Barre Syndrome was determined to be an other important medical event. Additional information has been requested.
Sore arm, severe muscle aches &  joint pains, headache,fever $ chills, loss of appetite, severe fatigue in bed four days. no strength to even hold a glass of water. Irritated
Administration Error- Patient was vaccinated in left arm around 10am on 1/12/21 using consent form signed 1/6/21.  Facility provided additional consent forms signed 1/12/21 at the end of the clinic and unknowingly included patient again.  Patient was vaccinated in right arm around 2pm. No adverse effects noted to date.
PATIENT STARTED TO HAVE RASH STARTING 11-8-2018, MORE SEVERE RASHES TODAY ON BOTH THIGHS AND ARMS.
Information has been received from a health professional concerning a male child who approx two weeks ago, in Oct 2005, was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt was seen at the office, yesterday on 17Oct05, with chickenpox with more than 30 lesions over his body. The child was being treated with acyclovir and a follow up visit was scheduled for next week. At the time of the report the pt had not recovered. No product quality complaint was involved. No other information was provided. The reporter considered chickenpox to be an other important medical event (OMIC). Additional information has been requested. The pt's classmates experienced chickenpox following exposure to varicella virus vaccine live (WAES0510USA08437).
Pt recv vax on 10/1/98; on 10/2/98 pt exp sweating, malaise, welt on left cheek, sore throat, fever, productive cough, runny nose, muscle aches; 10/5/98 pt imp
Right sided facial droop, specifically of eyelid. Started on waking, resolving within a few hours (not fully resolved yet). Unknown exact start time as it started while patient was sleeping.
This is a spontaneous report from a contactable physician through a sales representative. A female patient (a college student) of unknown age received on unknown date TRUMENBA 0.5 ml single dose, intramuscular. The patient experienced redness and swelling of the arm and general malaise that went away after one day. The outcome of the other two events was unknown. Follow-up (07MAY2015): Follow-up attempts completed. No further information expected.
This case was reported by a consumer and described the occurrence of hepatitis in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, the subject received the 3rd dose of the TWINRIX vaccination series (unknown). At an unspecified time after vaccination with TWINRIX, the subject developed jaundice and was admitted to the hospital (dates and duration unspecified) with non specific hepatitis, and elevated liver enzyme tests. At the time of reporting, the outcome of the events was unspecified.
Splotchy, red, macular, blanchable rash to upper left arm.  Non tender.  No ulcers, blisters, swelling or bleeding.  Irregular, but clear borders.
Shortness of breath, wheezing, unable to walk 30 steps without sitting due to shortness of breath Prescribed  asthma inhaler 11/9 Prescribed prednisone 11/17  Shortness of breath continues, but less severe
7:50 Flu shot given. 7:52 -> chest tightness, breathing, dizzy, red flush skin. EPIPEN 0.3mg injected at 752PM and called paramedics. Pt ok after 1st dose of EPIPEN.
product storage error; flu-like symptoms; head cold; chills; sore arm; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On 22nd April 2019, the patient experienced influenza-like symptoms, head cold and chills. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the influenza-like symptoms, head cold, chills and pain in arm were not recovered/not resolved and the outcome of the incorrect storage of drug was unknown.   It was unknown if the reporter considered the influenza-like symptoms, head cold, chills and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported that she overheard the pharmacy personnel state that the vaccine was not placed into refrigeration upon receipt of the shipment. The patient felt that she received Shingrix that was out of temperature range, which led to incorrect storage of vaccine. Later that evening, the patient reported flu-like symptoms consisting of a head cold and chills. The patient also reported a sore arm. At the time of reporting, the symptoms were not resolved. The reporter did not consent to follow up.
Systemic: Fainting / Unresponsive-Severe, Additional Details: After Admenstring Vaccine, noticed patient is fainting. Held patient to ground and called for hlep and pharmacy staff called EMS. Patient gained consciousness before EMS arrive. When EMS arrived, we relayed info to the EMS responders. They took over
I received my flu vaccine, voluntarily, and was 12 weeks pregnant. We heard the baby's heartbeat at that appointment. I was lethargic that night and for 2 days and could barely move. At my next prenatal appointment we found out the baby had died in utero, measuring at 12 weeks. I had no risk factors and have never had a miscarriage before. Nothing in my environment caused my miscarriage. I had an extreme reaction to the flu and I miscarried all within a day or 2 of having the flu shot.
blood pressure went up, with maximum BP of 173/110; hyperthyroid symptoms; had a bad thyroid reaction; Thinks it may be related to vestibular neuritis; he got bad vertigo, especially on bridges, which he now avoids; This is a spontaneous report from a contactable consumer (Patient). A 36-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, on 30Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: unknown) via an unspecified route of administration on an unspecified date for covid-19immunisation. On 30Jan2021 the patient experienced blood pressure went up, bad thyroid reaction, hyperthyroid symptoms, vestibular neuritis, bad vertigo. The reporter reported that he had a bad thyroid reaction after that second dose.  Patient reported that the reaction did not occur until about 3 weeks after the second dose and that he had issues in the past to get the right dose for his thyroid medication. The patient went on to say that sometimes in the spring, it (thyroid) produces more, patient had hyperthyroid symptoms.  The patient had to go to the ER for his reaction and blood pressure went up, with maximum BP of 173/110. The patient said he had never had an issue with blood pressure before. That all took place on 30Jan2021. reporter reported that the thyroid was almost cured, and that the patient no longer takes medication for that. The patient went to the VAERS website and found reports of thyroid issues, blood pressure increase, as well as vertigo. E-transmitted to DSU for possible duplicate or additional AE information. No Information section of the attached VR and referred to HCP for guidance on whether or not to get the booster dose.The patient received beta blocker and Lisinopril as treatment for the events. The patient underwent lab tests and procedures on 30Jan2021 blood pressure was 173/110. The outcome of the event of hypertension is not recovered while for thyroid disorder, hyperthyroidism was recovering. The outcome of the event of vestibular neuritis and vertigo was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Staff member notified DON of Hypertensive state at 0830 on 1/20/2021. Staff member has no PMH of HTN and does not take any Rx medications for any disease processes. Staff member checked BP with multiple cuffs which were consistently read in the range of 160-180 SBP, 98-104 DBP with an elevated pulse >100 as well. Staff member reported an accompanying mild headache and lightheadedness. Sent to ED for evaluation of new onset HTN per Medical Director advice. Staff member was released from ED with orders to f/u with PCP for further evaluation of HTN persists
Very abnormal menstrual cycles started after she received the Pfizer vaccine.  She has nearly 3 years of documented normal periods on her app, and once she was Vaccinated they became irregular.  In August 2021 she got her period for 5 days, then it stopped for 8 days, then she got it for 7 more days.  In September it was 7 days (2 days longer than normal). Then Oct and Nov it progressively became longer.  In December her period lasted 14 days.  On day 10 she passed out before school and had to go to school late.  On day 12 she had an appt with her OBGYN.  They did labs and an ultrasound.  There is a clear correlation that this is all from the vaccine.   Prior to continue to recommend vaccines for young females this absolutely needs to be followed up on.
Today 11/19/19, patient contacted myself at the pharmacy and reported symptoms. I advised her to seek medical attention. Her symptoms are as follows. On the first day, she experienced shallow breathing and broke out in rash as well as soreness in the arm. The following day she experienced increased swelling at the sight of injection. On the third day the swelling felt like it went further under the skin, decreasing mobility and increasing pain. Today, she expressed that the injection site had turned black and blue and the skin felt rough to the touch. The husband came and reported she had gone to the ER per my recommendation today 11/19/19. The ER confirmed it was an allergic reaction to the Prevnar 13 shot. She was given Clindamycin and Hydrocodone. She is to return for a follow-up appointment in 2 days to make sure it does not need to be drained.
Patient was inadvertently given the incorrect Covid-19 Moderna bivalent formulation (dark pink cap NDC 80777-283-02 instead of dark blue cap NDC 80777-282-05) as their second dose.
reported feeling lightheaded immediately after 2nd dose  of Moderna vaccine administration, also reports feeling lightheaded after 1st dose. Initial bp-  159/87 HR- 88, Sp02- 95%. Repeat bp 147/62, HR 81, denies feeling lightheaded. Repeat bp-128/70, HR-98 at 230pm. Pt denies dizziness, blurry vision, chest pain, sob.   Pt escorted to parking lot and denies any symptoms of adverse reaction.
05/11/2022 I noticed I had had an occasional cough and woke up at night with a slight sore. I woke up on the morning of 5/13/2022 and it was gone. That morning I was coughing, congestion, runny nose, had a very hoarse voice and headache. On 5/14/2022 I noticed I had a little of brain fog. I tested positive for COVID. I had a tele health visit with my doctor. I called my PCP and told him my symptoms. He sent in a prescription for Paxlovid. I started taking Paxlovid that day. I noticed a difference that afternoon. I woke up 5/16/2022 feeling good and am over it now.
The day after I had chills, body aches, fever100.3, nausea, headache, and it felt like I had the flu. I felt super sick and 02/23/2021, at 8PM, I was watching TV and I had severe chest pain and I went to ER, and they did lab work, and it came out that I had 3 blood clot on right leg behind my knee, I got an a TEE and they found a clot on my heart and the third they found on that Friday 02/26/2021 on my artery. They discharged me the next day and I started with blood thinner. It was kind of scary to go through all of that. I was told I was maybe going to be on blood thinners for possibly a year.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient was unresponsive for 30 seconds and recovered quickly - orange juice was given.
Information has been received from pediatric medical records and a pediatrician concerning a 19 week old male patient with a history of respiratory syncytial virus infection (Hospitalized at 2 weeks of age), failure to gain weight and stuffy nose who on 08-FEB-2008, was vaccinated with PEDVAXHIB.  Concomitant therapy included PEDIARIX, PREVNAR and ROTATEQ.  At this visit the patient's mother states that her son is still a little congested and occasionally snorts from a previous questionable ear infection.  On 11-APR-2008, the patient was again vaccinated with PEDVAXHIB.  Concomitant therapy included PEDIARIX, PREVNAR and ROTATEQ.  On 21-APR-2008, the patient experienced a cough, clear runny nose and some congestion.  He also had a little bit of wheezing.  No fever was noted (97.8).  He also had some diarrhea that has continue on and off with a little bit of spitting up but no true vomiting.  Laboratory diagnostic studies performed on 22-APR-2008 was a swab to test for RSV which was reported as positive.  The patient was alert and did not appear to be ill.  He was well hydrated with a moist oral mucosa.  He was smiling and quite active.  His lungs were clear, no rales, rhonchi or wheeze.  The physician wrote a prescription for a nebulizer machine and ALBUTEROL.  The order was to fill only if necessary and follow up if the baby was not improving or was worse.  On 02-JUN-2008, the patient was vaccinated with PEDVAXHIB.  Concomitant therapy included PEDIARIS, PREVNAR and ROTATEQ.  At this visit the mother was concerned about the patient's cough which he has had for the last four days beginning on 29-MAY-2008.  He has also had some slight wheezing associated with this.  No fever was noted but he has had some rhinorrhea.  The plan was to monitor the patient and his development and follow up when he is nine months of age.  The mother was in agreement with this plan.  On 05-JUN-2008, a follow up renal ultrasound appointment was made for 06-JUN-2008.  On 09-JUN-2008, a prescription for AMOX, 400/5, 3/4 tsp twice a day for 10 days for cough and "mallery eyes" was written for the patient.  Subsequently, the patient recovered from RSV and diarrhea.  The patient's cough, slight wheezing, rhinorrhea and "mallery eyes" persisted.  Additional information has been requested.  All medical records will be available upon request.
Information has been received from a physician concerning a male patient who on 15-AUG-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot #, dose and route not reported). The physician reported that the patient was diagnosed with pancreatitis today (on 15-SEP-2011). It was unknown if the patient sought medical attention. At the time of the report the outcome was unknown. Upon internal review, pancreatitis was determined to be an other important medical event. Additional information has been requested.
Patient received 2nd dose pfizer vaccine on 2/18/2021. On 4/20/2021 I was the CRNA for the patient. Before givining anesthesia, I placed him on monitors. The EKG showed Afib. Patient denied any history of afib and is regularly followed by a cardiologist. Patient case cancelled and sent to ER for workup. 12 lead EKG shower A flutter with RVR. Patient seen by cardiologist and given prescription for eliquis and told to followup.