chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer Covid vaccine was given as the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Pfizer Covid vaccine was given as the second dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Pfizer Covid vaccine was given as the second dose). At the time of the report, PRODUCT ADMINISTRATION ERROR (Pfizer Covid vaccine was given as the second dose) outcome was unknown. Not Provided          No concomitant medications provided. Action taken with mRNA-1273 in response to the event was not applicable. Caller would like to know if he is protected as Pfizer Covid vaccine was given as the second dose?
Pt recvd Hep B vax series in 1987, & recvd booster dose in MAR90, was revaxed in SEP90 & devel optic neuritis;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain, fever, weakness, general body pain and influenza-like symptoms. On an unknown date, the outcome of the injection site pain, fever, weakness, general body pain and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site pain, fever, weakness, general body pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 60 or 61 years. The patient experienced severe injection site pain, high fever, weakness, body aches, and general flu-like symptoms for 4 days post vaccination. The patient needed 2nd dose but she would hate to have to repeat this process in a few years. The patient stated that there was no one to follow up with.
no additional AE reported; dose of VAQTA with a labeled expiry of 7/11/2021 was inadvertently administered to a patient on 7/13/2021.; This spontaneous report has been received from a medical assistant, referring to a 42 years old patient of unknown gender. The patient's historical condition, current condition and concomitant medication were not reported.    Medical assistant warm transferred for assistance in reporting that a dose of  hepatitis a vaccine, inactivated(VAQTA) (formulation vial, dose: 1 ml, lot#T018670, strength and route were unknown, indication: prophylaxis) with a labeled expiry of 11-JUL-2021 was inadvertently administered to a patient on 13-JUL-2021 (expired product administered). The reporter stated there were no known temperature excursions involved. No additional information was provided, no additional adverse event reported.
Hep A vaccine was given to 2 month patient, instead of Hep B. No Symptoms reported by parent/guardian.
This spontaneous report as received from a physician refers to a 12 month old patient. On 21-AUG-2017 the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 21-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
Patient developed allergic reaction to vaccine within 8 minutes.  Patient c/o of lighheadedness  was given  Zyrtec at 8:51 a.m.  VS at 8:55 were BP 142/84, P 68 and O2 99%.  Patient c/o redness in face and throat and Benadryl 25 mg IM at 8:58 a.m.  Dexamethasone 4mg given IM at 8:59 a.m.  Patient c/o throat tightening.  EpiPen administered at 9:01 a.m.  VS B/P 129/76, P 77, 02 100%. 9:11 BP 129/77, P 80, S02 100%.  9:17 BP 107/66, P72, )2 98%.
Patient was administered the Bivalent Pfizer immunization as a first dose Covid immunization rather than the older Pfizer Covid immunization. The bivalent Pfizer immunization is only approved for booster shots as of yesterday (9/21/22).
On 12/11/2021 the following day after having the 3rd Phizer booster shot I started having extreme tiredness, runny nose, cough and was very cold for no reason.  The following evening/morning of 12/12/2021 at around 3:30 am I was woken with a loud ringing in my ears. Louder in my left ear than the right but very loud in both.  It has been nonstop 24/7 ringing since then.  Over the last 8.5 weeks it has gone down from time to time but varies and always comes up.  It has left my right ear from time to time and I have had the tone change but there is always ringing and sometimes a hiss and cricket sound.  The sound sometimes sounds like it is in my left ear and middle of my head,  or right and left ears, or right, middle and left, and sometimes just the left.  On average is has been in both ears more often than not but recently mostly the left.  The volume sometimes goes down but always varies and can go back to the loudness I've experienced since this started.  I went to Medical Immediate Care on 12/23/201 and saw Dr.  I informed him of the tinnitus started a day a half after the booster.  He checked me and stated that I had congestion and prescribed me Claritin D, Flonase, and 20mg of Prednisone for 5 days starting the 3rd day after the other 2 medications.  He stated that there have been other reports of complications after taking the Covid vaccine but there is no information on when I may get over my symptoms.  He gave me a referral to an ENT for an immediate follow up.  I saw the ENT, on 12/28/21.  A separate audiologist gave me a hearing exam and stated my hearing is within the normal range.  She stated that my ears were clear and there was no sign of congestion or problems with my ears and that the hearing test showed a slight difference in my left ear than right but not significant and not the cause of the tinnitus.  She checked my mouth, neck, head and ears.  She found nothing with those checks. She stated my ears are healthy with no congestion or ETD.  She stated that there are other patients also having issues after Covid vaccines.  She stated there is no cure and couldn't tell me if or when the tinnitus will get better as the data regarding the Covid vaccines is too new and incomplete. She gave me a follow up to the ENT MD specialist there at Northwestern  but the closest appointment I could schedule is 5/23/2022.  She also suggested trying white noise and sound masking for relief along with a referral for accupuncture as she stated it has been helpful for some to deal with ongoing  tinnitus.   It is 2/08/2022 and it has been 8 weeks and 3 days since the tinnitus started 1.5 days after getting the Pfizer covid booster shot on 12/10/2021.  The tinnitus has been nonstop in my left ear sometimes in my right.  It has lessened at times but has not gone and sometimes is as loud as the first night.  It seems to increase and decrease in volume randomly.  This has greatly affected my health, wellbeing, and quality of life.  I am hoping it is going down overall over time.
This case was reported by a pharmacist and described the occurrence of injection site bleeding in a unk patient who received ENGERIX B. On an unknown date, the patient received the 2nd dose of ENGERIX B (unknown). On an unknown date, Immediately after receiving ENGERIX B, the patient experienced injection site bleeding. On an unknown date, the outcome of the injection site bleeding was unknown. It was unknown if the reporter considered the injections the bleeding to be relate to ENGERIX B. Additional details provided as follow: It was reported that the blood came out while administering ENGERIX B.
within 10 minutes of second dose of vaccine pt reported new onset chest pain, rated pain 7/10, vitals signs obtained, EMS called, EKG obtained, received dose of aspirin and transported to ER for further evaluation.
07/21/2017 Patient was here in clinic for immunization appointment. During appointment she stated she had been recently injured and needed a Tetanus shot. Other immunizations available were reviewed with her and she stated she did not want to get the HPV9 immunization. She stated she did want the Hepatitis A Vaccine, tetanus immunization, and the meningococcal vaccine. Immunizations were drawn up and forms were completed in EHR. Patient was alert and oriented and cousin was at her side. She did state to me and her cousin that she was extremely scared of shots. Right deltoid area cleansed with alcohol and administered HAV IM and covered with bandaid. Area below in the right deltoid muscle cleansed with alcohol and Td was administered. As soon as this bandaid was applied patient stated she did feel well. I applied a instant ice compress to her chest and one to her neck. Patient remained conscious at all times. I called for help in patient care. Ammonia inhalant opened and waved under nostril a few times and patient commented about odor of it. She stated her throat was sore and her chest was hurting. I asked her if I could call a ambulance and she stated she was scared. I called 911 and told them I needed an ambulance immediately. B/P was taken and was 93/61. Heart rate was 88. Wet wash cloths applied to patients for head and neck. She remained conscious but kept complaining of chest pain and a very sore throat. Two first responders arrived. We were in the process of applying oxygen when the ambulance service arrived. The patient stood, turned and sat on the stretcher. She was taken to the ambulance. There a EMT tried to start an IV in her left antecubital area with no success times. I started a IV in her right antecubital area and it was flushed. EMT administered meds, through it per IV push. Patient transferred to Hospital where she was seen per MD. He stated he thought it was a vasovagal response from fear of injections. Once patient's caregiver and Mother arrived at hospital I returned to the clinic.
Immobilized left arm (2.5 days), swollen and hot red arm, sleeplessness (36 hours), hives outbreak, chills and achy.
This spontaneous case reported by a consumer, describes the occurrence of pruritus/scalp itching (started sometime after the patient received both Moderna COVID-19 vaccinations) and vaccination site pain (sore left arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 012M20A) for COVID-19 immunization. Concurrent medical conditions included allergy (NOS) and rheumatoid arthritis. Concomitant medications included loratadine for allergy, prednisone for rheumatoid arthritis, vitamins, oxycodone, venlafaxine, Zetia (ezetimibe), Vitamin D, Fiber (polycarbophil calcium), D-Mannose and zoledronic acid for an unknown indication. On Jan 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient had pruritus/scalp itching (started sometime after the patient received both Moderna COVID-19 vaccinations) and vaccination site pain (sore left arm). At the time of the report, pruritus/scalp itching (started sometime after the patient received both Moderna COVID-19 vaccinations) and vaccination site pain (sore left arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or treatment information. This case linked to MOD-2021-364408 (patient link).
23JUL92 pt recvd 1st dose of Engerix-B & subsequently devel flu-like sx;
Cellulitis at injection site of Varivax 10 cm x 13 cm.  DTaP n same leg at lateral site with no erythema, no edema.
5/27/10 Received Yellow Fever and Typhim Vi vaccines. After 1 hr. mother called to report that patient had a rash on neck and ears and difficulty breathing and they were going to the ER. Seen at hospital, received a steroid injection and discharged after 2-3 hours with PREDNISONE Rx.
Pain and discomfort at injection site, left deltoid, pain radiated into left shoulder, neck pain, upper back and right shoulder pain began around 2:00 pm on 3/28/06. Pt advised to take extra strength Tylenol and monitor temp. Still monitoring pt.
Patient called pharmacy on 10/22/09 to report his adverse event. He experienced a "rush" from head to toe shortly after receiving the shot on 10/13/09 but did not report to the immunizer. Three days after receiving the shot 10/16/09 - he reports experiencing headache, impaired memory, unstable walking & upset stomach.
In the morning around 8:00 Chronic cough all day long. I could not sing. I slept ok but I couldn't breath properly, I took home remedies to feel better. It lasted 7 weeks. It cleared up at last week of January.
Patient brought to the ED by EMS on 10/23 after husband observed patient being minimally responsive. Patient also with generalized weakness and lethargy. En route to the hospital, patient's husband received a call from the patient's nursing facility confirming that the patient tested positive for COVID. Repeat COVID testing done on 10/23 was also positive. Patient admitted 10/23-10/26. Patient has received the COVID primary series and two booster doses.
Severe migraine, and burning sensation on entire body.  Especially in back/neck, ribs and vaginal area (even when I pee).
Incident Details: Per an email sent out on 9/1/22 from a Clinic provider-"the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand." The patient, was seen in office on 9/2/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (pfizer) by staff in error as patients are now only supposed to receive the bivalent booster per Dr. email. Pt was due for booster at the time they received it, however the bivlalent booster was not yet stocked at clinic.  Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation  of monovalent covid boosters until clinic receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also ?monovalent? and ?bivalent? are new terms that have not previously been used when discussing booster vaccines.
Preterm labor at 28+ 6 weeks resulting in delivery of dichorionic diamniotic twins via c-section Pregnancy history - two prior full term deliveries in 8/2017 and 8/2019 This pregnancy: Estimated date of delivery 6/25/2021 Birth weights: 1550g and 1270g
Initial unsolicited case received from a consumer on 13 Mar 2017. This case involves a 62 year old female patient who was vaccinated with a dose of ADACEL (Batch number: U5476AA, expiry date: 04 Nov 2018, dose, dose in series was not reported) administered intramuscularly in left deltoid on 03 Mar 2017. The patient had no illness at the time of vaccination, and the patient had penicillin, and erythromycin allergies. Concomitant medications were not reported. On 03 Mar 2017, same day following the vaccination the patient experienced swelling, rash, soreness of upper arm muscle of left arm. Stated also within 24 hours the rash extended from upper arm down to wrist, experienced fever, headache, nausea, diarrhea, general malaise, and it was reported as of today on 13 Mar 2017, the patient still has swelling of upper arm, soreness of arm, and rash on arm. The patient required ER visit and was seen by her own physician for evaluation. The patient relevant lab tests were not reported. The patient was treated with antibiotic. The outcome of the events were reported as not recovered. List of documents held by sender: none.
1 y female for WCC, received PCV 13, Hib, MMR, Varicella. Sleepy, fussy after admin. Then next AM vomiting and diarrhea x 3 . No fever, 24 hrs later better.
9/9/21 pain at the injection site started . 9/13 21 pain spread up arm to neck and head
CHICKEN POX BLISTERS BEGAN ON 8/9/2007 SPREAD AND CHILD WAS DIAGNOSED ON 8/11/2007 WITH CHICKEN POX PT HAD FEVER X3 DAYS.
Pfizer-BioNTech COVID-19 Vaccine EUA Rash, itching, hives (throughout entire body), and swelling of the face.   04/17/2021 through 04/21/2021. Treated with over the counter medications.
Fever over 101 degrees  for 36 hours  headache, chills and cough after 1 dose. Took Tylenol and Muscinex. Took about 48 hours for fever to subside and another day to feel  better.
Patient indicates when urinating there was presence of blood. In addition, today she obtained the second dose, she had pain in her arm and in the mammary glands. She feels exhausted and have difficulty getting up.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 51 year old male. 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, intramuscular, batch number: 201A21A, expiry: 21/SEP/2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211038507, 20211038614, 20211038664, 20211038269, 20211039749, 20211038442, 20211038411, 20211002617 and 20211034734.
Inappropriate schedule of vaccine administered; Gum infection; a really bad one; Vertigo; Was not able to walk for about four hours after the shot; Feeling so weak; The second dose hit her hard; Dizzy; Swollen lymph nodes on the right side by the upper neck under her chin; Body ache all over; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVITIS (Gum infection; a really bad one), VERTIGO (Vertigo), GAIT INABILITY (Was not able to walk for about four hours after the shot), ASTHENIA (Feeling so weak) and VACCINATION COMPLICATION (The second dose hit her hard) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included CALCIUM, FISH OIL and MAGNESIUM for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced GINGIVITIS (Gum infection; a really bad one), VERTIGO (Vertigo), ASTHENIA (Feeling so weak), VACCINATION COMPLICATION (The second dose hit her hard), DIZZINESS (Dizzy), LYMPHADENOPATHY (Swollen lymph nodes on the right side by the upper neck under her chin) and MYALGIA (Body ache all over). April 2021, the patient experienced GAIT INABILITY (Was not able to walk for about four hours after the shot). On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PENICILLIN NOS for Gum infection, at a dose of 500 milligram. On 20-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, GINGIVITIS (Gum infection; a really bad one), VERTIGO (Vertigo), GAIT INABILITY (Was not able to walk for about four hours after the shot), ASTHENIA (Feeling so weak), VACCINATION COMPLICATION (The second dose hit her hard), DIZZINESS (Dizzy), LYMPHADENOPATHY (Swollen lymph nodes on the right side by the upper neck under her chin) and MYALGIA (Body ache all over) outcome was unknown.            After receiving second dose vaccine, patient also experienced high temperature for 2 days and light temperature for 3 to 4 days at least.   This case was linked to MOD-2021-325583, MOD-2021-326895 (Patient Link).
broken blood vessel; This is a spontaneous report from a sponsored program,  from a contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 12Feb2021 as a single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported. The patient received her first dose of the vaccine on 12Feb2021 and when it was given to her the healthcare provider said that she had a broken blood vessel, the patient was wondering if she was vaccinated properly. The clinical outcome of the broken blood vessel was unknown.    The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Diaphoretic, Pulse - 88, resp. - 15, vomited once, shaking,
On 08/07/2023, as I was finishing a yoga class and was supine on the yoga mat resting, I suddenly felt overwhelming nausea and dizziness. I could not sit up. I vomited twice and began to shake violently, and my skin got clammy.  EMS was called, and I had projectile vomiting in the ambulance on the way to the hospital.
Was having vertigo issues on May 10th by May 16th had extreme vertigo and loss of hearing in my right ear that to this date has not returned.I have been tested for crystals in my head to possibly having menieres. Both were ruled out. I had spent 3 days in the hospital. I had a CT scan,MRI on my brain and another MRI on my ear with contrast. Took prednisone for 15 days and 1 shot directly in my ear. Nothing showed up on the tests and no result with prednisone. ENT doctors believe it was a vascular event.Recourse for me at this time will be bicros hearing aids. Im reporting this because im not sure if the shots could have been a cause since its a mystery even to my doctors.
Client given normal saline instead of Pfizer vaccine. Client re-vaccinated 4/17/2021 with EW0162 IM in left deltoid.
pt recv vax 10OCT95 & devel warmth & a large area of redness @ the inj site;no tx necessary;pt recovered;
The patient described feeling weak, light headed, dizzy, fatigue, body aches and a moderate headache. Patient's symptoms got slightly better within first 12 hours after vaccine, but patient is still not feeling well but is feeling better than right after the shot.
Narrative: Patient stated to primary care MD she is allergic to flu vaccine once developed throat swelling secondary to it. Md flagged pt's chart as historical allergy to influenza vaccine.