chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Daily dose: CF, Solution for injection in prefilled pen. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant drugs were not reported.  The reporter's causality for the event COVID with Humira was no reasonable possibility.  Treatment medications were not provided.  It was unknown date if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and MYALGIA (body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced RHINORRHOEA (runny nose) and MYALGIA (body aches). At the time of the report, RHINORRHOEA (runny nose) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was not reported. No treatment medication was not reported.
p/vax pt reported fever 103-10 hr p/vax;shaking chills x24hr then nausea x 2 days;no c/o diarrhea, runny nose, cough;
Parent requested Moderna for their 17 year old child and RN administered the Moderna vaccine at parents request, and forgot that pediatric patients under age 18 could only receive Pfizer vaccine. Called CDC hotline and they said to keep patient on the Moderna series and administer the 2nd vaccine and document it as "off label" given that the EUA for Moderna is not covered for patients less than 18 years of age. Patient observed for 30 minutes and did not have any reaction.
Started coughing and becoming short of breath on May 12th Urgent care on 5/14/21 - Treated for bronchitis with Methylprednisolone 4mg Dosepack and Azithromycin 500mg and advised to use Albuterol inhaler and Nebulizer every 4 hours Primary Physician Visit 5/20/21 - Prescribed another round of Methylprednisolone 4mg Dosepack  Emergency Room Visit 5/25/21 - EKG/Chest X-Ray - no PE or Pneumonia - given IV of Magnesium  Primary Physician Visit 5/27/21 - Directly admitted to hospital
This case was reported in a literature article and described the occurrence of transverse myelitis in a 13-year-old subject of unspecified gender who was vaccinated with Hepatitis A vaccine (manufacturer unspecified), varicella virus vaccine (non-gsk). Concurrent medical conditions included asthma, eczema and seasonal allergy. On an unspecified date, the subject received an unspecified dose of Hepatitis A vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of Varicella virus vaccine (Non-GSK) (unknown). 18 days after vaccination with Hepatitis A vaccine and Varicella virus vaccine (Non-GSK), the subject experienced transverse myelitis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was possibly related to vaccination with Hepatitis A vaccine and Varicella virus vaccine (Non-GSK). This case has been linked to case B0739797A: same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that he CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Client was given an adult Hepatitis B instead of Hepatitis B pediatric .  Client did not have a reaction.
developed symptoms on 25Sep2021 and became sero positive for COVID-19; developed symptoms on 25Sep2021 and became sero positive for COVID-19; This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients (uncle and aunty). This is the 1st (uncle) of 2 reports. An elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Sep2021 (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No Covid prior vaccination. No other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient received the Pfizer BioNTech vaccine booster (completing the series of 3) and developed symptoms on 25Sep2021 and became sero positive for COVID-19 on an unspecified date, thus qualifying as a lack of efficacy AE (adverse event). The events did not result in emergency room visit or physician office visit. The patient underwent lab tests and procedures which included COVID-19: positive on an unspecified date. Therapeutic measures were taken as a result of the events included regeneron monoclonal antibodies. The outcome of the events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective, Covid-19 and BNT162B2.,Linked Report(s) : US-PFIZER INC-202101326365 same reporter/drug/event, different patient
This spontaneous report has been received from a pharmacist of unknown age who is also the patient. The patient's medical history and concurrent conditions were not provided. On 16-MAR-2016, the patient was vaccinated with the first dose of VAQTA (dose, route of administration, lot number and expiration date were not reported), and then on 16-MAY-2016 "two months later", the patient received a booster dose of VAQTA. Concomitant or co-suspect therapies were not provided. The reporter stated that this vaccination schedule was outside of the recommendations in VAQTA prescribing information. No adverse effects were reported, no product quality complaint (PQC) was involved. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to a 12 months old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 14-SEP-2016, the patients received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes on 29-AUG-2016. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
One week after the injection, the area was swollen. Pt. went to her dr. Dr. said it is infected. Pt was given antibiotic. Infection was gone.
Spotting worse this time. have to wear pads regularly Huge Lump in arm for 2 weeks Numbness down my entire arm Dizziness Diarrhea Nausea Headache Fatigue Red spots on my chest that have never been there before.
4 month old was given KINRIX; Expiration date 31-AUG-2021; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2021, the patient received Kinrix (intramuscular) .5 ml and Kinrix Pre-Filled Syringe Device. On 1st September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and expired vaccine used. On an unknown date, the outcome of the inappropriate age at vaccine administration and expired vaccine used were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follow: This case was reported by medical assistant.  On 1st September 2021, a 4 month old infant was accidentally given Kinrix intramuscularly which got expired on 30th August 2021, which led to inappropriate age at vaccine administration and expired vaccine used. The reporter consented to follow up.
This spontaneous report as received from a nurse practitioner refers to a 54 year old female patient. On 05-JUN-2013, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot number not reported). The patient developed redness (a 3 cm area) and mild pain at injection site the next day, on 06-JUN-2013. The patient developed a rash on her face that itched, but did not burn. The nurse practitioner suspected a poison ivy rash, because the rash crossed the midline on her face and prescribed calamine lotion which did bring some relief for the patient. The nurse practitioner cultured the lesions, but did not have the results back at the time of the report. The patient's outcome was reported as recovering. The patient sought medical attention via an office visit. Additional information has been requested.
Spikevax was administered in the lower back of left arm subcutaneously. Patient experiencing red, hot rash; pain; tenderness to touch; and itchiness. Watching for infection
Vaccine was given in the left joint, not the left muscle. Caused severe pain, unable to lift left arm, and am still unable to lift left arm and am still in severe pain.
The child received vaccine, three seconds later, Site Manager observed the child begin to shake and raise arms in upright and locked position bent at the elbows towards face. At that time RN  was called over and began evaluating child.  RN also came over and began calming child and evaluating him. The child came to within a couple minutes and began crying and stating he did not know what just happened and stated that he had a weird dream. RN began a set of vitals on child where blood pressure was noted to be 101/88 and pulse 58, respirations 22. Child began to sweat profusely and his skin color became pallor. Child's skin was also cold and clammy to touch however child was talking and coherent, child answering questions asked of him appropriately.  EMS was called to scene and arrived at that point began asking child questions which he was answering appropriately.  His skin color and sweating improved before being transported out of facility. Child was taken to Hospital.
Child has not had any adverse symptoms .   Pneumovac 23 was given in error - patient was to receive PVC 13
Erythema, induration at site, faint regular rash on abdomen and extremities.
A report has been resolved from a Health Professional concerning a 39 year old female patient. No medical history, no other health conditions and no history of vertigo was provided. The patient may have been taking an unspecified medication at the time, but she didn't think she was. In 2009 the patient received nasal H1N1. Within 24 hours of her vaccination she got very sick. Her vertigo started in the middle of the night, and it was very severe so that she could barely walk across the room. She was sick all over (not further specified) and stayed at home for 1.5 days before going to urgent care. The vertigo was not as severe as it was initially, but it had not gone away. Her neurologist and 2 separate ENTs told her that the virus in the vaccine caused nerve damage in her ear. When she was taking the mist the side of her nose hurt and she also had strong burning there. This was the same side where he ear was damaged. She had tinnitus, vertigo, and had lost hearing on that side. The outcome of the event of nerve damage, very sick, side of her nose hurt and burning is unknown. According to the reporter the assessment of the Serious criteria for the event of nerve damage was as follows: important medical event was considered to be non serious.
got covid, omicron I assume; got covid, omicron I assume; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got covid, omicron I assume". The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: Customer Verbatim: I had gotten my booster shot. And before the 2 weeks was up I got covid, omicron I assume. I have been wondering how this affects immunity  No follow-up attempts are needed. No further information is expected
Pt was given 4 mo shots on 2/5/14. Started vomiting at 11 PM the same day, and repeatedly on 2-6-14. Had one watery stool 2/6/14. Afebrile. Seen by CFNP 2/6/14 and diagnosed with enteritis due to rotavirus. Was given Rx for PHENERGAN nad told to increase flds, PEDIALYTE or rice water.
Situation:  Pt here for covid vaccine #2. After vaccination pt experienced reaction.   Background:  @ 0815 TEAM ALERT was called to covid vaccine clinic.  This RN arrived @ 0818 to find pt sitting in chair in observation room.  Received report from RN, pt received covid vaccine #2 and began experiencing cough, clearing throat, runny nose, and chills. Benadryl 25mg PO given @ 0810. Overall discomfort 1/10.   0818:  VS:  BP 132/98. HR 63. R 14. O2 Sat 98%. Pt c/o clearing throat, chills, coughing, itchy throat, itchy chest. Pt alert & oriented. 0820: overall discomfort 3/10. 0828:  VS:  BP 124/92. HR 63. O2 Sat 100%. Still experiencing above symptoms plus dizzines, lip numbness and discomfort in diaphragm region. "feels like it won't go down. Like something is stuck there." pt moved to gurney in hallway. 0842:  VS:  BP 122/86. HR 63. O2 Sat 100%. Pt still feeling diaphragm discomfort. States other symptoms are resolving. Noted pt no longer clearing throat. States lip numbness improved and diaphragm discomfort improving. Pt alert & oriented.  0855: Manager, spoke to pt. Advised pt she may go home when she feels okay. Pt states she feels well enough to go home. This RN advised pt to go home and relax for the remainder of the day, benadryl will make her feel sleepy. Advised pt to watch for symptoms of shortness of breath, difficulty breathing, and chest pain and go to ED if she experiences any of those symptoms. Pt verbalized understanding. VS:  BP 118/72. HR 63. O2 Sat 100%. 0857:  Pt left covid vaccine clinic ambulatory in stable condition.   COVID Vaccine Worksheet   1. Did the patient have an immediate allergic reaction of any severity such as urticaria, angioedema, respiratory distress, or anaphylaxis (<4 hours following administration of the COVID vaccine)?  Yes   2. Did the patient previously have an immediate allergic reaction of any severity to polysorbate or polyethylene glycol?  No   3. Has the patient had prior anaphylactic reactions from another vaccine, medication or any other cause?  No   4. Did the patient have an allergic reaction >4 hours after administration? OR have an expected side effect of the COVID vaccine?  No   Assessment:  Pt had reaction to covid vaccine. Pt reported previous reaction to first dose with similar symptoms.  After close observation and benadryl 25mg PO pt symptoms resolved and pt was able to leave clinic ambulatory in stable condition.
Information has been received from a health professional concerning a 36 month old male patient who on 12-JAN-2006 was vaccinated with MMR II (Lot# 648479/0635P) at a local health unit. Subsequently the patient developed autism. The patient has not recovered from autism. No product quality complaint was involved. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
Cough; Nasal congestion; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via unspecified route administration in the left arm on 16Mar2021 at 14:15 (at the age of 19-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On an unspecified date in Mar2021, the patient developed cough and nasal congestion. The clinical outcome of cough and nasal congestion was unknown.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Update the patient's first name, capitalized the first letter
Axillary soreness /pain in the same arm of the injection site. Urticaria, covering most of the deltoid muscle, with slight swelling.
I am reporting this as an error in administration of the vaccine. My child did not experience any adverse symptoms due to this error. My child received the vaccine and then we left the office. About 15 minutes later I received a phone call from the nurse asking use to come back because there was an accidental error in the dosage that was administered. The nurse told me that my child had accidentally received a lower dose than prescribed and we had to come back to get a 2nd dose. Although my child did not experience any adverse symptoms due to this error, it was inconvenient and my child experienced unnecessary anxiety by having to go back for a 2nd shot.
Vaccine was given on 3/14/13. Started feeling sick on 03/20/13. Her symptoms are throat hurting, hard to swallow, neck hurting, back hurting. Site of injection is fine. Denies any redness, swelling, and tenderness.
Fever; chills; body aches; nausea; burping; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the arm left on 06Apr2021 at 09:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included High Blood Pressure.  The patient had no known allergies to medications, food, or other products. The concomitant medications included Atenolol (MANUFACTURER UNKNOWN)from unknown date for unknown indication taken within 2 weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 15Mar2021 at 17:15 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021 the patient experienced Fever, Chills, Body Aches, Nausea, Burping and Diarrhea. No therapeutic measures were taken as a result of the event. The clinical outcome of the events Fever, Chills, Body Aches, Nausea, Burping and Diarrhea were not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report obtained from a contactable nurse. This nurse reported for four patients, this is the second of fourth reports. A 90-year-old female patient received PREVNAR 13 (Lot. L99275; Expiration date: 31Mar2017, NDC number: 005-1971-02) on 08Oct2015 at 15:00, intramuscularly in left arm, at 0.5 ml, single dose and the eighth dose of FLUZONE (Lot. UI456AA, Expiration date: 19Apr2016, NDC number: 49281-397-65, manufacturer: Sanofi Pasteur) on 08Oct2015, intramuscularly in right arm, at 1 DF, single dose. No illness was noted at time of vaccination. The vaccines was administered at the private doctor's office and was purchased with public funds. Relevant medical history included degenerative joint disease (ongoing) and diabetes (ongoing). The patient received, on an unspecified date, seven previous doses of influenza vaccine. Concomitant medications were unknown. The patient received the vaccinations on 08Oct2015 and within 2-3 hours experienced severe left deltoid pain and couldn't move her arm. Emergency room visit was required. Patient went to the hospital because she couldn't move her arm (hospitalization start date: 08Oct2015, hospitalization end date: 12Oct2015). Diagnosis was degenerative joint disease and that the immunization triggered an underlying syndrome she may have had. Clinical outcome of the events was unknown at time of this report. Nurse thought it was somewhat related to vaccination.