chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician, for the pregnancy registry for GARDASIL, concerning a 20 year old female with a history of 1 pregnancy and 1 elective termination who on 16-NOV-2007, 16-JAN-2008 and 03-SEP-2008 was vaccinated with a first, second and third doses, respectively, of GARDASIL (Lot # of the first dose 658222/0927U, Lot # of the third dose 660557/0072X).  Concomitant therapy included ORTHO TRI-CYCLEN.  Subsequently the patient became pregnant.  Her LMP was 29-APR-2008.  Estimated conception date was 13-MAY-2008.  Estimated delivery date was 03-FEB-2009.  On 16-JUN-2008 the patient had an elective termination.  The products of conception were not examined.  It was unknown if the fetus was normal.  There was no complication during pregnancy.  There were no concurrent medical conditions.  Upon internal review, "elective termination" was determined to be an other important medical event.  No further information is available.
Fever, Diarrhea, chills, body aches (unspecified) Narrative:
Patients reported hot/cold flashes, nausea, flu-like symptoms all throughout the night and has remained the same until following morning. After being notified, immediately instructed patient to be seen at Health Clinic for possible reaction to HPV vaccination. Pending doctor visit. Unknown outcome as of 25FEB2011, 10:30AM.
I knew that I was exposed because we found out the my grandson had gotten COVID-19 once we visited. I started coughing and sneezing in the middle of the night. I took a test that morning and it was positive with mild symptoms. I never ran a fever. My pcp recommended that I take the antiviral Paxlovid which I started taking. I do have less coughing an congestion currently.
Client received vaccines on 8-6-12 7pm on 8-8-12 woke up with headache & took TYLENOL. Later in afternoon developed temperature 101.6 with chills and headache returned. This was HPV #3 & Hep A #2. He had no reaction on prior doses.
Information has been received from a 42 year old female who on unspecified date, was vaccinated with the first dose of GARDASIL vaccine (yeast). On 21-AUG-2008 was vaccinated the second dose of with GARDASIL vaccine (yeast). No adverse events reported. No further information is available.
Patient got vaccinated for Janssen's COVID-19 vaccine and was sitting on a chair for 20 minutes to see any reactions with his friend sitting next to him. Patient's friend called for help because he was passing out for a few seconds or a minutes. I ran to the patient and asked him if he's okay and he said he was hot and sweating but okay. I called 911. He was awake and breathing normal while I was watching him until paramedic arrived. Paramedic took vitals and asked patient whether he wanted to go to ER. Patient refused to go to ER and signed for refusing on the document that paramedic provided. Patient left pharmacy to go home with his friend's escort.
Fine for 2 days. No reaction at injection site. Next day woke up with severe neck and shoulder pain and fever 101 degrees 0 muscle pain spread to entire body over next 48 hours. Fever 100-101 degrees while on ADVIL for 7-8 days. Severe muscle pain - especially neck shoulders for 2-3 weeks. Mild residual neck and shoulder pain now. 2009 - Developed quarter sized red blistered lesion - extreme itching at injection site - took nearly 6 weeks to heal.
Information has been received from a consumer concerning her daughter who was vaccinated with a dose of GARDASIL (dose, route and lot number not reported).  The consumer reported that her daughter had experienced HPV infections after she had received a dose of GARDSIL.  It was not specified if the patient sought medical attention.  This is one of two reports from the same source.  Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of myalgia upper extremities in a 75-year-old female patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia upper extremities and influenza like illness. On an unknown date, the patient experienced lip swelling. On an unknown date, the outcome of the myalgia upper extremities, influenza like illness and lip swelling were recovered/resolved. The reporter considered the myalgia upper extremities, influenza like illness and lip swelling to be related to SHINGRIX. Additional information was reported as follows: The consumer reported that after vaccination with SHINGRIX, her arm hurted at the muscle and she felt fluish for approximately one day. The patient was vaccinated with SHINGRIX on the right arm. The second morning after receiving the vaccination, she woke up with her upper right half of lip swollen, this lasted for half of the day and then the event was resolved. The patient had denied permission to contact their physician. The reporter was unable to provide any additional details at the time of reporting.
Erythema; pain in extremity; edema; peripheral Information has been received from a health professional concerning a 61 year old white female with degenerative joint disease, hormone deficient, hyperparathyroidism, codeine and "sodium pent" allergy who on 25-OCT-2005 later in the PM was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot #651523/0604R). Concomitant therapy included a IM dose in the left deltoid of influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated) (Lot U1777AA). It was reported that the patient had "2+" doses of influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated). On 25-OCT-2005 the patient complained of a red, painful and swollen arm after the immunization. It was reported that it lasted two days and the patient recovered.  Additional information is not expected.
Rash and hives on face; Rash and hives on face; throat itchiness; swollen face around eyes; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number EL9262, expiry date: unknown) via an unspecified route of administration in left arm on 15Feb2021 at 09:15 (at the age of 44-year-old) as a single dose for Covid-19 immunization in Hospital. The patient had known allergies: sulfa, penicillin, latex. The patient did not had any other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications (in two weeks) included melatonin, magnesium, cetirizine hydrochloride (ZYRTEC), and azelastine hydrochloride, fluticasone propionate (DYMISTA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number EL9262, expiry date: unknown) via an unspecified route of administration in left arm on 25Jan2021 at 08:15 as a single dose for Covid-19 immunization. On 20Feb2021 at 7:30, the patient experienced rash and hives on face, throat itchiness, and swollen face around eyes. Patient received treatment with Oratidine, Benadryl, and Prednisone for the events. The outcome of the events of rash and hives on face, throat itchiness, and swollen face around eyes was recovering.   No follow-up attempts are possible. No further information is expected.
Information has been received from a consumer concerning her 12 year old student daughter with no known drug allergies who on 09-MAY-2007 was vaccinated with the first dose of GARDASIL. On 08-AUG-2007 the patient was vaccinated with the second dose of GARDASIL. In September 2007, the patient developed severe nausea and severe dizziness, unable to function-can't walk, stand up, read, no computer work. The patient could not go to sleep at night because when she closed her eyes the dizziness was even worse, black outs. Symptoms lasted from 10 minutes to several hours. The patient missed a total of 30 days of school in 2007. This year she missed 27 days of school. Symptoms continued. Studies of X-rays, MRI, CT scan, vestibular testing, sleep studies, EEG were all negative. Severe nausea, severe dizziness, black outs, can't walk and missed a total of 30 days of school in 2007 and 27 days this year were considered to be disabling and other important medical events by the reporter. Additional information has been requested.   9/28/09 Note in vaccine records. Patient had 2 doses of Gardasil. Did not complete series.
Diarrhea x 2, low-grade fever and arm soreness. 2nd shot: Patient with severe headache, low-grade fever, lethargy and unable to go to work for 1 day. Nausea and vomiting. Afterwards, she has had a daily headache to this date, poor appetite and weight loss of 40 lbs.
DVT in left leg within 2 days of recieving the vaccine. No risk factors other than the vaccine.
This spontaneous report was received from a health care professional refers to an unspecified multiple patients of unknown demographics. On 24-SEP-2015, 02-OCT-2015, 06-OCT-2015 and 08-OCT-2015 the patients were vaccinated with improperly stored doses of GARDASIL 9 (L023230 28-JUL-2017) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. The outcome of medication error was unknown. This case is linked to: 1510USA008394 (same reporter link). Additional information has been requested.
Pt received influenza vaccine and Hep A dose # 1 vaccines on 2-26-14, aprox. 3 mins after receiving Hep A pt stated he didn't feel well. Pt remained conscious and responsive. Pt had no s/sx of resp. distress, no anaphylactic s/sx. Pt was assisted to reclining position and cool compress applied to forehead. Pt stated this happens when he has blood drawn but has not had this happen from vaccines in past. Pt VS 112/68 and second set 120/72, resp 17.
(L) arm swelling, itching, soreness, nausea, temp. Hospitalized 3 days. Ice pack and Benadryl. Did EKG and ECHO. 10/15/08 Reviewed hospital medical records of 10/2-10/04/2008. FINAL DX: local vaccine reaction Records reveal patient experienced weakness, nausea, itching, injection site swelling, induration & erythema left deltoid.  Cardiology consult done.
PT FELT TINGLING WE CALLED CODE GREEN AND THERE HE STARTED TO FEEL BETTER ALL VSS SENT HOME AFTER MONITORED X45 MIN
Information has been received from a physician concerning a 22 year old female who on 23-Jan-2009 was vaccinated in arm with the second dose of GARDASIL vaccine. On 24-JAN-2009, the patient developed a rash all over her body. It was reported that the patient does not plan on receiving a third dose. Lot number was not available. The patient sought unspecified medical attention. Additional information has been requested.
Persistent swelling of the feet and legs for approximately 10 days. Foot skin very sensitive to the touch, mild pain and itchiness.
Pt vaccinated with DTP/OPV/HIB developed inconsolable crying for 5 1/2 hrs occuring within 48 hrs of vaccine;treated in ER w/Ibuprofen.
FEVER 101 F; FATIGUE; HEADACHE; This spontaneous report received from a parent concerned a 20-year-old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced fever 101 Fahrenheit. On 06-APR-2021, the patient experienced fatigue. On 06-APR-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from fever 101 Fahrenheit, and fatigue. This report was non-serious.
Covid 19 diagnosis after first dose; headache; sore throat; feeling really bad; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (feeling really bad), COVID-19 (Covid 19 diagnosis after first dose) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (feeling really bad) and HEADACHE (headache). On an unknown date, the patient experienced COVID-19 (Covid 19 diagnosis after first dose). At the time of the report, OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (feeling really bad), COVID-19 (Covid 19 diagnosis after first dose) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) COVID-19 Positive.     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 assessment.  No concomitant medications were reported. Treatment information was not provided.
Large rectangular red hot to touch area harden area Appox 4?x3? still 5 days post 2nd shot- area well below area a shot  is given! I have a photo of the are post 5 days.
Patient started getting fevers and having febrile seizures at about 2.5 years of age. This last seizure she had happened 2 weeks after her vaccinations: MMR, Varicella, DTP. These were given to her day after she'd been treated in the ER for 2 febriles.
urticaria 15 hrs following immun w/vax; no treatment necessary-lasted approx 2 days;
Pt had vaccine on 9/26/16. Reported to pharmacy on 10/13 that she had arm pain all the way down and at flu shot site. She went to hospital - they told her anxiety from pain resulting from shot possibly. She still has the arm pain and they ruled out heart attack at hospital. Was in on 10/16 and says still pain and numbness in her arm.
Started having multiple febrile seizures 12-13 hrs after vaccinations 1st one was 10-15 minutes at home 2nd one in the ambulance around 10 minutes was evaluated at local hospital (postictal) then transferred to another hospital one more seizure there responded to treatment discharged on 1/6/16.
Needs to take antibiotics after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Needs to take antibiotics after vaccination) 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.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Needs to take antibiotics after vaccination). At the time of the report, VACCINATION COMPLICATION (Needs to take antibiotics after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment medications were reported
Vaccine given expired on 11/30/22 but given on 12/1/22.  Vaccine expiration date was entered wrong in the online system did not flag for expired vaccine.
Severe fatigue and back pain around site of previous surgery (T8-9 laminectomy w Syringo-subarachnoid shunt) for about 6-7 days immediately following 3rd dose and moderate to severe menorrhagia beginning around 7/5/22 with menstrual bleeding lasting daily or near daily until 10/25/22.
Bronchitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's family history included: "bronchitis" (unspecified if ongoing), notes: thinks the girlfriend got bronchitis from her family. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: BRONCHITIS (non-serious), outcome "unknown".  Additional information: It was reported that the caller's brother and his girlfriend received the Pfizer covid vaccine omicron. Caller stated the girlfriend thinks she got bronchitis from the vaccine. Caller was requested an email saying that bronchitis was not a side effect of the vaccine. Caller declined to be transferred over because she stated that bronchitis was not a side effect and thinks the girlfriend got bronchitis from her family. Caller stated she did not want to make a report. Caller stated she was thrilled she got the omicron vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt recvd vax on 24JUN92 & approx 2 days later devel a fine, red pruritic rash on chest, neck, shoulder, hands & behind knees; treated w/DPH w/some relief of sx;
2 days after Anthrax, the pt developed torso rash which lasted 1 day. No blisters and completely resolved. No fever at that time.
Blurriness in the left eye and muscle fatigue continuing for more than 2 weeks after the vaccine. Reduced muscle recovery after physical activities, even 2 weeks after the vaccine.
Achy pain in shoulders and neck. Very tired, worn out feeling. Chest tightness. No fever but very cold then hot.
PT SHOULD HAVE BEEN GIVEN A MENACTRA INSTEAD OF MEN B. HEALTH DEPT WAS NOTIFIED AND WE ARE WAITING TO HEAR FROM THEM WHAT WE NEED TO TELL PATIENT IN REGARDS TO REPEATING WITH CORRECT VACCINE AND IF THE MEN B WILL COUNT.
50 y/o female had COVID infection in February 2021. She works at a HCF and was told to get the vaccine.  She is c/o Flu like sx: Body aches, HA, low grade fever, watery nose, chills.   She is taking Tylenol q/6 hrs. Caller wants to know if she can take Nyquil or Alka seltzer along with her nasal decongestant.   PCC: Sx likely to be just side effects post vaccination. Advised to continue taking Tylenol if needed. In the event that she prefers Nyquil or Alka Seltzer, d/c Tylenol or make sure formulations do not contain same ingredients.  Sx should self resolve within 24-48 hrs. If sx persist or worsen seek medical evaluation. Keep self hydrated. PCC will fu.   4/25- no answer, no voicemail set-up
He felt dizzy again when he woke up early morning to use restroom; Today starting around at 8AM, his head feels as if it is stuffed (like heavy head); he feels like his ears will pop; Yesterday, he experienced a brief episode of dizziness while driving; Patient felt tired on same day of receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Patient felt tired on same day of receiving 1st dose), DIZZINESS (Yesterday, he experienced a brief episode of dizziness while driving), DIZZINESS (He felt dizzy again when he woke up early morning to use restroom), HEAD DISCOMFORT (Today starting around at 8AM, his head feels as if it is stuffed (like heavy head)) and TINNITUS (he feels like his ears will pop) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No medical history report provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ROSUVASTATIN and CLONAZEPAM for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FATIGUE (Patient felt tired on same day of receiving 1st dose). On 08-Apr-2021, the patient experienced DIZZINESS (Yesterday, he experienced a brief episode of dizziness while driving). On 09-Apr-2021, the patient experienced DIZZINESS (He felt dizzy again when he woke up early morning to use restroom), HEAD DISCOMFORT (Today starting around at 8AM, his head feels as if it is stuffed (like heavy head)) and TINNITUS (he feels like his ears will pop). At the time of the report, FATIGUE (Patient felt tired on same day of receiving 1st dose), DIZZINESS (Yesterday, he experienced a brief episode of dizziness while driving), DIZZINESS (He felt dizzy again when he woke up early morning to use restroom), HEAD DISCOMFORT (Today starting around at 8AM, his head feels as if it is stuffed (like heavy head)) and TINNITUS (he feels like his ears will pop) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        no treatment details reported.
allergic reaction with the COVID-19 Vaccine; the inside of body felt like it was shaking. She said it was hard to describe the feeling, but it was like her inside was speeding; the inside of body felt like it was shaking. She said it was hard to describe the feeling, but it was like her inside was speeding; Hives; This is a spontaneous report from a contactable consumer reported for self. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took codeine and experienced an allergy to Codeine. She said with the codeine allergy the inside of body felt like it was shaking. She said it was hard to describe the feeling, but it was like her inside was speeding. She said she also would get hives with the codeine allergy. The patient experienced she had the same kind of allergic reaction with the COVID-19 vaccine as with her allergy to codeine on 2021, the inside of body felt like it was shaking. she said it was hard to describe the feeling, but it was like her inside was speeding on 2021, hives on 2021. The patient asked if she should get the second COVID-19 Vaccine and asked if she only got the first COVID-19 vaccine shot, how protected would she be. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sore shoulder muscle; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder muscle) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced ARTHRALGIA (Sore shoulder muscle). At the time of the report, ARTHRALGIA (Sore shoulder muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment medication was provided.   Reporter did not allow further contact