chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female patient with no pertinent medical history and no drug reactions or allergies who between the age of 14 and 15 received 3 GARDASIL vaccinations (lot number, dose and site of administration not reported) from another physician. There was no concomitant medication. Physician reported that he performed a PAP test (on unspecified date) and the result of the test indicated that "one high risk HPV was detected but test did not indicate what the HPV type was detected". It was unknown if the patient sought medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Patient is fully vaccinated and boosted 10/28/2021.  Pt is COVID positive on 4/5/2022. 63y.o. male presented to the ED with palpitations.  Denies chest pain.  Postive for chronic abdominal pain. Positve nausea.  Positive cough and fever. Workup in ED with neg CT imaging. Pt has transaminitis. Leukocytosis mild. EKG showing sinus tachy w no evidence of ischemia. Given IV decadron. DVT prophylaxis with lovenox. Discharged home.
Tachycardia, headache, itchy throat, nausea, arm stiffness
Patient came in for the meningococcal vaccine and was mistakenly given the HPV (GARDASIL) vaccine.
patient felt light headed and dizzy within 5 min of Gardasil vaccine administration. Pt. layed down 8 minutes, sat up 10 min. Checked by physician and D/C to home
Rhabdomyolysis bilateral lower limb. Ataxia, metabolic acidosis.  5/23/08 Reviewed hospital medical records of 4/27-5/1/2008. FINAL DX: mild myositis, possibly secondary to tetanus vaccine; h/o seizure disorder secondary to head injury & possible anxiety disorder. Records reveal patient experienced a finger laceration on 4/26, was seen in ER & received tetanus.  Returned to ER 4/27 due to severe bilateral lower extremity calf pain & weakness.  Tx w/fluids, improved & transfered to inpatient rehab.
HA and HTN 11 mins post vaccination, then resolved; returned to facility with ongoing HA and BP 170s on 8/9/21 stated HA had been ongoing since vaccination
This case was reported by a nurse via sales rep and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles, rash and pain. On an unknown date, the outcome of the shingles, rash and pain were unknown. It was unknown if the reporter considered the shingles, rash and pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient received a dose of SHINGRIX in the office, within a week the patient returned as a follow up with rash on side and back. The reporting nurse diagnosed it as Shingles. The patient stated there was a slight pain at the rash site. No patient details were provided. The nurse agreed to be contacted for follow up.
This case was reported by a lawyer and described the occurrence of arm pain in a 48-year-old male subject who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. According to an interview between the subject and attorney(s), on 13 May 1999 or 14 May 1999, the subject received 1st dose of LYMERIX (unknown). On 14 June 1999, 1 month after vaccination with LYMERIX, the subject presented for his second dose of LYMERIX and reported progressively worsening arm pain. The arm pain subsequently became "debilitating", and he presented to the emergency room. Treatment included Oxycodone, and he was prescribed a "hand splint to keep his arm from curling in". He reported that the pain subsequently spread to his entire body including the neck, back and shoulders. He was out of work due to pain until September 1999. Additional problems included night sweats, difficulty opening his hand, cold intolerance in his left arm and hand, and occasional shoulder pain. At the time of reporting the events were unresolved.
Sore throat and swollen and sore lymph nodes on left side of neck/collar bone area.  Injection was given in left arm.
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (used expired vaccine) in a 45-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jul 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 21, 2021, patient administered expired product (used expired vaccine). On Jul 21, 2021, administered expired product (used expired vaccine) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-337434 (patient link). Most recent follow-up information incorporated: On Sep 28, 2021: Follow-up received contained non-significant information.
Sore arm; blurry vision; numbness and tingling in hands and feet; numbness and tingling in hands and feet; shortness of breath; heart palpitation; anxiety; feeling of not being well; This is a spontaneous report from two contactable consumers. A 21-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3181), via an unspecified route of administration, administered in Arm Left on 12Aug2021 at 16:30 (age at vaccination: 21 years) as dose number unknown single for covid-19 immunisation. Medical history was repoted as None. Patient had Pertussis vaccine allergy. There were no concomitant medications. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior vacccinations. Since the vaccination the patient was not tested for COVID-19. The patient experienced sore arm, blurry vision, numbness and tingling in hands and feet, shortness of breath, heart palpitation, anxiety, feeling of not being well on 14Aug2021.Patient received unspecified treatment for the events. The outcome of the events was no recovered.  Device Date was 20Aug2021.  No follow-up attempts are needed. No further information is expected.
Pt presented to clinic for 2-mo well child exam. Included in this were his 2-mo vaccinations. One of which was oral Rotateq. During admin of Rotateq, baby vomited. I checked with PCP regarding how to proceed and was instructed to re-administered the dose using a new vaccine. Followed provider's instructions with successful admin. .
Started 2000 10/07/08. Severe pain in joints, chills, fever 101 degrees. Took EXCEDRIN for H/A, SOB, took nebulizer 3xs in less than 12hrs. General malaise.
Within hour of receiving Flu shot noticed remarkable ringing in left ear that never have experienced. The ringing became worse followed by pain & pressure and partial hearing loss within two to three hours. Additionally, dizzy spells (vertigo followed). After pain and ringing in left ear didn't stop consulted an Ear doctor (Otolaryngologist). Several test were done including MRI and Audiology test that determined suffered partial hearing loss. Given low dose of Prednisone which did not work. As of 5/1/18 I have continuous ringing in left ear and occasional strong pain and pulsating in ear. I never had any ringing in ear prior to vaccination and had FLU shot every year for 25 years with no symptoms. I am 100% that the Flu shot caused my condition. I am now sensitive to noise especially high pitch noises.
Soreness on left arm, hoarseness & sore throat; severe blood shot eyes, aching body;
Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old female patient who inadvertently was given a repeat immunization of PREVNAR, ROTATEQ (Merck & Co Inc), ACT-HiB (Aventis) and PEDIARIX (GlaxoSmithKline) on 16-Jun-2008. On 09-Jun-2008, the patient received a dose of PREVNAR and other childhood vaccines. On 16-Jun-2008, the child inadvertently was given a repeat immunization because the patient's immunizations from 09-Jun-2008 were not recorded. No adverse event was reported. No additional information was available at the time of this report.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 27-SEP-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # N009777, expiration date: 04-MAR-2018 (frequency and route of administration were unspecified) for prophylaxis diluted with sterile diluent (manufacturer unknown) which did not undergo a temperature excursion. It was unknown if the patient experienced any adverse event. The ZOSTAVAX vaccine was exposed to 15 to 46 Fahrenheit degrees for a time frame of 45 minutes and it was found because of a digital data logger. There was a previous excursion to 6 to 14 Fahrenheit degrees for 1 hour and 45 minutes.
minor reaction to the first dose of the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (minor reaction to the first dose of the vaccine.) in a 58-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (minor reaction to the first dose of the vaccine.). At the time of the report, VACCINATION COMPLICATION (minor reaction to the first dose of the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-380069 (Patient Link).
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old female patient who received 0.5 mL dose of vaccines PENTACEL lot C5576AB, expiry date: 18-OCT-2019 via unknown route in the right thigh on 28-Sep-2018 with Merck sterile water (Lot N030721, Exp: 20-Jul-2020). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR and ROTARIX and  for Immunisation On 28-Sep-2018. It was an actual medication error due to Inappropriate reconstitution technique. It was reported that Act HIB portion of Pentacel given with sterile water. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
received an additional secondary dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (received an additional secondary dose of the Moderna COVID-19 vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (received an additional secondary dose of the Moderna COVID-19 vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (received an additional secondary dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information provided.
Left hip joint pain and right shoulder pain. Both were old injuries that completely flared after the 2nd dose. 3 months into it, I got this trigger thumb that was very random. I had never had anything like it. In the past week it has gone but the joint was very painful. I also have generally not felt well but I credit it that to just being in pain. It is concerning to me to have to take Aleve or Tylenol everyday just to deal with the pain.  On the day after the vaccine on my left hip joint where the pain was, I woke up and the tendon that runs to my leg was standing like an inch. It was much more intense in the first vaccination. It was rock hard. It went away after a few minutes. It was half the intensity with the second dose but both were very painful. I saw my chiropractor regarding my hip joint pain. He stated the pain would lessen with time
received Shingrix 1st dose 08/03/2023 and 2nd dose 08/23/2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 37-year-old male patient who received Herpes zoster (Shingrix) (batch number 4KG45, expiry date 13-JUL-2025) for prophylaxis.   Concurrent medical conditions included immunocompromised. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 23-AUG-2023, the patient received the 2nd dose of Shingrix. On 23-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: received Shingrix 1st dose 08/03/2023 and 2nd dose 08/23/2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 30-Oct-2023 No reactions were reported. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
immediately after vaccine given arm became warm, raised, red and rashy from above injection site to below site approx 12 cm across 1 1/2 tsp Benadryl given in office
Left arm beneath the point of entry very sore, swollen, skin fells warm rash area 2"x 4".
Immediate: Flu Like Symptoms - extreme fatigue and irritating rash at injection site that lasted for a week. I did report to the VSafe site but was very happy to get the lifesaving treatment. However, the symptoms were far worse after the second shot and the fatigue and brain fog has continued. Also, the rash, which was told and researched that it was normal has continued to appear (once per month) and spreads from the injection site to the neck area. I have been treating with medical cream. It continues to appear and irritating to the point of not sleeping. Also, unusual inflammation in my left elbow and wrist - arthritic like symptoms that did not set in until post vaccination. (Perhaps coincidence)  Facial Filler Swelling - then dissipated (not a medical side effect but disappointing considering the cost of medical fillers)
Light pink rash, hot to touch, a little swelling. She was told by my nurse (RN) to take 2 Tylenol every 4 hours and rest. Itched. Only lasted 1 day. Never had this problem before.
Tinnitus, worse in left ear.  Heavy feeling all over.  Headache, Tylenol 500mg q6h.
For 1st vaccine- I experienced first vaccine- one week later I got sick for 15 days, symptoms like I had Covid, body aches, chills.  For 2nd vaccine- after one week I experienced had excruciating headaches and shakiness that do not go away. I take Tylenol for pain and as a result have upset stomach.  I went to see my PCP who performed exams, lab work, x-rays, CT scan of the head, CT scan of the abdomen and my doctor does not find anything wrong for me. To this day I continue wit the headaches that do not go away. I do not feel well to do my daily living activities and I get anxiety.  I feel very tense and frustrated due to my symptoms.  I do not have the lot # for my vaccines to provide.
Fever, headache, inflammation under the place of injection (10x3 cm) that is worst with the days.
PER PATIENT SHE STARTED TO FEEL SOMETHING DIFFERENT NOT TOO LONG AFTER RECEIVING THE SHOT. AT NIGHT SHE NOTICED HER ARM GOT SWOLLEN. PATIENT CAME BACK TO SEE US THE NEXT DAY (09/16/2012). I NOTICED THE AREA RIGHT BELOW THE INJECTION SITE ALL THE WAY TO THE ELBOW SWOLLEN. PATIENT COMPLAINED OF PAIN IN THAT AREA. THE SWOLLEN AREA WAS WARM.
Pneumococcal vaccine given at 1122 on 8/16/07 prior to discharge wife called around 1500 hours concerned about swelling around patient's eye. Patient denies visual disturbances, itching, SOB, or feeling that throat closing. Patient did have a small laceration above eye to which bacitracin had been applied at 0850 hours. Patient went to express care chart notes facial swelling with edema to both eyelids. Benadryl 50mg IM given.
15 weeks pregnant female with localized rash on left lower back. Itchy, occasionally painful
Patient says inject site was sore, red, and irritated. Patient was unable to move/lift arm due to pain and irritation. Patient was very concerned and saw her doctor about the pain. Pharmacist advised patient to take ibuprofen/Tylenol, and any irritation at the injection site is a normal reaction. Not sure if the doctor prescribed her any other pain medications or steroids for the reaction.
Gave pt influenza in L arm and pneumonia in R arm on 9/29/09.  Pt came back to clinic on 10/2 with c/o pain in R arm.  Also had redness, warmth and edema - but not at immunization site.  He was immunized on lateral aspect of R arm, adverse effect appeared on medial aspect of R arm.
site of injection developed red mark; pain on site of injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (site of injection developed red mark) and VACCINATION SITE PAIN (pain on site of injection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (site of injection developed red mark) and VACCINATION SITE PAIN (pain on site of injection). At the time of the report, VACCINATION SITE ERYTHEMA (site of injection developed red mark) and VACCINATION SITE PAIN (pain on site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
pt recvd vax on 28OCT93 & 2 hrs later exp lightheadedness & an irregular pulse which was over 200; upon transport to hosp pt ex 2 cardiac arrests; dx Wolff-parkinson-White synd felt not vax related;
4 year old patient given a dose of Adacel, no AE; 4 year old patient given a dose of Adacel and not the ordered Pentacel, no AE; Initial information was received on 25-Aug-2020 and additional information on 26-Aug-2020 regarding an unsolicited valid non-serious case from the physician via phone.  This case involves a four years old female patient who was vaccinated DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Wrong product administered and Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient was concomitantly vaccinated with MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX) for prophylactic vaccination on 22-Aug-2020.  On 22-Aug-2020, the patient received a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6612AA, expiry date not reported) instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  No adverse event was reported at the time of reporting.   Laboratory data: not applicable. As corrective measurement: physician planning to administer the Pentacel to the patient in 14 days. Outcome: not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Itching at injection site Flushing Tachycardia Syncope Unable to control BUE?s. Felt very heavy
In observation the patient began to experience urticaria, and had a history of anaphylaxis.  He complained of an itchy forehead, which we began to monitor.  He then felt thickness of the base of the tongue, tingling of the lips.  He was given an oral dose of 25mg of Bendryl.  We began to monitor his pulse ox levels.  He remained at 98-99 sat on room air.  His heart rate ranged from 60-68.  He then experienced more itching of the arms, and continued itching of the forehead, thickness of the tongue.  A second oral dose of 25mg Benedryl was given.  After continual monitoring for 45 minutes his symptoms began to subside.  After another 15 minutes he felt his symptoms had resolved.  His final pulse/ox reading was 99% with a pulse of 67.  He was instructed to follow up with his PCP.  He was also instructed to monitor himself for further symptoms.  ER protocols given.  He left on his own.
10-21-15 Spoke with client on phone. Stated broke out in hives on Saturday and neck was stiff. Stated she bath in some cream from the hosp. and was taking BENADRYL. States rash on back, legs, and neck. Strongly encouraged pt to go to ER. She stated she called Dr and can't see her till tomorrow (10-22) and instructed pt to make sure she went to MD appt if she does not go to ER. Denies trouble breathing. States neck no longer stiff. Went to see Dr (10-22) and BP 240/140 (NP) sent to ER with rash no better and elevated BP.
pt exp hair loss (overall scalp thinning);h/a (p/2nd & 3rd doses);