chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 23-APR-2013 (lot number: H011350; exp date: 21-FEB-2015) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
sore throat; drainage; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), DRAINAGE (drainage) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), DRAINAGE (drainage) and HEADACHE (headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat), DRAINAGE (drainage) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported. no treatment details reported.
IMMEDIATELY AFTER VACCINATION I HAD DIZZINESS, VOMITING, MENTAL BLACKOUT, HIGH BLOOD PRESSURE, TOTAL FATIGUE, HEADACHE. THAT WAS SEEN BY PARAMEDICS
Dizziness immediately upon standing, followed by nausea and painful deep breaths.  Symptoms subsided and patient went home approximately 30 minutes later.  Several hours later, patient developed severe vomiting, back pain,  and experienced numbness in her leg that lasted through the night. She contacted pharmacy next morning and was advised to go to ER, which she did. She received treatment of IV fluids for dehydration and steroid treatment  and was sent home.
24 hrs post vax pt crying, uncontrollable 2 1/2 hrs; t104-105 ax fever;
Shingles; Had shingles 3 years ago and got shingles again; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 28Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included "lupus SLE" (systemic lupus erythematosus) and Sjogren's syndrome. The patient was allergic to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included prednisone (MANUFACTURER UNKNOWN); taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN), ascorbic acid; eucalyptus globulus oil; echinacea purpurea (ECHINACEA), sulfur (MANUFACTURER UNKNOWN), morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 07Mar2021 at 08:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that the patient had shingles 3 years ago, on 18Apr2021 at 18:00, the patient got shingles again after the second dose COVID vaccine. It was reported that it was possibly, the vaccine reactivated the virus. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with VIRLEX. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
No Adverse Event; AE submitted after call due to uncertainty of whether or not the last dose received was a monovalent booster or Bivalent.; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted after call due to uncertainty of whether or not the last dose received was a monovalent booster or Bivalent.) and NO ADVERSE EVENT (No Adverse Event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.   Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First dose) on 14-Jan-2021, Moderna COVID-19 Vaccine (Second dose) on 13-Feb-2021, Moderna COVID-19 Vaccine (First booster) on 14-Nov-2021 and Moderna COVID-19 Vaccine (second booster) on 15-Mar-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Family history included Cancer (Patient wife was diagnosed with cancer before 2021 Moderna Covid vaccinations) since an unknown date.    On 15-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Oct-2022, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted after call due to uncertainty of whether or not the last dose received was a monovalent booster or Bivalent.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted after call due to uncertainty of whether or not the last dose received was a monovalent booster or Bivalent.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted after call due to uncertainty of whether or not the last dose received was a monovalent booster or Bivalent.).    No concomitant medications were reported.  Patient had kept their boosters up with Moderna all the way and never had a problem or got COVID.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712892 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712892:Wife case
Red measles like rash covering entire body. Went to . Two days later pressure in chest and difficulty breathing. Went to Emergency Room.  Skin and eyes turned yellow, dry itchy, peeling skin. Liver not working properly. No prior skin or liver issues. Symptoms persist today.
swollen joints, numbness & tingling in rt hand unable to get up;blurred vision, fatigue now chronic carpal tunnel synd, chronic joint pain;seeing MD for complications;Annual follow-up dated 09/27/00 states the pt has fibromyalgia. Follow-up: 7/24/2000 Reporter calling in response to f/u letter she received from VAERS. I suggested she write in any updates and return it. She will also fax any pertinent medical records sometime in future. States the diagnosis of carpal tunnel syndrome was confirmed and she had surgery. Currently on Workmans Comp and unable to work. Otherwise the chronic joint pain has also persisted to present.
blacked out; hypotension episode; light headed; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0158), via an unspecified route of administration in the left arm on 10Apr2021 at 12:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included "fibro", anxiety, post-traumatic stress disorder (PTSD), depression. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Concomitant medications included gabapentin, duloxetine hydrochloride (CYMBALTA), amitriptyline hydrochloride (AMITRIPTYLLIN), esomeprazole. The patient previously took metronidazole and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 10:00, the patient experienced what she believed to be a hypotension episode and blacked out. The patient was still lightheaded but felt OK otherwise. She would follow up with the doctor if it continued. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was not resolved.
Redness (3 cm) and pain at injection site, dizziness, fever (subjective the next day; documented the 3rd day).
This spontaneous report received from a patient concerned a 58 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 24-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache. This report was non-serious.
I received my last dose on 29 Oct and have had a few significant side effects to include constant headaches and blurred vision, muscle pains, an onset of acne breakouts, and moles and my Menstrual cycle had been on and off for 3 weeks. Prior to this I had not had a Menstrual cycle in nearly 8 years since starting my Depo injections. Acne had never been a problem and I have noted moles developing on my body that were not there before. I am wanting to find out what if anything can be done to get some relief of the headaches and blurred vision and also is this Pfizer interfering with my Depo? These changes really concern me and I am not open to the booster as I feel more side effects can occur or worse.
Abdominal pain in the upper middle section near stomach, cramping, many bowel movements, some diarrhea, pain still exists today, 07/25/2012 along with diarrhea.
I felt a little funky after receiving my booster shot, but not enough for it to be a headache. My arm was sore and it felt itchy. I put gloves on my hand to avoid itching my arm in my sleep. I itched from underneath my breasts to the top of my thigh. The hives from underneath my breasts to my waist area was tiny red bumps and were the size of a pinhead. From my waist area to my thighs, the hives were much larger and swollen in size. I tried using a extra strength topical Benadryl gel to help try reducing the itchiness and spread. I didn't contact my doctor because the hives comes and goes as it pleases, but never fully eradicated.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-JAN-2013, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 2014, the patient was treated for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Information has been received from a 23 year old male patient concerning himself. The patient had no drug reaction/allergies. The patient's medical history included liver transplant on unknown date. On 09-JUN-2015 the patient was vaccinated with (Oka/Merck) VARIVAX injection, subcutaneously for prevention of varicella (dose, strength and lot# were not reported) at a clinic. Concomitant therapy included unspecified immunosuppressive drugs (the patient receiving immunosuppressive drugs was vaccinated with (Oka/Merck) VARIVAX was a drug administration error). On 10-JUN-2015 the patient experienced fever, injection site pain and swelling. The patient had not sought medical attention. No treatment was given for the adverse event. No lab diagnostic studies were performed. It had been three days since he received the vaccine and was still experiencing these adverse reactions. At reporting time the patient did not recovered. Additional information is not expected as there was no patient's contact information.
Screaming immediately after vaccine administered.  Body shaking, child expressed need to have "poo" "poo" and brought her knees to her chest for 30 minutes from 10 AM until 11 AM.  1:20 AM developed rash over legs.  Noted blisters on hands and feet.
strong menstrual cramps; Very bad; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on unknown date, at 55-year-old. Medical history and concomitant medication were not reported. The patient was very bad and had strong menstrual cramps. Outcome of the events was unknown.  No Follow-up attempts are needed. Information on lot/batch number cannot be obtained.
A non-serious spontaneous report of administration of H1N1 to 2 elderly patients was received from a consumer concerning a female patient who was in her 80's. Neither relevant medical history nor concomitant medications have been reported for this patient. On an unknown, the patient received H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Vaccine error.  We had an RN administer the Moderna Covid-19 Vaccine Bivalent Booster to a 17 year old female patient on 1/27/23 and the patient did not receive any primary doses prior to being given the bivalent booster dose.
fluid filled cyst ~4 cm diameter to right deltoid noted, non tender, non-ecchymotic
Bronchial spasm developed as part of an overall very strong reaction (fever, chills, aches, fatigue, headache). Other symptoms resolved after 4 days but tightness in chest did not. Was treated on day 5 for bronchial spasm and prescribed albuterol inhaler. Today is 10 days post injection and lungs still feel irritated but no longer tight.
100.5-101 Fever x 15 hrs thus far, chills, body aches, headache, fatigue-Ongoing
THE PATIENT EXPERIENCED HEADACHE ALL DAY ON THE DAY AFTER THE VACCINE WAS ADMINISTERED.  THEN SHE EXPERIENCED NAUSEA AND LOCALIZED HOT, RAISED, BRIGHT RED AREA AT INJECTION SITE, APPROX. 4" IN LENGTH.  PATIENT NOTICED IT 2 DAYS AFTER VACCINE ADMINISTERED.  NO FEVER.  WENT TO E.R. WHERE SHE WAS TOLD BY 2 DIFFERENT MD'S TO APPLY WARM AND COLD COMPRESSES AND DID NEITHER SINCE INFORMATION WAS CONTRADICTORY.  DID TAKE TYLENOL.
increasing mental health symptoms (anxiety, paranoia, sensory overload, dissociation) over the course of 5 weeks leading to inpatient hospitalization for 2 week, and followup intensive outpatient care for 2 months
pt recvd vax & p/dose exp Bell's Palsy; pt was seen by MD; event has not subsided;
Same day of vaccination later on that night I noticed my arm on the vaccination site that it was red, it was a circle shape, it was about 4 to 5 in round. It was hot, hard, swollen, some itching, & very sore. Have not recovered from it yet but its not getting any worst is starting to improve. Saw doctor on 1/27/2021 & now I'm taking zyrtic, Tylenol, & 1  dose of Motrin.
Headache, Myalgia, Fever, NauseaVomiting, Fatigue
Felt injection go right into my shoulder and up into my neck.  Next morning while water jogging felt some numbness in left forearm and hand (numbness went away after an hour).  Later that morning my lower back felt very weak and needed to rest for the remainder of the day.  Still feel some weakness in my lower back and left hand is a little bloated and stiff.
My right arm where I just got my second shot is twice the size of my left arm; I've taken pictures of my arm and my arm is twice the size its red and hot; I've taken pictures of my arm and my arm is twice the size its red and hot; I've been sick for days and this is disturbing; my whole arm is red and swollen; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in Arm Right on an unspecified date single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Previously, the patient received first dose of BNT162B2 for COVID-19 immunization. On an unknown date, the patient experienced right arm where the patent just got my second shot was twice the size of my left arm, the patient had taken pictures of my arm and my arm was twice the size it was red and hot, the patient had been sick for days and this was disturbing and my whole arm was red and swollen. The reporter was vocally frustrated, stated this had affected the patient's life. The patient know that people lives don't mean anything to anybody and people around here who the patient live around would not get the injection. Response was received by the Pfizer team that confirmed Pfizer Covid vaccine. Offered to provide website for more information, caller declined. Referred to HCP for evaluation and discussion. The outcome of event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Woke during night crying-mom noted pt was very hot-eye rolled & fluttered, body jerking briefly taken to ER t103; MD noted slight redness lt ear & also throat; given Amoxicillin;
Initial health care professional report received on 11 May 2010: This patient received MENVEO (batch number for vial# 027011 and for box# 100001) unknown dose, intramuscular on an unknown date. It was reported that the patient inadvertently only received the liquid component of MENVEO without the lyophilized MenA conjugate component. No adverse event occurred.
Approximately 15 minutes after receiving the vaccine, client started c/o itching to face and lips. Transported to triage area. Where she started c/o burning lips also. vital signs monitored, Benadryl 50mg po given. In a few minutes she reported chest tightness, labored breathing. 1:44pm Epinephrine was given IM. client was on 02 increased to 15 Liters. She admits to decreased chest tightness and itching of face improving. She was taken by ambulance to hospital, where she was admitted overnight for observation. She was given Benadryl and epi X2 more time, once in ambulance and once at the hospital. She denies any problems since then. She did say that approx 3 weeks ago she was a contact to a case of covi
bruising after 2nd shot; This is a spontaneous report received from contactable consumer.  A patient unspecified age and gender (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 Immunization, reaction(s): "headache after getting first Covid shot".  The following information was reported: CONTUSION (non-serious), outcome "unknown", described as "bruising after 2nd shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial report received on 15 March 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 7-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3723AA received on 21 June 2011, lot number C3723AA received on 06 September 2011 and lot number C3872AB received on 21 October 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 03 December 2011, approximately 1 month after the last dose. The subject developed a cough on 05 December 2011 and paroxysmal cough on 23 December 2011 without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 29 December 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 30 December 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 19 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 36 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Information has been received from a certified medical assistant (C.M.A.) referring to a 36 year old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 25-APR-2016 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (subcutaneous; lot# and expiration date were not reported) (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
nausea; fever; fatigue; headache; sick; dizziness; Lightheadedness; tested positive for covid; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, fever, fatigue, headache, sick, dizziness, lightheadedness, tested positive for covid.  The patient's medical history was not provided. Concomitant medications reported were Aspirin , Losartan, Megestrol, Januvia, Metformin, Glipizide for drug use for unknown indication.  On 28 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A)  unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, Nausea, Fever, Fatigue, headache, sick, dizziness, lightheadedness. On 8 Feb 2021, the patient experienced the events,tested positive for covid.  Treatment details included AZITHROMYCIN.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, nausea, fever, fatigue, headache, sick, dizziness, lightheadedness, tested positive for covid was unknown.
Dizziness, slight nausea. I became very tired around 11PM on the night of the shot. By 530 the next morning, I had a fever of 102.2F and hurt all over. I'm not sweating at all, and I feel like I have a head injury due to a headache and dizziness.