chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 27-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.) 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 WRONG PRODUCT ADMINISTERED (They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.).    No concomitant information was reported. This case is reported for patient 2 out of 3 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721695 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721695:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 3 (booster), single (Lot number: GH9703) at the age of 50 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "migraine" (unspecified if ongoing); "Epstein Barr infection" (unspecified if ongoing), notes: chronic post viral fatigue from Epstein Barr infection; "Allergies pineapple" (unspecified if ongoing), notes: Sulfa antibiotics, pineapple; "chronic post viral fatigue" (unspecified if ongoing); "Sulfa antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
nose ran so bad; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (nose ran so bad) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (nose ran so bad). At the time of the report, RHINORRHOEA (nose ran so bad) had resolved.        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 assessments.   No treatment information was provided.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2015, the patient was treated for a persistent and severe vesicular rash, 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 is unknown. Additional information has been requested.
On 12/3/14 patient received PPSV23. On 9/23/21 patient received the same vaccine again. Series administered incorrectly
Following injection patient passed out, was diaphoretic and had low BP of 56/35. Became responsive then speech became garbled and went into seizure (posturing and clonic movement) for approximately 3 seconds. Called 911. Became responsive before EMS arrived and refused ambulance to the hospital.
Info has been received from a registered nurse concerning a female with no history of allergies who on 10/31/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #644103/0710M). On 11/01/2002, 24 hours after receiving the vaccination, the pt developed severe flu symptoms without respiratory symptoms and a "cellulitis like" reaction described as swelling and pain in her right shoulder. The nurse reported that the pt had 3 separate visits to ER and that on 11/03/2002, an ER summary indicated that the pt still had swelling and pain in her right shoulder and an area of erythema that measured 4x4 (not further specified) at the injection site and that she was diagnosed with a local drug reaction. The nurse further reported that the pt was prescribed diphenhydramine hydrochloride (BENADRYL) and a methylprednisolone sodium succinate (SOLU-MEDROL) dose pack and on 11/04/2002, the pt, recovering from the experience, was seen in the physician's office and was instructed to continue her therapy with diphenhydramine hydrochloride and methylprednisolone sodium succinate. The nurse also provided info regarding other patients' experiences (WAES #0211USA00663 and 0211USA00880). The pt sought medical attention from an ER physician. Additional info has been requested.
Patient received Prevnar 13.   Patient should have received Pneumovax 23.  No adverse event noted.
6 days following 1st dose Moderna, developed chills, myalgia, shortness of breath, injection site arm pain
Rash, hives, possible fever.  Pt was given Benadryl.
Adverse impact began within 1 hour of receiving the injection. Headache persisted for 2 to 3 days along with fever. Treated with acetaminophen. Also have experienced chills, fatigue, lightheadedness. Loss of appetite. Symptoms were strongest on day one. It is now day three, and symptoms are diminishing.
I had a tingling sensation in both arms; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tingling of extremity. On an unknown date, the outcome of the tingling of extremity was unknown.   It was unknown if the reporter considered the tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received the shingrix vaccine and experienced tingling in both the arms. The patient asked, if this could be concern to not get 2nd dose. No further information reported. The patient consented to follow up.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, and concomitant medication. The ZOSTAVAX was recommended and prescribed to the patient for long-term prevention against shingles. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles, or severe herpes zoster. On an unknown date in 2016, the patient was treated for the onset of a rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
4"x5" Scattered papular eruption, left deltoid (near injection site).  Erythematous. Puritic
Fatigue, increased hot flashes first night; fever for about 24 hours; moderate nerve pain in wrist, mild pain in ankles; small rash developed after other symptoms remitted; moderate, persistent headache throughout
Very weak, headache, nausea, vomiting. Vomited 2 times on second day. Headache for a week. Weakness for 12-13 days. Local reaction, red, swollen and very sore 6-7 days. Low grade temperature 2nd day.
cold sweats; balance issues/balance was off; a very serious dizzy spell/dizziness; pulse is a bit lower than normal; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on 17Feb2021 12:15 (at the age of 78 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cold sweats, balance issues/balance was off, a very serious dizzy spell/dizziness, pulse is a bit lower than normal on 18Feb2021. Reported as, patient experienced an adverse reaction with the covid vaccine. He had a severe disease spell consisting of cold sweats, balance issues, and dizziness that they had to call (Number). When the paramedics came his EKG read normal but his pulse is a bit lower than normal. On Thursday (18Feb2021), around 10:30 or 11, he got a very serious dizzy spell and cold sweats. Patient states that it was very serious because his balance was off and the dizziness. The patient underwent lab tests and procedures which included electrocardiogram: normal on 18Feb2021, heart rate: a bit lower than normal on 18Feb2021. Outcome of all the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sore throat, intense, choking feeling. Fever and severe chills. Runny Nose, all these sypmtoms lasted for approximately 8 to 10 hours. Headache. Nausea, Vomiting, Dry Heaves, all these lasted 24 to 36 hours.
No adverse event; He received the first dose of GARDASIL 9 on 19JUL2022 and was scheduled for a 2nd dose today on 20SEP2022, but the patient states the administration of the 2nd dose was rescheduled to 23-SEP-2022; This spontaneous reported was received from a 45-year-old male patient, reporting on himself. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On an 19-JUL-2022, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not provided).   The patient informed that his second dose was scheduled for 20-SEP-2022, however the administration of the second dose was rescheduled to 23-SEP-2022. No additional adverse event was reported.
BODY ACHES; CHILLS; BANGING SEVERE HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 11-MAR-2021, the subject experienced body aches. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced banging severe headache. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 102.7. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 13-MAR-2021, and was recovering from banging severe headache, chills, body aches, and fatigue. This report was non-serious.
Fever; Pretty bad headache and body ache which feels like having Covid19 again; Pretty bad headache and body ache which feels like having Covid19 again; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 39-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The relevant medical history included he had Covid19 a few months ago from 14Dec2020 (got diagnosed with Covid19 on 14Dec2020. When he got diagnosed, he was managing symptoms with Zinc, Vitamin C and over the counter, the stuff like that). Concomitant medications were reported as none. The patient just got the first dose of the Covid19 vaccine yesterday and last night on 12Jan2021 at 2:00 he got a fever and experienced pretty bad headache and body ache which feels like having Covid19 again. He thought it was last month or a few months ago. So, he mentioned that it feels like having Covid19 again and wanted to know if this was normal. The patient just wanted to make sure those were typical side effects from what have seen so far. The outcome of the events was unknown.
Patient reported that he began feeling ill a couple hours after receiving vaccines.  Patient reports fever as high as 104, chills, extreme fatigue/malaise, nausea, and a roughly 5" x 5" red/warm/raised/hard area on his left upper arm where he received shots.  Paitent called on 10/2 for advice.  At that point he reported feeling better but his temp was still 99.5 taking medications.  Appointment was scheduled for 10/3 at 9:15 AM.  Patient did not show for appointment; outreach was attempted and patient's phone was off.
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 20-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
He became tired, cranky, decreased appetite, listless. He acted like he was sick but had no cough, congestion, or fever.  It started suddenly, lasted 3 weeks, then went away.
Fever, feverish, body aches, runny nose, cough, headache, fatigue, diarrhea
Fatigue, chilliness, headachy from ~6 pm-11 pm Fever (101.4) from about 11 pm through 6 am Ataxia from about 11 pm through 6 am Muscle and joint pain from about 11 pm through 6 am
Significant swelling, erythema, warmth, pain over the injection site and most of upper arm.
Pt experienced itching yesterday 10-06-10 area with swelling + redness. Area warm to touch per mother on yesterday 10-06-10 c/o being sore.
Had dizziness and ashen color within 30 minutes of vaccine.  BP was stable 108/60 mmHg.  She was observed for 30 minutes and given juice.  She was nervous about the vaccination prior to receiving it.  No allergy, shortness of breath, or hives.  She felt fine when she left.
Total body bone/ muscle pain for  8 plus hours / could not sleep all night Got up to use the bathroom in morning and started passing out/sweating profusely Could not call out for help nor make any noise to get husband?s help
10/26- presents with Covid sx-  fever, malaise, cough, decreased intake, nausea vomiting diarrhea, more lethargic with altered mental status and increased confusion from baseline and tested positive for COVID-19, 3 days ago (10/23, sx started 10/21).
Rapid onset significant swelling (lymphedema) in front of left ear and just behind left jawbone.  Began around 10:45am on March 13, by 11am the swelling was at least one inch, enough to distort left side of face and upper neck.  For context, I had been outside planting seedlings that morning and assumed a bug bite, but could not find any puncture wound consistent with a bite.  Alarmed, I immediately took a single benadryl tablet (over the counter) and gently massaged the area (during a zoom conference call!  Turned to my side so as to not alarm my colleagues!!).  I started to feel some drainage about 25 minutes later, and took a second benadryl around 12:15pm.  By late afternoon minimal swelling still present and left point of jawbone sore to touch.  Took one more benadryl  in the evening. Minor swelling but not disforming in the AM, took a final benadryl and by Sunday night March 14 the lyphedema was gone.   As I am a research psychologist, I started looking at the literature and reputable online resources early in the week (March 15/16/17); I found other reports of lymphedema post Moderna vaccine, noted reports that it is on the same side of the face/neck/chest as the vaccine (as it was in my case), and I concluded that THIS is the most likely cause of the swelling I experienced.  I had not ingested ANY food/drink that was new to me during this time, and, as previously stated, there was NO entry wound indicating a bug bite.   Thus, I am making this report to VAERS.  Please note my history of pulmonary sarcoidosis (in remission 20+ years) suggesting I have autoimmune issues, possibly.  I also suffer from Reyes Phenomenon (NOT the disease).  Intriguing, huh?
Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-FEB-2012, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, the patient experienced shingles and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine. On an unknown date in 2015, the patient was treated by a health care provider for shingles. It was also reported that, on unknown dates, the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased, and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
pneumonia & flu-like sx are reported in pt who recvd flu vax; pt exp aches & the following day exp fever & chills; sx abated w/APAP;
Weakness legs 2 hours after vaccine acute sudden onset paralysis 2.5 days later; Diagnosis Transverse Myelitis 12 days acute hospital, currently IP Rehab.
This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications. On an unknown date, the patient was vaccinated with M-M-R II, intramuscularly (strength, dose, frequency, lot# and expiration date were not provided) for prophylaxis (incorrect route of product administration).
Weakness, nausea, chills, pain in neck and arm where shot was given. Had a red welt and knot as big as 6"x4" in arm that spread.