chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 68 year old female with no known allergies who on 29-DEC-2006 was vaccinated SC with a 0.5 ml dose of varicella-zoster vaccine.  "Within 24 hours", on 30-DEC-2006 the patient developed an injection site reaction. The patient's symptoms included local heat, redness, pain and itching. Unspecified medical attention was sought.  At the time of the report the symptoms continued and the patient had not recovered.  There was no product quality complaint involved.  No further information was available.  Additional information has been requested. The patient had allergies to losartan potassium (WAES # 073USA00372)and hydrochlorothiarde (+) losartan potassium (WAES #0703USA00373).
11/27/12 Started feeling achy over entire body & some sharp pains shooting to hands, ankles. T 100.1. Felt vision was "off" as he mixed up the paint at work, normal by 11/28/12.
On or around 7/17/21 started with extreme weakness, headache, weight loss. Lastly, unable to even lift a coffee pot, climb one stsir, or rise from recliner. Rapid weight loss, even atrophy in hand. Visited PCP x2, before going to Emergency Room on 9/6/21 And being hospitalized until 9/14/21. Numerous tests and labs during that time. Now home with consult for Rheumotology. Home Health Nurse and Physical Therapist treating Patient in the home.
I am breastfeeding. My daughter had seizure like episodes starting on Saturday 1/2, Sunday 1/3, Monday, 1/4 and 2 times on Tuesday 1/5.
pt recvd vax w/local pain x 36 hrs; resolved; followed by paresthesias& weakness;
Small lump (1 CM) in injection arm after 3 days followed by large raised circular bump (8 cm in diameter) 7 days after 1st dose.  Red rash which is warm to the touch.  Rash and raised bump still visible at 10 days post dose.
8-19-12 --> earache glands swollen 8/21/12 - Doctor visit no diagnosis. 8-23-12 bumps & rash in hair - not itchy, painful, lump in middle of head. Stabbing pain 8-24-12 - Doctor visit "doesn't look like shingles" take MOTRIN for pain antibiotic KEFLEX begun 8-28-12.
Developed as sore throat, chills, body aches, a headache, eyes (red and felt like they were burning) a dry cough as well as nausea. Fever of 101.2 degrees F and increase respiratory rate.
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from Other health care professional via Sales Representative. This case involves Child female patient (age unknown) who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date in July 2018, the patient received a second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported, expiry date end of June via unknown route in unknown administration site. It was an actual medication error due to expired vaccine used. It was reported that an expired Pediatric FLUZONE QUADRIVALENT was administered to a child 2 days after it expired. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
- Throwing up, spitting up yellow phlegm, dizzy. Chills, fever, worn out.
Patient returned to clinic on 7/09/2021 for the second dose of Pfizer COVID-19 vaccine but did not have the CDC card with first dose information. Upon looking patient up to verify, it was noted that they had received a full series of Moderna COVID-19 vaccine on 12/30/2020 and 01/29/2021. The patient was advised that we are unable to administer the 2nd dose of Pfizer due to newly identified information. During discussing the situation with the patient, they advised they told the registration person that this was not the 1st COVID-19 vaccine. However, we are unable to verify that information due to inability to see previous answers to screening questions.
On 01/24/2023 the clinic staff realized that the ProQuad vaccine was being stored improperly.  The vaccine was stored in the fridge instead of the vaccine freezer.  This patient was identified as having received a dose of the vaccine that was stored improperly.  The patient will be brought back to clinic to request the ProQuad.  No adverse reactions from the initial vaccine were reported to the clinic.
came down with nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (came down with nausea) 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 NAUSEA (came down with nausea). At the time of the report, NAUSEA (came down with nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported.
Severe inflammation of thyroid only in the evening which radiated out under jaw to ears. Lasted approx.4 weeks. Fever every evening for approx. 4 weeks. Night sweats every night for the past 6 weeks and still continuing. Some of these have been drenching every hour for 4-5 hours. Sometimes less severe but these are ongoing. During the day none of these symptoms existed except a little soreness when touching the thyroid.
EXPOSED TO TEMPERATURE OUTSIDE RECOMMENDED RANGE, UNKNOWN VIABILITY OR POTENCY PER MANUFACTURER.
This spontaneous report refers to a patient  of unknown demographics. On an unknown date the patient was vaccinated with GARDASIL 9 (lot # L001312, expiry date: 24-FEB-2017) (dosing details unknown). On an unknown date the patient experienced unspecified adverse event. The outcome of the event was unknown . Additional information has been requested.
Headache, body aches, shaking reported 10/23/14 AM, has not sought further treatment.
Information has been received from a consumer concerning her 14 year old female daughter with no pertinent medical history, no drug reactions/allergies, who in April 2008 was vaccinated with the first dose of GARDASIL vaccine and on an unspecified date was vaccinated with the second dose of GARDASIL vaccine. There was no concomitant medication. In July 2008, the patient noticed that her hair began to thin out and within 2 months she lost all her hair. The reporter took her daughter to the dermatologist. The consumer specified they took test but did not provided what type of test. The consumer stated that "the patient had had wigs and shampoos, name of shampoo unspecified, to help hair grow back, but non of that was working." The dermatologist as well as the family doctor indicated this was due to GARDASIL vaccine. Therapy with human papilloma virus vaccine was discontinued. At the time of reporting, the patient had not recovered. This is one of two reports received from the same source. Additional information has been requested.
discoloration on both forearms up to shoulders/dark patch; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (discoloration on both forearms up to shoulders/dark patch) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 002F2119) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced SKIN DISCOLOURATION (discoloration on both forearms up to shoulders/dark patch). At the time of the report, SKIN DISCOLOURATION (discoloration on both forearms up to shoulders/dark patch) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   No Concomitant medication was reported.  No treatment Drug was reported.
About 10 minutes after the shots I was holding my son.  He started shivering and then passed out.  The doctor laid him on a table.  He lost all color in his skin and wouldn't talk.  About 20 minutes later he was looking better and then vomited a lot.  He needed to rest for about 20 more minutes.  As of now (this was this morning) he is okay.
Information has been received on 14-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 2016, the patient was treated by the patient's healthcare providers at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
No adverse event; 17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products.  Concurrent medical conditions included Pain. Concomitant products included ACETAMINOPHEN from 03-Aug-2022 to an unknown date for Pain, TAMSULOSIN from 02-Dec-2022 to an unknown date and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) for an unknown indication.    On 02-Dec-2022 at 2:17 PM, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 02-Dec-2022 at 2:17 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    This case contains information about 5th patient out of 17 patients as described by the reporter.  Concomitant medication dose details of Acetominophen was reported as to take 1-2 tabs, by mouth every 6 hours, as needed for pain.  Concomitant medication dose details of Tamsulosin was reported as to take 2 capsules, by orally every day after half hour, following the same meal each  day.  On 10-Mar-2021, the patient received first dose of 0.5 ml of Moderna COVID-19 vaccine.  On 09-Apr-2021, the patient received second dose of 0.5 ml of Moderna COVID-19 vaccine.  The patient was administered with a wrong third dose and no other adverse event was reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow up received included Reporter added, patient details updated, suspect product dose details and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:master case
Red itchy rash  developed on right shoulder around injection site on morning of 2 Feb 21 - 10 days after being vaccinated.  Rash area is approximately 2 inches by 3 inches
pain in his thigh after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in his thigh after second dose) 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 08-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced PAIN IN EXTREMITY (pain in his thigh after second dose). At the time of the report, PAIN IN EXTREMITY (pain in his thigh after second dose) outcome was unknown. Not Provided
Chills, body aches, headache, low fever, nausea, vomiting, stomach pain
Vx given  using sterile water/ reconstituted using sterile water instead of the provided diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Feb-2023 Reporter's Comments: The health care professional did not had information regarding the vaccine lot number, patient's initials, gender, nor vaccination date.  For the date health care professional mentioned as past weeks. The vaccine administration facility was the same as primary reporter.  The reporter consented to follow up. Additional Supportive Information: The patient was administered a dose of Rotarix but dose was reconstituted using sterile water instead of the provided diluent, which led to wrong solution used in drug reconstitution. This case had been linked with US2023032797, reported by the same reporter.; Sender's Comments:  US-GSK-US2023032797:Same reporter
Pt recvd vax 23OCT91 & devel small hives by afternoon hives were very large, c/o itching all over; denied fever; arm sore when touched or upon movement; noticed no redness or swelling;10NOV91 lips were swollen; 11NOV91 tongue was swollen;
fever 100.6/fever 99; left arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was sore) and PYREXIA (fever 100.6/fever 99) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm was sore). On 15-Mar-2021, the patient experienced PYREXIA (fever 100.6/fever 99). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, bid. At the time of the report, PAIN IN EXTREMITY (left arm was sore) and PYREXIA (fever 100.6/fever 99) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Body temperature: 100.6 (High) high. On 16-Mar-2021, Body temperature: 99 (High) High.     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.
Information regarding Prevnar was received from an investigator concerning a 12 month old white male participant in a study who experienced benign chronic neutropenia. At 5 months of age, the participant received the third dose on 1/24/02. The participant also received the third dose of Hib-Titer Vaccine, the third dose of Poliomyelitis Vaccine Inactivated, the third dose of Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine, and the third dose of Hepatitis B vaccine on 1/24/02. The patient has a past history of pyelonephritis, chronic otitis media, recurrent febrile episodes, and neutropenia. Indication for Prevnar was immunization. The product was administered on 1/24/02. The infant received 1 dose. Additional suspect medication included Hib-Titer Vaccine, Poliomyelitis Vaccine Inactivated, Hepatitis B Vaccine, Diphtheria/Tetanus Toxoid/Acellular Pertussis Vaccine, MMR, Varicella Virus Vaccine Live and Haemophilus Influenzae B. Concomitant medications were not reported. On 8/10/02, the infant was hospitalized to rule out sepsis. On that day, his absolute neutrophil count was 62 and neutrophil percentage was 1% of the total white blood cell volume (normal: 16-60). A diagnosis of neutropenia was made. Chronic neutropenia continued until 4/23/03 when the child was considered recovered with a normal white blood cell count. The investigator considered neutropenia possibly related to the study product. The medical monitor considered neutropenia related to the child's history of neutropenia diagnosed on 5/13/02 and not related to the study products administered.
This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ASTHMA (persisted asthma for a month), PYREXIA (Fever) and CHILLS (chills) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHMA (persisted asthma for a month), PYREXIA (Fever) and CHILLS (chills). At the time of the report, ASTHMA (persisted asthma for a month), PYREXIA (Fever) and CHILLS (chills) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were provided by the reporter. Reporter did not allow further contact.
5May92 vomiting, fever 101-102 ->clear liquid diet, lukewarm bath, APAP for T. To ER 5May92 evening D/T temp still high.
Nurse administered Pediarix (DTaP, IPV and Hepatitis B) and Pentacel (DTaP, IPV and HIB) on the same visit.  Child received 2 doses of DTaP and IPV at one visit.
(L) deltoid red, swollen, hot to touch, c/o pain 3/10 measures 60 x 60 mm with small horizontal blister on lateral side of deltoid where bondage tape has placed.
Cancer; This spontaneous case was reported by a non-health professional and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The suspect product dosage text was reported as unknown. No concomitant medication was reported. It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine was poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors were part of it along with Moderna. No treatment medication was reported.   Company comment This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. The reported cause of death was Cancer. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master; Reported Cause(s) of Death: Cancer
On 9/16/17 pt states at 2:20pm left eye froze and then she had double vision, 5 episodes that day went to ER has had numerous tests with no conclusive results all normal. On day 9/17-9/20/17 had at least one episode per day.
45 mins p/inject area became hot & sore in fact whole arm hurt when used it; felt better to let it hang; went home & took ASA w/relief; OK p/24 hrs;