chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immunocompromised; lobular carcinoma/breast cancer; This spontaneous case was reported by a patient and describes the occurrence of IMMUNODEFICIENCY (Immunocompromised) and INVASIVE LOBULAR BREAST CARCINOMA (lobular carcinoma/breast cancer) in an elderly patient of an unknown 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, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (Immunocompromised) (seriousness criteria medically significant and life threatening) and INVASIVE LOBULAR BREAST CARCINOMA (lobular carcinoma/breast cancer) (seriousness criteria medically significant and life threatening). At the time of the report, IMMUNODEFICIENCY (Immunocompromised) and INVASIVE LOBULAR BREAST CARCINOMA (lobular carcinoma/breast cancer) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient reported the vaccination provider said that they should receive one more. Patient talked to pharmacist who stated they would not give another vaccine. No treatment information was reported.  Company comment- This spontaneous case concerns an elderly patient of unknown gender with no medical history reported, who experienced the unexpected serious (life threatening and medically significant) events immunodeficiency and invasive lobular breast carcinoma. Two doses of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine were administered. Latency unknown as the onset date of the events and vaccination dates were not specified. Details of symptoms, clinical course, investigation reports and treatment were not provided. The benefit-risk relationship mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   Reporter did not allow further contact
Loss of smell and taste; Loss of smell and taste; Been sick (been in bed since the vaccine); 13 days between 1st and 2nd dose; Severe headache; Nausea; Fever of 105 F; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of smell and taste), ANOSMIA (Loss of smell and taste), ILLNESS (Been sick (been in bed since the vaccine)), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (13 days between 1st and 2nd dose) and HEADACHE (Severe headache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced AGEUSIA (Loss of smell and taste), ANOSMIA (Loss of smell and taste), ILLNESS (Been sick (been in bed since the vaccine)), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (13 days between 1st and 2nd dose), HEADACHE (Severe headache), NAUSEA (Nausea) and PYREXIA (Fever of 105 F). On 18-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (13 days between 1st and 2nd dose) had resolved. At the time of the report, AGEUSIA (Loss of smell and taste), ANOSMIA (Loss of smell and taste), HEADACHE (Severe headache), NAUSEA (Nausea) and PYREXIA (Fever of 105 F) outcome was unknown and ILLNESS (Been sick (been in bed since the vaccine)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2021, Body temperature: 105 (High) 105 F.         No concomitant medications were reported.  No treatment medication was reported.  On 18-Sep-2021, the second dose was administered and at night, the patient started to experience symptoms of severe headache, nausea, loss of smell and taste, fever of 105 F, the patient was sick and been in bed since the vaccine. The family physician was contacted.; Sender's Comments: This is a case of inappropriate schedule of product administration and concerns a 20-year-old, female patient with no relevant medical history, who experienced the unexpected events of ageusia, anosmia, illness,and the expected events of headache, nausea and pyrexia. The events occurred on the same day after the second dose of mRNA 1273. The rechallenge was unknown as there's no information available about the first dose. Causality was not provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.
On 09-23-10 Patient reported had a few hives the night of 09-22-10, awoke to find "covered with hives" the morning of 09-23-10. Pt stated in call that she had taken Benadryl and was instructed to continue to do so, and was instructed not to get final shot of series. Patient denied any airway swelling. Patient was instructed to call office if no relief or other concerns, and patient did not call office again for this event.
Throwing up; Diarrhea; Upset; being sick; food poisoning; Was told she can get the shot up to 17 days after the 1st shot and hers will be 18 days with the next dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number :1), for COVID-19 immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Throwing up"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; AFFECTIVE DISORDER (non-serious), outcome "unknown", described as "Upset"; ILLNESS (non-serious), outcome "unknown", described as "being sick"; FOOD POISONING (non-serious), outcome "unknown", described as "food poisoning"; WRONG SCHEDULE (non-serious), outcome "unknown", described as "Was told she can get the shot up to 17 days after the 1st shot and hers will be 18 days with the next dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Caller stated she got her 2nd shot Friday morning from Pfizer and she got sick with throwing up and diarrhea yesterday, she thought she got food poisoning and she was going to get tested for Covid today. She was pretty sure it was not Covid, she didn't had a fever. Caller apologizing for being upset stated she was not 100% today after being sick yesterday. Caller clarified it was the Pfizer Covid shot.
Sickness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Lot number: EN6204) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sickness".  Additional information: The patient stated that he received the first dose of the pfizer covid 19 vaccine on 20Mar2021 and his second dose was tomorrow. The patient stated he was sick earlier this week and was on day three of being over the sickness. Caller wanted to know if he can get the vaccine, specifically stating he was wondering if the sickness lowered his immune system and how this would affect the vaccine.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2015US026837, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 66-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 07 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Started getting sick on 12/17/2021, started with some slight aches and a nasal drip. Come Sunday, that turned into where I could feel it settle in my chest like I was getting a chest cold. I went Sunday to get a COVID-19 test and currently waiting for my results. On Monday, I called my PCP and we did a telehealth visit and I told her the aches, headaches, no fever, feels like everything is settling in my chest and a burning sensation in my chest. She said it could be early bronchitis and I was prescribed a z-pack for that. I actually called today because I'm getting worse and was told to go the med-express or ER.
On 3/15/21, patient called the pharmacy and stated he was short of breath and possibly had a rash. Recommended patient to be seen by a doctor. On 3/17/21, patient informed us that he did go to the ER, but they were unable to diagnose him with a cause for the SOB and were unsure if it was related to the vaccine or not.
Swelling & pain size of 1/2 golf ball advised to use cold compresses Motrin & call if worsen.
Severe headache; 101 Fever; Chills; Sweats; Vomiting; Joint aches; Fatigue; Brain fog; Confusion; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 19Apr2021 at 08:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos thyroidism and metabolic syndrome. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), liothyronine (MANUFACTURER UNKNOWN) and progesterone (MANUFACTURER UNKNOWN), all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 at 08:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation and received codeine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. On 19Apr2021 at 20:00, the patient experienced severe headache, 101 fever, chills, sweats, vomiting, joint aches, fatigue, brain fog and confusion. On the same day, the patient underwent body temperature test and the result was 101 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache, 101 fever, chills, sweats, vomiting, joint aches, fatigue, brain fog and confusion was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
My arm was not that sore or anything but Friday morning when I woke up my throat was really really sore and I felt congested.  My nasal mucus was green and I was also coughing up some green phlegm. I went to the walk in clinic because I had to go to work and wanted to make sure I was well enough.
This spontaneous report as received from a pharmacist via company representative refers to an unknown number of unspecified patients of unknown gender who were under the age of 50 years. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients were vaccinated with the dose of ZOSTAVAX injection (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
pt recvd 3rd dose of HIB vax on 21JAN92 & w/in 24 hrs pt devel a local rxn @ inject site on rt thigh; area was 3cm wide, non-tender, hard w/minimal erythema; treated w/warm compresses;
Starting 48 hours later from injection had fever (101.3), sweats and chills for 9 days. ADVIL only given. 7 days of BACTRIM DS as thought be a urine infection.
This case was reported by a physician via call center representative and described the occurrence of pain in arm in a elderly female 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 year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller was a dermatologist reporting that he has seen a patient who had had both doses of SHINGRIX. The patient experienced tender arm for a few days. The reporter was driving in his car and was not able to provide further details but was fine with follow-up from safety team. For tolerance to 2nd dose refer linked case US2018172571, reported for same patient.
Information has been received from a registered nurse concerning a 22 year old female, who on 08-AUG-2007 was vaccinated with a first dose of Gardasil (Lot# 658282/0929U). Concomitant therapy included Effexor. Subsequently, the patient experienced severe pain in her deltoid and she was unable to move her arm. The patient was seen in the emergency room but she was not admitted to the hospital. At the time of the report the patient was recovering. No product quality complaint was involved. The severe pain in her deltoid was considered to be disabling. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/6/2007: 9/13/2007. Initial and follow-up information has been received from a registered nurse concerning a 12 year old female with no pertinent medical history and allergies to vancomycin and oxycontin, who on 08-Aug-2007 was vaccinated subcutaneously in the left deltoid with a first dose of GARDASIL (Lot # 658287/0929U). Concomitant therapy included EFFEXOR. Subsequently, the patient experienced severe pain in her deltoid and was unable to mover her arm for 2 weeks. The patient was seen in the emergency room but she was not admitted to the hospital and treatment was unknown. At the time of the report the patient was recovering. No product quality complaint was involved. The severe pain in her deltoid was considered to be disabling, in follow-up the registered nurse did not consider the event to be disabling as previously reported. Additional information has been requested.
Uncontrollable crying, acute ear pain, fever of 101 degrees, and pain in injected leg.  Ear pain started in on ear and moved into second ear the following day.  Leg pain and fever persisted into following day as well.  Ibuprofen controlled fever, ear pain, and leg pain.  Called doctor who recommended warm oil for ear pain, but I did not do this.  On Feb. 10, 2011, became very ill with extreme temps.  Took son into see doctor, but nothing was diagnosed.  On 2/14/11, we went back to the doctor and patient (son) showed an ear infection and tested positive for influenza A.
Series of migraine flares; Hot flashes combined with ear; Sinus pain on day 4, 5, 6; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 09Apr2021 at 13:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gliclazide (CLARITIN), vitamins nos (MULTIVITAMIN) and mefenamic acid (ADVIL), all from an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 09:00, the patient experienced series of migraine flares, hot flashes and sinus pain on day 4, 5, 6. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, hot flashes and sinus pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
2nd dose of Moderna given at a 21 day interval vs 28 day interval. 2nd dose administered too early, invalid dose that will have to be repeated
Swelling of upper and lower left arm, pain with consequential inability to sleep, and inability to raise arm. Ice and Tylenol. Later Naproxene.
Shortness of Breath.  pain in back and chest area.  Went to Hospital and they found multiple blood clots had formed in my lungs.  Currently they are trying to determine what caused my body to form these blood clots
The employee did not have any adverse reactions from the vaccine.  The employee should have received the Pfizer vaccine as her 3rd dose, but was given the Moderna  vaccine instead.
fatigued; sweat for about a hour; difficulty breathing; Headache; chills; fever; body aching; Really Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), HEADACHE (Headache), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigued) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (chills), PYREXIA (fever), FATIGUE (Really Tired) and MYALGIA (body aching). On 15-Apr-2021, the patient experienced HEADACHE (Headache). On 14-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (difficulty breathing). On 14-Jun-2021, the patient experienced FATIGUE (fatigued) and HYPERHIDROSIS (sweat for about a hour). On 15-Apr-2021, CHILLS (chills), PYREXIA (fever), FATIGUE (Really Tired) and MYALGIA (body aching) had resolved. On 15-Jun-2021, FATIGUE (fatigued) and HYPERHIDROSIS (sweat for about a hour) had resolved. At the time of the report, DYSPNOEA (difficulty breathing) and HEADACHE (Headache) outcome was unknown.            No treatment information was provided.  The Action taken for mRNA-1273 (Moderna COVID-19 Vaccine) was unknown  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-137911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: ADR Form blank. Read Email.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Patient received first dose Pfizer on 07/02/2021 Patient received second dose of Moderna on 07/23/2021  Moderna administered as second dose in error.  Patient monitored 2hrs post administration, No adverse effects noted. Operations Officer and Medical Director informed and followed up with patient's mother.
Pain to right lower rib area and then on 10/12/2014 red rash in area and pain spreading to skin and around back on right side.  Dx with Shingles.
This is one case out of a cumulative total of 225 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 04 February 2014. These 225 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 04 February 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 11-month-old male subject (initials not collected) 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 not reported) received on 17 February 2013, (lot number not reported) received on 18 April 2013 and lot number C4359AA received on 20 June 2013, (routes and sites of administration not reported). The subject developed a cough on 18 November 2013 without a whoop approximately 5 months after the last dose. The subject also experienced post-tussive vomiting and sleep apnea, data not reported. Laboratory testing included positive PCR on 22 November 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 22 November 2013 for 4 days. The subject was not hospitalized. At the time of final contact on 20 December 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 32 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
After receiving vaccines, patient reported feeling light-headed, then passed out while resting in chair. Dr. immediately attended to patient. BP 125/75, HR 104. Patient reported this is a common reaction for him when receiving vaccinations. Patient assisted to lying position with legs elevated, for recovery.