chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red splotches on her arm and a little on her face/Arm was very splotchy; Also got kind of hot/Face a little hot; anemic; she thought she was getting shorter; second period which was pretty heavy; had her period twice in a month; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533 and expiration date not provided), via an unspecified route of administration, in arm right, on an unspecified date (at the age of 42-year-old), at single dose, for COVID-19 immunization. Medical history included allergy to steroid (patient did not remember the name of the steroid. Patient was given to her to stop from pre term labor when she had her last child. when patient took it, her heart pounds, almost like cardiac arrest. Was told to never do the steroid ever again); ongoing latex allergy; and allergic reaction to soap. No prior vaccination within 4 weeks. No family medical history. Concomitant medications were not reported. The patient previously took ibuprofen (MOTRIN) for back pain (It was usually around her period or if her back was injured. Patient had injured back so many times. It was not used as an everyday thing). Patient stated her period was usually normal. And patient had her period twice in a month. Patient was started a second period which was pretty heavy, was anemic, so was a little concerned. On 18Apr2021, the patient had heavy second period. It was started last night at dinner, was very unexpected. And it was still very heavy, like in the middle of patient's period. Patient had been taking MOTRIN, which she usually took for back pain. About a half hour after the shot, patient's face a little hot. Half hour after the shot. Patient's left arm was very splotchy/ red splotches in left arm and a little on her face, also got kind of hot. Patient thought it must be from the body wash. Patient never noticed that before. Patient had allergic reaction to soap before and it was usually immediate. Is possible to be from the body wash. The splotches had gone away. It was ended the night she got home, same day as the shot. No emergency room or physician's office required. Patient's height was 5'3" and stated that she thought she was getting shorter. The outcome of the events "had her period twice in a month" was not recovered; of event "red splotches on her arm and a little on her face/Arm was very splotchy", "Also got kind of hot/Face a little hot" was recovered in 2021; of other events was unknown.   No follow-up attempts are needed. No further information is expected.
Information has been received from a 71 year old female patient with hypertension and no known drug reaction or allergies, who on 20-NOV-2008, was vaccinated with ZOSTAVAX (Oka/Merck). Concomitant therapy included lisinopril, EFFEXOR, LEVOXYL, WAL-ITIN. The patient reported that the day after the vaccination, 21-NOV-2008, she developed a pimple below her mouth. Then, she started getting blotches on her face, which lasted on and off for 2 weeks. She reported that her face got swollen and her eyes were completely closed up by 06-DEC-2008. She was seen on 08-DEC-2008 and was given an unspecified shot, Z-PACK and prednisone. She felt like most of the symptoms resolved around 13-DEC-2008. However, about a week before the reporting date, her neck and ears were itchy. On 17-DEC-2008, her eyes were swelling again. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow-up information received on 13-FEB-2009, from her physician's assistant indicated that this patient had been traveling at the time of this adverse experience and had been exposed to many new and different environmental exposures, such as foods and soap. The reporter felt that this may had been the cause of this adverse experience. No further information is available.
No adverse event; a 13-year-old patient was administered the first dose of PROQUAD; This spontaneous report was received from a registered nurse, referring to a 13-years-old patient whose gender, pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   The nurse reported that, on 30-JUL-2019, the patient was vaccinated with the first doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection series as prophylaxis (product administered to patient of inappropriate age) (albumin status, concentration, vaccine scheme frequency, route and anatomical location of vaccination, lot number and expiration date were unknown), along with varicella virus vaccine live (oka/merck) (VARIVAX) Merck sterile diluent; considered concomitant medications. No adverse effects were reported.
Patient received second dose of SHINGRIX vaccine on 3/2/19 and started developing a really swollen, painful arm on her whole upper arm. She said it got worse on Sunday and also developed a fever of 100.9 degrees Fahrenheit, loss of appetite and had shakes/chills. She feels a little bit better today but her arm is still very red and swollen.
ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/1/2023,  1/18/2023,  1/25/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Hospitalized with COVID (pos 1/9 symptomatic x 2 weeks)  and CHF exacerbation with orthopnea, dyspnea, and 15 # wt gain in 1 week.
Pt recvd 1st dose of Hep B vax w/no noted problem; Pt recvd 2nd dose of Hep B vax 18AUG92 & w/in an hr following the vax, pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs; No further details were provided;
LEFT VIVOTIF UNREFRIGERATED FOR A WEEK BEFORE TAKING 2 DOSES; This spontaneous case report (PVX2019-2891) was received from a consumer on 22-Nov-2019. It described a male consumer who "left Vivotif unrefrigerated for a week before taking 2 doses" (PT: Product storage error), while being on oral Vivotif (lot number: 3003303) for typhoid fever prophylaxis.  Case report: The consumer stated that he took two doses of Vivotif, which have been left unrefrigerated for a week. He took the second dose on 21-Nov-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A patient took two unrefrigerated doses of Vivotif (Product storage error). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A patient took two unrefrigerated doses of Vivotif (Product storage error). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
pt recv vax AUG97 & NOV97 serum iron level rose from 92 to 157 (upper limit of nl=160);
Information has been received from a consumer concerning her 15 month old male child with no allergies or medical history who in April 1999, was vaccinated with a dose of MMR II (lot 628011/1545H). There were no concomitant medications. It was reported that within hours of receiving the vaccination in April 1999, the pt developed a high fever and hives. It was also noted that "prior to receiving the vaccination he had 25 words but since the day after receiving MMR II he has only a few words." Unspecified medical attention was sought. The mother was concerned that the vaccine may have contained thimerosal. Upon internal review, prior to vaccination he had 25 words but since day after receiving vaccine he has only a few words, was determined to be an other important medical event (OMIC). Additional info has been requested. Reported on 02/27/2003: "Follow up information from a nurse indicated that the patient had left the responsible physician practice in 07/1999, and his last office visit at that practice was on 06/23/1999.  Additional information has been requested.
3:10PM 'NAUSEA'. DENIES ANY PAIN OR SOB. GIVEN ALCOHOL SWAB TO 'SNIFF'  - 'DECREASED NAUSEA'. CAREGIVER WITH PT, STATES SHE WILL DRIVE HIM HOME, FIX HIM LUNCH (STEAK) AND STAY WITH HIM UNTIL 7PM TONIGHT. PT A/O, PINK, W/D, RESP WITH EASE, JOVIAL NOW. NO ACUTE DISTRESS. AMBULATORY TO EXIT - GAIT STEADY. 3-5-21 3PM TC CAREGIVER STATES THERE HAS BEEN NO NAUSEA OR ANY OTHER S/S.
This spontaneous report was received from a pharmacist refers to  a50 year old male patient. Concurrent conditions, medical history and allergies were not reported. The pharmacist stated that on 13-JUN-2015 (reported as one month ago), the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, anatomical location, lot number and expiration date were not reported), which is an inappropriate schedule of vaccine administration, by an unspecified provider. Other suspect and concomitant therapies were not reported. The pharmacist indicated that the patient was presented in her pharmacy for the second dose of GARDASIL, however it was not administered by the pharmacist die to the age restriction concerns. No adverse events were reported regarding the first dose of GARDASIL. Additional information is not expected because the reporter did not consent for further follow up.
pt recvd vax & exp nausea & dizziness; pt reports that MD is deceased, therefore no further info is abailable;
Chest pressure; High blood pressure; Sore arm at the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest pressure), HYPERTENSION (High blood pressure), VACCINATION SITE PAIN (Sore arm at the injection site) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced CHEST DISCOMFORT (Chest pressure), HYPERTENSION (High blood pressure), VACCINATION SITE PAIN (Sore arm at the injection site) and HEADACHE (Headache). At the time of the report, CHEST DISCOMFORT (Chest pressure), HYPERTENSION (High blood pressure), VACCINATION SITE PAIN (Sore arm at the injection site) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported. Patient not consulted cardiologist for the chest pain no lab work and cardiac tests have been done .
diarrhea; numbess (to the skin) on chest left side; Chest tightness; muscle aches; fatigue; headache; shivering; Low grade fever; injection site (left arm) pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included drug hypersensitivity (sensitivity to corticosteroids).   On 8th February 2023, the patient received the 1st dose of Shingrix (intramuscular). On 8th February 2023, less than a day after receiving Shingrix, the patient experienced injection site pain. On 9th February 2023, the patient experienced numbness, chest tightness, muscle pain, fatigue, headache, shivering and low grade fever. On 11th February 2023, the patient experienced diarrhea. On an unknown date, the outcome of the injection site pain, numbness, chest tightness, muscle pain, fatigue, headache, shivering and low grade fever were not recovered/not resolved and the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the injection site pain, numbness, chest tightness, muscle pain, fatigue, headache, shivering, low grade fever and diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment: The case was reported by the patient's husband. The patient received dose of Shingrix into left deltoid and experienced injection site pain (left arm). One day after vaccination, the patient experienced numbness on the left side of chest, muscle aches, fatigue, headache, shivering and low grade fever. 3 days after vaccination, the patient developed diarrhea. The patient saw her healthcare professional on 17th February 2023 and tested negative for Covid. The patient was offered steroid to treat the effects but declined due to a sensitivity to corticosteroids. Nothing else was reported. The reporter consented to follow up. Might follow up with HCP.
heart rate was high - 74; lethargic; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic) and HEART RATE INCREASED (heart rate was high - 74) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced LETHARGY (lethargic). On 04-Mar-2021, the patient experienced HEART RATE INCREASED (heart rate was high - 74). At the time of the report, LETHARGY (lethargic) and HEART RATE INCREASED (heart rate was high - 74) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate increased: high 74.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
1.  - Occurrence Date: 03/12/2021. After patient received her Covid-19 vaccine shot, patient walked towards RN, and asked for a trash can. Patient was directed towards the trash can where patient took her mask off, and blood was observed coming from her nose. Patient also started vomiting. Supervisor was called. Patient was given a basin, and was taken to the ER for evaluation.
chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHILLS (chills) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.  The patient had chills as a result of the vaccine.
Bronchitis twice; Four colds; Nose has been running constantly; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis twice), NASOPHARYNGITIS (Four colds) and RHINORRHOEA (Nose has been running constantly) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (Bronchitis twice), NASOPHARYNGITIS (Four colds) and RHINORRHOEA (Nose has been running constantly). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at an unspecified dose and frequency and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Adverse event, at an unspecified dose and frequency. At the time of the report, BRONCHITIS (Bronchitis twice), NASOPHARYNGITIS (Four colds) and RHINORRHOEA (Nose has been running constantly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Arm hurts badly; whole body is stiff; 99.6 temperature; Feel very crappy; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Arm hurts badly), MUSCULOSKELETAL STIFFNESS (whole body is stiff), PYREXIA (99.6 temperature) and FEELING ABNORMAL (Feel very crappy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurts badly), MUSCULOSKELETAL STIFFNESS (whole body is stiff), PYREXIA (99.6 temperature) and FEELING ABNORMAL (Feel very crappy). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm hurts badly), MUSCULOSKELETAL STIFFNESS (whole body is stiff), PYREXIA (99.6 temperature) and FEELING ABNORMAL (Feel very crappy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 99.6 (High) Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include medications for acid reflux.
A non-serious spontaneous report of accidentally got in the child's eye was received from a health professional concerning a five-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. During FLUMIST administration on 09-Dec-2011, some FLUMIST got in the child's eye. The patient's eye was rinsed out and there were no adverse events. The patient had no redness or irritation. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
About 4 days after the third Pfizer shot, I started having a constant head humming, tingling in my head, intermittent headaches and inflammation in my head. This has been ongoing for four months now. Only about 4 weeks ago the tingling, inflammation and headache feeling in my head and face went away. I still have humming in my head. This became more intermittent; still a daily occurrence, but it's not constant. I've also had excessive fatigue and excessive hair loss. My hair has come out in clumps every day. I had bloodwork done. My thyroid is normal and so was my full blood panel.
I developed bad stomach issues starting the 21st of May and it progressed up until 05/24 when I was hospitalized. I experienced a lot of pain in my abdomen and I had LOTS of irregular blood labs. At first, they thought I had a UTI but after blood work and a urine test, they determined it was more likely an Autoimmune issue. I was hospitalized for 4 days and I checked myself out. After a month period of time, I ended up having to have surgery on my stomach, and then all of a sudden I had a bunch of blood moles all over my body (cherry hemangiomas) and its progressing still to this day. Also, I started having a lot of Neurological symptoms like a burning sensation running through my body at the same time and I'm still bruising all over my legs to this day. I have been to the ER numerous times since the vaccine.
On approximately, 7/15/1999, the vaccinee began to experience flu-like symptoms. In early August, 1999, it was "obvious" to the reporter that her husband's illness was "more serious than (the reporter and her husband) had thought." The vaccinee called his physician and was advised to have an immediate chest x-ray. When the physician compared it to the previous one of 2 years earlier, it was "obvious that something was wrong", as there was "fluid around his heart and at the lower porion of his lungs." He was hospitalized on 8/11/99 and released on 8/14/99. Cardiologist dx'd the pt as having pericarditis due to a viral infection. The vaccinee has been reportedly advised to forego the third dose of Lymerix. The most recent information, received on 5/15/2000, reports the condition of the vaccinee as unknown.
Headache, chills and weakness. Fever.12 hours after vaccination. Extreme confusion, seeing something not there, total weakness,  36 hours after vaccination. All back to normal 24 hours after vaccination.
Rash that looks like red tiny bumps; Tired; Heart fluttering; Tingling in my left arm down into my finger tips; Heart burn; A spontaneous report was received from consumer, concerning herself, a 45-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a heart fluttering, tingling in left arm up to fingertips, heart burn, rash that looks like red tiny bumps and felt tired.  The patient's medical history was provided as mixed connective tissue disease.  Concomitant product use was provided by the reporter. Following products were listed: Multi Vitamins, Calcium Vitamin D, Vitamin C, Vitamin B12, Zyrtec, Plaquenil, Imuran, Protonix and Probiotics.  On 23 Feb 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 014M20A)  intramuscularly in the left deltoid muscle for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient felt heart fluttering for 2 days. The event resolved on 25 Feb 2021.  On 23 Feb 2021, after 30 minutes of administration the patient felt tingling in her left arm down to the fingertips, which lasted for 5 minutes. The event resolved on the same day.  On 23 Feb 2021, the patient experienced heart burn since the shot. The outcome of the event is unknown.  On 24 Feb 2021, the patient felt a bit tired. The event outcome is recovered/resolved.  On 28 Feb 2021, the patient experienced a rash which is spread throughout the body. The outcome of the event is unknown.  The patient also described that she is immunosuppressed and she has mixed connective tissue disease.  No treatment information was provided.  Action taken with mRNA-1273 in response to events were not provided.  The outcome of the events, heart fluttering, tingling in left arm up to fingertips, heart burn, rash that looks like red tiny bumps and felt tired was considered to be resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. Further information has been requested.
Information has been received from a medical assistant referring to a 9 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 05-OCT-2018, the patient was vaccinated with VAQTA (dose, frequency, route, lot number R013858 and expiration date 12-JUN-2019) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects reported.