chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen upper lip the next morning.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6203, expiration date was not reported), via an unspecified route of administration, administered in left arm on 12Mar2021 13:30 (at the of 41-years-old) as dose 1, single for covid-19 immunization at public health clinic/veterans administration facility. The patient medical history included rheumatoid arthritis, asthma, anxiety, covid-19. Concomitant medications included levonorgestrel (MIRENA), tofacitinib citrate (XELJANZ), venlafaxine hydrochloride (EFFEXOR), folic acid, sumatriptan, all taken for unknown indications from an unknown date. The patient previously took amoxicillin and experienced known allergies: amoxicillin. The patient did not receive any other vaccine within four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient experienced swollen upper lip the next morning on 13Mar2021 12:00 AM. The patient did not receive any treatment for the adverse event. The outcome of the event was recovered on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
A non-serious spontaneous report of pregnant 18-year-old got H1N1 LAIV was received from a consumer/mother concerning her daughter, a 18-year-old pregnant female. The patient's medical history included seasonal allergies and depression. Obstetrical history included gravida one and para zero. The patient was six month pregnant (second trimester) at the time of vaccination. The EDD was in between the 4th to the 9th February 2010 and LMP was uncertain. The concomitant medications included regular flu vaccine received on the same day of H1N1 vaccination, prenatal vitamins during pregnancy and venlafaxine for depression, when she realized about the pregnancy she weaned herself off this drug over several weeks (all occurred during the first trimester). On 26-Oct-2009, the patient received H1N1 Vaccine, Intranasal for an unknown indication. On 27-Jan-2010, the patient gave birth vaginally to a 7 lb 8 ozs, healthy baby boy who measured 19.5 inches long. Both were well and healthy. The patient did very well with the vaginal delivery and had no complications. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments were not applicable. The outcome of vaccine exposure during pregnancy was considered resolved. Additional information was received on 23-Feb-2010 and incorporated into the narrative: Medical history, concomitant medications, obstetrical history, EDD, information about delivery and status of baby, weight and length of baby.
pt recv vax 10JAN97 11:00;pt returned 4PM w/nausea, dizziness, h/a, tight throat, & swelling on lt arm & lt side of the face;tx w/DPH, cold packs & toradol;pt went to ER w/migraine & tx w/steroid, antihistamine w/pain med;knot inj site
COVID 19 Treatment; COVID 19 Treatment; Dose 1, 2, 3 of BNT162B2 and Dose 4: Moderna Vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Jun2022, outcome "not recovered", described as "Dose 1, 2, 3 of BNT162B2 and Dose 4: Moderna Vaccine"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) Negative, notes: Negative COVID test 26Dec2022; (29Dec2022) Positive, notes: Positive COVID test and return of symptoms 29Dec2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient took Paxlovid as treatment, start date was 20Dec2022 and stop date was 25Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events interchange of vaccine products, vaccination failure , COVID 19 and the suspect drug BNT162B2 cannot be excluded.
Localized swelling, redness and blistering at immunization site.  Now with scar/keloid formation 1/2cm in length.
Went to sleep feeling feverish with chills, then woke up around 1am/2am shaking. My chest felt very tight and I was breathless. I put my fitness watch on to see my heart beat because I was feeling as breathless as after a very long run. My resting heart rate was jumping between 170-180 bpm. It subsided after roughly 15 minutes but my chest did remain tight.
24 hr later arm red hot swollen 5X5, chills, fever, HA in 48hrs, red/ purple, swelling starting 72 hrs later
S/S started day after injection on 4/21/16. Right arm inflamed, red, itching, hot to touch, painful down to wrist and enlarge lymph nodes in right leg. Seen at hospital 4/23/16 with dx of cellulitis per patient. States put on steroid, KEFLEX and BACTRIM.
Flu like symptoms; Left arm was hurting and really sore top and underneath; Diarrhea; Numbness in tongue/ Numbness in nostrils; Loss of taste is getting better; Loss of smell is getting better; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Left arm was hurting and really sore top and underneath), DIARRHOEA (Diarrhea), HYPOAESTHESIA (Numbness in tongue/ Numbness in nostrils) and AGEUSIA (Loss of taste is getting better) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Left arm was hurting and really sore top and underneath), DIARRHOEA (Diarrhea), HYPOAESTHESIA (Numbness in tongue/ Numbness in nostrils), AGEUSIA (Loss of taste is getting better) and ANOSMIA (Loss of smell is getting better). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Left arm was hurting and really sore top and underneath), DIARRHOEA (Diarrhea), HYPOAESTHESIA (Numbness in tongue/ Numbness in nostrils), AGEUSIA (Loss of taste is getting better) and ANOSMIA (Loss of smell is getting better) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Information has been received through the Merck pregnancy registry from a physician concerning a 15 year old black female who on 01-FEB-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On the same day, after vaccination, an urine HCG test was performed and was positive. The patient's last menstrual period was reported to be "in very early January 2007." No additional information was provided. Follow-up information was received from a nurse practitioner. It was noted that varicella virus vaccine live (Oka/Merck) was not administered for immigration purposes and that the patient was not tested for varicella antibodies prior to vaccination. The patient had an ultrasound on 15-FEB-2007 which confirmed an EDD of 11-OCT-2007. The patient had an additional ultrasound on 04-JUN-2007 which was normal. The patient had no previous pregnancies. The patient had no local reaction at the injection site and no varicella or herpes zoster symptoms post vaccination. Additional information received indicated that concomitant therapy included prenatal vitamins. On 01-OCT-2007, 38 weeks from her last menstrual period the patient delivered a normal live born female. The newborn's weight was 3244 gm. There were no complications, no diagnostic tests, no infections, no illnesses and no concurrent medical conditions during pregnancy. The patient did have elevated blood pressure during labor, treatment of elevated  blood pressure was not reported. No further information was provided. No further information is expected.
The patient received MenQuadfi IM when he had just received Menactra IM on 1/19/23 and was supposed to received one of the meningococcal B vaccines today (Trumenba or Bexsero).  Wrong vaccine given
Angina Myocardial infarction Narrative:  employee reports 3 separate  hospitalizations related to MI
About 5 min after receiving shot, his head went to the side, lost consciousness. His legs, arms, hands went stiff and he started shaking. His eyes rolled back in his head, textbook seizure. Lasted a little less than a minute. When came to he said he couldn?t see anything. After about 30 seconds he could start to see. He turned pale, felt like he was going to throw up. But never did. A few minutes later he started to get a little color back in his face. He is tired but was better.
On 6/18/07 awoke with swelling and tenderness at injection site. Applied cold and warm compresses as needed, today 6/19 small amount of swelling no reddness, some tenderness to touch.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. Since an unspecified date in November 2014, doses of RECOMBIVAX HB, which were improperly stored (incorrect product storage), were administered to unspecified number of patients, (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were noted. No concomitant therapies were reported. This is one of several reports received from the same reporter. Additional information is not expected, because the reporter not consent further follows up.
She developed hives on April 11th and her whole body was itchy. She was unable to sleep on April 11th due to being itchy; She developed hives on April 11th and her whole body was itchy. She was unable to sleep on April 11th due to being itchy; She developed hives on April 11th and her whole body was itchy. She was unable to sleep on April 11th due to being itchy; This is a spontaneous report from a contactable consumer. A adult female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Apr2021 (age at vaccination unknown) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. The reporters friend, the patient informed the reporter on 12Apr2021, that she received the Pfizer vaccine on Friday, 09Apr2021. The patient developed hives on 11Apr2021 and her whole body was itchy. She was unable to sleep on 11Apr2021 due to being itchy. Therapeutic measures were taken as a result of hives, itchy and being unable to sleep which included treatment with Benadryl. The clinical outcome of the events developed hives on 11Apr2021 and whole body was itchy; was unable to sleep on 11Apr2021 due to being itchy was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 3 weeks after vaccination, patient developed myalgias, arthralgias, joint swelling, malaise, and severe blisters and swelling of her upper and lower lips.  She did not seek medical attention and symptoms have completed resolved by today (except for some residual inflammation and scarring of the lips) by my exam of the patient today.  Patient is concerned and convinced that symptoms are related to vaccine. However, I (her physician) am not convinced of a relation between the vaccine and her symptoms.  However, having not had the opportunity to examine the patient at the height of her symptoms, I am at a clinical disadvantage.
Cold; Sleepy/slept all day; Chilly; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), SOMNOLENCE (Sleepy/slept all day) and CHILLS (Chilly) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced NASOPHARYNGITIS (Cold), SOMNOLENCE (Sleepy/slept all day) and CHILLS (Chilly). At the time of the report, NASOPHARYNGITIS (Cold), SOMNOLENCE (Sleepy/slept all day) and CHILLS (Chilly) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Patient sat in her chair, covered up with blankets and slept all day.   This case was linked to MOD-2021-364868 (Patient Link).
Within 3-5 minutes after receiving a TDAP and HPV vaccine, the patient c/o feeling faint when she stood up.  She was immediately assisted to an exam table where she was placed in a horizontal position BP = 102/66.  Her skin color was pale and she was diaphoretic.  After 15 minutes she was raised to a sitting position BP = 106/72 skin color improved & was warm & dry.  After 5 minutes of sitting, she felt much better and was discharged.
3/30/21 at 1:30 am until 4/1/21 approximately noon: 103 F fever, chills, joint aches, extreme fatigue, loss of appetite, difficulty sleeping, headache, brain fog. 4/1/21 until present: tachycardia / racing heart rate as high as 125 bpm, feeling flushed as though I have sunburn but without any sun exposure, forgetfulness / trouble focusing / brain fog , Insomnia and frequent awakenings from sleep, feeling dehydrated and head achy or thirsty frequently, more frequent than normal urination, urine clear or pale yellow.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 68-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. In December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In December 2018, 6 hrs after receiving SHINGRIX, the patient experienced pain. The patient was treated with paracetamol (Tylenol). In December 2018, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but could be 67 or 68 years. The batch number for SHINGRIX was not reported. Two and half months before the date of reporting, the patient received SHINGRIX on the right arm. The patient experienced soreness and lasted for 6 to 8 hours. The patient received Tylenol for the soreness. The reporter consented to follow up.
pt recvd vax & exp some inflammation @ inject site muscular & joint discomfort & leg pain in the calf; pt did not have fever or nausea; seen by MD dx adverse react to Hep B vax;
On Item #17: dosing didn't indicate or not exactly sure but the dose was 0.5mL
Woke up in middle of night with intense chills and could not breathe. Fainted. Woke up on floor disoriented. Partner was ready to call 911 until I was able to breathe again.
client was in observation and felt flush and states that her face was feeling like it was tingling. denies pain or SOB. Vitals stable with bp 126/86  and hr 85. baseline  pox 98% on her prescribed 2L of oxygen. within 5 minutes client states that this feeling is all gone. Repeat vitals at 1414 were 113/78 and pulse 84. Client states that she feels fine and refused any further treatment.
noticed the large difference in the size of my left breast.Again, there are no lumps or signs of lymph node swelling but my entire breast is larger; experiencing left sided chest pain; felt muscular in nature; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 15:30 (Lot number: FH8028) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: other medical history: Seasonal allergies; "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: IBUPROFEN; LARISSIA; LEVOCETIRIZINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0169, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 29 years old, for COVID-19 immunization, reaction(s): "left breast increased in size by 1 cup size. There are no lumps and no signs of lymph node swelling"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Right), administration date: 31Mar2021, when the patient was 29 years old, for COVID-19 immunization, reaction(s): "left breast increased in size by 1 cup size. There are no lumps and no signs of lymph node swelling".  The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021 15:30, outcome "unknown", described as "Booster"; CHEST PAIN (non-serious) with onset 24Nov2021 06:00, outcome "recovered" (25Nov2021 18:00), described as "experiencing left sided chest pain"; MYALGIA (non-serious) with onset 24Nov2021 06:00, outcome "recovered" (Nov2021), described as "felt muscular in nature"; BREAST ENLARGEMENT (non-serious) with onset 25Nov2021, outcome "not recovered", described as "noticed the large difference in the size of my left breast.Again, there are no lumps or signs of lymph node swelling but my entire breast is larger". Therapeutic measures were not taken as a result of chest pain, myalgia, breast enlargement.  Follow-Up (30Nov2021): Follow-up attempts are completed. No further information is expected.
Patient in observation area at 3:40 diaphoretic and pale, vaccine lot 1816022 tells the EMT feeling dizzy. Patient was seated in a wheelchair and taken to observation area EMT 3:50 vitals BP 130/90, Res 19, SPO2 99, Dex 84, HR78. Patient was left in observation. Patient reports having hypertension and does not take his medication daily. 4:00pm Doctor is called and gives instruction to leave patient in observation for another 3min and then d/c patient reports feeling better and was discharged to go home.
This male subject was enrolled in a study. On 08 February 2013, he received the 1st dose of GSK PRIORIX or Merck's MMR II co-administered with GSK HAVRIX 720 JUNIOR, Merck's VARIVAX and Pfizer's PREVNAR 13. This subject received PRIORIX. On 01 March 2013, 21 days after the 1st dose of Blinded vaccine, 21 days after the 1st dose of HAVRIX 720 JUNIOR, 21 days after the 1st dose of VARIVAX, 21 days after the 1st dose of PREVNAR 13, this 12-month-old subject developed petechiae. The subject was hospitalised. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the petechiae may have been caused by investigational product, HAVRIX 720 JUNIOR, VARIVAX and PREVNAR 13 and that the event was possibly due to a viral infection. Investigator Comments: Received immunizations PREVNAR, HAVRIX, MMR and VARIVAX on 08 February 13. 01 March 2013 subject presented with left otitis media and petechiae under left eye, and nonspecific viral appearing rash on trunk and extremities. OMNICEF prescribed. CBC drawn and results normal except for EOS 4.0%. On 02 April 2013, subject presented with nasal congestion for two days, fever of 100.4, petechiae on extremities and face and bruising on face following a fall. No mucosal involvement. No blood noted in urine or stools. No meningism. Subject was admitted to the hospital for further evaluation on 02 April 2013 and discharged on 03 April 2013. Awaiting records for further information. Has appointment scheduled with primary care provider on 12 April 2013. Causality is listed as related to study vaccine at this time due to the known association of thrombocytopenia with MMR vaccine. We are awaiting for a final diagnosis at the subject's visit with primary care physician on 12 April 2013.
Information has been received from a registered nurse concerning a child who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient's mother called the physician's office to report that her child developed a chicken pox-like rash more than 2 months after receiving the vaccine. The parent asked if the patient was considered contagious. The parent also called the physician's office about her child being given the vaccine and then was exposed to another child with chicken pox and the child who was immunized developed chicken pox. The patient was not seen to confirm. On 10/20/03 it was reported that the adverse event had been reported long after the parent called. The physicians office had no idea who the patient was. It was also reported that another child was vaccinated with a dose of varicella virus vaccine live and developed breakthrough chicken pox. It was also reported that a 9 month old patient was inadvertently vaccinated with a dose of hepatitis A virus vaccine inactivated. No further information is expected.
Low grade fever, headache, nausea, chills, fatigue, moderate soreness throughout injected arm.
Patient received VARIVAX on 9/21/10 and mom states that on 10/11/10 she noticed he had 6-8 blister looking spots on face and leg. Very itchy and looked like chicken pox. I recommended she monitor and call if rash looked infected or symptoms worse.
Patient reports pain at the injection site, then developed chills and fever, body aches, muscle aches. Also reports headache and neck pain.