chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This serious case was received from a health professional on 27 December 2008. The patient was enrolled in a study for which Sanofi Pasteur was not the sponsor. A 38-year-old female patient received an intramuscular right deltoid injection of ADACEL (lot number C2456AA) on 03 May 2006. The patient was pregnant at the time of injection, and date of last menstrual period was 30 December 2005. Past medical history included asthma, obesity (BMI 40), varicose veins, occasional migraines, and a herniated disc at age 25 (since resolved). Obstetric history included two previous pregnancies, resulting in one live birth and one spontaneous abortion prior to 20 weeks gestation. She had a history of superficial thrombophlebitis in a previous pregnancy. Concomitant medications included COMBIVENT, PULMICORT, and prenatal vitamins. Prenatal testing was all normal, including chorionic villi sampling, serologies, fetal stress test, ultrasound, and genetic screening. During pregnancy, the patient developed superficial thrombophlebitis and symptomatic gall stones. On 12 October 2006, at 41.2 weeks gestation, the patient delivered a 3345g female infant via normal vaginal delivery. Apgar scores were 8/10 at one minute and 9/10 at five minutes. Due to the precipitous nature of the second stage of labor, one dose of ampicillin was given for GBS prophylaxis. A nuchal cord X 2 was easily reduced. The health professional who reported this case also reported 15 other serious and non-serious events. These events are captured in case numbers 2008-04101, -04103, -04104, -04105, -04106, -04107, -04108, -04109, -04110, -04111, -04112, -04113, -04114, and -04115. Documents held by sender: None.
covid vaccine breakthrough case  dose 1  4/16/21  Moderna 002C21A dose 2  5/14/21  Moderna 005C21A
Pt recvd Engerix-B & 7JUN92 devel a rash & hives all over body; approx 10JUN92 felt general malaise, chills, swelling & pain in joints; had ER visit & was told had the flu; 2nd ER visit told has arthritis; MD dx serum rxn;
Pt received the vaccine at 12:30 and walked up to pharmacy drop off let my tech know that she is feeling dizzy. I ran out with my cart she said she feels like she is about to faint. She asked for water, ice packs and a trash can because she felt like she is about to vomit. She started vomiting and she felt better afterwards. Paramedics came and her vitals were fine they said she doesn't need further medical attention. She ate some gold fish and drank more water. She was feeling normal and I walked her out when her mom was here and drove her home.
04/19/21 TELEPHONE CALL: I was asked to call this patient who has been experiencing a rash and swelling  since 4/9. She received the J&J vaccine 4/8. Rash described as very itchy, starting on extremities, especially wrists, hands,  arms, legs, back. Not anterior trunk, not head or neck but head was itchy. She  had swelling where the rash was/is, no asymmetric swelling. Much of it has  resolved - she states it is "much better" now. Now the rash is mostly just on her  hands and wrists, with a little swelling. Her joints do not bother her. No headache, fever, pain other than usual achiness from her medical conditions  that include myasthenia gravis and DM. No flare or change in symptoms or state of  her chronic illnesses. She has been taking benadryl at night, 12.5 - 25 mg, since 4/11, and using  hydrocortisone cream on the rash. She has had a new puppy since  4/13. She gardens and works in her yard. She is active in walking, gardening,  weeding, and her activity has not decreased since this began. Although she could  have been exposed to weeds or plants in her yard that she might react to, she is  covered when she goes out, long pants, shirt, boots etc. She has not used any new  soaps, detergents, etc; cannot think of any new exposures. I offered medical evaluation here, but she is comfortable monitoring it at home  since it is getting better. I advised her to come in for evaluation if rash or  swelling became worse, asymmetric, or if new symptoms begin.
Headache starting about an hour after vaccine and lasting about 36 hours; Very drowsy; This is a spontaneous report received from a contactable consumer (Patient). A 38-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported) via an unspecified route of administration, administered in Arm Left on 05Feb2021 09:30 as Single Dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. Concomitant medication included vitamin D (received within two weeks). Patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 05Feb2021, the patient experienced headache which started about an hour after taking vaccine and lasting about 36 hours, also she was very drowsy as well all-night Friday and Saturday morning. The events headache and drowsy were recovered on an unspecified date on Feb2021 without taking any medications.   Information about lot/batch number has been requested.
Pt states that following flu shot admin. he became ill with muscle and joint pain and chills. Getting progressively worse over next 2 months. Pt was seen by MD and diagnosed with polymyalgia rheumatica questionable exacerbated by flu shot.
Afluria Quadrivalent MDV 0.25ml was given to a child between the age of 6 month - 35 months.  On the vial, box the vaccines came in and the instruction sheet. It states okay to give this vaccine to these age groups.    6 month - 35 months 0.25ml   36 months and older 0.50ml The state does not approve this vaccine for the age group of 6 months-35 months. -Due to the amount of mercury and its not preservative free. -The vaccine is prepared from virus grown in embryonated chicken egg and inactivated with beta propiolactone. Each 0.25ml dose contains 12.25 mcg mercury/dose Patients mother states that patient had to reactions to the vaccine.
Patient was given a second flu shot during the same flu season. She received a Flulaval Vaccine on 10/22/2022 from her doctor's office and then received a Fluzone High Dose vaccine on 11/10/2022 from the health department. Nurse received verbal consent from client to do the flu shot on 11/10, but patient must have forgotten that she received the flu shot already. It was discovered during data entry that client had already gotten the flu shot. Nursing facility where patient resides was notified.
"Pus sores that scabbed over." Four other children reported having chickenpox at same daycare four of 5 children have had varicella immunization. Per mom pt has had "chickenpox" twice. 1st time November 2002 and 2nd time 1/3/04.
Extreme dizziness, nausea, racing heart, headache. Symptoms improved within 8 hours of onset of symptoms.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13May2021 17:00 (Lot number: EW0182) at the age of 13 years as dose 1, single and administered in arm left, administration date 03Jun2021 16:00 (Lot number: EW0187) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Seizure disorder petit mal" (unspecified if ongoing), notes: Verbatim: seizure disorder petit mal; "Encopresis" (unspecified if ongoing), notes: Verbatim: Encopresis. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "His arm hurt"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "His arm swelled up". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Additional Information for Other Conditions: states this was diagnosed back when he was 3. Patient states he takes a laxative, Dulcolax, daily and he did have one that day and has been taking it for awhile, it's an ongoing battle. Follow-up attempts are completed. No further information is expected.
No adverse events were noted at the time of this report. This report is being filed  to document a vaccination error that occurred during the vaccination process.. During the dilution process to prepare a Pfizer Covid vaccine 1.4 mL of normal saline was used instead of the correct 1.8mL as specified by the manufacturer resulting in a overly potent dose.  Exactly one shot was given out of the vial prior to the error being discovered. No additional doses were used out of the incorrectly diluted vial.  The patient was made aware of the error as soon as it was discovered and  contacted at the end of business day to confirm no adverse events at that point.
Event free for 1 week then last night (1/23/21) experienced painful full body ache (no position could relieve discomfort so could not sleep) Felt queasy but not to point of throwing up Felt some acid reflux
Patient came into the clinic and received a flu shot on 10/13. Patient was seen on 10/21 because of the pain in her shoulder. Patient was given a steriod to help with the pain. Patient pain continued and an xray was ordered on 11/14. X-ray results were normal. Patient and provider wanted to continue with an MRI. Peer to peer is now being required as insurance denied the MRI. Patient came in for another appointment on 12/06 and was also referred to physical therapy. Patient has been following up with the clinic and provider about the shoulder pain and would like the clinic to cover an MRI to see what damage the flu shot caused in insurance continues to deny the MRI.
VARIVAX was administered to patient while it had a temperature excursion; Patient is asymptomatic/No additional AE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot #W031813, with an expiration date on 05-OCT-2024), administered for prophylaxis (strength, and route of administration were not provided).  Nurse reported that varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient while it had a temperature excursion. The patient was asymptomatic and no adverse events were reported.  The dose of varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to a temperature excursion of 24.4 degrees Fahrenheit (°F) during a time frame of 5 hours, 51 minutes and 0 seconds.  There was no prior temperature excursions reported.
I experienced tachycardia, almost lost consciousness in the early morning of 1/13/21. I had to call 911. When EMT's arrived about 10 minutes, my heart rate went down to 100bpm. I decided not to go to hospital and just continue observation. I still have a feeling of increased nervousness and palpitation in my chest today.
Patient experienced a fever starting March 7, 2022 around 2:00  pm. Patient took Acetaminophen for symptom relief. Hives occurred on March 10, 2022 and lasted until March 14, 2022 with severity ranging from severe to mild, respectively. Patient found relief with Benadryl and Acetaminophen. Patient says that she is anxious today, March 15, 2022, and anticipating hives but has yes to experience a hives episode. Patient also stated that although she found relief with Benadryl, it has worsened her restless leg syndrome.
48 hours post vax, after nursing, became fussy, crying very hard for 10-15 minutes, then noted to be cold, clammy pale then limpish and grunty respiration ok after 10-15 minutes.
The vaccine given was one day past the recommended storage date for refrigerator storage.  Hospital does not have ultra cold freezer storage.  The vaccine had been in our refrigerator for 10 weeks and 1 day.    The patient did not have an adverse reaction.   The location was notified.   Pfizer was called for recommendations and we were told that it was up to the patient's physician whether or not a new vaccine was needed.  The physician was notified and no new orders were given for the patient.
Approx 3 days after receiving my 3rd Covid vaccine, I developed a feeling of ?fullness ? in both ears with significant hearing loss, especially in my left ear. Approx 7 days later, I developed a constant ringing/buzzing in my left ear. Both side effects have continued to date.
My husband started feeling on his right side waist area.. It felt like a belt burn on that area and it was painful. Continued until Thrusday. and on Friday he felt nauseus and chills.  He also had a fever.
COVID-19 Booster Reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (COVID-19 Booster Reaction) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Multiple sclerosis exacerbation. Concurrent medical conditions included Dementia, Obesity, Wheeze and Memory disturbance. Concomitant products included OCRELIZUMAB (OCREVUS), ALBUTEROL [SALBUTAMOL] and MONOCLONAL ANTIBODIES, GRANULOCYTE for an unknown indication.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2022, the patient experienced IMMUNISATION REACTION (COVID-19 Booster Reaction). At the time of the report, IMMUNISATION REACTION (COVID-19 Booster Reaction) had resolved.            Patient took booster dose.  No treatment medication were provided.
Information was obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 16 year old female patient who on 29-MAY-2007 was vaccinated IM in left arm with a dose of Gardasil, lot #657737/0522U. Concomitant suspect therapy administered on the same day included a second dose of Varivax, lot #657102/0455U given in left arm; and Vaqta, lot #657304/0246U. Other concomitant therapy included Menactra. After a few moments of receiving the vaccinations the patient developed syncope and her blood pressure dropped. After the vaccinations she left the room and had loss of consciousness for 10 seconds. Her blood pressure was 88/54. She felt better after resting, and walked out of the office with her mother. She was reported as recovered. The reporter considered decreased blood pressure and syncope to be immediately life-threatening. The original reporting source was not provided. No further information is available. A standard lot check was performed. All in-process quality checks for the lot number 0455U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
1-9-2021  @ 1:45 AM Chills temp 98.4f.  4AM "I can't getup"  helped to BR sat on commode while I prepared a cath and then assisted to cath while sitting. warm to touch temp 102.4f. " I need something to eat".  I brought a glass of milk and his monitor BS 113 drank 1/2 cup of milk and helped back to bed. complained of nausea-no emesis. 4:35 temp 99.4f " I think I can sleep now" 8:36AM  98.8 T sleeping.  9:45AM  ate 1/2 bowl cereal 10 U insulin, 1/2 cup coffee 1 glass water with medications.  10:15 resting in chair 98 t.   10:51PM  97.8  BS 228  28 u long acting Woosey most of day ate poorly "not hungry" 2 glasses of water during day.  no other problem
A physician reported that a pt received an injection of flu shield on 11/26/2001. Subsequently, the pt developed swelling at the injection site. No further info was available at the date of this report. the reporter indicated that 2 patients experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying info is provided.
Migraine Has also become more frequent; Within 24 hours of receiving the booster I came down with fever; had clear blood in urine.The bleeding persisted for 4 days before it turned brownish black and stopped.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) via COVID-19 Adverse Event Self-Reporting Solution. The reporter is the patient. A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 (Lot number: Ew0191) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9261, Location of injection: Arm Left), administration date: 26Jan2021, when the patient was 35 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK9231, Location of injection: Arm Left), administration date: 05Jan2021, when the patient was 34 years old, for Covid-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset Sep2021, outcome "recovered with sequelae", described as "Within 24 hours of receiving the booster I came down with fever"; BLOOD URINE PRESENT (non-serious) with onset Sep2021, outcome "recovered with sequelae", described as "had clear blood in urine.The bleeding persisted for 4 days before it turned brownish black and stopped."; MIGRAINE (non-serious) with onset 27Sep2021, outcome "recovered with sequelae", described as "Migraine Has also become more frequent". The events "within 24 hours of receiving the booster i came down with fever", "had clear blood in urine.the bleeding persisted for 4 days before it turned brownish black and stopped." and "migraine has also become more frequent" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, blood urine present, migraine.  Additional information: No other vaccine received in four weeks and no other medications in two weeks. No covid prior vaccination. No Known allergies and no other Medical history.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions between -14 and -10 degrees Celsius for 3 hours and 45 minutes and between -9 and 8 degrees Celsius for 3 hours and 30 minutes. There were no previous excursions reported. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA008347:
pt. fainted after administering vaccine I proceed to assist the pt in lying on the table. The pt's eyes rolled back in her head so I got a doctor to assist me. After stabling pl. check BP 108/76 is ok.
Directly after receiving immunizations, became dizzy, faint. Recovered before leaving, nausea continued. For next four days nausea and dizziness continued. No fever noted per mom. Had fatigue for 1 week.
X1 day macular popular lesions, mild erythema, no itching, no CP no SOB.
Her Skin was itchy; Her Skin was prickly; A little Fatigue; Tingling her left arm and fingers; Face was red and hot; Redness went down her neck; Her hands were cold; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling her left arm and fingers), FEELING HOT (Face was red and hot), ERYTHEMA (Redness went down her neck), PERIPHERAL COLDNESS (Her hands were cold) and PRURITUS (Her Skin was itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acid reflux (oesophageal). Concurrent medical conditions included Hypertension and Cholesterol.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PARAESTHESIA (Tingling her left arm and fingers), FEELING HOT (Face was red and hot), ERYTHEMA (Redness went down her neck) and PERIPHERAL COLDNESS (Her hands were cold). On 30-Jan-2021, the patient experienced PRURITUS (Her Skin was itchy), PARAESTHESIA (Her Skin was prickly) and FATIGUE (A little Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 30-Jan-2021 at a dose of 1 dosage form. On 29-Jan-2021, FEELING HOT (Face was red and hot), ERYTHEMA (Redness went down her neck) and PERIPHERAL COLDNESS (Her hands were cold) had resolved. On 30-Jan-2021, PARAESTHESIA (Tingling her left arm and fingers), PRURITUS (Her Skin was itchy), PARAESTHESIA (Her Skin was prickly) and FATIGUE (A little Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified high blood pressure, cholesterol and gastric reflux medications.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received and contains Reporter contact details updated.
Starting 07/21/2022, I started having more allergy issues and I took ZYRTEC which kind of helped but not much. I got wheezy and used my rescue inhaler and took BENADRYL. These helped a bit but still didn't make it go away. The next day I had the same symptoms. On 07/23/2022, my daughter tested herself and was positive for COVID-19. I tested myself the same day and was negative. By 07/24/2022, I tested myself again with an at-home COVID-19 test which came back positive. At this time, I was also coughing and had a sore throat. I found out the COVID-19 test I had at home was expired by about a week, so when my daughter got home she had brought a new COVID-19 test which I took and confirmed that I was positive. I started isolating myself more into my room and self treated the symptoms. The sore throat, headache and lack of appetite got slightly worse. I started feeling better by 07/30/2022. I decided to wait until today 08/02/2022 to test again and it came back negative. I had diarrhea yesterday but haven't since. I still have a slight cough to this day but no other symptoms. Also, during this infection, my blood sugar was very erratic which is normal for me when I'm sick.