chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/7/21 around 630pm began to feel ill and had sore arm. By about 1030pm, had significant body aches, headache, clammy skin, vomiting, diarrhea, near passing out, fast heart beat, with fever. These symptoms lasted about 48 hours. The next 48 hours just had ill feeling with extreme fatigue. Come 4/12/21, I had nausea, headache, fever of about 100.4 and body aches. By 4/14/21, I ended up going to the ER for shortness of breath, chest tightness, extreme fatigue and voice hoarseness. Those doctors performed several labs to include Chest CT which showed elevated D-Dimer levels. An EKG was performed which was baseline. Ultrasound of my veins was performed. They also did a COVID test which was negative. They sent me home and told me to rest and drink lots of fluid. On 4/16/21, I had a video call with my doctor who didn't like the sound of my voice and straining to catch my breath and I was sent to urgent care/ER. They admitted me as an ER visit due to my continued shortness of breath, cough, sore throat, night sweats, dizziness, chest tightness along with my voice being hoarse. Another COVID test was performed and was negative. During their exam, my oxygen levels were dropping into the low 80s and my heart rate was in the 120s and 130s. Their CT scan was down so they sent me to another ER where another CT scan was performed. Another COVID test was performed and was negative.  My D-Dimer was elevated, liver enzymes was slightly elevated and again my oxygen levels were lower than would like to see and elevated heart rate. I ended up being admitted into the hospital for an overnight stay to monitor my symptoms. They treated me for suspected blood clot, shortness of breath, chest tightness. I was given 2 shots of heparin in the stomach, IV fluids, multiple vitamins in attempt to boost my immune system, along with ADVAIR and Albuteral. My discharge diagnose from the hosptial was Acute Bronchitis, Anxiety disorder, Recent Moderna 2nd dose COVID vaccine with significant side effects in the form of fever, generalized weakness and dizziness.
This spontaneous report as received from a other health professional refers to a female patient of unknown age with no reported medical history. On 27-FEB-2012 the patient was vaccinated with GARDASIL dose 1 (route, dose and lot number unknown). On 05-SEP-2012 the patient was vaccinated with GARDASIL dose 2 (route, dose and lot number unknown). No other suspect therapies or concomitant medications were reported. On 31-MAR-2013 the patient is in the office to receive her third dose. 27-FEB-2013, 367 days after onset therapy the patient experienced received first dose on 02/27/2012, second on 09/05/2012 is unknown (inappropriate schedule of vaccine administered). Additional information is not expected.
Erythema and edema on left arm from shoulder to elbow starting approximately 24 hours after receiving Anthrax (5) vaccination. Denies any other symptoms.
lymph nodes under her left arm became painful; lymph nodes under her left arm became  swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (lymph nodes under her left arm became painful) and LYMPHADENOPATHY (lymph nodes under her left arm became  swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced LYMPH NODE PAIN (lymph nodes under her left arm became painful) and LYMPHADENOPATHY (lymph nodes under her left arm became  swollen). In September 2021, LYMPH NODE PAIN (lymph nodes under her left arm became painful) and LYMPHADENOPATHY (lymph nodes under her left arm became  swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not provided.  Treatment details were not provided.   This case was linked to MOD-2021-335078 (Patient Link).
numbness and tingling to right arm x 1 month.  Prescribed Diclofenac topical.  Referred to Ortho.
Had fever and vomiting for 3 days.  Per mom cried non-stop for over an hour the day following the vaccine.  Temp 104.5.  No concerns of dehydration.
This spontaneous report as received from a medical assistant refers to a 66 year old female patient. Patient's concurrent condition included a convulsive disorder. Patient was allergic to iodine, shellfish, phenobarbital, DILANTIN and TEGRETOL. On 06-MAY-2016, the patient was vaccinated with PNEUMOVAX 23 in an unspecified arm (lot # M005287, expiration date 08-OCT-2017). Concomitant therapies included atorvastatin, montelukast (manufacturer unknown) and divalproex sodium. That evening after vaccination, the patient developed pain, swelling and warmth at the injection site. The next day after vaccination the patient's symptoms became worse as the day went on, until eventually the pain became excruciating. Patient sought medical attention-she placed a call to an unspecified physician. The physician informed the patient to go to the emergency room. The patient was seen at the emergency room, was administered prednisone, BACTRIM, and BENADRYL and was released the same night without being admitted. No laboratory tests were performed. Patient went back to the physician's office on 09-MAY-2016 and at that time "she was feeling much better after 4 doses of antibiotic and 3 dose of prednisone" (hence outcome of injection site warmth and injection site swelling was considered as recovering), but was still experiencing mild pain and erythema. The medical assistant reported that they have not been in contact with the patient since then. Outcome of injection site pain and erythema at the time of report, was considered to be not recovered. Causality assessment was not known. The PNEUMOVAX 23 vaccine was administered by a new employee at the facility and this may have played a role in the reason for the reactions. The reporter requested a lot check for PNEUMOVAX 23 with lot # M005287, expiration date 08-OCT-2017. This is one of the two reports received from the same reporter (linked to 1605USA006411). Additional information has been requested.
vaccine administered at 17 years age/under 18; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered at 17 years age/under 18) and HEADACHE (Headaches) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered at 17 years age/under 18) and HEADACHE (Headaches). On 05-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered at 17 years age/under 18) had resolved. At the time of the report, HEADACHE (Headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient did not take any treatment medication for the headache.
Information has been received from a LPN concerning seven pts who were vaccinated with Comvax. The reporter noted that seven out of ten infants had experienced a reaction at the injection site described as hard, size of golf ball, tender to touch and slightly red. The experiences last 6-8 weeks. The pts were "mostly two months and a couple were four months old". The pts sought unspecified medical attention. No further details were provided. Additional information has been requested.
Nurse drew 1.3mL of diluent but then withdrew 0.2mL into that same syringe and administered the full syringe (1.5mL) into patients arm. Vial was not diluted properly.
pt recvd vax 4DEC95 & was fussy & crying x 5 days was adm p/5 days;
This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness in the chest), COUGH (coughed up some phlegm) and NECK PAIN (soreness in both sides of the neck) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Heavy smoker. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced CHEST DISCOMFORT (tightness in the chest), COUGH (coughed up some phlegm) and NECK PAIN (soreness in both sides of the neck). At the time of the report, CHEST DISCOMFORT (tightness in the chest) and COUGH (coughed up some phlegm) had resolved and NECK PAIN (soreness in both sides of the neck) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications include Blood pressure medication. Treatment medication included Acetaminophen. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: F/U received on 14-may-2021,Updated event outcome of neck pain from recovered to not recovered.
Malaise/not feeling well; This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The pharmacist on the line stating a physician called in to report that the patient received Shingrix and had severe malaise for a week to 10 days. The patient basically did not feel well.  The reporter consented to follow up. The caller has no further details and further patient identifiers. No further information regarding responsible physician was provided.
side effect on March 18, 2021: a red and itchy rash  about 5 inches at the site(arm) of covid Moderna vaccine injection after one week of the 1st dose.
Severe dizziness and vertigo on 15 December 2021 morning (after about 5 weeks of covid vaccination). Vertigo kept reoccurring for 2-3 days and subsided. Now I don't have any more vertigo episodes.  Dizziness gradually subsided in about a month's time as well. However, sudden tinnitus (buzzing sound) occurred in my right ear after a week of vertigo occurrence and is still continuing.
Fever starting 4/27/06. Fussiness starting 5/2/06. Lymphadenopathy and Parotitis.
I started having strong contractions,  they lasted for 2 days, it was basically full labor, it subsided by Monday morning, the 20th, my water did not break. I have not been checked.yet how dilated I am now, but based.on intensity,  and given this is my 2nd child, it feels like i am at 4 cm now. I see my doctor on the 24th.
Felt ill day after infection, by 7:00 p.m. 6/17/09, had high fever chills, muscle aches, pain down spine.  Severe muscle aches, child sobbing.  Took to ER ater child blacked out. Ran blood tests adn CXR, all normal.  Rehydrated adn sent home.  Took Ibuprofen for fever/aches.  Recovered by Friday 6/19/09 - SSM
Nauseous - wanted to throw up , also had an upset stomach  called the doctor was advised to rest up due to vaccine effect and afterwards had noticed spots all over my skin specifically near my eyes, and had a headache then called the doctor again and had my daughter pick me up and took me to the doctor.  When I arrived at the doctor's office they said my blood pressure was high and I was given an iv medication then after a few hours was feeling better and blood pressure was normal as well
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-year-old patient of unknown gender. On 06-MAR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N027002 (expiration date 28-SEP-2019). This is one of multiple reports received from the same reporter.
Headaches; Feeling kind of sick; This is a spontaneous report from a Pfizer-sponsored program regulatory authority Support. A contactable consumer reported for a 6-decade-old female patient (reporter's daughter) who received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date in 2021 as SINGLE dose for covid-19 immunization. Historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 29Jan2021 as SINGLE dose for covid-19 immunization and experienced arm soreness. Medical history included breast cancer and had a lump and everything removed on an unknown date in 2013 and it was unknown if ongoing. Concomitant medication was not reported. The caller stated that her daughter experienced headaches and feeling kind of sick (caller stated that her daughter never gets sick, however immediately after she got a second Covid shot, she got headache). The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Severe myalgia originating in right arm near injection site. Moderate headache and Fever of 103.0. Rigors (shivering) continuing for around 3 hours after onset of fever. Fever reduced to 99.3 approximately 12 hours after onset. Mild myalgia for a period of 24 hours after onset.
On 4/26 and 4/27 pt received a total of 5 vaccines (MGC, Hep A, Hep B, in left upper arm IM on 4/26) and Pneumococcal subq in left triceps area and Tdap IM in left upper arm on 4/27/07. Early on a.m. of 4/28/07, pt experienced fever, headache, body-aches, nausea and a reaction surrounding vaccine site in left triceps. Site was painful, hot to the touch, pruritic, red and edematous. There was a knot at the site the size of a goose egg and the redness, pain and swelling went from his left upper triceps area to his elbow. Systemic symptoms resolved over next 24 hours with round the clock administration of Tylenol. No adenopathy. No paresthesias in LUE. Pt has no history of previous vaccine adverse reactions. The reaction surrounding the vaccine site diminished significantly by 2 May. Fever workup was done and reveled no evidence of infection.
PT MOTHER REPORTS A KNOT IN THE BABY'S THIGH WHERE VACCINE WAS GIVE. MOTHER STATES THAT BABY DOES NOT ACT LIKE IT IS PAINFUL, BUT PARENTS CAN FEEL THE KNOT WHEN THEY TOUCH BABY'S LEG. TOLD PARENTS TO WATCH SIGHT AND HIS BABY STARTS TO ACT LIKE THE LEG IS CAUSING HIM DISCOMFORT TO CONTACT THEIR PCP.
this has prevented her from doing her exercises; couldnt sleep well due to pain; I cannot bend down; had never experienced a symptom like this one before, do not know how to explain it¨; Tired; choke with my breath; pain in ribs; pain internally in the lungs; I get out of breath when I'm speaking; normal mild pain in arm; swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (choke with my breath) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O1UC21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (normal mild pain in arm) and PERIPHERAL SWELLING (swelling in arm). On 30-Apr-2021, the patient experienced CHOKING (choke with my breath) (seriousness criterion medically significant), MUSCULOSKELETAL CHEST PAIN (pain in ribs), PULMONARY PAIN (pain internally in the lungs), DYSPNOEA (I get out of breath when I'm speaking), MOBILITY DECREASED (I cannot bend down), UNEVALUABLE EVENT (had never experienced a symptom like this one before, do not know how to explain it¨) and FATIGUE (Tired). On 03-May-2021, the patient experienced INSOMNIA (couldnt sleep well due to pain). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (this has prevented her from doing her exercises). On 03-May-2021, PAIN IN EXTREMITY (normal mild pain in arm) and PERIPHERAL SWELLING (swelling in arm) had resolved. At the time of the report, CHOKING (choke with my breath), MUSCULOSKELETAL CHEST PAIN (pain in ribs), PULMONARY PAIN (pain internally in the lungs), DYSPNOEA (I get out of breath when I'm speaking), INSOMNIA (couldnt sleep well due to pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (this has prevented her from doing her exercises), MOBILITY DECREASED (I cannot bend down), UNEVALUABLE EVENT (had never experienced a symptom like this one before, do not know how to explain it¨) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported. Treatment information was not provided.  Company comment:Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue is consistent with the product safety profile.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue is consistent with the product safety profile.
fever, diarrhea, cough, body aches starting on 9/20/21
This is a spontaneous report from a contactable pharmacy technician and a contactable pharmacist via a Pfizer representative. This physician reported similar events for 3 patients, this is the first of three reports. An elderly female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swelling of injection site and itching all on an unspecified date with outcome of unknown. The swelling of injection site got worse and the patient had to go to the doctor for an antibiotic to reduce the swelling. The reporter stated she thought the swelling worsened because the patient was itching it and that made it worse. The patient was treated for both the events. Sender's Comments: Linked Report(s): US-PFIZER INC-2017231547 Same reporter/ product, similar events, different patients; US-PFIZER INC-2017231548 Same reporter/ product, similar events, different patients.
Patient apparently passed out while waiting after receiving vaccine. She was sitting in a chair and fell over to her right side. She appears to have had a petit mal seizure. Her pupils were very dilated and it took her several minutes to become fully responsive, although she was unresponsive for just a short period of time. She is a student and the EMS staff who responded to the 911 call reports that she is well known to them, as she has a history of "pseudo-seizures".  Patient's BP was 138/84 and SPO2 was 98%. Pt was transported to ED around noon, and was back to the clinic by 1:15 to collect her eyeglasses that had been left where she was sitting.
face was really red like an allergy; blood pressure went up to 170; face was really red like an allergy and neck was very red; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional. (Reference number- 00457128) and transmitted to Sanofi on 02-Feb-2021  This case involves a 68 year old female patient who had face was really red like an allergy (hypersensitivity), while she received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On 30-Dec-2015, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UI517AA and expiry date: 23-Jun-2016) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed face was really red like an allergy (hypersensitivity) with their symptoms face was really red like an allergy and neck was very red (erythema) and blood pressure went up to 170 (hypertension) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Laboratory data was not provided.  Patient was given 4 shots of steroids and her symptoms resolved after a few days.   Patient also had to take Benadryl and went to a dermatologist because the redness on her face would not go away.  At the time of reporting, the patient was not recovered from erythema and recovered from  rest of the events.
Initial misuse report received from a consumer on 30 April 2013. A female patient received an expired dose of MENACTRA. No more information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Diarrhea; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea and vomiting are consistent with the product known safety profile.