chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the Covid-19 vaccine. She reports symptoms of lightlessness, taste in mouth. Pt stated she is unsure if she had a seizure since she has a hx of seizure disorders. Pt did take medications this morning. Pt does not have any facial swelling.    Pt started feeling unwell at 11:02am   Vitals: B/P: 110/74 HR: 110, 105, 100 02: 87   11:20: Vitals: B/P: 112/74 HR: 98, 86 02: 97   11:32am:  BP: 116/76 HR: 86 02: 97   11:45am:  B/P:112/72 02: 97  HR: 86   Pt stated she feels ok now, husband is here with pt and is driving her home. Pt aware to mention this to health care provider, pt verbalized understanding
About 10 minutes after receiving DTaP & IPV, while walking to the car, pt complained of belly pain, shortness of breath & itch. Returned to office. RR = 24, no audible wheeze (still sobbing), slight pallor & faint urticaria noted on abdomen & back. Had emesis after attempt to give 1 tsp. BENADRYL. After about 30 min of observation, resps even & non-labored. Improving rash. Had additional emesis & diarrhea x 1 at home - resolved.
VS 121/64, HR 73, OxSat 98%.  Vaccine received and pt. States he blacked out.  No loss of consciousness, but foggy.  Alert x 3.  VS obtained when pt. Placed on cot and monitored by Fire fighter.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-DEC-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose-0.5ml, strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Case number PHEH2014US015634, is an initial spontaneous report received from a pharmacist on 05 Aug 2014. This report refers to an 18 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: unknown) intramuscular on 04 Aug 2014. It was reported that the vaccine leaked from the injection site once the needle was removed. The outcome of the event was unknown. Seriousness and causality assessment was not reported. No further information was provided.
Pt rec'd Gardasil in (L) upper arm. Observed x 10 min w/o problem. Left office - returned a short while later c/o pain in forearm and (L) hand; pt had a bruise at base of thumb. (L) forearm and hard cool to touch. Injection site ok.
Started having a cold and felt really fatigued. Went and got tested for with a PCH COVID-19 test at urgent care and it was positive. Was prescribed meclizine for 7 days. Started feeling better. Had another COVID-19 PCH  test - negative.
I had a reaction to the second vaccination with a fever, tiredness and incredibly sore arm. But the real issue began two weeks after my second Moderna vaccination on February 13. Not evident at first because symptoms did not all begin at the same time,  this inflammatory reaction ended up lasting about two months and, I  think, only stopped when I was given 800 m of acyclovir 2* daily for a herpes outbreak, which was the final symptom in the sequence of symptoms.  Here's what happened, in early March my hands started to hurt like I developed serious arthritis overnight. Next I started getting pain in my upper left mid-back, which progressively worsened over the next 8 to 10 weeks (I had a kidney ultrasound to rule out kidney stones or a tumor). By the end, I barely could sleep or eat the pain was so bad and the pain was worse when I was lying on my back or side.  During this time, my resting heart rate, which is usually 65 beats a minute, was 95 to 100 bpm and my breathing rate went way up too (I wear a digital watch so could see this was a marked change from my normal). When I traveled in April and was going through the TSA screen,  the x-ray showed my back and left arm lit up. I was pulled aside for a pat down because they couldn't  explain what was causing my back to appear all white in their x-ray.   Finally, I was so stressed by the pain, that by the end of April, I had a herpes outbreak, and I haven't had one of those in more than two decades. That is when the doctor gave me the acyclovir.   All along I had been taking anti-inflammatories (glucosamine and chaga). But within 36 hours of taking  acyclovir, it was as a switch was flipped and most of my symptoms went away or practically so. While the pain in my back disappeared, it took a week for my hands to get back to normal.   I have no way of proving this but I think somehow the acyclovir stopped my body's ongoing inflammatory reaction to the vaccine and I am reporting this to VARS only because by the time I got relief, the pain had become so intense, along with the sleep deprivation, that I was having suicidal thoughts.  If acyclovir somehow can be used to treat vaccine reactions, I feel I have a duty to report.
I started having symptoms in the morning with sore throat, and I was at a convention and that night I started having a little cough and the next morning, the sore throat was more but not really bad just like a normal sore throat didn't make me think that I had COVID-19 but on Monday I was coughing so bad I about vomited but when we got back home on Tuesday we got an email that we had been exposed to COVID-19. I went to the clinic the next day and tested positive for COVID-19 and they gave me the infusion, medication like a Z-PAK and some antibiotics. My gastroenterologist thinks I am having a increase of certain white cells months later as of today.
Red and itchy rash ( the size of a plum) developed on Day 8, following Moderna vaccine injection #1. Benadryl  helped with the itchiness
covid 19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (covid 19) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other  vaccines in the 4 weeks prior to COVID-19 vaccine and was also unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.     On 29-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-724032 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724032:same reporter
Day after vaccine, I ran a 102 degree temperature, had severe fatigue and a severe headache. The fever broke overnight, but the fatigue and headache have continued into a second day.
pt recvd 1st dose of Engerix-B 23JUN92 & 5 days p/inject pt exp intense back pain w/no other stimulus, pain radiating down legs; major c/o pain & paresthesias; acute L4-5 radiculoneuropathy;
Continued soreness and pain at injection site followed by achiness, throbbing and tenderness radiating to right elbow. Stiffness in arm muscles making normal range of motion difficult. Weakness when carrying heavy items with right arm.  Currently undergoing physical therapy after one steroid shot.
Vasovagal syncope, nausea, lightheadedness, dizziness, weakness, bradycardia, confusion.  Immediately regained consciousness, but remaining symptoms Slowly improved over 20-30 minutes
Patient was at immunization clinic for second pfizer immunization with his mother and older brother.  His brother had his immunization and patient had his second immunization given reassurance and diversion for immunization offered to lay down for immunization but refused.  Giving home instructions to family and patient stated felt funny, color pale, unresponsive for approximately 5 sec, lowered to floor turned on side,  patient became nauseated and vomited x 1 small amount of brown emesis,  Skin moist and warm to touch pale.  EMS here to assist and taken back to observation area via wheelchair. Report given to EMS. Patient awake.
Achiness, fatigues, nausea, runny nose, shortness of breath, heaviness in the chest
had the shivers really bad with her 2nd dose of the Moderna vaccine; it knocked off her feet for a day; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (had the shivers really bad with her 2nd dose of the Moderna vaccine) and FATIGUE (it knocked off her feet for a day) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (had the shivers really bad with her 2nd dose of the Moderna vaccine) and FATIGUE (it knocked off her feet for a day). At the time of the report, CHILLS (had the shivers really bad with her 2nd dose of the Moderna vaccine) and FATIGUE (it knocked off her feet for a day) outcome was unknown.            Concomitant medications were not provided. Treatment details were not provided.
development a lump in the lymph node under the arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (development a lump in the lymph node under the arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (development a lump in the lymph node under the arm). At the time of the report, LYMPHADENOPATHY (development a lump in the lymph node under the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Menses started a week early after first covid vaccine.  Since vaccination her menses have been abnormally extremely painful. Since vaccination her cycles have gotten shorter. Prior to vaccination she had a predictable 25 day menstrual cycle . She said since vaccine starting with the cycle immediately following her cycle shortened to 21 days and more painful. She also has a day or two of spotting before her period starts that she did not have prior to getting the vaccine. To this day at her annual exam  her periods are starting to get longer than 21 days  but are not back to  normal  yet.
CHILLS; HEADACHE; BODY ACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 03:00 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache and body ache was not reported. This report was non-serious.
sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore right arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced MYALGIA (sore right arm). At the time of the report, MYALGIA (sore right arm) outcome was unknown.            No concomitant drugs were provided. No treatment drugs were reported for the first dose.   This case was linked to MOD-2021-065924, MOD-2021-065924 (Patient Link).
pain started occurring in both shoulder on 26OCT92, sometimes alternately; rt shoulder pain occurs consistently w/ adduction; pvt MD advised against further vax;
Received the 1st dose February 24th at 11am. Around 4:00 pm started feeling extremely fatigued and that progressed all evening. Fatigue has persisted for 4 days. Starting Friday February 26th I've had a sore throat, congestion and very sore weak joints. Sunday the 28th being by far the worst day. Today Monday March 1st I am feeling some better but not great.
Lethargy, with frequent awakenings to initial state. Emesis 1 time; no sepsis.
I had an appointment on  02/02/2021. My blood pressure was 200/100 the first time then she took it again and it was 200/88. Wanted me to stop eating salt, had to get cholesterol down. It continued into June.
Pain on the same side of the injection/Spread back down to elbow, then down to hand/Radiated down arm; Muscle ache; Bruises; Numbness that radiated down arm; Felt off; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruises), PAIN IN EXTREMITY (Pain on the same side of the injection/Spread back down to elbow, then down to hand/Radiated down arm), HYPOAESTHESIA (Numbness that radiated down arm), MALAISE (Felt off) and MYALGIA (Muscle ache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) for COVID-19 vaccination.     Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), PANTOPRAZOLE, PARACETAMOL (TYLENOL) and MELOXICAM (MOBIC) for an unknown indication.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced CONTUSION (Bruises), HYPOAESTHESIA (Numbness that radiated down arm) and MALAISE (Felt off). On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain on the same side of the injection/Spread back down to elbow, then down to hand/Radiated down arm) and MYALGIA (Muscle ache). At the time of the report, CONTUSION (Bruises), PAIN IN EXTREMITY (Pain on the same side of the injection/Spread back down to elbow, then down to hand/Radiated down arm), HYPOAESTHESIA (Numbness that radiated down arm), MALAISE (Felt off) and MYALGIA (Muscle ache) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2021: dose 1 details were added, concomitant medications were added,
pt recv vax 4AUG95 & in MAY97 pt devel chickenpox consisting of approx 100 lesions w/low grade fever;
Patient has been experiencing pain in her right arm since the vaccine. Reported that she was diagnosed with nerve damage from vaccination
No adverse affect reported from patient. Clinic held Moderna vaccine at lower temp than recommended by Moderna. Vaccine was held at -90 to -60 degrees Celsius. Moderna deemed vaccine viable for use.
Patient is 28 year old male with complaints of hives that started showing up within the first week of getting home from deployment.  He reports it was about the first week in May of 2008.  He reports the only place he will get hives is on the left upper arm.  Never has hives anywhere else on the body.  He gets hives 1-2 times a day and they seem worse at night.  He reports that they are typically silver dollar sized and he typically has 6-8 hives at a time.  He has not taken anything for them but they go away in 1-2 hours.  He complains the hives are itchy and they can awaken from sleep due to the itching.  No dizziness or lightheaded.  No known triggers.  Nothing known to make better.  He reports that all his Anthrax shots and his Smallpox shot were in the left arm.  His last Anthrax shot was in 16 May 2008 and he feels that his reactions started after that shot.  He thought it was spider bites initially but when they kept coming back in the same area he thought that was unusual.
This spontaneous report as received from a Licensed Practical Nurse (L.P.N.) refers to an unspecified patient of unknown age and gender. On 20-MAR-2015, the patient was vaccinated with an expired dose of ROTATEQ (oral, expiration date 01-MAR-2015, dose, frequency and lot# were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. Additional information has been requested.
Fatigue for over two days, stiff arm for over 48 hours and a lump on neck near shoulder and lymph node swelling.
I am itching all over my body. My left hand has swelling in it. It hurts and where it is swollen it is sore. My arm is weak. It is hard to lift my left arm up and put it across my chest because that hurts. It hurts in my lymph nodes and my joints. I had to go the the ER on 12/31/20 because of this. they gave me a shot of Prednisoneand Hydroxyzihe that helped for a coupled of days and then I had to go back to the ER on 1/6/21 because of the same symptoms. They gave me Benadryl,prednisone and pepcid. I am still itching.
First dose was administered into gluteal region; Case reference number US-BN-2021-000281 is a spontaneous case report initially received from consumer on 22-Mar-2021, and concerns a female patient.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided.  On 17--Mar-2021, the patient started therapy with RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for animal attack administered into gluteal region (Product administered at inappropriate site).  On 20--Mar-2021, patient received second dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for animal attack administered in deltoid region.  At the time of this report it was not known whether the patient developed any adverse event.  No further information was provided.  This case is linked with cases US-BN-2021-000280 and US-BN-2021-000282 (same reporter).; Reporter's Comments: Product administered at inappropriate site is listed by convention. Reportedly, the patient received the first dose of RabAvert in the gluteal region. No adverse events were reported. Product administered at inappropriate site is not related to the RabAvert but to a human action.; Sender's Comments: Product administered at inappropriate site is listed by convention. Reportedly, the patient received the first dose of RabAvert in the gluteal region. No adverse events were reported. Product administered at inappropriate site is not related to the RabAvert but to a human action.
Slight swollen throat; swollen lymph nodes about 24 hours after vaccination; Drug use in unapproved population; off label use; throat/lymph nodes were swollen and hurting a bit; throat/lymph nodes were swollen and hurting a bit; nasal congestion began to occur; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old adult female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: ewo161 and expiry date was not reported), via an unspecified route of administration in left arm, on 28Apr2021 at 03:15 PM (age at vaccination was 31 years), as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reportedly the patient had no allergies and had no illness, but the patient was breastfeeding (ongoing). The patient was not pregnant at the time of vaccination. It was reported that the patient had no Covid prior vaccination and was not Covid tested post vaccination. The patient also did not have other vaccine in four weeks. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: ER8734 and expiry date was not reported), via an unspecified route of administration in left arm, on 31Mar2021 at 03:15 PM (age at vaccination was 31 years), as a dose 1, single for COVID-19 immunization. On 29Apr2021 at 07:00 PM about 24 hours after vaccination the patient had slight swollen throat/lymph nodes. 36 hours after vaccination, throat/lymph nodes were swollen and hurting a bit (Apr2021). After 48 hours, nasal congestion began to occur  (Apr2021). It was 5 days after receipt of the vaccine, the patient had a slight swollen throat and nasal congestion. It was reported that the patient did not receive treatment for the adverse events (slight swollen throat, swollen lymph nodes about 24 hours after vaccination, throat/lymph nodes were swollen and hurting a bit, nasal congestion began to occur). Outcome of the events (swollen lymph nodes about 24 hours after vaccination, throat/lymph nodes were swollen and hurting a bit) was recovering and events slight swollen throat, nasal congestion began to occur was not recovered.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021511243 Maternal/Child
Lying in bed after midnight I got so cold my whole body was shaking. I had flannel sheets, an electric blanket on #4 and a heavy down comforter over me. I was still shivering and my teeth were chattering. Never been that cold in my life.  It is now 9:00 a.m. I am still cold but not shivering. Also feel weak.
Severe headache, body fatigue, unknown pain at the righthand side of the body and feeling nausea