chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 07-APR-2014 was vaccinated with (Oka-Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pt called on 6/21/21. Pt received 1st dose of Pfizer vaccine on 6/18/21. Pt states she noticed a red, itching/burning bump at the injection site the size of a grape today on her left arm. Advised pt to go to urgent care to evaluate her arm, pt states she will go to urgent care.
On March 2, areas of red rash with welts started to appear on inner knees. By evening an continuing into the night of March 3, these red rash areas with large welts spread all over body. A steroid ointment and antihistamine were used to calm. After approximately 5 days the rash was gone. This rash appeared to look like the internet article pictures from BFF and Self, only the pictures were of the arm of injection.
Body ache; Sore arm at injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), VACCINATION SITE PAIN (Sore arm at injection site) and PYREXIA (Fever) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced PAIN (Body ache), VACCINATION SITE PAIN (Sore arm at injection site) and PYREXIA (Fever). On 17-Feb-2021, PAIN (Body ache) and PYREXIA (Fever) had resolved. On 23-Feb-2021, VACCINATION SITE PAIN (Sore arm at injection site) had resolved.            No concomitant medications were provided. No treatment drugs were reported.  Action taken with respect to mRNA-1273 was not applicable.  Patient reported having symptoms within 12-24 hours from vaccine. Soreness at injection site persisted for a week.   This case was linked to MOD-2021-095439 (Patient Link).
Patient calls to the pharmacy and indicates that is suffering from dizziness, rash and itching in the whole body and fainting.
Flu-like aches and extreme weakness throughout the body starting 7-8 hours after injection. Went to sleep the night of the injection feeling the onset of these side effects, which intensified throughout the night and disturbed quality of sleep.  Weakness and pain kept me in bed for the entire next day, with shooting pains up my skull behind my ears. Was unable to even sit up for more than a few minutes without pain and fatigue making me lie prone again. No fever, but felt hot throughout body. No chills - or maybe very mild chills.   Treatment: took a capsule of skullcap in the middle of the day, which seemed to alleviate my discomfort enough to let me nap.   Flu-like side-effects ceased abruptly around 10pm on 4/29 the day after injection, lasting about 24 hours total.  The following day, 4/30 around 7pm (so ~48 hours after injection), I developed COVID arm during moderate physical exercise. Suddenly felt and saw a hot, red, swollen rash on my upper left arm under - not around - the injection site (I am right - hand dominant). Rash is visibly swollen, mainly itchy, and tender/painful to touch if I press  on it.  Rash persists 8 hours later as of this writing. No treatment attempted for rash.
-Severe pain in joints and tendons in both arms (started on left side (injection side) then migrated to the right side as well and back pain  -swollen lymph nodes in the left armpit lymph node increased to 2-3?. Both lymph nodes in throat (left and right side) significantly increased 1-2? (7/15/21 through today 7/17/21) -mild fever highest recorded 102F (11pm 7/14 through 7/16/21) -major sweat spells (7/15-7/17/21) -tinted -very light pink urine twice. First time 7/15/21, second 7/16/21. Seems like blood in Urine noticeable on toilet paper, odor similar to blood/metallic  -throbbing pain in my lower right back not constant on 7/16/21, today currently not experiencing this -major body aches and chills 7/15/21-today -inside of mouth on the inside of my lips/cheeks tender and metallic taste -headache but today 7/17/21 major migraine  -tired and low energy all days -nausea on/off all days  -major
Vaccine recipient completed vaccine screening form and indicated he had never received a dose of Covid 19 vaccine, when entering information into system, noted he was fully vaccinated with Pfizer.
I had a sore arm after receiving the vaccine which lasted two days.  I started to feel symptoms of sore throat, swollen lymph nodes, exhaustion, chills and fever of 102 degrees on 07/26/ 2022.  I went to a drive through testing spot, and I tested positive for COVID-19.  I contacted my primary care doctor and was given the prescription Paxlovid but I did not take it due to medication that I take.  I took Tylenol to help with the symptoms.
On 10/8/2021 patient got vaccinated around 10am. She later that afternoon started feeling feverish and tired. During the night she was experiencing fever and frequent urination. Around 6:30am she was taking a shower and felt dizzy and fainted. She woke up in the floor unconscious. Later that morning she fainting again and fell on floor.
Information has been received from a pharmacist concerning a patient with unknown drug allergies and unknown medical history who "about 3 weeks ago" on approximately 30-APR-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently, the patient developed hemolytic anemia on an unspecified date. Medical attention was sought. The patient had an office visit. The patient's hemoglobin level was 7. At the time of report, the patient's status was unknown. No further information is available.
Hair is falling out rapidly in the shower and every time "I" brush it; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 29Apr2021 at 14:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 08Apr2021 at 15:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 10May2021, the patient's hair was falling out rapidly in the shower and every time she brushed it. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hair is falling out rapidly in the shower and every time she brush it was not recovered at the time of this report.
Ear aches in both ears, still knee joints. Nothing done for the knees. Used ear drops in both ears to try to remove any wax buildup. I usually have to remove wax approximately once per year. There has never been a pain associated with wax build. The pain is still there. Both started ~4/11/2021, between v-safe reporting events.
Pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever.  Sysmptoms started several hours after vaccine; became gradually worse through following day.  Felt very much like pneumonia without the coughing.
PATIENT CALLED THE PHARMACY TODAY TO STATE THAT APPROXIMATELY 18 HOURS POST INJECTION THE PATIENT STATED EXPERIENCING EXTREMELY SORE ARM. THIS RADIATED UP TO PATIENTS NECK AND CONTINUED TO CAUSE JOINT PAIN ALL OVER ENTIRE BODY. PATIENT HAS ALSO EXPERIENCED CONSTANT RINGING OR BUZZING IN THE EARS.
Pt went to the restroom and stated he started feeling dizzy. Pt sat on the floor so he would not fall.
Vertigo; Tinnitus; Ear pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for COVID-19 immunization. The following information was reported: VERTIGO (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown"; EAR PAIN (non-serious), outcome "unknown". The events "vertigo", "tinnitus" and "ear pain" required physician office visit. Therapeutic measures were taken as a result of vertigo, tinnitus, ear pain.  Additional information: Patient did not have Other Conditions and Other Products. When probed for COVID-19 Vaccine LOT number, consumer stated, I did not had that in front of me, I am sorry. When probed for treatment for occurred events, consumer stated, I had been to several doctors but there was no treatment. Actually, I need to go back on that one. I did go and they put me on antibiotics. Date and time of vaccination, consumer stated, 19Dec2022. I did not know. It may be around 1 o'clock. Vaccination facility type, consumer stated, it was at a Pharmacy.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Narrative: 79yo male patient who had not received medical care since 2013 died on 1/5/2022 of unknown cause. Pt had received a covid vaccine on 1/14/2021. Likely pt's death is not related to covid vaccines given pt's advanced age and long length of time between death & date of vaccine administrations.
PATIENT HAD LABS DRAWN THAT WERE NOT DUE TO VACCINE BUT NOTED TO HAVE A DECREASED PLATELET COUNT. CONTINUED TO HAVE DECREASING PLATELET COUNT FOR TWO MORE DRAWS.
Myalgia, Rash, 10/10 pain in back, shoulders, neck, rash all over chest and R arm.  Narrative:  Other Relevant History:
I had the first dose on January 19th, a week or ten days after I saw my vision become blurry. I went and saw the eye doctor who stated I have a fluid buildup and received eye drops which helped with vision improvements. After the Feb 16th Vaccine my vision began to get worse again after about 7-10 days post vaccine. I had alot more fluid in my eye buildup this time. On the second visit, I was asked if I had the vaccine. The doctor believed that there may be a correlation with the vaccine and my symptoms. Cystoid Macular Edema was the diagnosis. I was given a prescription called BromSite and after about 8 months of treatment I am beginning to see an improvement in the blurriness of my eyesight. Around November 2021 the fluid was beginning to go away again.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 60 year old female. Initial information was processed along with the additional information on 15-JUL-2022. The patient's height and weight were not reported. The patient was not pregnant at the time of vaccination. The patient had no any drug allergies. The patient was previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration were not reported, batch number: 202A21A and expiry: Unknown) dose was not reported, 1 total administered on 09-APR-2021 for covid-19 prophylaxis. It was unknown whether the patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). Age at time of vaccination 58 years old. The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: Unknown) dose was not reported, 1 total administered on 04-JAN-2022 for covid-19 prophylaxis. Age at time of vaccination 59 years old. Concomitant medications included Wellbutrin (bupropion hydrochloride), Vitamin D (ergocalciferol), Valtrex (valaciclovir hydrochloride), Z stack vitamin, Probiotic (bifidobacterium lactis) and steroid dose pack. On an unspecified date in 2022, the patient experienced covid-19 captured as suspected covid-19 infection (dose number in series 2). The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number and expiry were not reported) dose was not reported, administered from 24-JUN-2022 to 29-JUN-2022 for treatment of COVID-19. The patient was received other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that on 04-JUL-2022, the symptoms returned which include fatigue and scratchy throat subsumed under suspected covid-19 infection (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was not reported. The patient was recovering from suspected covid-19 infection. This report was non-serious. This report was associated with a product quality complaint: 90000242437 and 90000242438.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Pt became pale and quiet almost immediately after injection. Assisted to floor. BP done, 72/40. Pt able to respond that feeling weak. Mother present, states pt had been out most of day, had gone to gym and walked. Pt able to answer that minimal fluids last couple hours. Felt better after rested. Able to drink H2O. BP up to 100/56. Dr in and spoke with pt and mother at length. Pt able to get up to chair on own. After 45 minutes, opted to continue vaccinations. Given 2nd MENVEO and later BEXSERO #1. Tolerated well. Went home 30 min after last 2 vaccines given.
Swelling in the lymph nodes: Within 1-2 days after my first does, I noticed tenderness under my right arm (armpit), that lasted about a week. Within 24hrs after my second dose, I noticed extreme tenderness under both arms (armpits), that lasted 3-4 weeks. Additionally, within 2 days after my second dose, I could feel swelling and a lump under my right arm. Within a week, I could feel and see a lump under each arm in the armpit. The right arm had a large golfball-sized lump, that was hard, red, and had swelling around it, causing tenderness and discomfort under my arm and a little into my chest, just near my armpit. The left arm had a smaller ball-shaped lump, that was not as hard, but also red and had swelling around it. The swelling and lumps under each arm started to decrease about 1-2 weeks after the second dose and all symptoms of swelling, tenderness, were gone within 6-7 weeks after the second dose.
The patient was brought to the clinic by her daughter and grand daughter for evaluation of dementia and other chronic conditions and acute complaints. Her daughter said that while she is here she would like to get her vaccinated against COVID, because she said that the patient had not gotten her COVID vaccine yet. She was given the Moderna Vaccine 0.5 mL and given a Vaccine card with the return date for the 2nd dose. On 11-04-2021 when billing was being conducted, there was a question about previous COVID vaccines being given. At this time WEB IZ was accessed and it was discovered that the patient had gotten a dose of MODERNA on 07/14/2021 and 08/13/2021 at other facilities. The patient's caregiver has been contacted and reports no negative effects or events up to this point. She was instructed that for any signs of reaction or any change in the patient's status that the patient is to be evaluated immediately.
DEBILITATING HEADACHE FROM JULY 30 2021 UNTIL JULY 23 2022
After dose 4 of the Pfizer vaccination, Woke up with left side abdominal pain and constipation also experienced fatigue.
1/11 vaccination 15 minutes later, HA.  Tylenol, didn't work. 5pm vomiting; got worse. 1/12 By am, was vomiting every 15 minutes. HA turned into a 10/10 blinding migraine. Went to urgent care that afternoon.  Reglan, and IM injection for migraine.
covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2022, 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. In December 2022, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.        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 medication was reported.  Patient was over 65 years old. Patient stated the event happened about a month after receiving the vaccine, it was not an immediate side effect and now he's fine and happy. No treatment information was reported.   Reporter did not allow further contact
Information has been received from a health professional concerning a 59 year old retired white female with controlled mitral valve prolapse who on the morning of 12/11/2002 was vaccinated in the left deltoid with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 644104/0873M).  there was no illness at the time of vaccination.  Comcomitant medication included hormone replacement therapy.  On the evening of 12/11/2002 the patient developed a fever of 102F, nausea, had a left arm that was all swollen, "ached all over", and had to stay in bed 2 days.  It was reported that on 12/14/2002 the patient recovered.  It was noted that 4 other patients received a dose of pneumococcal vaccine 23 polyvalent (MSD) and, subsequently, experienced adverse events (WAES # 0301USA00947, 0301USA01143).  Additional information is not expected.
Pain and swelling of lymph nodeabove collarbone; swelling of lymph node above collarbone; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 16:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had reported no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), fexofenadine hydrochloride (ALLEGRA) bupropion hydrochloride (WELLBUTRIN) all were from unknown date and for unspecified indication, and unknown medication from unknown date for birth control. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 17:00, noticed onset 6 days after injection, the patient experienced pain and swelling of lymph node above collarbone on the same side as the injection. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as the result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain and swelling of lymph node above collarbone on the same side as the injection was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizzy weak feeling, heart rate increased to 138. Came down quickly. Continued to feel weak and shaky for a couple of hours after,  Heart rate was in the 70?s and blood pressure 120/80.
On 1/15 when I woke exp throbbing pain in right hand thumb,index, long finger.) The next day less pain dint have to take any Tylenol.
Patient states that immediately after the vaccine he had chest pain for approximately 15 minutes and then it resolved without any interventions. The next day he reports he had a sore neck. The sore neck lasted approximately 1 week in duration.
5 minutes - severe flushing on face/chest and headache, 45 mins - sneezing, 1 hour - itching, chills, 2 hours to 24 hours - continued headache, chills, high fever (102), body aches, nausea, fatigue, stiff joints, tingling lips and tongue, difficulty swallowing, wheezing, MS symptoms, very high sugar levels (450 - out of normal range), began to subside in severity after 24 hours but was out flat for 4 days before feeling better, occassional bouts of chills and itching as well as ongoing need to sleep continued for over a week, huge raised swollen area appeared at injection site - from shoulder to elbow, very hot - used a cold pack to help reduce swelling. Throughout all of this, used large amounts of Benadryl, Advil, Albuterol, drank lots of fluids, used emergency insulin, and had Epi-Pen on hand.
This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. The patient did not have any medical history or concurrent conditions. On 02-SEP-2015 the patient was vaccinated with M-M-R II (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication and (Oka/Merck) VARIVAX (lot number and expiry date unknown) (dose regiment and frequency unknown) for an unknown indication. It was reported that the patient was not taking any  medications concomitantly. On 28-SEP-2015 the patient reported that she was pregnant (maternal exposure before pregnancy). On an unknown date approximately in 2015 the patient became pregnant. The Last Menstrual Period and Estimated Date of Delivery was not known. There were no lab diagnostics study performed. It was reported that the patient sought medical attention and visited the office (details unspecified). There was no treatment given for the adverse event. The pregnancy outcome was outcome pending. The outcome of maternal exposure before pregnancy was unknown. The action taken with the suspect drug therapy was unknown. There was no product quality complaint reported. Additional information has been requested.
nausea; vomiting; diarrhea; headache; chills; low grade fever; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EK9231), on 15Jan2021 13:30 at SINGLE DOSE in Left arm for COVID-19 immunisation. Facility type vaccine was Doctor's office/urgent care. Medical history included High blood pressure, chronic obstructive pulmonary disease (COPD). Concomitant medication in two weeks included acetylsalicylic acid (ASPIRIN), carbamazepine, lisinopril, metoprolol. The patient experienced Nausea, vomiting, diarrhea, headache, chills, low grade fever, muscle pain on 16Jan2021 19:00. The outcome was recovering. No treatment for AE. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Muscle cramps in legs and numbness in sole of feet. Imbalance, leg weakness. Legs feel warm. Leg paralysis.