chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nothing at first (not on Wed 10-13-2021 or Thursday 10-14-2021. But Friday Oct 15, 2021 patient awoke 2:30 A.M. stomach not well. Got "sick" 5 AM and again 8:10 AM and also 8:00 P.M. In between, visited Clinic. Saw nurse abt 1:30 PM, experiencing extreme fatigue, nausea, severe headache...Situation improved but not all better Sat 10-16-2021.  Patient awoke Sunday 10-17-2021 at 2 A.M. with red welts on arms. Slept and woke again 7:30 AM with more red welts. Described as bright red and mildly itchy. Condition lasted through Monday 10'18/2021.  Right foot swollen around ankle. Patient visited Family Practice 11:20 AM Monday 10/18/2021 to discuss symptoms and possible treatment.
PATIENT REPORTED TINGLING/PINS AND NEEDLES SENSATION IN TONGUE AND TIGHTNESS OF THROAT. EMS WAS CALLED AND PATIENT WAS TAKEN IN AMBULANCE BY EMS.
Patient stroke/CVA. Onsite EMS was called vitals 218/96 BG 164 HR 88 99% O2. Patient treated, transported to the hospital.
Pt received Pfizer mRNA COVID vaccine on 21Sept21 and noted that he felt very tired after the vaccine. About 8 hours after receiving the COVID vaccine, he felt like 'he had a rock sitting on his chest that was pressing in and sitting on his chest'. He also started feeling lightheaded and losing feeling in his hands. He called his mom who recommended he go to the ED. At the ED, he had an EKG that was concerning for pericarditis and received ASA in the ED which improved his symptoms. He was monitored in the hospital for about 1.5 days with serial EKG, troponin, and had an echo which was unremarkable for pericaridal effusion; troponin, ESR and CRP reported normal. He was discharged home in stable condition and his symptoms gradually improved over the next week without further medications.
Patient woke up next morning with sore arm at injection site. It started swelling, becoming red and hot throughout the day. She went to urgent care and was diagnosed with cellulitis and given antibiotic cephalexin.
Severe nausea, dizziness, headache, all over weakness, diarrhea, body and joint aches, chest ache, hiccups x  2 hours, post nasal drip, feel fever/chilled.   Had to call out sick from work.
Patient experienced a local reaction of redness, hot, and swelling at the site of injection. When she first reported it on 2/12/14 it was the size of an orange, and very hot but when I called her to see if it resolved she said it swelled almost to her elbow. She states that it was completely resolved after 4 days. She used ice to try to take down the swelling. She had no other side effects it did not itch.
chillls and fever, shaking, got worse by the hour, ribs hurting, throat hurting back hurting, mouth numb, arm hurting
Rash all over stomach and back, very bad on face and neck , sore and beat red
This is an instance of breakthrough COVID-19 disease after which a death occurred. The individual was vaccinated with the Pfizer product on 01/13/2021 and 02/03/2021. The individual became symptomatic for COVID-19 disease on 12/27/2021 and tested COVID-19 positive via antigen test on the same day. I could not find a record of this person being hospitalized, but they died on 01/05/2021. They were a resident in a long term care facility.
Phoned me at 09:37am- c/o "swollen arms, hot" denied breathing problem, denied hives, was working at Census Bureau- Nurse came in and gave flu shots on Tues. 11/12/2002.
Developed hives within 24-48 hours of 2d covid shot. Hives were over entire body (not just limited to arm.) Went to med center and was given shot and continued to take medicine for hives for about 2 weeks; subsequent follow-up with GP because reaction seemed to also lead to stomach issues, diarrhea, nausea for multiple weeks following; lost 12 pounds during nausea time frame.  Overall seems to have significantly improved (months later) but am concerned about another dose.
Within 10 minutes of vaccination, patient developed increasingly blurry vision, hearing loss, a feeling of faintness, cold, clammy skin, and sweating. Patient was asked to lie down on the floor with feet elevated but patient did not want to leave the chair she was sitting in. Patient was feeling increasingly faint and experiencing increasing panic due to her vision and hearing loss. EMTs were called and responded within 20 minutes of the call. Patient vision and hearing were returning by the time EMTs arrived. They checked her blood pressure, heart rate, oxygen saturation,  and blood glucose - all were within normal range. The patient refused transport to the hospital and left with her significant other as her driver after she was feeling normal again.
zoster within 1-2 days after vaccination; This case was reported by a physician via sales rep and described the occurrence of herpes zoster in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced herpes zoster. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the herpes zoster was recovered/resolved.   It was unknown if the reporter considered the herpes zoster to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix and experienced herpes zoster which was resolved. The patient treated with antiviral therapy. A medical history that is significant for herpes zoster other than age-one patient is in the 60s with diabetes. The reporter consented to follow up. No further information wa available. This case was linked with case US2020AMR214291.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR214291:same reporter
swelling at injection site about the size of baseball with redness and very hot and itchy but no rash.  Aches and hard to raise arm to the back or pick up any weight.  Hurts to lay on it.
Started my period the next day-10 days early. I?ve had regular periods for 2 decades and I?ve never had an early period. Extreme bleeding-appeared to be almost double in quantity and horrible cramping-more than I have ever had with a previous period. I?ve had 2 children and minus the time pregnant and breastfeeding each of them I?ve always gotten my period monthly and occasionally it would be a few days late-but never early. I proceeded to have a bad headache that ebbed and flowed for at least 5 out of 7 days of that week. I am now  39 days out from the start of that period and have not had another period yet-which is also strange.
No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 22-month-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 17-JUL-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, unk, lot #W024971, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes.  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
extreme exhaustion, sleepiness, shortness of breath,loss of appetite, dizziness and cognition problems
Patient felt light-headed during period of observation approximately 10 minutes post vaccination.  Temporarily went limp and lost consciousness for 15-20 seconds before regaining consciousness.  Was given supportive care for apparent vasovagal reaction and released from the clinic upon recovery approximately 45 minutes later.  Follow-up phone call was made at 3:30pm that day.  Patient stated they felt "much better" but did take a nap in the afternoon.  Patient also stated that they have a history of passing out following blood draws.
Narrative:  74 y.o. male patient with CAD s/p 3v CABG (2013), HFrEF (26-30%), p.A.Fib. (not on AC 2/2 recent GI bleed), ETOH/HCV cirrhosis complicated by ascites, chronic HCV s/p treatment, DM2, and COPD (not on home O2), and multiple hospitalizations in the past 6 months, most recently 9/07-9/10/21 for AKI 2/2 acute on chronic heart failure. He presented back to the ED 10/06/21 c/o "swelling all over" and soa. rapidly declined, with increasing pressor requirements, altered mental status, increased work of breathing, and increased respiratory congestion. We met with patient's wife and dtr at bedside, and they are in agreement with transition to comfort care only. It appears patient is too unstable to be transported home. If patient is stable enough to transfer, his family is agreeable to transfer to the Hospice IPU after discontinuation of pressor support.. Pt transferred to inpt hospice and died shortly after. Pt had received covid vaccines on 3/30/21 & 4/29/21. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
Broken Hip; fall; Miss the 42 day window to recieve the second dose; Sore Arm; A spontaneous report was received from a Consumer concering her sister, 84-year-old female patient, who received Moderna's COVID-19 and experienced sore arm/pain in extremity, fall, broken hip/hip fracture, miss the 42 day window to receive the second dose/incomplete course of vaccination.  The patients's medical history included parkinson's disease. Concomitant medications reported included warfarin, I-toxin, memantine, L-dopa, carbidopa, Iron tablet, pantoprazole, vitamin D, imipramine.  On 20-Jan-2021, prior to the onset of event, the patient received the first dose of mRNA-1273  (lot number 029K20A) intramuscularly for COVID-19 infection prophylaxis. Following administration of the vaccine the patient experienced a sore arm.  On 17-Feb-2021, She fell in the home and broke her hip. She was hospitalized and that  was a medically significant event. She missed the 42 day window to receive the second dose due to prolonged hospitalization. Treatment was provided for the injury.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events sore arm, fall, hip fracture, miss the 42 day window to receive the second dose was unknown.; Reporter's Comments: This report refers to a case of missed dose for mRNA-1273, lot not applicable. Additionally, it was incidentally reported a not related hospitalization due a fall and a hip fracture and some vaccination site events. Based on reporter's causality, the serious adverse events of fall and hip fracture is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the vaccine site event, a causal relationship cannot be excluded.
Patient woke up with difficulty breathing after 1st dose. Difficulty swallowing after 2nd pill. Went to ER. Patient has many allergies.
it felt like a bee sting with the stinger left in; with a little bit of swelling; skin feels "rough" to the touch; sore arm; Headache; arm felt itchy; felt like a bee sting with the stinger left in in and a rash; 4 inches below the injection site there was redness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm), PRURITUS (arm felt itchy), PAIN (it felt like a bee sting with the stinger left in), SWELLING (with a little bit of swelling) and DRY SKIN (skin feels "rough" to the touch) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PRURITUS (arm felt itchy), RASH (felt like a bee sting with the stinger left in in and a rash) and INJECTION SITE ERYTHEMA (4 inches below the injection site there was redness). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (it felt like a bee sting with the stinger left in), SWELLING (with a little bit of swelling), DRY SKIN (skin feels "rough" to the touch) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (arm felt itchy), PAIN (it felt like a bee sting with the stinger left in), SWELLING (with a little bit of swelling), RASH (felt like a bee sting with the stinger left in in and a rash) and HEADACHE (Headache) outcome was unknown and INJECTION SITE ERYTHEMA (4 inches below the injection site there was redness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   This case was linked to MOD-2021-117738, MOD-2021-117738.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Details of 1st and 2nd dose AEs
After receiving the vaccine her head was feeling heavy, a little tingling in pinky.  After laying down when she got up her body felt like it was on fire, that went on for about a week. Couldn't drink orange juice. She had a rapid heart rate, she took ibuprofen which helped for a couple of hours also took some Benadryl. Also had heartburn and felt nausea.
Information has been received from a physician, via a company representative, concerning a 36 month old patient (gender unknown) who on an unspecified date was previously vaccinated (route unknown) with a dose of Varivax (lot # unknown). Subsequently, on an unspecified date, the patient experienced mild case of breakthrough chicken pox after previously being vaccinated. The patient had developed approximately 5 lesions. The patient  had recovered. Unspecified medical attention was sought. No product quality complaint was involved. No additional information is expected.
Fever BODY ACHES Narrative: employee states temp of 104 for 2 days with severe body aches
Large swollen gland on left  side of neck.  Sore gland.in left armpit area.
Severe diarrhea; This is a spontaneous report from a contactable consumer reported for a female patient (wife) that:  A female patient of unspecified age received bnt162b2 (PFIZER BIONTECH COVID 19 Vaccine, Solution for injection, Batch/Lot no and expiration date not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated after first dose of vaccine she experienced like 3 days of severe diarrhea. At the time of reporting, the outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Delayed anaphylaxis. Treated with diphenhydramine and albuterol at 90 minutes post vaccination, epinephrine at 125 minutes post vaccination. Patient release from ER after 4.5 hours, discharged home.
I woke up the morning of December 5th, I had sinus drainage, on Tuesday I developed a fever (99.5) and then other times when I had a sinus infection it lasted 3 days, but on Wednesday fever went to 100.5. I had a home COVID-19 test, and it was positive. I went to Urgent Care facility, and I had another test, and it was also Positive, they recommended prescription, on Wednesday I started taking Paxlovid.
I have painful hives at injection site with a hard lump larger than two quarters under my skin at injection site. I will follow up with my pcp.
Patient presented to the Medical Clinic on 8/18/06 with c/o 3-4 day history of chest/back/neck pain, dry cough, tenderness under L axilla, fever on and off which he had been treating with Motrin. Smallpox vaccination site noted with redness, whitish lesion @ 1cm diameter surrounded by 5cm erythema. Diagnosed as reaction to smallpox vaccination. Orders received for Robitussin DM 1 tsp QID prn, Motrin 400mg po QID prn, rest, fluids and quarters times 24 hours.
Initially fever, bodyaches, sore throat and dizziness but now w/ persistent dizziness, nausea and mild hypoxia - 90 to 95%.  Mild SOB and cough.
requested medical records, but never received them; pt had a positive COVID TEST on 9/4/21; per death certificate pt died in the hosp ER/outpatient with the causes of death being Acute Hypoxic Respiratory Failure and COVID Pneumonia
Dose 2: headache, drowsy/tired, foggy head, body chills, sore arm Dose 1: sore arm
immunocompromised patient was given .25ml for third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient was given .25ml for third dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 31-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient was given .25ml for third dose). On 31-Aug-2021, ACCIDENTAL UNDERDOSE (immunocompromised patient was given .25ml for third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Follow up was received and contains no new information.
After receiving vaccines client stood up so sister could receive hers. Client was instructed to sit down in the other chair, but before he sat down he fainted and landed on his right side. He regained consciousness right away. Client was place on cot with leg elevated and juice given. Upon examination he had bit his right upper lip, his right side of his head and his nose. Client had slight amount of blood coming from right nare. Ice pack placed behind client's neck and on client's nose. Juice was given. Client stated his nose was hurting and he thought it was broken. After 20 minutes on the client resting in supine position he sat up and stated his head hurt. Client's mother was instructed to bring client to the Urgent Care once they left to be evaluated. At 14:45 client stated he felt ok to leave. He slowly stood up and the nurse and his mother walked him to the car.
Adverse event: Vaccine administered 16 days after beyond use date, less effective. Treatment: Pt will return to our office to get additional vaccine, as recommended by Pfizer.
The next day I had very limited energy/felt like a shell of myself. Day 3 I woke up with extreme sinus cavity pain on my left side and a stye in my eye which progressed to get very severe to the point of on day 4 the top part of my face swelling and being hot.  I called HCP and did a virtual visit and was placed on an antibiotic and eye ointment for 7 days.  At the end of the antibiotic being completely taken the stye was completely gone but there was a still an aching in the sinus cavity.  A week later it became severe again and my left eye started swelling underneath so I had another tele appointment with HCP and was given a 10 day antibiotic - Augmentin and antibiotic eye drops
Starting about 25 minutes after the injection I had Minor tongue and throat swelling ,severe headache, pain at injection site with stiff muscles and a lump following about 8 hours after injection.
CARPEL TUNNEL DIAGNOSIS; WEIGHT LOSS; TINGLING SENSATION IN RIGHT ARM/HAND; POSITIVE COVID TEST 3 WEEKS AFTER; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included: cardiac event, stents, vertigo, and stenosis back surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. Concomitant medications included naproxen for tingling pain. On JUL-2021, the patient experienced positive covid test 3 weeks after. Laboratory data included: COVID-19 virus test (NR: not provided) positive. On an unspecified date, the patient experienced carpel tunnel diagnosis, weight loss, and tingling sensation in right arm/hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling sensation in right arm/hand, carpel tunnel diagnosis, weight loss and positive covid test 3 weeks after was not reported. This report was non-serious. This report was associated with a product quality complaint 90000207743. This case, involving the same patient is linked to 20211240483(dose number in series was 2).; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Patient was given expired vaccine per BUD by 1 hour and 57 minutes. Contacted Pfizer and Pfizer's extended data stability allows for extra day (32 days) for BUD, so vaccine has no excursion and is ok.
Patient c/o tingling lips and throat irritation after receiving 2nd dose. Patient was taken to exam room for assessment and vital signs were taken.  Patient was then evaluated by provider FNP and Benadryl 25mg IM was ordered and administered.  Vitals taken again and patient was observed another 30 minutes and then released.
Mild rash and injection site (red and hard). Has not had any medication but plan to monitor site. Notified to seek help in ER if signs of anaphylactic reaction occurs.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 22 years old female patient who on 26-JUL-2012 was vaccinated with a dose of GARDASIL (dose and route not provided) (lot #670048/0963AA, expiration date on 09-APR-2013). Concomitant therapy included HAVRIX (lot # AHAVB532, expiration on 03-FEB-2014). It was reported that on 26-JUL-2012 after vaccination "later", the patient called the office and mentioned she was 3 months pregnant. Her LMP was on 08-APR-2012 and her EDD was on 13-JAN-2013. The patient sought medical attention, she contacted the nurse. Follow-up information was received from a registered nurse concerning a 22 year old female patient. It was reported that the patient had no adverse reactions at all to the vaccination. It was confirmed that the baby was born healthy and is normal with no congenital anomalies. Mom and baby are fine. Additional information is not expected.
COVID 19 VACCINE unknown manufacture none listed on vaccination card. Shortness of breath noted the next morning and fatigue noted the next morning after receiving vaccine.  They have not gotten worse but are not getting better
Approximately  17 hours after injection, left arm , at injection site, became flaming red, hot, hard and itchy . Three days later it is slightly better. Started Benadryl yesterday. Rubbing with 1% hydrocortisone.
Tired, body aches, headache, ear pain,  fever (highest 103.4), chills, hives and fast heart rate. Symptoms lasted six days.
Redness to injection site beginning the date of vacination which grew to the size of a 4" circle.  Intense pain in the left shoulder, neck, upper arm and left elbow.