chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the Jonson & Johnson COVID vaccine at 11:37am and was waiting in the lobby for the 15-minute observation period. The patient began to feel dizzy, then short of breath. A code was called and the clinic team responded to the patient. Patient appeared to have a seizure lasting ~90 seconds (patient has known history of seizures) and was unresponsive for 30 - 45 seconds. Was moved to the floor from sitting to prevent a fall. Became responsive after lying on the floor ~15 seconds. Was observed to have a rash on her neck that resolved. Reported that her face felt itchy. 911 was called and fire department arrived on scene. FD escalated to paramedic response and patient was ultimately transported to ED for concern of allergic reaction and seizure. Patient departed unit via ambulance at 12:23pm (38 minute code duration).  Vitals: 11:48am: BP 152/95, pulse 112, O2 100% 11:54am: BP 141/84, pulse 80, O2 100% 11:58am: BP 138/85, pulse 79, O2 100% 12:03pm: BP 135/84, pulse 76, O2 96%
results showing no rubella titres; she received 1 dose of the M-M-R II vaccine on unspecified date in 1987 and 1 dose of   M-M-R II on an unspecified date in an unspecified year and she is pregnant; This spontaneous prospective pregnancy report was received from a certified nurse practitioner of unknown age via company representative regarding herself. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unspecified date in 1987, the patient was vaccinated with one dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) of one dosage form (strength, lot number, expiry date, route of administration were unknown) for vaccination(prophylaxis). On an unspecified date in an unspecified year, the patient was vaccinated with another dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) of one dosage form (strength, lot number, expiry date, route of administration were unknown) for vaccination(prophylaxis). An unspecified test was performed on an unspecified date in 2005 or 2006 with the result showing no rubella titres (rubella antibody negative). The patient became pregnant((maternal exposure before pregnancy), the last menstrual period (LMP) was 12-OCT-2018 and estimated date of delivery (EDD) was 19-JUL-2019. The outcome of the pregnancy was pending at the time of report. No treatment was provided for adverse event. It was unknown whether patient sought medical attention. Outcome and causality assessment were not provided by the reporter. No product quality complaint(PQC) was filed.
Patient developed a bruise approximately 2 to 3 inches in diameter at the injection site on the left tricep. Patient also described some mild general pruritis.
This spontaneous report as received from a medical assistant refers to about 20 unspecified patients. On an unknown date, about 20 patients received improperly stored doses of VARIVAX (Merck) (lot #, expiration date, dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Fever FLUSHED, DIZZY, FEVER, CHILLS, FATIGUE Narrative:
red rash-swelling lt leg sat 12OCT;body sensitivity lt side;Sat 12OCT & Monday 14OCT went to MD given cream for leg;no better during week;went to another MD 31OCT;severe cold diff breathing 28OCT;took 10 days to reduce most sx;
Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included STERILE DILUENT lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the STERILE DILUENT used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to an 11 month old male patient. The patient administered the vaccine on 25-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067.
Pharmacy intern accidentally administered an expired vaccine that was drawn up on June 1, 2021. We believe it is Moderna COVID-19 vaccine, but we are not absolutely certain. Father of patient said patient did not have any adverse effects and will return with the patient to be revaccinated with the correct vaccine.
Awoke with "excruciating" pain in right arm. Pain has continued with minimal relief until current time. Now it is difficult to move the arm. Cannot carry a purse or objects heavier than a purse.
Information has been received from a physician concerning a 14 year old female patient with no medical history who on 25-JAN-2012, was vaccinated with a first dose of GARDASIL, (lot number 668261/1397AA), (dose, route not reported) for prevention of HPV. Concomitant therapy included MENACTRA. On 26-JAN-2012, one day after receiving the first shot of GARDASIL, the patient experienced swelling at the injection site and numbness down the left arm and also on the lower left extremity. The patient also had swelling and purpling of the limbs and digits. The patient also was extremely fatigued and had uncontrollable bowel movements. On an unknown date, the patient was taken to the ER (hospital unknown) and was put on steroids and BENADRYL. Therapy with GARDASIL was not discontinued. At the time of the report the patient's outcome was recovering. The patient sought medical attention. Swelling at the injection site and numbness down the left arm and also on the lower left extremity, swelling and purpling of the limbs and digits, extremely fatigued and uncontrollable bowel movements were considered to be disabling. Additional information has been requested.
Itch arms, backs of hands, both sides of race. Rash & vesicles noted 11/24 with weeping.
9am injection, 9pm Arm pain, 3am severe chills, sweats, 4am nausea (almost vomiting) - took 4mg ODT Zofran,  6am 1000mg Tylenol and 8mg methylpednisolone, prolong tachycardia (4 hours, 6:30 am to 11:30am with minimal activity), Thought about going to emergency room but didn't. profound fatigue, moderate bodyaches, moderate headache, malaise, no appetite, brain fog,  11:00 am took aspirin. By 2pm started feeling better. By 9pm (24 hours later) was feeling only body aches and minor headaches until next morning. by 36 hours felt resolved.
whelps, round rings around shot site. some redness. slight soreness in arm shot was given.
Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Seizure-Medium, Systemic: Weakness-Mild, Additional Details: 911 called to evaluate patient. patient was awake and alert at time of departure with ems
Patient presented with swollen, red welt on front of left arm in the bicep region, separate from where the injection was given. Patient stated that the welt was noticed 6-7-18 (vaccine given 6-5-18) and was very swollen, red, and hot to the touch. When presented to pharmacy, she reported the welt and stated that the swelling had gone down since the previous day and it was not as red or hot to the touch. She stated that following the vaccine her arm was sore in general to lift or move and she was more fatigued than usual, which were side effects she was expecting from the vaccine. The welt, however, was very distinctly separated from where the vaccine was administered, but she does not recall any other events that would have caused the welt to occur so wondered if it was related to the vaccine.
Localized reaction-- 2 sites left deltoid region. Site 1- 2 cm x 0.5 cm, Site 2- 9 cm x 2 cm- erythema, warmth, upper arm swelling 1.5 cm greater on left side (non-dominant). Tx- cool compresses, hydrocortisone ointment, NSAIDS
Same night after patient received patient had swelling of whole thigh - generalized, although injection site was not red or swollen but entire thigh was swollen. No fever. Pt. refused to walk.
Mild head ache and lightheaded ness started within a few minutes. Fast heartbeat followed. After my 15 minute wait time before leaving, I told them my experience. They took my blood pressure which was 175 over something. They let me leave when it was down to 144 over something. Within a few  minutes after we left I experienced a severe hot flash, my air cutoff, and I felt weak/faint. I experiencedy airways close, then open again. Nothing like I have experienced before with an asthma attack. This was different. My husband pulled over and I was able to call 911. My heart was racing. The paramedics asked me about the rash on my chest which I new nothing about until he mentioned it. Said my face was flushed? And
Patient admitted with DKA after being found down at home. DKA was treated with insulin drip and IVF per protocol, and resolved. She was transitioned to lantus 55 units bid, and novolog for 1:2 carb coverage + sliding scale with meals and hs. She was treated for a yeast UTI with fluconazole which has resolved. Due to her chronic impaired mobility and weakness after prolonged hospitalization, she is discharged to a HCF for short term rehab with plans to move to assisted living after rehab is completed.  ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
"maybe a sore arm"; "normal things"; Dose administered after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE PAIN ("maybe a sore arm"), VACCINATION COMPLICATION ("normal things") and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903 and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced INJECTION SITE PAIN ("maybe a sore arm") and VACCINATION COMPLICATION ("normal things"). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) had resolved. At the time of the report, INJECTION SITE PAIN ("maybe a sore arm") and VACCINATION COMPLICATION ("normal things") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided by the reporter.  No treatment information was provided.
FEELS LIKE A KNOT DEEP INSIDE THE LEG; SEVERE STOMACH PAIN; LEG ACHY; STOMACH BURNING; UNUSUAL BURPING; STOMACH DISCOMFORT; SEVERE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-APR-2021, the subject experienced headache. On 16-APR-2021, the subject experienced stomach burning. On 16-APR-2021, the subject experienced burping. On 16-APR-2021, the subject experienced stomach discomfort. On an unspecified date, the subject experienced feels like a knot deep inside the leg, severe stomach pain, and leg achy. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, feels like a knot deep inside the leg, severe stomach pain, stomach burning, burping, leg achy, and stomach discomfort. This report was non-serious.
Seen for acute visit on 3/27/06. Pt noted to have indurated approx 3mm and 1 mm around each after 2 vaccine sites on left thigh, slight erythema, macular rash area, no signs of cellulitis.
Headache, bone pain/ache, tiredness, watery eyes, runny nose, lack of smell,  very congested that and I can barely hear. Going on day 3 with these symptoms no fever.
Information has been received from a medical assistant (also the site supervisor) referring to unspecified number of patients of unknown age and gender. On an unknown date in march 2015 or April 2015, the patients were vaccinated with improperly stored VARIVAX (dose number, dose, route and lot# not reported). No symptoms reported. This is one of several cases from the same reporter. Additional information has been requested.
FEVER, BODY ACHES, AND FACIAL SWELLING started at 1200 on 01/06/2021. took 400 mg po motrin and 25 mg po bendaryl. At 4am took and additional 25 mg Benadryl po. and at 1000 took third dose of benadryl po 25 mg. Pt. states that he left eye is watering. Pt. states that she has a little bit of facial swelling still at 1023 am on 1/6/2021.
3/26/2021 (day after) - headache for 24 hours. Took Tylenol 8 days after shot - rash that was on the upper left arm. It was warm to the touch and itched a little. Took Benadryl (didn?t help), Tylenol and applied anti-itch cream.  9 days after shot - experienced joint pain in both wrists and backs of hands. Took Tylenol.
Pt recv vax on 3/2/99; on 3/4/99 pt exp LA pain-shoulder to wrist w/ swelling; dx=radiculopathy
Patient claimed to have a sore arm, redness at injection site, swelling at injection site, and muscle was hard at injection site, and fever at injection site.
Woke up with hives from waste up, shortness of breath, and took test to monitor if issues was going on with heart, bloodwork showed that she was allergic to (PEG) in vaccine
10/23/07 ER visit. 10/24/07 Doctor saw for bilateral arm and leg myalgia. Rx Oxycodone. 10/27/07 Doctor appointment for recheck; myalgia, labs drawn. 10/31 RNG saw for possible vasculitis. Patient told to continue on Prednisone. 11/09/07 RNG saw patient; admitted to hospital; GI bleed. 11/13/4 Doctor saw for GI bleed. Admitted for GI bleed.  12/17/2007 MR received for ER visit of 10/23/2007 with Dx: Myalgias.  Pt presented to ER with c/o cramping in the low back, starting at the buttocks and descending down to the calves. Cramping also noted in the biceps area. (+) fever and chills.  had similar muscle cramping with some past medications. Txd with pain meds and D/Cd.  Pt admitted 11/9-10/2007 with DX:  Acute GI bleed. Pt has been on prednisone recentlyand ASA and Plavix. Presented with melenic stools and coffee ground and fresh blood emesis. C/o lightheadedness and sweats.  Re-admitted 11/13-16/2007 with sx of dizziness with a Hgb of 7.3 following an upper GI bleed with ulcer. Hgb up to 8.2 after 2 units PRBCs. DX:  Acute blood loss anemia.  Possible GI Bleed.  Recent upper GI bleed.  Transfused 3 units during hospitalization with stablization of Hgb.  Known CAD, LAD drug eluting stent.  EGD showing healing ulcer.  Erythematous esophagus. Diverticulosis seen on colonoscopy.  Flat polyps, not biopsied.  Large hiatal hernia on prior EGD.  Free reflux on prior EGD, documented GERD.  Esophagitis. Gastric cardia nodule, biopsy OK.  Duodenal bulb based ulcer.  Protonix BID tx.  Plavix and ASA on hold.  Hypothyroid, on Synthroid, changed from dessicated thyroid recently.  Reaction to Flu vaccine with possible neuropathy, central vs peripheral.  Ongoing feet numbness and tingling fingers 2' to Flu vaccine.  Remote thyroidectomy.  Remote L breast CA.  Remote appendectomy.  Remote knee bone spur removal.  Remote umbilical hernia repair.  Family hx of throat CA and breast CA.  Ex-smoker.  Demerol and Flu shot allergies.
Fussiness; Low grade Fever of 100.8; Yellow sticky gunk coming out of eyes; Runny nose.
severe fatigue, muscle aches, nausea, headache which resolved within 24 hours
stressed from various things; This week I got a cold sore (stressed from various things) , which I get every few years. This time, it was very small, and lasted only a very short time; This is a spontaneous report from a contactable physician (patient) received from a Pfizer-sponsored program, Pfizer.com - General Company Information. A male patient of an unspecified age received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on Feb2021 (at an unspecified age) at 2nd dose, single dose for COVID-19 immunisation. Medical history included cold sores (which the patient gets every few years). The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 received on an unspecified date for COVID-19 immunisation. The patient reported that on Mar2021, the patient got a cold sore, because he was stressed from various things, which the patient gets every few years. However, this time, it was very small and lasted only for a very short time. The patient wonders if the vaccine reduced the severity and duration of the cold sore. The patient stated that it was an interesting coincidence or perhaps a causal relationship. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt c/o  nausea and headache.  Reported very nervous about getting vaccine.  1013 Vital Signs - 139/80; HR 96, Spo2 99.  1018 reported I may be hungry VS - 129/75; HR 86: SPO2 100. 1025 VS 125/75; HR 86, sp02 100 reported HA, Warm, I am so nervous.  At 1030 VS 130/83, HR 97 SPO@ 100 pt reported All I want to do is eat.
Pt recv vax on 9/25/98; on 10/3/98 pt exp macular, red lesions on abdomen &face; yeast diaper rash; tx=Mycolog II to diaper area BID 15 gm.
About 5 hours after my vaccine I had already been asleep for around 30 minutes when I was startled awake by my own rapid heartbeat, it was beating so fast and hard that I could hear it and it woke me up. I reviewed my literature about the vaccine I received at the pharmacy and saw this reaction could be due to an allergic reaction but as an uninsured person I had to just wait it out to see if it would go away. I drank a lot of water and started developing a headache but my heart rate finally slowed down enough that I was no longer alarmed, but it was still faster than usual. I went back to sleep around 2am only to awake once again around 5am because I had begun to experience the worst body aches I?ve ever felt as well as nausea and a pounding headache. I live on a semi truck with no bathroom so my fiancé had to take me to my parents house so I would have access to a bathroom. I took ibuprofen and Tylenol for my pain and took 6 showers in 24 hours just to soothe my body aches. It felt worse than any flu I?ve ever had (I received the flu vaccine back in January if that matters). I was extremely ill and had no appetite and pretty much just slept and cried for about 36 hours total, but yesterday afternoon I finally felt a little better although still experiencing a terrible headache. Today I woke up feeling completely fine. I just wanted to report my side effects.
Severe left leg pain with generalized muscle pain throughout the body along with severe muscle cramps in various locations that came and went. Increased fatigue, increased headaches. This has continued to date to the point of walking with cane due to extreme difficulty in straightening and putting weight on left leg when first getting up from laying or sitting position.
chills; mild fever; This is a spontaneous report received from a contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Chills", "Mild fever"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Chills", "Mild fever". The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "mild fever".  Additional information: Patient reported mild fever and chills for less than 24 hours after bivalent. Symptoms were less than with initial COVID-19 vaccine and previous booster. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain and swelling at injection site; pain and swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain and swelling at injection site) and VACCINATION SITE SWELLING (pain and swelling at injection site) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for an unknown indication.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain and swelling at injection site) and VACCINATION SITE SWELLING (pain and swelling at injection site). On 08-Mar-2021, VACCINATION SITE PAIN (pain and swelling at injection site) and VACCINATION SITE SWELLING (pain and swelling at injection site) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications reported.  This case was linked to MOD-2021-042819 (Patient Link).
toe pain, toe swelling, toe erythema Narrative:  Patient received first Pfizer COVID-19 vaccine dose 1/18/21. On 1/29/21, patient reported bilateral toe redness and swelling at nail bed during routine visit. Was examined via virtual appointment and referred to podiatry. Patient presented for second vaccine 2/8/21 and accepted dose. At 2/12/21 routine visit, patient reported presenting to ED for evaluation due to worsening pain, however cause was not determined (treatment records not available). Reported that symptoms have not resolved (as of 2/12/21) however they did not worsen after administration of second dose.