chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 15:00 as dose 1, single (Lot number: HG4627) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Had a-fib." (unspecified if ongoing); "ablation" (unspecified if ongoing); "dust" (unspecified if ongoing); "grasses" (unspecified if ongoing); "Allergies to common media" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Carbocaine for dental, reaction(s): "known allergies: Carbocaine"; Carrageenan, reaction(s): "known allergies: carrageenan". Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE, Batch/Lot No: G6742, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 19May2023, when the patient was 75-year-old, for COVID-19 immunization; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: GH9694, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 20Sep2022, when the patient was 75-year-old, for COVID-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FK9893, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 25Apr2022, when the patient was 74-year-old, for COVID-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FF8839, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 25Sep2021, when the patient was 74-year-old, for COVID-19 immunization; bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 03Mar2021, when the patient was 73-year-old, for COVID-19 immunization; bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL8982, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 10Feb2021, when the patient was 73-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure.
Patient immediately experienced pain at the site of injection, after her second dose of Pfizer COVID-19 vaccine, given 21-days after first dose.  Site of injection was very high, close to shoulder.  Arm was initially bruised.  Arm on 5-5-21 (at doctor office visit) is not as weak as it was the first couple of day.  Still sore to lift her arm.  Ache in quality. Patient diagnosed with bursitis from inappropriate injection technique, given too high on arm.  Patient prescribed etodolac 400 mg twice day for pain and inflammation.
Intense, uncontrollable shaking of entire upper body, chattering of teeth, for about one hour.  Body aches & pains intermittently; subsided within 12-24 hours.  Did not seek treatment. Significant fatigue following day, fine after about 36 hours after vaccination. Did not seek treatment.
Arm swelling, itching, redness and pain.  Swollen and tender lymph nodes in armpit areas on side of injection. General malaise.
injection site got bigger; redder; more sore; soreness; mild coldness; Headache; very low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (mild coldness), HEADACHE (Headache), PYREXIA (very low grade fever), VACCINATION SITE SWELLING (injection site got bigger) and VACCINATION SITE ERYTHEMA (redder) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FEELING COLD (mild coldness), HEADACHE (Headache), PYREXIA (very low grade fever) and PAIN (soreness). On 19-Mar-2021, the patient experienced VACCINATION SITE SWELLING (injection site got bigger), VACCINATION SITE ERYTHEMA (redder) and VACCINATION SITE PAIN (more sore). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, FEELING COLD (mild coldness), HEADACHE (Headache), PYREXIA (very low grade fever) and PAIN (soreness) had resolved and VACCINATION SITE SWELLING (injection site got bigger), VACCINATION SITE ERYTHEMA (redder) and VACCINATION SITE PAIN (more sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported..
Site of injection became very warm, swollen and erythematous. The central area was 27 mm in diameter. The erythematous area that extended outward measured 60 mm across and 75 mm vertically. Hydrocortisone cream was applied, followed by an ice pack.
Pt took Flu shot at local drug store - 45 min to 1 hour later - had sudden onset of chills, weakness and jerking - (patient waited in store for required 20 minutes).
Symptoms started within a couple of hours - the radius of the rash on the injection site was a lot larger than the first vaccine. It was about 4 inches. Red and warm to the touch. No itching; no raised skin. Just a lot bigger than what I had after the first vaccine. It lasted three of four days and it went away.
p/vax pt devel lt arm redness & low grade fever, rt arm had bruised oblong area, had tingling down rt arm but consciously aware of tingling from rt elbow to hand since 6/7/99.
Felt dizzy and exhausted first day, very weak.  Napped for 2 1/2 hours.  Still weak second day, still very dizzy felt like i was going to fall, had to stop walking and lower my head to gain balance back.
Moderna COVID-19 Vaccine. Approximately 12 hours after the vaccine, I ran a temperature of over 101 degrees which lasted 36 hours. Also, fatigue, chills, muscle aches and a severe headache.
About an hour after receiving the vaccine my throat became itchy and my soft palate had minor swelling with bumps; About an hour after receiving the vaccine my throat became itchy and my soft palate had minor swelling with bumps; About an hour after receiving the vaccine my throat became itchy and my soft palate had minor swelling with bumps; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on the right arm 21Dec2020 08:00 at SINGLE DOSE for COVID-19 immunization at the hospital.  It was reported that the patient had allergies with algae in lakes and had reaction (throat became itchy and soft palate had minor swelling with bumps).  Concomitant medication included melatonin (MELATONIN). Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. On 21Dec2020 09:00 (about an hour after receiving the vaccine), the patient throat became itchy and her soft palate had minor swelling with bumps. The patient mentioned that algae in lakes gives me a similar reaction. The patient did not receive any treatment for the events. The patient recovered from the events on an unknown date.
I developed pericarditis, was sent to the hospital where they treated me with the use of anti-inflammatory medication.
up to 30cm across elbow progressive rxn to whole lt arm p/vax;pt seen @ ER 2 days post shot;pt noted erythema & swelling on 15OCT grew bigger in size & progressed down to elbow;area hot, red, swollen, itchy;
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with M-M-R II, route and dose were unknown. No co-suspect drugs or concomitant medications were reported. The reporter stated that 7 vials of expired sterile diluent were used by his facility recently to reconstitute M-M-R II. No adverse experiences have been reported, and he stated that due to the fact that only the lot number and expiration date are recorded for the M-M-R II vial on the patients' records, he does not know which of the patients recently vaccinated received the expired sterile diluent. Additional information has been requested.
My daughter had a reaction after all these shots given at her 12 months. She had a high fever after 103. Then severely broke out in red bumps all over body and began vomiting. She was diagnosed with Henoch-Schonlein Purpura once taken to her Pediatrician and got blood work.
First and second day (1/21/2021 and 1/22/2021)  after receiving vaccine: sore arm, slight fatigue. Fourth day (1/25/2021), extreme vertigo, nausea, vomiting, weakness, unable to stand. Husband called primary care physician who said I should go to ER immediately. Blood pressure elevated. Fluids administered. Chest X-ray, CT head. Morning of 1/26/2021,MRI brain w/o contrast. Later same day: MRA head, MRA head IAC w/ and w/o contrast. MRI IAC, MRV w/o contrast. Ultrasound carotid duplex bilateral. Diagnosed with Right Vestibular Schwannoma, benign, measures approximately 1.5 x 0.9 x 1 cm. Remained hospitalized until 1/27/2021 about 7:00pm. Follow-up with physician. primary care physician; (Otologist and Neurotologist,) and (Clinical Audiologist) at. Follow-up treatments will include consultations with above physicians, additional MRIs and CTs, and possible targeted radiation or surgery.
stomach cramp; pain in arm; fever; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13th May 2019, the patient received Shingles vaccine. On 14th May 2019, 1 days after receiving Shingles vaccine, the patient experienced stomach cramps. In May 2019, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm, fever and stomach cramps were unknown.   It was unknown if the reporter considered the pain in arm, fever and stomach cramps to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that after receiving Shingles vaccine, arm was sore and had a fever. On the date of reporting, the patient stated having severe stomach cramps. The patient asked whether the events occurred are normal or not.
Large welt half dollar size, redness,  painful swelling itching. 1 week after shot. Chills, twitching, tickle sensation in legs hours after shot, followed by headache shoulder and neck pain. Lethargy for two days after.
9 days p/recvd vax pt had t101-103 & mom states pt had a sz (eyes rolled back) & stopped breathing (no pulse-whole body turned blue-mom) did CPR called ambulance;
Notified by mother that one hour after child received vaccines, she developed allergic attack on skin. Red, irritated questioned Hep B vaccine. Only new vaccine to child has treatment available. Instructed to contact her MD regarding continuation of vaccine series.
Patient reported to pharmacy redness, swelling, and pain on upper left arm around 3pm. She said it began when she woke up in morning and was progressively getting worse and expanding in area. She went to a walk-in clinic to have it seen by a doctor. The doctor prescribed an antibiotic, cephalexin at 4:30pm.
COVID 1 vaccine on 1/20/21 then 14 days later Shingles 2 shot 2/3/21 (102.2 fever) and then 14 days later COVID 2 vaccine (102 fever).  Started seeing behavior shift week of 2/21/21- 3/4/21.  Three different business associates reported patient acting out of the ordinary.  3/5/21 started hallucinating.   Been in hospital 4 times between 3/6/21- present.  Been in hospital continuously since 3/27/21.  Has been tested for everything and only main abnormality is that CSF barrier shows signs of injury and CSF protein was elevated (3/7 - 60, 3/15- 68, 3/27 - 73, then back to normal 4/1/21 - 42).  Started treatment for autoimmune encephalitis on 4/2/21 and did 5 days of steroid drip.  Did not improve with that treatment so doctors decided not to do plasma exchange at this point.  Neurologist now indicating that psychiatrist will treat for psychotic symptoms.  Healthy 71 year old male, no medications, no history of mental illness, no existing health conditions, no history of depression or anxiety, worked out 3 times a week with personal trainer, very involved in community, sharp mind.   Complete personality change directly after vaccines.
pt recv vax 24MAY95 & broke out w/chicken pox on 26MAY95; ran fever on PM of 6JUN95 & all day on 7JUN95 had sz on evening of 7JUN95 taken to ER:
p/recv vax the pruritic sensation exp p/the 1st dose exacerbated; 13hr p/the vax last dose; has devel bilat tinnitus; unk recovery at present;
Patient received a 1st dose of Pfizer BV instead of Pfizer MV.
Prolonged arrhythmia episodes starting after 1st dose; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left in Feb2021 12:00 (Batch/Lot Number: EL3247) (at the age of 67-years-old) as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Medical history included thyroiditis, non-specified atopic dermatitis and allergies: fragrances used in cosmetics/cleaning products. There were no concomitant medications. The patient previously took melaleuca alternifolia oil (TEA TREE OIL) and experienced allergies: tea tree oil. The patient experienced prolonged arrhythmia episodes starting after first dose on 12Mar2021. It was unknown if this will be permanent. The patient considered the report as serious. Did not results in death, not medically significant, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, no intervention required and no congenital anomaly/birth defect. There was no treatment for the event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Body chills. Joint's ached. Fatigue. All mild.  Lasted just the Friday after. No symptoms on Saturday. Just rested all day. and hydrated.
The patient stated that she was in extreme pain for 5 days post COVID-19 vaccination and then achy for several days after that.
Patient received their vaccine and sat in a chair, within approx. two minutes the patient told another patient they felt hot, I was already walking to the patient to check on them,. The patient's eyes were glazed, Almost immediately the patients eyes rolled back in his head. I shook his arm and shouted to him , he was unresponsive with agonal breaths.. I shouted for help from the other nurses. RNs came immediately. We moved him to the floor, called for an epinephrine injection to be prepared, I began to prepare the site for epinephrine injection to his thigh, nurse checked for pulse... at this time the patient was still unresponsive with agonal breaths... no pulse was felt so compressions were commenced by RN. Nurse gave approx. 15 compressions to the patients chest ,  the patient spontaneously  began to recover. Carotid and radial pulses were felt at this time. Breathing returned to normal. While this was occurring, we called a code blue and 911 was activated. By the time 911 responded the patient was fully conscious , alert and responsive. He could tell us his name and how he felt prior to this incident. The patient was transferred via a  stretcher by EMS 911 and RN accompanied him to the ER to give a report. The timeframe for being pulseless and having agonal breaths lasted no more than 30-40 seconds. Patient denied any history of a seizure disorder. No  epinephrine or IM Benadryl were administered at the incident site by the responding staff due to the spontaneous recovery.
The patient had bilateral lower leg swelling and pain after getting the J&J vaccine on 9/23/21. The patient still has residual left foot nonpitting edema currently. The patient also had a rash with bumps all over her body and abdominal discomfort but that resolved now. The patient has been having a headache ever since the shot. She went to the ER for symptoms on 9/28/21.
Tdap given in (R) deltoid IM, five minutes after administering vaccine, area noted to have red rash, small amount swelling. No pain noted. Drs. was notified, BENADRYL 25 mg P.O. given. Temp 98.5 (Tympanic, Pulse 85, Resp 20). Child left office with father without further complaints.
Very sore swollen and red arm-left for four days. Fever and warmth at the site. Missed school.
Swollen lymph node; Just above my right clavicle was swollen; Sweats; Headache; A low grade temp; Chills; Muscle pains; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (Just above my right clavicle was swollen), HYPERHIDROSIS (Sweats), LYMPHADENOPATHY (Swollen lymph node), HEADACHE (Headache) and PYREXIA (A low grade temp) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced HYPERHIDROSIS (Sweats), HEADACHE (Headache), PYREXIA (A low grade temp), CHILLS (Chills) and MYALGIA (Muscle pains). On 18-Feb-2021, the patient experienced SWELLING (Just above my right clavicle was swollen) and LYMPHADENOPATHY (Swollen lymph node). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, SWELLING (Just above my right clavicle was swollen), HYPERHIDROSIS (Sweats), LYMPHADENOPATHY (Swollen lymph node), HEADACHE (Headache), PYREXIA (A low grade temp), CHILLS (Chills) and MYALGIA (Muscle pains) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-016832 (Patient Link).
Two things happened at same time: Gout (never had before); A bad ear infection - that was treated with one kind of antibiotic drop and then it was flushed out and then a different drop with an oral Augmentin - which resolved it pretty much in a week. Not treatment for Gout except Ibuprofen.
PAIN AND KNOT AT VACCINATION SITE BECOMING INCREASING INTENSITY  UP TO SHOULDER AND DOWN ARM. THIS PAIN IS INTERMITENT AND OCCURS WITHOUT WARNING MOSTLY DURING SLEEPING HOURS. IT IS AN INTENSE PAIN WHICH AWAKENS PATIENT FROM DEEP SLEEP ANDVCAN LAST SEVERAL HOURS. PATIENT STATES IT IS THE WORST PAIN HE HAS EVER HAS HAD AND  CONTINUES TO PRESENT DATE.  THIS WAS REPORTED TO NURSE WHO GAVE VACCINATION AND TO DR. SEVERAL TIMES FOLLOWING INJECTION  AND DR DID NOT THINK VACCINE WAS RESPONSIBLE UNTIL LAST REPORTED ON 4/29/2019 AT WHICH TIME HE CONCURRED WITH FILING THIS REPORT.
Covid arm   Itchy, rash, a little swollen and warm   Almost a cramping like pain in thigh muscle and bicep, which came and went for three days
Every menstrual period has been abnormally heavy since taking the 3rd dose. I'm on birth control, so I rarely used to get periods. But I had two periods in the month of February 2022 and this has never happened before. I will be seeing my doctor soon this month in March 2022.
fever; headache; coughing up more phlegm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 18Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "sinus issues" (unspecified if ongoing), notes: she also has a history of sinus issues; "cough" (ongoing), notes: still had a cough with some phlegm yesterday when she took the shot; "phlegm" (ongoing), notes: still had a cough with some phlegm yesterday when she took the shot; "COVID", start date: 23Sep2021, stop date: 2021, notes: she tested positive for COVID on 23Sep2021 and that it lasted for about 14 to 15 days. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 19Oct2021, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 19Oct2021, outcome "unknown", described as "headache"; PRODUCTIVE COUGH (non-serious) with onset 19Oct2021, outcome "unknown", described as "coughing up more phlegm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: she tested positive for COVID on 23Sep2021. She mentioned that it lingered longer like a week later. She mentioned that it lasted for about 14 to 15 days, She mentioned that she still had a cough with some phlegm yesterday when she took the shot. She was advised by her boss to get even though of her condition and she mentioned that it was approved by the primary care, She mentioned that today, she is having a fever, a headache, and is coughing up more phlegm. She mentioned that she also has a history of sinus issues. She is asking if this is normal and for what to do. Response: Mentioned to caller that the general recommendations from the CDC is that people who had COVID can still safely receive the vaccine but would have to wait out isolation and recovered before getting it. Mentioned to caller that the fever and headaches are common side effects of the vaccine. Mentioned to caller that having a cough is not contraindicated with the vaccine but should be mentioned to the HCP before getting the vaccine as a general precaution.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administration of improperly stored vaccines to unknown patients after the temperature excursion; No adverse event; This spontaneous report was received from an office manager referring to a patient of unspecified age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 20-JAN-2022, temperature excursion occurred. On an unspecified date in 2022 (reported as after temperature excursion), the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, (strength, dose, frequency, and route of administration were not provided); which lot # U020244 has been verified to be a valid lot number with expiration date: 28-JUN-2023, administered as prophylaxis. The temperature excursion occurred at a temperature of -14 degrees Celsius for 7 hours (product storage error). No previous temperature excursion was reported. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA004997: US-009507513-2205USA005067:02167789 US-009507513-2205USA005130: US-009507513-2205USA004990: US-009507513-2205USA005126: US-009507513-2205USA005023: US-009507513-2205USA005071: US-009507513-2205USA005229: US-009507513-2205USA005002: