chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From office visit note dated 2/14/23: still struggling with arthritis and fatigue.  This started after her last COVID booster and she still having a lot of stiffness in her hands and her right shoulder along with significant fatigue.  All of this is keeping her from achieving her previous level of function
tiredness; muscle ache at injection site with penny sized welt at injection site; muscle ache at injection site with penny sized welt at injection site; This is a spontaneous report from a contactable nurse (patient) via Pfizer sales representative. A female patient of unspecified age (reported as Age: 32; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not available), via an unspecified route of administration on 28Dec2020 at 12:30 PM at single dose for COVID-19 immunization. The patient medical history included had COVID 34 days before in 2020. The patient's concomitant medications were not reported. Currently patient was experiencing tiredness, muscle ache at injection site with penny sized welt at injection site in Dec2020. Event took place after use of product. The outcome of the events was unknown.  Information on the Lot/Batch has been requested.
Father lied about the patient's dob to get vaccine before ACIP approval.  No adverse events after injection
Pain in my arm; Pain in chest; Pain in back; Redness where I got the shot; Swollen; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in my arm), CHEST PAIN (Pain in chest), BACK PAIN (Pain in back), VACCINATION SITE ERYTHEMA (Redness where I got the shot) and VACCINATION SITE SWELLING (Swollen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included PREDNISONE, LEVOTHYROXINE SODIUM (LEVOXYL), FLUDROCORTISONE, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), MULTIVITAMIN [VITAMINS NOS], UBIDECARENONE, VITAMIN E NOS (COQ10 COMPLEX) and VITAMIN E NOS (VITAMIN E [VITAMIN E NOS]) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in my arm), CHEST PAIN (Pain in chest), BACK PAIN (Pain in back), VACCINATION SITE ERYTHEMA (Redness where I got the shot), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Soreness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain in my arm), CHEST PAIN (Pain in chest), BACK PAIN (Pain in back) and VACCINATION SITE SWELLING (Swollen) outcome was unknown, VACCINATION SITE ERYTHEMA (Redness where I got the shot) was resolving and VACCINATION SITE PAIN (Soreness) had not resolved.            The patient reported that the injection site started becoming red and swollen. She had been experiencing pain in her arm, chest, and back since then. She also said that the injection site was not as red anymore but she did have soreness there.  Action taken with mRNA-1273 in response to events was not applicable.
Developed a red rash a week later-looks a bit like psoriasis.  Started in my groin, now on both thighs, upper arms and left forearm
Patient reported to RN  a first dose reaction to Moderna COVID vaccine (LOT# 042L20A, exp. 07/05/2021) on 01/23/2021. Patient reported she did not receive a second dose of Moderna COVID vaccine. RN assessed patient. Patient reported "subtle" throat swelling approximately one hour after vaccination. Patient reported symptom lasted for 3 days and took benadryl for 3 days. Patient denied itchiness, rashes, and difficulty breathing. Patient reported history of environmental allergies, no chronic conditions, and no current medications. Patient followed up with PCP, and PCP recommended for patient to receive Janssen due to first dose Moderna COVID vaccine reaction. At 1257, RN elevated to Clinical Supervisors. Clinical Supervisors elevated to medical consult team. Medical consult team approved patient to receive Janssen.  RN advised patient to wait for 30 minutes in observation and educated patient on signs/symptoms of when to alert observation staff. At 1506, patient received a single dose of Janssen COVID vaccine (LOT# 1855191, exp. 04/11/2022) in the left arm. At approximately 1521, RN assessed patient. Patient denied throat swelling, itchiness, rashes, and difficulty breathing. At approximately 1537, RN reassessed patient. Patient denied throat swelling, itchiness, rashes, and difficulty breathing.  RN educated patient on signs/symptoms of when to seek emergency care, to follow up with PCP, and to sign up on V-safe.
soreness in his arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (soreness in his arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 032L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-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 experienced VACCINATION SITE PAIN (soreness in his arm). At the time of the report, VACCINATION SITE PAIN (soreness in his arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Antibody test: 83.9 (Low) S antibody count dropped to 83.9.. In December 2021, Blood test: not reported Results were not reported. On 18-Dec-2021, Antibody test: not reported Anti SARS CoV N and S tests Results were not reported.. On an unknown date, Antibody test: 110 (Low) S test showing a count of 110.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has stated that not sure whether was possible that the booster created absolutely no S antibodies and failed to trigger an immune response in the patient. No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-417990 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2021: Added reporter occupation as other health professional, Lab tests, event outcome as recovered.
Pain at injection site radiating to neck; Pain at injection site radiating to neck; This is a spontaneous case, reported by a pharmacist to Company (reference number: SEQ19-03673) on 01-Oct-2019, concerning a 41-year-old, female patient.  The patient's medical history and concomitant medications were not provided.  On 19-Sep-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular (IM), anatomical location: deltoid, batch number: P100100576 and expiration date:31-May-2020] for influenza prophylaxis.  On an unknown date in Sep-2019, after vaccination, the patient experienced pain at injection site radiating to neck. Two weeks after vaccine administration, the patient complained of shoulder pain that started one week prior vaccination. The corrective treatment for the events was not provided.  At the time of this report, the outcome of the events was not resolved.  The reporter assessed this case as non-serious and did not provide causality assessment to Afluria Quadrivalent .  Company comment: The patient developed vaccination site pain and pain (reported as radiating to neck) associated with the suspect product, Afluria Quadrivalent. Chronology is plausible. More information regarding medical history and concomitant drugs is needed. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: The patient developed vaccination site pain and pain (reported as radiating to neck) associated with the suspect product, Afluria Quadrivalent. Chronology is plausible. More information regarding medical history and concomitant drugs is needed. Causal role of the suspect vaccine is assessed as possibly related.
I can't see, I have like a blind spot; Ocular Migraine on both sides; little bit of chest pain; Having trouble of pain; affecting my vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ocular migraine on both sides" (unspecified if ongoing), notes: I only have this once before when I had anesthesia long time ago (history). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization, reaction(s): "intermittent chest pain". The following information was reported: BLINDNESS (medically significant) with onset 20Nov2021, outcome "unknown", described as "I can't see, I have like a blind spot"; MIGRAINE (non-serious) with onset 20Nov2021, outcome "unknown", described as "Ocular Migraine on both sides"; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Having trouble of pain; affecting my vision"; CHEST PAIN (non-serious) with onset 20Nov2021, outcome "unknown", described as "little bit of chest pain". The reporter seriousness for the events was reported as unspecified. Stated that, the patient was having trouble of pain, had the Covid Vaccine the 2nd one last night (on 19Nov2021) and today was having ocular migraine on both sides, it happened twice so far today, it was affecting the vision and only had this once before when the patient had anesthesia long time ago (history). Stated that, the patient had a kind of intermittent chest pain with the first (dose) but it went away and the patient was wondered whether this was the side effect of this vaccine or should the patient be worried about this. Stated that, second shot the patient mean that had a little bit of chest pain today but it was kind of it came on and run away really suddenly and then the ocular migraine started about half an hour later, the first one lasted for about 30 minutes. Stated that, when probed for vaccine LOT#, the patient was not going to be able to seeing it and the patient couldn't see through that. Stated that, the patient had like a blind spot because of the (incomplete sentence). The patient was informed about Pfizer Medical Information Department. The response included was enquired that, did the patient needed to call somebody else. Stated that, could the patient try primary care either as the patient didn't know where was to call and didn't want to spend 1000 of dollars, they were not there they said, they were there or not. Stated that, if the patient was having some kind of blood clot or some kind of stroke, the patient didn't know whether the patient should be concerned or not. Stated that, the patient didn't know whatever the patient need to do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After almost a week after the shot patient got a big rash on the arm where she got the shot. She two shots in 1 arm only. It was not painful she said but it's a big rash. I advised her to go see her doctor but she wanted to apply Calamine lotion which I said she can try. Told her to update me if anything changes or if she went to the doctor.
Multiple episodes of syncope resulting in facial, head, back, rib injuries/lacerations. Required transport to ER by ambulance and kept overnight for observation.
his first case of tennis elbow in his right elbow; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 71-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 02Mar2021 (Age at vaccination 71-years-old), as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient has been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 09Feb2021, 08:15 AM (Age at vaccination 71-years-old) as dose 1, single for COVID-19 immunization and had first bout of gout in his left ankle. On an unspecified day of Mar2021, one week after shot patient experienced his first case of tennis elbow in his right elbow. On an unspecified day of Jun2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative, Nasal Swab. The clinical outcome of the event was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, one intramuscular dose, for prophylaxis (with either lot # N014464, expiry date: 31-JAN-2020; lot# N020352, expiry date: 10-APR-2020; or N014464, expiry date: 19-DEC-2019). The vaccines underwent a temperature of 47 Fahrenheit degrees (°F) to 77°F (50.7°F), by a time frame of 1 hour 30 minutes, with no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA001401: US-009507513-1801USA008097:
Headache; Fatigue; Soreness in left arm where she received the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Lot number: EP7533) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Headache" (unspecified if ongoing). Concomitant medication(s) included: ALEVE taken for headache. The following information was reported: HEADACHE (non-serious) with onset 05Apr2021, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 05Apr2021, outcome "not recovered", described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 05Apr2021, outcome "recovering", described as "Soreness in left arm where she received the vaccine".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021556052 similar report from same reporter
Adverse Effects Tues 4/6: About mid afternoon felt deep chills and body aches, both of which lasted until the next morning. About 4pm, felt an  uncontrollable need to sleep; felt like someone conked me over the head and I was out like a light. Wed 4/7:  Awakened still chilled and achy, but that eased by early afternoon. Fatigue continued; felt like I was moving through mud and fog. Thu 4/8: Felt better, but very slow, sluggish, a bit headachy. Mid-afternoon, I had trouble staying awake. I napped a bit. By bedtime, everything was gone; felt normal.   Treatment I just wore warm clothes, covered myself in a blanket, drank water, rested, and slept when the urge hit. Didn't leave the house; only lazed about talking with my husband, watching tv (was too fatigued and weak to hold a book to read).
LOW GRADE FEVER; MUSCLE ACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced low grade fever, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever and muscle ache was not reported. This report was non-serious.
t 101 at 6am 1dec94;seen for HM & afebrile at 9am;apap given at 6am; recvd vax & began to shake all over;10:30 to clinic; again crying, alert, breathing well;
Patient is a physician.  He reported palpitations and tachycardia the evening of vaccination (about 4 hours after vaccination) when he was at home.  It did subside within 2-3 hours.
This is copied directly from what patient wrote down for us.  Symptoms started the afternoon of 5/2/19. "First started feeling very hot,then within a few minutes, cold. Then pain went up my arm to shoulders, neck and down back.  Arm was sore-pain went from arm up to shulders and neck then down back. the pain/toxins keep moving from muscle of one area to muscle in another area.  It is still on-going-pain remains in areas of back, neck and shoulders-has gone to glutes also."  Patient also described it feeling as like her muscles were contracting/stiff all over.
Vaccination adverse reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        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 medications were reported.     Patient reported that she would be having a medical surgery in the next two week.  No treatment medications were reported.
SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness. This report was non-serious.
Arm pain within 5-6 hours followed by chills, cold sweats, weakness, whole body aches, fatigue, inability to function for activities of daily living. Symptoms and signs resolved by noon the next day. Note: separate event form filled out for spouse who had vaccine at same time.
Swelling of chin with tingling radiating to her mandibular angles x 4 hrs. Resolved without intervention or medication
Skin allergy; "bad rash all over body"; "Itchiness all over body"; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 15:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 22:00, the patient experienced skin allergy, a bad rash all over body and itchiness all over body. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events skin allergy, "bad rash all over body" and "itchiness all over body" were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
nausea; vomiting; upper back & lower back pain/I have back pain; I have on back I have very sharp pain in my lower back and in my back; I cannot sit for long period, I have to lay down; temperature of 101-102°F/I had high temperature of 101; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 12May2021 (at the age of 35-year-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from Aug2020, to an unknown date. The patient concomitant medications were not reported. On 12May2021, the patient experienced temperature of 101-102 degree Fahrenheit. The patient had high temperature of 101. On 17May2021, nausea, vomiting and back pain on back very sharp pain in lower back and in back; patient cannot sit for long period to lay down. Consumer reported the patient took the Pfizer shot (Pfizer Covid vaccine) a week ago on Wednesday (confirmed as 12 May 2021), 8 days ago, he had this reaction. He took it 8 days ago on the first day on the first he had high temperature of 101 and then he had back pain, nausea and vomiting for the 5th, 6th, 7th, 8th day he had on back and very sharp pain in his lower back and in his back and he cannot sit for long period, he had to lay down so he just, why that was and this is his first shot he took, he had Covid back in august, this way I have same feeling. But the back pain, back sharp pain was just too much, he cannot stand it, he spoke with his regular doctor. The patient underwent lab tests and procedures which included body temperature increased: the first 4 days 101- 102 degree Fahrenheit on 12May2021. The clinical outcome of the events were unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Pain and swelling started in right axilla and spread up into right side of chest wall and upper portion of right breast, over clavicular area into the right side of neck.  Site was not red but intensely painful.
Mother and daughter stop by the clinic to show child left arm was swollen, redness and hot to touch. Child stated was painful and itchy on the site of injection.