chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 10:30 PM started to get a sharp burning pain above left collar bone and halfway up side of neck, which turned into 10/10 pain over the course of an hour. Area had slight swelling and redness above left collar bone and at the left side, base of the kneck. Went to the ER, and was given motrin and ativan and sent home. Woke unable to move kneck or raise left arm without extreme pain. Area/skin extremely sensitive to the touch, such that even a gentle touching caused extreme pain. A red line started to appear from the front/top of the shoulder down the left arm (~3 inches long). Started treatment with Cephalexin, Doxycycline, ibuprofen, and methocarbomal (4/24/2020). Redness spread and swelled over the next 3 days, becoming raised and more sensitive across the bicep underneath both injection sites (roughly 2x5 in in length) . Movement was difficult because it caused severe pain. Around 4 days after initial ER visit, swelling and redness started to subside. By 5/4/2020 pain was gone and redness was mostly faded, stopped taking antibiotics, ibuprofen, methocarbamol. By 5/8/2020 no more symptoms, swelling, or pain. Slight redness on left arm underneath injection site.
Little nauseous; This is a spontaneous report from a contactable consumer. A 79-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Medical history included diabetes mellitus, hyponatraemia, Macrocytic anemia, Bad back and visual impairment. There were no concomitant medications. The patient previously took tylenol and tramadol for back pain. The patient experienced little nauseous on an unspecified date. The outcome of the event was unknown.  Information on the batch number/lot number has been requested.
One hour post vax, the pt became dizzy, confused, decrease in comprehension, complained of headache and neck burning, dry mouth, "Hot", had URI. The pt had fatigue and ache 1 week prior to vax. Diagnosed with disassociative reaction of unclear origin
suicidal thoughts; allergic reaction; a rash; throat swelling; erratic moods; This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 29-year-old on an unspecified date at single dose for covid-19 immunisation. Medical history included allergies to Sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included calcium; bifidobacterium lactis (PROBIOTIC); magnesium, all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The allergic reaction included a rash and throat swelling. Psychological/neurological effects included suicidal thoughts and erratic moods. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The events were serious for being disability. Facility where the most recent COVID-19 vaccine was administered in Doctor's office/urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient received the medication for events. The outcome of events was not recovered.  Follow-up attempts are needed. Further information is expected.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Vasovagal reaction to injection. Patient recovered consciousness within the minute. No injuries.
Right UE - localized at inject site. Reddened, itching, hives, small amount of edema. Increased temp.
aft vax pt exp local redness, swelling in rt arm, erythema & induration
At 3:15pm, patient c/o of some pain/discomfort to left chest wall area on a pain scale 1/10. According to patient, pain/discomfort to chest wall was non- radiating and no pain reported to jaw area, to left upper extremity and no om COVID-19 Vaccine Monit Narrative:
it felt like the needle went on her nerve and that it was not a pleasant experience on either occasion; 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 in her 70's received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "it felt like the needle went on her nerve and that it was not a pleasant experience on either occasion".  Additional information: She received the 2nd dose of the Pfizer covid vaccine. The nurse gave it to her through the syringe which had a couple of bubbles that were left in there. The amount of the vaccine looked like a small amount. When she injected her, the patient jerked her arm. Caller also reports that on the 1st injection it felt like the needle went on her nerve and that it was not a pleasant experience on either occasion. The patient asked if Pfizer provided a statement on the need for a booster dose (3rd dose) and Is Pfizer investigating the need for a booster dose. It was replied that The need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. On February 25, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. It is important to have a vaccine technology that allows us to both provide boosting doses if needed and to address potential changes in the virus itself if a new variant emerges that the vaccine does not protect against.  While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine in our laboratory studies, we are taking multiple steps to be ready in case a strain becomes resistant to the vaccine.  The administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine is not approved. Pfizer is unable to make any recommendations regarding administration of a booster dose of Pfizer-BioNTech COVID-19 Vaccine; Pfizer does not suggest or recommend the use of the vaccine in any manner other than as described in the authorized EUA Prescribing Information (if US)/authorized product monograph. Note to frontline: This FAQ should only be used if someone specifically asks about the Pfizer statement on booster doses. For all other general inquiries about booster doses, please refer to the SRD titled "Administration of More Than a 2-Dose Series (Booster Dose)". Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Painful left arm after Tdap on 6/8/15. Used ice packs over towel. Seen rheumatology on 6/10/15 who prescribed steroid pack for RA pain in finger and other joints. Patient found this helpful for RA pain, but as I understand it the left arm pain continued and she experienced fitful sleep due to this. Today she awoke with a rash on her left arm and hot flashes through out the day. There was some initial itching, but she used essential oil on it and there is not further itching. The pain continues. No breathing difficulties, facial edema, or swallowing difficulties. Afebrile. No lesion, erythema, or edema at injection site-there is tenderness. Anterior to injection site there is a 7 x 2.5 cm erythematous hive. second rash mid medial forearm raised 3.5 x 4.5 cm erythematous wheal appearing lesion with 1-2 mm vesicle x 2 at lower periphery. Continue prednisone, add OTC anti-histamine, tramadol for pain. Tylenol for fever sensation (may take along with Tramadol), CLARITIN or ZYRTEC or ALLEGRA (usually one adult dose daily), ice packs as needed (covered so not directly touching skin. ED for worsening or new symptoms.
Seen 2 days after immunizations given with red raised area at site of VARIVAX; c/o tingling in hand 6 cm induration.
Death Cause-Loss of Oxygen; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported) via an unspecified route of administration on 08Oct2021 (at the age of 74 years old) as dose 3 (booster), single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient previously received the first dose and second dose of BNT162B2 (lot numbers were not reported), via an unspecified route of administration on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunisation. The patient did not receive any other vaccines in 4 weeks and it was unknown if the patient had other medications was received in 2 weeks. The patient experienced loss of oxygen as death cause on 11Oct2021. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Event resulted in life threatening illness (immediate risk of death from the event). The patient died on 11Oct2021. An autopsy was not performed.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death Cause-Loss of Oxygen
Pt called in to report right arm swollen up to shoulder & painful & red. By 11/2/12, arm was not swollen or painful, but still red. Pt did not feel it was necessary to seek medical attention.
pt passed away at home; no medical records; had a positive COVID test on 1/7/21 at Pharmacy; death certificate listed COVID 19 as a condition contributing to death
She got her vaccine, she starting vomiting, having sweats, dizziness and weakness and she continues to do this on and off since the vaccine.  She has not talked to a doctor and has not taken anything for it yet.  She got the flu vaccine a week ago, but did not have any reaction to that.
The left face is paralyzed, unable to perceive the movement of the muscles The left eyelids cannot be closed completely. While closing the eyes, and there is no pressure on the left eye. The left lip is uncontrollable, and water will flow down when drinking There is no sense of muscle movement on the left face when smiling
Information has been received from a physician concerning a 12 month old female with no allergies and no past medical history who on 04/23/2001 was vaccinated with varicella vaccine. Concomitnat therapy included MMR. It was noted that there were no other "routine medications." On 05/02/2001, the pt developed an elevated temp for one day, a mild rash with multiple papules all over the body, and red eyes. Additional info has been requested.
Patient states that he started having adverse event symptoms about over a week after the shingles shot. Pt. states he is experiencing dizziness all day with difficulty in balancing. He feels that ZOSTAVAX may have neomycin some which in the past other he used similar drugs that he experienced the same symptoms.
How long do the side effects of 2nd shot last; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long do the side effects of 2nd shot last) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long do the side effects of 2nd shot last). At the time of the report, VACCINATION COMPLICATION (How long do the side effects of 2nd shot last) outcome was unknown.            No Relevant concomitant medications was reported.  Treatment information was not provided.
Issues with being fuzzy headed; Achy joints; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Issues with being fuzzy headed) and ARTHRALGIA (Achy joints) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Issues with being fuzzy headed) and ARTHRALGIA (Achy joints). At the time of the report, FEELING ABNORMAL (Issues with being fuzzy headed) and ARTHRALGIA (Achy joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported.  Treatment medication were not reported.
Developed redness/swelling in about 20 hours post-injection: induration 4x5cm; redness 10x10cm mid arm. Empirically started on DURICEF went to ER. beginning better slowly-? Cellulltis vs local rash.
Severe headache, ringing in ears, blurred vision, double vision, nausea, brain fog and unbalance.
pt recv vax & devel worsening of the learning disability & swollen glands;f/u from MD;parents were concerned about autism being a side effect of MMR;
received first dose of Moderna COVID-19 vaccine on 26APR2021 and she is about 8 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (received first dose of Moderna COVID-19 vaccine on 26APR2021 and she is about 8 weeks pregnant) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 29-Nov-2021. On 26-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (received first dose of Moderna COVID-19 vaccine on 26APR2021 and she is about 8 weeks pregnant). On 26-Apr-2021, EXPOSURE DURING PREGNANCY (received first dose of Moderna COVID-19 vaccine on 26APR2021 and she is about 8 weeks pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 26apr2021, post vaccination, the patient reported that she experienced symptoms of exposure during pregnancy  The patient was  8 weeks pregnant.  No treatment information was provided NO Concomitant information was provided
Information has been received from a health professional concerning her 4 year old granddaughter with no past medical history who "before she was 12 months old" was vaccinated with varicella virus vaccine live. There was no concomitant medication. On 12/11/03 the pt broke out in chickenpox, described as "pretty mild and does not include a fever." The pt was considered as not recovered. There was no product quality complaint involved. There were no relevant diagnostic tests or lab data. Additional information has been requested.
The mother found the baby in the crib in cardiac arrest and not breathing suddenly and unexpectedly. He had a tem of 101 in the AM. He was acting fine with good feeding.
Brain fog, head ache, persistent, hard to think, be creative, etc ever since the vax.
She broke out in hives all over her body and continues to have hives/hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (She broke out in hives all over her body and continues to have hives/hives) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension (Taking Amlodipine.). Concomitant products included AMLODIPINE for Hypertension.    On 04-Jan-2023, the patient received fourth 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 URTICARIA (She broke out in hives all over her body and continues to have hives/hives). The patient was treated with FEXOFENADINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE (ALLEGRA F) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (She broke out in hives all over her body and continues to have hives/hives) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported by patient that she received 4 doses of Moderna COVID-19 vaccine.  First dose, Shot #1: First Primary monovalent dose on 13MAR2021 (Lot# 036A21A & Exp. Date: unknown).  Second dose, Shot #2: 2nd Primary monovalent dose on 10APR2021 (Lot# 042B21A & Exp. Date: unknown). Third dose, Shot #3: First Monovalent Booster dose on 09NOV2021 (Lot# 037C21A & Exp. Date unknown).  Patient stated that she did not receive another vaccine within 4 months of the Bivalent booster. Patient stated that she did not had any reactions with the first 3 vaccines. Two weeks after the Bivalent booster, she broke out in hives all over her body and continued to had hives. At first it was not going away. She spoke to her doctor and started taking Allegra. If she took the Allegra every day the hives (called it Line Hives) disappear. If she missed the Allegra for just one day, the hives came back. Her doctor told her that she was not the first to get hives from Moderna Vaccine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2023: Follow up received and had no new information.
Day one 02-05-21 , slight red hot and swelling, receded after 4 days. Day nine, 02-13-21, large swelling to size of half a tennis ball, very hot and red , tightening and irritation of throat, also both lower cheeks on face turned red and hot and irritated. Cheeks receded after 2-3 hours after taking Benadryl.  next morning day 10 after vaccine I had a rash on right forearm, right thigh and breastbone, those rashes dissipated after one hour. Doctor instructed me to start Benadryl immediately and to take second dose after 4 hrs and continue every six hours which I did  and continued from 2-13-21 thru 2-24-21. Also to use Hydrocortizone cream 3 times a day and he also put me on Prednisone 20mg for 5 days.
blood pressure increased; blood pressure consistently high; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure increased) and HYPERTENSION (blood pressure consistently high) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, CARVEDILOL and LISINOPRIL for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure increased) and HYPERTENSION (blood pressure consistently high). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure increased) and HYPERTENSION (blood pressure consistently high) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Blood pressure measurement: (High) Blood pressure increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.
Went into almost convulsive-like shaking with no control of right arm twisting inward.  Never lost consciousness.  No pain.  Very alarming and she began to cry out "what is happening to me?"  After 15 minutes of shaking, she was very dizzy.  Since that time a year ago, her fine/minimal familial extension tremors became severe gross tremors that prevent her from even lifting a cup to her lips.
Patient suffered from substantial edema and redness to the area of the injection site to the left thigh
pt recv vax 6FEB96 & on 14FEB96 pt exp a local rxn w/erythema & swelling which peaked 1wk p/vax;pt exp completely resolved;
Fever ranging from 102-104. Lasted 2-3 days.  visibly swollen glands in neck and groin. Still visable one week later (9/4/19). Rash appeared a day or two after fever resolved.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M035694, expiration date 07-NOV-2017 for prophylaxis (dose, route and site of administration were not reported). The dose experienced a temperature excursion of 6 to 14 degrees Fahrenheit for 22 minutes. There were previous excursions of 6 to 14 degrees Fahrenheit for 25 minutes and 15 to 46 degrees Fahrenheit for 5 minutes. The Data Logger was involved. No adverse effects were reported. Additional information has been requested.
Within 2 hours of vaccine, I experienced severe vertigo while laying down. This vertigo persisted for a bit over 6 months. I took vestibular physical therapy.
New daily persistent headache that has been continuous since time of injection on 9/18/21. Some days the headache will be more painful as a migraine. While other days it can feel more like a vague tension headache.  Symptoms are treatable with pain relievers but only temporarily. No HX of migraines or any chronic illnesses.
Patient  received first dose of Pfizer COVID-19 vaccine at 0815. At 0823, patient stated she felt dizzy and like she was having "flutters in her chest". She has a severe allergic reaction to shellfish and carries an epipen. She walked to gurney and was laid down. Vital signs as charted on the flow sheet: BP 107/61, HR 75, SpO2 96%. Patient stated she has not had anything to eat or drink today. Patient given juice. 0831 Patient states she still has feeling of throat itchy. Offered to be seen in the ED. Pt Declined. 0831 Given Benedryl 25 mg PO x 1 dose. 0838 Husband was called to pick patient up at the vaccine clinic. 0844 Husband here at bedside. Patient was sitting up and stated she felt better. 0855 Pt offered wheelchair to the car. Pt declined and stated she felt well enough to walk with husband to elevator and car.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose was not reported, administered on APR-2021 for covid-19 prophylaxis. 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 patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000265083 This case, from the same reporter is linked to 20221263145.
Developed constant ringing in ears (Tinnitus) within an hour of vaccination, it has not subsided since...
Stephen's Johnson Syndrome (blisters on arm and tongue); Swelling arm; Pain in body (left side); Fever; Sweats.