chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Monovalent dose administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient).    It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient ID was reported.  Concomitant product use was not provided by the reporter.  It was reported that 77 Monovalent doses administered after the BUD to patients 12 and up. Breakdown of doses were as follows- 37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A.  Treatment information was not provided.
Pt contacted clinic on 2/6/09 (injection given on 02/4/09) stating after third HPV injection she experienced mild swelling @ site with moderate pain and bilateral shoulder , elbow, and wrist join pain (no recent trauma noted), throbbing in (R) side down to fingers, cannot sleep on (R)Side.
This initial non-serious spontaneous case was reported on 25-Sep-2017, from other non-health professional, concerning a pregnant female of unspecified age. On an unspecified date, the patient was administered with the influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). It was reported that a pregnant woman was administered with INN flu vaccine.
Redness, swelling, induration 13x15 cm. Advised cold compresses and Tylenol.
The patient received her first dose of VARIVAX, at approximately 12 months of age, and received the second dose of VARIVAX, at approximately, four years of age; Patient experienced breakthrough chickenpox, described as approximately 30 papular lesions, some slightly pustular, on trunk and neck, with mild itching, but was afebrile; This spontaneous report was received from a consumer regarding his 9 year old female daughter. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were no reported.   Approximately in 2010 (reported as "approximately 12 months of age), the patient received her first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX). Approximately in 2013 (reported as "four years of age) she received the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (inappropriate schedule of product administration) for routine vaccination (prophylaxis) (strength, dosage, frequency, route of administration, lot number and expiration date were not reported).  On 17-JUN-2019, the patient experienced breakthrough chickenpox, described as approximately 30 papular lesions, some slightly pustular, on trunk and neck, with mild itching, but was afebrile (Varicella). No treatment was given for the event. Also, no lab diagnostics or studies were performed.  The action taken of the event Varicella was not reported. The causal relationship between the event and vaccine varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
fatigue the evening of injection lasting 4-5 days, fever Tmax 99.9  starting 72hrs post vaccine lasting 24hr, myalgias x 48hrs starting with the fever, mild injection site soreness, managed with ibuprofen
Severe vomiting within  45 minutes of receiving vaccine. I had 4 distinct vomiting episodes, vomiting 3 or 4 times  during each episode.  I took a single dose of Zofran at about 2 pm and had last vomiting episode around 4 pm. Vomiting episodes lasted a total of about 6 hours. I had chills for about an hour right after 1st vomiting episode. I had significant left arm pain that prevented use of arm for 2 days. I also had extreme weakness the 1st day, I couldn?t get out of bed except to vomit. I got the vaccine on Wednesday and didn?t feel fully recovered until Sunday.
Woke up 3AM; Lightheaded; Sweating; Fever 104 F on chest and 101 F on the forehead; Chills; Pain all over the body; Nausea; Injection Site Hurt; This spontaneous case was reported by a health care professional and describes the occurrence of INSOMNIA (Woke up 3AM), DIZZINESS (Lightheaded), HYPERHIDROSIS (Sweating), PYREXIA (Fever 104 F on chest and 101 F on the forehead) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 024L204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (Injection Site Hurt). On 04-Feb-2021, the patient experienced INSOMNIA (Woke up 3AM), DIZZINESS (Lightheaded), HYPERHIDROSIS (Sweating), PYREXIA (Fever 104 F on chest and 101 F on the forehead), CHILLS (Chills), MYALGIA (Pain all over the body) and NAUSEA (Nausea). At the time of the report, INSOMNIA (Woke up 3AM), DIZZINESS (Lightheaded), HYPERHIDROSIS (Sweating), PYREXIA (Fever 104 F on chest and 101 F on the forehead), CHILLS (Chills), MYALGIA (Pain all over the body), NAUSEA (Nausea) and INJECTION SITE PAIN (Injection Site Hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 104 (High) fever of 104 F on chest and 101 F on forehead.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment medication included muscle relaxer.
itching; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included shingles vaccine with an associated reaction of pruritus (received 1st dose on an unknown date, refer link case US2023AMR036645).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pruritus. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR036645   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The reporter reported the case via interactive digital media. The patient had shingles they were bad took. One vaccine fifty dollars Later got second vaccine. The patient had itching every now and then. Note: it was unknown whether itching was after 1st dose or 2nd dose or after both doses. Therefore, conservatively captured for both doses.; Sender's Comments:  US-GSK-US2023AMR036645:
Could not stay awake fully; Arm pain persistent; Growing lower back pain; Fever; Night sweats; Chills; General body aches (especially at shoulder joints in both arms); General body aches (especially at shoulder joints in both arms); Brain fog; Very specific muscle spasm in left upper thigh on backside/persistent muscle spasm; This is a spontaneous report from a contactable 31-year-old female other health professional reported that: A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EL9262) as single dose and on unspecified date, route of administration patient received bnt162b2for covid-19 immunisation. Medical history included autoimmune thyroiditis. Concomitant medications received from unspecified date frequency and unspecified indication were levothyroxine (LEVOTHYROXINE) dose was at 88mcg, ethinylestradiol, norgestimate (TRI-LO-SPRINTEC). The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Facility where the most recent COVID-19 vaccine was administered in hospital. The patient was not pregnant at the time of vaccination. The patient was not allergic to medications, food, or other products. On 26Jan2021, the patient experienced fever, night sweats, chills, general body aches, brain fog, very specific muscle spasm in left upper thigh on backside/persistent muscle spasm, could not stay. On 27Jan2021, awake fully, arm pain persistent, growing lower back pain, growing back pain.  Reported event was reported post 2nd vaccination: 1st night experienced fever, night sweats, chills, general body aches (especially at shoulder joints in both arms), brain fog, and very specific muscle spasm in left upper thigh on backside; 1st day post could not stay awake fully with arm pain persistent and growing lower back pain; 2nd night post continued to experience night sweats and w/ persistent muscle spasm that was previously mentioned in left back thigh and growing back pain. The patient was not received treatment. Outcome of the events were recovering.
pt recv vax 8JUL97 & pt devel abscess on axillary area, legs & buttocks;31JUL97 pt was treated in ER where one of the abscess was drained & packed;
Got a severe pain where the shot was given and couldn't move my arm at all. The upper arm and the elbow were badly swollen for 5 days.
Some reaction from each one of the shots; Contracted covid after the shot; 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 COVID-19 (Contracted covid after the shot) and VACCINATION COMPLICATION (Some reaction from each one of the shots) 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. In August 2021, the patient experienced COVID-19 (Contracted covid after the shot). On an unknown date, the patient experienced VACCINATION COMPLICATION (Some reaction from each one of the shots). At the time of the report, COVID-19 (Contracted covid after the shot) and VACCINATION COMPLICATION (Some reaction from each one of the shots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
Patient on 5/13/21 received the J&J vaccination. On 10/31/21 patient received one dose of Pfizer. Then on 11/18/21 patient received a second dose of Pfizer. Per booster recommendations it was appropriate for patient to receive first dose of Pfizer but not the second dose. Patient confirmed that he had received both doses of Pfizer vaccine. No side effects or issues reported.
After Dose 2 got my monthly nucala injection on 2/15 I started getting muscle spasm/ cramping in left foot was painful and very high anxiety. I started exp cramping in my lower arms I have been to ER, PCP, Ophthalmologist and Neurologist. I'm having terrible headaches as well. The Opthamologist applied eye drops that cause me to go to ER on 4/2 had blood work, checked pressures in eyes, prescribed medications nausea/dizziness, pain in my head and IV for low sodium.
Pt reports on 02/05/2002 deltoid was red rash and sore. Pt went to the health unit on 02/08/2002 reporting arm was red and sore and warm to touch. Fever on 02/11/2002 put into the health unit. Recommended Benadryl on 02/13/2002 and pt improved.
Onset of symptoms was about 9  to 10 hours after receiving the vaccine.  Started out with mild muscle soreness. This progressed while I was sleeping to become quite extreme. I woke up at 1:00am  (10 hours after vaccine) to fever, chills, muscle soreness in entirety of body and pain/aching joints. When I got up to get some Tylenol my body began shaking uncontrollably. I would describe this as muscle tremors. It was quite vigorous to the point where all my muscles  were very tight and felt like stone. I quickly took a Benadryl (25mg) paired with Tylenol (500mgs) to battle the reaction.   I laid back down to try and stop the tremors but they continued for a good fifteen minutes or so until the medications started to work. Afterward I felt much better. The muscle tremors stopped completely, but I continued to have chills, fever, and aching joints well into the next day. Fatigue was extreme and I slept on and off for about 24 hours. After the initial 24 hours period, all symptoms went away and I was 100% back to normal.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 92-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.    This case was linked to mod-2021-117522 (Patient Link).
05/12/05 has chicken pox looked like bee stings. went to urgent care on Tuesday PM has about 10 spots. Complaints of chests hurting off and on. Green drainage, congestion and cough. No temp. TX Benadryl, Amoxicillin doenst work. Scattered scabbed lesions. Temp normal, neck supple, lungs clear Zithro 200 1 1/2  3/4 Chicken pox. Send TX to VAERS.
No adverse effects were reported; the patient was inadvertently administered an expired dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-JUL-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # N019608, expiration date: 09-JUL-2019 (exact dose, injection site and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with expired sterile diluent (MERCK) lot number N006322, expiration date: 11-JUL-2019 (exact dose, injection site, route of administration and indication were not provided). No temperature excursion had  occurred. No adverse effects were reported.
Pt recvd vax on 23APR92 & 25APR92 devel brief episode of nausea, vomiting & diarrhea; pt recovered in less than 24 hrs; No further details were provided;
it hurt like heck; Initial information received on 11-May-2023 regarding an unsolicited valid non-serious case received from a Patient.  This case involves an unknown age and unknown gender patient where patient had tetanus toxoid vaccine and it hurt like heck.  The patient's past medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a Booster dose of suspect tetanus toxoid produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, frequency, formulation, strength and expiration date: not provided) for prophylactic vaccination, Information on the batch number was requested and it hurt like hell (injection site pain) (unknown latency) following the administration of tetanus toxoid.  It was unknown if there were lab data/results available.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event (it hurt like heck).  At time of reporting, the outcome was Unknown for the event it hurt like heck.
I was ok when I had waited 15 mins after the shot. The next day I noticed a rash appearing in the middle of my chest. Then on Friday (two days later) I was getting ready to go to work and my throat closed up to where I couldn't even breathe or drink water. I immediately went to the hospital.
Mild Pain above injection site Narrative:  Pt reports mild pain above injection site. Does not interfere with daily activity.
Narrative: 50yr patient received Moderna #1 then while waiting 15min developed sensation of tongue swelling and tingling over the anterior chest. EKG revealed non-specific ST/T wave changes (QTC 0.435) and tongue did appear to be swollen with mild hives. Given oxygen supplementation, 4 baby ASA and 911 called taken to local ER. Local ER visits #1 Summary: allergic reaction given Benadryl and Pepcid then sent home. Patient called telephone triage later same day to report sx returning (mild HA, chest tingling/numb, dizziness, head feels heavy). Triage told patient to call 911 which patient did present to a different ER. Local ER visit #2 unknown outcome.
Pt reported back to the clinic 35 minutes after receiving the vaccine reporting feeling dizzy with tingling of lips and tongue tingling along with chest tightness/shortness of breath
patient had surgery after the first and second doses of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (patient had surgery after the first and second doses of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SURGERY (patient had surgery after the first and second doses of the vaccine) (seriousness criterion medically significant). At the time of the report, SURGERY (patient had surgery after the first and second doses of the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.  This case concerns a patient of an unknown age and gender with a history of Cancer, who experienced the unexpected serious event of Surgery. The event occurred at an unknown time after the second dose of Spikevax. The medical history of Cancer remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with a history of Cancer, who experienced the unexpected serious event of Surgery. The event occurred at an unknown time after the second dose of Spikevax. The medical history of Cancer remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.
After the injection I experienced soreness at the site. Within that same period I started having a lot of muscle pain in my arm, shoulder and neck that I attributed to exercise. Yesterday, the area around the injection site began itching, became swollen and a light rash developed. Today, the itching has gone away, but the injection site is still swollen and and I have muscular pain at the injection site, and on the upper part of my back and the lower part of my neck on my right side.  My husband is a physician so he has examined the site and is monitoring it.
had the same tingly arm sensations but they were more mild but not as bad as the second shot; 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 (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; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "felt something itchy on the left underside of her arm/ itching/ had the same feeling on the right side from armpit to wrist". The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "had the same tingly arm sensations but they were more mild but not as bad as the second shot".  Additional information: She has a lot of allergies, she used to get allergy shots a long time ago. With the two boosters from Pfizer, she had the same tingly arm sensations but they were more mild but not as bad as the second shot. She became more accustomed to it and knew how to deal with it.  She doesn't remember if vaccine was given on left or right side. While waiting after the injection she was fine but after she got in car, she felt weird little mosquito bite, and then started to grow. Sensation never went away 100% but subsided and got tolerable. When she got Covid, all of a sudden it came back, a twingy feeling under both arms. She takes no medications and is very healthy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.