chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Sedation, Myalgia, Arthralgia,  NauseaVomiting, Pain/Swelling/Itching @ injection site, Swollen lymph nodes, Light sensitivity Narrative:
Red, itchy, warm spot at injection site, local and generalized. No rash reported, nor shortness of breath, nor rapid heart rate. No systemic side effects reported. Advised to monitor and seek physician advice or hospital if condition worsens or other symptoms present. Benadryl suggested for itch.
Dizziness, HYPERtension & Tachycardia Narrative:  PT BP increased shortly after vaccine administration, and then decreased back to normal limits after resting for 30 minutes. PT later reported that their BP increased about an hour later, and they sought alternate provider care and is being follow up with their PCP
Patients girlfriend is claiming that patient passed away in his sleep 3 days after getting the vaccine.  Reported chills and tiredness. No other information was given
Two and 1/2 hours post vax, pt complained that both hands were swollen. Within a short time (30 minutes) she began coughing, wheezing. 911 was called when symptoms continued to worsen and she was transported to hospital. Pt related that immediately upon receiving vax, tasted "funny" possibly metallic taste at back of her mouth. She had no further complaints until she reported puffiness in her hands 2.5 hours later.
Information has been received from a company representative concerning a male who has been working in the VARIVAX processing unit and has been diagnosed with Guillain Barre Syndrome. The patient has been out of work on disability since January 2007. Unspecified testing was done to diagnose the symptoms of his illness. The patient and his wife believe that the illness is a result of working with VARIVAX product. Additional information has been requested.
Anaphylactic reaction; Chest pressure; Rash (on neck,belly and arm); Metallic taste in mouth; Hot flashes; Headaches; A spontaneous report  was received from a 49-year-old female nurse, who was also a patient, who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headaches.  The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 22 Dec 2020, at 7:00 pm, approximately 15 minutes prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly, for prophylaxis of COVID-19 infection.   On 22 Dec 2020, approximately 15 minutes after the mRNA-1273 vaccination, the patient experienced anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headaches. She was taken immediately to the emergency room. Laboratory values included a negative troponin level and low potassium at 3.3. All other laboratory results were normal. Treatment included prednisone for five days, diphenhydramine hydrochloride, famotidine and paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events, anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headaches was not reported   The causality assessment for the events, anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headache was not reported.; Reporter's Comments: This case concerns a 49-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), reporting an unexpected event of anaphylactic reaction, chest pressure, rash, metallic taste in mouth, hot flush and an expected event of headache. The events occurred the same day, 15 minutes after vaccine administration. The reporter did not provide the causality assessment for the events. Due to the temporal association between the events and administration of the vaccine, a causal relationship cannot be excluded, and the events are assessed as possibly related to vaccine.
I had some itching after the vaccination, but it went away. On 3/11 I noticed a red rash and had a lot of itching. I went to my PCP after work and he said it was "covid arm"
prolonged inconsolable screaming beginning 2 hrs p/vax given-lasted 3 1/2 hrs;
2 days after both vaccines, I started my period 2 days after each vaccine. I currently have an IUD and have not had a period in years. Other side effects were typical sore arm and muscle aches.
sweating; Headache; Felt like a freight train hit her; Dizziness; soreness and aching in her body/ Body Aches; chills off and on; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 14:00 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious) with onset 01Sep2021 01:00, outcome "recovered" (03Sep2021), described as "sweating"; HEADACHE (non-serious) with onset 01Sep2021 01:00, outcome "recovering", described as "Headache"; FEELING ABNORMAL (non-serious) with onset 01Sep2021 01:00, outcome "recovered" (03Sep2021), described as "Felt like a freight train hit her"; DIZZINESS (non-serious) with onset 01Sep2021 01:00, outcome "recovered" (03Sep2021), described as "Dizziness"; PAIN (non-serious) with onset 01Sep2021 01:00, outcome "recovered" (03Sep2021), described as "soreness and aching in her body/ Body Aches"; CHILLS (non-serious) with onset 01Sep2021 01:00, outcome "recovering", described as "chills off and on". Therapeutic measures were taken as a result of hyperhidrosis, headache, feeling abnormal, dizziness, pain, chills.  Additional information: This report was not related to a study or program. It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that she received the shot on Tuesday, 31AUG2021 and she had a bad reaction on Wednesday and Thursday and today she was feeling better, except for a lingering headache. Patient stated on Tuesday night she felt like a freight train hit her, she was sweating, had chills off and on, body aches, dizziness, soreness and aching in her body.  Follow-up attempts completed. No further information is expected.
The pt developed intermittent urticaria. Treated with Benadryl 50 mg prn.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient was told to sit down and wait for 15 min but for unknown reason she stood up and fell forward, hit the head somewhere and had a cut on her forehead about 1and half inches long. this is her booster shot of Moderna, first 2 shots were Pfizer from another location.  911 was called and they arrived 15 to 20min later .
This case was reported by a other health professional via call center representative and described the occurrence of rash in a 19-year-old female patient who received FLUARIX QUADRIVALENT (batch number 34RE5, expiry date 30th June 2018). On 3rd October 2017, the patient received FLUARIX QUADRIVALENT .5 ml. On 11th October 2017, 8 days after receiving FLUARIX QUADRIVALENT, the patient experienced rash and skin lesion. On 13th October 2017, the patient experienced back pain, fever, chills, sweating and burning leg. The patient was treated with acyclovir and Aloe Vera Gel. On an unknown date, the outcome of the rash was recovering/resolving and the outcome of the skin lesion was unknown and the outcome of the back pain, chills, sweating and burning leg were recovered/resolved and the outcome of the fever was recovered/resolved. The reporter considered the rash, back pain, fever, sweating and burning leg to be unrelated to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the skin lesion and chills to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient experienced a rash on her back. On 12th October 2017, the patient was acting as a caregiver for another patient that was diagnosed with shingles and the patient had Ramsey Hunt Syndrome but that patient never had a flu shot. On 13th October 2017, the patient was seen in the emergency room with complaints of her back hurting, she felt bad with fever, chills, sweating, pain and her rash still presented on her back and right chest and right front shoulder and she had burning down her legs. She was treated with Acyclovir and pain medications. She also used 100 per cent aloe vera gel and the live plant on her lesions. The reporter stated that the patient's condition had improved now. The lesion on her back was pretty much gone with a couple of red spots remaining. The patient lost two days off of work. The reporter also indicated that the patient had stressors with her Mom passing last year.
At the time of the vaccine I was 38 weeks pregnant. The day after the vaccine I was very tired but this was the only side effect i got directly after. On March 12th I was induced at Hospital. I was given the epidural that night and started having terrible headaches almost immediately. I gave birth on 3/13 to a baby girl 8lbs 5oz 21 inches long. Overall, labor went smoothly except for the headaches that were immobilizing. On sunday, March 14th I was diagnosed with a spinal fluid leak from the epidural. I received a blood patch that night to resolve the issue. I was discharged on March 15th late morning. On the evening of March 15th I went back over to the ER at Hospital for a second blood patch due to continuing headaches. I was released from the ER 4-5 hours later. On the morning on March 17th I woke up with continuing debilitating headaches and went over to Hospital. They admitted me to do scans on my brain. I was released on March 19th in the late afternoon with the diagnosis of a large spinal fluid leak from the epidural. After laying flat for a few more days the headaches resolved themselves on March 23rd. I have had follow up scans done to confirm that the spinal fluid leak is gone. I was told it is very odd that the blood patches didn't work the first two times i receivced them.
Patient stated that he passed out 5 days after he took second booster of Moderna vaccine.
Lot number might be 026L20A. My first Moderna shot was on 1-7-2021. My arm was a bit sore, red, and swollen for just a couple days and then it was fine. On 1-14-2021 I woke up with a sore upper left shoulder (the joint, not the surface injections site), left neck, throat, and jaw. It hurt a bit to eat. Later that day the injection site became hard, red, and itchy again. By 1-16-21 the injection site was no longer itchy but my shoulder, neck, throat and jaw have continued to be sore, on and off. I don't know what else could be causing this - it's not bad but it's odd. The soreness feels like lymph gland swelling. I have not consulted a doctor because it's not bad but may call clinic. I called the Moderna 800 number and filed a report that way but decided to also file this report.
2 inch diameter black bruise with 1/2 inch additional radius that was light green/blue around; sore arm which occurred mid-afternoon the day after administration; fever the night of.
This spontaneous report was received from a physician referring to a 7 years old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 22-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fhrenheit degrees for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766:  US-009507513-1709USA012768:
Client became lightheaded and clammy.  Responsive to verbal and tactile stimulation.  No loss of consciousness.  Alert, aware and responsive.  Skin noted to be moist and clammy to touch.  Pale complexion.  Dad was present during event.  Dad stated client was recovering from COVID-19.  Had his last negative test on 5/14/2021.  Dad did not want 911 services activated, however, he stated and nursing also advised that he take client to see his PCP.  Upon exit, client was alert, verbal and ambulatory.  No sign of acute distress.  Exit at 3:47pm.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an 18-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Polyarticular juvenile rheumatoid arthritis, chronic or unspecified.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in pre-filled pen. In 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving. Not provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant product was provided. No treatment information was provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trail. Primary reporters contact for lot number information was unsuccessful. Company comment-This spontaneous case concerns a female patient aged 18 years with no medical history reported, who experienced the unexpected non serious of Covid 19 on an unknown date after receiving a dose (dose number not specified) of mRNA-1273 vaccine in the covid 19 vaccination series. COVID-19 test done on unknown date in 2022 was positive. No further clinical course, other lab results or treatment details were reported.  Outcome of the event covid-19 is resolving at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 18 years with no medical history reported, who experienced the unexpected non serious of Covid 19 on an unknown date after receiving a dose (dose number not specified) of mRNA-1273 vaccine in the covid 19 vaccination series. COVID-19 test done on unknown date in 2022 was positive. No further clinical course, other lab results or treatment details were reported.  Outcome of the event covid-19 is resolving at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.
Hives develop has administration of Influenza vaccine at local pharmacy, sought treatment 1 day later at Urgent care.
Experienced muscle pain, felt tired and weak, headache and shivering after receiving Shingrix 50MCG injection.
24 hours after vaccine on (R) deltoid, patient developed myalgias, temp to 101 F, malaise, nausea, diarrhea and redness and soreness at vaccine site tracking down her arm. Slowly improved over 2-3 days with ibuprofen, ice, supportive care.
17 years old; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 901D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old). On 18-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Pt presented to office with cellulitis of left arm where vaccine was administered.  Pt was placed on antibiotics.
Patient developed pain and redness several hours after vaccinations. This became increasingly swollen and painful; by next day streaking present.
had the vaccine and had shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the vaccine and had shingles twice since then. The patient thought severity was lessened, but not prevented. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
pt recv vax 17JAN97 p/leaving clin pt got cold;denies any other sx;17APR97 mom called to state pt had rxn to vax;pt stated went to allergist on 23JAN97 & told what happened told not to take anymore hep B shot;denies any allergies yeast;
Arm that received injection, red, hot and swollen. Took benadryl and claratin and symptoms improved in 5-6 days
Severe anaphylactic shock reaction. Hives, throat swelling, breathing affected, blood pressure spiked 178/118, dizzy / lightheaded.
After administering the vaccine, the pharmacist realized that the beyond use date from retail location was 2/12/22.
Patient developed papular rash on lower and upper body and a temp of 101.9. Pt received Tylenol and a CBC was taken. Rash appeared 7 days after vaccination.
annoying sweats at night/woke up completely sweaty; light tingle on the shot area; The vaccine is making him feel worse than the illness; swelling in the lymph nodes of his neck/feels like if a grape is in there; pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (annoying sweats at night/woke up completely sweaty), VACCINATION SITE PARAESTHESIA (light tingle on the shot area), FEELING ABNORMAL (The vaccine is making him feel worse than the illness), LYMPHADENOPATHY (swelling in the lymph nodes of his neck/feels like if a grape is in there) and VACCINATION SITE PAIN (pain in the left arm) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084521A and 032H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021. Concurrent medical conditions included Penicillin allergy.   On 21-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In February 2022, the patient experienced HYPERHIDROSIS (annoying sweats at night/woke up completely sweaty), VACCINATION SITE PARAESTHESIA (light tingle on the shot area), FEELING ABNORMAL (The vaccine is making him feel worse than the illness), LYMPHADENOPATHY (swelling in the lymph nodes of his neck/feels like if a grape is in there) and VACCINATION SITE PAIN (pain in the left arm). At the time of the report, HYPERHIDROSIS (annoying sweats at night/woke up completely sweaty), VACCINATION SITE PARAESTHESIA (light tingle on the shot area), FEELING ABNORMAL (The vaccine is making him feel worse than the illness), LYMPHADENOPATHY (swelling in the lymph nodes of his neck/feels like if a grape is in there) and VACCINATION SITE PAIN (pain in the left arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. No Treatment medications were reported. It was reported that patient was absolutely certain that he will not get a booster dose of the Vaccine.
T.C. from Pt. at 2:50pm 11/25/08; reports swelling of (R) arm when PNEUMOVAX was administered. Stated symptoms began approximately 2 hrs post vaccination. Advised to apply ice, take ibuprofen every 4-6 hrs; call physician  if symptoms persists.
flu-like symptoms and fatigue the following day, only able to rest very sore at injection site for 3-4 days took 400mg ibuprofen once the following day
Patient states she had fatique, weak and nausiated. Had diarrhea over the weekend following administration.  Patient followed up with PCP 1 week after administration of vaccine.
A shingles like rash appeared on both legs. From knees to ankles. Extremely itchy and pimply looking. Home treatments of mainly calamine lotion to stop the itch
2-3hrs p/HIB pt had 6 hrs of inconsolable & high pitched crying; Seen in ER next morning & was afebrile; Mom states pt felt warm;
Arm is extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is extremely sore) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is extremely sore). At the time of the report, PAIN IN EXTREMITY (Arm is extremely sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided. Treatment information was not provided.
Severe pain, severe loss of strength, range of motion severely limited, redness, bruising, skin sensitivity, inflammation, lethargy, sweats/chills, full body heat rash. Symptoms arrived in 24 hours, symptoms escalated 48 hours, reached peak at 72 hours. It took a full week (7 days) for inflammation/redness/pain and sensitivity to subside. Range of motion and strength restored, but still muscular pain after 9 days.
A patient presented to the pharmacy and reported she has been experiencing a skin reaction after her first dose on May 16 Sunday.  Her injection site (left arm) showed  inflammation and edematous pink plaques at a size about 8 inches. This injection site reaction developed about 9 days after vaccine administration with mild pain and itching. Patient was recommended an anti-histamine, otc steroid cream and cold compression.
Mom states that baby had a fever of 100 - 103 last night and today. States baby screamed for 35 minutes up to 1 hour. The left leg is slightly swollen and the baby was given Tylenol. MD advised to give pediatric DT only. Diagnosed as a pertussis reaction.