chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was sitting in a chair in the waiting area the 15 minutes when he fainted from the chair after 12 minutes. was nauseous and light headed still after 5 minutes. call 911 and paramedics checked him out. patient refused to go to hospital. mom took him home
feet swelling; yellow bumps; fever; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PERIPHERAL SWELLING (feet swelling), MASS (yellow bumps) and PYREXIA (fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thalassemia.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and PYREXIA (fever). On 06-Mar-2021, the patient experienced PERIPHERAL SWELLING (feet swelling) and MASS (yellow bumps). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and DICLOFENAC DIETHYLAMINE (VOLTAREN EMULGEL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain), PERIPHERAL SWELLING (feet swelling), MASS (yellow bumps) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
This spontaneous report as received from a pharmacist refers to a 78 years old female patient. The patient did not have any pertinent medical history or drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (route and dose were unknown, lot # was reported as H013017, expiration date was 20-DEC-2012) on 08-NOV-2012. No other co-suspects were reported. Concomitant medications included LOPRESSOR, CRESTOR, metformin and aspirin. On 09-NOV-2012 the patient developed a large area of redness that was warm to touch and continues to spread around injection site" after receiving ZOSTAVAX. Treatment of TYLENOL and ice were given for adverse event. The outcome of event was reported as not recovered/not resolved. No lab diagnosis studies performed. The patient had sought unspecified medical attention. Additional information has been requested.
pt recv vax 19AUG92 & stated that exp an unspecified rxn & discontinued the vax series; No further details were provided;
First reaction was dizziness and the listed, fever, chills and fatigue listed.  Three days after the shot I began to have terrible symptoms as though I had a bladder infection, burning on urination, pain and pressure as though I needed to urinate, but did not.  Tests were taken at the doctor's office with swabs and a urine culture.  All tests came back negative for yeast, bacteria, etc.  The symptoms have mostly faded by now, one month after the second shot.  I have NEVER had this happen before and I have not had a UTI for over fifteen years.
broke out 11APR98 on face-mom said rash like all over pt face on 13APR98 mom called & said on stomach also red, no itching, no swelling;
approx 6 hrs p/vax pt started to feel bad like had a cold; so took some DDH; 17MAR95 had hives on neck & arms; lt arm was scarlet red & swollen; @ inj site pt exp a lot of burning & site was hard & hot;
Second vax produced lasting pain and limited range of motion in right arm progressing to include all joints and muscles of arms and legs.
Fever, chills, body aches beginning at 1 am Friday morning lasting throughout the day.  Full body rash mainly on abdomen, arms, back and groin area beginning Saturday and fading by Sunday.  Swollen injection site beginning at 3 pm Friday lasting until Sunday evening.  Sore arm Friday and Saturday.
9/23/21: Abnormal pressure headache, improving 9/24/21: Red itchy spots on arms/hands, feet/ankles, stomach, getting worse Also reports tight ankle, both wrists, and joint pain   On 9/28/21: pharmacist advised oral and topical antihistamines
05/31/2021 My left breast became extremely sore, that lasted for 2-3 weeks. Then right breast felt strange but not hurting. Not all the time, but like something is crawly inside and half way down the right arm. This is still ongoing.
8 days later the injection site became red and raised after being active in the sun. As the day went on, the site became more swollen and itchy. There is significant localized swelling and tightness in the deltoid muscle where the injection was.
It started with a feeling of malaise fatigue.  My nose and ears started to get stuffy.  By the evening my temperature was up to 102 degrees, body aches, and really tired. I did a home test and it was positive.  My husband tested positive a few days before. I called my doctors office that evening and my pharmacy to see what was safe to take over the counter until I heard back from my doctor. The Pharmacist suggested some Tylenol and see how that works.  My doctor prescribed Paxlovid on March 3, 2023.  I started it that night.
aching muscles & joints, esp hips & knees skin tender to touch; nausea, dizziness, intermittent weakness; fever, chills; no vomiting; no rash;
Swelling of Arm. Began at day 1 Rash along entire upper arm down to elbow  began day 2 Headache  joint pain  began at day 1
By 10 PM I was freezing cold & sweating at the  same time. Felt terrible with shaking chills, headache. Headache became bad enough I vomited 3x's Temperature was 100.2 but felt more like 102 A few hours later I was able to keep a little bit  of gingerale down. Was able to sleep later &  Slept part of next day
Administered expired vaccine to the patient,Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient,Dose administered after 30-day use by date or after manufacturer date of expiry) in a 79-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient,Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient,Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator reported as unknown. Vaccine was expired on 07-Apr-2022.No  temperature excursions for the vials was reported. Total of 173 doses were reported with the lot number 070H21A.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up document included no new information.
PATIENT CAME IN FOR SECOND SHINGRIX VACCINE AND WAS INADVERTENTLY GIVEN MODERNA INSTEAD.  ONCE WE REALIZED WHAT HAPPENED, SHINGRIX WAS GIVEN AS WELL AND THE MODERNA VACCINE GIVEN BECAME HIS THIRD BOOSTER DOSE
tender to touch; size of the redness is 5cm; headache; body aches is severe; had high fever 102; This spontaneous case was reported by a physician and describes the occurrence of TENDERNESS (tender to touch), ERYTHEMA (size of the redness is 5cm), HEADACHE (headache), MYALGIA (body aches is severe) and PYREXIA (had high fever 102) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tender to touch), ERYTHEMA (size of the redness is 5cm), HEADACHE (headache), MYALGIA (body aches is severe) and PYREXIA (had high fever 102). At the time of the report, TENDERNESS (tender to touch), ERYTHEMA (size of the redness is 5cm), HEADACHE (headache), MYALGIA (body aches is severe) and PYREXIA (had high fever 102) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included Tylenol A Liter of IV fluid. No concomitant medication was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-094833 (Patient Link).
2 days after MMR (right arm) and IPV (left arm)this patient had daily fevers and right shoulder and right hip pain (without arthritis - arthalgia only.)  ESR = 63, Nomral C3,C4. ANA-neg, RF-neg, ASO titer=0. 11/30/07 Reviewed pcp med records which included vax dose & lot #s.  Note of 10/9/07 reveals patient was in good health on day of vax. 1/18/08 Reviewed hospital medical records which reveal patient experienced right arm pain x 2 wks & right leg pain x 10 days & fever x 2 wks.  All symptoms began 2 days s/p vax.  Admitted 10/25-10/29/2007.  Exam revealed restricted ROM right shoulder, shotty inguinal lymphadenopathy, right axillary lymph node swelling.  Peds Rheum, ID, Heme/Onc FINAL DX: Fever & arthritis.
very mild symptoms; mild soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very mild symptoms) and MYALGIA (mild soreness in the arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included FISH OIL for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (very mild symptoms) and MYALGIA (mild soreness in the arm). At the time of the report, VACCINATION COMPLICATION (very mild symptoms) and MYALGIA (mild soreness in the arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Treatment medications was provided.   This case was linked to MOD-2021-298226 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow up received and contains no new information regarding 1st Dose.
Narrative: Per ER MD: "2nd dose of covid vaccine today then went home. His family found him unresponsive and started CPR and he woke up."
I immediately started having a pain run from the vaccine location in my arm to my neck. I have continued to have a severe (catch) or some call (Crick) in my neck since the vaccine .  The arm pain subsided in about 24 hours, but on day three since the vaccine, I cannot turn my head for the catch in my neck.
fever >105 from 4 hrs p/vax x 4 days w/pain & swelling @ site of DTP;
Pt received Covid vaccine on 1/20/21 at Clinic ran by Public Health. Pt c/o increased redness, raised area and warm to touch, localized reaction. Pt instructed to use Tylenol and cold pack area
Starting 04/17/2022, I woke up in the middle of the night with a sore throat and it went away. I was fine until 04/19/2022, where when I woke up I had a sore throat again and mild nasal congestion. I took an at home test for COVID-19 and it was positive. I went to a clinic, where it was confirmed I was positive. At 5pm on 04/19/2022, I was treated with a monoclonal antibody infusion. By 04/20/2022, I was symptom free.
Patient states that 8 hours after administration of PCV13 developed arthralgia, myalgia, anorexia, nausea, and fever.
This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a adult female patient who received dTpa vaccine. Co-suspect products included glycerol unknown for an unknown indication. Concurrent medical conditions included infected toe. On an unknown date, the patient received dTpa vaccine and glycerol at an unknown dose and frequency. On an unknown date, less than a day after receiving dTpa vaccine and unknown after starting glycerol, the patient experienced feeling hot, generalized pruritus and hypersensitivity. The patient was treated with BENADRYL. On an unknown date, the outcome of the feeling hot and generalized pruritus were not recovered/not resolved and the outcome of the hypersensitivity was unknown. It was unknown if the reporter considered the feeling hot, generalized pruritus and hypersensitivity to be related to dTpa vaccine and glycerol. Additional details were provided as follows: The age at vaccination was not reported. On an unknown Monday, the patient went to the emergency room due to an infected toe and received dTpa as tetanus shot for the infected toe. During the night she woke up with her body on fire and itching all over. The patient took BENADRYL as treatment which provided some relief. The patient thought that the symptoms might be related to an allergic reaction to Glycerol. It was unknown, if the patient received BOOSTRIX or another dTpa booster from another manufacturer. The patient called the hospital back to find out which vaccine she had received and she was provided with GSK number to call. It was reported that, limited information was obtained as caller disconnected the call.
2 hours after vaccine administration parents noted that pt. complained of injection site pain and refusal to use that extremity (Right Leg).  Site became red and markedly swollen despite treatment with Ibuprofen and cold compresses.  Pt then became febrile and because of her diagnosis of sickle cell disease was directed to seek care in the Emergency Department, and subsequently admitted.  Pt. developed aplastic crisis (hgb of 6.6 and 0% reticulocyte ct.) and required PRBC transfusion.  Had increased WBC (24,000) and was began on IV Vancomycin as a recommendation by our Infectious Disease team.  At the time of this report pt is still inpatient at hospital.
Rapid heart rate (140bpm-160bpm) @ 7:00 PM on day of vaccination.  Heart rate was normal (60-66bpm) the morning of Friday, 02/26/21. Double vision was experienced the morning of Saturday, 02/27/21, 2 days after vaccination. Double vision continues at this time (12:15 PM).
This is an initial spontaneous report by a contactable nurse via a Pfizer Sales representative who reported on three patients. This is the third of three reports. A currently 4 year old patient (age and gender not specified), received a dose of PREVNAR 13 (lot number 916971), administered by intramuscular injection in the thigh as a catch-up dose on 30Sep2010. Relevant medical history and concomitant medications were unknown. Vaccines given on the same day or taken within the last four weeks were none. On 30Sep2010, the patient experienced rashes at injection site with a radius greater than 2-5 inches. The event did not require an emergency room or doctor visit. Relevant laboratory data was unknown. At the time of the report the patient had not recovered from the event. Follow-up (17Oct2011): Follow-up attempts completed. No further information expected.
Arm sore; rash on chest; tight chest; numbness and swelling on left side of face; numbness and swelling on left side of face; numbness and swelling on left side of face, throat; numbness and swelling on left side of face, throat; numbness and swelling on left side of face, throat, and tongue.; numbness and swelling on left side of face, throat, and tongue; This is a spontaneous report received from a contactable other health care professional (Patient herself). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration (at the age of vaccination 33-year) in Left Arm on 07Mar2021 10:30 as 1st dose, single for COVID-19 immunization. Medical history included asthma, Known allergies, endometriosis, anxiety and depression. Concomitant medications included fluoxetine hydrochloride (PROZAC); clonazepam (KLONOPIN); albuterol (SALBUTAMOL); elagolix sodium (ORILISSA) and lamotrigine (LAMICTAL). The patient haven't tested COVID prior and post vaccination. On 07Mar2021 10:30 the patient experienced arm sore, rash on chest, tight chest, numbness and swelling on left side of face, throat, and tongue. Therapeutic measures were taken as a result of the events. The patient visited Emergency room for the events. Patient was treated with Epi-pen, benadryl, albuterol, prednisone. The seriousness of the events was reported as non-serious. The clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
he's whole arm up to the shoulder area turn red and became warm.; he's whole arm up to the shoulder area turn red and became warm.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 13 year-old male patient received bnt162b2 (COMIRNATY), administration date 21Dec2021 (Batch/Lot number: unknown) at the age of 13 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 21Dec2021, outcome "recovered" (21Dec2021) and all described as "he's whole arm up to the shoulder area turn red and became warm." Therapeutic measures were not taken as a result of erythema, feeling hot.  Additional Information: Caller stated that a 13-year-old male (date of birth: DOB) came in before his second dose; and mentioned that during his first dose, he's whole arm up to the shoulder area turn red and became warm. This event was anticipated for about 20 minutes with no treatment. Caller wants to know if this situation is considered a contraindication for the patient to get his second dose of Pfizer COVID vaccine. Pharmacist did not administer the second vaccine/Longer than 21 days since first vaccine. Caller states that he was calling from (Pharmacy name and address withheld), about the Pfizer Comirnaty vaccine, adult, for ages 12 and over. Caller stated he had a patient come to the pharmacy today for his second dose of vaccine. During the pre vaccine interview, the patient's mother states that her son had a reaction to the first dose of vaccine, on 21Dec2021. The mother reported that after the injection, her son's whole arm felt warm and the arm turned red and after 20 minutes the warmth and redness dissipated without any treatment.  Caller agreed to file a safety report. Caller stated that he did not want to give the patient a second dose of vaccine, until he found out if it was safe to give the vaccine to the patient, after his reaction after the first dose? Caller states if it is safe to give the patient a second dose, or if there is any contraindication with the initial reaction to the first vaccine? . Seriousness was not provided for reported events. History of all previous immunization with the Pfizer vaccine considered as suspect reported as No. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as unknown. Seriousness criteria was reported as non-serious for all reported events. Any AE(s) did not require a visit to Emergency Room and Physician office.  Prior Vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) reported as  Unknown. Patient's Medical History reported as unknown and Family Medical History Relevant to AE(s) as not provided. Relevant Tests reported as unknown.  Follow-up attempts completed. No further information is expected.
Positive Saliva test for COVID-19 post vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive Saliva test for COVID-19 post vaccination) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced COVID-19 (Positive Saliva test for COVID-19 post vaccination). At the time of the report, COVID-19 (Positive Saliva test for COVID-19 post vaccination) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test: (Negative) Negative. On 28-Jan-2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up received on 01-JUN-2021 and it contains No new information
had Shingrix and got 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 4 months after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had the Shingrix shot for shingles and got shingles about 4 months later. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Developed slight fever, chills, muscle aches, nausea, tired, pain in arm at injection site and most importantly, noticed the morning of the 7th:  pain deep in the left armpit and swelling of the left armpit leading onto the left breast (following lymph nodes?).
late second dose / First dose was given on Jan2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by pharmacist on behalf of a physician. The age at vaccination was not applicable for this report. The age group of the patient was not reported. but selected as an adult as per vaccine indication. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter called for information regarding the administration of a late 2nd dose of Shingrix. The reporter consented to follow up but mentioned that it would be best to contact the physician, but pharmacist could not provide consent on their behalf.
Pt co L hand tingling.  started 5 minutes after getting injection in L deltiod.   States it feels like she fell asleep on her arm.  This did not happen after her 1st covid vaccine.  Instructed pt to contact provider if tingling persists or increases.
Metallic taste after first vaccine and after second vaccine. Chills, aches, feverish after second vaccine. Hard lump under injection site. Minor redness.