chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 5 minutes of administration of vaccine intranasally patient became ill. Symptoms included light-head, perspiring, clammy feeling. Patient remained alert. Paramedics where called and patient was transported to hospital.
sore left arm; LOW fever; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (sore left arm), MATERNAL EXPOSURE DURING PREGNANCY, and PYREXIA (LOW fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (40 weeks 4 days) in October 2014, In vitro fertilization and Miscarriage in October 2020. Concomitant products included PRENATAL VITAMIN and BABY ASPIRIN for an unknown indication.    On 13-Jan-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 18-Nov-2020 and the estimated date of delivery was 05-Sep-2021. On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore left arm) and PYREXIA (LOW fever). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy.  On 13-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY had resolved. At the time of the report, PAIN IN EXTREMITY (sore left arm) had not resolved and PYREXIA (LOW fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, Pregnancy test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided. Estimated Date of conception was 18-Dec-2020
Fever, severe weakness, body aches, severe  headache, swollen painful swollen lymph nodes, painful swollen injection site lasting almost 48 hours at the moment. Symptoms slightly improving during this time.
Second dose administered after exposure to room temperature greater than 24 hours; Second dose administered after exposure to room temperature greater than 24 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Second dose administered after exposure to room temperature greater than 24 hours) and PRODUCT STORAGE ERROR (Second dose administered after exposure to room temperature greater than 24 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Second dose administered after exposure to room temperature greater than 24 hours) and PRODUCT STORAGE ERROR (Second dose administered after exposure to room temperature greater than 24 hours). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Second dose administered after exposure to room temperature greater than 24 hours) and PRODUCT STORAGE ERROR (Second dose administered after exposure to room temperature greater than 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided. Storage condition at the time of the excursion: refrigerated storage. Maximum temperature reached: 10 degrees Celsius. Excursion duration: 1 hour 20 minutes. Date vial(s) moved from freezer to refrigerator: 01-Oct-2021.   This case was linked to MOD-2021-374037 (Patient Link).
Lump noted on left shoulder on 2/9/03 (three days after vaccine administered). 1.5cmx2cm raised indurated area at the site of vaccine administration. No tenderness, warmth, or erythema.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 03-DEC-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # H020901, expiry date 05-JUL-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Hives and itching to arms and chest. Benadryl 50mg po given with improvement of symptoms until the following day when she blistered on arms and face. Went to physician who diagnosed shingles secondary to allergic reaction to seasonal flu vaccine.
Hives and slight rash on left side of neck and chest, itchy and red.  Did take Benadryl that did help.  Had a little rash area on chest next morning 10/27/15, took another dose of Benadryl that morning on 10/27/15.
tested positive for COVID the other day; tested positive for COVID the other day; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 27Apr2021, outcome "unknown" and all described as "tested positive for COVID the other day". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2021) Positive, notes: tested positive for COVID the other day. Additional information: Patient tested positive for COVID the other day. Patient experienced a metallic and bitter taste in his mouth which lasted for a few hours. Patient had read in the site that altered sense of taste is a possible side effect.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT CALLED 18 DAYS POST FIRST DOSE OF VACCINE. SHE STATED THAT SHE IS STILL EXPERIENCING ARM PAIN THAT HAS RADIATED FROM THE INJECTION SITE DOWN TO HER ELBOW AREA. SHE STATED THAT HER ARM HAS A BURNING SENSATION, TENDERNESS, AND SENSITIVITY. SHE STATED DISCOMFORT WHEN HER ARM IS IN CERTAIN POSITIONS.
Starting 6-7 hours after the vaccine I began to have the most severe ear pain that would not go away with Tylenol/ibuprofen. I was unable to get up/sit up on my own. My lumbar spine seized up and spasmed feeling like I had an acute injury. I had chills but no fever.
Felt like I got run over by a truck. Flared up everything. Pain, fatigue, stiffness, respiratory symptoms, stuffiness. Felt like there was no oxygen, but I puffed the inhaler and I was fine. Lasted about 5 days.
Within 1 hour of receiving the vaccine, I had mild tongue swelling, shortness of breath, fingers swelling, intense sweating and faintness. Within 24 hours of receiving the vaccine, hives developed on my left thigh. The tongue swelling, shortness of breath and faintness happened on and off for the first day. It resolved on its own by the next day. The hives got progressively worse and peaked roughly 48 hours after getting the vaccine. They slowly faded, but are still faintly noticeable. I had general malaise  for the rest of the week. I have photos showing the progression of the hives.
Approx 1 inch red, raised, warm to touch cellulitis to left upper thigh. Treated with amoxicillin (400mg/5 ml) 5 ml po BID x 10 days.
A physician reported that a 5 month old infant (gender unspecified) developed drug resistant Streptococcus pneumoniae meningitis on 02/2/2002. The infant received two doses of Prevnar, two months apart. In November 2001, the infant (at age 2 months) received the first dose. The infant is a twin, and it was reported that both twins developed meningitis (see HQ1255711MAR2002). The physician noted that the infants had no daycare experience, no immune deficiencies or drug sensitivities. They were "resistant to all" except vancomycin and chloramphenicol. At the time of this report, the infants had not improved. No further info was provided. This event was considered medically important.
interstitial cystitis was improved; smell hot electric wire (on and off); tasted weird things in mouth; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS INTERSTITIAL (interstitial cystitis was improved), PAROSMIA (smell hot electric wire (on and off)) and TASTE DISORDER (tasted weird things in mouth) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concomitant products included HYDROXYZINE for Cystitis interstitial.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced CYSTITIS INTERSTITIAL (interstitial cystitis was improved), PAROSMIA (smell hot electric wire (on and off)) and TASTE DISORDER (tasted weird things in mouth). The patient was treated with MELATONIN at a dose of 1 mg once. On 31-Mar-2021, PAROSMIA (smell hot electric wire (on and off)) and TASTE DISORDER (tasted weird things in mouth) had resolved. At the time of the report, CYSTITIS INTERSTITIAL (interstitial cystitis was improved) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was Not Applicable.     This case was linked to US-MODERNATX, INC.-MOD-2021-092725 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092725:1st dose case
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild
Right deltoid with redness and slightly raised area 3 inches by 1 inch - itching generalized body itching. Patient present to clinic 10/31 examined-treated with Benadryl
urticaria on all extremities, chest, abdomen and head. Took PO 50mg benadryl at 2000 and awaiting outcome at this time.
Information regarding PREVNAR was received from a healthcare professional regarding a 7-month-old male patient who experienced pneumococcal bacteremia.  The patient received the third dose on 15-Jul-2009.  The patient also received the third dose of PENTACEL (Aventis-Pasteur) on 15-Jul-2009.  The patient experienced a high fever.  On 25-Aug-2009, blood culture was positive for highly resistant streptococcus pneumoniae.  Initial treatment included ROCEPHIN but changed to AUGMENTIN when blood culture came back positive.  On 27-Aug-2009, blood culture was negative.  The patient recovered.  This event either required emergency room or doctor visit.  QA results were within specifications of Lot number D46874, C87310 and D335501.  No additional information was available at the time of this report.
He wasn't feeling well after the shot and I just took it as somewhat "normal" and then  came down with a fever and was having extreme hallucinations with hysteria. This latest all night and into the morning. We were able to comfort him through it and was lethargic for the next 24 hours.
Red erythema round patch approximately 4-4.5cm diameter on left arm at site of vaccine, mild to moderately pruritic with mild heat and pain- has progressed over last 36 + hours to make me wish to report reaction as well as read literature currently posted on line to assure that this is not considered dangerous but I should report reaction.
Blotchy, redness skin, side of neck began 11/3 p.m. with chills. Increased redness, with burning & itching sensation upper lids, forehead, (R) side neck - no rash or hives. No respiratory sx. similar sx with sulfa reaction in past.
This spontaneous report as received from a consumer refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with incorrect storage doses of PEDVAXHIB. Temperature excursion: 48.0 degrees Fahrenheit for about 5 and a half hours. This is one of three reports received from the same source. Sender's Comments: US-009507513-1708USA006931: Original Case: 1708USA006823; US-009507513-1708USA006823: Original Case: 1708USA006823.
Developed hives w/in 24hrs of shots w/a fever of 102F;
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (she broke out with hives on arm, back, chest, stomach and face; they are cluster hives that are blistering turning red, burn and are getting worse) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 006B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (she broke out with hives on arm, back, chest, stomach and face; they are cluster hives that are blistering turning red, burn and are getting worse). The patient was treated with HYDROXYZINE for Urticaria, at an unspecified dose and frequency. At the time of the report, URTICARIA (she broke out with hives on arm, back, chest, stomach and face; they are cluster hives that are blistering turning red, burn and are getting worse) outcome was unknown.            Concomitant products were not provided. Treatment products were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-jun-2021 and contains no significant information
Received first dose of the Moderna vaccine LOT: #001B21A. Pt flagged down EMT. Pt reported feeling dizzy, hypertensive and right arm soreness. BP: 160/96, pulse: 68. EMT offered pt EMS at 1434. Pt refused EMS. Pt stated that she had an allergic reaction to the flu vaccine years ago and that she took her hypertension medication in the morning. Pt stayed an extra 15 minutes for observation. Pt symptoms subsided. Pt left vaccination site at 1447 with a steady gait.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The patient received Shingrix and had shingles. The reporter consented to follow up. No additional information was provided.
Fainting - never lost consciousness   Shot given 10:10am.  Was in waiting room and reported feeling light headed at 10:25am.  10:25am. Faint/dizzy/supine  BP 124/77   Pulse 74. Respiration. 16  10:30am Supine  BP  135/73. Pulse 63  10:35am. Supine  BP.  134/80. Pulse 66  10:40am. Sitting  BP 135/72. Pulse 62  ***follow-up call made 12:27pm had to leave message
Swelling at inject site 10 days post vax. Pt describes area as mildly pruritic and painful. States L hand mildly numb.
No additional AE; The nurse stated Pneumovax 23 that underwent a temperature excursion was administered; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 16-JUN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe at the dose of 0.5 milliliter (ml), lot # S021740 with an expiration date reported and validated as 25-MAR-2021, for prophylaxis (dose number, route of administration and anatomical location were not reported). It was stated by the nurse that the vaccine underwent a temperature excursion (product storage error). No additional adverse events were reported, nor product quality complain involved.   It was reported that a data-logger was involved (captured in Marrs #2007USA002972).  This is one of the several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S021740; expirationdate: 25-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA002422:01631944 US-009507513-2007USA002972:01631948
Started feeling extremely dizzy, probable vertigo. Was severe for a few days, then subsided a little but she still feels it.
I started having what seemed like allergies. The morning of the 10th I drank my morning coffee and it did not taste right so I got out my at home COVID-19 test which came out positive. I reached out to my doctor via phone and she recommended DELSYM DM and TYLENOL. She also sent me in an albuterol inhaler to help. She said if it got worse she could prescribe me something but wanted to try the over the counter medications first. It did not completely clear up until 03/22/2023 and I was still having a positive COVID-19 test up until then.
second dose on 09/29/2021, developed shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included diabetes.   On 29th September 2021, the patient received Shingrix. On 29th September 2021, less than a day after receiving Shingrix, the patient experienced shingles. On 29th September 2021, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient received shingrix vaccine and developed shingles in exact same dermatone as previous shingles. The patient was diabetic. The reporter consented to follow-up.
Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore left arm). At the time of the report, PAIN IN EXTREMITY (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.   This case was linked to MOD-2021-079722 (Patient Link).
Headaches; Burning Urination; Feeling lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (Burning Urination), DIZZINESS (Feeling lightheaded) and HEADACHE (Headaches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DYSURIA (Burning Urination) and DIZZINESS (Feeling lightheaded). On 20-Mar-2021, the patient experienced HEADACHE (Headaches). At the time of the report, DYSURIA (Burning Urination), DIZZINESS (Feeling lightheaded) and HEADACHE (Headaches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medications was provided.  No treatment medication was provided.  Patient got her second shot on 18-Apr-2021.   This case was linked to MOD-2021-267205 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: New adverse event was added. First dose information was updated. Action taken updated.
Developed a rash in my left armpit the next day. The second day after vaccination I started to feel tingling in both legs that has continued on and off to date.
Red, warm, round place on arm where vaccine was administered. Patient stated that this area itches.
Spark in brain causing a trip in my step. By evening I was sick all over. Followed by severe Chest Pain, back pain, stomach pain, fluid in lungs and heart. Elevated liver and cysts on liver. Weight loss of 14 lbs within 10 days. Confusion and inability to concentrate, depression, constipation, foul taste, dulled all 5 senses, numbness all over my body - behind legs, face, lips, ears, chest, etc.  Loose teeth. Taken to ER by ambulance when we thought I was having a heart attack on 11/17/2016. 3 day stay  no medical professionals would acknowledge all symptoms were related to the vaccination of PCV13. Started passing out and falling in hospital. Sent home to call GP within 5 days. Waited 5 days, no return call. Feeling very confused, lots of pain, needed sleep desperately. Took medicine and went to sleep. Next morning husband found me with loud breathing and called EMS. Stayed 7 days in hospital  3 in ICU. No diagnosis.
Within 5 minutes of giving the vaccine, patient presented with feeling dizzy, numbness, slurred speech, skin rash on chest and wheezing. He was sent to ER by EMS. In route was given BENADRYL. Per mother's information within about 40 minutes of being in the hospital was back to normal. In the hospital he was observed for about 6 hours.
After shot states she started to have muscle spasms, with pain, swelling and tenderness. Diagnosed with mild cellulitis on 9/6/02. After shot given, patient said her mother told her she had similar reactions in the past and should only take half doses.
Patient complained of burning and aching at site immediately after injection. Returned to health center 2 hours later with flushed face and hot feeling. Rash localized to cheeks and chin (erythema). No other rashes/hives present.
Patient was given Moderna vaccine for 3rd dose. Patient does not fall under the approved Moderna age group.
SOFT BALL KNOT SIZE, RED, SWOLLEN, ITCHING, HARD