chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In the last 2 years patient had a mild case of COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (In the last 2 years patient had a mild case of COVID) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (In the last 2 years patient had a mild case of COVID). At the time of the report, COVID-19 (In the last 2 years patient had a mild case of COVID) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient received 4 Moderna COVID-19 vaccines so far. Patient was going on a cruise on 6 AUG 2023 and was debating getting another dose of the Moderna COVID-19 vaccine. Patient never had any side effects from the vaccine so far but was concerned about that with another dose. in the last 2 years they had had a mild case of COVID.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-734062 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734062:Same Reporter
Developed ringing in left ear a week after vaccine administered.   Very loud at times. Worse at night making sleeping difficult.  Exhausted.   Has not improved 2 1/2weeks now since vaccine. Getting louder.
Rec'd flu vaccine 12/5/01 4:30pm. Developed fever, chills, headache. 11am 12/6 Tx with tylenol - Sx free as of 9pm 12/6/01.
Pt recvd 1st dose of Hep B vax 01NOV89 & 02NOV89 devel generalized pruritus & mild shortness of breath w/o wheezing. Sx resolved spontaneously by next day.
Diagnosed with shingles on 9/17/21 Rash on neck Extreme pain in neck/spine
SUSPECTED COVID 19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a 26 year old White male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 21-SEP-2021, the patient tested Covid-19 positive using the Rapid antigen test. It was reported that the patient had breakthrough Covid-19 and the symptoms were low fever, scratchy throat, and congestion and he took Tylenol (suspected Covid-19 infection and suspected clinical vaccination failure). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000194298.; Sender's Comments: V0: 20210944277-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This vaccine was administered by outside facility from anther medical office two days ago (8-21-23). Pt began having symptoms of arm pain, followed by red rash on arms, chest, neck and face along with facial swelling. Pt was treated with prednisone, hydroxyzine and pepcid to begin on 8-23-23.
Severe joint pain, headache, chills with shaking severe. Weakness lasting 4 hrs. As of 10/19/04 at 11AM pt c/o med joint pain, fatigue and mild headache
This case was reported by a consumer via patient support programs and described the occurrence of vaccination failure in a elderly male patient who received Influenza vaccine. Concomitant products included ADVAIR DISKUS and VENTOLIN HFA. In October 2017, the patient received Influenza vaccine. On 2nd January 2018, less than a year after receiving Influenza vaccine and an unknown time after starting ADVAIR DISKUS and VENTOLIN HFA, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza A virus infection (serious criteria hospitalization). On an unknown date, the patient experienced bronchitis (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza A virus infection and bronchitis were recovering/resolving. The reporter considered the vaccination failure, influenza A virus infection and bronchitis to be unrelated to Influenza vaccine. Additional details were reported as follows: The patient was transferred from the Program. The age at vaccination was not reported. The patient stated he had been taking ADVAIR DISKUS and VENTOLIN HFA for many years dates unknown. He stated he tried stopping ADVAIR DISKUS for awhile (missed doses), dates unknown, but it didn't work and he got sicker, so his physician told him he must stay on it. The patient did not know the manufacturer of the flu vaccine he received, but understood that many flu shots this year are ineffective against the flu strain. The patient said that he gets bronchitis all the time and he thought he was experiencing bronchitis either end of December 2017 or early January 2018 and was hospitalized on 2nd January 2018 for several days and was diagnosed with Type A Influenza (lack of drug effect). At the reporting date, the patient stated he was finally starting to feel a lot better. The patient was also upset that he has to make selections in the phone tree when calling the GSK Program. He appreciated the medications he receives from GSK but did not appreciate what he calls the system around getting these medications being so unhelpful. The patient has denied permission to contact their physician and did not provide information of the same. The patient did not wish to receive any follow up mailings about this report but would speak by phone. The patient declined to provide all the details for this report.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "pneumonia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reports severe arm pain that resulted in inability to move right arm. She also reported a bruise that spanned from her deltoid to almost her deltoid. She also said her right hand swelled up. She ended up going to the ER to get it treated. Interaction between Xarelto and Clarithromycin is the most likely cause of this reaction due to the 2-fold increased systemic exposure to Xarelto due to pharmacokinetic interaction (i.e. increased risk of abnormal bleeding).
Information has been received from a health professional concerning a female in mid 60's who on approximately 10-NOV-2005 was vaccinated in the deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 651329/1047P).  Subsequently, the patient experienced fever, and erythema and edema at injection site.  Subsequently, the patient recovered.  No further information is available.
Patient was administerd a 0.3ml undiluted dose of the pfizer pediatric bivalent covid 19 vaccination instead of the 12+ bivalent pfizer covid19 vaccination. the error was caught a couple hours after administration and so far no adverse reactions have been reported from the error per patient
This spontaneous report as received from a physician who is the female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). On an unknown date the patient experienced pain and swelling at injection site. The patient sought medical attention via doctor visit. It was unspecified whether laboratory diagnostic studies were performed. The outcome of pain and swelling at injection site was reported as recovered/resolved. Additional information is not expected.
I received my first Moderna shot on 2/25.  The shots were being administered by Health Department.    My vaccine was on 2/25/21 at 2 p.m.  No immediate reactions. On 2/26 and 2/27, my arm was sore at the injection site.  No other reactions. On 3/4, my injection site was no longer sore, but became itchy.   On 3/5, I noticed that the injection site has a golfball-sized red area at the injection site.  It is not raised.  It is slightly itchy. It does not hurt. On 3/5 I googled the symptom and discovered articles about "Covid Arm."  I decided to report my experience due to it seeming to be a rare, but reported, occurrence.
pt recv vax 21AUG97 & while in exam room waiting pt slid down to the floor & had brief tonic-clonic movements;pt was pale & clammy but did not lose bladder control;episode <1min & recovered fully in 2-3min;exam nl reassured vasovagal episod
Initial report received on 02 December 2009 from a health care professional. This case involves a 46-year-old female who is one of two cases in a cluster reported by the same reporter. The other patient's information is reported in 2009-05287. A 46 year old female with no known allergies received in the left arm an injection (route not reported) of ADACEL (lot number not reported) on 05 October 2009. On 20 October 2009, the patient was seen the the doctor's office for swelling, lump and "purplish" discoloration at the injection site. The exact date of onset was not reported. The patient had no reported illness at the time of vaccination. The patient's recovery status was reported as unknown. Follow-up information received on 08 January 2010 from a healthcare professional. The patient;s recovery status was reported as recovered.
14:50  Client reported tingling sensation on L hand/ fingertips approximately 5 minutes after the vaccine was received. No other symptoms presented. Client was A/O  x 4, no respiratory distress observed. initial V/S BP 138/98, HR 81, RR18 and 02 sat of 97% on RA.  3:33, patient feels better and said she does not feel the tingling anymore. Instructed to call her PCP for further evaluation or call 911 for SOB or respiratory distress or any symptoms of anaphylactic reactions. Patient  left the vaccination site without complaints
First adverse effects started the night after the booster shot was given and incuded chils, fever, muscle aches, tiredness, and loss of appetite--lasting about 22 hours.  In November around the 14th, I started with intense pain on my left side near my rib cage.  It became so bad I went to urgent care and was diagnosed with shingles.  I was given meds for this and for pain.  Doctor said there was a rash, but no blisters.  I took meds and symptoms disappeared in about 3 days, but reappeared 3 more times in other locations.  Again, I took meds and symptoms disappeared each time after about 3 days.  Read where shingles from booster were usually mild, compared to other shingle incidents.  I considered each of these mild as I had no blisters and had the nerve pain for only about 24 hours each time.  i have never had shingles before.  ok
Tingling tongue, swollen tongue, swollen lips, small rash on upper arm near injection site and opposite forearm, tightening in throat, inability to swallow,  difficulty breathing,  unable to breathe,  Inability to talk, pale, hoarse voice, intermittent cough,
ALT(alanine aminotransferase) 101; AST (aspartate aminotransferase) levels elevated; This is a spontaneous report from a contactable consumer. A 50-year-old female patient (not pregnant) received the first dose of bnt162b2 (BNT162B2 also Covid 19 vaccine brand Pfizer, lot EL1284), via an unspecified route of administration in the left arm on 29Dec2020 07:00 at SINGLE DOSE for Covid-19 immunisation. He received the vaccine in a hospital. Medical history included menopause and acid reflux. He had allergies to medications, food, or other products: Sulfa, Levaquin, Loestrin Fe. Concomitant medications included methylprednisolone and pantoprazole. On 30Dec2020, his ALT(alanine aminotransferase) and AST (aspartate aminotransferase) levels were elevated. ALT 101 and AST 54 on 30Dec2020. Has reverted back to normal levels ALT 18 on 14Jan2021 AST 20 on 14Jan2021. No treatment given. The outcome of events was recovered.
Raised red area around site of injection in left arm, upper remained red and raised until Sunday 10/22/06. Also reported that pt was sleepier, redness started 10/20/06. Had fever 101 eve of 10/19/06. Reported per PC with mother Motrin was given per mom.
pt recv vax & w/in 5 mins, exp dizziness, lightheadedness, general discomfort described as not feeling the same as before & flushing; The nurse felt that the pt's sx may have been due to the pt's apprehension about the inj;
pt. had local reaction to the vaccine given. Th site showed redness, induration and warmth in the site.
I started with a headache and strong body aches that disturbed my sleep the night of the vaccine. The next day I experienced continued headaches and bothersome dizziness, like vertigo. Dizziness and headaches continued into the third day, the tapered off the fourth day after the injection. I stayed in bed a lot for a couple days because of the side effects.
TH - No immediate swelling FRI- exhausted no swelling SAT - Face, neck, hand swollen   Said take benadryl SUN - Very swollen, face, neck hands, lymphnodes, breasts   MON - Very swollen, face, neck hands breasts, abdomen  (gave prescription Methylprednisolone) TUES - Very swollen, face, neck, hands, lymphnodes, breasts, stomach WED Very swollen, face neck, hands, lymphnodes, breasts, stomach Thurs - Back to  ER - got steriod shot FRi - first day I was not swollen too bad, but face and neck a little swollen upon awaking, and still can't wear - hands swollen, other areas getting better  Today (SAT)  VEry swollen upon waking up, hands, neck, lymphnodes, breasts and abdomen (Out of prednisone)
Musculoskeletal stiffness: fever Information has been received from a requistered nurse concerning a patient who was vaccinated "years ago" with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Two weeks post-vaccination, the patient experienced muscular stiffness and developed a fever.  The patient sought unspecified medical attention. Additional information has been requested.
Fever 100.4, chills, aches, rash on right chest, arm pain at the injection site, took Tylenol. Fever lasted 24 hours. 7/8/21 noticed rash,
Patient initially developed symptoms of COVID on 8/10 with + test on 8/15. Patient was previously admitted from 8/17- 8/23 at hospital for COVID pneumonia and acute hypoxic respiratory failure. Was treated with steroids, remdesivir and antibiotics.  Discharged home on oxygen , steroids and antibiotic. Returned to hospital on 8/25 due to hypoxia despite home oxygen. O2 sats on arrival at 80% and placed on Vapotherm with improved oxygenation. Chest xray showed worsening bilateral multifocal pneumonia. Required intubation and mechanical ventilation on 8/28. Found to have pulmonary embolism throughout lungs and evidence of right heart strain on CTA on 8/30.  Started anticoagulation with heparin. Acute worsening of chronic kidney disease and started on CRRT and levophed.  Due to continued deterioration family decided on comfort care on 9/11.
fevers with shaking (unlikely seizures based on description) followed by itching at site of injection and diffusely scattered papules
Aches/Achy; Exhaustion; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches/Achy), FATIGUE (Exhaustion), HEADACHE (Headache) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006021A and 012A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Aches/Achy), FATIGUE (Exhaustion), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of every 6 hours. At the time of the report, PAIN (Aches/Achy), FATIGUE (Exhaustion), HEADACHE (Headache) and PYREXIA (Fever) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got shot in the morning, took Tylenol, in the evening, took an extra nap, slept for a couple hours and it got resolved in a day.   This case was linked to MOD-2021-379489 (Patient Link).
Post vax, the pt developed Guillain-Barre syndrome. No further information was available at the date of this report. FU received indicated the patient was an elderly female who received 1999-2000 formula influenza virus vaccine. See related case HQ5472103JAN2001.
Right arm swelling from flu shot given on 10-2-09. Pt given a brace for  (R) arm.
Severe body aches, vomiting, high fever (102 degree), sweating, chills ,can't keep food down, Migraine headache, nausea, diarrhea, couldn't sleep, constantly feeling ill. Feeling like someone is "poisoning me." Constant reactions like being "overdosed." Symptoms have lasted at least a week. Still ongoing.
missed a week of work; pain; GI problems; This case was reported by a consumer via call center representative and described the occurrence of activities of daily living impaired in a female patient who received Hepatitis B vaccine for prophylaxis.   The patient's past medical history included chickenpox and mumps. Previously administered products included Hepatitis B vaccine with an associated reaction of pain (1st dose received in october 1995 for further tolerance refer case US2020AMR209271), Nordette (Discontinued in 2011), MMR with an associated reaction of pain (for further tolerance refer case US2020AMR209271) and Dtap with an associated reaction of erythema (for further tolerance refer case US2020AMR209271).   In May 1996, the patient received Hepatitis B vaccine. On an unknown date, more than 2 years after receiving Hepatitis B vaccine, the patient experienced activities of daily living impaired, pain and gastrointestinal disorder. Rechallenge with Hepatitis B vaccine was positive. On an unknown date, the outcome of the activities of daily living impaired, pain and gastrointestinal disorder were recovered/resolved.   It was unknown if the reporter considered the activities of daily living impaired, pain and gastrointestinal disorder to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Hepatitis B vaccine experienced missed a week of work, she was in pain and had GI problems. The reporter informed that she  had a hard time with vaccine her physician  advised against Boostrix in 2005 (she did not get it) instead she wears gloves in public and keeps her hands clean. The reporter did not consented to follow up. No further information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209271:For 1st dose
Patient came in to see provider as they had an injury and requested to get the ADACEL. Nurse grabbed the PEDIARIX vaccine in error and administered that to the patient.
Injection site hot; Puritic skin reaction in the site of the injection/itching; Raised red area at the injection site/Red injection site; raised red area at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Raised red area at the injection site/Red injection site), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Puritic skin reaction in the site of the injection/itching) and VACCINATION SITE SWELLING (raised red area at the injection site) 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 24-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, the patient experienced VACCINATION SITE ERYTHEMA (Raised red area at the injection site/Red injection site), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Puritic skin reaction in the site of the injection/itching) and VACCINATION SITE SWELLING (raised red area at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Raised red area at the injection site/Red injection site), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Puritic skin reaction in the site of the injection/itching) and VACCINATION SITE SWELLING (raised red area at the injection site) outcome was unknown.        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.   Concomitant medication was not reported. Treatment medication was not reported. 9-10 days post injection the patient experienced a pruritic skin reaction in the site of the injection. This included itching, hot, raised red area at the injection site.; Sender's Comments: This case concerns a patient of unknown age and gender who had NS events of unexpected vaccination site reaction, vaccination site pruritus, and expected vaccination site erythema.  Event onset occurred 9-10 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Chills; icky feelings; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), CHILLS (Chills) and VACCINATION COMPLICATION (icky feelings) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included INFLIXIMAB (REMICADE).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness), CHILLS (Chills) and VACCINATION COMPLICATION (icky feelings). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.            Reporter did not allow further contact