chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 17 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered to patient of inappropriate age was not reported. This report was non-serious.
After I administered the flu shot, patient developed a quarter size knot near injection site. Monitored patient and notified him of the reaction. Patient stated he felt fine. Gave patient Benadryl and counseled him to take it before bedtime to help with the swelling.  Counseled patient on what to look for if reaction worsened. After several minutes, the swelling did not worsen so I let the patient leave. Patient said he felt fine to leave.
Suspected vaccination failure; get shingles; had three (3) of the injections; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient had 3 injections and still got shingles. The patient got 3rd dose of Shingles vaccine, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report as received from a physician assistant (P.A.) via a company representative refers to her mother, a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # not reported). On an unknown date the patient developed a "localized reaction". It was unspecified whether the patient sought for medical attention. The outcome of localized reaction was unknown. The relatedness for localized reaction was unknown for ZOSTAVAX. This is one of several reports received from the same source. Additional information has been requested.
severe fever, sleepiness, could not walk or stand for 2 days...bed ridden
DURING THE DAY. BODY ACHES. DURING THE NIGHT- DEVELOPED FLU LIKE SYMPTOMS FROM 8PM TO 3AM (BODY ACHES, CHILLS, JOINT PAIN, BUT NO FEVER) TOOK ADVIL WITH NO RESULTS.
1047: After receiving COVID vaccine, pt c/o tightening in left side of chest 1050: BP 148/70 HR 75 RR 16 SpO2 98% Temp 37.2  Benadryl 25 mg po given.   1110: Observed for 20 mins after Benadryl given. Resolved, VS stable, "felling better." Advised if symptoms return/persist to contact PC P.  Left with family member.
SWollen supraclavicular lymph node on site of injection!!!!! 10 other friends reported the same exact symptom!!!! Should be stated with calling Moderna. Should be in the literature. Its very scary!!
1/4/21: Severe headache, not relieved with OTC meds or prescription migraine meds. 1/7/21: itchy rash/hives on arm, legs, back and under chin.  One dose of Benadryl at that time with no relief.
Less than 24 hours after pt received immunization she had what was described as generalized seizure like activity.
Delayed localized swelling, erythema, warmth to the injection site  Increased dizziness from baseline  Increased head pressure
Pt woke on 10/14 AM w/rash - papules, pustules, & vesicles all noted on exam about 1 pm 10/14. Pt o/w well, no fever, no known exposure to CPOX.
3/17/10 Quarter size on left arm hot, freezing at night, couldn't get warm. 3/19 spot 2x2 red/hot, itching still cold. 3/19 spot 4x4 red/hot, itching 3/20 still 4x4 & hot. Thought I was coming down with a odd don't feel good. 3/21 spot still there but fading & cold gone. 3/22 spot down to quarter size. 3/23 spot quarter size. Redness finally fading. Redness from day one all around the site, hard & red.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 14-DEC-2015, patient received improperly stored VARIVAX dose 1, from lot # L015045 (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Symptoms returned and antigen tests turned positive on 5/21. Pt still symptomatic on 5/25 with  positive antigen test; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Symptoms returned and antigen tests turned positive on 5/21. Pt still symptomatic on 5/25 with  positive antigen test) in a 40-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.        On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, the patient experienced COVID-19 (Symptoms returned and antigen tests turned positive on 5/21. Pt still symptomatic on 5/25 with  positive antigen test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 14-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Symptoms returned and antigen tests turned positive on 5/21. Pt still symptomatic on 5/25 with  positive antigen test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 21-May-2022, SARS-CoV-2 test: positive (Positive) positive. On 25-May-2022, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a 40-year-old male patient with no relevant medical history, who experienced the non-serious unexpected AESI COVID-19,  after receiving the second dose of mRNA-1273 on an unknown date. Patient was treated with Paxlovid for 5 days and symptoms returned with a positive antigen test.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant medications information was reported.  Device date was reported as 25-May-2022.; Sender's Comments: Company comment: This is a spontaneous case concerning a 40-year-old male patient with no relevant medical history, who experienced the non-serious unexpected AESI COVID-19,  after receiving the second dose of mRNA-1273 on an unknown date. Patient was treated with Paxlovid for 5 days and symptoms returned with a positive antigen test.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a health professional concerning an approximately 64-year-old female with no known allergies who on 28-SEP-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650331-0749P).  Subsequently, in September 2005 the patient developed swelling from her shoulder to her elbow.  She was given antibiotics.  It was unknown if the patient was on other medications, and the patient's status at the time of the report was unknown as well.  Additional information has been requested.
7/19/08 went to ER for erythema and tenderness at injection site. Received KEFLEX sent home.
pt recv ax & w/in 24hr devel vomiting lasting a few days & diarrhea (up to 10 stools/day) persisting for approx 4 to 5 days;A stool sample was positive for rotavirus antigens;
< 24 hours after injection the pt's arm began to turn red, feel hot to the touch, these signs worsened over the next 12 hours. The child was seen by his primary care provider and diagnosed with a staph infection. He was treated with an antibiotic injection and oral antibiotics. The redness and warmth have resolved.
small blisters on both palms; had sore arm; had a bunch of red rashes all over body; This spontaneous case was reported by a patient and describes the occurrence of BLISTER (small blisters on both palms), PAIN IN EXTREMITY (had sore arm) and RASH ERYTHEMATOUS (had a bunch of red rashes all over body) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H21A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: Flu shot (within the last couple of months). Past adverse reactions to the above products included No adverse event with Flu shot.    On 14-Nov-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. In November 2022, the patient experienced BLISTER (small blisters on both palms), PAIN IN EXTREMITY (had sore arm) and RASH ERYTHEMATOUS (had a bunch of red rashes all over body). At the time of the report, BLISTER (small blisters on both palms), PAIN IN EXTREMITY (had sore arm) and RASH ERYTHEMATOUS (had a bunch of red rashes all over body) had not resolved.            Concomitant drugs were not reported.  Patient received dose 1 of Moderna on 11-Feb-2021 with lot number 030M20A, dose 2 on 11-Mar-2021 with lot number 030M20A and 1st booster dose on 09-Dec-2021 with lot number 056M21A.  It was reported that patient never had similar events in the past and did not seek any medical care.  Treatment medications were not provided.   This case was linked to MOD-2022-675721 (Patient Link).
Information has been received from a registered nurse concerning a female (age not reported who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine (lot not reported). Subsequently, the patient felt sick to her stomach but did not faint. The patient's status was not reported. Additional information has been requested.
Headache (Slight); Sore arm; Low grade temperature; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache (Slight)), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade temperature) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     It was reported that patient has never been diagnosed/tested positive for COVID-19.  Concurrent medical conditions included Drug allergy (Allergy to Sulfa), Lupus nephritis (Lupkynis (Vaclosporin) from 01-Dec-2021 for Lupus nephritis, bid, 7.9 mg 6 pills/ day, LOT 4244068AA) and Sjogren's syndrome. Concomitant products included MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-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 HEADACHE (Headache (Slight)), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade temperature). At the time of the report, HEADACHE (Headache (Slight)), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade temperature) outcome was unknown.            The patient received both dose (1st and 2nd dose) in the morning (am).  The patient reported that she did not had adverse effect with the first 3 Moderna shots, low grade temperature, headache (slight) and sore arm but nothing out of the ordinary.   No treatment information was provided.   This case was linked to MOD-2022-538122, MOD-2022-569112, MOD-2022-569113 (Patient Link).
low grade fever; couldn't lift my arm; I was completely flattened; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of low grade fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID vaccine with an associated reaction of pyrexia (on an unknown date received COVID vaccine).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced low grade fever (Verbatim: low grade fever), mobility decreased (Verbatim: couldn't lift my arm) and activities of daily living impaired (Verbatim: I was completely flattened). The outcome of the low grade fever, mobility decreased and activities of daily living impaired were resolved (duration 24 hrs).   The reporter considered the low grade fever, mobility decreased and activities of daily living impaired to be possibly related to Shingrix.     The company considered the low grade fever, mobility decreased and activities of daily living impaired to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAY-2023. This case was reported by a consumer via interactive digital media. The patient received Shingrix and felt completely flattened, low grade fever and could not lift arm for 24 hours.  The patient asked colleague have had shingles, patient would do anything to avoid it.
felt a little tender where the shot was; This is a spontaneous report from a contactable consumer (patient). This consumer reported for two patients (herself and her husband). This is the first of two reports.   An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 09Jan2021 at single dose for Covid-19 immunization. Medical history included ongoing cancer cell on eyelid. The patient's concomitant medications were not reported. The patient reported that she received the first dose of Pfizer vaccine on 09Jan2021. The patient reported that she has not had any reaction at all, maybe felt a little tender where the shot was, also reported as felt nothing except maybe a little soreness on the arm in Jan2021. She added that she is due to get her next shot on 30Jan2021 and is also due to have a surgery; she added eye surgery as she have a cancer cell eyelid and she was supposed to have cancer surgery on the 1st, and wanted to know if there would be a complication if she had the vaccine two days before that surgery. She also wanted to know if they will be getting the vaccination on 30Jan2021 and what to do if the facility run out of the vaccine when they are due for the second shot. The outcome of event is unknown.  Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : same reporter, suspect product, and event, different patient
face got swollen and got red; face got swollen and got red; I got wet nose right there swelling a little bit same time; I got wet nose right there swelling a little bit; This is a spontaneous report from a contactable consumer (patient reported for herself). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727 and Expiration date was unknown) via an unspecified route of administration, on 18Mar2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included cardiovascular disease, anxiety, depression. Patient had open heart surgery, a double bypass when she was 44 and she was only 53 now though. The patient concomitant medications included acetylsalicylic acid (ASPIRIN ANALGESIC); atorvastatin; midodrine; metoprolol; clopidogrel; ronalazine; duloxetine taken for anxiety depression; meclozine hydrochloride (MECLIZINE HCL); hydrocortisone; glyceryl trinitrate (NITROGLYCERIN); zinc sulfate (ZINC SULPHATE); gabapentin; vitamin d nos; paracetamol (ACETAMINOPHEN) additional Information for acetaminophen: 1000mg each time and alprazolam (XANAX). On 18Mar2021, patient stated at the first she got the reaction, but they were gone after 30 minutes her air way did not get stopped but her face got swollen and got red and she thought she got wet nose right there swelling a little bit same time. Patient stated that was the first time she got a vaccine on March 18th and experienced face swollen but she was fine after that. When probed for the concern, Patient stated, "she may have call it one symptom she guessed adverse and adverse reaction to her second dosage of vaccine, and she need somebody about it. Patient had her first dosage on 18Mar2021 and had her second dosage on 08Apr2021 that April 8th on Tuesday really did not have reaction, did not get any nauseous, headache but her right was feeling like sinusy whatever but she do not have any sinus issues and then she was feeling little nauseas and then her right hand for some reason she got bruise on the top of her hand and then that bruise moved to left part of upper hand and gotten a big knot there and now it was black and blue and it was also like ball and her husband and she thought that could be a blood clot. she probably got headache and had a headache every single day with sickness and felt like little vomit and not having a very good appetite not at all. Patient stated she got the second reaction, it was 5 days later, it was 13Apr2021." Patient stated that she had Xanax if she was having the anxiety attack and that was alprazolam, 0.5 mg tablet. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Felt sore arm night of October 18th, fatigue and sore arm morning of Oct 19th, left work early on the 19th and around 2pm broke a fever.  Slept with fever for 4-5 hours, fever completely resolved around 8pm. Still experienced fatigue the following day. October 20th experienced swollen lymph node in right arm (shot arm). Experienced pain in side area that prevented full movement of right arm. Lymph node swelling and pain persisted for several days. To this day, right side still occasionally feels tender and movement is somewhat limited.
Pain, swelling, tenderness in right arm, near injection site.  Ongoing at day 42 after 2nd injection
Patient received influenza vaccine (AFLURIA) on 10/10/2013. Patient reported through the ED that at the time of the administration of the vaccine, the site of the injection became red and swollen with some urticaria. It eventually scabbed over and resolved on its own without incident. Patient stated that the scab and redness returned approximately 2 weeks prior to being seen in the ED. He decided to get it checked out this time and hence reported to the ED on January 6, 2014. There was a quarter sized scabbed area in the right deltoid with slight redness but no drainage. Patient was diagnosed with cellulitis and was given 10 day supply of SEPTRA DS. Infection resolved. Sulfamethoxazole/trimethoprim one tab BID.
Evening after the vaccine: "Last night, out of nowhere, I instantly got a severe headache, muscle aches, felt nauseous, had stomach pain and eventually ended up vomiting. I went and laid down because my body was shaking so much I couldn't control myself. "
FLUZONE PFS, that were expired was administered with no adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health care professional.  This case is linked to cases 2022SA418835(CLUSTER), 2022SA417297(CLUSTER), 2022SA419920(CLUSTER), 2022SA418873(CLUSTER), 2022SA419928(CLUSTER), 2022SA419132(CLUSTER), 2022SA419111(CLUSTER), 2022SA417976(CLUSTER), 2022SA417246(CLUSTER), 2022SA417992(CLUSTER), 2022SA417624(CLUSTER), 2022SA419912(CLUSTER), 2022SA417187(CLUSTER), 2022SA417608(CLUSTER) and 2022SA419169 (CLUSTER).  This case involves a 1 year old female patient and Fluzone QIV PFS (Influenza quadrival A-B vaccine [Fluzone QIV], that were expired was administered with no reported adverse event.   The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine for prophylactic vaccination; pneumococcal CONJ 7V (CRM197) (Prevnar) for prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for prophylactic vaccination.  On 07-Oct-2022, the patient had received a dose of suspect influenza quadrival A-B vaccine Suspension for injection standard at a dose of 0.5 ml total (lot UT7378MA, expiry date- 30-Jun-2022) via intramuscular route in the left vastus lateralis for immunization.  On 07-Oct-2022 the patient received fluzone pfs, that were expired was administered with no reported adverse event (expired product administered) (latency : same day) following the administration of influenza quadrival A-B vaccine.  Action taken - not applicable.  Outcome - Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Red/purple swelling in right arm around and down from injection site. MD prescribed antibiotics to treat.
Hospital on 1/2 - then again on 1/5, transferred and admitted to hospital, discharged 1/6 Abnormal reflex/weakness   back pain  paresthesia and weakness of legs abdominal pain  evaluation for possible GBS post covid 19 vaccine
Jokingly my boss said she had heard if you go the Johnson & Johnson shot is supposed to magnetize your shot site. Again, jokingly we tried it and it pulled my (cotton) cardigan up with magnet. When we got a bigger magnet take off my cardigan on bare skin, magnet actually stuck to my skin. I still have a huge knot on my left arm and where the magnet stuck was actually where the sit was
About 12 hours after HPV & HEP A she had red glassy eyes, fever to 102 for 2 days, weakness, (generalized), arms weak & thighs, decreased appetite.