chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tiredness; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tiredness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form., RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) had not resolved.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I went for a flu shot and Pharmacy provider gave me a Covid-19 Booster by mistake. This was just THREE days after I got another Covid-19 Booster shot at alternate Pharmacy. The provider did not ask me anything about my previous Covid-19 vaccines and when they were given, if she had, she would have realized I just got one three days ago. The form that I filled in and she had it with her clearly said I was getting a Flu shot.
I receved the H1N1 vacine on Oct 31, 2009.  I got a slight fever, body aches, and extreme nauesa.  Symptoms went away 4 days later.  This time I was about 15.5 wks pregnant.  When we wnt to our 18 wk appt to find out the sex there was no heartbeat.  The dr said the baby measured about 15.5 wks.  12/09/09 MR received for DOS 09/09/09. Pt presented for first OB visit. 7 weeks viable fetus.   12/09/09 MR received for DOS 11/19/09. Pt c/o discomfort in low back, hips, neck and muscle. Tx: Tylenol or Darvocet.  12/09/09 MR received for DOS 11/24/09. Pt presented for confirmatory US after fetal death in utero and anomaly screen.  DX studies: US confirmed absence of fetal heartbeat. Pt underwent medical induction.  12/09/09 MR received for DOS 12/04/09. DX: Fetal demise. Pt presented after pregnancy loss at 18 weeks. Fetus was 13-14 wks in size. Coagulopathy panel sent for testing. 12/21/2009 MD orders for 11/24/2009 noted IV ABX, Dilaudid for pain, noted discharge 11/25/2009.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Apr2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "allergies to pets" (unspecified if ongoing); "allergies to trees" (unspecified if ongoing); "allergies to dust" (unspecified if ongoing); "allergies to grass" (unspecified if ongoing); "Known allergies: whey" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Known allergies: doxycycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 29Sep2023 to 03Oct2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300322179 same patient, different drug/AE;
physician have administered QUADRACEL instead of PENTACEL to a 2-year-old patient with no reported AE; vaccine administered to a 2 year old with no reported AE; Initial information received  on 05-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old and unknown gender patient whose physician have administered quadracel instead of pentacel to a 2-year-old patient with no reported ae (adverse event) and vaccine administered to a 2 year old with no reported ae while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation, strength: unknown) lot number not reported in unknown administration site as Immunization.The patient used the product previously. Lot number requested.  On an unknown date the physician have administered quadracel instead of pentacel to a 2-year-old patient with no reported ae (wrong product administered) and the vaccine administered to a 2 year old with no reported ae (product administered to patient of inappropriate age) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (physician have administered QUADRACEL instead of PENTACEL to a 2-year-old patient with no reported AE, vaccine administered to a 2 year old with no reported AE).  At time of reporting, the outcome was Unknown for all.  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.
Pt went to MD complained of shooting pain in back and arm where shot was administered. Patient has had severe pain since day of injection until present. She reported complaint to pharmacy provider 7/25/14.
3 inch diameter swelling, redness, and fever at injection site  within 8 hours of vaccine.  Nausea about 11 hours after vaccine, lasting through night.  Next morning, nausea gone; general malaise all next day.  Felt well 36 hours after vaccine.
The day after the vaccine was administered. a large red circle that was tender and warm to the touch but felt firmer than the rest of my skin and had a slight itchy sensation.
- Fever - Aches - Fatigue - Muscle Cramping - Soreness at injection site
This spontaneous report as received from a registered pharmacist refers to a 3-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-DEC-2017, the patient was vaccinated with one dose of GARDASIL 9 injection, intramuscularly, lot # N020352 (also reported as n020352), expiration date 10-APR-2020, for prophylaxis. No adverse effects were reported.
chills, short of breath  Narrative:  Patient contacted provider on 20FEB2021 at 1635 stating she was not  feeling well. She states her symptoms were chills, fever 100.4, shortness of  breath, body aches and tachycardia up to 166. She stated she received her 2nd  COVID vaccine on 19FEB2021 around 1300. She stated she initially felt  tachycardic at midnight, however symptoms have worsened. she states she has  drank a half gallon of water today already. She also reports some chest tightness. I  checked on her with other personnel and she advised to go to ED. She is ambulatory  and stable. (No further information in chart after this as of 3/18/21.)
Bladder infection ( first one in life ) / treated with an antibiotic / waiting on outcome
Developed a sore throat on 6/23 and took a test but it came up negative. Developed a fever later that evening with a headache and severe fatigue. I tested positive on 6/25. I reached out to my NP on 6/27 and received the PAXLOVID. I finished the medication on 6/30 but was still showing positive. My symptoms had mostly subsided other than slight fatigue and runny nose.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates the patients were vaccinated with PEDVAXHIB (lot#, expiration date, dose and route not reported), which were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Fevers 102-103.8 beginning right after vaccines given. Also c/o ST, SA, nausea. Continues to have intermittent fevers, ST, lethargy and irritability for 2 wks post vacc. Mom feels behavior is diff't after vaccines.
PATIENT DEVELOPED REDNESS, HEAT, INDURATION AND SWELLING AT THE INJECTION SIGHT (RT LEG) WITHIN A FEW HOURS OF THE INJECTION.  SHE WAS TREATED WITH COOL COMPRESSES, BENADRYL, AND PREDNISOLONE.
pt recv vax 14APR97 & sever hr later pt c/o stomach aueasiness, t101 & pain & redness @ inj site;@ 24hr arm was swollen, tender & erythematous from shoulder to elbow;no mucosal swelling, SOB or rash elsewhere;
Two days after the vaccine she developed a migraine with nausea and vision changes. Later that evening she did not have feeling in her left leg and left arm. She was unable to walk or move either limb. She was taken to the ED but left without being seen after 3.5 hours as things began to resolve. She has had no issue since then.
The evening of my vaccine I started getting a red lump at the injection sight. The next day (today) it continued to get bigger throughout the day.  It?s currently about half dollar size. The reason I?m mainly concerned is because my son (he?s 22) also got vaccinated at the same time and he has the same red lump, but his just popped up today. When we received the injection the woman who gave it made a comment that the syringes head been leaking after it started running down my arm. After we left the pharmacy my son said his also ran down his arm. Neither of us have ever had a reaction from a vaccine
Patient experienced redness and itching at injection site. Red area was about 4 inches in diameter.
This spontaneous report as received from a certified medical assistant, refers to an unspecified amount of patients of unknown age and gender. The medical assistant reported that doses of VARIVAX (Merck) INJ (dose, route and lotnu mber not provided), which have been exposed to temperatures outside of the recommended range, have been administered to patients on unspecified dates since 17-FEB-2015. No adverse effect was reported. Additional information has been requested.
Product storage error; Poor quality vaccine administered; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event) in an adult male 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.   On 11-Jan-2023, the patient received 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 PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided    The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Product storage error) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medications were reported. No treatment medications were reported.  This case contains information for the 96 of 100 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
With in 24 hours. Experienced flu like symptoms, including pain behind the right ear. Muscle pain increased to the point pt believed she had a stroke. Dx by MD was Bell's Palsy. Tx began 48 hours after shot.
Approx. 7 AM on 8/10/17 pt. C/O of (R) arm pain. 8/10/17 - pt. became nauseated w/vomiting, pale and hypotension. Was sent to school nurse, Mom picked him up and gave MOTRIN and fluids.
Itching all over body (still ongoing) without lingering rash with occasional bouts of heartburn.  3 days after initial onset I went to an urgent care facility as the inside of my throat and ears began to itch as well.  I was prescribed Medrol 4 mg oral tablet for 6 days and also began taking one 25 mg  Diphenhydramine tablet before bed.
Started to itch all over. Took BENADRYL, went to bed woke up in the middle of night, roof of mouth burning throat sore. Full blown cold, cough, congestion it is starting to go away after 1 week. I have had the flu shot for past 30 yrs. Never got sick.
H1N1 shot->24 hr later fever 101 and stomatitis, seen in office 2/2/10. 2/5/10 Fever gone, drinking, decreased appetite.
Rash on both inner thigh; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 95-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. In February 2019, 14 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: Two weeks after receiving the vaccine, the patient developed a rash on both inner thighs. Emergency Room (ER) visit was required. Reporter consented to follow-up. There is a discrepancy with respect to the outcome of the events rash. In Argus core the outcome is reported as not recovered, however in provided source document it is recovering/resolving. The outcome of this events retains as per the structural field.
Child who was 11 years and 9 months old at the time of vaccination was inadvertently given a dose of Pfizer COVID19 BioNTech intended for patients 12 years and up. There were no adverse events, no symptoms, no treatment required. The vaccine was well tolerated without incident. Mistake was not detected until provider attempted to submit the record through the portal and the system would not take the information. At this point, the incorrect dose had already been given.
2:00 woke up from nap, cried uncontrollable for 15-20 minutes. Wouldn't use left arm or lie on it. No fever. No redness or swelling. Cried several times during night on 2-20.  Treatment-warm pack, Tylenol and Ibuprofen alternated every 4 hours. Would cry certain 4 hours since last pain med.
SOB/RESP DISTRESS, ACUTE RESP FAILURE, ACUTE RENAL FAILURE, DEATH
Breakthrough case admission after 3 vaccines  Moderna 5/18/21 Lot# 023C21A;  Moderna 6/22/21 Lot# 033C21A;  Moderna 12/22/21 Lot# 041J21A
Shingles 3 days after 1st dose; The blisters are dry already; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles was unknown and the outcome of the blister was recovering/resolving.   It was unknown if the reporter considered the shingles and blister to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient developed shingles 3 days after getting the first dose of the vaccine.  The patient also developed blisters that were dry already. Additional Supportive Information: The follow up would not possible as no contact details were available.
About 17 minutes after the HPV vaccine administered, patient felt uncomfortable in the arm beneath her injection.  She then said her arm mildly hurt and thought it looked swollen.  Patient then felt it was hard to breathe.  She became pale.  She was close to fainting.  After about 5 minutes she stated it felt better.  Initial O2 sats were 99-100 d.  She rested for 20 minutes and drank some mountain dew and was able to go home without difficulty.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported). Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT), LEVOTHYROXINE and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Baby became serevely jaundiced requiring UV light therapy and a 5 day stay in the NICU.
Slight rash around nose and chest on 5-13-08. More rash on forehead and chin on 5-15-08. Doctor prescribed VALTREX for 7 days.
There is a hot, hard lump on my left arm about 4 inches below the injection spot. Not painful or irritating. Not itchy. Just feels hot inside and out. Have taken ibuprofen. Injection was 2 days ago.
C/o heart racing and "thickness in throat" within 1/2 hr of vaccine.  Seen in ED HR 70s, BP 163/83 RR20 SpO2 100% on RA.  NSR on ECG. Treated with Prednisone 40mg po and Pepcid 40mg po.  D/c home on Benadryl po and Prednisone PO @ 4:40pm. 7/7/11 c/o diarrhea 4 hours after vaccine, now resolved.  Continues to c/o hoarseness and "lump in chest".
30 minutes, post vax, the pt had tingling in arm. No pain or swelling. PE-nml.
AFTER THE SHOT PATIENT SAT DOWN FOR 15 MINUTES IN A CHAIR AT THE WAITING ROOM AND AFTER THAT HE PROCEED TO THE FRONT END CASH REGISTER TO PAY FOR SOME VITAMIN BOTTLES ADN HE FAINTED AND FELL ON THE FLOOR. HIS WIFE THEN HELPED HIM TO GO BACK TO THE CHAIR IN WATING ROOM AND GAVE HIM SOME WATER AND HE RECOVERED.
Arm at injection site was swollen w/i 24 hrs of injection. Cont'd to swell to size of baseball w/i 48 hrs. Redness & fever at site. Dr states allergic reaction to Hep B shot.
Choked with food; Started wheezing trying to expel the food; felt like her throat closed when choking with the food; Hard to breathe when choking with the food; Difficulty lifting her left arm; A spontaneous report was received from a consumer concerning a 70 years-old, female patient who received Modern's COVID-19 vaccine (mRNA-1273) and  experienced choking with food/ choked on food, Started wheezing trying to expel the food/ wheezing, felt like her throat closed when choking with the food/ throat tightness, hard to breathe when choking with the food/ breathing difficulty, difficulty lifting her left arm/ Arm discomfort.  The patient's medical history was not reported. Concomitant product use included blood pressure medication.    On 02 Feb 2021, prior to the onset of the events, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 02 Feb 2021, approximately 3 hours after getting the vaccine, she started eating and choked with the food, and when trying to expel it, she started wheezing, felt like her throat closed and was hard to breath more than usual for this kind of situations. She also has difficulty lifting her left arm.   The seriousness criteria were considered as medically significant for the event choked on food.  Treatment information was not reported   Action taken with mRNA-1273 in response to the events is not reported.   The events choking with food/ choked on food, Started wheezing trying to expel the food/ wheezing, felt like her throat closed when choking with the food/ throat tightness, hard to breathe when choking with the food/ breathing difficulty, difficulty lifting her left arm/ Arm discomfort were considered resolved.; Reporter's Comments: This case concerns a 70-year-old female who experienced a serious unexpected event of choking along with NS unexpected events of throat tightness, wheezing, dyspnea, and arm discomfort.  The events occurred 3 hours after the first dose of mRNA-1273. Treatment not reported. Event outcomes resolved. 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
received a positive test; received a positive test; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 11Mar2021 (Lot Number: UNKNOWN) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that he received his first dose of the vaccine on 11Mar2021 and was scheduled to receive his second dose of the vaccine on 01Apr2021. He stated that last Tuesday he started having symptoms of COVID-19 and took a rapid test that came back negative in Mar2021, but then received a positive test on Thursday 25Mar2021. The patient would like to know if he was still able to take the second dose of the vaccine on Friday. The patient would like to know if there is any information on the quarantining timeline since he has received a positive COVID-19 vaccine. He stated that his wife and children were also tested but came back negative for COVID-9 but did not know if the same quarantining guidelines would apply to them. The patient underwent lab tests and procedures which included COVID-19 virus test which showed negative on Mar2021 and positive on 25Mar2021.The outcome of the events was unknown.  Information on the batch/lot number has been requested.