chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.; No Adverse Event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Vial was individual vial with multi dose 0.5 ML. Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 7th out of 19 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master case (Patient 1)
Patient had a tightness in the chest, after about 10 minutes then shortness of breath, the nurse at the school where a flu clinic was given administered EPIPEN and she was taken to the E.R.
Within 12 hours of receiving vaccines (DTaP, IPV, PCV-13, ROTATEQ) pt developed fever to 102 and extreme irritability. Admitted to hospital for 4 days - explosive diarrhea and vomiting. Stools guaiac positive (for blood), concern for intussusception w/ ROTATEQ.
Light headed with mild shakiness about 20 min after the shot. Only lasted about an hour or two.
Swelling at the injection site Hot to touch at fever site Hardness at injection site  Redness at injection site On ongoing and worsening for over a week Started Benadryl yesterday
I had fever, chills, cough, and fluid build up.  I also had difficultly breathing.  I went to ER.  I had low oxygen levels.  They did CT scan and blood work.  I was test positive for Covid-19.  The CT scan showed a lot of lung damage.
Rash - both arms, redness to cheeks, history a anaphylaxis. Complaint of difficulty breathing.  Hydrocortisone cream applied bilateral arms. Patient took Benadryl 50mg tablet. Onset of symptoms was observed within 60 minutes of vaccine injection. Symptoms improved within 45 minutes.
The week of April 5, I believe it was April 5 & 6, I thought that I was coming down with a sinus infection. I was having some blood when blowing my nose  and remember seeing some small, hard balls which I now realize were clots. I did not go to the doctor because my back was very bad and  I was in a lot of pain and  I had an upcoming appointment with my doctor. I believe that the symptoms resolved after 2 or 3 days and I did not even mention it to my doctor when I saw him.  I felt  a lot of pain in my leg, but this is probably due to my ongoing  sciatica/radiculopathy /bursitis problems that I experience.
Fever; Cough; Body aches; Headache; Back pain; Dizziness; increased heart rate; Insomnia; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on right arm at 09:30 AM on 21Dec2020 at single dose for COVID-19 immunization. Medical history reported as none, no known allergies. The patient's concomitant medications were not reported. The patient experienced fever, cough, body aches, headache, back pain, dizziness, increased heart rate, insomnia at 01:00 PM on 24Dec2020. All events were reported as non-serious. The patient received Tylenol as treatment. The outcome of events was unknown. The patient was not diagnosed COVID prior vaccination, patient was not tested COVID post vaccination.  Information about lot/batch number has been requested.
Severe arm pain; bad pain where she cant move her arm nor sleep with the pain; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Severe arm pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Severe arm pain) (seriousness criteria hospitalization and medically significant) and SLEEP DEFICIT (bad pain where she cant move her arm nor sleep with the pain). The patient was hospitalized on 07-Jun-2021 due to PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY (Severe arm pain) and SLEEP DEFICIT (bad pain where she cant move her arm nor sleep with the pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  Toradol was given for the severe pain the patient experienced.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
ADACEL was inadvertently administered to a consumer who had a previous dose in 2020 with no adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient to whom experienced diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was inadvertently administered who had a previous dose in 2020 with no adverse event.  The patient's past vaccination(s) included ADACEL in 2020. The patient's past medical history, medical treatment(s) and family history were not provided.   On Unknown date in Sep-2022, the patient received 0.5 ml  dose once (1X) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (strength,lot number and expiry date not reported) via unknown route in unknown administration site for immunization who had a previous dose in 2020 with no adverse event (inappropriate schedule of product administration) (latency: on same day).  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 guidelines. 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.
Yesterday (05/04) in general seemed hyper. Not her norm. Then around 3pm seemed to have aphasia. Trying to talk but could not get words out or words formed. Moderate to severe headache at this time. Has hx of headaches but no hx migraines. Tried tylenol and ibuprofen and did not help headache. Speech/cognitive impairment seemed to improved then developed moderate chest pain and numbness/"cold feeling" down left arm.  That lasted a few hours. Fever was last evening. No fever today. 05/05 only remaining complaint severe headache.
Abdominal pain and vomiting, It turned out to be appendicitis and he underwent surgery to remove it.
A 62-year-old female patient receives second dose of bivalent booster, due to lack of documentation and evidence of the bivalent booster dose she received in September.
Initial report was received from a consumer on 14 November 2012, and involves a case of misuse, inappropriate age at vaccine administration. An 88-year-old female patient received an injection of FLUZONE Intradermal, sanofi pasteur Inc., (lot number, route, site, side and dose in series not reported) on 22 September 2012, which is indicated for patients 18 to 64 years of age. On 08 October 2012, 16 days post vaccination, the patient was found dead. The patient's past medical history was reported as not applicable (n/a) and illness at time of vaccination was reported as none. The patient used home oxygen. It was not reported if an autopsy was done. No other details were provided. The patient's outcome was reported as fatal on 08 October 2012. Documents held by sender: None.
Case number PHEH2014US021289 is an initial spontaneous report received from a nurse on 20 Oct 2014. This case refers to a 10-years-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 013011A), at dose of 0.5 ml intramuscularly on 17 Oct 2014. No adverse event was reported following this administration error.
Big bump after second dose; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Big bump after second dose) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN MASS (Big bump after second dose). At the time of the report, SKIN MASS (Big bump after second dose) outcome was unknown.            No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Potential adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Potential adverse event) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced ADVERSE EVENT (Potential adverse event). At the time of the report, ADVERSE EVENT (Potential adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Headache, Myalgia, Fever, NauseaVomiting, shaking, chills Narrative:
After 5 minutes I experienced nausea. After fifteen minutes I notified the staff and they took me to another room. It proceeded to feeling like I wanted to vomit. I got a tingling sensation on the back of my tongue. The nurse wanted to give me Benadryl but I had driven myself. I took Benadryl once I got home.  By then, I had an aspirin taste in my mouth and change in taste along with the other symptoms. I slept through the evening with the Benadryl.  The next day the injection sight was very sore without movement or touch. I also had diarrhea. No other symptoms since.
At 1st got headache then  body aches, woke up the next day (tuesday 10/12/2021) with a fever 100.05 and 1/2 my face felt numb and strange. Woke up the next day (weds 10/12/2021) and had a stomach ache that slowly progressed to a severe pain in lower right abdomen area. Had to be taken to the ER and was diagnosed with appendicitis and had my appendix removed the next day (thursday 10/14/2021).  Ive never had an issue with my appendix prior to this
Severe back ache necessitating days off from work (until 11/18/2015).  Never experienced anything like this.  This is the only second time I have taken the vaccine.
I got up an collapsed. Then, I started vomiting and could not stop. I went to the ER. I was out of it and don't remember what test they did on me. The next day, I was told that I had a small bowel blockage and was tested positive for COVID-19.
no additional adverse event / no reaction noted; GARADSIL 9 versus a flu vaccine; This spontaneous report was received from a pharmacist and assistant director and refers to a 22-month-old female patient. The patient had no known allergies (NKA), none illnes at the time of vaccination, none concomitant medications and concurrent conditions.  On 04-NOV-2021, the patient was inadvertently vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1659422, expiration date 04-SEP-2021, intramuscularly (dose and anatomical location were not reported) for prophylaxis versus a flu vaccine (wrong product administered). The patient was in flu clinic to receive flu vaccine and her sibling to receive hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (also reported by assistant director as HPV 9). Siblings were both in the room and the health professional inadvertently gave hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) to the patient thinking it was flu. No patient's reaction was noted (no adverse event). No prescription drug treatment was required.  It was reported by the assistant director that new processes in place were implemented to minimize/eliminate error, for example separate baskets for each patient or one patient per room when possible. Provider, poison control, pharmacy and manufacturer were notified. Internal reporting was completed as well as a new process.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. No information about their medical history, concurrent conditions or concomitant drugs was provided. On an unknown date, only two months after the second dose, the patient was vaccinated with the third dose of GARDASIL (site and route of administration, lot# and expiration date not reported). No adverse effects were reported. Additional information has been requested.
This spontaneous case reported by a nurse, describes the occurrence of decreased weight (weight loss), pyrexia (fever 102), vaccination site pain (pain at injection site), headache and chills in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 002C21) for COVID-19 immunization. No medical history reported. On Apr 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 28, 2021, patient had pyrexia (fever 102), vaccination site pain (pain at injection site), headache and chills. On May 3, 2021, patient experienced decreased weight (weight loss). On May 1, 2021, pyrexia (fever 102), vaccination site pain (pain at injection site) outcome: unknown. At the time of the report, decreased weight (weight loss), headache and chills outcome: unknown. The reporter did not provide any causality assessments. Treatment information was included Tylenol and ice packs on face. Action taken with mRNA-1273 (Moderna COVID-19 vaccine): not applicable.
Pt recvd DT/OPV/HEP B in AM @ 6PM was noted to not be bearing weight/refusing to walk; x-rays neg; no hx trauma; CBC, ESR neg;
Temp began Friday 9/18/00, spiked to 103 on 9/20/2000. Client broke out in rash, c/o general achiness and weakness, cough & sore throat, these sx were mild until 9/20/2000. Went to physician on 9/25/2000. Prescribed antihistamine for rash
achy arm on the injection site; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/ batch number: EN9810 and expiry date unknown), via an unspecified route of administration on 02Feb2021 (at 70 years old) at a SINGLE DOSE for COVID-19 immunization. The patient's medical history included blood pressure, blood thinner, and heart rate; all from an unknown date. Concomitant medications included atenolol, oral at 50mg, once daily for blood pressure; baby aspirin (acetylsalicylic acid) oral at 81mg, once daily as blood thinner; fish oil oral at 1000mg, once daily; hydrochlorothiazide, oral at 12.5mg, once daily for blood pressure; and levothyroxine, oral at 88mcg, once daily for heart rate; all the products were taken from an unspecified date for a long time and ongoing. It was also reported that patient takes blood thinners and other heart medications. The patient received the first dose of the vaccine today and noticed the information on the fact sheet after the shot. She is on baby aspirin and asked if she should still take it. Patient also asked what pain medication can she take; can she take Tylenol for her achy arm on the injection site? The patient further reported that when she got her shot, she didn't read the paper, but it says, "if you are on blood thinners" and does that affect this? She takes blood thinners and other heart medications. She asked if any of her medications affect her shot, she has not taken any today and she wanted to ask about that. Her only concern is the possible blood thinner interaction with the vaccine. With regards to the second dose, patient mentioned they didn't schedule her yet because she had to check and see where to get the second dose. She wanted to be more educated for the second dose. The outcome of "achy arm on the injection site" was unknown.  No follow-up attempts are needed. No further information is expected.
Headache starting same day as vaccine. Day 2...9" x 4" inflammation on upper arm with 2 bulls eye red areas measuring 4" in diameter.  Hard lemon sized lump under skin, very hot to the touch. Saw doctor on day 3. Ice packs and Tylenol suggested as well as Benadryl. On day 4 intense itching started. Had to seek medical attention on day 5.  1% hydrocortisone cream added. Saw doctor again on say 6.  Arm is "calming down" but there is still some inflammation, warmth, a hard lump. I also had an ocular migraine the morning of day 4. Still showing signs of reaction.
ACUTE RESPIRATORY FAILURE CARDIOGENIC SHOCK 2/20/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report was received from a certified medical assistant concerning a 9 year old patient of unknown gender. No medical history or concurrent conditions reported. On 12-MAR-2014, patient was vaccinated with VAQTA, 50/1.0 U/ML, injection (dose, route and lot number not provided). Co-suspect or concomitant therapies were not reported. The child patient received an adult dose of VAQTA. No adverse event reported. No product confusion just medication error. Additional information is not expected.
Nausea, headache, uneasy stomach, diarrhea, general malaise.
patient got total of three doses of Moderna Vaccine; patient received two doses of Moderna vaccine half hour apart in addition to a first vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (patient received two doses of Moderna vaccine half hour apart in addition to a first vaccine) and PRODUCT ADMINISTRATION ERROR (patient got total of three doses of Moderna Vaccine) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 053C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (patient received two doses of Moderna vaccine half hour apart in addition to a first vaccine). On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (patient got total of three doses of Moderna Vaccine). On 30-Jul-2021, EXTRA DOSE ADMINISTERED (patient received two doses of Moderna vaccine half hour apart in addition to a first vaccine) had resolved. At the time of the report, PRODUCT ADMINISTRATION ERROR (patient got total of three doses of Moderna Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was reported.
SIDE EFFECTS; TIREDNESS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced side effects, tiredness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness, and headache, and the outcome of side effects was not reported. This report was non-serious.
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 18-year-old female patient who received Bexsero for prophylaxis. On 13th August 2018, the patient received Bexsero. In August 2018, less than a week after receiving Bexsero, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to Bexsero. Additional details were provided as follows: The nurse told GSK representative that one of their patients received the Bexsero prefilled syringe on Monday. The patient experienced swelling at the injection site. She had to go to the hospital for that but reporter did not know if the patient stayed overnight.
SEVERE RASH ON THE BACK AND THE CHEST THAT THE PATIENT WAS GIVEN PREDNISONE SHOTS AT DR'S OFFICE.
All day I?ve felt dizzy and I feel feverish and generally sick. When I stand up too fast I feel like I?m gonna pass out