chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.) 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. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.) and NO ADVERSE EVENT (No adverse event) outcome 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 assessment was provided for UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.).    It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  No treatment information was reported   This case was linked to US-MODERNATX, INC.-MOD-2023-727606 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727606:Patient 1 out of 4 patients
Chest pain, abdominal pain, brief loss of consciousness, nausea, dizziness
Soreness after each injection.  Sneezing and runny nose after 2nd injection
Redness, swelling covering 3 inch area hot to touch about 1 inch away under vaccine site, lower spread to inner arm. (Left arm). Suggested after inspecting on 11/19 to visit PCP.
Information was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On an unknown date the patients were vaccinated with doses of improperly stored Gardasil 9 injection (lot # M005714, expired on 30-OCT-2017) once, intramuscularly (dose and frequency unknown). Therapy with GARDASIL 9 was continued. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Stomach is crampy; Muscle joints hurt; Bad headache; Chills; Threw up; Bad fever; Passed out; Loose bowels; Sweating; A spontaneous report was received from a consumer concerning a 53 years old male patient who developed passed out/loss of consciousness, diabetic/diabetes mellitus, loose bowels/diarrhoea, bad fever/pyrexia, sweating/hyperhidrosis, muscle joints hurt/myalgia, stomach is crampy/abdominal pain, bad headache/headache, threw up/vomiting and chills.     The patient's medical history included diabetes and sinus infection. Products known to have been used by the patient, within two weeks prior to the event, included Metformin and sinus medication.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 036A21A) on 8 Mar 2021 in the left arm for prophylaxis of COVID-19 infection.    On 9 Mar 2021 around 10 AM the patient started feeling bad. Patient threw up, had loose bowels, bad fever, couldn't get warm for 3 hours, was sweating, and passed out. On 10 Mar 2021 patient stated that all his muscle joints hurt, and his stomach is crampy, and has a bad headache and chills. The medically significant event is loss of consciousness. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) passed out, diabetic, loose bowels, bad fever, sweating, muscle joints hurt, stomach is crampy, bad headache, threw up and chills was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 23Jul2022) and NO ADVERSE EVENT (No adverse event) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 23-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 23Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 23Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 23Jul2022). Concomitant medications were not reported.  Patient received full dose. They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions. Treatment medications were not reported.
after the second covid dose, patient reported that she felt that her throat is closing. observed her for a few minutes and called 911. Emergency management services examined her and told her that her breathing  is ok and heartrate little high because she was looking anxious . but she insisted her throat is closing. Ambulance took her to the emergency room . She called the pharmacy after 4 hours and said that she was treated with allergy medication in the ER.
pt recvd 2 doses of Engerix-B & 17AUG92 had swelling of glands, chest & back pain; seen by MD; recvd ATB treatment;
a few minutes after getting  vaccine patient started to have left knee redness/itching and then whole body itching. has a erythematous papular rash that is also very itchy on her back had chills that night
I had the shot on Thursday, 12/9. I took one Tylenol as I went to bed that night.   We were keeping over-the-counter medicine doses on a dry erase board, so I apologize because I do not have dosing amounts and times. The over the counter medicines we have on hand were aspirin, Tylenol, and ibuprofen.   I didn't develop a fever until Friday, 12/10. I had anticipated this happening and spent most of the day sleeping.  During the day at around 2-3, I noticed I had a temp of 103 and I developed the chills. I took a lukewarm bath and my temp went down to around 101. My temp that day stayed higher than I am used to with fevers. At ten o'clock, my fever was 105. I took another lukewarm bath and then my husband took me to the ER.
unusual amount of bleeding; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HAEMORRHAGE (unusual amount of bleeding) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (unusual amount of bleeding). The patient was treated with VITAMINS NOS ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, VACCINATION SITE HAEMORRHAGE (unusual amount of bleeding) 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 medications were not provided by reporter.   Reporter did not allow further contact
Irregular periods, early periods, extremely painful periods, vomiting before and during periods, daily headaches
After immunizations given. Suddenly sneezed mucous came out, crying throat hurt. Vomited shortly after, continued talking about throat, hives all over thighs, ears red. EPIPEN given.
Within 8 hours of the send dose, I started getting  a fever, headache and chills. About an hour after I started vomiting and got a dry cough.  That happened throughout the night and was fatigue.  I got checked for Covid, because I work on the Covid unit. I was extremely dehydrated when I got the the Urgent Care, and I got an IV Fluid . Within 48 hours it was like nothing happened, all my symptoms went away and I felt great.
Hives, intense itching, sunburn feeling on scalp, back, chest, ears, nostrils, eyelids Started 2 hrs after vaccine.  Lasted 6 days.  Took oral benedryl every 4 hrs for 5 days.  Applied cortisone cream topically.
Pt started itching and had little red raised bumps.  Began to feel a swelling in the throat.  Called her physician and was advised to take an antihistamine and Pepcid twice a day for 5 days.  11/8 had very little change.  Went to Dermatologist and was told it was an allergic reaction.  Was given a cortisone injection.  Was told it might 24 to 48 hours to see improvement.  11/9 Still very little improvement.  11/11 Throat no longer felt swollen and itching was less.
She has been off and on throwing up since about 2am but not every hour on the hour; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (She has been off and on throwing up since about 2am but not every hour on the hour) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021 at 2:00 AM, the patient experienced VOMITING (She has been off and on throwing up since about 2am but not every hour on the hour). At the time of the report, VOMITING (She has been off and on throwing up since about 2am but not every hour on the hour) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, COVID-19: 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 product use was not provided. Treatment information was not provided.
5 minutes post vax pt developed redness, swelling and hives at injection site. Approximately 30 minutes later pt had redness, hive like swelling and heat on right upper portion of thigh.
I received the first injection on 12/17/2020 and a several days later started having vaginal itching, redness, discharge, throbbing feeling and contacted my gynecologist.  I was prescribed a fluconazole 150mg tablet once over the phone. I felt better after a couple weeks. I then started to have persistent symptoms start again. I received the 2nd injection of vaccine on 1/07/21. I contacted my gynecologist again and was told to come in for an office visit. I was diagnosed with a vaginal yeast and bacterial infection. On 1/21/21 she prescribed a 10 days course of Boric Acid suppositories, metronidazole 500 mg , and metronidazole topical cream . I finished all medications and felt better. Then started to have symptoms again on 2/19/21 again and called the on-call physician as the office was closed. I was prescribed fluconazole 150mg once dose Q3Days for 2 total doses over the phone.  I have had no other symptoms to date now.
Seizures, Myalgia, numbness in lower extremities Narrative: She has hx of Epilepsy, which notes at times has been triggered by headaches in the past. Currently, on Topamax. She then was seizure free for 24 hours, returned to station 04/05/21) and noted photo sensitivity to a light in her work area causing nausea and headache. She went to the bathroom had additional seizure activities-falling striking head and went to ER for evaluation. Released with follow up with Neurologist. Post fatigue and headache for several days following event.
TDAP given 11/19/2008. 11/21/2008 general achiness all over arms, legs muscles hurt to take MOTRIN.
11/04 right arm swollen and hot and red size of golf ball at injection area. Temp 102. Tylenol given Headache, decreased appetite while have fever.
The following morning patient presented with tongue swelling, left sided head ache, and swollen face. Roughly 24 hours post administration symptoms have slightly improved. Pharmacist recommended Benadryl to treat swelling and to report to ER if symptoms persist or worsen.
Symptoms began 15 Hrs. after receiving my 2nd Moderna vaccine.  Chills, Frozen joints (couldn't walk) lasted for 3 Hrs.  Then profuse sweating with a fever that lasted for 3 Hrs.   I was back to my normal self 24 Hrs. later.  This 2nd vaccine was given 4 wks. 5 days after I received the 1st. vaccine.  I reported my reaction to the 1st. vaccine on 02/28/2021 Temporary that I developed Covid Arm (Red Rash around the injection site) four days later ...Benadryl taken for 4 days with Mometasone cream and it cleared up.
Swelling on arm; Redness on arm; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date 5th July 2021) for prophylaxis.   On 27th April 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 27th April 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age of the patient could be 78 or 79 years old. The patient received dose of Shingrix in the left arm. The patient was a doctor and is adamant that vaccine was administered subcutaneously to him and his wife. The pharmacist reported that, the patient was adamant, who received dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The reporter was from different pharmacy location in same town, who was notified of patient's events. The reporter was familiar with pharmacist who signed off on vaccination and believes that pharmacist knew what he was doing. This case was 1 of the 2 linked case. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (Recovered or resolved with sequel).
We accidentally gave an extra dose of flu shot to the patient-last flu was two weeks back. no adverse events reported so far. He should have gotten two shots this year and got three.
This case was reported by a consumer via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced fever, chills and pain. On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the fever, chills and pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient informed that he experienced mild fever and chills after vaccination with SHINGRIX, which lasted for several hours. 1 day after vaccination with SHINGRIX, the patient experienced achiness. The fever broke but the patient experienced achiness all the next day after vaccination.
Pt complained about ongoing headaches, body aches. Pt called in sick to work for one day. Pt said symptoms are gone.
Information has been received from a registered nurse concerning a female office receptionist who on 24-FEB-2009 was vaccinated IM with the second 0.5 mL dose of PNEUMOVAX (661529/0868X). Concomitant therapy included PROTONIX and BENICAR. Later that night the patient developed high fever, swelling of the entire left arm, and left axilliary nodes and flu-like symptoms. the patient was advised to take ADVIL and BENADRYL. At the time of reporting the patient was recovering. It was reported that two other patients experienced the similar adverse events after being vaccinated with the same lot number of PNEUMOVAX. Additional information has been requested.
On Tuesday, patient ran a temperature that maxed at 101.5, Motrin given. Wednesday 101.5 again and Thursday 102.5. Motrin was given all days. Saturday morning, day 5, patient woke with a rash on her trunk and face...
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Vaccine received post its 30 days Expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 11:59 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 11:59 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported. Patient's ethnicity was reported.  Vaccine administration time was given as 02-Apr-2022 at 11:59:54 No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
The day after receiving the vaccine, patient reported increased heart rate most of the day which she noticed when she was at the gym. Self-reported HR of 195 when she was at the gym and said her HR stayed above 130 all day. She also experienced nausea and a dull headache.
Syncope shortly after administration, followed by light-headedness, pallor, and tremor for about an hour after vaccination Treatment given includes hydration (Gatorade), elevating legs above head, turning on a fan for air circulation, and placing cool rag on forehead. Patient took about an hour to recover enough to stand up completely. Pt declined ambulance and drove self home.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 22Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "some arthritis" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Jan2023 to 18Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm / pain goes down her arm / pain is in the upper arm mostly / still have issues on arm), JOINT INJURY (elbow feels like it needs to pop) and VACCINATION SITE PAIN (pain in same arm where got injection) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (amoxicillin), Allergy to antibiotic (Keflex) and Allergy to antibiotic (Avelox). On 26-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm / pain goes down her arm / pain is in the upper arm mostly / still have issues on arm), JOINT INJURY (elbow feels like it needs to pop) and VACCINATION SITE PAIN (pain in same arm where got injection). At the time of the report, PAIN IN EXTREMITY (pain in arm / pain goes down her arm / pain is in the upper arm mostly / still have issues on arm), JOINT INJURY (elbow feels like it needs to pop) and VACCINATION SITE PAIN (pain in same arm where got injection) outcome was unknown. 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. Patient had lost sense of taste and smell in October 2021. No Concomitant Medications were provided by the Reporter. No Treatment Information were provided by the Reporter.
crying screaming 8hr w/high pitch cry-slept x 1hr period x 2 & during the 8hr;
Pt was seen in local ER on 10/21/08 about 36 hours after shot complaining of redness, swelling, and discomfort of right arm, temp of 100 F
UTI.  Nurse follow up on 11/15/04 states: "dysuria; acute cardiopulmonary arrest;   Death Certificate received which revealed COD as acute cardiopulmonary arrest, ischemic heart disease & COPD, all with chronic anemia and renal insufficiency as contributing factors.
About 8 hours after receiving the vaccine, I experience a severe migraine the radiated down my neck and was accompanied by nausea. I slept for 12 hours and the symptoms are almost completely resolved.