chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, 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. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  No adverse event was reported for any of the patients.  Treatment medications were not reported.     This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received: Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
On 04/24/2022 at 06:30PM I had back to back migraines for two hours. I had the same occurrence at the exact same time the next day 04/25/2022. I do have a history of Migraines but it is unusual to have them back-to-back and at the same time.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On an unknown date the patients was vaccinated with (Oka/Merck) VARIVAX lot # L050956, expiration date 17-DEC-2017 and lot # M008171, expiration date 16-FEB-2018, subcutaneous. The registered nurse reported that improperly stored doses of (Oka/Merck) VARIVAX lot # L050956, expiration date 17-DEC-2017 and lot # M008171, expiration date 16-FEB-2018 have been administered to unspecified patients on unspecified dates since 04-OCT-2016. No adverse effects have been reported. The outcome of incorrect product storage and no adverse event is unknown. No further information provided. Temperature: 12.7F. Time frame: 8 hour, 10 minutes. No previous temperature excursions. Call was due to a data logger: Yes. Additional information has been requested.
Child received shots on 7/10/01 AM and noted swelling and redness to upper thigh. Warm, moist compress was applied at 21:00. Noted swelling and redness to outer and upper thigh in the AM. Warm and moist compress applied and 30 minutes, looked better. Then child out on visit with parents for several hours. Noted left thigh with a lot of swelling and redness to inner thigh, over and outer thigh at 17:00 on 7/11/01. Sent to ER for evaluation  and had no treatment at ER.
Patient received FLUMIST vaccine on 9-1-2011 - by next day was irritable & fever at night approximately 103 (9/2). (9/3) Fever on Saturday 104 degrees F. Fever of 103 on Sunday. Patient was fine not exposed to anyone sick before vaccine - vaccine made her irritable, not eating, high fever.
This spontaneous report as received from a Registered Nurse via field representative regarding a 58 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date in 2013 (also reported as 3 years ago), the patient was vaccinated with ZOSTAVAX, one dose once, route unknown (also reported as injection). Concomitant thereapies included ZYRTEC. On an unspecified date after administration of ZOSTAVAZ the patient developed itchiness that started in her hands and ran throughout her arm. The patient sought medical attention and followed up with an unspecified Dermatologist who told her that the itching was non-vaccine related. The field representative could not confirm if there was a rash involved with the itching. The outcome of event was unknown. Product quality complaint (PQC) was not filed. The reporter's causality assessment to the event was not provided. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Addison's Disease" (unspecified if ongoing); "hypopituitarism" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Reglan, reaction(s): "Known allergies: reglan". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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-202300223980 Same patient differnt drugs and events;
No adverse effects reported; more than a year ago the patient received Gardasil 9/ in the pharmacy now to receive second dose; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported.  On an unknown date, reported as more than a year ago, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number 1637641, expiration date 16-FEB-2022 (exact dose, site and route of administration were not reported) for prophylaxis.  On 09-OCT-2019, reported as "now", the patient was in pharmacy to receive second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse effects were reported.
Started having a headache, cough and extreme fatigue, tested for COVID-19 and was positive. Called doctor and was prescribed Paxlovid.
I have had extreme georgific tongue very painful and peeling raw all the time and burning mouth sydome also very painful 24 hours a day and unable to work
This spontaneous report was received from health care worker refers to a patient of unknown age and gender. Patient medical history and current conditions was not reported. On 14-MAY-2015 the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # J013555 and expiry date 2-MAY-2015) of dose 0.5 ml via subcutaneous route. No adverse effect was reported. The outcome of the event was unknown. Additional information has been requested.
somewhat more uncomfortable post-vaccine time; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 06Oct2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 08:30 as dose 4 (booster), single (Lot number: GJ3277) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "MCS (Multiple chemical sensitivities)" (unspecified if ongoing); "graves' disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE , Site and Route of injection: Upper right arm, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 01Feb2021, for Covid-19 immunization, reaction(s): "somewhat more uncomfortable post-vaccine time"; bnt162b2 (DOSE 2 , SINGLE , Site and Route of injection: Upper right arm, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 22Feb2021, for Covid-19 immunization, reaction(s): "somewhat more uncomfortable post-vaccine time"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE , Time (24hr): 13:00, Site and Route of injection: Upper right arm, Route of administration: Intramuscular, Batch/Lot number: FH8030), administration date: 02Nov2021, for Covid-19 immunization, reaction(s): "somewhat more uncomfortable post-vaccine time". The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "somewhat more uncomfortable post-vaccine time".  Additional Information: Regarding family medical history relevant to adverse events (AES), it was reported that "nothing other than slightly heightened (for a few days) immune system reactions-no follow-up care needed from any medical facility or physician". The patient had MCS (Multiple chemical sensitivities) and Graves' disease (in remission from graves' disease), over reactive immune system in general that probably contributed to a somewhat more uncomfortable post vaccine time. She commented that she doesn't know why the form was sent to her, she had normal post-vaccine reactions (a few days only each time) each of the 4 times she was vaccinated against COVID. She had the 2 initial vaccines for the first course, and then 2 booster, a year apart.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201279899 same patient/vaccine/event, different dose;
Patient received 2 doses of Moderna vaccine at the age of 16.  No adverse reactions reported to this office.
This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a adult female patient who received SHINGRIX. On 17th February 2018, the patient received SHINGRIX. On 17th February 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm and erythema of extremities. On 18th February 2018, the patient experienced feeling down, fever and chills. On an unknown date, the outcome of the swelling arm, feeling down, fever, erythema of extremities and chills were recovered/resolved. The reporter considered the swelling arm, feeling down, fever, erythema of extremities and chills to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm red and arm swelling. On 18th February 2018, 1 day after receiving vaccination, the patient experienced feeling down, fever and chills. About 48 hours after the onset of chills, the patient states that she was better. The patient was in hurry and did not have time to answer additional questions.
pt recv vax 20MAR98 & mom reported pt recv 10 pox;didn't know if rash crusted over;
62M with complex medical history incl IDDM, CVD, stroke and hx of allergies to oral meds and anaphylaxis to multiple foods (peanuts, monosodium glutamate) requiring evaluation for reaction to first dose of moderna vaccine. Does not carry epi pen with him though he has been prescribed one in past.             Vaccine administered 10:02am. Immediately after vaccine patient reported dizziness that persisted for about 60 min. He reports similar if less severe dizziness after flu vaccine one month ago and that he often feels dizzy after taking his morning dose of nortryptiline which he took today.            Symptoms evolved to include mild nausea, feeling that abdomen was "shaking", and headache. No SOB or chest pain, feeling of throat closing, or rash. Patient AO x 3 throughout evaluation and talking throughout.             Fasting BG 234. Took basalglar 40u this AM and 5 of aspart. Drank 8oz chocolate milk 9:30am which is his typical breakfast.             He notes that his home BP this past week was elevated into SBP 170s though typically is in the 120s/70s without antihypertensive medications. Prolonged dizziness and hyperglycemia (454). Regular insulin 5u SQ administered. Patient symptoms after 60 min. Repeat BG essentially unchanged but patient symptomatically back to prevaccine baseline.   Discussed with ID on call. Plan for transport to SMMC lab for CH50 and tryptase with instructions to patient to repeat in more than 24 hours (to establish a baseline). Patient given strict ED precautions.
CLIENT RECEIVED PEDIATRIC FORMULATION OF PFIZER VACCINE 0.2ML. CLIENT 12YO AT TIME OF VACCINATION SHOULD HAVE RECEIVED PFIZER GRAY CAP 0.3ML.
No adverse effects reported; patient received a "booster dose" ofMMR II (R031680 exp 11/1/2020) on 5/15/2019 and then the patient received another dose of MMR II (S014430 exp 5/9/2021) on 9/13/2019; This spontaneous report as received from a medical assistant refers to a 44 year old patient of unknown gender. No information on patient's pertinent medical history, concomitant medication and drug reactions or allergies was provided.      On 15-MAY-2019, the patient was vaccinated with "booster dose" of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant human albumin (rHA) lot # R031680  has been verified to be a valid lot number, expiration date 01-NOV-2020, dose was not reported) ) subcutaneously, for prophylaxis. On 13-SEP-2019, the patient was vaccinated with another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant human albumin(rHA) lot # S014430 has been verified to be a valid lot number, expiration date 09-MAY-2021, dose was not reported) ) subcutaneously, for prophylaxis. No adverse event was reported.
Two and a half years ago I had 2 Lyme vaccinations on 02/19/1999 and 03/19/1999. Since then I have developed auto-immune arthritis in all of my joints. The annual follow up states, "I still don't know if my low-grade inflammatory process and elevated rheumatoid factor all due to the vaccine, but I still have those problems and occasional "flu-like" symptoms that mimic fibromyalgia, as well as moderate inflammation joint changes.
mild sx 25May2022 then plus Ag on 26May2022; mild sx 25May2022 then plus Ag on 26May2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 24-year-old female patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "unknown" and all described as "mild sx 25May2022 then plus Ag on 26May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive, notes: COVID test post vaccination COVID test type post vaccination: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Device timestamp: 27May2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19 cannot be totally excluded.
Father called today 12/2/19 stating that when patient got home had excruciating headache + joint pain lasting through 12/2/19 am.
Redness, swelling, soreness through 3rd day. Redness about 1 inch wide and 6 inches long at immunization site on upper left arm. Shot on 1/8/19 and still redness and discomfort on 1/11/19. Ibuprofen for soreness.
Child reported to mother on 10/28/09 "bumps" on arms. Mother gave CLARITIN. Morning on 10/29-"hives" on face, spreading to stomach, back. "Arms are bad." Mother phoned medical provider. Is now administering BENADRYL. No wheezing or respiratory problems. Temp 99 10/30. PC to medical provider-child treated with OMNICEF 10/6 for URI. Child was not seen by provider following hive breakout. PC to mother-hives improving.
pt w/fever & mild erythematous maculopapular morbilliform rash involving trunk, abd, back, neck, face;
pt recv 1st vax; exp itching all over body;to MD who felt cause of itching unk;recovered;recv 2nd vax, exp itching;f/u revealed that pt was dx & tx for scabies which caused itching;
Patient came into pharmacy 2 days post vaccine with a very swollen, red & blotchy left arm. He stated it was very hot, almost burning and had felt dizzy at times. No difficulty breathing or fever. Recommended that he go see MD. RXN started 1 day post vaccine.
Left Arm of vaccination, 24hours of vaccination lymph node inflamed under the Left arm with Dose 3. Contacted physician and they gave you directives of care and if it lasted greater than one month to come in. Then a month later went in for a visit since the issue was not resolved. Then 3-4 weeks after notice a rash and little balls or bumps under the skin like red bumps. Hidradenitis Suppurativa - clogging of the sweat gland ducts. Physician prescribed keflex antibiotics for 10 days and it lasted a week. Then she went back to the physician who then he extended for additional 7 days. No cure but treatment.
On 20JUN91 pt recvd DTP/OPV @ 1130AM & @ 530PM pt started gagging, eyes rolled back, head jerking, lasting 45min; Taken to Hosp- t100.6; no tx given;
itching all over her body; Sore left arm; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient family member or friend and describes the occurrence of PRURITUS (itching all over her body), PAIN IN EXTREMITY (Sore left arm) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 27-Apr-2021, the patient experienced PRURITUS (itching all over her body), PAIN IN EXTREMITY (Sore left arm) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 27-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, PRURITUS (itching all over her body) and PAIN IN EXTREMITY (Sore left arm) 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.   The patient found out that she was pregnant on 18-JUN-2021.  No Concomitant medications were provided. No treatments were provided.   This case was linked to MOD-2021-235643 (Patient Link).
Cellulitis on injection sites. Treatment of diphenhydramine 12.5 mg/5 mL was started on 1/7/16 for 10 days.
Muscle aches and pain Migraine Diarrhea Nausea Stomach pain Everything begaon on Saturday afternoon, mMarch 6, 2021. Approximately 24 hours after getting vaccine. Side effects have not subsided. Some relief from muscle aches and pain and migraine from Ibuprofen. No relief from Diarrhea even when taking Immidium. Nausea settles down with Zofran.
Slight fever; Arm pain; This is a spontaneous report from a non-contactable consumer (patient). A 20-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: EW0164) via an unspecified route of administration, administered in left arm on 16Apr2021 11:15 (at the age of 20-year-old) as dose 1, single for COVID-19 immunization at public health department (public health clinic/veterans administration facility. Patient medical history included migraine and IBS from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient did not received any other vaccines within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Apr2021 07:00, the patient experienced slight fever and developed arm pain. The patient did not received any treatment for the events. The outcome of events was recovering.  No follow up attempts are possible. No further information is expected.
Extreme headache, sensitivity to light, nausea (no vomiting). Basically had to call into work and try to sleep the next day.
COVID breakthrough case. The patient was experiencing generalized weakness. In the emergency department, the patient tested positive for COVID.
Fever 102, tiredness,  weakness, headache,  shaking,  sore throat, congestion,  bloody mucas
Rash around  injection site (about 3 inches in diameter), lump under the skin, slight pain and itching.
pt recv vax 13MAR96 & 14MAR96 grandma noted episode of limpness & paleness lasting 1-2hr & pt sleeping longer than usual;pt awoke @ 0930 & seemed fine;episode was during sleep;no fever, no resp problems & no sz noted;13MAR high pitched cry
This patient developed diarrhea the next day after her Moderna COVID vaccine and then about a week after her injection developed at least a moderate cellulitis to her left upper arm, expressed purulent fluid from the area. On 03/17 she was seen in the office for the above and for cellulitis to upper arm that warranted ATB/Keflex. She still plans on getting her second dose of the vaccine.
Feeling very cold followed by very hot along with weakness, paresthesia. BP was initially in the 170s and his temp. was >99.