chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse event; monovalent vaccine for 6 to 11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6 to 11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6 to 11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6 to 11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6 to 11 years old administered instead of bivalent vaccine).    Concomitant medications details were not reported by the reporter.  Patient age was 48 years 5 months.  It was reported that patient received 0.5ml of the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine.  Treatment details were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-657547, US-MODERNATX, INC.-MOD-2022-657560 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657560:Same reporter US-MODERNATX, INC.-MOD-2022-657547:
Child has history of seizure disorder (1st seizure after prior vaccine). Had seizure within 24 hours of receiving his DT and Hib vaccines. (His Tegretol level was also sub-therapeutic). Mother reported seizure. Pt not seen by a doctor for the event.
On the 8th day after getting the vaccine I noticed a large lump at the sight of where the injection. There was also a large red patch there. It itched, but was painful to touch. It lasted for about 5 days.
Slight SOB; General aches; fatIgue; Nausea; Headache; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (Slight SOB), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (General aches) and FATIGUE (fatIgue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy, Iodine allergy, Penicillin allergy (PCN), Sulfonamide allergy, Drug allergy (Compazine), Lung sarcoid (Prednisone, Advair, Albuteral, Nasonex. No recent changes in status of chronic condition.) since 15-Jun-2015 and Hypokalemia. Concomitant products included MOMETASONE FUROATE (NASONEX) from 15-Jun-2000 to an unknown date for Allergy, POTASSIUM from 01-Jun-1990 to an unknown date for Hypokalemia, CYANOCOBALAMIN (B12-VITAMIN) for Nutritional support, PREDNISONE from 15-Jun-2015 to an unknown date and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 01-Jun-2019 to an unknown date for Sarcoidosis.   On 11-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 08-Feb-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). On 07-Dec-2021, the patient experienced DYSPNOEA (Slight SOB), MYALGIA (General aches) and FATIGUE (fatIgue). At the time of the report, DYSPNOEA (Slight SOB), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (General aches) and FATIGUE (fatIgue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was given Cocomitant B12  start date was given as 06/15/015. Patient's year of birth was on 1950.   This case was linked to MOD-2021-006006, MOD-2021-404883 (Patient Link).
Client admitted to hospital with cough and shortness of breath. Diagnosed with Covid pneumonia.  Information obtained through state report. This writer unable to receive any additional information. Client admitted to local Medical Center. . Please reach out to them with any additional questions.
Chicken Pox Follow up 02/23/05: Manufacturer and lot number of vaccine unknown.
Severe chills,  weakness,  malasia  severe joints pain in hands, elbows and  knees,  nausea  Decrease appetite  Generalized body aches  Mental confused,, disoriented   For 72hrs
Erythematous macules on anterior chest, left palm of hand and face. Some periorbital edema bilaterally.
Dermatographia; This spontaneous case was reported by a patient and describes the occurrence of MECHANICAL URTICARIA (Dermatographia) in a 33-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included FEXOFENADINE and PREDNISONE for an unknown indication.    On 05-May-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 19-May-2023, the patient experienced MECHANICAL URTICARIA (Dermatographia). At the time of the report, MECHANICAL URTICARIA (Dermatographia) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had red whelps then spread all over body after two weeks of the booster. Started itching and burning and today got diagnosed with dermatographia.  The patient did not experience any additional symptoms/events. There were no lab data/results available. No treatment medications were reported.
KNOCKED OUT FOR 30 HOURS; BODY ACHES; HAD BEEN A LITTLE  NASAL; CHILLS; HEADACHE; FEVER; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 subject experienced knocked out for 30 hours, body aches, had been a little nasal, chills, headache, fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the knocked out for 30 hours, chills, headache, fever, body aches, tired and had been a little nasal was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Child received vaccines on 12/11/2020, 10 days later mom notice red hard welty area on (L) thigh. Now on 12/13/2021 Family had bout of vomiting the child also had low grade fever. So on 12/21/2020 had red hot to touch area with 3 Little pimples where vaccines given 10 days ago. Area is swelled and red in area. Then on 12/23 PCP seen voiced its a rash typical with MMR/Varicella Lump from injection.
On evening of vaccines given patient had a fever of 105.0 degree F rectal. He had a seizure that lasted 15 minutes. Patient was taken to ER and left ER with a temperature of 97.2. As of today 6/14/23 he is still running a fever of 102.2 rectal. Parent advised to monitor closely, treat fever with tylenol and if he has another seizure that lasts longer then 5 minutes to call EMS.
Information has been received from a nurse concerning a 13 month old patient who on 05-MAR-2008 was vaccinated orally with the first dose of ROTATEQ.  On 09-MAY-2008 was vaccinated orally with the second dose of ROTATEQ and on 10-JUL-2008 was vaccinated orally with the third dose of ROTATEQ.  On an unspecified date after receiving all 3 doses of ROTATEQ, the patient was taken to the ER and tested positive for rotavirus   Additional information has been requested.
Uncontrollable shivering, couldn't get warm, woke me up from sleeping, body aches - joints and muscles, no fever,  could not get comfortable through most of morning.  Symptoms started to taper off about 6 hours later which left me exhausted.  Advil did help some later in day.  Minor headache most of the day with body aches.  Similar reaction to a Reclast injection (infusion) 3 years earlier.
The patient didn't report any adverse events. The patient received a thawed vaccine from the refrigerator on day 74.  The vaccine expires 70-72 days after being thawed in the refrigerator.  This vaccine could be expired.  We are waiting for the manuf., Pfizer, to contact us informing us if the vaccine is stable beyond 72 days. Pfizer did inform us that it is stable for up to 72 days in the refrigerator.
fever; body aches; chill; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (body aches) and CHILLS (chill) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), MYALGIA (body aches) and CHILLS (chill). At the time of the report, PYREXIA (fever), MYALGIA (body aches) and CHILLS (chill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were provided. No medical history was provided.
Right upper arm red and swollen ice packs applied Benadryl RX given fever.
Migraine the next, including double vision (migraine with aura); This is a spontaneous report received from a contactable other health care professional (Patient). A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EJ1685), via an unspecified route of administration on 01Feb2021 at 12:45 (at the age of 68-year-old), as 1st dose, single, in left arm for COVID-19 immunisation at Hospital. The patient's medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, on an unspecified date. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Codeine and experienced drug hypersensitivity. On 02Feb2021 at 09:00, the patient experienced migraine the next, including double vision (migraine with aura). Gone in the evening, but returned the next morning, with 3rd strong headache. Patient did not received treatment for the adverse event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was resolved on an unspecified date.  Follow-up attempts are completed. No further information is expected.
7/20/02 8mm size knot in RAT-no redness-usual ADL-tender to touch. 7/17/02 temp of 102 degrees on 7/17/02 pm-resolved by mid morning of 7/18/02.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a elderly female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, 1 day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and less than a week after vaccination, the patient experienced injection site tenderness, pain ankle and ankle swelling. The patient was treated with Ice Pack (Nos) and TYLENOL. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site tenderness were unknown and the outcome of the pain ankle and ankle swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site tenderness, pain ankle and ankle swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient received Cortisone (NOS) shot in knee, a week before SHINGRIX shot. The patient received first dose of SHINGRIX about 9 days ago from the date of reporting. The reporter reported that the patient experienced injection site reaction at 24 hours after dose that included swollen, red whelp that almost looked infected and was seen by urgent care and determined to just be injection site reaction. The reporter reported that this had improved since, but still was sore to touch and had 3 inch diameter swelling at injection site. The reporter reported that a couple days ago from the date of reporting (less than a week after receiving SHINGRIX), the patient developed swelling and pain in her ankle, was seen by ortho doctor for x rays which were negative for infection or gout. The reporter reported that now after 4 days of ankle pain and using ice pack and TYLENOL that the ankle pain persisted.
Gave the booster shot 3 months post 2nd dose instead of the 6 months as recommended; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave the booster shot 3 months post 2nd dose instead of the 6 months as recommended) in a male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave the booster shot 3 months post 2nd dose instead of the 6 months as recommended). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave the booster shot 3 months post 2nd dose instead of the 6 months as recommended) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter.  No treatment medications provided by the reporter.   Reporter stated patient experienced no adverse event.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: No adverse events reported by reporter On 12-Nov-2021: Patient details ( Initials, gender) were updated
a patient was administered improperly stored PEDVAXHIB; This spontaneous report was received from a nurse and refers to a 9-week-old male patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, historical drugs and concomitant medications was provided.  On 04-AUG-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular, lot # S036823, expiration date: 31-MAR-2022 (dose not reported) for prophylaxis.  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 33 minutes in the temperature above 47 degrees Fahrenheit / 9 degrees Celsius (8.9 C). There was no previous temperature excursion. Digital Data Logger was involved.  The outcome of medication error was unknown.
Localized reaction; erythema in right anterior thigh 7cm x 8cm.
Redness and swelling at injection site (worse on 1/17 per pt - was better on 1/18).
Pain at the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe (batch number Unknown, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age of the patient at vaccination was not reported. The nurse practitioner stated that one of his two sons, age unknown, received a dose of Bexsero on an unknown date. At an unknown time, after the dose of Bexsero was administered, he experienced pain at the injection site. On an unknown date, approximately 2 weeks after the start of the pain at injection site, the pain at injection site resolved. No other information stated by the reporter due to limited time. All other information was unknown. The reporter consented to follow up. This case was linked with other cases US2021AMR061888 and US2021AMR061889; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR061888:Same reporter. Patient #2. US-GLAXOSMITHKLINE-US2021AMR061889:Same reporter. Patient #3.
After receiving vaccines client was checking out of the clinic. Client became pale and compained of weakness and dizziness. She was eased to a chair by staff and reportedly lost consciousness for approx 2 minutes. She was seen by the Clinic physician and cleared to go home.
1/6/21 Twitching in left eybrow and eyelid  1/16/21 Started with fatigue in legs, over next couple of days muscle aches all over, bone pain, fatigue,  1/18 First Covid Test 1 Negative  Continued symptoms  1/21  Went to PCP  Covid rapid and Covid lab both negative          Labs drawn all within normal limits  Symptoms continued including occasional leg cramps, random muscle twitching, sharp needle like pain in foot, feeling shaky, waking to numbness hands
Arm is numb upper left arm near injection site. About 2cmx2cm big.  Numbness travels to my inner arm down the arm to my wrist (thumb side) arm and is constantly itchy everywhere. Also still slightly sore and not able to sleep on at night.
Vertigo/dizziness. Lost control and fell to the bed on the first symptom morning. Vertigo lasted for 10 days with varying, unpredictable intensity. Then, it was downgraded to occasional dizziness until now, Day 14. The vertigo restricted my movement and driving out of precaution. After reading similar experiences at website and others, started taking Ibuprofen and diphenhydramine, which helped a bit. Currently waiting for my second shot in 5 days warily.
2 Weeks after the injection the patient began have extreme sensitivity to cold in fingers and feet. Such that he uses cotton gloves to fetch items from the refrigerator. Once he gets a chill in either extremity a chill runs through his body and the pain and discomfort is 10/10. It has limited his activity and exercise regime and impacts his life on daily basis.
Received 0.5ml instead of 0.25ml for booster; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Oct-2021 and was forwarded to Moderna on 28-Oct-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received 0.5ml instead of 0.25ml for booster) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 28-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Received 0.5ml instead of 0.25ml for booster). On 28-Oct-2021, INCORRECT DOSE ADMINISTERED (Received 0.5ml instead of 0.25ml for booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided   This case was linked to MOD-2021-367420 (Patient Link).
This case was reported by a nurse via call center representative and described the occurrence of injection site inflammation in a 72-year-old female patient who received SHINGRIX. On 18th April 2018, the patient received SHINGRIX (intramuscular) .5 ml. In April 2018, less than an hours receiving SHINGRIX, the patient experienced injection site inflammation, injection site itching, injection site pain, injection site warmth and injection site erythema. In April 2018, the outcome of the injection site inflammation, injection site itching, injection site pain, injection site warmth and injection site erythema were recovered/resolved. The reporter considered the injection site inflammation, injection site itching, injection site pain, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the nurse who reported for herself. The health care professional stated that the pharmacist who administered the SHINGRIX vaccine to her told her that he had 2 patients who had to go the Emergency Room after receiving the vaccine. She stated they weren't admitted and they didn't die. This is all the information she provided to the reporter. The patient had previous vaccinations but had never experienced these types of side effects with other vaccines. The patient was administered SHINGRIX in the left deltoid and within hours (less than a hour), her left arm became inflamed and hot to touch. Less than a day after receiving vaccination, Then a red area about the size of an apple appeared and prevailed until yesterday. She said the area was painful to the touch. Two days after receiving vaccination, the patient experienced injection site itching. The reporter did not know the lot number or expiration date. Even though she said her symptoms have resolved, she was still aware of the vaccination site. The reporter did state she was told orally and in writing the possibility of these side effects. This case was linked to the case US2018071814, reported by the same reporter.
02/25/2021 woke up and my whole-body aches and fatigue. Later in that day I had a bad flare of my Pancreatitis, so I went to the ER.  The flare up lasted for 3 hours on 09/25/2021.
Mom reported the following morning after immunizations child had oral temp of 102 with redness and swelling in LUA. Seen in office on 10/4/15 when mild swelling and redness was noted and marked. Child had minimal discomfort. Mom will give MOTRIN.
pt states 1- 1.5 hrs p/MMR vax began to feel dizzy, lightheaded & disoriented; pt is employed by hosp so went to ER; pt in ER x 4 hrs & then drove home;3JUL92 noticed swelling of lt side of face & lt side of neck-under jaw area; hot & sweat