chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse Event; received a Moderna original vaccine as a booster instead of a bivalent Moderna COVID19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (received a Moderna original vaccine as a booster instead of a bivalent Moderna COVID19 vaccine) and NO ADVERSE EVENT (No Adverse Event) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (1st dose, lot number FK5127) on 10-Nov-2021, Pfizer vaccine (2nd dose,lot number FK5127) on 01-Dec-2021, Pfizer vaccine (BOOSTER andlot number FL8095) on 23-May-2022. Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 23-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received a Moderna original vaccine as a booster instead of a bivalent Moderna COVID19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (received a Moderna original vaccine as a booster instead of a bivalent Moderna COVID19 vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            No concomitant medications was provided. No treatment medications was provided.
Patient experienced pain through entire shoulder, back and down the arm. Patient has limited range of movement from the shoulder as a result. Patient is experiencing physical pain throughout the region and has issues sleeping and with day to day activities (i.e. putting on clothes). Patient has claimed that the condition had worsened since September 2020 but has remained at a consistent level since.
Narrative: 1/20/21 Vomited x3 nonbilious and was found to have a fever (100.4 degrees F). Pt reports fullness, saying his belly feels hard. on exam abd distended / tympanic abdomen, decreased bowel sounds. Trafered from clinic to acute care to r/o acute abdomen. 1/19 vaccine given 1/17 - abdomen visibly rounded, patient looks uncomfortable. Patient denied pain x 3, reports feeling full. Abdomen is soft, nontender. Normoactive bowel sounds x 4 - scheduled to receive enema on 1/18. 1/16: noted to have a distended stomach, positive bowels sounds denied pain or discomfort. Ate 50% of dinner, During pm care abdomen noted to be more distended than at the start of shift. - txed with suppository Patient has BM. PMH includes dementia, hypothyroidism, dysphagia, ataxia, drug-induced tremor, schizoaffective disorder, chonic constipation, anemia, bipolar, HL
Sudden sharp stomach pain and nausea. Got the 1st shot at 2: 15 pm and got stomach pain and felt nauseous after a couple of hours. The pain was very sudden and a sharp pain. I had never experienced such a pain before. I never had stomach problem before. The pain didnt last long and was better after about an hour but was feeling discomfort until the next day. The 2nd dose (3/2/2021, Pfizer-EN6202) triggered it and I felt the same sharp stomach pain again. It last longer and the discomfort persisted. In the 2nd week of March, I experienced abdominal pain, nausea, vomiting, bloating and sharp stomach pain. I was diagnosed with stomach ulcer - very unbelievable as I never drink alcohol.
Did not get 2nd dose on time; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get 2nd dose on time) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get 2nd dose on time). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get 2nd dose on time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Description of Event or Problem: the HCP stated that the patient was unable to make it hence did not get the 2nd dose on time. No  concomitant medication provided by the reporter. no treatment information provided by the reporte
My head started pounding, my injection spot is really sore, I?m also starting to feel achy? (body aches). Muscles all over my body are throbbing, I?m also starting to feel really hot/ warm.. possibly fever.
still got the flu; Initial information received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who still got the flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious event of still got the flu (influenza) (latency: unknown) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown
No adverse effects reported; improperly stored vaccine, ROTATEQ has been administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 12-AUG-2019, the patient had been administered an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R027191 (verified to be a valid lot number), expiration date reported and established as 15-JUL-2020, by oral route, for prophylaxis. The vaccine was improperly stored at a temperature of 29.3°F, during a time frame of 7 hours and 57 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA000484:
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: EMS came to store and took patient to hospital
She is asking if it is okay that she took the steroid shot; She has problems in her shoulder due to arthritis.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: She has problems in her shoulder due to arthritis. The patient's concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "She has problems in her shoulder due to arthritis."; POTENTIATING DRUG INTERACTION (non-serious) with onset 12Mar2021, outcome "unknown", described as "She is asking if it is okay that she took the steroid shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vaccine was reconstituted using only 0.9mL of liquid - patient received 0.3 mL - almost a double dose of vaccine.  patient is being followed - no adverse event yet.
Itchy; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itchy) and RASH (Rash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 Vaccination.     No medical history was provided by the reporter.  Concomitant products included CORTISONE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy) and RASH (Rash). At the time of the report, PRURITUS (Itchy) and RASH (Rash) 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.
Redness & swelling noted to Right deltoid. (2.5cmX3cm) C/O muscle pain and headace
a DVT in his left calf after the second vaccine; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 18:15 (Batch/Lot Number: ER8735) at the age of 51-years-old as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications was none, patient did not received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (Lot number: ER8733) on 01Apr2021 16:00 at the age of 51-years-old in Left arm for covid-19 immunization and experienced a superficial blood clot in his left calf. The patient experienced a deep vein thrombosis (DVT) in his left calf after the second vaccine on 16Apr2021 6:30 PM. Event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the events included had a shot of enoxaparin sodium (LOVENOX) and am taking rivaroxaban (XARELTO). The patient underwent lab tests and procedures which included blood test: negative on 06May2021, Nasal swab covid-19 test: negative on 27Apr2021. The outcome of the event was not recovered.
Magnetic at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Magnetic at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Magnetic at injection site). At the time of the report, VACCINATION SITE REACTION (Magnetic at injection site) outcome was unknown. Not Provided          Concomitant medications were not reported. Treatment information were not provided.
ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 11/6/2021 ACUTE RESPIRATORY FAILURE ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/6/2021 ACUTE RESPIRATORY FAILURE ACUTE RESPIRATORY FAILURE 11/6/2021 ACUTE RESPIRATORY FAILURE
Patient's mother states she fainted  about 15 mins after leaving the office. Pt could not remember feeling bad or faint, she just knows she woke up confused.
achy arm; achy shoulder; headache; neck pain; back pain; Inappropiate schedule of vaccine administered; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2018).   On 3rd June 2019, the patient received the 2nd dose of Shingrix. On 3rd June 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 4th June 2019, the patient experienced pain in arm, shoulder pain, headache, neck pain and back pain. On an unknown date, the outcome of the pain in arm, shoulder pain, headache, neck pain and back pain were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain, headache, neck pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain in arm, shoulder pain, headache, neck pain and back pain after receiving 2nd dose of Shingrix. The patient received 2nd dose of Shingrix 10 months after receiving 1st dose, which led to lengthening of vaccination schedule. This case is linked to case US2019101097, reported by same reporter
High fever came and went (102.1, 102.2, 102.6, 100.3) starting at 2am (still symptomatic at 11pm) Stomach discomfort/unsettled but no diarrhea  Pain at injection site almost immediately after administration which persisted, but no axillary lymphadenopathy  Extreme headache and joint pain (hips, right hand ring finger and middle finger)
Adverse Reactions To Coronavirus Vactionations; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse Reactions To Coronavirus Vactionations) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse Reactions To Coronavirus Vactionations). At the time of the report, VACCINATION COMPLICATION (Adverse Reactions To Coronavirus Vactionations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported. Treatment medications was not reported.
Case number PHEH2014US024973, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 50 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 04 NOV 2014. The  nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration (incorrect storage of drug).
Next morning, patient had a rash and swelling on forehead and back of hands. She took a benadryl and went to the emergency room.
It started with a retinal migraine which I have never gotten before, then I lost my vision. My anxiety took over and I started to panic. I went to the emergency room where they tested me for having covid-19 which was negative. I lost the feeling on the right side of my body. I felt extremely nauseated and weak. I became very flush and pale while having cold sweats. This lasted 4 hours. After this I was just weak the rest of the day.  This happened two times to me. Both on normal days where I was supposed to be working. Luckily I work in the clinic. The dates this happened where on 03/18/2021 and 03/26/2021 both in the morning.
Vaccine was administered one day after beyond use date. Pfizer corporation was contacted in regards to stability and clinical pharmacy advisor contacted in regards to vaccinate again.
One week after the injection I started developing a rash that started out the size of a quarter and has been getting increasingly worse since it developed 4 days ago.  The rash is now larger than a softball and is swollen, red and itchy. Along with the rash I have been increasingly experiencing shortness of breath when talking, clammy skin, excessive sweating, body aches, and fatigue. The bottoms of my feet have also been itchy. I have been taking Pepcid and Benadryl which have helped to alleviate symptoms. I contacted my primary care doctor and hope to speak with her in the next 24-48 hours.
Large hive type rash (3 inches in length) developed around injection site 2 weeks after 1st dose.
Here today with mom with c/o of right leg pain. Mom states patient was here 5/2/18 and got his 15 month shots. Mom states since the shots patient has been crying when he puts weight on his right leg. Mom states patient has been eating less and fussier. Mom states patient has had fevers off and on from 101-102. Right thigh pain right anterior thigh where he got his PREVNAR, started 4 hrs after the vaccine. No bruise, not hot, moves joints well. Mom said a few days didn't bear wt.
Client c/o generalized weakness, stated that symptom began immediately after receiving vaccine.  Client was seen by EMS and assessment rendered.  Vitals are BP 177/87, HR 66, O2 97.  Client express that symptoms decrease and cleared to go home by EMS.
Beginning on 04/11/21  I began a fever of 102 degrees.  This temperature lasted on and off for a week. I was then feeling very tired and not myself. I was then unable to perform my regular daily activities without needing to rest. I was unable toe exercise like I had before the shot. I then was out on06/05/2021 and was walking quickly and passed out. I then passed out 2 days later. I stopped my regular exercise program for a week. Began exercising again on 06/13/2021, I then passed out again on 06/17/2021. I then maintained a slow key summer. Began a regular routine again on 08/29/2021. On 09/10/2021 I passed out and ended up in the hospital with cardiac arrest, with an arterial ventricular block and then a pacemaker to treat the problem.  During my 5 day stay in the hospital many tests were completed all showing normal results.
No adverse event; Vaccine administered after beyond use date 07-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022) 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 EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022).    No concomitant medication was reported.  Reportedly, the vaccine BUD date was 07-Jul-2022.  No treatment information was provided.
On 5/23/03 patient had a physical for kindergarten which included updating of booster shots. He recieved MMR in the left hip area, DTaP in frontal left thigh area and Polio in the right frontal thigh area.  The following morning a 1"x1" "welt" was observed at the left frontal thigh injection sight.  In the course of 8 hours the injection sight increased to the size of 5"x5".  I telephoned a 24 hour nurse line listed on my insurance card and a registered nurse advised me to take patient to the emergency room since what I had described sounded like an adverse reaction. The area involved was checked over in the emergency room and a blood test and urine test was given to rule out possible cellulitis.  Both tests came back negative for infection and patient was observed for 3 hours and released.  Benedryl and Children's Motrin was reccommended for irritation and pain relief.  The following morning (5/25/03), I placed a phone call to the emergency room due to the fact that the welt increased even further.  I was told to keep an eye on the area and come back if I felt it was warranted.  Patient was seen by his doctor on 5/28/03 at which time it was determined that the area involved was the sight of the DTaP injection.  He also ruled it an adverse reaction and should keep this in consideration when it is time for his next booster.  As of today (5/29/03), there is still a large "blotchy" area on his left front thigh and a lump at the injection sight.
15 days p/receiving vax pt had sz; hospitalized until 28DEC; D/C home w/no meds; currently w/o neurologic sequella;
Presented to the ED  with SOB,- appears to be from pulm edema, with superimposed OHS,chronic hypoxic respiratory failure, COVID pneumonia, solumedrol, duonebs,cefepime,lasix,HFNC, remdesevir,  zinc