chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 16-NOV-2015 at time- 16:04, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.1 and 2.3 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Person developed cellulitis in upper arm where PPSV 23 was given.  Person was seen the next afternoon by her PCP's office and began Cipro 500 mg po bid x 7 days. Swelling redness and warmth resolved by 08/18.
Feelings of weakness; Nausea; Chills; Sickness; Flu like symptoms; Black stool; Diarrhea/still had a little diarrhea; Unable to eat; Body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), INFLUENZA LIKE ILLNESS (Flu like symptoms), FAECES DISCOLOURED (Black stool), DIARRHOEA (Diarrhea/still had a little diarrhea) and FEEDING DISORDER (Unable to eat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034P21A, 044A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced HEADACHE (Headache). On 16-Nov-2021, the patient experienced ILLNESS (Sickness), INFLUENZA LIKE ILLNESS (Flu like symptoms), FAECES DISCOLOURED (Black stool), DIARRHOEA (Diarrhea/still had a little diarrhea), FEEDING DISORDER (Unable to eat), MYALGIA (Body ache), NAUSEA (Nausea) and CHILLS (Chills). On 18-Nov-2021, the patient experienced ASTHENIA (Feelings of weakness). At the time of the report, ILLNESS (Sickness), INFLUENZA LIKE ILLNESS (Flu like symptoms), FAECES DISCOLOURED (Black stool), DIARRHOEA (Diarrhea/still had a little diarrhea), FEEDING DISORDER (Unable to eat), MYALGIA (Body ache), ASTHENIA (Feelings of weakness), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills) had not resolved.            The patient experienced her intestinal did a number on her, and she still has a little diarrhea. No concomitant medication was reported. No treatment medication was reported.
Pt has not had any adverse events. Pt was given the child dose of the covid vaccine instead of the adult dose.
pt reports a very itchy rash on arms and thighs that appeared about 1 hour after vaccination and continued for 4 days. the pt reports that he did not apply any creams or take any medications for the reaction. the patient also reports feeling "mixed up."
Information has been received from a 53 year old female with a penicillin allergy who on 09/06/2005 was vaccinated with a 1.0ml third dose of Hepatitis B virus vaccine.  There was no concomitant medication.  On 09/08/2005 the patient experienced fever, fatigue and weakness.  Medical attention was not sought.  No laboratory diagnostic test were performed.  At the time of the report the patient was recovering.  There was no product quality complaint involved.
DIFFUSE LEFT THIGH SWELLING.  LEFT THIGH RED AND SWOLLEN
Rec'd flu shot. 9/22/15 in (L) arm-developed shooting pain later that day-feels like its getting worse-some restriction of motion.
1st shot in JAN-2022; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on January 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received first dose of Shingrix on January 2022 and the 2 to 6 month time had exceeded. The reporter wanted to know patient need to start again by getting two shots spaced apart 2 to 6 months or one more shot in next week will be fine. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Follow-up would not possible as no contact details were available.
Our vaccinator gave a Pfizer booster dose to a patient who had already received their booster. This was due to the person who registrant the patient  failing to properly check our state vaccine information systems (databases). Vaccinator did not have this information readily available to him and was vaccinating based off of what was presented to him on the patients physical paperwork
10 days after receiving H1N1 live and Varicella lack of appetite, extreme lethargy, seizure hyperextension, dolls eyes (fixed gaze), small amount foamy saliva, seizure lasted 5 minutes. Low grade fever (99 F).
SWELLING AT INJECTION SITE. THE SIZE OF A SILVER DOLLAR. RED AND RAISED. 2 DAYS LATER IT IS RED RAISED AND THE SIZE OF A BASEBALL. ARM IS SORE.
pregnant female patient received FLUZONE vaccine/ NO AE; Initial information received on 01-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional and physician.  This case involves 24-year-old female pregnant patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (exposure during pregnancy).  Data regarding this pregnancy were received prospectively.  Patient was exposed to the vaccine at gestation period of 20 weeks.  The date of last menstrual period was reported as 20-Apr-2021.  The estimated due date is 25-Jan-2022.  The patient past medical treatment, family history and concomitant medication were not provided.  Patient had any medical history, concomitant disease or risk factor  On 01-Sep-2021, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [lot 477325SA, expiry date: 30-Jun-2022] via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was the case of vaccine exposure during pregnancy (latency same day). The patient was pregnant when she received FLUZONE vaccine.   It was not reported if the patient received a corrective treatment for the events.  It was not reported whether patient experienced any adverse reaction after the injection.  Pregnancy outcome was unknown at the time of report.
This spontaneous report as received from a consumer refers to an 82 year old female patient with drug reaction/allergy to many unspecified medications. On an unspecified date in September 2013 the patient was vaccinated with ZOSTAVAX (subcutaneous injection, in the arm, strength, dose, route, lot # and expiration date not reported). Other suspect therapies included influenza virus vaccine (manufacturer unknown) (in the other arm, strength, dose, route, lot # and expiration date not reported). Concomitant therapies included unspecified medications for thyroid and cholesterol, atenolol and OCUVITE. On an unspecified date in 2013, a few dates after the vaccination the patient developed severely itchy patches on her skin starting on her back, legs, arms and breasts. She described them as "like patches of thick skin". Her itchy skin patches were diagnosed as prurigo. The patient also developed growths on her scalp that felt "like the head of a nail" that were diagnosed as "nerve endings". Most of them have gone away  but one or two will appear from time to time. The patient also reported that she felt "like there are needles going through her toes" and felt that there were "aliens in her body". Also, her intestines were infected as she had constipation. The patient was not diagnosed with shingles. The patient sought medical attention, and was treated for the patches with unspecified topical gel and unspecified shots, and for the constipation with colostrum powder. It was also reported that "blood tests" were performed on the patient (results and dates not provided). The outcome of the events was reported as not recovered / not resolved. Causality assessment was not provided by the reporter. Additional information has been requested.
Dizziness; Weakness; Feels like I am going to fall down when I am standing; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, ASTHENIA, and PRESYNCOPE in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced DIZZINESS, ASTHENIA, and PRESYNCOPE. At the time of the report, DIZZINESS, ASTHENIA, and PRESYNCOPE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
I was very fatigued the day of the vaccine (4/13).  The next day (4/14) I was achy and also fatigued, particularly in the afternoon and evening.  The third day 4/15) I was still fatigued but not as much.  I felt a bit like I felt when I had COVID 19 in November 2020.  The 4th day, 4/16 I felt pretty normal.  However I continue to feel fatigued in the afternoons, and I wonder if its related.
Information has been received from a female physician assistant (age not reported) who on 03 Oct 2006 was vaccinated intramuscularly with the first 0.5ml dose of HPV vaccine. Concomitant therapy included an unspecified therapy for asthma. On 03 Oct 2006, immediately after receiving the HPV vaccine, she developed extreme pain on her skin and broke out in hives all over her body. The physician assistant stated that it felt like a cat clawing on her skin. The physician assistant went to the emergency room and was treated with asthma medication but was not admitted. No ER date was provided. On an unspecified date, the patient was recovering from the events. On 05 Dec 2006, the patient was vaccinated with a second dose of HPV vaccine. Subsequently, the patient developed an outbreak of hives in a circle around the site of injection. At the time of this report, the outcome of the event was unknown. The physician assistant considered the events of extreme pain on her skin and broke out in hives all over her body to be other important medical events as the patient was treated with asthma medication in the ER (OMIC). Additional information has been requested.
Patient states she had increasing aching and pain with movement in arm/shoulder for 7-10 days. She went to healthcare provider to receive steroid injection on 11/3/22. She said it helped for 4 months. She received a second steroid injection  in early March. She did not get relief.  Last week she got an MRI. She states she has bursitis and rotator cuff injury.
Parent called me at the office on Oct 19, 2009 stating that her daughter was having symptoms. Fever, cough, body aches, chills and fatigue. Daughter was have these symptoms on Oct 18, 2009. Mom checking temp frequently and giving her TYLENOL for fever. Pt is responding to medication. Mom keeping her home from school.
This is a spontaneous report from a contactable consumer reporting for himself. A 79 years old male consumer received pneumococcal 13-val conj vac (dipht crm197 protein) (unknown manufacturer) on an unspecified date in 2016 (2 months before the report) in left upper arm at single dose for immunization. Relevant medical history was none. Concomitant medication included influenza vaccine in Oct2016 in right arm for immunization. Since an unspecified date in 2016, about a week after getting the vaccine, the consumer experienced whole body aches (could barely get out of bed) and pain mostly in his left arm at the injection site. Pain was worse when he woke up in the morning. He went to the doctor about 4-5 weeks before this report due to body aches and took an unspecified steroid for 2-3 days and the symptoms went completely away but about 2 days before the report the pain was coming back; he started feeling the pain mostly in his left arm again and some other areas in the body. Relevant tests were none. The final events outcome was unknown. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Rt upper arm red and swollen. Received immunization on 2-18-19. No fever or vomiting. No C/O pain. Ice pack applied as needed. Info provided per Mom.
patient's wife stated that her husband had developed a very itchy, spotty rash around groin and on top of scalp
Pt received the incorrect vaccine. Pt  was given Moderna Pediatric Monovalent NDC 80777-275-99 instead of Moderna Bivalent NDC 80777-0282-05
Symptom onset 11 d after vaccination: Diffuse itching/rash/hives/urticaria starting on the posterior scalp, then arising in asynchronous, asymmetrical patches all over body including palms; partial response to antihistamines (diphenhydramine >> loratadine) persisting >6 days after improving substantially after day 2. No known exposure to other potential allergens or irritants.
Headache, HYPOglycemia, TROUBLE WALKING, EXISTIN REACTIVE HYPOGLYCEMIA Narrative:
No adverse event; Vaccine administrator said that the syringe malfunctioned and the patient did not get his entire dose; Likely that the patient received a higher than normal bivalent vaccine dose; This spontaneous case was reported by a nurse and describes the occurrence of SYRINGE ISSUE (Vaccine administrator said that the syringe malfunctioned and the patient did not get his entire dose), ACCIDENTAL OVERDOSE (Likely that the patient received a higher than normal bivalent vaccine dose) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Nov-2022, the patient experienced SYRINGE ISSUE (Vaccine administrator said that the syringe malfunctioned and the patient did not get his entire dose) and ACCIDENTAL OVERDOSE (Likely that the patient received a higher than normal bivalent vaccine dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, SYRINGE ISSUE (Vaccine administrator said that the syringe malfunctioned and the patient did not get his entire dose), ACCIDENTAL OVERDOSE (Likely that the patient received a higher than normal bivalent vaccine dose) 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 assessments were provided for SYRINGE ISSUE (Vaccine administrator said that the syringe malfunctioned and the patient did not get his entire dose) and ACCIDENTAL OVERDOSE (Likely that the patient received a higher than normal bivalent vaccine dose).    Concomitant medications were not reported.  Reporter reported about her son who received his first Moderna Covid-19 bivalent vaccine and not all of the vaccine went into the patients arm. Patient did not report any other adverse reactions however when the pharmacy technician gave patient the first dose the vaccine administrator said that the syringe malfunctioned and the patient did not get his entire dose.  However, the technician consulted with the Pharmacist and gave the patient a second dose. It was likely that the patient received a higher than normal bivalent vaccine dose.  Treatment medications were not reported.
9:00 am Received my Covid-19 vaccine 9:05 am I developed a severe sore throat 9:20 I developed dizziness and a headache 9:45 facial and tongue tingling, swollen eyes and wheezing 10:00 presented to Emergency Services 10:10 received 50 mg IV benadryl & decadron 1015 severe throat swelling and difficulty breathing IM Epinephrine and Racemic Epi given 10:25 Able to breathe again 14:30 Discharged home with 4 days of dexamethasone
Besides the typical fever, chills, headache and arm soreness on day 1 and 2, I developed a rash and a feeling of pins and needles throughout my body (except my face) (on Day 2 post vaccine administration).  Urgent care on day 3- prescribed loratidine 2x a day and prednisone 1x a day.   Day 7- very mild itching.
Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL. After the vaccination the patient fainted. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. No further information is available.
Patient had generalized itchiness for a few minutes after her Moderna booster shot. Also, patient verbalized difficulty of swallowing and some SOB.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. M2L20A) for COVID-19 vaccination.     NO medical history information was reported.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 18-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. M2L20A) for COVID-19 vaccination.     NO medical history information was reported.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 18-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
two lumps that have appeared in my neck/on the left anterior and is the size of a large blueberry or small grape/on the right anterior and is the size of a pea; This is a spontaneous report from a contactable consumer reporting for herself   A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247) on 25Feb2021 at 11:15 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. The patient had not medical history. Concomitant medications were not reported. On 06Mar2021 at 12:30 pm the patient noticed two lumps that have appeared in my neck. One is on the left anterior and is the size of a large blueberry or small grape. The other is on the right anterior and is the size of a pea.  Patient sawher primary care physician and she has ordered a CT scan to be performed and told patient that this could be potentially COVID vaccine- related. The patient received unspecified treatment. At the time of the reporting the patient had not yet recovered from the event.   No follow-up attempts are possible. No further information is expected.
No additional AE/PQC; five doses of the VARIVAX that underwent the temperature excursion were administered; This spontaneous report was received from a physician referring to a 4 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 18-JUN-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 ml once, lot # S008695, expiration date not reported, but upon internal validation established as 21-MAR-2021, strength and route were not reported) which was underwent the temperature excursion for prophylaxis (product storage error). The storage temperatures of varicella virus vaccine live (Oka/Merck) (VARIVAX) were -9.2 Celsius degrees for 30 minutes and -14 Celsius degrees to -10 Celsius degrees (-14.3 Celsius degrees) for 30 minutes. There was no previous temperature excursion. Data logger was involved. No additional adverse event (AE) or product quality complaint (PQC).   This is one of 5 reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA011114: US-009507513-2008USA011596: US-009507513-2008USA011215: US-009507513-2008USA011552:
Immediately after vaccine rec'd last Thursday, I immediately after shot I began to feel weird like something in my throat and it's still there, my arm was hurting, that night I was able to sleep, Friday it started getting more sore, Saturday I noticed I could not sit because my butt cheeks were hurting, then I started feeling leg and hand cramps on my left side,  Then Sunday my arm, leg, back, spinal cord everything was hurting and I was extremely thirsty and I couldn't lay down, sit or even walk. I have not been feeling good at all. Also, I have lupus
Case number PHEH2012US010694 is an initial spontaneous report received from a health care professional on 23 May 2012. This report refers to a patient whose age, gender, medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that the patient was vaccinated only with the MenCWY-135 liquid conjugate component of MENVEO (batch number: A1103Z, expiry date: Mar 2014) through unspecified route and site on an unknown date and did not receive the MenA lyophilized conjugate. No adverse event was reported following the maladministration. No other information was provided.
I got up to use the bathroom at 4:30 this morning. I was extremely shaky but made it. I was using the bathroom and had the feeling that I was going to vomit. Next thing I know I was seeing stars and I fainted and fell off the toilet face forward and hit my head on my tile floor. I don't remember getting to the couch, but my dad was awake to let out the dogs and I couldn't really speak but he heard me and came downstairs and got me water and a cool rag. I was sweating but shivering. I am nauseous and have slept a total of 13 hours since 4:30am. I am pretty sure I have a concussion. I have a headache, on and off chills, muscle spasms beginning at 9:00PM on 1/14/21. I also have ringing in my ears. My resting heart rate is typically between 75-85 and I checked it at 7pm and it was 100. I have not sought out medical attention and have been debating it all day.