chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received two COVID-19 vaccinations and then contracted COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient received two COVID-19 vaccinations and then contracted COVID-19) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient received two COVID-19 vaccinations and then contracted COVID-19). At the time of the report, COVID-19 (Patient received two COVID-19 vaccinations and then contracted COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment details were reported.  Pharmacist could not confirm if the patient received the Moderna vaccine or Pfizer's vaccine.  Company comment: This case concerns a female patient of an unknown age with no reported medical history who experienced non-serious unexpected event of special interest COVID-19. The event occurred unspecified period of time following the second dose of mRNA-1273. However, it should be noted that no details regarding vaccination were provided. Furthermore, the Reporter could not confirm whether the patient received the Company product or Pfizer's vaccine. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age with no reported medical history who experienced non-serious unexpected event of special interest COVID-19. The event occurred unspecified period of time following the second dose of mRNA-1273. However, it should be noted that no details regarding vaccination were provided. Furthermore, the Reporter could not confirm whether the patient received the Company product or Pfizer's vaccine. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report as received from a registered nurse refers to an approximately 17 or 18 year old twin male patient. On 06-AUG-2013 the patient was vaccinated with GARDASIL lot # H020002, expiring 08-AUG-2015 dose 1 (route and site not provided). On 06-AUG-2013, about 10 minutes following GARDASIL vaccination, the patient experienced syncope with tonic-clonic movements; however the patient remained awake and alert during the syncope. The syncope lasted about 15 minutes. No lab diagnostic tests were performed. The patient sought medical attention by office visiting. On 06-AUG-2013, the patient recovered from the events. The causal relationship was not provided. This is one of several reports from the same source. Additional information has been requested.
Arm was swollen to the elbow; Began to itch again,itching; Redness/swelling/lumpiness began to wrap around her arm to her armpit; Arm hurt; Migraine; Vertigo; Dizziness; Flu like; Lumps the size of quarters in a 4 x4 inch patch, 3 inches below injection site; Just didn't feel good,Very sick and went to bed; Arm was red; Nausea; Achy Muscle and joints; (Right arm) was sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen to the elbow), PRURITUS (Began to itch again,itching), SKIN MASS (Redness/swelling/lumpiness began to wrap around her arm to her armpit), PAIN IN EXTREMITY (Arm hurt) and MIGRAINE (Migraine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen to the elbow), PRURITUS (Began to itch again,itching), SKIN MASS (Redness/swelling/lumpiness began to wrap around her arm to her armpit), PAIN IN EXTREMITY (Arm hurt), MIGRAINE (Migraine), VERTIGO (Vertigo), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu like), VACCINATION SITE MASS (Lumps the size of quarters in a 4 x4 inch patch, 3 inches below injection site), MALAISE (Just didn't feel good,Very sick and went to bed), ERYTHEMA (Arm was red), NAUSEA (Nausea), ARTHRALGIA (Achy Muscle and joints) and MYALGIA ((Right arm) was sore). On 24-Mar-2021, PERIPHERAL SWELLING (Arm was swollen to the elbow), PAIN IN EXTREMITY (Arm hurt), MIGRAINE (Migraine), VERTIGO (Vertigo), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu like), VACCINATION SITE MASS (Lumps the size of quarters in a 4 x4 inch patch, 3 inches below injection site), MALAISE (Just didn't feel good,Very sick and went to bed), ERYTHEMA (Arm was red), NAUSEA (Nausea), ARTHRALGIA (Achy Muscle and joints) and MYALGIA ((Right arm) was sore) had resolved. At the time of the report, PRURITUS (Began to itch again,itching) and SKIN MASS (Redness/swelling/lumpiness began to wrap around her arm to her armpit) had not resolved.            The Treatment history was not reported. Patient's all of the symptoms went away again after 7-8 days except for the itching and redness/swelling of her arm. Patient feeled about 70%.   This case was linked to MOD-2021-290851, MOD-2021-291781 (Patient Link).
weak; Chills; HEADACHE/ Head was hurting her going through her eyes; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), CHILLS (Chills) and HEADACHE (HEADACHE/ Head was hurting her going through her eyes) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Planning to become pregnant since an unknown date. Concurrent medical conditions included Asthma and Graves' disease.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced ASTHENIA (weak), CHILLS (Chills) and HEADACHE (HEADACHE/ Head was hurting her going through her eyes). At the time of the report, ASTHENIA (weak), CHILLS (Chills) and HEADACHE (HEADACHE/ Head was hurting her going through her eyes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported No treatment information was provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Double vision experienced in right eye upon waking up this morning. Contacted health care provider. Recommended eye drops over the next few days and to call back if symptoms persist.
mixed series vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (mixed series vaccination) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE on 08-Apr-2021. Concomitant products included LORAZEPAM from 26-Jan-2015 to an unknown date for Anxiety, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA) from 29-Jun-2016 to an unknown date for Blood pressure, TRAZODONE from 23-Dec-2019 to an unknown date for Sleepy, MINOCYCLINE from 17-Feb-2020 to an unknown date and TESTOSTERONE from 16-Sep-2019 to an unknown date for an unknown indication.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (mixed series vaccination). On 26-Jul-2021, INTERCHANGE OF VACCINE PRODUCTS (mixed series vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received and contains significant information updated reporter details, suspect product information route and anatomical site, vaccine facility information, concomitant medications, Events start date was updated.
Patient came to the local Health Center for his "initial" dose of COVID.  When he came in, he told the Customer Access Representative that this was his 1st COVID shot.  He told the me that he was here for his initial Moderna shot.  Moderna COVID-19 0.5 ml given IM to right deltoid, without difficulty.  After documenting the vaccine, I noticed in the database that patient received a J&J vaccine on 7/20/2021 at a local Pharmacy.  Lot # 203AZIA.  This Moderna COVID-19 was actually a Booster to the J&J, but was given at a higher dose that the normal Booster dosage. I called, today, to check on the patient, but he was out of his home, in the woods, with his in-laws.
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions included asthma and allergy to cashews. On 20-JUL-2016, the patient was vaccinated with GARDASIL 9, (lot # 040164 (not valid), expiry date: 20-FEB-2018 at a dose of 0.5 ml, (route of administration: intramuscular). Concomitant therapy included triamcinolone cream. After 3 hours of vaccination, the patient experienced an itchy rash on chin and back. The patient was not hospitalized. The patient contacted doctor and was treated with BENADRYL and ibuprofen. The event was recovered on 21-JUL-2016. The causality of the event was not reported. Additional information has been requested.
Information has been received from a doctor of pharmacy concerning a 62 year old male patient with diabetes and no known drug allergies /drug reaction who on 24-Apr-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot#664092/0198Y) subcutaneously. Concomitant therapy included Lasix, Lisinopril (manufacturer unknown), glyburide (unspecified), ferrous sulfate (unspecified), Tricor, Cialis and minoxidil (unspecified). It was reported that the day after vaccination the patient experienced dry cough. The patient spoke with the pharmacist. There were no laboratory diagnostic test performed. It was reported that the patient was recovering at the time of the report. Additional information has been requested.
Fevers backed off; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fevers backed off) and FATIGUE (Exhaustion) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included Long COVID in April 2020.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fevers backed off) and FATIGUE (Exhaustion). The patient was treated with UBIDECARENONE (COQ 10) at an unspecified dose and frequency; ZINC at an unspecified dose and frequency; VITAMIN D [VITAMIN D NOS] ongoing since an unknown date at an unspecified dose and frequency; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency; ECSTASY at an unspecified dose and frequency and MULTIVITAMINS [VITAMINS NOS] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PYREXIA (Fevers backed off) and FATIGUE (Exhaustion) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported.  Treatment medications include extra D, supplements and electrolytes. Non drug information includes patient consumes coconut water, protein drink.   This case was linked to MOD-2021-376668 (Patient Link).
Myopericarditis after Covid-19 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown manufacture), for COVID-19 immunization. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "Myopericarditis after Covid-19 Vaccination". The patient underwent the following laboratory tests and procedures: Echocardiogram: Normal; Electrocardiogram: Unknown result; Imaging procedure: Unknown result; Magnetic resonance imaging heart: unknown results.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200057449 Same article/ drug/event and different patient;
Immediately after receiving influenza vaccine, pt had syncope episode. Became alert in seconds, layed on floor for 10 minutes with 4 RN's attending. BP WNL, O2 at 8 L applied. Pt dizzy and faint upon sitting. EMS called, had second syncope episode. Pt transferred to hospital via EMS.
Fatigue, lasting about 21 hours; slight headache. Resolved by itself with no treatment.
Pt presented to clinic with fatigue, SOB, general body aches on 3/22--treated for pneumonia, recheck on 3/24 found PE on CT.  Admitted to hospital
Later that night, I got low grade fever, body aches, chills and a headache. The headache became really severe the next day. And about two or three days later it was really severe - and it lasted a good three weeks. On the 20th I had donated blood - I asked the staff and they said it should be fine to donate after receiving the first vaccine.  I called my primary care doctor for CAT SCAN of my  head. I almost heard a pop in my head so I was worried. My headaches didn't go away even with taking Ibuprofen and Tylenol around the clock for almost three weeks. I don't drink caffeine anymore but at that time I was trying to drink caffeine  to try to help my headache go away and that didn't help.
Child brought in by mother for TD. Child also accompanied by sister. Administered TD in lt deltoid IM. After giving TD. Child stood and walked beside her mother. Mother states child passing out. CHN was standing right beside child. Noted child's eyes rolling back, CHN put arms under child's axilla and laid her on the floor without injury. child's body became rigid and extremities shook. Noted salvia at mouth and tears in eyes. Child came out of activity without noted injury. Child was frightened when she became alert. Child calmed and reassured by CHN. 8:40 am pulse 68 reg. BP 110/76. RR16. Ice pack placed behind child's neck and she remained on the floor. Ambulance called for transport to ER. Child states she did not eat this am. 8:50 am BP 120/80 pulse 68 neg RR 16. Skin warm pink calmy. Child A&ox3. ER staff arrived they took BS results 101. 8:55 am Child taken to R on wheeled cart by ER staff. Child's mother and sister Followed. 08/10/2005 TC to Dr ,PCP reported incident to Nurse. 08/10/2005 TC to ER states client was treated and released this AM. Message left requesting DR. call CHN. 08/10/2005 RTC from Medical Director, Informed Dr of incident. Dr said it was a Vasovagal response. VAERS form completed and mailed.
Significant neck pain and muscle spasm 48 hours after vaccination, aseptic meningitis 3 weeks after vaccination requiring hospitalization.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 02/17/2021 and 03/10/2021. They did not have a known specific symptom onset, but became suddenly short of breath while walking and collapsed. They presented to emergency department and were admitted to hospital on 01/08/2022; they tested positive for COVID-19 upon this hospital admission. It was determined that the individual had complications of anoxic encephalopathy, cardiac arrest, and an acute myocardial infarction. Given poor prognosis, the individual was transitioned to comfort care and died on 01/12/2022.
High fever first night 102.5.  Body ache  Chills  Misery
Raised burning rash on legs, itching has started on upper torso, back and upper arms, Severe fatigue and some lower abdominal pain
Information has been received from a physician concerning a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number not provided) while she was pregnant. The LMP and EDD was not known. The patient was under the care of the reporting physician for seeking medical attention. The outcome of the pregnancy was unknown.
pt recv vax 5JAN96 & 9JAN95 pt exp vomiting,diarrhea,myalgia & nausea;pt believed sx were d/t vax;
Swelling and redness at injection site, swelling of lymph nodes in the same arm as injection site, painful
Getting  dizzy  after Getting  the phizer  2nd booster shot  every  day  that I can not work  due to the  dizziness
DTP admin to pt 29Apr92. Mom noticed reddeness @ inject site 5May92 then inspected by RN-erythema 2"wide X 3"long.No induration, afebrile,0 limintations in ROM.Sl tender to touch. P/-warm compresses to be applied by mom tonight & tomorrow.
arm soreness; This case was reported by a consumer and described the occurrence of pain in arm in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2021, the patient received the 1st dose of Shingrix. On 2nd September 2021, several hours after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient self reported this case. The patient received Shingrix injection around noon today (day of reporting) and a couple hours later he had soreness on the arm where he received the injection, he still had some soreness (arm soreness, unresolved). The patient asked could he take advil for arm soreness. The patient consented to follow up with his doctor.
On 10/08/2023 we received a notification from GSK about a documentation issue with a specific lot of Arexvy. Product quarantined.
Patient almost immediately showed signs of possibly passing out, her forehead was beaded with perspiration, she was extremely lightheaded and lost all color.  This persisted about 20 minutes until she started to feel better.  Patient stayed on premise for 45 minutes.  I followed up with the patient a day later, she was in bed, in pain feeling nauseated, with body aches and chills.  It was painful for her to roll over .Patient felt even too weak to walk.     I checked again on 9/6/21.  Patient was better but her symptoms had persisted for 4 days.
H/A w/fever x 2 days, temp 102 for 2 days; no n/v; Tx APAP by mom;
Sleeplessness; Nervousness; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Sleeplessness), NERVOUSNESS (Nervousness), FATIGUE (Tiredness) and HEADACHE (Headache) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.No concomitant medication was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Sleeplessness), NERVOUSNESS (Nervousness), FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, INSOMNIA (Sleeplessness), NERVOUSNESS (Nervousness), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.      Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt recv vax; had HA, n & v since vax;no fever or d;; on f/u pt's HA improved, no v in past few hr;unable to contact MD;
About 8 minutes after receiving injection, Pt stated that she wasn't feeling well. She passed out for about 2 minutes. Pt came too and was taken to ER via wheel chair. at ER pts bp was 69/33 HR:42 O2 was 100%. pt was pale and diaphoretic.
After immunizing technician gave the shot patient immediately started yelling at technician saying they hit a vein and said they could feel it all the way down to their toes and they felt it all over their body; Patient did bleed and swelled at the injection site but did not bleed through the barrier -site bandage;  He told technician that it was done incorrectly and was going to report us to the cdc and we were incompetent and it was a terrible experience;  He kept saying he was a nurse for 25 years and he had many degrees and we did not know what we were doing;  He said he had many degrees and he knew we had hit a vein;  Would not allow me to talk to him after that ; he walked away from the pharmacy;  He ask to be tested with an antibody test at this time also;'
Shortness of breath, chest pain; heart palpitations; dizzy - that started pretty much right away within an hour or so after the vaccine and lasted up through today - I'm still having them. They found I have a hole in my heart. And now they need to close it. I have never had a problem with my heart before until after this vaccine and did not know about a hole in my heart. An EKG has never found it and I have never have had a heart murmur. It's harder to do my job then it ever has been. It has affected the quality of my life.
The pt experienced a fever several hours post vax, crying, hard to console, and jerking in sleep. The fever was 101.3 at the office exam. CNS irritability with fussiness and crying with little manipulation and very temporary calming only with usual comfort measures.