chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had second shot outside of 42 day window; A spontaneous report was received from a consumer concerning a 69-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced second shot outside of 42 day window (Inappropriate schedule of vaccine administration).  The patient's medical history, was not reported. Concomitant medications reported included bupropion, lamotrigine, Librium, progesterone/ estrogen, magnesium glycinate, deplin and suboxone.  On 13 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 012A21A) intramuscularly for prophylaxis of COVID-19 infection. Patient took second dose outside of 42 day window.  No laboratory details was provided.No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, second shot outside of 42 day window, was considered as resolved on 27 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # 012A21A  with no associated AEs.
CDC reports: 2 mo infant had screaming episode lasting approx 3 hrs following DTP/OPV immunization.
Body aches, my right arm where I got the injection is feels heavy, swollen feet, sore throat and tiredness.
This case was reported by a physician and described the occurrence of shoulder pain in a subject of unspecified age and gender who was vaccinated with FLUARIX. On an unspecified date, the subject received a dose of FLUARIX (unknown) and experienced shoulder pain and shoulder tendonitis. At the time of reporting the outcome of the events were unspecified see cases A0753545A and A073549A.
1st dose in Oct2021, 2nd on Oct2022; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In October 2021,received 1st dose).   In October 2022, the patient received the 2nd dose of Shingrix. In October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 18-Jan-2023. Reporter's Comments: This case was reported by patient via interactive digital media. The patient's doctor's office never sent him/her a reminder for his/her 2nd dose. When the patient went for his/her annual visit in October 2022 they gave him/her another dose.  The patient asked was he/she covered. Additional Supportive Information: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. Follow-up would not possible as no contact details were available.
3hr p/vax pt devel an inj site rxn characterized by redness, warmth, & swelling which extended below the elbow;pt treated w/DPH & ice & was recovered @ date of this report;
Just over 24 hours after I received my 2nd Covid-19 vaccine shot I experienced standard symptoms such as being tired and onset of a headache. However, the headache quickly became a migraine- the worst headache I have ever had. I had never experienced a migraine in my life. The migraine became chronic as it would not go away. The severity of the migraine pain became increasingly debilitating and began manifesting additional symptoms including severe nausea, lethargy, and body aches. This led to a CT scan on 2/3/21 which was negative. Then an appointment with Neurologist on 3/14 where an occipital block (shot) finally provided some relief to the chronic migraines. I had an MRI on 3/25/21- minor nerve inflammation behind right eye. This was in response to a sudden 3rd nerve palsy that occurred on 3/23/21 (as diagnosed by eye doctor). It slowly improved and returned to normal over the following weeks. Prior to this, I had never had a single eye issue in my entire life in any way whatsoever. A CTA scan was then performed on 4/13/21. Results were negative. Another Occipital block performed on 4/20/21 to treat ongoing chronic migraines (as described). Migraines and described symptoms improved temporarily once again until nerve block faded and severe symptoms returned in early June. Severity persisted until debilitating - 6/24/21 vomiting in the middle of the night - extreme nausea, lethargy and muscle ache. Strongly considered Emergency Room visit, but saw Neurologist the following morning instead. Another occipital block administered. 7/7/21 began Physical Therapy at suggestion of Neurologist as a supplemental interim treatment while we awaited insurance approval for Botox migraine injections. First Botox injection administered on 8/16/21. Botox helped initially but faded quickly. Migraines return mid September and quickly increases in severity as the month progressed. 9/22/21 vision in right eye suddenly develops varied and fluctuating gray spots. Eye Doctor appointment on 9/24- no official diagnosis. Eye condition does not improve. 9/27/21 Admitted to Emergency Room for vision loss in right eye, admitted to hospital that night. 2 days of intravenous steroids in hospital - 3 MRI scans - all negative. Dismissed from hospital and continued intravenous steroid for 3 more days at neurology clinic. Vision improves 10% but significant vision loss in right eye remains. 10/25/21 Appointment with eye specialist at local Eye Institute. Vision loss is deemed permanent - unidentified inflammation of optic nerve restricted blood flow and damaged optic nerve (ischemic optic neuropathy).
Diarrhea; Injection site pain; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Diarrhea) and INJECTION SITE PAIN (Injection site pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and INJECTION SITE PAIN (Injection site pain). At the time of the report, DIARRHOEA (Diarrhea) and INJECTION SITE PAIN (Injection site pain) had resolved.        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.   No concomitant and treatment medications were reported.
pt recvd vax & exp rt arm pain & numbness w/movement for 4 days; pain later localized to the inject site; sx lasted 2 wks;
sweaty; temperature 85.7F; muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee); 100.4F fever; heart rate 115; muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee); A spontaneous report was received from a 45 years female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 100.4F fever, heart rate 115, muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee)(LLT: muscle tightness and muscle tenderness any site ), sweaty, temperature 85.7F.   The patient's medical history included tested positive for COVID.   No relevant concomitant medications were reported.    On 30-Dec-2020, prior to the onset of the events nodule size of a quarter on the injection site red, injection site red and injection site warm to touch, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) via unknown route in left arm  for prophylaxis of COVID-19 infection.  On 12-Jan-2021, the patient experienced 100.4F fever, heart rate 115, muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee) (LLT: muscle tightness and muscle tenderness any site), on 13-Jan-2021 experienced sweaty.  Laboratory details included 100.4 F, heart rate: 115 and temperature: 85.7 F.  Treatment details included Tylenol for 100.4 F fever throughout the night 12-Jan-2021. She used the CPAP machine all night 12-Jan-2021.  Action taken with mRNA-1273 in response to the events 100.4F fever, heart rate 115, muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee)(LLT: muscle tightness and muscle tenderness any site), sweaty, temperature 85.7F was not provided.  The outcome of the events 100.4F fever, heart rate 115, muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee)(LLT: muscle tightness and muscle tenderness any site ), sweaty, temperature 85.7F was not provided.  The reporter did not provide the assessment of the events 100.4F fever, heart rate 115, muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee)(LLT: muscle tightness and muscle tenderness any site ), sweaty, temperature 85.7F to study drug.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Day 7 started feeling dizzy took blood pressure and was 188/80. Fever was 99.8. Achey body and headache. After 3 days blood pressure went down and all was back to normal.
45 minutes after receiving Janssen vaccine, pt became SOB & complaining of tight chest.  BP 120/80 Pulse 110  Pt was transported to Hospital & parents notified.
Extreme long standing arm pain with inability to raise arm, progressed to other arm.  Diagnosed with Subacromial bursitis, shoulder capsulitis, SIRVA
can't swallow/ had a little bit of like something stuck in throat, something in throat, had on day one and difficulty swallowing/ swelling of throat, hard to swallow; tightness in throat; blurred vision/ Little bit of blurry vision and within an hour or two it went away; patient did not even get enough breathing; Swelling of throat; This is a spontaneous report from a contactable consumer (patient) reporting for self.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA7484) via an unspecified route of administration, administered in Arm Left on 17Aug2021 as single dose (at the age of 44) for COVID-19 immunisation. The patient's medical history included blood pressure from an unknown date and ongoing. The patient's concomitant medication included lisinopril taken for blood pressure measurement from an unspecified start date and ongoing and other medications. The patient as cannot swallow/ had a little bit of like something stuck in throat, something in throat, had on day one and difficulty swallowing/ swelling of throat, hard to swallow on 02Sep2021, tightness in throat, blurred vision/ Little bit of blurry vision and within an hour or two it went away on 17Aug2021, patient did not even get enough breathing, swelling of throat both on an unknown date in 2021. The events were reported as non-serious. It was reported that patient called to ask for medical recommendation and medical advice to treat side effects, patient took Pfizer COVID vaccine 1st dose on 17Aug2021, and next hour after 1st dose had a little bit of tightness in throat, blurred vision that went away within an hour or two, could breathe fine but there was tightness in throat eleven days later patient cannot eat, cannot swallow, having difficulty swallowing small pills, and it was difficult to swallow grapes, the grapes skin gets stuck. Therapeutic measures were taken as a result of swelling of throat includes Benadryl. The outcome of the event swelling of throat was not recovered while it was unknown for other events.  Follow-up attempts are completed. No further information is expected.
Muscle tightening, visual disturbances, jaw tightness, lethargy, "feeling drugged".
pronounced fatigue which is impacting her work/ excessive tiredness/nodding off at work; This spontaneous report as received from nurses regarding a non-pregnant 36-year-old female patient. The patient's concurrent conditions included polycystic ovarian syndrome (PCOS), endometriosis, rheumatoid arthritis, anxiety, seasonal allergy and coeliac disease. The patient had drug reactions included nausea due to erythromycin, and brain zaps due to duloxetine. The patient's concomitant therapies included elagolix sodium (ORILISSA), phenylpropanolamine hydrochloride (reported as norephedrine), lisdexamfetamine dimesylate (VYVANSE) (reported as VIVANCE), pantoprazole sodium (PROTONIX), montelukast sodium (SINGULAIR), duloxetine hydrochloride (CYMBALTA), fluticasone propionate (+) salmeterol xinafoate (ADVAIR), albuterol sulfate (manufacturer unknown), abatacept, alprazolam (XANAX) and fluticasone propionate (FLONASE).     On 11-JAN-2021 the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milligram (anatomical location of administration not reported; lot number 1687292 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) with expiration date 25-AUG-2022) intramuscularly once for prophylaxis.    On 12-JAN-2021 (conflicting information: also reported as 11-JAN-2021), the patient experienced pronounced fatigue which was impacting her work. The patient had excessive tiredness and nodding off at work. The patient had not sought medical attention. No treatment or additional exam had been performed by the reporting time. The outcome was reported as not recovered. The patient was inquiring that how long this side effect would last.     The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Patient reported tightness in throat; swollen glands after injection; This is a spontaneous report from a contactable pharmacist. A 41-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EJ1685, expiry date not reported), intramuscular on 21Dec2020 12:30 at a single dose in the left arm for COVID-19 immunization. Medical history included heartburn, insomnia, wheezing and penicillin allergy (type of reaction not noted). The patient had no covid prior to vaccination. Concomitant medications included albuterol [salbutamol] PRN (as needed) for wheezing; buspirone at 10mg tid (three times a day); ethinylestradiol, norgestrel (CRYSELLE, reported as Cryselle 28); and trazodone at 100mg once a day (qhs (at bedtime)). Patient had no other vaccine in four weeks. The patient previously took erythromycin and experienced known allergies (as reported; type of reaction not noted). On 21Dec2020 12:30 PM, the patient reported tightness in throat and swollen glands after injection. Rapid response was called and patient returned to work with a follow up check by rapid response. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The events tightness in throat and swollen glands after injection recovered on an unknown date.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The reporter stated that on unspecified dates ranging from 15-JUN-2015 through 18-JUN-2015, the patients received doses that were improperly stored of PROQUAD (Merck) (strength, lot number, expiration date, dose # and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
red and raised blisters on chest; itchy; burning; red and raised blisters on chest; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (red and raised blisters on chest), PRURITUS (itchy), BURNING SENSATION (burning) and ERYTHEMA (red and raised blisters on chest) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026BZIA and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLISTER (red and raised blisters on chest), PRURITUS (itchy), BURNING SENSATION (burning) and ERYTHEMA (red and raised blisters on chest). At the time of the report, BLISTER (red and raised blisters on chest), PRURITUS (itchy), BURNING SENSATION (burning) and ERYTHEMA (red and raised blisters on chest) had resolved.            The concomitant medications blood pressure medications, antidepressant  , sleeping  pills, vitamins, anti-histamines was reported.         .  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up information received on 26-Jul-2021 contains significant information all adverse events outcome updated to recovered.
Information has been received from a physician concerning a female who was vaccinated IM with the second dose of Gardasil. Subsequently the patient passed out within 5-10 minutes after receiving the vaccine. The patient went up to the circulation desk to pay before leaving and made it to the parking lot. The physician reported that the patient began to feel some nausea and dizziness so she came back into the physician's office. It was unclear as to when and where the patient passed out. The physician reported that they had taken the patient's blood pressure and let her rest while back in the office and someone came to pick her up . The patient's outcome was not reported. Medical attention was sought. Additional information has been requested. 10/06/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning an 18 year old female with no prior history of drug reactions who was vaccinated intramuscularly into the left deltoid on 07-MAY-2007 at 09:15 AM with the second dose of GARDASIL. Subsequently, the patient passed out within 5-10 minutes after receiving the vaccine. The patient went up to the circulation desk to pay before leaving and made it to the parking lot. The physician reported that the patient began to feel some nausea and dizziness so she came back into the physician's office. It was unclear as to when and where the patient passed out. The physician reported that they had taken the patient's blood pressure and let her rest while back in the office and someone came to pick her up. Medical attention was sought. In additional information received on 11-JUL-2007, the attending physician reported that the patient felt dizzy and lightheaded secondary to the vaccine. Her blood pressure was stable and temperature was OK. On 07-MAY-2007, the patient recovered from the nausea, dizziness, syncope, and being lightheaded. No further information is expected.
No adverse event. Moderna was accidentally given to 13 yr old as workflow was not followed. Staff identified the error when they were looking at dose 2 appts. Parents declined to proceed with dose 2 since it's not approved for authorization yet.
Headache, Myalgia, Fever, SkinRash, CoughWheeze & ErythemaMultiform Narrative:  Other Relevant History:
Patient reported dizziness and unsteady gait after receiving vaccine. BP 121/57 (pulse 69), O2 sat 98%. Followup: 129/68 (pulse 64), 98% O2 sat.
This spontaneous report was received from a Registered Nurse refers to a 14 month old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 01-MAR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB, lot # N012921 (expiry date: 28-FEB-2020) for prophylaxis (incorrect product storage). The vaccine was concomitantly reconstituted with properly stored sterile diluent (MERCK). The vaccine underwent a temperature excursion of 34.70 F for 0.25 hours. No adverse effects were reported. The call was because of a data logger. On 01-MAR-2018, the patient was vaccinated with other dose of LIQUID PEDVAXHIB for prophylaxis (lot#, expiry date and dosage not reported). No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA000815: US-009507513-1809USA002916: US-009507513-1809USA002918: US-009507513-1809USA002919: US-009507513-1809USA002920: US-009507513-1809USA002921: US-009507513-1809USA002922: US-009507513-1809USA002923: US-009507513-1804USA000815.
Pt had flu and PPV23 admin IM to L arm on 11/2/20 and subsequently developed localized Pain and swelling that traveled down to hand, swelling improved but continued to have some Pain in elbow w/reduced ROM, but gradually improving
Soreness, swelling, heat  (L) upper arm and developed several hrs after injection, Rx BENADRYL/VICODIN and cold packs.
Systemic: Fainting / Unresponsive-Mild, Additional Details: About 10 minutes after patient received shot he was sitting in a recovery chair and passed out. He was given a bottle of water and crackers as well as the NP from the Minute Clinic came over to check on him and he was okay by this time. At 30 minutes after the shot patient has been checked on and is doing well and will have a ride home with person he came with and will be followed up on tomorrow.
pt recvd vax & exp soreness @ the site of inject; In a 48 hr period pt sx progressed to aching of the pt's whole arm; shoulder & neck feeling achey; also exp erythema @ inject site;
The patient was brought into the ED via EMS on 9/24/23 for evaluation of shortness of breath that started the day prior. EMS reports initial O2 sat at 90%, which improved to 92-93% after 2 L of O2, and was sitting at 97% with 16L of O2 en route. EMS also reports dyspnea on exertion. A COVID PCR test performed in the ED resulted positive. Ultimately, the patient was admitted 9/24/23 - 9/27/23 with discharge diagnoses including acute hypoxic respiratory failure secondary to COVID-19 infection, among other diagnoses. The patient did not require additional oxygen after he was admitted. Of note, the patient has received the primary COVID vaccine series and one booster.
Information has been received from a registered nurse concerning a 19 year old male patient who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # not reported) on an unspecified date.  Concomitant therapy that same day included a dose of tetanus vaccine.  Subsequently the patient developed nosebleeds for about two weeks after vaccination.  He had no history of nosebleeds.  His platelet count was reported to be low normal at approximately 140,000 (units and normal values not reported).  The patient had never had a vaccination before as he had been home schooled.  In order to enter college, he needed several vaccinations.  Subsequently the patient "fully recovered" from the nosebleeds.  Unspecified medical attention was sought.  Additional information has been requested.