chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient who had received Quadracel at age 10 years old, which would be his 4th IPV dose, with no reported adverse event; Initial information received on 08-Aug-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 10 years old patient of an unknown gender who had received Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel] which would be his 4th ipv dose, with no reported adverse event.  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 Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine Suspension for injection (With an unknown expiry date, strength, lot number) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient received Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine which would be his 4th ipv dose, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, For a patient who had received Quadracel at age 10 years old, which would be his 4th IPV dose, would he need an additional dose of IPV or would the Quadracel count as his 4th dose. His 3rd IPV dose was given at age 6 months.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
None stated.  Follow-up states vaccines was not given in this clinic therefore I  do not have the lot number.
Patient accidently given Moderna vaccine at age 16. Patient tolerated vaccine well and had no adverse reaction, anticipates receiving second Moderna dose.
10 days after first Covid vaccine shot, my arm (injection site) starting slightly hurt and suddendly has reddish color. Reddish color kept growing. About 10 hours from my first notice, reddish part slightly swelling and became hard.
Patient with history of diabetes, CKD stage 3, COPD, and CHF. He was brought to the ED by EMS on 2/1/23 for evaluation of hypoglycemia and altered mental state. He was mildly hypoglycemic (blood sugar in the 70s) prior to presentation. En route to the ED, EMS reports the patient became less responsive. He became apneic and so was placed on bag-valve-mask ventilation.  A COVID PCR test performed in the ED resulted positive. Patient was intubated in the ED as he needed additional respiratory support and was not maintaining airway sufficiently to start BiPAP. He was admitted 2/1/23 - 2/7/23. Patient rapidly improved and was extubated on 2/3/23.  Discharge diagnoses include acute hypoxic respiratory failure and COVID pneumonitis, among other diagnoses. Patient has received the primary COVID vaccine series.
This case was reported by a pharmacist and described the occurrence of injection site redness in a pt who received Engerix-B for prophylaxis. On an unknown date, the pt received vaccination with Engerix-B. At an unknown time after receiving Engerix-B, the pt  had "deep red" coloration at the injection site and vomiting. The outcome of the events is unknown.
FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On 22-MAR-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious.
3 days after immunization, patient developed blurred vision, redness, and pain in left eye. Visited ophthalmologist to diagnosed as corneal swelling from vaccine.
Chicken pox (post vaccine)-mother reported child was exposed at pre school One confirmed case. Child felt feverish, didn't feel well. Examined by doctor. Chicken pox confirmed.
2nd dose received 8am 1/27. Fever, 102.1 and severe headache 1/28, 12 am.  Developed Shingles 1/28, 10 pm. Shingles lesions continue to develop at the time of this report, despite starting Valtrex 1/29 am
Information has been received from a physician concerning a 64 year old female with a history of seizures on 03-MAY-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included DILANTIN and LIPITOR. It was reported that on the night of 03-MAY-2007, the patient experienced a seizure and at 11:05 PM she was taken to hospital. The patient was hospitalized until the next morning. The hospital performed blood level tests on DILANTIN and increased her DILANTIN level before she was released. It was noted that the patient was hospitalized less than 24 hours. CT scan was also performed on the patient. At the time of report the patient had recovered. A product quality complaint was not involved. Additional information has been requested.
Patient reported feeling a tingling in her left side of head 13 minutes after receiving immunization. I explained that should not be an effect of the shot, especially that quickly. I did offer to call Dr. She refused and wanted to call herself. I offered our phone. She left AMA. No mark on arm at time and no swelling. Called doctors office at 11:20am. Heard from employee at the office that the patient had talked to, RN. RN reassured her the tingling is not an affect from the Shringix shot. Patient wished to be seen. Patient in office with NP at 12:05pm. Per other employee, NP could not verify that the symptoms were caused by the shringrix vaccine. NP told patient that if she wanted additional attention that she would need to go to the ER. She refused and left the office AMA.
Patient became extremely lethargic, staring into space for more than five hours at a time..no response to verbal prompts...refused to eat anything for almost a day..kept throwing hemself on the floor, banging his head, and his legs were like spaghetti ..he would not walk, and was unable to put any weight on his legs without them buckling..he cried incessantly for hours at at a time, and this lasted almsot two days...
3NOV92 pt states recvd Flu/Pneumonia 26OCT92; 48 hrs later exp head-leg-hand pains & chills; did not take temp-no thermometer; 3NOV92 states skin hurts to the bone & chest feels tight;
On day 8, injection site became hard and swollen. Skin around injection site developed rash and it became itchy.
I received the first dose of the Pfizer COVID vaccine on 12/19 at 3:30pm. The next day I began to feel fatigue, body aches, joint pain, headache, and a fever of up to 100.9 that began around 2:00pm. It was fully resolved by the next morning.
Patient was hospitalized due to recurrent mechanical fall sec to generalized weakness with COVID-19 infection, and rhabdomyolysis, without respiratory symptoms. Infection was treated with vitamin-C/vitamin-D/zinc.  He was started on IV hydration. 7 days after hospitalization he was transferred into rehab for an additional 7 days.n
At 9:30am patient had a seizure lasting 5-10 seconds. Provider examined the patient after the reaction, patient was dizzy and tired.
Patient initially had come in on 5/11/21 to receive her second dose of the COVID vaccination, but was advised to follow-up with her cardiologist before administration due to the first dose causing palpitations. She returned today (5/19/21) with the cardiologist's approval on the second dose administration. Patient started to feel unwell 15 minutes post vaccination. Patient's BP was high >160/100. Patient was given some water and advised to stay put and to call someone to pick her up as she had a child with her. Her BP was being monitored along with her symptoms. Her BP was creeping up and she felt like her chest was getting tight, she looked flushed as she was panicking. She claimed her face was getting numb. She was given 4 tablets of 81mg Aspirin and 911 was called both with her approval. The ambulance had arrived and was monitoring her but she refused to go with them as her mother-in-law was there now to take her. She left with her mother-in-law and son. She was highly advised to get medical attention.
Bump on arm at the injection site which grew  throughout the day and then turned red.   I believe he?s called Moderna Covid Arm. Followed on line advice and iced it and drank water.  Never itched, just larger and red and tender.  Still red after two days, but not as swollen or tender.  Just reporting so you have good records for those that experienced this.  A little worried about my second shot.
This spontaneous report as received from a nurse refers to a 6   week old patient of  an unknown gender. On 19-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot # K006805 and expiry date: 24-MAR-2016. No adverse events were reported. No product quality complaint PQC was reported for ROTATEQ. This is one of several repots from the same reporter. Additional information has been requested.
headache a pain sale of 5 or 6/10.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache a pain sale of 5 or 6/10.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for Hypertension, HYDROCHLOROTHIAZIDE and METOPROLOL for an unknown indication.    On 07-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 HEADACHE (headache a pain sale of 5 or 6/10.). At the time of the report, HEADACHE (headache a pain sale of 5 or 6/10.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included ibuprofen.
-Severe migraine 12-13 post admin -Next morning could not raise head + severe vertigo
Site began to itch shortly after receiving vaccine. Noticed red rash on chest next day with c/o itching. Has spread to back over next 2 days. Looks "blotchy" "hive like".
Six hours after first dose there was arm pain and hotness.  Overnight, I woke up with sweats and my whole arm was throbbing and hot to the touch.  The next morning after the dose (18 hours after) I experienced headache and dizziness as well. Arm pain lasted 3 days then subsided. I also experienced pain in my armpit.  On 3/6/21 , 8 days after my first dose, my arm began to hurt again and now it is inflamed and there is a rash at the injection site. Armpit hurts again as well .
I had a rash that started on my ankles at the sock area that traveled up my, leg. It was very red and very uncomfortable to the touch. I tried to use lotion but that did not help. I switched laundry detergent and that didn't help and I also changed soaps but that didn't help either. I used Bactine with lidocaine and got some relief. It started to go away about 2 months ago. The shot/booster is good but I was never contacted about my concerns. Tested positive for Covid 19 on 05/15/2022.
Information has been received from an 81 year old female consumer with allergic to amoxicillin and KEFLEX and with no pertinent medical history who in October 2011, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not reported). Concomitant therapy included PLAVIX, LIPITOR, TRICOR and levothyroxine. On 12-JAN-2012 the patient got the shingles. It started with a feeling like a dagger in her back so the patient went to the doctor and was prescribed a muscle relaxer. The patient had no rash. But the pain got so intense that the next day she went to the emergency room and got a stronger pain medication. Then the patient had pain under her left breast. 4 days later she got a rash on her back. There were 5 patches of rash the size of a half dollar. The patient was using a lidocaine patch. Then she was prescribed oxycodone and stayed in bed for about 2-3 weeks. Lab diagnostics studies included blood work (result not reported). The patient did not fully recover until March of 2012. Upon internal review, the patient's stayed in bed for about 2-3 weeks was considered to be disabling. Additional information has been requested.
I blank out get up to go somewhere forget where I'm going. I feel like I'm exp dementia. I was in a situation where I lit a match for the bonfire didn't get out the way burned my both leg in April. Then pushing a lawn mower stopped and the lawnmower ran me over in June. This is very frustrating nothing like this has ever happened to me. I scheduled a appt with the doctor due to COVID I wasn't able to go in cause it wasn't life threatening. To this day I still feel fuzzy and tired than usual.
This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unkonwn age and gender. On unknown dates, the patients received an unspecified number of improperly stored doses of GARDASIL (dosage, route and lot # not provided). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Infection, swollen, inflamed & pain 4 or 5 Office Visits Dr. 1- Office Visit another Dr. 3-Office Visits Dr. (Urgent Care). 1-Office Visit Dr.
This spontaneous report as received from a physician refers to a 25 year old female patient. On an unknown date in August 1999, the patient was vaccinated with RECOMBIVAX HB, dose and route not reported. Concomitant therapies included amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, ADDERALL and CELEXA and unspecified birth control. On an unknown date in August 1999, the patient experienced hives. The outcome of hives was unknown. Follow up information received from physician who stated that, the physician did not have further information concerning the RECOMBIVAX HB the patient did when she was 10 years old. Causality was not reported. This case had been linked to 1409USA000559 as same patient link. Additional information has been requested.
Received H1N1 injection @ 8pm, at 9pm started having repeated episodes of vomiting and diarrhea. Numerous calls were made to above number and messages left to contact MO H1N1 information line - no return calls were received. No additional information is available.
Severe allergies that lasted over 2 years.  Constant mucous in the nose, chest.  Reoccurring ear infections.
Patient experienced cough, throat swelling, increased heart rate, sweaty, body aches, diarrhea, chills, watery eyes; headache evening following flu shot. Took aspirin 325 mg tablet: went to bed.
Every bone and muscle in my body hurts, low grade fever, chills, severe headache, triage I also nerve on left side (where I have had shingles) hurts so bad I feel like I need root canals in every tooth.
had lots of flare ups/legs get tired easily and standing for a long time is hard/feeling fatigued; needing cataract surgery; upset stomach; hair is falling out; mildly depressed; feeling fatigued; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-AMGEN-USASP2022214483 (Agency).  This serious spontaneous report (USASP2022214483) was reported to Agency on 08/DEC/2022 by a consumer and involves a female patient who experienced had lots of flare ups/legs get tired easily and standing for a long time is hard/feeling fatigued [PT: rheumatoid arthritis], needing cataract surgery [PT: cataract], upset stomach [PT: abdominal discomfort], hair was falling out [PT: alopecia], mildly depressed [PT: depression] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement. The patient's concomitant medications included folic acid, losartan potassium, methotrexate, prednisone, Levothyroxin (levothyroxine sodium). The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient after she got her COVID-19 shot and booster she had lot of flare ups and upset stomach. The patient reported that her hair was falling out and that her legs get tired easily and standing for a long time was hard. The patient was feeling fatigued and scored mildly depressed on survey and needing cataract surgery. No treatment information was received. The outcome of the events rheumatoid arthritis, cataract, abdominal discomfort, alopecia, depression were reported as unknown. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events rheumatoid arthritis, abdominal discomfort, alopecia, cataract and depression. The causal relationship between the events rheumatoid arthritis, cataract, abdominal discomfort, alopecia, depression and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. No follow up attempts are possible. No further information is expected.  Agency comment: This safety report does not necessarily reflect a conclusion by Agency that etanercept, device caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual report does not change the safety profile of the product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Enbrel is under agreement with Agency.
Light headed/dizzy shortly after vaccine in office - given juice and laid down briefly. Went to school = "out of it" and tired, almost like sleep state. After school went home and took 2 hr. nap. Work to 6p lacrosse game - was slow, tired and weak, still "out of it".
Raised, Red, Itching patches across entire body consistent with allergy response as well as hypertension, and racing heart. These events started 7-10 days post dose and was described by a nurse as a possible delayed immune response.
Soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2) via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced soreness at the injection site on 14Jan2021, developed 6 hours after vaccination. The patient had not recovered from the event at the time of report.  Information on the lot/batch number has been requested.
Since becoming fully vaccinated my body temperature has remained higher/ Now itstands at 97.6 and sometimes up to 97.8 I've felt noticeable more uncomfortably warm the past 2 months.; my last 2 menses have been heavier; I have felt more fatigue then normal during that time; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 28Mar2021, since becoming fully vaccinated, the patient's body temperature had remained higher. Her normal body temperature that she had over the course of her entire life had always been 97.3 (units not specified). Now it stands at 97.6 (units not specified) and sometimes up to 97.8 (units not specified), she had felt noticeable more uncomfortably warm the past 2 months. Second, her last 2 menses have been heavier and she has felt more fatigue then normal during that time. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. On an unknown date, the patient underwent body temperature test and the result was 97.3 unspecified units. On an unknown date in 2021, the patient underwent body temperature and the result was 97.6 unspecified units and 97.8 unspecified units respectively. Therapeutic measures were not taken as a result of the events reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events since becoming fully vaccinated her body temperature has remained higher/ now it stands at 97.6 and sometimes up to 97.8 she had felt noticeable more uncomfortably warm the past 2 months, last 2 menses have been heavier and have felt more fatigue than normal during that time was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected. .
Pain/soreness, red rash/welt, itching on left arm near shoulder and armpit. Began 7 days after shot and symptoms mostly resolved within 4 days. Internet search indicates these symptoms are consistent with "covid arm" associated with Moderna shot.
This spontaneous case was reported by a patient and describes the occurrence of SLEEP DEFICIT (Little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (Excessive dreams), INSOMNIA (Severe insomnia) and CHILLS (chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SLEEP DEFICIT (Little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (Excessive dreams), INSOMNIA (Severe insomnia), CHILLS (chills) and FATIGUE (Fatigue). At the time of the report, SLEEP DEFICIT (Little sleep), NIGHTMARE (Nightmares), ABNORMAL DREAMS (Excessive dreams), CHILLS (chills) and FATIGUE (Fatigue) outcome was unknown and INSOMNIA (Severe insomnia) had resolved. Concomitant medication list was not provided. The patient wanted to report some side effects that patient had with both booster doses. It was reported that the patient took second booster 8 months apart. The patient's insomnia was reported to last for over 5 days. Treatment information was not provided. This case was linked to MOD-2022-590478 (Patient Link).