chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient complained of tingling extremities (legs, hands and feet).  She also complained of feeling slightly faint and dizzy.  she did not pass out.  She did not have shortness of breath or palpitations.  She also felt weak.  We had the patient lay down and elevate legs/feet.  about 15 minutes after that she was feeling back to her normal self.
Fever, chills, nausea, and fatigue. Kept waking up during the night being hot or cold. The next day mild fever and chills, but still feeling fatigued.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unspecified dates (either 17-SEP-2015 or 18-SEP-2015) the patients wre vaccinated with improperly stored GARDASIL 9 (lot # L011846, expiration date 16-JUN-2017; Lot # L014415, expiration date 25-JUL-2016; Lot # L013429, expiration date 21-JUL-2017) (dose and route of administration were not reported). No adverse effects or product quality complaint were reported. This is one of the three cases reported by the same source. Additional informtaion has been requested.
Feel like crap; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 26th January 2021, the patient received the 1st dose of Shingles vaccine. On 27th January 2021, 1 days after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingles vaccine in the afternoon of day before reporting date. The patient felt like crap now.
about a week after the second vaccine I had some arm pain and neck pain         the neck and shoulder pain was and is still so bad I did go to my provider and they put me on muscle relaxers and 800 ibuprofen      the pain is still there and sometimes very unbearable
Swelling and redness at injection site (Right deltoid muscle). Fever of 101 F. Treatment: Loratadine: 10 mg by mouth daily and Prednisone 45 mg by mouth daily.
Patient with extreme nausea and vomiting that started soon after receiving the Moderna vaccine.  Patient with loss of consciousness, diaphoresis and garbled speech during a foley catheter exchange thought to be from dehydration.  Patient was admitted to Hospital for observation for 2 days
second dose which has been given with 3 months apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a elderly female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   In January 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. In January 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15th Apr 2022 Reporter's Comments: The registered pharmacist reported that a patient received in January 2022 a second dose of Havrix which was given with 3 months apart instead of 6 months. The reporter consented to follow up.  Additional Supportive Information: The patient received havrix 2nd dose earlier than recommended which led to shortening of vaccination schedule.
pt started to get a fever around 10 pm that same evening that he had the vaccine, temp peaked at 4 am to 103.6 . pt reported feeling fine 8 am on 6/3/19
I received the vaccine around 1400 and about 20 minutes later I started itching and wheezing and having stridor, my throat and neck visibly swelled and I had hives on my chin, neck, chest, armpits, and arms that started spreading from my scalp to my toes, and I had mid sternal chest pain and was dizzy and cold. I took 4 doses of my albuterol inhaler on the way to the ED, received IV SOLUMEDROL, BENADRYL and PEPCID at first and 500ml bolus of saline, then received VESTARIL and PEPCID prescriptions for the following week. I was diagnosed with anaphylaxis and systemic skin reaction and the MD in the emergency department believes it was an additive in the vaccine this year. The CDC stated the only change was the addition of gentamicin. I was not sick at the time, and am not symptomatic with my asthma as a baseline. I rarely use my rescue albuterol inhaler, maybe twice a month. Over a week later, I am still wheezing, using my inhaler more frequently and reactive to temperature and allergic stimuli, I have not returned back to my baseline. I have asthma and anaphylaxis as my only medical history. I am allergic to KEFLEX, codeine, SINGULAIR and red wine products (which causes the anaphylaxis previously). I have never had a reaction to any other vaccinations. I have my flu shot yearly for the past six years with no reactions or symptoms. Thank you and let me know if I can provide any more information . I hope by doing this I can prevent it from happening to someone else.
Headache, Chills, Body Aches, Fatigue, Soreness, Nausea
I did okay with the first dose only experienced site pain and fatigue. This second dose has not been pleasant: I am experiencing injection site pain, headaches, body aches, chills, and back pain.
Pt. recieved DTAP and CHICKENPOX in L leg area on 6 Feb. 07. The area is warm to touch and appr. softball size.  no c/o pain with pt. Pt does c/o itching. Pt was seen by provider and given instructions for what to look for in future and to return if condition worsens.
Intense pain and then fainting with some jolting, lost bladder control.  Chills, headache, nausea, intense stomach pain the next night.
heart palpitations; Slight headache; Muscle Aches; Left arm hurt; chills; Very high blood pressure; This is a spontaneous report from a . A contactable consumer (reported for herself). The 69-year-old female patient received first dose BNT162B2 (Pfizer Covid-19 Vaccine Lot Number: EP7534 and Expiry date: Unknown) via an unspecified route of administration on left arm at a SINGLE DOSE on 18Mar2021, for COVID-19 immunization. Medical history and concomitant medication were not reported. On 18Mar2021 (the night she received the Pfizer Covid Vaccine, dose one) she woke with her heart pounding (heart palpitations), slight headache, muscle aches, and left arm hurt. When she went to the doctor, on an unspecified date in Mar2021, they took her blood pressure, and it was very high. It was stated that she went to primary care physician and then she was sent to a Cardiologist. On 26Mar2021, she underwent electrocardiogram and echocardiogram, results were normal for both the investigations. On the same day 26Mar2021, she also had Holter monitor test done (electrocardiogram ambulatory) however the results were pending. On 20Mar2021, the patient recovered from the events of slight headache, muscle aches, left arm hurt and high blood pressure, the outcome of the event of pounding heart was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a Licensed Practical Nurse refers to a 13 week old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided. On 28-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020,  for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293:
This spontaneous report has been received from a pharmacist via company representative referring to a female patient of unknown age. On approximately 24-Oct-2015 (reported as about a month ago) the patient was vaccinated with ZOSTAVAX (route and lot# not reported), 1 vial at unspecified time. The pharmacist learned in an unspecified way (either phone call or a visit back to the pharmacy by the patient,) that the patient started experiencing pain at an unspecified time, on the day the ZOSTAVAX was administered. The patient reported that she was having pain in the unspecified arm that she received the vaccine. The patient was still in pain at the time of reporting (24-NOV-2015). The causality was not reported. Additional information has been requested.
rt arm bright red, 4inches in diameter inj site slightly raised 1/2inch; very painful, sore mass, malaise, +1 edema
Information has been received from a consumer concerning her daughter who was vaccinated with the third dose of GARDASIL. Subsequently the patient experienced mononucleosis. the patient sought unspecified medical attention. No further information is available
Fever; Chills; I couldn't Sleep; This is a spontaneous report received from a contactable consumer (Patietn). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302; Expiration Date: May2021), Solution for injection, via an unspecified route of administration, administered in Arm Left on 23Feb2021 11:00 (at the age of 48-year-old) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for blood pressure abnormal. Patient historic vaccine included first dose of BNT162B0 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot: Not reported), Solution for injection, via unspecified route of administration, via unknown route on an unspecified date as single dose for COVID-19 immunization. On 23Feb2021, the patient experienced fever, chills and couldn't sleep. The patient underwent lab tests and procedures which included body temperature: 103, 102 and 101 on 23Feb2021. It was reported that, yesterday she received her second dosage of Pfizer vaccine. First one was okay for her, it was a little arm pain, but yesterday was terrible for her. She got the shot at 11 O'clock at the daytime, she was fine she was able to work. She worked from 3 to 11 but when she came at night like 11 in the evening, she came home took her shower yesterday started to chill and whole night she couldn't sleep. She had fever 103; 102; 101 and she couldn't even sleep. Her complaint was chills and fever whole night today. At that moment, at the night time she didn't take anything (did not take any treatment) she took a shower thought it is going to help her. The events were recovered on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
VACCINE WAS INEFFECTIVE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: emphysema. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the reporter indicated that the patient felt vaccine was ineffective (dose number in series 1) and stated she did not have anything left to boost- referring to the level of protection that remained from Janssen vaccine. On 01-NOV-2021, the patient additionally received Moderna vaccine (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported for prophylactic vaccination. It was unknown if the patient had any adverse events after Moderna vaccine (dose number in series 2). The reporter stated that she heard the vaccine was only good for 2 months and was concerned about patient for the level of protection against COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was ineffective was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000214573. This case, from the same reporter is linked to 20220160825.; Sender's Comments: V0: 20220160740-covid-19 vaccine ad26.cov2.s- Vaccine was ineffective. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
pt recvd vax @ hops p/birth of daughter; pt was breastfed & on 20MAR94 mom noted a fine red rash on body of baby; rash lasted 2-3 days & then resolved;
pt recv vax 22OCT97  AM & 1PM mom reported pt had a car accident p/left clinic several blocks away;pt reported seeing dots before her eyes & having trouble moving arms & legs & then hit 2 other cars;pt treated & released from ER;
p/vax pt devel inj site rxn @ pnu-imune 23 vax characterized by swelling, redness & warmth;
Stuffed nose, baby was crying for 2 hours in a row, high pitched screaming, like absent and not responding to me. He was like in shock. Unable to eat due to stuffy nose. I have him Tylenol and finally he felt sleep for 8 hours (he usually sleeps only 5 hours in a row). This morning he woke up and acted normal, smiling, etc. He ate a bottle.
Parent stated pt's right arm was red and swollen on 12/16/06.   On that day mom talked to MD by telephone and was told to put ice to area and give tylenol for pain.  Today 12/18/06 mom reports pt's right arm continue to be red and swollen but less than 12/16/06.
Woke up next morning with low grade fever 100.3, and congestion which lasted a little over 12hrs. Then had mild cough which lasted 24hrs.
Beginning 12/22, I experienced a sore throat. Beginning 12/23, I also experienced a cough. The sore throat resolved on 12/27. The cough has yet to fully resolve.
pain and weakness of left upper arm; normal passive ROM, but is unable to actively raise her arm past 15 degrees
Recieved injection on Wednesday, 1/6/2021.  On Friday, 1/15/2021 woke up with a small red area on arm near injection site.  Each day rash increased in size.  On Wednesday, 1/20/2021 seen by provider and given steroid injection.  Size of rash had increased to 4 inches by 6 inches, red, raised rash.
got sick" for two days; some days she can't taste/taste "comes and goes"; "got sick" for two days; didn't feel right" for a week; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("got sick" for two days), FEELING ABNORMAL (didn't feel right" for a week), FEELING ABNORMAL (got sick" for two days) and AGEUSIA (some days she can't taste/taste "comes and goes") in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 20-Nov-2020, Hashimoto's disease, Upset stomach and Scalp disorder. Concurrent medical conditions included Drug allergy (ibuprofen, causes rash on chest) and Drug allergy (Claritin (increases heart rate and causes anxiety).). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMIN 15 for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ILLNESS ("got sick" for two days) and FEELING ABNORMAL (didn't feel right" for a week). On an unknown date, the patient experienced FEELING ABNORMAL (got sick" for two days) and AGEUSIA (some days she can't taste/taste "comes and goes"). At the time of the report, ILLNESS ("got sick" for two days), FEELING ABNORMAL (didn't feel right" for a week), FEELING ABNORMAL (got sick" for two days) and AGEUSIA (some days she can't taste/taste "comes and goes") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided by the reporter. Action taken with mRNA-1273 in response to the events were not Applicable.
receiving both doses of the Shingrix vaccine she has been getting shingles/ suspected Vaccination failure; receiving both doses of the Shingrix vaccine she has been getting shingles; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (first experienced when she was 21 years old and it developed 2 to 3 times a year since then). Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 9th July 2019, refer case US2020AMR246180).   On 4th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 9th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and injection site pain to be related to Shingrix. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional information was provided as follows: The patient reported that since receiving both doses of the Shingrix vaccine she had been getting shingles every 2 months. Patient reported pain at the injection site during administration of both doses of Shingrix and said it lasted a few seconds and then resolved. This case was considered as suspected vaccination failure as details regarding time to onset for target disease was unknown at the time of reporting.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR246180:same patient
After 2 hrs, light headed.Became lethargic. Generally not feeling well. After 6 hrs feeling nausea. Vomiting after another hour. Nausea and vomiting lasted about an hour. Went to bed. Next day, 21 hrs later felt ok. Day proceeded normally.
10 days after immunization patient developed flu like symptoms with pharyngitis, tonsillar exudate and injected scleras. On 6/1/12 patient woke up with multiple arthralgias. Unable to walk neck and back pain. Referred to ER for further eval.
numbness and swelling of the tongue; numbness and swelling of the tongue; mild blurred vision; back pain; This is a spontaneous report from a contactable other healthcare professional. A 49-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via intramuscular route of administration on 21May2021 at 15:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. No relevant medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in left arm on an unknown date for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 15:00 the patient experienced numbness and swelling of the tongue, mild blurred vision and back pain. Therapeutic measures were taken as a result of the events (Unspecified) checked for vitals. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events numbness and swelling of the tongue, mild blurred vision and back pain were recovered on 21May2021.   No follow-up attempts are needed: information about lot number cannot be obtained.
p/ pt recv vax approx 3yr later pt devel breakthrough case of classic chickenpox & fever of 102f, continued to develop lesions for 5 days. seen by MD who noted approx 300-500 lesions.
There were no adverse events from the first or second Covid vaccine.  I received the booster on 10/11 /2021 and my arm hurt very bad for a week. Right after that I developed dry patches on my skin. An area on my back, one on my stomach and one on my neck. About one week after that I started getting a rash. It was small at first, just a few bumps. Then it began to spread until there were itchy raised bumps all over my entire body, from my head to my feet.  The itching is maddening.
11:40 complained of severe itching all over. She was immediately taken to MD. She was given Solumedrol 12 mg IM, Benadryl 50 mg IM, Epinephrine 0.33 cc SC etat. Given Rx of Benadryl orally and Epi pin and Prednisone to take home. Slept well during the night and plans to return to work 11-7-03. 11-6-03 follow-up unable to work today due to sleepiness. Plans to work. 11-7-03 Doing well.
This non-serious initial spontaneous case, was received on 22-Sep-2017, concerning a 29-year-old, adult pregnant female patient. The patient did not use contraceptives. The patient's last menstrual period date was on 22-Jan-2017, foetus status was not reported. The patient had no pregnancy in the past. The infant gestational age was 34.5 weeks and there was no evidence of defect or adverse findings from prenatal test. Concomitant medication included: Prenatal vitamins. On 21-Sep-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, batch number: WT54607, expiry date: 30-Jun-2017 (expired dose), route of administration and anatomical location: not reported). It was reported that the pregnant patient received the expired vaccine. The patient experienced adverse event, but no adverse reaction was experienced in the foetus. The estimated date of delivery was on 29-Oct-2017. It was stated that, the mother and the baby was good with no problem. No other information was provided. The outcome of the event was not reported. Follow-up report received from the reporter on 17-APr-2018: The reporter confirmed that the estimated date of delivery was 29-Oct-2017 and the patient was not enrolled in the registry. It was stated that, the mother and the baby was good with no problem. No other information was provided. Amended narrative accordingly.