chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lowest BP taken 100/80, 20 minutes following immun; pt fell off a stool in lab; eyes were open but was unresponsive to verbal or painful stimuli (Ammonia inhalant used & immediate response);
Starting at 9:30 pm the night of the vaccination the patient developed flu-like symptoms, and had "heart pounding", she also was up going to the bathroom every hour all night. She also had blurred vision. All symptoms were resolved the next day.
This spontaneous prospective pregnancy report was received from a nurse and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-FEB-2017, the patient was vaccinated with VARIVAX subcutaneously, which had lot # of M027342, an expiration date of 01-JUN-2018 (dose and anatomical place of vaccination were not provided), for prophylaxis. Nevertheless, on the same day, the patient found out that she was pregnant. Nevertheless, the patient's last menstrual period (LMP), estimated date of delivery (EDD), the number of weeks of the pregnancy, the outcome of pregnancy and the fetal outcome was not know. Additional information has been requested.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On multiple unspecified dates the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # K010213, expiry date 17-JAN-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was reported. No insertion and removal related event was reported. The action taken with the suspect therapy and outcome of the events was unknown. This is one of the two reports from the same source. Additional information has been requested.
This case was reported by a consumer and described the occurrence of retinal artery occlusion in a elderly patient who received SHINGRIX for prophylaxis. The patient's past medical history included cataract operation (In 2015) and ophthalmic herpes zoster (In 2015, four days later after cataract operation patient developed Shingles in that eye.). Previously administered products included ZOSTAVAX, Prednisone and Acylovir. In October 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a month after receiving SHINGRIX, the patient experienced retinal artery occlusion (serious criteria GSK medically significant), retinal vein occlusion (serious criteria GSK medically significant), loss of vision (serious criteria GSK medically significant) and anterior ischemic optic neuropathy (serious criteria GSK medically significant). The patient was treated with acyclovir, medication unknown (Patch) and prednisone. On an unknown date, the outcome of the retinal artery occlusion, retinal vein occlusion, loss of vision and anterior ischemic optic neuropathy were unknown. It was unknown if the reporter considered the retinal artery occlusion, retinal vein occlusion, loss of vision and anterior ischemic optic neuropathy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided however, it could be 77 or 78 years. The patient had 2 prior cases of Shingles before starting SHINGRIX. Earlier patient treated her shingles with old Shingles vaccine ZOSTAVAX and was treated with Prednisone and Acylovir. In late October 2018, the patient received new Shingles vaccine SHINGRIX and in mid November 2018, the patient had venous and arterial occlusion in the retina of that eye. The patient have no vision in that eye and worded an eye patch. The patient has lost vision in her right eye therefore cannot drive anymore. They has gone to retina specialists and were told that it was an eye stroke due to age. The patient was aware that the two Shingles vaccines were very different. The patient wanted to question that, was there any indication of interaction between SHINGRIX and the Prednisone and Acylovir that she was still being treated with. The patient's internet searches stated that the SHINGRIX interaction data base was incomplete at the time of reporting. The physician contact information was not provided.
flu like symptoms; wiped out feeling; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021. The most recent information was received on 06-Apr-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and FEELING ABNORMAL (wiped out feeling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in May 2020.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and FEELING ABNORMAL (wiped out feeling). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and FEELING ABNORMAL (wiped out feeling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant product details were not provided   This case was linked to MOD-2021-068383 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Significant: event outcome updated. Patient says she is fine
Client presented at a vaccination site on 11/28/21. The client reported he received his first dose Pfizer COIVD vaccine on 11/07/21. He reported within 15 mins he had a very ?bad headache? for two weeks straight after. Client reported tiredness for one week and a feeling of ?diarrhea like sensation? for 1.5 weeks without having the diarrhea. Client told he did have dizziness and lightheadedness within the 15 minutes after the injection. Client told he didn?t report the symptoms to the EMT in the observation station. Client told he took Ibuprofen 800 mg with help for headache for two weeks straight. Client told he has hypertension and controlling with Lisinopril 10 mg daily. Client told he didn?t follow-up with his PCP. Client told he has no known allergy. At 1110, PHN took client?s vitals: BP 126/79, HR 52, R 18, O2 Sat. 99%. Client is requesting second dose Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the second dose Pfizer COVID vaccine. Per the doctor, approval to proceed with the second dose Pfizer COVID vaccine was obtained from medical consult team via text message from clinical project coordinator. Client received Pfizer COVID vaccine, LOT#: FF8841 on 11/28/21 at 1148 by vaccinating nurse. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1218 unassisted and with a steady gait.
Painful and swollen arm (left deltoid) at injection site. Diminished after 24 hrs. but still painful. Patient applied ice.
ELEVATED BLOOD PRESSURE; This spontaneous report received from a consumer concerned an adult of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: alopecia. 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 APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the patient experienced elevated blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was non-serious.
had miscarriage after the vaccination; This is a spontaneous report from a Pfizer sponsored program via non-contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. This is a maternal report. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration, on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was pregnant at the time of vaccination. The patient had a miscarriage after the vaccination on an unspecified date. The mother reported she became pregnant while taking BNT162B2. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The outcome of the event was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and  the causal role of BNT162B2 vaccine cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product 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-202101144532 Same reporter/event, diff patient
My arm is swollen under the armpit all the way down to the  start of the breast tissue.  There is throbbing pain in the arm also.
Lightheadedness an dyspnea after receiving COVID 19 vaccine. Patient states that 5 minutes after receiving the vaccine, he felt "out of it." He felt like he was "in a dream." He reported feeling palpitations, shortness of breath, and chest pain. He denies feeling overly anxious. He states that the chest pain is substernal with no radiation. He reports it is pleuritic in nature. He states it is currently a 4/10, feels like a pressure on this chest; He received 50mg Benadryl and 0.3mg epi x2 by EMS and was brought to the ED for further evaluation.  Admitted from ED for observation on 12/18/2020 and discharged on 12/20/2020.
She got the vaccine, she was fine, no problems.  She woke up, Down's syndrome, and her sister-in-law saw that she was white faced, and looked like she was going to throw up, but said that she was achy and nauseous.  She has swelling to the injection site, a small dot.  She feels a little warm, but no fever, 97.9.  Has not taken anything for her symptoms.
Patient received high dose flu vaccine 9-28-11. At 4:00 P.M., became nauseated and had a large emesis. Went to take a shower lost balance and fell backward into tub. Wife found him 3 hours later. Back pain x 24 hours. Right sided weakness for 1/2 day.
I get one every single year. Never an issue or reaction.  Bled very bad upon injection. Instant bruising. Developed large red swollen spot under infection site. Warm, very painful. Tried Tylenol and ice. Continues to get worse. Can?t touch it and interrupts sleep.  Also had some wheezing start in.
pt recvd vax & had bruising on left cheek bone on side of eye & on both buttocks; "scruthes" on cheeks & buttocks but scratches were under skin; had fever & ear infection;
This spontaneous case , initially received on 02-Nov-2016, was reported by a health professional and concerns a 65 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 12-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, route of administration: not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-206, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 12-Sep-2016, doses were administered. Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
This spontaneous report as received from a healthcare worker refers to a patients of unknown age and gender. It was reported that RECOMBIVAX HB that was improperly stored since 07-APR-2014 to 22-JUL-2014, was administered to unspecified patients on unspecified dates. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
2nd dose of Moderna vaccine given to my upper right arm on 2/10@ 11am.  By 5am on 2/11 I found my arm to be swollen with a raised around red patch.  This was located 4 inches below the injection . It measured 2 1/2 x 2? in diameter. It is raised it is hot it is hard and it is very swollen. It is now 48 hours after the vaccine that I am reporting this in the condition has not changed .
arrhythmia; the issue I am having now currently with my heart; issue with my vision; I would see these like a squiggly line sometimes they are more than one and they are separate/one big circular squiggly line; booster; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "macular degeneration in one eye " (unspecified if ongoing); "cataract" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant), outcome "unknown", described as "arrhythmia"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "the issue I am having now currently with my heart"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "I was also having issue with my vision; I would see these like a squiggly line sometimes they are more than one and they are separate another time there is just one big circular squiggly line and that''s kind of what I was seeing"; IMMUNISATION (non-serious), outcome "unknown", described as "booster". Patient stated that the Pfizer vaccine that she got was causing arrhythmia and the issue she was having now currently with her heart. Patient was reporting that she had some side effects. Questioned as to whether or not the Pfizer vaccine that she got was causing arrhythmia and the issue she was having now currently with her heart. She had issue the night before the report with her heart and she also had issue with her vision as well. Stated that she does have macular degeneration in one eye and trying to develop cataract (Intent history) in both and so periodically 'I will see'. In the past she would see these like a squiggly line sometimes they were more than one and they are separate another time there was just one big circular squiggly line and that's kind of what she was seeing the night before the report. It stayed with her for good hour, hour and half and then finally stopped and just few minutes ago before she was doing a phone call those smaller squiggly line came back in to her vision and  that was she just remembered when she was on hold that also being going on but that started back just the night before the report and few minutes ago. Stated that she got the COVID 19 Vaccine booster on the 19th (as reported).    The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient vomited about 15-20 minutes after she received her vaccine. She came back inside to tell me but she was unsure if it was related to the vaccine but she wanted to let me know. She said she felt better after she vomited.
8days following vax pt devel vomiting & diarrhea; seen in ER on 3/22 & was tx w/unspecified medication & sent home; ER MD rpt suspected otitis media & pharyngitis
I experienced Joint pain, mild fever, fatigue and a headache. I also had pains in my leg. The pains only lasted for a day but I was extremely tired and lethargic.  I had my flu shot 2 weeks prior to getting the covid shot also.
vomiting after each dose; This case was reported by a pharmacist via sales rep and described the occurrence of vomiting in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, refer case US2021AMR141807).   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced vomiting. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vomiting was unknown.   It was unknown if the reporter considered the vomiting to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR141807:same patient
12/21- Vaccine administration 12/22 @ 12am Sore at injection site 12/22 @ 9pm soreness at injection site subsides 12/26 @ 10am severe headache and muscle aches; not relieved with Tylenol; cough, stuffy nose 12/27- headache and muscle aches still apparent, but moderate; not relieved with Tylenol 12/28- headache and muscle aches still apparent, mild.
On 3/16, around 8:55a, I received the vaccination. Around 3p, my arm started getting sore. I felt fine all day until around 10 something that night. I got really tired and had a slight headache. About 15 minutes later, I had chills. I checked my temperature and it was 99.8. I took Tylenol and went to sleep. I woke up in the middle of the night to use the restroom and my whole body was aching. I went back to sleep. I got up at 6am to get ready for work. My whole body was still aching and I was nauseated, had a pounding headache and really bad chills. I took my temperature and it was 102.9. I immediately took some Tylenol and laid back down for about an hour. I took my temperature again and it was 102.4. I have been taking Tylenol around the clock and  drinking water and powerade because I do not have an appetite. The lowest my temperature has been is 101.9. My temperature keeps fluctuating. I have also broken out in a whole body sweat 3 times.
After the first dose I  had facial spasms on the right side of my face. Those facial spasms were continuous up until my second dose of Pfizer. I am menstruating for an average of three weeks or longs. I am spotting in between. I started to take Iron supplements due to feeling fatigue attributed that to loss of blood while menstruating.  It is now august and I have been bleeding non stop since July. I am tired and to be honest am regretting getting the vaccine. This is depressing and starting to take a toll on me mentally and physically.
sx: itching treatment: Benadryl, pepcid & solumedrol.
Tired; body aches; pressure in the head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Cancer in remission" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious) with onset 29Mar2021, outcome "unknown", described as "Tired"; PAIN (non-serious) with onset 29Mar2021, outcome "unknown", described as "body aches"; HEAD DISCOMFORT (non-serious) with onset 29Mar2021, outcome "unknown", described as "pressure in the head". It was unknown if therapeutic measures were taken as a result of fatigue, pain, head discomfort.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced vasovagal reaction, no loss of consciousness and was monitored for 30 minutes. He recovered after 30 minutes and was discharged home.
child presented in the ER with tEmp of 105.3 rectally. MD reports no signs of infection were evident at that time. 06/23/05 5:00PM/
Pt started to scream @ 105PM to the point where turned blue & drawn up in a ball; t103.5F about MN; Pt slept all day 5SEP91;
(09/08/2021) itchy sore throat, headache, fatigue, ear ache, eye soreness, low grade fever. COVID test did not detect, no other treatment suggested or given.
Patient developed redness and swelling at the injection site about the size of a half-dollar. Pt stated that she had taken Zyrtec and put Benadryl cream on the site. On 7/25/15 size of affected area was bigger about 3 inches x 3 inches, pt was instructed to take Benadryl and continue cream. Spoke to pt on 7/28/15 pt states that the area has not really changed but it is not bothering here. Instructed pt to have her primary care physician look at the reaction site.
After vaccine given, some swelling after (same) day. Swelling increased daily after injection. Today is red, warm and measures 10cm x 9cm (L) arm.
Severe nausea; retching, approximately 3 episodes of vomiting. Cyclic pyrexia until early AM of 4/12; myalgia. Loose, watery stool began afternoon of 4/11; ceased by morning of 4/12. Intermittent nausea through evening of 4/12.
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 30-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Patient received full vaccination with 2 doses of Pfizer Vaccine.  First dose was on 1/29 and second on 2/19/2021.  No significant reactions.  We were informed that she then had PCR ++ Test for COVID-19 on 3/8/2021.  No hospitalization reported after testing positive.
Patient with complaints of arm pain shortly after injection, that worsened over time.  Seen by orthopedics on 9/28 and diagnosed with shoulder impingement and was given cortisone injection.
Red rash & bumps on back & arms; began 2 hrs p/immun & lasted x 6 hrs;