chrisvoncsefalvay/vaers-outcomes huggingface dataset:
with a 3 months period, my hemoglobin shut down to 6.4 from 10; with a 3 months period, my hemoglobin shut down to 6.4 from 10; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 50 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "autoimmune disease" (unspecified if ongoing), notes: "they don't know what exactly it is, it is not lupus, but it's sclerodermal mixed polymyositis and basically mixed connected tissue disorder"; "sclerodermal mixed polymyositis" (unspecified if ongoing); "mixed connected tissue disorder" (unspecified if ongoing); "hemoglobin low" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for Covid-19 immunization. The following information was reported: HAEMOGLOBIN DECREASED (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 01Sep2021, outcome "unknown" and all described as "with a 3 months period, my hemoglobin shut down to 6.4 from 10". The patient underwent the following laboratory tests and procedures: full blood count: (unspecified date) low, notes: I have low blood count; haemoglobin: (unspecified date) no higher than 10, notes: so my hemoglobin is always no higher than 10; (unspecified date) bounce between 8-10; (01Sep2021) 6.4. The patient specified that he has an autoimmune disease, "they don't know what exactly it is, it is not lupus, but its scleroldermal mixed polymyositis and basically mixed connected tissue disorder". The patient added "My immune system is always heighted (sounds like not verified to caller) up and I have low blood count, so my hemoglobin is always no higher than 10," "bounce between 8-10." "with a 3 months period, my hemoglobin shut down to 6.4 from 10." The patient specified that on 01Sep2021 hemoglobin was 6.4. The patient wanted to know if there is any evidence or findings about covid vaccine decreasing the hemoglobin.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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
Arm showed redness and swelling approximately 4 inches below the injection site.  Patient was seen by physician and diagnosed with an allergy to a component of the flu vaccine
Pain in shoulder area that just got progressively worse to the extent I could not lift my arm.  Have range of motion now but still have pain while lifting arm.
On 10/22/21 I received my booster of Moderna (half dose). On the next day I had a rather slight case of malaise and my arm hurt for a few days.  On November 1 in the late evening my entire head/scalp itched as if I had an allergic reaction to hair color (which I did not).  November 2, more itching scalp and then the crown of my head to the back of my neck felt hard and numb upon touching. I felt as if my neck were swollen and it continued to swell and be hard into the evening. Went to a local ER and was told I had Cellulitis on my neck. The next day visited my PCP who told me he disagreed with cellulitis and that it appeared I had a systemic allergic reaction to something that was causing hives/itching to rage in my body in various places on and off all day and night.  Ran a course of steroids for five days along with an antihistamine.  It is now Day 12 and while I am less bothered by the itching due to taking Zyrtac twice a day, my body continues to have a large histamine response from seemingly no catalyst. I actually skipped a Zyrtac dose last night and awoke with more severe itching so it is not gone.  Both my PCP and a dermatologist now believe it is reasonable to assume that my booster shot has given me this delayed reaction. Nothing else seems to be the trigger.
Post vaccine I have not had a regular mensural cycle. The first cycle post the first vaccine was light and nearly clear. Then went to heavy and painful. I am tracking ovulation because I am trying to conceive and since the vaccines I have not reached peak ovulation. Regardless of what type of ovulation test I take my hormones never show there is a peak. My periods went from completely regular and ovulation very regularly, everything down to the same day or 1 day difference to now being sometimes a week off. This is without trying for the last 3 months due to irregularities post vaccine.
4/28 @ 4 pm day of vaccine, lower back achy & stabbing pain, like laying on nails. 1 hour later progressed to include middle back, by 6 pm entire back to base of neck in pain & stabbing pain would focus on 3-4 spots and move around. Fever 99.8 @7:23 pm, 100.5 @ 7:46. Bad chills all evening. Advil taken. 4/29 back pain improved when fever decreased but worsened as fever increased. Advil & later tylenol. Hot & then cold throughout day.  By 1 pm, back pain just middle & lower back, by 5 pm just lower back, woke on 4/30 and back pain gone.  Arm pain at injection site began 2 hours after vaccine, couldn't raise arm more than 2 ft from legs, pain better but still persists.
Three waves of discomfort... felt like ice water was poured inside of my body.  Extreme  weaknesses of arms/legs.  Visual issues.  First wave within 60 seconds of shot (ended up on floor - embarrassing!).  Second, and most severe, wave about 10 minutes later while sitting in chair.  Apparently, I passed out with my eyes open.  Hubby got nurse.  They said I was unresponsive.  Nurse checked blood pressure and heart rate after second wave - both normal.  Third wave, much less severe, hit after 10 more minutes.  Ice water/weakness feeling in arms and legs and not so much in chest area.  Nurse speculated it could be low blood sugar (based on medications).  Have never had low blood sugar event previously AND had eaten about an hour prior to vaccination.  However, drank 4 ounces of orange juice, just in case.  Went home about 20 minutes later... no other significant side effects.  No swelling/redness at injection site.  No other illnesses, etc.
I developed Covid arm. I woke up out of my sleep with burning pain, The lump reappeared at the injection site it was hot to the touch itchy and painful with a large red patch Immediately took Tylenol and marked rim with marker to see how and if it got bigger Which it did. This was day nine after the shot. It is now day 12 no more pain but continues to grow in size of red area. No pain just itching Occasionally
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna. The reporter stated that no adverse reactions were reported by any patients. No treatment medications were reported.
Patient given a pediatric dose of Hep B instead of an adult dose.  Administering nurse spoke with GSK Representative and patient was scheduled to receive the adult Hep B vaccine on 07/05/2022.  No adverse outcomes reported.
Patient called this AM (1125 A.M.) to report 2 "quarter sized" skin areas of irritation that appear hives or lesion-like. Referred to urgent care & MD & told to take BENADRYL too.
5/31/2021  Allergic reaction mid afternoon, hives itchy throat   6/11/2021 Allergic reaction, hives, itchy throat, swelling of the tongue/lips difficulty swallowing & breathing
9 days after first injection, 5 inch diameter circle of redness, heat, rash, itching, edema.   This was similar to the sensation of gettting stung by a couple bees.  This was followed by nausea and chills.  The intensity lasted 2 hours.and the arm site was irritated for a couple days.
I premedicated with Diphenhydramine, fexofenadine and loratadine as suggested by the urgent clinic from my previous adverse event. 10 minutes after the 2nd shot I felt hot flashes in my L glut region, then 15 minutes  in I started to feel tongue swelling and slight throat swelling (maybe 10-20%). I felt this decrease but was still present 25 minutes after the shot, I notified a rep at the nurses tent. They asked some questions and said they could take me into the tent but that if I felt it was improving to just wait 15 more minutes, I did that and left after. I continued to have some tongue swelling the next day and continued taking all 3 antihistamines for maybe 3 days. I previously had sensitivity to spicy foods and my tongue feeling inflamed but not swollen from the previous shot, this again occurred the 2nd time. I maintained this with gradual dissipation of symptoms until about 3/1/21. I believe all my symptoms were resolved at that point.
vax given 645PM;parent called nurse 8:45 pt was feeling achy, crampy;@ first thought to be menstrual cramp;low grade fever 3 day
Rash after 2nd dose; This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On an unspecified date, after second dose, patient experienced rash. It was reported that event took place after the use of product. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt limping since getting immunizations. RLE pain. No redness no swelling no hardness. Tx: Heat, elevate, ibuprofen.
2-minute memory lapse while doing household chores. Completed a task (loading laundry) that I had no memory of doing. After confirming that no other family members had done it for me, I almost called the police because I was convinced someone else must be in the house, i.e., I was that sure that I hadn't done this. First time I have experienced anything like this, ever. No family history of dementia, etc. So I guess it's worth reporting. I understand memory might be affected by Covid, but I don't believe I have been infected.
FOR 3 WEEKS FOLLOWING THE VACCINATION:   I had aches in all of my joints (elbows, wrists, and knees).  I thought maybe i am developing arthritis.  This lasted for approx 3 weeks and then suddenly stopped. Was it joint inflammation?   I had no other symptoms.   I did not visit the doctor. Within 5 hours of the vaccination, symptoms started with pain in both of forearms.  Overnight I developed fever, lethargy , aches and pains.  Took Tylenol.  Slept for approx 36 hrs.  I felt much better after 40 hrs.   I was not concerned.  I would say my symptoms were moderate or worse. In March of 2020, I had shortness of breath in my left lung .  It lasted for days.  I was concerned but I did not visit the doctor.  It eventually went away.  Could I have had Covid then?  A sure possibility but I will never know!
Diarrhea, loss of appetite, nausea lasting 3 days as of this writing
- Macular rash appeared to face and torso after Proquad and quadracel vaccines today in office.  Rash was not puritic, no hives, no vomiting, no facial swelling, no difficulty breathing.  Benadryl given in office, observed without resp distress.  Will list under allergies although more likey adverse reaction, reaction was low. VAERS report made.
Approximately 36 hours after vaccination was administered experienced mild confusion & memory failure. There was mo pain or other physical manfestations. Confusion resolved itself overnight; mild memory lapses continue. It seemed to be a very specifc event -- perhaps a TIA?
sinus headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (sinus headache) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022, the patient experienced SINUS HEADACHE (sinus headache). The patient was treated with ACETAMINOPHEN for Sinus headache, at an unspecified dose and frequency. At the time of the report, SINUS HEADACHE (sinus headache) outcome was unknown.            No concomitant medication was provided. On 19-Jan-2022, the patient received the booster dose. The night prior, the patient had taken 2 pills of Acetaminophen for a sinus headache. After booster dose the patient took Tylenol.
Patient lost consciousness 10 minutes after receiving first dose of covid vaccine. He collapsed on the floor while seating in the monitoring area. Emergency number was called and paramedics arrived at the scene 5 minutes later. BP and glucose level was within normal limit but he was taken to the hospital.
Right before the shot, patient seemed out of it. Do not know if that is how he is on a day to day basis. He could answer questions from the nurses but would respond really slowly. He received the shot on his right arm then he went to stand in the nurse window. Around 10 minutes later, we heard a thud and glass fall down and saw that he had fallen on the floor. His eyes were open and he was responsive. He had the same slow demeaner. He said that his legs felt weak so he fell. The paramedics were called and the staff nurse told them that he had fallen about 10 days ago. He had no issues with his first Covid dose. The paramedics took him to the nearest hospital.
This is a new problem. Episode onset: 3 days ago, day after vaccine. The problem is unchanged. The rash is diffuse. The rash is characterized by itchiness (vesicular). Associated with: varicella vaccine 1/19/2017. Past treatments include nothing. Varicella without mention of complication.
Headache ,Fever ,Nausea, joint pain,  diarrhea, loss of taste and smell tested positive for Covid 19 on 12/31/2020
I was fine for the first 10 days just a sore arm the first day and that was it.  Then on day 11 my arm felt strange and warm.  I took off my shirt and notice that I had a big welt on my arm and it was red and hot to touch.  I took some Benardyl and it didnt seem to make any difference.  On day 12 it started to itch a bit and was still a welt.  On day 13 the welt went down and it is still a bit red.
Patient states that 4 days after receiving the first dose of the Pfizer covid-19 vaccine, she developed a rash on her left foot, then spread to left arm and face.
A few hours after vaccine (February 27): extreme fatigue.  Sunday, February 28: Extreme fatigue throughout the entire day,  mild headache,  mild muscle aches all over the body,  mild nausea Starting Monday, March 1st: less fatigue,  mild headache,  mild nausea, sharp pain in both knees, noticed ringing in ears Tuesday, March 2nd: mild headache, sharp pain in both knees,  ringing in ears Wednesday, March 3rd to present day: persistent ringing in ears (affecting sleep), sharp pain in right knee when bending. Knee pain continued to get worse.
Client received her vaccine and immediately after injection she reported ?feeling weird and anxious?. VS: 1130 BP 192/82,  1134 138/79. She denied CP, SOB, dizziness or syncope. Her symptoms resolved within 15 minutes .
Patient is a 76 y.o. female patient of DO with history of  CHF, CKD stage III-IV, CAD with prior CABG, multiple stents, hypertension, hyperlipidemia, OSA on CPAP, urine incontinence, insulin-dependent 2 diabetes, chronic weakness, osteoarthritis, degenerative changes, morbid obesity, who presented from home with generalized weakness, confusion. She was found to have COVID and rhabdomyolysis.  She received fluid resuscitation with improvement in her creatinine as well as her CK.  She remained hemodynamically stable throughout her hospitalization with improved mental status and never had any respiratory issues.  She worked with physical therapy and was able to ambulate 42 feet with a walker.  Ultimately, patient was hemodynamically stable and discharged home on 9/28.  Her husband who was also hospitalized at the same time was discharged the same day and they went home together.     Discharge diagnosis   Acute on chronic Encephalopathy, metabolic , resolved Hx of Dementia Non-traumatic Rhabdomyolysis Generalized Weakness Hypokalemia SARS-Covid-Positive  Vitamin D deficiency Chronic kidney disease stage IV CAD s/p CABG/stents Chronic elevated troponin Chronic HFpEF Morbid obesity Hypertension OSA on CPAP Hyperlipidemia Osteoarthritis Anxiety/depression
Patient stated that about an hour after vaccination her neck and jaw started to swell, and 20 minutes later her face went numb. Patient also stated that she had a metallic taste in her mouth. Patient also stated that her tongue stayed numb for 24-36 hours. Patient didn't go visit doctor.
This case was reported by a pharmacy intern and described an adult male pt who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The pt's medical history, concurrent conditions and concurrent medications were not reported. On unspecified dates the pt received three doses of Engerix B (lot numbers not specified). On an unspecified date later, a hep B surface antibody titer was less than 10 mIU/ml (negative). The pt then received another three shot series of Engerix B (lot numbers not specified), and on an unspecified date later, a repeat hep B surface antibody titer was less than 10 m IU/ml (negative).
I became very achy, had a headache and fever of 102.4. I had ear aches and was hearing a pounding in my ears for 3 days. I was still experiencing symptoms on Thursday after being dosed on Monday. I had vivid dreams on Wednesday night that were very detailed.  Thursday I began to have GI effects with nausea and diarrhea. I was not able to eat until late Wednesday evening.   I did drink water and took Tylenol.
Mom report baby shaking left hand , weakness left leg and hand on 9/20/22  in am. Went to Er all test negative. Ct negative, labs negative. Sent home for monitoring
pt recv vax 12JUN96 & 17JUN96 pt exp an erythematous visceralis rash over entire body, big blotchy welts, swollen lips & eyes were swollen shut;presented to MD ofc 20JUN96 & an anaphylactic rxn was suspected;
Pt reported mild swelling at the site of TRUMENBA injection on R delt, redness, no pain or itching, noticed 1 day after the vaccine by pt's mother, 6cm diameter, felt slighlty warm to touch. Pt was seen on 8/17/18, noted decreased swelling and redness. Was advised to ice it 2-3 times/day, to call if no improvement or worsening.
This case was reported by a consumer via call center representative and described the occurrence of viral infection in a 79-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced viral infection, cold and drug dose administration interval too long. On an unknown date, the outcome of the viral infection was recovered/resolved and the outcome of the cold and drug dose administration interval too long were unknown. It was unknown if the reporter considered the viral infection and cold to be related to SHINGRIX. Additional details were reported as follows: The reporter stated he received 1st SHINGRIX dose in August 2018 and asked if it's too late to take the second dose (late dose). The reporter said his local pharmacy should be receiving it this week, which led to to lengthening of the vaccination schedule. The reporter also mentioned that after his first dose less than a year after vaccination the patient got a viral infection of some kind. Probed further to understand viral infection as a cold. The reporter did not give consent to follow up.
LIGHT FEVER; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced light fever. Treatment medications (dates unspecified) included paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light fever. This report was non-serious.