chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After vaccines pt stood up and became dizzy.  She said she felt like she was going to pass out.  Then complained of chest tightness and said it was hard to get a full breath.  Pt fell to floor.  Pt was alert & no SOB noted.  0.3 mg of Epi given in right arm and ems called.  EMS evaluated pt and mom refused transport since pt felt better.
Fatigue, fever, chills for 3 days.  Changes in menstrual cycle since then. Flow has changed, time between periods has changed.
pt became dizzy, fell to ground; disoriented-recovered w/in 10mins;hx of fainting; signs & sxs of a vasovagal reflex syncope
I was okay until after arriving home at which time I developed and headache and exhaustion. I went straight to bed for 2 days with headache, stomach pain, couldn't eat or drink. I started to feel a little better but still was unable to eat and was fatigued. When I did try to eat I got terrible diarrhea almost immediately. Over the next few days, realizing this was probably not normal, I contacted the advice nurse at my provider and eventually talk to a doctor on Friday (March 5). That doctor thought it sounded like I contracted COVID. I had a test that day that came back the next day negative. I have an appointment to talk to my regular doctor on Wednesday (March 10), particularly to get advise about whether to get the 2nd dose on March 20. My blood pressure has been unusually low (as low as 85/58) but is now about 120/60. I did not have a fever. My breathing has been more labored than usual, but my oxygen level is at 97% and my pulse is around 65.
I had a fever of 103 degrees for 24 hours.  I had body aches, chills, headache and rash over most of my body.
Fully vaccinated, not boosted.   COVID infection breakthrough with inpatient hospital stay on a medical unit.
Injection site Rxn: Redness and swelling Flu like symptoms for 24 hours.
Aching arms and chest. Severe fatigue - loose stools. Tingling in arms and finger - 2 days.
Stomach ache; Restless; Couldn't sleep; Headache; So hot she couldn't keep cool; This is a spontaneous report from a contactable consumer (patient). A 98-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8982, expiration date not reported) via an unspecified route of administration at the left arm on 12Jan2021 15:45 at a single dose for COVID-19 immunization. The patient's medical history included arthritis, she is in a wheelchair (can't walk), gallbladder out a year ago (2020) and she her right hip replaced. No family medical history. There were no concomitant medications. The patient usually sleeps well. Clarified she received the first dose of the Pfizer COVID 19 vaccine 12Jan2021 15:45PM in the left arm. She was fine after the injection then 13Jan2021 in the afternoon she had a headache for two hours; that night she was restless and couldn't sleep; she was so hot she couldn't keep cool. Then this morning 14Jan2021 her headache is gone but she has a little stomach ache. Mentioned they haven't brought breakfast by yet and that might help. She was planning to get the next dose of the vaccine 02Feb2021. She has been living in an assisted living facility now for three years; and she can't get outside; and has not seen her family due to the virus. The facility where the vaccine was administered was in an assisted living facility. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events did not require a visit to physician or ER. No relevant tests done. Outcome of the events headache, feeling hot, restless was recovered on 14Jan2021; stomach ache was recovering and unknown for the other event.
This case was reported by a consumer via call center representative and described the occurrence of erythema in a 83-year-old female patient who received SHINGRIX for prophylaxis. On 19th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. On 20th August 2018, 1 days after receiving SHINGRIX, the patient experienced erythema and tenderness. On an unknown date, the outcome of the erythema and tenderness were recovered/resolved. It was unknown if the reporter considered the erythema and tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine on right arm. After receiving SHINGRIX, the patient experienced red area on her arm which was about 6 to 7 inches long and 3 inches wide. Her arm was very tender for about 8 days. The reporter was consented to follow up. This case had been linked with case US2018GSK230650 for the same patient reported for the same reporter.
Patient is an employee that works with patients.  Pt. received 2nd dose of Pfizer COVID19 vaccine on 2/11/21.  Pt. reports COVID like symptoms starting 4/23/21 and tested COVID positive on 4/24/21.
Injected in shoulder instead of arm (per pt) resulted in bursitis. Treated with prednisone. Pain came back after she stopped prednisone. Pt have pain when she moves her arm around.
Started on lower left leg at cellutis, leg swelled to double in size, deep red rash, then blisters, skin opened up and started to drain, then got what appeared to be a staph infection,  doctor ordered topical antibiotic then burning inflamed red rash and more blisters, then when it started to clear up a new  rash over right arm, then chest, then left arm and still burning hot and still not responding to Benadryl. Tried topical Benadryl too
One day following vaccination, experienced onset of scattered erythematous patches on trunk, shoulders, back, abdomen. Three days after vaccination, experienced swelling of the right side of the face.
Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient has a known history of allergic reactions to vaccines (delayed onset after the vaccine has been given). Patient was watched/monitored for 30 minutes on 5/4/21 with no signs/symptoms of an adverse reaction. Patient presented on 5/13 with a large rash around the injection site 10 days after administration.
This spontaneous case, initially received on 30-Mar-2017 was reported by an other non-health professional (consumer) and concerns about 11 Years old male patient. Administration of Company suspect drug: FLUVIRIN was administered for Influenza immunization on 04-Oct-2016 (Dose: 0.5ml, via intramuscular route of administration, solution dosage form where frequency was one single dose and batch number was not reported). Patient was previously immunized with a first dose of flu vaccine. Adverse reactions/events and outcomes: On 04-Oct-2016, the patient received FLUVIRIN at pharmacy. On 11-Mar-2017 the patient also experienced fever and cough. He was diagnosed with influenza on an unspecified date in Mar 2017. At the time of vaccination the patient was healthy and had no medical history. Nasal swab confirmed influenza. The patient was treated with TAMIFLU. On 13-Mar-2017, the events were reported as recovered / resolved. Reporter's Assessment: The reporter assessed the causality as related. Follow up received on 24-Apr-2017: Patient's immunological status, prior vaccination details, information regarding medical history and lab test were updated. Follow up received on 09-May-2017: Since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review (APR) of FLUVIRIN vaccine, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event.
patient was tested routinely for COVID and found positive on 12/1/21. However on an interview with the Infectious Disease physician, he stated that he was symptomatic " a few weeks ago". Unclear if previous test done. Currently asymptomatic, other than shortness of breath from cardiac issues. Patient presented with chest pain and was taken to the Cath Lab for STEMI on 12/1/21
had an episode of HTN 160/110; Thunderclap headache; This is a spontaneous report received from contactable reporter(s) (nurse and Other HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Feb2021 (Lot number: EN6202) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Controlled HTN" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "MS" (unspecified if ongoing); "known_allergies: Beta Blockers" (unspecified if ongoing), notes: Name of Drug as Reported: Beta blockers; "known_allergies: Adhesive tape" (unspecified if ongoing), notes: Name of Drug as Reported: Adhesive tape. Concomitant medication(s) included: oral MONTELUKAST [MONTELUKAST SODIUM] 10mg tablet. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The following information was reported: HYPERTENSION (medically significant) with onset 20Mar2021, outcome "recovered with sequelae", described as "had an episode of HTN 160/110"; THUNDERCLAP HEADACHE (non-serious) with onset 20Mar2021, outcome "recovered with sequelae", described as "Thunderclap headache". The events "had an episode of htn 160/110" and "thunderclap headache" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (20Mar2021) 160/110; (unspecified date) 150/100; sars-cov-2 test: (17Apr2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of hypertension, thunderclap headache, as the patient was started on cozaar.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information and underlying medical history of hypertension, the event "episode of htn 160/110" is not related to the suspect product BNT162B2. The event occurred 21 days after the vaccination. This case will be re-assessed should additional information becomes available.
I contracted COVID-19 on 06/09/2022 with symptoms of congestion, ear ache, headache, body aches, low grade fever, brain fog, and fatigue. I was prescribed a Z-Pack on 06/16/2022. I was also taking Sinex plus Mucus and Flonase for me symptoms. I was ill for 7 days before my symptoms began to resolve. I am still experiencing lingering brain fog and fatigue, but my other symptoms resolved.
I have a continuous tingling feeling in my left arm from the injection.  There are times when I loose feeling in my arm and the injection spot is still sore after 2 months.
Patient received a covid vaccine with a 1ml syringe. The vaccine was administered into the patients arm and as the vaccine was injected the nurse and patient noticed the vaccine to be dripping down the patients arm and leaking out around the plastic of the syringe. The pharmacy was made aware and the patients vaccine was repeated. Management and pharmacy was made aware.
Feelings of dizziness; sore arm; sense of derealization; hard to focus and concentrate; floating outside of my body; going to faint; heavy fatigue; sweaty palms & feet; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 28Apr2021 at 13:15(at the age of 22-years-old) as a single dose for COVID-19 immunisation. Patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication was not reported. Patient had no known allergies to food, medication or other products. On 28Apr2021 at 16:45, the patient experienced feelings of dizziness, heavy fatigue, sweaty palms & feet, sore arm. The main symptom he was reporting was a sense of derealization. He felt like he was going to faint at certain times and it was hard to focus and concentrate. It felt like he was floating outside of his body and the only thing he could do was try to focus on not fainting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feelings of dizziness, sore arm, sense of derealization, hard to focus and concentrate, floating outside of my body, going to faint, heavy fatigue and sweaty palms & feet were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
After the shot pt felt faint and their lips went blue,  then after sitting for a couple minutes the pt experienced back and neck pain,  after 10-15 min it went away and pt felt better
Expired vaccine was given. Vaccine had been expired for four days.  Moderna has been notified and we are waiting for a response from them as to what the next steps are. Update: Moderna informed Facility today; "The vaccine administered on May 24, 2022 from lot number 033K21-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
Extensive Upper Arm Swelling and Pain by 02/02/2018 6:00 pm. Swelling and Pain Moved to Elbow Area by 02/03/2018 8:00 am. Swelling and Pain Moved to Forearm Area by 02/04/2018 8:00 am.
Flushing/sweating, dizziness. Has history of anxiety. BP 101/60 (pulse 66), O2 sat 100%.
i got a shot still got shingles/ Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not reported. The patient got shingles vaccine and still got mild case of shingles. The patient stated that he/she was glad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Patient experienced cellulitis like reaction that required hospitalization (ICU) and numerous antibiotics. Patient received vaccine on 9/2/14. Patient discharged from hospital on 9/8/14.
had the virus twice; had the virus twice; stroke; paralyzed; This is a spontaneous report from a contactable consumer (patient's sister). A 95-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 (had the virus twice). The patient's concomitant medications were not reported. The reporter said the doctor wants her to give consent whether to allow the patient to take the booster dose, and the flu vaccine. She said they came to an agreement that her sister (patient) will not get the booster dose until she gets the antibiotics out of her system. With that, consumer wanted to know if her sister should still get the booster dose or if it would just put her in danger. The patient experienced stroke and was paralyzed. She had the virus twice and had already received both doses of the Pfizer-BioNTech Covid-19 Vaccine. The patient just got off antibiotics because of "Cipus." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
I received a Shingrix vaccine approximately 1 month after my second COVID vaccine.  I had an adverse reaction to the second Shingrix shot that was a huge blister that eventually had to be lanced by a doctor.  I have never had this type of a reaction to any vaccine before.
Moderna COVID-19 Vaccine Overall aches, mainly in hips and legs.  Aches lasted for whole day (Starting the day after the initial shot, first dose) , resolved around 10 am the following day.  About 30 hours of a feeling of being "worn out."
Minor fever, body/joint aches, cold chills, light-headed, nausea, diarrhea, vomiting.
Developed a hard nodule close to the injection site almost immediately. Lasted a couple of days.
Medical Information Potential AE; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Medical Information Potential AE) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Medical Information Potential AE). At the time of the report, IMMUNISATION REACTION (Medical Information Potential AE) outcome was unknown.            No concomitant medications were reported.  It was reported that Paxlovid had helped the patient and it was day two. However, the metallic taste was so strong, it was not a mild thing, it was very strong. The only time patient had relief was if got a menthol cough drop and could not took any more cough drops, it was driving crazy. Altered taste was quite a euphemism. It was like sucking on aluminum, could not taste anything but this metal. Patient was fully vaccinated with Modema vaccines.
pt had immediate swelling at injection site.  rph stayed in room with pt for 5min to observe and then administered one dose of diphenhydramine 25mg.  pt then stayed in the pharmacy area for 30 min while rph observed. no further reaction was reported.
Swollen right arm pit; right arm pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Lot number: FD#218) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CLARITIN-D. Vaccination history included: Covid-19 vaccine (1st dose), for COVID-19 immunization; Covid-19 vaccine (2nd dose), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (non-serious) with onset 12Dec2021 10:00, outcome "not recovered", described as "Swollen right arm pit"; PAIN IN EXTREMITY (non-serious) with onset 12Dec2021 10:00, outcome "not recovered", described as "right arm pain". The events "swollen right arm pit" and "right arm pain" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of peripheral swelling, pain in extremity.  Additional information: The reporter stating events as non serious. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
An additional dose of Polio (IPV) was administered. Given 2 instead of just 1. Mom reports sl. fever and irritability day after immunizations were given.
abnormal high pitched crying; have not resolved whether or not to give more pertussis vax;
Wheezing and difficulty breathing, swollen glands in neck, swelling and pain in injection arm. Pain in hip and shoulder joints, pain in leg and arm muscles, mild rash at and above injection site.
muscle pain; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 1,SINGLE), for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; FATIGUE (non-serious), outcome "unknown", described as "tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had had 3 COVID vaccines (3/6/21, 3/27/21, 9/29/21) all Pfizer, which had resulted in a change in my menstrual cycle. My period was starting later each month, having significant headaches, cramping, and intermittent bleeding (which most likely were cysts but I did not have any ultrasounds). I thought I was experiencing per-Menopause and my PCP did a hormone panel, which was normal. But my menstrual changes have continued for the next 2 years (to present day). I had not considered that this could have been related to my COVID vaccines until my 4 shot and the significant issues.   Per my PCP bloodwork, I had also developed increased blood clotting factors.   I contracted COVID for the first time Holiday weekend May 2022. I was rx'd Paxlovid by my PCP and took the full course but had significant COVID symptoms for 1.5 months after having COVID including heart palpitations, shortness of breath, fatigue, and confusion.   I started having significant menstrual type cramps and ovarian pain after my 4th COVID vaccine. They progressed with more pain throughout the month. Then, as I was flying back on Monday Aug 15, 2022, my ovarian cysts ruptured very painfully where I wasn't able to move for several minutes and had to be escorted off of a plane I was taken by ambulance to airport, waited 12 hours to be seen, then it was confirmed via ultrasound that I had ruptured ovarian cysts. I have continued to experience such cysts monthly for the past 7 months to this day, which are worsening over time. I then developed a blood clot in my left bicep at the same time. And still contracted COVID exactly 2 weeks after my vaccine (even though I was double masked in the airport, plane, and hospital). It was a horrible experience, I was discharged at 3 am onto the streets with no luggage and had to find a way back to the airport to get home .   I was COVID positive for the second time on Aug 21, 2022 (90 days later than my first COVID positive occurrence).  I was rx'd Paxlovid by my PCP and took the full course. I had fewer COVID symptoms for a shorter duration than the first time I had it.   Because of the blood clotting risk, I have not been able to take a hormonal rx to help with the ovarian cysts and am experiencing ongoing challenges. Over the past 30 days, my cysts have bled for 25 of those days and continue today.