chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive test result to COVID-19 and developed symptoms; Positive test result to COVID-19 and developed symptoms; still sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Positive test result to COVID-19 and developed symptoms"; ILLNESS (non-serious), outcome "unknown", described as "still sick". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Additional Information: consumer stated she and her husband are still sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
IMMEDIATE SWELLING AT INJECTION SITE. SOME BLEEDING BUT CONTAINED. PATIENT DID NOT COMPLAIN OF PAIN OR PRESSURE FROM SWELLING.
Left arm from shoulder down to elbow with a red itchy rash, started 8/7. Treateint with BENADRYL.
Syncope (brief episode) after administration of ADACEL. Nausea, no vomiting. Good response to fluids and crackers.
This spontaneous report as received from a healthcare worker refers to a 16 year old patient. On 02-JUN-2015, the patient was vaccinated with the first dose of GARDASIL and on 03-AUG-2015, the patient received second dose of GARDASIL 9. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 79 year old patient of unknown gender. On 15-JUL-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J002242, expiration date 21-MAY-2014, 0.65 ml, subcutaneous). Concomitant therapy was not reported. No adverse effects were reported. Additional information is not expected.
Hard to breathe; Having a sharp pain in her back "where her lung was"; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) reported herself.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Saturday at noon in Mar2021 (Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 28Mar2021 the patient experienced a sharp pain in her back where her lung was and she was hard to breathe on 29Mar2021. The patient stated that she received her first covid vaccine dose on Saturday at noon and last night she began having a sharp pain in her back 'where her lungs were'. She reported that she thought it would go away last night but when she woke up it was still there and its now hard to breathe. The outcome of the event hard to breathe was unknown. The outcome of the event having a sharp pain in her back where lung was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Brain Fog /confusion since shot..  Arm (left) the shot was administered is still  lacking in strength (just holding  a cell phone wears it out). 2 weeks to the date, after the shot, I experienced extreme pain in all joints in left arm ( elbow, wrist, finger joints)  The pain extruded to the middle of my rib cage from the left side. Shot site still mildly sore.. Brain fog still continues.
Unapproved Age; Wrong Product Used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   On 12-JUN-2023, the patient received Havrix. On 12-JUN-2023, an unknown time after receiving Havrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved Age) and wrong vaccine administered (Verbatim: Wrong Product Used). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Jun-2023 The infant's mother was notified and instructed to call the office if the infant showed unusual signs and symptoms and she had called in with any issues. The Vaccine Administration Facility was the same as Primary Reporter. The medical assistant reported that 6 month old infant was supposed to received PCV15 vaccine and was inadvertently administered a dose of Havrix instead, which led to inappropriate age at vaccine administered and wrong vaccine administered. The reporter consented to follow up.
This case was reported by a healthcare professional and described the occurrence of shortness of breath in a 77-year-old subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specific s on each individual subject were not provided.
Patient was admitted to hospital. 11/13/06 Symptoms of stomache, not feeling well, then she had a seizure. Was brought to Emergency Room. Then to PICU for encephalitis, respiratory failure (intubated). 8/6/08-records received for DOS 11/13-11/29/06-DC DX: Glomerulonephritis status post seizure. Admitted with facial swelling and abrupt onset of altered mental status and seizure. Over 2 weeks prior to admission facial swelling persisted and gradually developed similar swelling in hands and feet. Four days prior to admission found to have proteinuria which is also date of immunizations. One day prior to admission developed malaise confusion and headache. On day of admission developed nausea and abdominal pain and vomiting. Began shaking entire body and was unresponsive for approximately 30 minutes. Intubated and ICU.
FEELING DIZZY; PAIN IN THE BACK OF BOTH LEGS (BOTH CALVES) AND FEELING PAIN ON THE OTHER ARM (RIGHT ARM); HEADACHE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced feeling dizzy. On 23-SEP-2021, the patient experienced pain in the back of both legs (both calves) and feeling pain on the other arm (right arm). On 23-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from feeling dizzy, and headache on SEP-2021, and had not recovered from pain in the back of both legs (both calves) and feeling pain on the other arm (right arm). This report was non-serious.
Information was received on 19-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is being claimed that the patients,  their physicians and their pharmacists use ZOSTAVAX vaccine in the manner in which it was intended. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 07-AUG-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent stain of  herpes zoster. On or about 06-DEC-2016, the patient was treated by her physician for a painful and blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required  extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
granuloma annulare; immune issue; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMA ANNULARE (granuloma annulare) and IMMUNE SYSTEM DISORDER (immune issue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced GRANULOMA ANNULARE (granuloma annulare) and IMMUNE SYSTEM DISORDER (immune issue). At the time of the report, GRANULOMA ANNULARE (granuloma annulare) and IMMUNE SYSTEM DISORDER (immune issue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that red blotches appeared on left arm. Then on left leg, below knee. Since then blotches had appeared on various parts of body. Diagnosed by Dermatologist and primary care physician as "Granuloma Annulare". Also with an immune issue. Blotches were not itchy or swollen just ugly to look at. IT was not going away, just increasing in number. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.   Reporter did not allow further contact
I started to get chills and a headache in the evening. I had a fever of 99degrees. I got tested the next day and I tested positive for COVID-19. The second day I had headache, chills muscle aches and I was exhausted. My sense of taste and smell but I did not lose them. I was prescribed an antibiotic, steroids and an inhaler. My oxygen levels were very low. I recovered over the next two weeks. I ended up getting Pneumonia about three weeks after the infection. The Pneumonia took about a month to clear.
I was given my first Covid vaccine on 3/6/21. About 12 days later I started having some difficulty breathing, pounding heart and some dizziness. My symptoms got worse one the next week and a half. I went to an emergency room on 3/28/21 and was admitted to an ICU with a Saddle Embolus of Pulmonary Artery with Acute Cor Pulmonale. Many blood clots in my lungs and one very large one in the artery between my heart and lungs. I am now on Blood Thinners.
Marked swelling, redness, and itching of left arm from shoulder to elbow (injection was in left deltoid). Some pain, but mostly itching.  No fever, no trouble breathing, no vomiting.  Otherwise acting well.
In your shot. 1. 100 temp 2. 101 temp 3. 102 temp for 4 days; I was so sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, 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 1, SINGLE), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "In your shot. 1. 100 temp 2. 101 temp 3. 102 temp for 4 days"; ILLNESS (non-serious), outcome "unknown", described as "I was so sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was unknown. Patient had trouble with the 3 shots pt. had. Is there eggs, milk products and aluminum die. In patient shot. patient was so sick that  patient , scared to get a booster shot.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
UNKNOWN SIDE EFFECT; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced unknown side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unknown side effect was not reported. This report was non-serious.
This spontaneous report as received from a male patient (unknown age) refers to himself, with history of chickenpox (1947, when he had around 5 years old"). In December 2007, the patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. On 02-DEC-2012, the patient was diagnosed with shingles. The location effected by blisters and scaring was his left waistline. Treatment consisted of only application of calamine lotion twice daily. To date, the patient still had a rash which seems to be fading. The patient inform the failure of the dose of vaccine he had by his internist MD. The patient studied the causes and prognosis of living with this virus the rest of his life. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Excessive, heavy menstrual bleeding from March to June without stop (bled daily for the better part of 4 months). Presence of clots discharging from my body when I used toilet or showered. Heavy cramping and pain. Stopped my period mid June and then started around July 4 with heavy cramps, bleeding and clots which then lasted 5 days and stopped.   Prior to this, I did not hardly have a period because I have an IUD with hormones. (Morena)
Evening of vaccine--upper arm red/warm/swollen; afebrile. Presented to Urgent care and started on Bactrim and oral prednisone for cellulitis. Followed up in our Clinic 10/16/17 as swelling was worse of right upper arm and extended to shoulder, new red streaking right forearm to wrist, itching w/intact skin. Stopped Bactrim, started Omnicef with follow up 10/17/2017 w/decreased swelling, no streaking. Remained itchy. Stopped oral prednisone. zyrtec 10 mg daily.
Heart pain 3-4 hours after injection. Heart pain subsides 13 hours after injection. Chest pain center near sternum, chest tightness in center of chest 8 hours after injection. Chest pain is ongoing since injection and is now day 5. The chest pain worsens when lifting heavy objects, bending over, and laying down.
patient had sore arm, the muscle was hard, erythema with a rash and warmth. It started the day before the patient came into the clinic. Patient was advised to used Tylenol, Benadryl (if not contraindicated) and ice pack 30 min on each time she use it with an hour or so in between use
2/23 5am diarrhea in bed with some blood; 24th  diarrhea, 2 bouts in a.m. at 7 pm stomach pain, gas, nauseus sweating chills, 25th woke up feeling better, but in the night again complained of stomach pain and nausea; on 26th again some liquid diarrhea in bed (Blood?)  Since 28th no problems
Mild nausea.  ate some crackers and felt better. released after 30 minutes.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2023 as dose 5 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 23Apr2023 to 27Apr2023. The patient has no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300176662 same reporter/patient different drug /AE.;US-PFIZER INC-202300177575 same patient/drug, different dose/events (Dose 5).;
within 20min post injection student c/o itchiness, hot to the touch and redness at injection; hydrocortisone cream and ice pack applied; 2 hours post injection starting having headaches, fatigue, malaise, decreased appetite, nausea which all lasted until 10/7 am; on 10/7 am body started feeling hot , still had headache and fatigue
Threw up 150 times .. could not keep anything down including water.  Second day after the shot, I was able to take a sip of tea and keep it down and tried to take a sip every 10 minutes.   Headache and Nausea Aches and Pains Took 2 1/2 days off work
Case number PHEH2013US022535 is an initial spontaneous report received from a nurse on 24 Oct 2013: This report refers to a 44-year-old female patient. Her medical history included asthma. She was vaccinated with FLUVIRIN (batch number: 1308101 and expiry date: Mar 2014) on 30 Sep 2013. On the same day after vaccinations, she developed a red, raised and hot reaction at the injection site after vaccination as well as asthmatic symptoms. The reaction was the size of a baseball/softball. She was treated with asthmatic medication DULERA and was given SOLUMEDROL shot. SOLUMEDROL shot resolved the reaction and she was stable when she left the pharmacy. It was reported that the event resolved in less than one day. No further information about seriousness and causality was reported.
Within 5 minutes of vaccinations, patient fainted and fell face down. He had been instructed to sit after vaccination. Emergency care was administered. EMTs arrived within 10 minutes & he was transported to hospital by ambulance.
Subsequent to receiving one dose of varicella virus vaccine live on 8/20/97 and on 03/23/99, the pt experienced 8 lesions and fever. On 3/27/99 or 03/28/99, the pt recovered.
On  1/9 /21, after walking 5 miles and taking a hot shower I had large welts that were red on the inside of both thighs.  Within 1 hour they were gone and did not return.
This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (Lot # reported as 1021215, expiry date: 10-JUN-2017) (Incorrect product storage). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
A report has been received from a Physician concerning a child, male subject, who had been receiving FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced arm muscle pain. The outcome of arm muscle pain is unknown. The report was considered to be non-serious.
confusion/was not coherent; blurry vision; vomited; cardiac outcomes went up, from the lab results they were elevated; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (confusion/was not coherent), VISION BLURRED (blurry vision), VOMITING (vomited) and CARDIAC OUTPUT INCREASED (cardiac outcomes went up, from the lab results they were elevated) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced CONFUSIONAL STATE (confusion/was not coherent) (seriousness criterion hospitalization), VISION BLURRED (blurry vision) (seriousness criterion hospitalization), VOMITING (vomited) (seriousness criterion hospitalization) and CARDIAC OUTPUT INCREASED (cardiac outcomes went up, from the lab results they were elevated) (seriousness criterion hospitalization). At the time of the report, CONFUSIONAL STATE (confusion/was not coherent), VISION BLURRED (blurry vision), VOMITING (vomited) and CARDIAC OUTPUT INCREASED (cardiac outcomes went up, from the lab results they were elevated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had his first dose of the Moderna COVID-19 vaccine yesterday and immediately felt the vaccine go to his chest and down to the toes; 30-40 minutes after had confusion, blurry vision; he made it to a hospital in Dallas where he vomited, he could not read at the moment, could not call 911, did not know how to send his location, how to call or text, he was not coherent. Was admitted in the ER with altered mental state, he was not responsive when she went to see him. He stayed overnight, his cardiac outcomes went up, from the lab results they were elevated. They performed CT scans, neurological checks, a holter monitor, MRI, multiple blood works and everything was clear.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Injection site reaction, swelling, fever, nausea. Reported several weeks after admin-> In PNEUMOVAX23 arm.
p/receiving the flu vax c/o itching @ the site, flushing of the face w/in another 1-2" c/o difficulty swallowing & breathing; gave DPH; to er;
Patient received second pfizer vaccine on 10/05/2021 and received booster pfizer 01/14/2022 ( approximately 2 months early).   Patient called 01/18/2022 patient at this time does not report any adverse reactions. Patient has been advised to contact the clinic is experiencing any reaction and seek medical attention.
Received shot Wednesday night, developed arm soreness and mild flu like symptoms on left side of my body and facial paresthesias on the left side of my face. Twelve hours later, after waking up those same symptoms were only on the right side of my body. Friday morning, mostly normal physically just with some overall fatigue. Friday afternoon I started to get hives on my chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until Monday mid-day when Benadryl was not helping reduce the hives and so I had full body hives. I did try an drugstore cortisone cream which did not help.  Sought treatment at an urgent care as I was feeling anxious and could not control the itching. I and was diagnosed with likely allergic reaction to the covid-19 vaccine.