chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within a few days of this first COVID vaccine dose (vaccinated 1/15/2021) I began experiencing moderate to significant upper right abdominal quadrant pain.  After looking at an anatomy diagram I was able to identify this as the affected area as my liver.  I had routine labs done on 1/22/2021 (1 week later) and these labs showed elevated ALT.  Prior to this I have never had elevated ALT.   This upper right abdominal pain continued persistently for approximately 8 weeks.  During these 8 weeks I received my second dose of the COVID vaccine (Pfizer/BioNTech, also Lot# EK9231) on 2/5/2021.  Immediately after the 2nd dose I experienced an increase in acuity of the upper right abdominal quadrant (liver) pain.  The acuity eventually subsided with moderate pain persisting and moving to periodic through July/August 2021.   To date (6/1/2022) I still periodically experience transient episodes of mild to moderate liver area pain.  On 3/23/2021 my follow-up labs showed ALT barely back in range (23 U/L).    On 9/14/2021 some follow-up labs showed ALT back to "my personal normal" (pre-vaccine) range of 17 U/L.
Chronic, primary stabbing/burning headache diagnosed as nummular headache at top of head began May 9, 2021; headache and stabbing/burning pain has not stopped since May 9 and has worsened since May 9, 2021, 26 days after my second covid vaccination.   Pain began without other trauma, no change in medications, or discernable cause.  Other symptoms began in July 2021 including unexplained nausea, weight loss, rashes on head and legs, muscle and bone pain, insomnia, ocular pain, nose and throat pain, hair loss, and anxiety.  Other symptoms lasted for approximately 45 days.  Primary headache, which remains largely non-responsive to current drug therapies of gabapentin, amitriptyline, and botox, continues to current day.
Abnormal mentral bleeding. I have had uterine ablation and have not had a period for a year. Bleeding began 8 hours after vaccine
First day after injection soreness, light swelling and redness of injection site. By the second day swelling and redness had spread. Tenderness of site was more pronounced followed with itchy skin. By the third day the injection site redness and swelling had started to spread around the top part of the arm starting to go under armpit area still having tenderness and itching of skin. By the fourth day the swelling and redness had increased to the point the arm was extremely tender and felt hard.  I saw  fit to go to urgent care at this point to be on the precautionary side due to the extreme discomfort and limited mobility due to swelling. Doctor informed me I was having a reaction to the vaccination I received and suggested that I do not get the second dose because the reaction could be more severe.  I was prescribed a steroid to take. After roughly a week the swelling had went down significantly and the itching was not as prominent  however there is now a bruise like discoloration of the skin at the injection site.
Fever (102) - evening after. Increased irritability (-) PE - resolved over 2 days.
This spontaneous report was received from a healthcare worker refers to a 12 months old patient of unknown gender. On 15-OCT-2014, patient was vaccinated with an improperly stored dose of MMR II (lot# J016232, Expiry: 19-DEC-2015, therapy type: HSA, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
Pt waited for 15 mins observation, left the center, then returned at 1117 with vomiting, flushing and sweating.  Patient was instructed to lie down, was given water and an ice pack.  Patient was observed for 45 mins.
Information has been received from a physician concerning a female who was vaccinated with Gardasil first dose. Subsequently, the patient developed a rash over their entire body. Unspecified medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
This was a vaccine error.  The Pfizer vaccine vial was diluted with 0.8 mL of saline instead of 1.8 mL of saline.  The patient received a 0.3 mL dose.  Due to the dilution error, the pt received a higher-than-normal dose of vaccine.
Patient returned to vaccine center about two hours after first dose Pfizer COVID vaccination. Patient reported to have swelling to neck and face/jaw. Post vaccination nurse who had seen patient earlier noted mild swelling to neck, jaw and tongue. Airway clear, vital signs 131/98, 101bpm, saturation 97%, RR 16, awake alert, patient speaking full sentences, handling saliva, tolerating PO liquids. Nurse and pharmacist at bedside. EMS called to evaluate. EMS evaluated and transported to the Emergency Room. Patient reported to have a history of similar symptoms intermittently due to a chronic rheumatologic condition.
pt recv vax;woke screaming then went to resp arrest;911 called;to er;felt baby coming down w/ cold; cont w/ fevers & d; to er again & was checked by MD;
pt recv vax MAY96 & 8MAY97 pt devel a serious case of chickenpox that consisted of 200 lesions over body;
Patient asked for the RSV vaccine and already received a dosage on 09/08/2023 and we didn't catch that he shouldn't be getting a second dosage.
Numbness of hands, legs, buttocks, mouth; hospitalized for 2 weeks; plasmapheresis administered (18 liters); released to rehab center; still unable to stand or walk after 3.5 weeks; numbness still present;
Lt arm where vaccine was given has a red area just above elbow the size of an orange which is warm to the touch.
Swollen lymph node in left armpit. Intense pain underarm and along left breast.  Pain on inside left arm down past elbow.
Information has been received from a registered nurse through a Merck Pregnancy Registry concerning a 22 year old female with a drug reaction to erythromycin (vomiting) with no pertinent medical history. The patient had done a few home pregnancy tests prior to the administration of the GARDASIL. On 09-APR-2007 prior to vaccination, the patient had a pregnancy test in the physician's office and was vaccinated intramuscularly, into the left arm with a 0.5 mL dose of GARDASIL, (Lot # 657617/0384U). There was no concomitant medication. It was reported that the patient was pregnant after receiving the vaccine. Follow up phone call information obtained from a registered nurse reported that the patient had an early termination of pregnancy. No complications were reported, and the patient subsequently finished the GARDASIL series. Upon internal review, early termination of pregnancy was considered to be an other important medical event. No further information is expected.
Inappropriate preparation of medication; Only received diluent; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate preparation of medication) and inappropriate dose of vaccine administered (Verbatim: Only received diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-MAY-2023 The reporter reported that the patient received only diluent part of Priorix vaccine. The patient received only diluent of Priorix vaccine, which lead to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The reporter agrees to follow up from GlaxoSmithKline.
NERVE TINGLING IN HANDS AND ARMS FOR SEVERAL DAYS, WEAKNESS IN LEGS,  SEVERE DEBILITATING JOINT PAIN , SHOULDERS, ELBOWS, BACK, HIP, KNEES, THIGHS ,CALVES AND GROIN. CHILLS, SLIGHT HEADACHES AND SLEEP DISTURBANCE
The patient was a 5-year-old male, S/P heart transplantation on 3/23/09 secondary to obstructive cardiomyopathy. About 2 hours after an H1N1 influenza vaccination on 10/30/09, he became irritable, belligerent, and talking gibberish. He presented to his PCP, who also noted an urticarial rash. His symptoms resolved shortly after a dose of diphenhydramine.
Blood coming in mouth; Pain in right arm at injection; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6203, patient was 67-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 08Mar2021 at 08:05 as single dose for COVID-19 immunisation/Prevention. Medical history included barrett's oesophagus. Concomitant medication(s) included omeprazole (OMEPRAZOLE, dose: 40 mg daily) taken for barrett's oesophagus from Jul2020 to an unspecified stop date. Reported that patient and his wife both received vaccine. He experienced having blood in his mouth and injection site pain. His wife had other symptoms which completed in separate report. There was no prescriber. The nurse that administered said it had to be in the shoulder joint. He is unable to confirm if given intramuscularly. His second dose is scheduled for 29Mar2021, at 7:55 am. He would like to know if the bleeding in mouth and nose have been reported before. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. It was reported that blood coming in mouth in late evening. It was not a lot, but you could notice. Like some time when you take a high dose aspirin and blood gets thin like in nose or mouth. Very minor. He noticed 3-4 times and after 5 cold gargles it was better. He has not taken any aspiring, he right arm sore at injection side. 17:00-18:00 about 10 hours after receiving. On 10Mar2021, the patient experienced blood coming in mouth, on 08Mar2021, the patient experienced pain in right arm at injection. No ER or physician's office required. No prior Vaccinations within 4 weeks, no AE following prior vaccinations. The outcomes of events were recovering.  No follow-up attempts are possible. No further information is expected.
She got her 2nd vaccine, they kept her 30 minutes as she had problems with the 1st one, her BP was okay and that she could drive home and was told to drink a lot of water.  She went home and after every bottle of water she had 3-4 episodes of diarrhea and kept drinking water all day and after 3-4 she did not have any more diarrhea.   She had some pain in her arm.   She started having visions of chicken scratches/white lines across her eyebrows from the left to the right across her whole forehead.    She always has this vision discrepancy all day long inside the house and outside when she goes and gets the mail.  She first went to the eye doctor as she was having floaters, white lines visually appearing but have not had them for a long time, and these did not go away and they were not the usual floaters like she had before.  They got her in the office immediately and that doctor said that he did not have an answer for her and he didn't find anything wrong with her eyes.   She told him that she was worried about what happened after the vaccine.    She went to her PCP and she ended up in the hospital as she has a problem with her left rotator cuff and needs surgery on that but is waiting for her leg to heal from total knee surgery.   When she lays down at night she has chest pains, and didn't know what it was and was told that there is a nerve that runs down from the shoulder and crosses over to the heart and gives the feeling of chest pains.  She had tests done and they did not give her any answers to what the pains were.   She then went to her PCP again and told her about the vision issues and she didn't have an answer to her issues either.  Her daughter suggested that perhaps her BP was an issue and she brought that to her attention and she told her to document it and to FU this week with her nurse to see that everything was working okay.  She states that her BP has never been the same, she has never had a BP problem before.  She takes it every morning between 9-10 AM.  131/86, 139/80, at 5:00 132/74, 148/88, 133/84, 139/92, yesterday was 137/83, today 132/84.   She has been placed on BP medicine, Cardizem 30 mg.
Facial Swelling; Fever; Headache; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 41-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. The patient had previously received penicillin (MANUFACTURER UNKNOWN) and experienced allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient experienced facial swelling, fever, headache and nausea. The patient did not receive any treatment for the adverse events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events facial swelling, fever, headache and nausea were resolving at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained
Patient reports she noticed a rash of hives at approximately 4:00pm the day of the vaccination. Patient states soon after the rash she felt body aches from head to toe (so much she had to lie down) and she felt her heart race (over 100bpm). Patient states she rested the rest of that evening and when she got up the next morning, she felt fine. The patient states she feels the problematic vaccine was the Shingrix because she had received a dose of the RabAvert one week prior without any problems.
Dizzy, tunnel vision, brief syncopal episode. BPs 84/55 (pulse 53); final BP 110/67 (pulse 59). Given juice and water before discharge.
My neck started itching gradually more annoying by last week of March. I started exp redness below my neck looked like eczema.
Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment drugs were not provided
This spontaneous case was reported by a patient family member or friend and describes the occurrence of ATRIOVENTRICULAR BLOCK (blockage in his heart) in a male patient of an unknown age 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 ATRIOVENTRICULAR BLOCK (blockage in his heart). At the time of the report, ATRIOVENTRICULAR BLOCK (blockage in his heart) outcome was unknown.            Concomitant medications were not reported.                                       No treatment information was provided by the reporter.    The report stated that the patient experienced a blockage in his heart. The outcome of the event was unknown. No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
"brain fog"- unable to speak clearly, or speak at all, complete numbness of hands, then return of feeling- spontaneously comes and goes. This is in a 88 year old who previously was walking 1/4 mile unassisted, making dinner himself, doing all ADLs- has completely declined since 2nd dose.
Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient came back to the pharmacy after about 45 minutes of getting vaccine. She had a rash all over her chest and body. No difficulty breathing or swelling in face. Patient given Benadryl and told to take 50mg every 6 hours. She also was given an EpiPen to take home in case of emergency use (she would need to visit ER if used). Followed-up with patient on 10/02/2021 but not reached.
Headache shortness of breath, chest pain fatigue Narrative:  was seen at the ED a day after vaccinated; treated with Zofran, Toradol and Benadryl. Has hx of asthma.
I tested positive for COVID-19 on 12/21/22. I had a sore throat, chills, fever of 101, congestion, fatigue, loss of taste and smell. I contacted my doctor and she prescribed PAXLOVID, but I didn't take it. I did take TYLENOL and CORICIDIN. I am feeling better now, but still have lingering congestion and fatigue.
On 01 February 2021 a 97 year old male was administered the Pfizer COVID vaccine.  Side effects began as fatigue and difficulty communicating.  On 08 February 2021 the male became bedridden and developed a fever with chills.  Over the next few days he struggled to eat, drink, and eventually to breath.  The 97 year old died 25 February 2021.
At 10:50 am a 43 years, female complain of a Metallic taste and ear pain after receiving the vaccination Moderna. Patient has a history of Chronic Nerve pain. No known allergies noted. V/S BP 118/79, HR 77, RR 16, O2 100%.  11:15 am BP 123/88, HR 77, RR 16, O2 100%. Patient was observed for 30 minutes. Patient stated that the ear pain was a 2 out of 10, 10 being the worst pain. Metallic taste had went away. Patient was discharged with family.
Information has been received from a licensed practical nurse (L.P.N.) concerning an 13 week old male who on 23-NOV-2010 was intramuscularly vaccinated with a dose of 0.5 ml PNEUMOVAX 23 at left thigh (lot # 664079/0633Y). The reporter stated that the patient was inadvertently vaccinated with PNEUMOVAX 23 instead of PREVNAR 13, staff error. No adverse effects reported. The patient sought unspecified medical attention. Follow up information was received from the licensed practical nurse who reported the patient was continuing to do well. Regarding the wrong drug administered, the reporter confirmed it was staff error and had nothing to do with improper labeling. Additional information is not expected.
Patient came in feeling anxious about the vaccine. RPh spoke with her for 5 minutes before giving the vaccine and she felt calm and reassured getting it. 10 minutes after vaccine patient complained of feeling lightheaded and that her heart was racing. She said she took no blood pressure medicine and that it was controlled with a "Zeal" drink. RPh checked her blood pressure 3 times, with the last reading being 174/100. RPh advised patient to go to the ER. With her consent we called 911 and EMS arrived. They checked blood pressure again and it was 194/105. She said she felt calmer and didn't want to go to the ER. I told her to call her PCP as soon as she got home. I followed up with her after she got home and she said she left a message with the Dr. I had her check her blood pressure and she called back a few hours later and it was 134/88. RPh advised her to continue monitoring it a few times today and make sure she speaks with the doctor before the weekend.
Pt developed localized swelling, redness, warmth, mild tenderness in left anterior thigh within 48 hours of immunization.
Back Pain aggravated; This spontaneous case was reported by an other and describes the occurrence of BACK PAIN in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Back pain, Rheumatoid arthritis, Abstains from alcohol, and Non-smoker. Concomitant products included RINVOQ and PLAQUENIL for Rheumatoid arthritis.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN. At the time of the report, BACK PAIN had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Magnetic resonance imaging: unknown Inconclusive. In March 2021, X-ray: unknown Inconclusive.         No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received on 04-JuN-2021 included no new information.
Right hand soreness and numbness, afebrile, pain with movement limits use of hand, no weakness. Right knee aching, worse with waking. BP 139/93, pulse 97
Case number PHEH2015US020152 is an initial spontaneous report from a pharmacist received on 08 Oct 2015. This report refers to a 30-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1514901) intramuscularly on 08 Oct 2015. One hour after vaccination, he started seeing spots, felt dizzy and experienced loss of peripheral vision. The outcome, seriousness and causality of the events were not reported. Seriousness assessment of the events seeing spots and loss of peripheral vision were upgraded based on the available information in the source document.
This spontaneous report was received from a nurse referring to a 1 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 21-SEP-2018, the patient was accidentally vaccinated with PROQUAD (rHa) lot number: N015624, expiration date: 15-NOV-2018, 0.5 ml once, subcutaneously, for prophylaxis, that was improperly stored in the range -9°C to 8°C for 24 hours (strength was not provided). PROQUAD was administered along with VARIVAX for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). The VARIVAX did not have a temperature excursion. There was not digital data logger involved. The reporter informed that PROQUAD was given in error instead of the M-M-R II, which was what the child was supposed to receive. The nurse confirmed it was not product confusion but human error. It was unknown if STERILE DILUENT (unknown lot number and expiration date) used for reconstitution of PROQUAD and VARIVAX was properly stored. No adverse effects were reported.