chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My face, tongue, and throat swelled; My face, tongue, and throat swelled; My face, tongue, and throat swelled; I had a high, persistent fever; My body felt numb; Couldn't stop shaking; I have had severe pulmonary and heart issues; I have had severe pulmonary and heart issues; Severe electrical-like pain in my left leg and occasionally my right; Vomited blood and bile; Vomited blood and bile; I lost 15 pounds; My iron levels are low; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN8730), via an unspecified route of administration in left arm on 28Mar2021 at 10:00 (at the age of 18-years-old) at dose 2, single for COVID-19 immunization. Medical history included asthma and allergic rhinitis. She has known allergies to egg, tree nut, sulfa, and penicillin and mentioned that she experienced anaphylaxis to all these. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Concomitant medications included montelukast, triamcinolone acetonide (NASACORT), salbutamol (ALBUTEROL), ascorbic acid (VITAMIN C), and colecalciferol (VITAMIN D). She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received sulfur and experienced allergy causing anaphylaxis. She also previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205), via an unspecified route of administration in left arm on 07Mar2021 at 10:00 (at the age of 18-years-old) at dose 1, single for COVID-19 immunization and did not experience any severe side effects. Facility where the most recent COVID-19 vaccine was administered was reported as other. During the first dose, the patient didn't have severe side effects. She has a history of anaphylaxis, and on 29Mar2021 at 00:00 (also reported as about 12 hours after the second dose), her face, tongue, and throat swelled. She had a high, persistent fever. Her body felt numb and couldn't stop shaking. Since then, she had severe pulmonary and heart issues. Her body uncontrollably shakes and jolts. She has severe electrical-like pain in her left leg and occasionally on her right. She vomited blood and bile to the point where she lost 15 pounds. Her iron levels were low because of it. She mentioned that she was still being tested for cardiovascular problem with unknown result on an unspecified date in 2021. Therapeutic measures were taken as a result of the events. The events required doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were reported as serious causing disability.   No follow-up attempts are possible. No further information is expected.
Pain at injection site; then 2 1/2-inch diameter redness, swelling, and heat below injection site. Within 8 hours, body aching, headache, weakness, fatigue, shivers, which lasted 30+ hours. Gradually getting better, but pain and redness continue below injection site.
Pericarditis :severe, pleuritic chest pain, with subtle T-wave inversions, mildly elevated troponin, elevated CRP and ESR-- developed symptoms  approx 50-54 hours after immunization) Also had 36 total hours of severe arthralgias, myalgias, fatigue, fevers and chills.
Top of roof throbbing sore throat, headache very cold and runny nose. Just started today these feelings
Disruption in menstrual cycle. Normal cycle, menstrual bleeding stopped 7 days prior. Started heavy bleeding with large clots and severe abdominal pain within 2 hours of injection.  Menstrual cycles have always been regular and moderate. Still same bleeding/pain after 48 hrs.
Approximately 5 hour post vax pt began to develop hives on back which spread. Pt treated with Benadryl. Pt did not experience respiratory stress. Pt seen by physician who advised pt to continue Benadryl for 3 days. Advised to go to ER is respiratory stress occurs.
Pt given TD on 2/12/03. Complains of migraine headache also on 2/13/03. Returns to clinic with nausea, warm and swollen at injection site; pain radiating to armpit and shoulder. Gave her a Depo-Medrol shot. On 2/14/03 she returned with vomiting, nausea and itching. Headache continues. Gave her Phenergan. On 3/3/03, pain still present in arm. On 3/5/03, arm still bad with decreased ROM.
Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. Subsequently the patient experienced unspecified injection site reactions. The patient sought unknown medical attention. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
shivering; This case was reported by a consumer via interactive digital media and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2021, the patient received the 2nd dose of Shingrix. On 21st January 2021, 1 days after receiving Shingrix, the patient experienced shivering. On an unknown date, the outcome of the shivering was not recovered/not resolved.   It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received shingles shot on Wednesday and since Thursday been experiencing shivering episodes at least 2 a day.  The reporter asked was that normal.
Severe body aches starting 2/12 about 12 hours after injection lasting almost 4 days.
1 of 3 pt recv vax from same vial who exp a local rxn;event occurred 3-5 days p/vax;described as local redness-4" in diameter @ inj site w/soreness;MD visit-ice recommended for tx-recovered;
symptoms chills no fever went to urgent care for shortness of breath transported to ER diagnosed with COVID;  prescribed blood thinner and oxygen. Treated with Paxlovid; Tylenol and saline. Also contradicted pneumonia.
A small nodule about 1 cm in diameter and several papular rashes around right thigh.
Could not lift my arrm; Sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-SEP-2019, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced mobility decreased (Verbatim: Could not lift my arrm) and pain in arm (Verbatim: Sore arm). The outcome of the mobility decreased was resolved and the outcome of the pain in arm was resolved (duration 1 week).   It was unknown if the reporter considered the mobility decreased and pain in arm to be related to Shingrix.     It was unknown if the company considered the mobility decreased and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JUN-2023 The reporter was the patient who refused to provide demographics. After vaccination she had her arm sore for a week and she could not lift her arm because it hurt. Reporter never completed the series due to the side effects.  No other information provided by the reporter.  The reporter did not consent to follow-up.
Received FLUBLOK in left arm. In about an hour started itching. Next morning woke with red arm, swollen and hot. 4.5 inches across and 3.25 inches vertically. Continues to itch.
Myalgia, NauseaVomiting, pain at injection site Narrative:  Other Relevant History:
While eating breakfast the next morning after my shot, I got dizzy/light-headed and fainted, falling to the floor. I was "out" for ~2 minutes, according to my MD wife. After 2-3 minutes ,I felt fine and went and played tennis 15 Minutes later. I don't think that I have never fainted in my life time. I take no prescriptions for anything. I do still have a sore shoulder from the fall, since I was sitting in a "Bar stood" at a counter at the  time  of the fall.
Local swelling at injection site with induration, blister formation, pain, warmth, fever and chills within 24 hours of injection. Tx: Acetaminophen/ cold compress/ Allegra/ dexamethasone IM 4mg.
A patient called and informed me that she received the Moderna Covid-19 vaccine 2 weeks ago (1/24/20) and one week later, around 2/1/20 her arm started to get red around the injection site. The patients stated around 2/3/20 the redness started to subside but was itchy so she thought she may have been bitten by an insect and started applying  rubbing alcohol to right deltoid daily. The patient stated, since 2/3/20, the redness has grown down her arm to her bicep.  I instructed the patient to take Benadryl and informed the her of the signs and symptoms of anaphylaxis and when to seek medical attention. I also instructed the patient to report the reaction to her Doctor. A couple hours later the patient presented to the pharmacy and showed me the rash on her arm. I showed the patient were the Benadryl is located and how to take it.  I called the patient 5 hours later and the patient stated that she has taken one dose of Benadryl and the rash has somewhat reduced in size.
Drawling; Pain in the arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SLOW SPEECH (Drawling), MYALGIA (Pain in the arm) and FATIGUE (Fatigue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SULPHASALAZINE for an unknown indication.   On 15-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 15-Aug-2021, the patient experienced SLOW SPEECH (Drawling), MYALGIA (Pain in the arm) and FATIGUE (Fatigue). On 15-Aug-2021, MYALGIA (Pain in the arm) had resolved. On 17-Aug-2021, SLOW SPEECH (Drawling) and FATIGUE (Fatigue) had resolved.            Relevant concomitant medications were also included immunosuppressants.  The treatment information was  not provided.  It was reported that patient was immunosuppressed.
Patient received his 2nd Moderna vaccine 6 days sooner than it was due.  I spoke to him and he said that he was feeling fine and that he would let me know if he had any adverse reaction.
Mother called clinic, stated daughter began to feel "achy and had a headache while at school on 9/25/2012."  Was very achy and sore during volleyball game. Had fever overnight temp 103 per report and still feeling the same symptoms day of report on 9/26/2012.  Patient recieved Menactra MCV4, Influenza IM Fluzone, pres free, and HPV Gardasil (second dose) immunizations during this visit.  Encouraged supportive care at this time, possible side effects of vaccine per VIS sheet and encouraged to contact physician if worsening conditions as could be some other illness not immunization.
presented with fever, hypoxia, nstemi,; + Covid at NH PTA; Admit 9/13 medical with Covid infection; tx with 9/14 remdesivir, steroids, singulair, zinc; O2 at 2 LPM initially, weaned to RA by discharge
I started having a headache, fatigue, sneezing. I felt like I had a cold for another 10 days after. I tested positive for COVID-19 for about a week following. I still felt pretty tired and fatigue a week following. I wasn't prescribed anything, but I took acetaminophen for my headache and rested until I recovered.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 22-OCT-2016 to 31-JAN-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot #: L048848 with expiration date: 09-AUG-2018 (route and dosage schedule were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. The administered vaccines experienced temperature of (48 grades Fahrenheit), more than 46 grades Fahrenheit but less than 77 grades Fahrenheit for 24 hours and on 02-DEC-2016 (33 grades Fahrenheit), between 32 grades Fahrenheit and 36 grades Fahrenheit for 60 hours. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA003016: US-009507513-1702USA004995: US-009507513-1702USA004997.
Injection site-Right deltoid area-with erythema/warmth and induration - less than 10 cm-approx. 8cm. Per PCP, apply ice to the area, Ibuprofen and expect resolution over the next few days.
No additional adverse events reported.; on 11/22/2019 a patient was administered a VAQTA vaccine that expired on 11/15/2019; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.       On 22-NOV-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # R025518, expiration date 15-NOV-2019, dosage detail, strength and route were not reported) for prophylaxis (expired vaccine used). No adverse events were reported.
neck issues; Headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Feb2021 (Lot number: EN6203, Expiration Date: 20Jun2021) at the age of 68 years as dose 2, single and administered in arm left, administration date 30Jan2021 11:30 (Lot number: EN9581, Expiration Date: May2021) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Feb2021, outcome "recovered" (Mar2021), described as "Headaches"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "neck issues". Therapeutic measures were not taken as a result of headache.  Additional information: Callers weight was variable from 185-186 pounds. Callers height was close to 6 feet, but at time of report, it was 5 foot 11 inches. He guessed it was variable too. He received the vaccine in his left arm in case it got sore, because he is right handed and she was sitting on his left and it was right to her. He told the caller about having a headache for 1 and a half weeks after the 1st dose and experiencing after the 2nd shot a headache 3 weeks. On 30Jan2021, caller confirmed that this was a Saturday he received his first dose and then his headache started Monday or Tuesday. It was not severe, it was kind of there. Caller moaned. Guessed it was 1 to 1 and a half weeks and kind of went away. Caller added the 30th was a Saturday and he was not positive on when it went away. Caller experienced a headache after the second dose, for 3 weeks, plus or minus a couple days, but a long time. On 20Feb2021, he received his second shot and on the 22 or 23Feb2021, his headache started. He was not positive on the end date. It lasted 3 weeks and all of a sudden it went away. Caller added he was glad because it was getting pretty old. Caller added that he had things going on in his neck and thought perhaps this was what caused the issues. It started 2-3 days then cleared up after awhile and his system mellowed out. Then 2-3 days after the second one, there the headache was again only a little worse than the first, this was not coincidence. So it could not be due to the neck issues. He has not had any more sense then nor had it happened before. Caller could not recall the time of onset of his headache but did add the first headache started in the morning after the vaccine, the 2nd or 3rd day, it was kind of there. Time of Onset (24 hour clock) was unknown. No Emergency Room and Physician Office was required. No relevant tests was done.  No follow-up attempts are possible. No further information is expected.
Commencing approximately 18 hours after the vaccination (which was my second Pfizer vaccine), I developed a rash that started under my arms and on my lower abdomen.  Within approximately 4 hours the rash had spread across my chest, up my neck to the chin, around my waist and up the center of my back, and down the insides of my arms.  The rash remained inflamed and red, and the skin sensitive, for approximately 72 hours before it began to fade.  Within 5 days of beginning, the rash had subsided completely.
PT after injection at home mother states child fever 100, 10 cm x 8 cm welt and child had wheezing, lethargy and malaise per mother.
Having pain in the other side of his arm; This is a spontaneous report from a contactable Pharmacist. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0177), via an unspecified route of administration, administered in an unspecified arm on 24May2021 (at the age of 55-years-old) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that she has a patient there that came for his second dose of the Pfizer and he complained about having pain in the other side of his arm from the first dose. The reporter stated that she knew the sore arm goes away after a week or so and it should be on the same side of the arm that you were poked at. The patient said he "feels like" there was a bee sting on the other side of his armpit. The reporter stated that she knew that was not a part of the listed side effects for not giving a second dose, like an anaphylaxis reaction. The reporter wants to know if this would be something that was an issue for giving the patient his second dose and the patient has an appointment with his doctor on 01Jul2021. The reporter seriousness and investigation assessment were not provided. The outcome of the event was reported as unknown.  Communication:"Specific product name was not provided by the caller and was only referred to as "The Pfizer" and by First and Second dose. DSU agent was unable to verify a specific product name, as caller declined to complete report".  No further details were obtained or provided.
Off-cycle/irregular menstruation. Patient started menstruation after initial dose of vaccine (vaccinated Apr 18 2021, started bleeding Apr 27) and then started again after second dose of vaccine 09 May 2021 (started bleeding 11 May). This is a 15 day gap between starts, which is highly irregular. Both vaccination events were followed by (known) common side effect of soreness and fatigue.
The day after receiving my first dose of the Pfeizer Covid vaccine I experienced a severe uterine cramping unlike any uterine cramp I have ever had before. It was similar to a menstrual cramp but came on faster and more severely than any I have ever experienced. I was not on my period and the pain was so severe it had me doubled over and crying for a good 20 minutes. Once it finally subsided I still felt tender in my lower abdomen the rest of the day. I also experienced painful intestinal spasms and constipation afterward that lasted 24 hours.  About a week after my shot the injection site swelled up and became hot and itchy. At this time I also began to experience a shortness of breath when trying to yawn or take in deep breaths. The inability to take a deep complete breath lasted for 4 days before going away.
Two days post vax, the infant suffered fever and screeching screams. His face was distorted; he appeared as if he were in immense pain. At the age of 12 months the infant was overly active. At 18 months of age he reacted aggressively with changes in routine. For example, he was told to play in his room instead of playing in the living room. He reacted by angrily throwing clothes out of the drawer.   He did not play with toys appropriately. He did not know how to play with other children. He used very few words. When he wanted something he usually pulled me. However he could say a few of the words from the Barney song like "I love you". He never said mommy or daddy. There were no words after this. Later on he was unable to focus on activities. He like spinning objects, watching then go around. At 4 years of age he had a seizure (grand mal). He later experienced another seizure within 2 weeks. He was placed on Tegretol. Pt has impulsive behavior, inability to concentrate, obsessive behavior. Three different physicians have diagnosed him. Physician 1 - HDD, ADHS, OCD, Physician 2 - autism, Physician 3 - seizure disorder.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Dose number: 2/The patient was 6-7 years old, and received the gray cap formulation of the COVID-19 Vaccine (the formulation for patients 12 plus); Dose number: 2/The patient was 6-7 years old, and received the gray cap formulation of the COVID-19 Vaccine (the formulation for patients 12 plus); sick with vomiting; sick with vomiting; This is a spontaneous report received from contactable reporter(s) (Physician).  A child patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 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: Covid-19 vaccine (DOSE 1, lot number unknown), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), VOMITING (non-serious) all with onset Oct2023, outcome "unknown" and all described as "sick with vomiting"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 18Oct2023, outcome "unknown" and all described as "Dose number: 2/The patient was 6-7 years old, and received the gray cap formulation of the COVID-19 Vaccine (the formulation for patients 12 plus)". It was unknown if therapeutic measures were taken as a result of illness, vomiting.  Additional information: The pharmacy administered the wrong formulation to the patient. The patient was 6-7 years old and received the gray cap formulation of the COVID-19 Vaccine (the formulation for patients 12 plus). After receiving the vaccine, the patient became sick with vomiting.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
0735 developed hives, itching; 0800 progressed to shortness of breath; employee walked to emergency room for treatment.
Swollen arm, ~ 3 inch area around injection site; infected; left arm; affected arm shoulder to elbow upper arm; hot to touch; prescribed antibiotic (Cephalerin).
pt vaxed 24JUL92 & exp a severe inject site reaction which included swelling of the arm from the shoulder to below the elbow, redness & warm to touch; tx inlcuded heat; sx persisting 27JUL; afebrile; resolved 30JUL; arm nl;