chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My tongue and face swelled up about 40 minutes after the injection.; My tongue and face swelled up about 40 minutes after the injection.; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 49 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6202) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypersensitivity to liprinsol from an unknown date and unknown if ongoing , rubber sensitivity from an unknown date and unknown if ongoing. The patient experienced the tongue and face swelled up about 40 minutes after the injection leading to swollen tongue and face on 26Feb2021 11:00 with outcome of recovered.   No follow-up attempts are possible. No further information is expected.
Beginning 8 days after injection I had a horrible headache along with redness, swelling and firmness at injection site and just below injection site on right arm.  The area was hot to the touch.  It covered about the size of a tennis ball on my arm. I took acetaminophen and ibuprofen to help the headache with little relief and Benadryl for the arm symptoms. Swelling and firmness subsided the next day but I still have a lighter red mark the size of a baseball, maybe a little bigger, on my arm as of 1/18/21. Headache went away a couple days after onset and I never had a fever.
Received Moderna vaccines on 2/12, 3/12/21 COVID-19 positive by PCR on  1/10/22 admitted to hospital/ICU on 1/10/22 for evaluation of low hemoglobin (5.0), incidental finding of COVID 19
This spontaneous case reported by a consumer, describes the occurrence of musculoskeletal stiffness, mass (too many bumps), rash (rash on the back of the neck), rash (rash on the chest) and rash (rash on the face) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced musculoskeletal stiffness, mass (too many bumps), rash (has a rash on the back of the neck), rash (rash on the chest), rash (rash on the face) and chills. At the time of the report, musculoskeletal stiffness, mass (too many bumps), rash (rash on the back of the neck), rash (rash on the chest), rash (rash on the face) and chills outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. Reporter did not allow further contact.
Chills, headache, fever (99.6), nausea, unable to eat, fever increased to 100.2, 100.4, 100.8 then 100.9
gastritis; Bowels were soft not formed; queasiness; threw up; stomach ache; tight muscles; discomfort in the stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), MUSCLE TIGHTNESS (tight muscles), ABDOMINAL DISCOMFORT (discomfort in the stomach), GASTRITIS (gastritis) and FAECES SOFT (Bowels were soft not formed) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L2O1) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), MUSCLE TIGHTNESS (tight muscles), ABDOMINAL DISCOMFORT (discomfort in the stomach) and VOMITING (threw up). On an unknown date, the patient experienced GASTRITIS (gastritis), FAECES SOFT (Bowels were soft not formed) and NAUSEA (queasiness). The patient was treated with PROBIOTICS NOS ongoing since an unknown date at a dose of 1 dosage form and GLYCYRRHIZA GLABRA ROOT (DGL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), MUSCLE TIGHTNESS (tight muscles), ABDOMINAL DISCOMFORT (discomfort in the stomach), GASTRITIS (gastritis), FAECES SOFT (Bowels were soft not formed), VOMITING (threw up) and NAUSEA (queasiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included aloe juice, Pepto, sucking ginger candies.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Reporter's Email address added.
My daughter experienced a tonic clonic seizure. She was diagnosed with epilepsy. After consulting with the doctor we established she was likely having absence and myoclonic seizures since around 2014. She had her last GARDASIL shot on 11-27-2013. There is no familial history of seizures and she does not follow the typical JME seizure pattern.
Patient was given adult dose of Hep A instead of the intended pediatric dose of Hep A
ELEVATED C-REACTIVE PROTEIN; BALANOPOSTHITIS; LONG TERM FEVER; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and alcohol user, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient did not have any history of drug abuse or illicit drug use. Patient never had long-term fever and balanoposthitis before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included sertraline hydrochloride. On 18-MAR-2021, the patient experienced long term fever. On 20-MAR-2021, the patient experienced balanoposthitis. On an unspecified date, the patient experienced elevated c-reactive protein. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Rule-out other possible causes., and C-reactive protein (NR: not provided) Elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from long term fever, and balanoposthitis, and the outcome of elevated c-reactive protein was not reported. This report was non-serious.
Tinnitus, no treatment. Subsided after the first and second injection, became permanent after booster in August 2021.
This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6201), at the age of 58, via an unspecified route of administration, left arm, on Apr 7, 2021, single dose, for COVID-19 immunisation. The patient's medical history: unknown. The patient's concomitant medications not reported. The patient experienced flu for 2 days, nose was runny, fever, shaky and sweating on Apr 7, 2021. 2 days later she was fine. The events started on the same night after the 1st vaccine. The outcome of the event sweating recovered on Apr 7, 2021. The outcome of all the other events recovered on Apr 9, 2021. Follow-up attempts completed. No further information expected.
When I received the first shingles vaccine last month, I was  pretty sick the next few days  with extreme flu-like symptoms.  I told the pharmacist what happened with the first shot and she told me that people who have a bad reaction with the first shot are usually good with the second.  So I went ahead and got the second shot.  I got very sick that evening, and 4 days later, I still don't feel well.  My reaction was fever, chills, extreme sweating, body aches, joint soreness, headache, nausea, stomach cramps, dizziness.  I couldn't even stand up the day after the second shot without feeling like I was going to pass out.  I notified the pharmacist and my doctor as soon as possible about the whole incident.
administration of Kinrix to 13 month old.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 13-month-old female patient who received DTPa-IPV (Kinrix) (batch number 237C4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were reported as follows: This case was reported by the nurse. The nurse reported administration of Kinrix to 13 month old, which led to inappropriate age at vaccine administration. The reporter consented to follow-up. The case has been linked with US2021AMR054797, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR054797:same reporter
This spontaneous report was received from a pharmacist regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored GARDASIL lot # K006960, expiration date 19-FEB-2017 and lot # K010215, expiration date 05-MAY-2017 Incorrect product storage). No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter.
Client states woke up the next morning with welps, itching, soreness and swollen upper left arm.
local & transient pain down lt arm;inj site warm & swollen 7 days p/vax given;tx warm compresses & naproxen;sx are beginning to subside;
12-24 hr after vax, pt devel neck pain, stiffness, and "hot rashes" at inject site.
Patient received a DTaP vaccine on 9-7-07. Reported back to clinic on 9-14-07 with a 8 or more inch of redness and swelling on the right thigh.
This spontaneous report was receive from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. The nurse informed that on an unknown date improperly store doses of VAQTA (route, strength, dosage, lot number and expiration date were not reported), were administered to patients. No adverse effects were noted. This is one of several cases received from the same reporter. Additional information has been requested.
Patient reported that N/V started 0n 8/30/2013 that night after TD. Reporting vomiting 5 times and unable to keep anything down. Was seen by Dr on 9/3/2013 was given IV fluids & Phenergan 25mg IM. Patient was discharged in stable condition stating that she feels better.
Fell asleep after injection.  Awoke limping with red, hot, tender swollen leg within 5 hours of IZ. Remained hot, became itchy, leg color uneven with dots on back of thigh.  Sxs x 1 1/2 weeks.  Carried > 1 week.  Temp 100 1 week later for 2 days.  Now with bump.  Wakes at night saying my shot is hurting me and asks mom to massage.
10/27/2021- I formed a large blood clot on my lower calf 10/25/2021 Another large blood clot had formed on my left inner arm Ultra sound was performed- 10/29/2021 was determined, i have blood clots
Covid19 breakthrough. 1st vaccine received on 03/29/21.  Pt presents with c/o right lower quadrant abdominal pain, cough, nausea, vomiting and diarrhea.  Pt unable to take insulin for 2 days due to N/V.
soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness in his arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced MYALGIA (soreness in his arm). In March 2021, MYALGIA (soreness in his arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Patient fainted right after the HPV vaccine was given(patient was sitting down). I raised patient's legs, applied ice pack to her neck and head, patient came back right away. Cold water and a chocolate bar was given to her to help with her symptoms. I observed patient for about 40 minutes. Patient left the clinic accompanied by mom feeling well.
Soreness and pain in muscle of immunized arm. This soreness has continued 3 weeks post-immunization.  Negative findings by Patients MD upon office visit.
This case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a 2-month-old patient who received PEDIARIX. Co-suspect products included ROTARIX and PREVNAR. On an unknown date, the patient received PEDIARIX at an unknown dose, ROTARIX at an unknown dose and PREVNAR. On 12th March 2016, an unknown time after receiving PEDIARIX and ROTARIX, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 12th March 2016. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to PEDIARIX and ROTARIX. Additional details were received as follows: The reporter stated that, after receiving previous vaccinations with PEDIARIX, ROTARIX and PREVENAR 13, the patient died.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN and CARVEDILOL for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information mentioned that the patient was given Benadryl and an Epi pen if she needed to use it.
It was actually her first period; with a heavier flow for 6 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 14:00 (Lot number: FH8020) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: MELATONIN. The following information was reported: MENARCHE (non-serious) with onset 28Oct2021 09:00, outcome "unknown", described as "It was actually her first period"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 28Oct2021 09:00, outcome "unknown", described as "with a heavier flow for 6 days". Therapeutic measures were not taken as a result of menarche, heavy menstrual bleeding.  Additional information: It was her first period with a heavier flow for 6 days in a bright red blood colour, nothing light or red-brown blood colour. No other vaccine was taken in four weeks. Other medications in two weeks included gummy vitamins and gummy melatonin. The patient was not covid tested post vaccination. The patient did not have any known allergies.  Follow-up attempts are completed. No further information is expected.
Erythema and small amount of induration at vaccine site.  Very tender to touch. 1/30/2011: States iinduration was size of golf ball.   2/1/2011: 2.5 cm by 4 cm induration. 12 cm by 12 cm erythema.
received both vaccines, I have shingles/ Suspected vaccination failure; shingles on left outer thigh; raised red area; patch of blisters.; itchy blisters; This case was reported by a consumer and described the occurrence of vaccination failure in a 67-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had bouts of shingles since age of 30 and she had one or two episodes a year, always had been on an extremity, on a forearm or an outer thigh).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, generalized raised red spots limbs, blister and pruritus. On an unknown date, the outcome of the vaccination failure, generalized raised red spots limbs, blister and pruritus were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, generalized raised red spots limbs, blister and pruritus to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 24-Nov-2022 Reporter's comment: The patient was 67 years old. The patient received both shingles vaccines in the last year to supposedly prevent mire shingles outbreaks. The patient currently had shingles on her left outer thigh.  The same severity.  A raised red area with a patch of itchy blisters. The patient stated that the vaccine did not work at all. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
I waited about 30 minutes.  Felt tingly and a bit light headed but cracked it up to being tired from the shot.  I got in my car and about 5 minutes out driving in the middle of traffic,  I felt like I was going to pass out like I had once before with anaphylaxis- at the wheel.  There is no mistaking the feeling.  I could not feel my pulse at all.    Fortunately I had a EpiPin in my car and I was able to jab it in my leg and within a minute or two I had the energy to turn the car around and get back to the folks at site who were wonderful.  I then took benadryl as advised and the EMS were called.  I was taken to site where they gave me a steriod, pepsid and monitored me until I went home later that evening.  I was told to take benadryl for the next 24 hours and I did.
As described by patient's wife, patient has been having intermittent dizziness since receiving his Covid 19 vaccination.  Dizzy when his arms are raised above his head and at random times during the day.  Patient saw cardiologist and was assured the dizziness was not due to his cardiac condition.
Information has been received from a physician concerning a 5 year old male with no known drug allergies or allergies to egg who on 3/3/2006 was vaccinated SC with a 0.5ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot #649755/0380R). Suspect vaccination administered on that same day include a dose of diphtheria toxoid + pertussis vaccine (unspecified) + tetanus toxoid and a dose of poliovirus vaccine inactivated (unspecified). It was noted that all vaccines were administered at different sites. The physician reported that on 3/3/2006, several minutes post vaccination, the patient vomited, became dizzy and tachycardic. He began to develop hives and his lips and face started to swell. The physician gave PO Diphenhydramine HCL Benadryl, but the patients symptoms continued. The physician them administered epinephrine EPI PEN and the symptoms began to resolve. The physician noted that the patient was observed in the office for about 1 1/2 hours after the onset of his symptoms. The patient subsequently went to the ER for evaluation. ON that same day, the patient was noted to have fully recovered. Vomited, dizzy, tachycardic, hives and lips and face started to swell were considered to be immediately life threatening by the reporting physician . The reporting physician also considered the patients experienced to be other important medical events (OMIC). Additional information has been requested.
At approximately 10 PM on the day of the vaccination (7 hours after the vaccination time of 3 PM), patient became extremely fatigued and went to bed. Patient slept from approximately 10 PM on Sunday October 9th through approximately 9 AM Thursday October 13th, 2022, with occasional trips to the bathroom or for water.  Patient did not eat anything on Monday the 10th, but tolerated dinner on Tuesday the 11th and Wednesday the 12th.  Patient experienced headache, chills, fever of approximately 102 Fahrenheit, off and on throughout this period, and cold sweats.  For approximately 2.5 hours between 1 AM and 3:30 AM on Thursday, October 13th, patient had to be assisted to take a shower and eat, then was returned to bed.  At approximately 9 AM Thursday October 13th, patient woke up and resumed normal activities of daily living and appears to have completely recovered.   Patient was unable to work and had to take two sick days in addition to normally scheduled day off.
Itching and hives beginning 12 days after vaccine, so I'm not sure if caused by or related to vaccine.  This was the first time I've ever had hives. They ranged from mild to moderate, occurred over different parts of the body, everywhere except face, on and off for approximately 16 weeks, declining in intensity and frequency.  Relieved with over the counter allergy medicine.
Initial report was received from a health care professional on 15 December 2011. The reporter also reported another adverse event which is captured in case 2011-12361. A 46-year-old female patient (age reported as 37-years) had received the first dose of an intradermal injection in the left forearm of TUBERSOL 5 TU, sanofi pasteur Ltd., lot number C3763AA on 26 September 2011. The patient also received an intramuscular injection in the left deltoid of FLUZONE, sanofi pasteur Inc., lot number UH454AB on 26 September 2011. Six hours later (date not reported), the patient had shortness of breath and wheezing. The patient was seen by Urgent Care and the emergency room (ER) where she was treated with prednisone. Illness at time of vaccination and concomitant medications were reported as none. The patient had no known allergies (NKA). No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
Prolonged somnolence unable to wake up for 5 hours followed by high pitched cry for 2 hours.
"Mood", rash on face, soreness in skin, chilling, cough, sore throat, swelling and pain eyes, weight loss, earache, muscle aches, leg pain, tight chest, nose pain, dry skin, itching, back pain, ringing in ears (May 15-16-2016 vomited and diarrhea). Seen my Dr. No help still have problems. Sick May 15-16-2016, May 23, 24, 2016. I have seen Family Dr, several times he said he could do nothing. Vision bad.