chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 5 year old son who was vaccinated with MMRII. Concomitant therapy included DPT. Subsequently the patient experienced an allergic reaction. No other information was provided. Additional information is not expected.
site soreness, low grade fever, body aches, headache; 24hr duration; OTC Aleve TID and Nyquil one time dose
covid she can't shots, she fell down in August when she wasn't taking any mediciation, "my body can't handle injections; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 66 year-old 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. Past drug history included: Cimzia, notes: she had reactions from Cimzia, DPT, Humira; Dpt, notes: she had reactions from Cimzia, DPT, Humira; Humira, notes: she had reactions from Cimzia, DPT, Humira; Flu, notes: she had reactions from Cimzia, DPT, Humira react to carrier in all the shot flu. The following information was reported: FALL (non-serious), outcome "unknown", described as "covid she can't shots, she fell down in August when she wasn't taking any mediciation, "my body can't handle injections".  Additional information: During the call the patient stated. "she had reactions from Cimzia, DPT, Humira react to carrier in all the shot flu and covid she can't shots, she fell down in Aug when she wasn't taking any mediciation, "my body can't handle injections, and Her HCP provided her a 2 month sample of Xeljanz XR 11 mg." The patient is prescribed Xeljanz XR extended release 11 mg tablets. Call was not transferred to Pfizer Product Safety.  The lot number for bnt162b2 was not provided and will be requested during follow up.
The same evening the patient got the shot she had pain on the distal lateral site of the same arm. She said she had a golf size bruise that settled down with ice and ibuprofen. She said she had pain on a 8 from 0-10. By Tuesday she said it wasn't as bad anymore.
This is my 2nd pregnancy. Due date of 06/10/21. After the 2nd shot I developed hives on my right arm and in my inner thighs. An ultrasound 6 days after my 2nd injection showed an umbilical vein varix on baby.
This spontaneous case was initially received on 27-Oct-2015. The case report was received from a Health Professional and concerns a 25 years old female patient. Weight: not provided, Height: 64 inches. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication prevention of influenza on 22-Oct-2015- unknown stop date, Batch no: 11749211A, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On 22-Oct-2015, after starting/ treatment with AFLURIA the patient experienced partial dose of the AFLURIA vaccine/didn't get the full dose, part of it was running down her arm (non serious, outcome: Unknown), the needles were loose and needed to be tightened/needle loose on syringe (non serious, outcome: Unknown). Action taken: not applicable. For relevant test results see appropriate report section.
I had a "normal" but larger reaction to the vaccine, including a rising temperature for 48 hours, tiredness, cold/hot, and generally not feeling well for 48 hours. My joints hurt some for about a week. A few weeks later, my ears started ringing and just have never stopped since then. It started loudly in my left ear and I went to urgent care, my primary, and my allergist. My allergist gave me prednisone, zyrtec-D, and singulair, which helped a lot, but it never went away (just lessoned). It has been that way since for almost a year.
I developed a huge red hot rash on my arm that was injected on 2/19. On 2/24, I went to Urgent care because it has continued to grow. They prescribed me medicated cream and it has now gotten less red, but is still very large and discolored.
Very high fever, dizziness, loss of bowel and bladder control, loss of muscle control, diarrhea.
exposure during pregnancy; muscle soreness at injection site; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Prior use). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 21-Sep-2020 and the estimated date of delivery was 11-Jul-2021. On 14-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. On 14-Jan-2021, EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2020, Pregnancy test: positive Positive. On 21-Jan-2021, Amniocentesis: low level 10% of mosaic turner syndrome Low. On 21-Jan-2021, Ultrasound scan: no abnormal findings normal. On 28-Dec-2021, Ultrasound scan: no abnormal findings normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-165269 (Patient Link).
weakness in the left hand; pins and needles in the face and hands; stiff and achy joints; headache; fever; stiff and achy joints; This spontaneous case was reported by a non-health professional and describes the occurrence of MUSCULAR WEAKNESS (weakness in the left hand), PARAESTHESIA (pins and needles in the face and hands), JOINT STIFFNESS (stiff and achy joints), HEADACHE (headache) and PYREXIA (fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced MUSCULAR WEAKNESS (weakness in the left hand), PARAESTHESIA (pins and needles in the face and hands), JOINT STIFFNESS (stiff and achy joints), HEADACHE (headache) and ARTHRALGIA (stiff and achy joints). 29-Apr-2021, the patient experienced PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MUSCULAR WEAKNESS (weakness in the left hand), PARAESTHESIA (pins and needles in the face and hands), JOINT STIFFNESS (stiff and achy joints), HEADACHE (headache), PYREXIA (fever) and ARTHRALGIA (stiff and achy joints) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, COVID-19: positive She had a diagnosis of COVID19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  Concomitant medications were provided
Client dry-heaved 5 times, turned completely pale, stated feeling faint, and also stated that she suddenly felt very hot immediately following the administration of the HPV vaccine. Cool and moistened paper towels were placed on the back of client's neck. Blood pressure was taken - 68/49, and after approx. 7 min. it was repeated to show a rebound of 86/72. Client was monitored for 15 minutes before releasing from clinic in good condition and walking on her own without further incident.
1 week after getting  COVID vaccine shot,     Rash/swelling occurred at site of the shot.  Modera vaccine received.
This spontaneous report was received from a licensed vocational nurse, referring to multiple unspecified patients. Ages, genders, medical history or concurrent conditions were not reported. On 18-JAN-2016, 20-JAN-2016, 21-JAN-2016, 22-JAN-2016, 26-JAN-2016, 27-JAN-2016 and on 28-JAN-2016, improperly stored doses of ROTATEQ (lot # L013204, expiration date 28-JAN-2017) 2 ml, oral, were administered to unspecified number of patients. No adverse effects have been reported. It was also reported that temperature ranging was from 31 F to 35 F, the time frame was cumulative for 56 hours, it was not previous temperature excursion, and it was not product quality complaints involved. Additional information has been requested.
Patient received the vaccine on 10/13/14. On 10/14/14 patient noticed the injection site was becoming red, but it was minor. On 10/15/14 the patient said the area became red, warm, swollen, and a lump was forming. She estimates the area is about 3-4 cm in diameter and tender/uncomfortable. Patient was advised to ice the area and take BENADRYL.
Side effect was headache, which I do not normally have headaches.  Lasted about 30 hours.  Tylenol and Aleve helped but did not get rid of it.
Information has been received from a nurse via a company representative referring to a male patient of unknown age. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies. On an unspecified date, the patient was vaccinated with a dose of GARDASIL 9 intramuscularly (strength, dose, lot # and expiration date were not provided) for vaccination. The nurse reported that after an unspecified amount of time, the patient passed out after receiving dose. The patient bashed head and had to go to emergency room at a Hospital, where the patient received unspecified treatment. No lab diagnostics/studies performed. The patient returned to physician's office 1 day later and he was fine. The outcome of the event was reported as recovered. The causality assessment was not provided. Upon internal review, the event of "passed out" was considered to be medically significant.
Patient was given HPV9 vaccination at 2:55 pm on 11/16/16 in left deltoid. Patient was instructed to lay down on bed after injection in case of any adverse reaction. After documenting injection and visual examine of patient I left the exam room. Less than 1 minute after leaving the exam room the patients sister yelled for help. Myself and another employee ran into patients room to find patient demonstrating seizure like activity on table. Father was at bedside talking to patient. Patient stopped shaking and knew who she was and who father was. Patient stated she felt nausea and numbness in hands. Pulse ox was done O2 was 100 percent, heart rate was 40. I ran to get Physician. Doctor assessed patient. Heart rate dropped to 39 and patient started to shake again. Doctor informed RN to draw up EPI and Oxygen was started on patient, 911 called per Doctor. After starting oxygen on patient her heart rate started to rise and EPI was not given per Doctor. Staff and family talking to patient explaining what we were doing and why. Patient responsive and answering Doctor's questions. Mother was at patients side at this time. Ambulance arrived, patient was transported to Hospital for further evaluation.
The patient did not experience any adverse physical side effects. The patient was administered an expired dose of Moderna. The dose expired at EOD on 1/3/22 and was administered at 12pm on 1/5/22.
Delayed local reaction on day 6-7 of redness, Induration, itching, mild tenderness at site of injection. Redness about 4cmX5cm.  18 weeks pregnant  Due date: 6/23/21
pt recvd vax 28FEB96 approx 1030AM; fever & irritability w/screaming started 29FEB96 @ 5:30; irritability w/intermittent screaming for 4hrs & temp up to 102 @ time of office visit
Soreness developed along with redness at the site. Assessed today, no redness or swelling present. Reported soreness in joint and down to elbow (left arm). Advised see pcp. Appt. today (10/27/2011).
Stomach cramps, cold sweat, when trying to walk to the restroom (I was at church) I drew the attention of others because I was staggering. From my perspective things were going black and I was  trying to get to the restroom before I passed out. Stool leakage before I made it to the toilet. Approximately 30 minutes confined to toilet with constant diarrhea. Too weak to walk to car. Had to be shuttled. Checked blood sugar it was 211. At home diarrhea continued along with waves of nausea. Blood sugar continued to climb even though I was not eating. Diarrhea continued through the night. Blood sugar continued to rise, even though I was only consuming chicken broth and a small amount of rice. Today, August 8, I still feel weak. My stomach aches, my blood sugar is now at 400, not sure if I have a slight fever.
loss of appetite; Fever of 99.4,; body aches; headache with sharp stings in back of head; This is a spontaneous report from a non-contactable consumer. This 15-year-old female consumer reported that: A 15-year-old female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, Lot number ew0165) via an unspecified route of administration in right arm on 24Aug2021 03:30PM (at the age of 15-year-old) for COVID-19 immunisation. The patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, Lot number ew0179) via an unspecified route of administration in right arm on 03Aug2021 (at the age of 60-year-old) for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination and was not tested post vaccination. On 25Aug2021 the patient had fever of 99.4, body aches, headache with sharp stings in back of head and loss of appetite. The patient was treated with pain relief pills. Events resolved on an unspecified date.   No follow up attempts are possible. No further information is expected.
on 1/21/2021, 1/22/2021 chills, fever 103,  fatigue muscle pain Treatment: Tylenol
The patient presented to the ED on 8/4 with 2-3 day history of progressive SOB that had gotten worse in the past 24 hours.  She tested positive for SARS-CoV-2 on 8/4 with an antigen positive test.  On 8/12/21, the patient took a turn with desaturation and difficulty breathing on high flow oxygen at 15L. The family opted to make her comfort care and she expired at 1715 on 8/12/21
Patient inadvertently received the Fluad vaccine for patients over 65 despite being <65 years of age.  Patient reported feeling pain at injection site the following morning (11/11/2023) but it was not any more severe than when he gets other vaccinations. It was not necessary for him to take anything to help with pain.
He was given shots at health department. Three hours later he spiked a 104 fever and started shaking, vomiting and developed a rash on his leg. At the hospital, his heart rate was elevated as well.  He is still running fever and has mild rash today.
In early March, 2023 my neck started hurting, I thought the pain would go away but it persisted throughout the month. It just would not let up. i made an appointment with my physician to find out if it was something I needed to be concerned about. We discussed my symptoms; he performed a physical exam. Currently he has concluded it is a muscular issue, I do have a follow up exam with him id June to see if the pain has resolved.
This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. On 14-JUL-2004, the patient was vaccinated with the first dose of 0.5 milliliter (ml) of M-M-R II (lot number and expiry date unspecified), subcutaneously. On 15-OCT-2013, the patient was vaccinated with an expired dose of 0.5 ml (second dose) of M-M-R II (lot number and expiry date were reported as 1374AA and 26-AUG-2013 respectively), subcutaneously. No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
2 days after vaccination, patient developed peripheral neuropathy type symptoms in bilateral feet with burning, pins/needles in distal aspects of both feet.  Patient was not seen until 7/21/21 at which time she reported the symptoms which had not yet resolved, but she did notice some mild improvement with over the counter multivitamin and alpha lipoic acid supplements.
I received Covid vaccine #2 shot on 2/12/21 ~1:15 pm. I did not have any adverse effects till around 10 pm that night.  I started with very chill feeling which I know is one of the expected SE. No issue with #1 shot. On 2/13/21 ~9:15 am, while I was preparing breakfast, I felt sudden nausea, dizziness and collapsed on the floor. I don't remember how long I lost consciousness. My 9 yo child came in and called me because he heard broken plate sounds. Then, I regain consciousness.
A physician reported that she inadvertently received a subcutaneous injection of FLU SHIELD on 15-OCT-1999. Within 24 hours, she developed an injection site reaction characterized by redness. The patient recovered within 48 hours.
When I received my Moderna booster shot, I was 14 weeks pregnant with my son. My son was born 5/13/2022, and he weighed in at 8 lbs., 5 oz. I was originally planning to give birth at home, but since I tested positive for COVID on 5/12/2022, I had to give birth at the hospital. At the time of my son's birth, I was 39 weeks pregnant. It was an uncomplicated vaginal delivery, and my original due date had been 5/18/2022. My son tested negative for COVID at the hospital on 5/14/2022. However, he tested positive on 5/18/2022 when a rapid test was done at home. He was asymptomatic.
Patient presented to the office with a case of shingles in the area just superior and lateral of the left orbit.
This initial spontaneous case was received on 31-Oct-2017 reported by a pharmacist and concerns a 62-year-old adult male patient. On 30-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 179523, expiry date: unspecified date in Jun 2018). It was reported that FLUAD was administered to a 62-year-old adult patient and had no reactions reported. The outcome of the events was not reported. The reporter assessed the events as non-serious.
This spontaneous report was received from a pharmacist referring to a pharmacy technician of unknown age and gender. Medical history, concurrent conditions Concomitant medications were not reported. On an unknown date, the pharmacy technician suffered an accidental topical to exposure to the powder from a vial of ZOSTAVAX, 1 standard package vial of 1, lot # K018175 and expiration date in January 2016, that may have been leaking. The pharmacist reported also that ZOSTAVAX was stored at room temperature, as it had already been pulled from the freezer some time ago, and was slated for return to the distributor (incorrect product storage). No adverse events were reported. and Product Quality Control (PQC) was filled on 18-NOV-2015. This is one of two reports received from the same source (MARRS # 1511USA009847). Additional information has been requested.
Information has been received from a registered nurse concerning a 13 year old female who on 12-OCT-2007, was vaccinated with a dose of Gardasil (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. This is one of several reports from the same source.
3 shingles shots and still got shingles/suspected vaccination failure; Shingles; Three doses of Shingles vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: 3 shingles shots and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and extra dose administered (Verbatim: Three doses of Shingles vaccine). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received three doses of Shingles vaccine still experienced Shingles. The patient stated that the Shingles vaccine works as good as the Covid vaccine. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received extra dose of Shingrix in error, which led to extra dose administered. Follow-up would not possible as no contact details were available.
13NOV97 c/o h/a, stomachache & fever x 2 days;PMD dx Bell's palsy rt poss secondary to hep B vax;referred to neuro MD;eval 14NOV97;agreed w/dx;f/u visits on 17NOV & 24NOV97 showed improvement;dx remains the same;next appt 2wk;