chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am breastfeeding mom; I am breastfeeding mom; sore arm; This is a spontaneous report from a contactable other HCP (Patient). This other HCP reported for two patients (mother and baby). This report is for mother. A 39-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE; Solution for injection) via an unspecified route of administration, administered in left arm on 10Mar2021 14:15 (Batch/Lot Number: EN6199) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and patient's concomitant medications were not reported. No known allergies reported. The patient stated that I am breastfeeding mom, I (myself) didn't have any other reaction other than a sore arm on 10Mar2021 17:30. There were no other vaccine in four weeks and there were no other medications in two weeks. Patient did not have COVID prior vaccination and also patient was not COVID tested post vaccination. Treatment was not received for any AE. The outcome of event was recovered.   No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : PFIZER INC-2021287948 Mother/Baby case
Patient noted generalized aches 12/16/2003 around 2 PM.  Temperature was 104.  She took Tylenol at 4 PM and midnight and again the morning of 12/17. Complaints of fever, dry cough, runny nose and dry throat. No headache, no respiratory distress.
1st dose 12/21/20 with no reported side effects.  3:00pm c/o blurred vision BP 180/110 neck and chest tightness headache  5:30pm BP 172/109 tachycardia and SOB nausea  BP still 185/107 so went to prompt care who sent via ambulance to ER.  Given nitro, fluids and morphine.  Sent home. Next morning BP 188/118 and 213/122.  C/o body aches temp 99 and loss of smell and taste. Saw primary care provider 1/14/21. Added Lisinopril and increased current betablocker and said was vaccine reaction. BP there 209/122 pulse 126.  PCP did not test for COVID. Reports she did Binax test herself after visit and was negative
Moderna COVID-19 Vaccine EUA  given approximately 7:50 am on 1/25/2021 I left deltoid. By 4 pm, arm sore, noticeable  fatigue and headache. Approximately 7 pm, chills started and headache much worse.  Temperature was 100.7. Took a Tylenol.  Around 8:30 pm became extremely nauseous and began vomiting. Vomited several times, and became dizzy and near syncopal and confused. Eyesight blurred. Husband called 911. Taken to Hospital and was in hospital until 1/27/21.
Fist sized swollen gland near collar bone on right side.; This is a spontaneous report from a contactable healthcare professional, pharmacist. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an intramuscular route of administration in the right arm on 08Apr2021 at 12:00, (at the age of 63-years old) as a single dose for COVID-19 immunisation. The patient's medical history included diabetes and high cholesterol. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. It was unknown whether the patient had received any other vaccines within 4 weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an intramuscular route of administration in right arm on 18Mar2021 at 12:00, (at the age of 63-years old) as a single dose for COVID-19 immunisation. On 11Apr2021 at 12:00, few days after receiving the second dose, the patient had experienced fist sized swollen gland near collar bone on right side, which was resolved after about 4 days. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. No therapeutic measures were taken as a result of adverse events. The events did not result in doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event, fist sized swollen gland near collar bone on right side was recovered on 15Apr2021.  No follow-up attempts are needed. No further information is expected.
Moderate to severe thigh muscle soreness, with joint pain in legs and arms. I thought there may have been blood clots. I also believed I had water retention in my legs since my weight unexpectedly jumped about 6 pounds in 2 days. I was given a diuretic to help at the emergency room before leaving. Apparently, the likelihood of clots was minimal.
THE PATIENT WAS 17 YEARS OLD AT THE TIME OF ADMINISTRATION AND PHARMACY STAFF DID NOT REALIZE THAT SHE WAS NOT 18 YEARS OF AGE UNTIL AFTER THE VACCINE WAS ALREADY GIVEN.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On unknown dates, those patients were vaccinated orally with improperly stored doses of ROTATEQ injection (lot # L047185 with expiry date: 17-SEP-2017 and lot # L013204 with expiry date: 28-JAN-2017; strength, dose and site of administration were unspecified). The administered vaccines underwent the temperature excursion at 25 degree Fahrenheit for 11 hours and at 50 degree Fahrenheit for 3 hours 26 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Shingles/  flared up shingles; eye surgery; This non-serious case was reported by a consumer via patient support programs and described the occurrence of eye operation in a 62-year-old female patient who received mepolizumab (Nucala) for drug use for unknown indication.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient started Nucala and the 2nd dose of Shingles vaccine. On 22-MAR-2023, an unknown time after starting Nucala and an unknown time after receiving Shingles vaccine, the patient experienced eye operation (Verbatim: eye surgery). On an unknown date, the patient experienced shingles (Verbatim: Shingles/  flared up shingles). The action taken with Nucala was unknown. The outcome of the eye operation was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the eye operation and shingles to be related to Nucala and Shingles vaccine.     It was unknown if the company considered the eye operation and shingles to be related to Nucala and Shingles vaccine.   GSK Receipt Date: 05 Apr 2023. This report was submitted via the online direct entry reporting system. This report was submitted by site: GSK Program. Patient reported she took Nucala medication 3 weeks prior to eye surgery performed on 22 Mar 2023. Patient also reported she had 2 shingle shots recently, and the second shingle shot flared up her shingles and made them worse. Patient gave consent to contact her from safety department should any additional questions arise.
Pt recvd vax & devel nausea, chills & a swollen arm & required hospitalization;
Narrative:  Pt was vaccinated in a timely manner in Feb/Mar 2021 but was hospitalized due to positive COVID test 8/20/21--admitted due to weakness, experienced hypoxia, improved and was later discharged.
On  2/26/ 2021,, when I awoke,  Left arm in the area of the injection site  was reddened, sore an warm to touch.  This continued throughout the day.
Make me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient stated that Just received his/her second shot, hope it did not make sick like the first shot, but better than getting shingles as his/her doctor says. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ (lot # and expiration date were unknown) orally for prophylaxis. The sterile diluent was properly stored. No adverse effects were reported. The stored temperature included 47 F to 77F for 42 hours, 24 F to 35 F for 35 days and below 24 F (lowest -34 F) for 12 days. There was no previous temperature excursion. Data logger was involved.
PT C/O NUMBNESS, TINGLING TO FACE AND LOWER EXTREMITIES AND "FEELING HAZY" 15 MIN AFTER VACCINATION,  PT WAS MONITORED, VITALS STABLE, GIVEN BENADRYL ELIXIR PO PER REQUEST, VITALS RECHECKED AND STABLE, RESP EVEN AND UNLABORED, NO ACUTE DISTRESS, PT DEPARTED FACILITY 1 HOUR AFTER VACCINATION WITH RETURN TO BASELINE AND NO COMPLAINTS.
Pt came home from school very tired and sleepy.  Laid down to rest.  Woke up later with fever 102.4, headache, and hurting all over.  Symptoms are continuing, it has now been 42 hours since reactions began.  Fever is not going any higher, goes down with fever meds.  Pt is not eating well, but can drink liquids.
Vomiting, nausea, fever, muscle weakness, pain at injection site, back pain
Dizziness, lightheadedness. Patient complained of difficulty swallowing but is able to drink water and eat food now. Patient took benadryl 50mg
Adverse reactions with the second vaccine shot; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Adverse reactions with the second vaccine shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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 an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reactions with the second vaccine shot). At the time of the report, VACCINATION COMPLICATION (Adverse reactions with the second vaccine shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter
Patient developed a 102.8 fever the morning after receiving vaccines. No other signs or symptoms. Treated with Tylenol.
9-month old male received an expired dose of Ipol with no reported adverse event; Initial information received on 20-Apr-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves a nine month old male patient who was vaccinated with an expired dose of IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On an unknown date, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot R1B252M and expiry date: 13-Mar-2021) (Frequency: once) via an intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  Reporter relationship: (HCP) health care professional Product used: used still using product: no  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Ache muscles and joints, Sore arm where I received the shot and felt tired. Took Ibuprofen on 4/18 and started to feel better shortly after. I took 3 does and feel much better this morning (4/19) I have not taken and additional Ibuprofen today.
On November 20, 2021, 3 months after receiving the 2nd dose, I was diagnosed with Shingles
Patient reports fever up to 102 degrees F since receiving vaccination. Patient advised to consult their PCP for follow up.
Significant pain in entire upper extremity with progression to weakness, numbness, and tingling over the next few days.  Two weeks out, pain improved but with worsening of weakness, tingling and numbness.
Received vaccine 1/7/10. Next day experienced extreme fatigue, muscle weakness, falls, chills, poor appetite. Seen in physician office on 1/11/10. Weakness improving, still felt "off-balance", appetite improving.
Covid positive; Covid positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable consumer reported for patient (husband). This reporter reported similar events for 2 patients (reporter and reporter's husband). This is 2nd of 2 reports reported for reporter's husband. A male patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter and her husband both had vaccine on Friday and they discovered that they both are Covid positive on Monday. Reporter does not have symptoms but her husband (patient) does, the question is wants to know whether they should still get the second shot? Events outcome was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021049653 Same reporter, same drug/event, different patient
Painful injection. Localized pain around injection site and general arm soreness. Soreness did not extend beyond arm. Headache morning after.  Neck soreness morning after. Heavy fatigue and sluggishness.
RECEIVED MODERNA 1ST DOSE VACCINE. LATER IN THE DAY STARTED WITH ITCHING  OF UPPER CHEST.  PROGRESSED INTO THE EVENING.  TOOK 25MG BENADRYL WHICH DID NOT HELP.  FELT ANXIOUS ALL NIGHT, FULL BODY ITCHING,   SHIN WAS RED AS WELL. HCF EVALUATED EMPLOYEE,  SENT TO ER. IN ER 3/31/2021 08:56 VITALS HYPERTENSION BP 191/115, TACHYCARDIC PULSE 111, TEMP 100.2F, NEUTROPHILIA. GIVEN 1 LITER OF NORMAL SALINE, 25MG IV BENADRYL, 125MG IV SOLU-MEDROL, 20MG IV FAMOTIDINE, 20MEQ ORAL POTASSIUM CHLORIDE, 650MG ACETAMINOPHEN, 25MG IV BENADRYL (2ND DOSE).  DISCHARGED FROM ER WITH HYDROXYZINE 25MG ORAL TAB EVERY 6 HOURS;PREDNISONE 20MG ORA TAB TWO TABLETS (40MG) DAILY, TRIAMCINOLONE CREAM 0.1% TWICE DAILY
Back pain, nausea, dizziness x 2-3 days. Followed by itchy, erythematous, maculopapular rash, confluent in areas, started on his chest spreading down abdomen to genitals up the neck, to the chin and started to erupt on the arms.
"Both arms itch from injection site to hands." He feels if his motor skills feel abnormal like he's "Drunk." Symptoms started 8 days after vaccination.
On February 25, 2023, I began to feel a low grade fever in the afternoon. On the February 26, I had fever most of the day. On February 27, I called my doctor and he did a video with me. About 02:20PM, I went to his lab for a COVID-19 test. I had a runny nose, a dry cough, night sweats for four nights.
The day after the shot a 2 -3 inch red spot appeared on her arm.  it was raised and painful.  by day 2 the spot was 3.5 inches, red raised and painful.  after day three the redness started to fade, but there was still pain at the injection site.  by day 6 there was a slightly darker area around the injection site, almost like a bruise.  The area was no longer raised, but was still tender to the touch.  as of today, two weeks out, there is still pain at the injection site as well as a small bump.  The pediatricians office has stated this is a normal reaction and advised us to massage the injection site to alleviate the bump and ice the area as necessary.
Pt received high dose FLUZONE shot on 11-22. Pt came to pharmacy on 11-24 stating the day after the shot she developed redness and bruising around injection site. Also it ached like sore muscle.
Narrative:  PATIENT REPORTS RECEIVING HER FIRST COVID INJECTION ON 03/18/21, ON THAT SAME DAY SHE REPORTS HAVING A BLISTERY RASH AROUND HER WRIST AND THAT HER VEINS TURNED BLACK & bulging ON THE LEFT ARM. Also hives and itching at the area of injection site. SHE DID NOT SEEK MEDICAL ATTENTION AND SAYS THE RASH DISSIPATED 1.5 HOURS LATER AND HAS NEVER RETURNED. NO OTHER EFFECTS REPORTED. WHEN SHE WENT TO GET HER SECOND INJECTION (on 4/15/21) AT THE HOSPITAL. SHE SHOWED PICTURES TO THE STAFF AND THEY DECLINED TO GIVE HER THE SHOT AND ADVISED HER TO SEEK ADVICE FROM PCP FIRST. Vaccination clinic instructed pt to have PCP provide a note approving administration of covid dose #2.
My daughter was talking until she recieved her 12 months shot then she stopped. She also had a great big bruise where the shot was giving, it was there for months. There is still a little discoloriation where that spot was.  2/17/09 Received PCP vaccine records & medical records of 4/16/08-1/23/2009 FINAL DX: autistic disorder; eczema; developmental speech disorder Records reveal patient in good health on 4/16/08.  RTC 9/22/08 to discuss speech loss & hearing concerns x approx 4-6 mo.  Referred for speech/hearing eval. & if found wnl to refer for autism eval.  Seen in ER & PCP office 9/26 for viral gastroenteritis.  RTC 10/20 & referred to developmental clinic for likely autism. RTC 12/22/08 for AOM, URI.  RTC 1/23/09 for new onset eczema x 1 mo.  4/28/09 Received Behavioral Clinic medical records of 11/13/08-2/14/2009. FINAL DX: autism spectrum disorder; mixed expressive-receptive language disorder; developmental delays.
The person who administered my shot gave it to me in my elbow and affected my nerve and caused nerve damage. It felt like a tooth ache. My doctor stated I would have to wait for it to heal and it may never heal but the pain lasted for 2 weeks.
Myalgia, Arthralgia, Fever, SkinRash, Rash, UrticariaPruritus, tenderness to L fore arm and upper L arm at injection site, Narrative:
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756524A, A0756526A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Child received adult HAV instead of childs, no adverse reaction noted. No swelling at injection site.
eyes swollen on 9MAY98 in AM-went to clinic & given DPH & told not to finish hep b series;later lips became swollen;swelling dec 19MAY98;again took DPH 11MAY98 swelling dec but still present;
The pt experienced a 2 1/2 - 3 inch red area that was raised, tender and warm to touch. Treated with cool compresses and Tylenol. Antibiotic started.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-395985 (Patient Link).
8PM 10-1 sinus congestion, body aches. 10-2 body aches all day. 10-2 4 PM Low grade fever. 10-3 am feel fine all symptoms gone.
The evening of immunization mother reports that his arm was "throbbing". The next day he had a fever 102 degrees, dizzy, weak, headache and injection site size of baseball to size of softball. Mother took him to MD 7/14/2004 who gave him Zyrtec and an antibiotic.
Extreme pain in left shoulder. Left first or pointer finger...achy felt sprained. Throbbing pain in left forearm before elbow. Pain in left armpit/breast/lymph nodes. Pain in lower left leg, through knee and thigh.
ON 1-7-2022 AT FACILITY, PATIENT REPORTED SHE HAD NEVER RECEIVED A COVID VACCINE - THIS WAS CONFIRMED THREE TIMES. I EXPLAINED TO HER THAT SHE WOULD BE RECEIVING HER FIRST OF TWO DOSES OF MODERNA. I EXPLAINED COMMON SIDE EFFECTS/DURATION AND PATIENT EXPRESSED UNDERSTANDING. I ALSO EXPLAINED THAT SHE WOULD NEED A SECOND DOSE IN 28 DAYS OR 4 WEEKS. UPON ENTERING VACCINE ADMINISTRATION IN DATABASE, I DISCOVERED SHE HAS RECEIVED 1 DOSE OF PFIZER ON 7-22-2021.
Immediately after injection, VR developed metallic taste in mouth as well as lightheadedness. HR was within normal limits. BP was 150/90. VR stated that lightheadedness persisted even after 1/2 hour of observation. He elected to go home at that time and refused EMS services and hospital evaluation.
Profuse sweating (20 mins after injection), headache ( like migraine), muscle soreness in left arm, balance off, soreness at injection site
Tdap given 7/19/07 s/s of leg pain, neck swelling and chest heaviness experienced by 7/20/07. Reported s/s to EHS on 7/24/07. Seen by PA-C on 7/25/07, blood work drawn r/o infection or Lyme disease or tick bite. Rx for Allegra. All blood work received back on 8/8/07 - neg.