chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given their booster in 2.5 months instead of 5 months. Patient didn't have any kind of adverse reaction while at the pharmacy.
Inconsolable crying. The follow up received on 6/10/03 states chief complaint: The pt is here to follow up on his recent hospitalization reaction. He had diarrhea all day Saturday. He is eating more but less often. He is sleeping through the night now. He has had a little bit of a cough. No more screaming episodes. No other issues. Objective: Well-developed, well-nourished white male in no apparent distress. Ears are normal. Mouth and throat are without lesions. Neck is without adenopathy. Cardiac exam revealed a regular rate and rhythm. Lungs were clear. Abdomen was soft with good bowel sounds. There was no tenderness noted. No masses palpated. Extremities are normal. Impression & plan: Follow up hospitalization for immunization reaction. At this point we will give him DT when he is due for his immunizations next and follow up from there. The hospital record received on 3/30/04 states immunization reaction. Diarrhea is mentioned in the PMD's post hospital f/u visit note but it occurrred after the reported event and should not be coded for the event.
Shortly after receiving her  Covid vaccination, patient complained of a weird taste, dizziness and feeling faint. I monitored the patient closely, checked  her vital signs and everything was normal. Medical history revealed patient has type 2 DM and HTN. I asked patient if she had taken her meds and eaten breakfast (time was 11:15am at this point). She said she took her meds but hadn't eaten breakfast. I bought her orange juice and a few snacks. In less than 5 minutes after eating/snacking. She mentioned that she was feeling remarkably better. I monitored her for 15 minutes more to make sure she was fully recovered. She was very grateful and felt at ease leaving the pharmacy. I will check on her later.
Reported to be irritable evening vaccine received. After going to sleep he gasped, stiffened and was jerking look "out of it." Jerking lasted only a few seconds. However "out of it" look lasted an hour. Color good. Afebrile. Appetite decreased. No BM in few days eating. No vomit.
lack of effect; COVID-19; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 13Apr2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FF2587, Expiration Date: 31Mar2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "lack of effect"; COVID-19 (medically significant), outcome "unknown". Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot FF2587 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF2587, fill lot FF2556, and the formulated drug product lot FE5315. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of  the reported events cannot be totally excluded.
fever; extreme chills; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sensitive to chemicals" (unspecified if ongoing), notes: He mentioned that he is always on the outside of the reactions and that he is sensitive to chemicals. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, He added that he already received 3 other boosters before this and the last booster received was last Feb2022), for COVID-19 immunization; Covid-19 vaccine (1st booster,He added that he already received 3 other boosters before this and the last booster he received was last Feb2022), for COVID-19 immunization; Covid-19 vaccine (2nd Booster, He added that he already received 3 other boosters before this and the last booster he received was last Feb2022), for COVID-19 immunization; Covid-19 vaccine (3rd Booster, He added that he already received 3 other boosters before this and the last booster he received was last Feb2022), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 14Oct2022, outcome "unknown", described as "extreme chills"; PYREXIA (non-serious) with onset 14Oct2022, outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: HCP called for patient regarding the Pfizer Covid19 vaccine bivalent booster dose. Caller stated that he received the booster dose 8 days ago, 10Oct2022 and 4 days after he developed fever and extreme chills. He added that he already received 3 other boosters before this and the last booster he received was last Feb2022. He mentioned that he was feeling good the first several days after receiving the vaccine, however, for the last 4 days, he was confined in his home with fever and extreme chills. He just recently taken note of his temperature, just this last 2 days. He also mentioned that he was still able to go on hiking last Sunday. He wanted to know if these SEs his been feeling are reported side effects, considering the duration of the SEs.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Mild headache, arm soreness, nausea, and fatigue lasted about 24 hrs. Hives started Saturday afternoon and was present all day Sunday. Disappeared during day on Monday and reappeared at night. Same thing on Tuesday.  Doctor on Tuesday told me to take Zyrtec daily.
Pt had rash red, warm to touch on left bicep that continued to spread for greater than 24hrs. Pt was advised to take TYLENOL and BENADRYL and to seek medical attention if further development.
This solicited report has been received from a consumer (patient's mother) referring to her 15 year old son, who was enrolled in a Market Research. The patient's concurrent conditions, medical history and concomitant medication were unknown. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose and route were not reported). According to the reporter, the patient had had one shot of 3 and she was waiting to hear from the doctor if her son needed to have shot #3. The reporter also said there was a new study out that said 2 shots might be enough. Since it was a painful shot (injection site pain), the reporter didn't want her son to have more than he needed. The outcome of injection site pain was unknown. The causality was not reported. Additional information is not expected as there is no consent for follow up.
inc fever to 105,lethargy, dec appetite, dec fluid intake, awake all noc;c/o inability to walk;muscle twitching but not sx during inc fever;
Started menstruating two weeks early; This is a spontaneous report received from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6206) via an unspecified route in the left arm on 17Mar2021 (at age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included graves disease and allergy to wheat, hazelnut and shrimps. Concomitant medications included montelukast (MANUFACTURER UNKNOWN) and propylthiouracil (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, the patient started menstruating two weeks early and did not really have an explanation. The patient had not received any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for irregular period was recovered on an unknown date.   No follow-up attempts are possible. No further information is expected.
Blood Clotting; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood Clotting) in a 59-year-old female patient who received mRNA-1273 for COVID-19 vaccination. The patient's past medical history included No adverse event. On 26-Feb-2021, the patient received first dose of mRNA-1273 ) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced THROMBOSIS (Blood Clotting) (seriousness criteria medically significant). At the time of the report, THROMBOSIS (Blood Clotting) had resolved. Not Provided.  The action taken with mRNA-1273 (Intramuscular) was unknown. Treatment information was not provided. Concomitant medications were not reported. Company Comment: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
pt recv vax 12NOV92 & 1-2 days post vax pt devel redness one inch in diameter around inj site w/mild itching which lasted a few days; Follow-up: 8/22/00 f/u information to previous Hep B vaccine AE of 11/12/92 reported on 3/9/98 (VAERS ID 108514). Pt. is firefighter EMT who is potentially subject to Hep B exposure on the job. Had received 2 doses of Hep B in past with significant localized reaction to dose #2. Pt. recently had titre which did not show immunity to Hep B. As preservative - free formulation is now available, pt. was tested intradermally for reaction. Dose was 0.1cc in R arm. Within 24-48 hrs he developed swelling, redness, induration, and pruritis at injection site. A granuloma later formed which has nearly abated.
Mom did not see it till now child c/o pain yesterday on left upper arm. No itching no fever. Using arm normally. 25 cm x 30 cm erythema and induration noted left lower upper arm.
Dizziness on days 5-7  Fainted on day 5 after first dose
Began to notice neurological events, foot dragging, stumbling.  Over a period of 4 months:  Pain in lower back then progressed to hips, thighs, knees, toes.  August 10, 2021:  pain in neck, head, progressed to jaw claudification,  Could not eat.  By October had lost to 85 pounds.  Diagnosed with Occipital Neuralgia:  Cortisone injection in Neck.  November 4, 2021:  Diagnosed with Giant Cell Arteritis.
Several hours after injection pain at the site by it's difficulty movement of he arm, next day increasing swelling and redness by 9pm on 11/5 thought she should go to the ER. Given Benadryl and ice packs, by 11/7 felling better and improving.
Pt reports "celiac-like" symptoms that began approximately 15 minutes after receiving flu vaccine. Pt reports "constant diarrhea" beginning 15 minutes after vaccine, continuing through the night and into the following morning (11/18/22). Pt also reports fatigue, nausea, joint pain and "a rumbling feeling" in her stomach onset 15 minutes after vaccine. Pt reports that she is gluten intolerant and has diagnosed Celiac Disease, but verbalizes that she did not eat any gluten products during or after the day of her vaccine.  Pt did not report symptoms to this Clinic until today (11/18/22 at approx 0745) and verbalized that symptoms were ongoing.
On 27SEP91 pt had ped DT/HIB & 3 days later exp static encephalopathy fr hypoxic encephalopathy in newborn period, devel crying episodes, poss myoclonic seizures; seizures were not observed in hosp setting; devel upper resp sx; t100 R;
Patients mother came in reporting low sugars in the 30's twice a day starting the day after the vaccine was administered. Patient was self titrating insulin and drinking sunny D to bring the sugar back up. Spoke to patient a week later and was told the sugars have started to rise back up.
can the first moderna shot cause nausea and diarea two weeks after the shot; can the first moderna shot cause nausea and diarea two weeks after the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (can the first moderna shot cause nausea and diarea two weeks after the shot) and NAUSEA (can the first moderna shot cause nausea and diarea two weeks after the shot) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (can the first moderna shot cause nausea and diarea two weeks after the shot) and NAUSEA (can the first moderna shot cause nausea and diarea two weeks after the shot). At the time of the report, DIARRHOEA (can the first moderna shot cause nausea and diarea two weeks after the shot) and NAUSEA (can the first moderna shot cause nausea and diarea two weeks after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information was reported by the reporter.   Reporter did not allow further contact
- low grade fever - hacking cough - runny nose, eyes - sneeezing Taken to see doctor on 01/20/2011
I have a sharp, pain in my left arm at the injection site, frequently. I am having severe outbreaks of painful lesions in my mouth, so painful that I can't eat, and it is difficult to talk. I am also getting these lesions on other parts of my body. My vision is changing in my right eye, and sometimes it is so blurry that I can't see. I don't know if this is related, but I am also having swelling in both feet- I never had that problem before the vaccine, and I read that it can cause heart problems.
I woke up and my arm started to really itch. My left arm had hives come up and then began to get red and swollen.
Moderna COVID-19 Vaccine EUA Severe dizzyness/spinning when bending over.  would have fallen over headfirst if I hadn't righted myself. It was not like room was spinning but I was going into a black vortex. Scared to death.
This spontaneous report was received from a registered nurse concerning 3 patients of unknown age and gender. The nurse reported that on 31-OCT-2012, the patients were vaccinated with M-M-R II (lot# 1506AA/ Exp. Date: 23-SEP-2013) (dose and route not reported) that was improperly stored that was exposed to 40 F degree for 7 hours. No adverse symptoms were reported. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
No additional adverse event reported; The pharmacy student stated that on 6/2/2020, the patient was inadvertently administered properly stored PROQUAD (S0l 7244, 2/1/2020) along with three other properly stored vaccines: VARIVAX; This spontaneous report was received from a pharmacy student, referring to a 16-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 02-JUN-2020, the patient was inadvertently administered with a properly stored doses of mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number S017244, which has been verified to be valid, expiration date reported and valid as 01-DEC-2020); varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S025612, which has been verified to be valid, expiration date reported and valid as 18-AUG-2021); and concomitantly vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number S036823, which has been verified to be valid, expiration date and reported as 31-MAR-2022) as prophylaxis; and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) (indication, lot number AW5491 and expiration date on an unspecified day in December 2021) (dose, vaccination scheme and anatomical site of vaccination, were not reported for any of the vaccines) as prophylaxis (inappropriate schedule of vaccine administered). A properly stored sterile diluent (MERCK STERILE DILUENT) was used to reconstitute mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX). No additional adverse event were reported.
11/23/21 AT APROX 16:20 BEGAN FEELING LIGHT HEADED AND DIZZY. ALSO C/O PALPITATIONS AND CHEST PAIN. FAINTED AND UNRESPONSIVE FOR SHORT TIME. SENT BY EMS TO hospital. RECEIVED ANTI-ANXIETY, ANTI HYPERTENSIVE AND CLONIDINE.   SENT HOME APROX 22:30PM.
The morning after the shot, I began coughing up bloody discharge (clumps with darker blood) and bright red blood.
About 24 hours after, I started getting a little tired but did not think much of it. By dinner time I felt exhausted and weak. I stayed in bed all day and rested for about 12 hours. After sleeping I was fine.
Pt. had a reaction to COVID-19 1st dose.  Symptoms expressed by patient are blurred vision, chest pain when breathing and dizziness.  Pt. takes blood pressure medication name unknown at this time, meals today for pt. were toast and tea early morning.  VS taken by EMS: 179/95,94, 100%, 97-2T, standing blood pressure 193/93, 92, 100%, no hospital as requested by patient.  Patient asked by EMS to stay further for more observation.  If symptoms continue patient states she will go to nearest urgent care for further follow up.
Itching face/back-5 minutes after.  tightness in throat-10 minutes after.   fullness in ears- 30 minutes after. Taken to ER approximately 25-30 after injection for evaluation. Symptoms not escalating, eventually treated with Benadryl, steroids and Pepcid, held briefly for observation, released with Claritin and steroid prescription to take for the next few days.  I was instructed to premedicate for the 2nd dose. Approximately 5-6 hours after dose developed tightness in chest, tingling face/lips/mouth/fingers. Symptoms persist still, self medicating with Benadryl and klonapin.
Joints ache, severe headache, skin problems, photophobia, short term memory loss, eye syndrome, hearing loss, dermatitis, sensorineural hearing loss of combine types, pterygion, polyarthralgia, Blepharitis, allergic conjunctivitis. I am a 36 year old male; after several tests provided by the Medical Center (2 MRI's, DEXA, Bone Scan and XR's from hospital) the results showed that I have develope osteopenia, T11 & T12 collapsed and L5 S1 severe degeneration. There was also found on this tests that I have rheumatoid arthritis.01/1/2010 there is pain in my spinal cord and joints and the medication given to me doesn't lease the constant pain.
After going to the Dr for a well visit he noticed a lump on my thyroid.  I have never had lumps prior.  I went to get an ultra sound and it was discovered I have 4 lumps of various sizes ranging from .06 cm, .07 cm, .08 cm and 2.8cm.  I am scheduled for a needle biopsy on 9/13/21.  Will not know any outcome until after the biopsy.  The two largest ones are on the right side and the two smaller ones on the left.
Rash noted on trunk, right side rib cage 3 days post vaccine.  Saw Nurse practitioner on morning of   02/23, Diagnosed as Shingles. Rx ordered for Valtrex, Prednisone.  Started med that afternoon.   I had the Shingles Vaccine in September, 2019.
Hives started on shoulders and then spread all over. Started 7/7/09 same evening received shots hives continued to AM, mom notified MD of hives. Recommended to take infant to Doctor. Dr told mom was reaction to shots. Told her to give more BENADRYL. Mom took Infant to Dr Friday 7/10/2009.
Severe pain in vaccinated arm (like hit with a baseball bat) started 12 hours after vaccination and lasted 2 days; Red circular rash an inch or so below vaccination site...noticed a few days after vaccination, still have 6 days after vaccination; Two nights of brief chill s
The injection was given in my left shoulder, higher than I've ever had an injection for the flu shot previously. I also noted after the injection that the individual administering the vaccine was new. I knew this because she has difficulty drawing my blood after my vaccination and needed to ask for assistance. I also confirmed with the office after the vaccination that she was indeed new to the office. My left shoulder was extremely sore the following week, but I have always felt discomfort following my flu vaccination. I began noticing increased pain and limited mobility in the weeks to follow. I made an appointment with the practice who administered my vaccine and advised on my shoulder pain. The Dr referred me to the Orthopedic. At my appointment with Orthopedic, I received an Xray and multiple mobility tests. The Dr diagnosed me with Frozen Shoulder, but ordered an MRI to be sure. I had the MRI and it was confirmed that I have frozen shoulder, I have been advised that it should resolve itself anywhere from months to years. I am an active 38 year old female, now unable to exercise. I am having restless nights due to my shoulder pain and the inability to sleep properly on my shoulder.
This spontaneous report was received from a health care worker refers to 5 unspecified patients. Patients medical history and current condition was not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL (Lot number and expiry date not reported). No adverse effects reported. Product quality complaint was not reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Bleeding like on there periods; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Bleeding like on there periods) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (Bleeding like on there periods). At the time of the report, VAGINAL HAEMORRHAGE (Bleeding like on there periods) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medications were not provided by reporter.