chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took last dose 2 days late; Spontaneous report received on 14FEB2020.  A pharmacist reported that a 51-year-old male consumer "took last dose 2 days late" (PT: Inappropriate schedule of product administration) while being on Vivotif for immunisation. He took the first three doses of Vivotif as per schedule. He was scheduled to take the last dose of Vivotif on 12FEB2020 but he took it on 14FEB2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first three doses of Vivotif as per schedule but he took the last dose two days later than it was scheduled for (Inappropriate schedule of product administration). Vivotif doses should be taken every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first three doses of Vivotif as per schedule but he took the last dose two days later than it was scheduled for (Inappropriate schedule of product administration). Vivotif doses should be taken every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Day 2,3. Mild soreness, headache; day 8, large bump in arm, hot to touch, itchy; day 9 worsening arm symptoms (injection Arm), fatigue, headache, achey; day 10 facial puffiness, left arm very achey/painful at wrist and thumb area, could not open a jar, elbow achey; left eye swelling, headache and neck achey, chills, no fever. Began steroid dose day 12, started steroids, symptoms resolving within 8 hours, day 13, awoke with puffy face, mild pain in same spots but much better.
Positive covid test required hospitalization.   History of B Cell Lymphoma (Cancer) Going thru Treatment Patient  admits to SOB, Confusion / Patient is doing chemo / still in hospital on a regular unit
03/25/2021 at 7 pm i developed body aches, chills and fever which resolved in 12 hrs ams then just had muscle aches for a few days after.  then on day 5 - 03/29/2021 i developed a severe rash on my hands and feet urticaria.  saw pcp and then dermatologist at clinic.  unsure if from the vaccination at day 5 but was the only thing different.  still have some today 04/02/2021 but resolving with big dose antihistamines and cream.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-AUG-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 27-FEB-2015, the patient was treated by a family health care facility (by an unspecified healthcare professional) for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the herpes zoster was unknown. Causality assessment was related. Additional information has been requested.
sore arm; Fever 100.6 degree temperature; Shivers; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (Shivers) and PYREXIA (Fever 100.6 degree temperature) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) 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. On 21-Mar-2021, the patient experienced CHILLS (Shivers). On 01-Apr-2021, the patient experienced PYREXIA (Fever 100.6 degree temperature). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (Shivers) and PYREXIA (Fever 100.6 degree temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were not reported by the reporter.   This case was linked to MOD-2021-066171 (Patient Link).
Feeling sleepy a couple of hours after, tired, nausea, fever , chills, cold sweats, swollen arm, injection site is hard/red and swollen. Swollen lump under my left armpit, feeling of being dehydrated and getting full faster when eating. My arm feels very heavy and the day after the injection my body felt very heavy and body aches!!
Mother states redness and swelling began 24 hours post vaccination. States noticed today the swelling in the left pectoral area. Today 08/26/04 about 6cm circumferential band of erythema around arm, mild, nontender soft tissue swelling into deltoid and left pectoris.
Was taken by ambulance to ER on 10-30-07 with BP of 100/20 and vomiting. He was in the ER for 6 hrs and was given IV therapy. CLIENT STATES HE ATE SOME OLD LUNCH MEAT + STARTED VOMITING SHORTLY AFTER.
Pt states he developed fever and chills in the evening, following flu and pneumovax administration. He additionally developed a croupy cough and dyspnea that lasted a week, with exacerbation of his underlying COPD/emphysema. He reported that symptoms were improving at the time of his visit on Oct 18, 2010. Patient was also unaware that he should report an adverse event and how to do so.
A consumer report has been received concerning a 40 year old, female patient. The patient's medical history and concomitant medications were not reported. Since an unknown date the patient had been received FLUMIST QUADRIVALENT (intranasal). The patient reported that she had FLUMIST every year for the last nine years and she had never any reaction to the vaccine. On 12-oct-2014, her husband and son received FLUMIST QUADRIVALENT. About an hour later FLUMIST she started symptoms of tightness in chest and wheezing. She was treated with albuterol. Episodes of nightly cough and shortness of breath continued for next two weeks. The doctor said she probably had inhaled some of the FLUMIST and it caused an allergic reaction. The doctor prescribed SYMBICORT, which she took daily. The outcome of the event of tightness in chest, wheezing, night cough and shortness of breath was unknown. The report was considered to be non-serious by reporter.
sick in the stomach; lot of nausea; diarrhea,; vomiting; This is a spontaneous report from contactable other health professional from a Pfizer sponsored program A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR), via oral route of administration from 2018 (Batch/Lot number was not reported) and ongoing, at 11 mg, once daily for rheumatoid arthritis. Medical history included rheumatoid arthritis. The patients concomitant medications were not reported. Patient reported that she had to stop Xeljanz 5 days after getting her COVID-19vaccine and will be stopping again for 5 days after her second dose on 02May2021 per md instructions. no adverse event reported related to stopping but had COVID-19 vaccine side-effects : "I was sick like a dog", sick in the stomach, a lot of nausea, diarrhea, vomiting" and drunk a lot of gatorade, she took it on a Sunday and feeling better the following Tuesday. patient restarted Xeljanz after md aware. Outcome of the events were recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
4 hours after immunizations, patient began to cry inconsolably. After a brief break for a feeding and a nap, he began crying again. After being calm for several minutes, he went limp and quiet. His eyes rolled back and he went pale and possibly dusky. He was unresponsive for approximately 45 seconds. He was brought to the emergency room. His work-up was negative and he was admitted for observation over night. Medical Records received on 1/27/2005 states impression in ER was ALTE (Acute Life-Threatening Event). Discharge Summary received on 2/18/2005 states secondary diagnosis of mild anemia.
sz activity for 2 1/2-3mins; seen @ ER w/workup neg; EEG done 1wk later;
Wednesday 9/2/15 - redness at injection site. Thursday 9/3/15 - Large (2) hives on right hip. Red line down spine, and larger area of redness and warmth around injection site. Injection site stung and itched. Was sick to stomach, little lightheaded, which continued through Friday. On Friday 9/4/15 still had all the above symptoms, but it would burn and hurt to urinate and was very tender in that area. Saturday 9/5 and Sunday 9/6/15 - still had all above symptoms, but also had heartburn, it hurt to take a deep breath and had lots of chest tightness. I was so bad on Sunday evening with tightness in my chest that I was contemplating going to emergency. 9/8/15 - One week later, still have hives on hip, somewhat painful urinating, chest tightness doesn't seem to be like it was on Sunday, and injection site still a little red and stinging off and on.
none Nurse Mgr/APRN at the Health Dept. discovered that the above mentioned Pfizer vaccine was not properly removed from the regular freezer (-25C to -15C) on 10/13/2021. The Pfizer vaccine was moved from the ultra cold freezer to regular freezer on 09/28/21 and should have been removed from the regular freezer the end of the day on 10/13/21 and placed in the refrigerator for 31 days. The vaccine was not removed on this day from the freezer. The vaccine is still in the freezer today 10/25/21. It was investigated and found that the vaccine was use in clinic Monday 10/18 through 10/23. NP called Pfizer Med and spoke with an attendant, walked her through the scanario and she made NP aware that vaccine could not be used past day 17 after being in the regular freezer, voice that vaccine stability could not be determined and that vaccine should not have been used the 3 day grace or day 17 and should have been moved to the refrigerator on day 14 after removed from regular freezer. Patient was notified of the incident.
erythema and pruritic at injection site spread to elbow Recommend antihistamine cream and oral antihistamine for c/o itching; cool compresses for erythema; caller verbalized understanding and will relay info to her cousin, the patient
3RD DOSE MODERNA COVID VACCINE GIVEN 12/28/2021, #069H21A; pt resides in SNF; she had a positive COVID test on 8/22/22 in facility; 9/16/22 brought to hospital with AMS; found to have thrombocytopenia, hypotension (given IV fluids and vasopressors), and bilateral pneumonia; required intubation; acute renal failure, required CRRT; suffered Ventricular Fibrillation, pulse was lost; pt was DNR and she passed away in the hospital
far as the second shot goes, it seemed to her that maybe it would be a good idea to reschedule a little farther out, wait one moths or two months; chest feels somewhat compressed and breathing is not normal; chest feels somewhat compressed and breathing is not normal; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated she had her first Pfizer Covid vaccine on 16Apr2021 and scheduled a second shot for 03May2021. She stated she had no problem with the first shot, and she was planning on getting the second one, over the course of the days in between, nothing serious that would make her to go running to a doctor, stated her chest felt somewhat compressed and her breathing was not precisely normal. She further stated the thing is it was not enough to be concerning to do anything about but as far as the second shot goes, it seemed to her that maybe it would be a good idea to reschedule a little farther out, wait one month or two months to isolate what she was feeling. She was asking if it was okay to postpone her second dose. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Patient signed up for a pfizer booster appointment at the pharmacy. He did not have his vaccine card with him but verified with the immunizer that he indeed has pfizer for his first and second vaccine. Later that night he came back to the pharmacy with his vaccine card and it was then that we found he received moderna for the the first and second dose and pfizer as his booster dose.
Warming of the injection site initially  Progressing to a larger area of the arm Just warm to hot
I will have to locate the lot number.  Within 4 hours after injection, she developed respiratory illness and cough that has lasted  2 weeks now.
pt recv vax 8JUL97 & 23SEP97 pt exp mild rash which consisted of 13 lesions described as 5mm papules & macules;lesions located mainly on chest & back of trunk, but there were also some lesions on lt arm;rash described as typical varicella l
SWOLLEN REDNESS IN ARM LOCATED BELOW AREA IN WHICH INJECTION WAS ADMINISTERED.
fever 100.9, headache, extreme fatigue, body ache, sore in mouth, headache is throbbing
I had extreme swelling of my arm, redness, swelling and a rash. I used over the counter antihistamines and creams to alleviate symptoms.
Initial unsolicited report received from a nurse via other pharmaceutical company (Pfizer) on 13 October 2015. This case involves a female (age not reported) patient who was vaccinated with a dose of FLUZONE (batch number, expiration date, dose, dose number, route and site of administration were not reported) and a dose of Flu shot on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date following the vaccination (with Flu shot), the patient developed some adverse reaction to thimerosal with the preservative that she had got with the flu shot in the past and on an unspecified date following the vaccination with FLUZONE, the patient developed swelling in arm. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none. Follow up information received from a nurse on 20 November 2015. On an unspecified date, following the vaccination patient experienced erythematous reaction and reaction with the Flu shot preservative. Outcome of event was not reported. Follow up information received from nurse on 17 February 2016. It was reported that patient had adverse event with previous Influenza vaccination.
Sore arm. Around 5 and 6 pm, I was feeling and chilled and then hot - my temp was going up until it got to about 102. I felt horrible. I started takin Tylenol and piggy backing it with ibuprofen 4 or 5 hours later. That took the fever down. I had shaking, chills, sore arm and my whole body hurt - felt like I had been working out - hips, legs, etc. I experienced these symptoms until the next day - still was running around 100 degree fever - so I was improved but still sore, fever, etc. The next day, on Friday, I was okay - 36 hours about. Shingles symptoms were still be experienced as well. The right side hurt with the reaction and left side hurt with Shingles. I returned to work on February 24th but I am still having - around the clavicle and where the blisters were that skin is still sensitive and sore. I have to scoop neck clothing. I can function with work duties.
Received Pfizer vaccine on 1/13/21, 2/4/21 and 11/17/21. Presented to ER on 1/31/22. presented with fall at nursing home, found to have rapid heart rate 140's.  Found to be COVID positive on 1/18/22. She was going to be discharged back to the nursing home.  However, she  went into atrial flutter with rapid ventricular response.  Heart rate was in  the 140s.  She did receive Cardizem.  There was no improvement.  She will be  initiated amiodarone at this time.  Admitted to the ICU due to COVID positive. COVID positive on screening test. H/O COVID positive on 1/18/22.  Maintaining saturation on room air. Off isolation. Discharged to on 2/1/22
This spontaneous report was received from a physician, via company representative, referring to a female child of unknown age. Information regarding the patient's medical history, concurrent conditions or concomitant medications was unknown. On an unknown date, the patient was vaccinated with GARDASIL 9, intramuscularly as prevention of human papillomavirus (HPV) (dose, anatomical location, lot number and expiration date were not reported). On an unknown date, after receiving GARDASIL 9 the patient experienced seizures. Furthermore, the patient visited the neurologist and received treatment to the aforementioned event. It was unknown if any laboratory diagnostic was performed. At the time of the report, the outcome of seizure was unknown. The reporter did not provide causality assessment between the event and vaccination with GARDASIL 9.  Upon internal review the event seizures was determined to be medically significant.
rt thigh swollen @ site 2"x3" underlying muscle swollen; no rashes; vax mark on lt thigh-no inflamed;
Initial reaction to the second dose was as expected - within first 24 hours, minor fever of 100 and fatigue. That resolved within 48 hours.  I felt completely fine until 8 days after the second dose (4/9/2021) woke up extremely dizzy upon getting out of bed. Dizziness and mild nausea continued for 24 hours. Dizziness was positional, became dizzy upon standing up, leaning head back, leaning head over and back up. The following day, 4/10/2021, dizziness was gone but I experienced extreme fatigue, slept 9 hours at night, had two 1+ hour naps, and then slept another 9 hours that night. Day 10 woke up feeling 100% fine today and have been fine all day, 4/11/2021.
Migraine (6 hours), fever (6 hours), arm pain (injection site arm, ongoing), exhaustion (ongoing), joint and muscle aches (ongoing).
caller received second pfizer vaccine yesterday. today has headache, tired, low grade fever, chest pain above nipple on one side. has not received medical attention for chest pain.
Red scattered, no raised rash to legs/abdomen/neck.  About 12-18 hours after immunizations.  No respiratory involvement.  Benadryl 4mg every 6 hours.
Patient developed varicella and has since recovered. Thought to be due to being on Humira (adalimumab) at home.
Information has been received from a physician concerning her 18 year old daughter who was vaccinated on unspecified dates intramuscularly with 0.5 mL of Gardasil (lot numbers not reported).  It was reported that the patient experienced severe pain at the injection site during administration of all three doses of Gardasil.  The physician reported that "the pain resolved without requiring treatment and the patient completely recovered."  No further information is available.
Patient called pharmacy on 9/11/21 (2 days after injection) complaining of redness, swelling and pain from injection arm. Patient did not complain of any purulent or clear liquid coming from injection site.  Patient did not seek out treatment from over-the-counter or health professionals.  Patient was advised to go to emergency or physician if does not get better with help of over-the-counter medication in the next day or two.
Presented w/ fever/cough X 5days. Covid + pneumonia/sepsis. Tx / dexamethasone, remdesivir, O2.
Information has been received from a 24 year old female patient who was vaccinated with a complete series of GARDASIL (lot # not reported). The first dose was received in April 2007, the second dose in July 2007 and the third dose in October 2007. Concomitant therapy included birth control pills (unspecified). In approximately September ("Fall of 2007"), the patient started to notice that she had been losing hair more than normal and it had gotten worse recently. At the time of the report the patient's adverse experience had not improved and the patient had not recovered. Blood work was conducted by an endocrinologist. Additional information has been requested.
Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows The age at vaccination was not reported. After receiving Shingrix, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding time to onset and laboratory confirmation of shingles were not provided. On 9th October 2021, the patient got shingles again, refer case US2021AMR210317. The patient asked if there was something wrong with vaccines.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR210317:Same reporter.