chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives; This is a spontaneous report from a contactable pharmacist. A 42-year-old female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 20Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hives on an unspecified date. Reporter had a female patient who received the 1st dose of the Pfizer Biontech Covid vaccine last 20Jul2021. Patient broke out in hives, took Benadryl then felt fine. Patient asked if she can get the 2nd dose today. Outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Patient administrated VARIVAX as an intramuscular dose, rather than subcutaneous dose; This spontaneous report has been received from a pharmacy intern referring to a 21 years old male patient. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were unknown.  On 22-SEP-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot# S019462 has been verified to be a valid lot number, expiration date: 24-JUN-2021, strength was unknown) 1 dose intramuscularly, rather than subcutaneously for prophylaxis (incorrect route of product administration). The pharmacy intern would like to know if she needed to administer another dose.
Shingles; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 04Feb2021 11:15 (Lot Number: EN6202) (at the age of 84-years-old) as 1st dose, single, and dose 2 via an unspecified route of administration, administered in Arm Right on 25Feb2021 11:15 (Lot Number: EN5318) (at the age of 84-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included ongoing high blood pressure from 2011 (diagnosed around 10 years ago), and also had flu-like symptoms from an unknown date that occurred years ago, at least 20 years. Patient previously took flu shot on an unknown date at unspecified age (unknown manufacturer, NDC number, lot number, or expiry date) for immunization. Concomitant medication included lisinopril taken for high blood pressure from an unspecified date in 2011 (for probably 10 years) and ongoing. Patient reported that a couple of days (about 3-4 days) after receiving the first dose of the Covid-19 vaccine, she got shingles. Patient reported that by the time she went for the second vaccine, date later provided as 25Feb2021, the shingles were pretty well cleared up. Patient reported that she went to see her physician before getting the second dose of the Covid-19 vaccine. Patient reported that her physician stated that the shingles looked good, that they were almost cleared up, and the patient was ok to have the second dose of the Covid-19 vaccine. Patient reported that following the second dose of the Covid-19 vaccine on 25Feb2021, she had another reaction from the Covid-19 vaccine and experienced a recurrence of the shingles. Patient reported that she saw a doctor at the vaccination facility and told the physician that she had the shingles. She called her physician and her physician called in a prescription for her. Patient reported that at time of call on 13Apr2021, she was still suffering with the shingles. Patient reported that the shingles have gotten a little better. Patient reported that she wanted to let Pfizer know about the shingles, stating that she didn't know if anyone else has gotten shingles from the Covid-19 vaccine. Event required visit to physician's office. Event did not require visit to emergency room. The outcome of event was recovering.  No follow-up attempts are needed. No further information is expected.
Information has been received from a licensed practical nurse concerning a patient who on 13-OCT-2010 was vaccinated with a dose of MMR II (dose, route and lot# not reported). On 28-OCT-2010 the patient developed hives and rash 15 day after receiving vaccine injection. The patient called physician for medical attention. At the time of the report, the patient's outcome was not provided. No further information is available.
Terrible heartburn lasting for over 2 hours - woke me out of a sound sleep and kept me up for 2 hours.  I have never had heartburn in my life before!  This heartburn has persisted through the next day - current time is noon on 12/21/2011 and I still have it.  THis is so bad, I may never again get the flu shot!
Information has been received from Pfizer, Inc. (manufacturer control # 2016488291) on 08-NOV-2016, which was originally received from a pharmacist referring to a 73 year old male patient. Information about concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with first dose of PNEUMOVAX 23 (strength, dose, lot #, expiration date and route were not provided). One year later, the patient was inadvertently vaccinated with the second dose of PNEUMOVAX 23 instead of PREVNAR 13. Additional information has been requested.
Lat 4 1/2" X 4" circular swelling red, no Cellulitis, past 2 days vaccine's. applied ice pack which minimized swelling.
Pt was due for Meningococcal-MCV4. I made the mistake and gave pt VAXNEUVANCE instead. I notified vaccine supervisor, clinic manager and Clinic Dr. I am trying to contact mom and let her know of the mistake and to bring pt back to administer the correct vaccine.
This spontaneous report has been received from a 64 years old female consumer with allergy to shellfish and allergy to sulfa medications. This patient was vaccinated with ZOSTAVAX (dose and route were not reported) on 27-NOV-2012. No other co-suspects were reported. Concomitant medications included: PREDNISON. On 01-DEC-2012 the patient experienced redness and itching at the injection site, mild discomfort and slight headache. After of left forearm upper arm itchy red bumps, accompanied by "heat". The patient was treated for the events. The outcome of mild discomfort, left forearm upper arm itchy red bumps, slight headache, itching at injection site, redness at injection and heat is unknown. The relatedness for redness at injection site, heat, left forearm upper arm itchy red bumps, slight headache, mild discomfort and itching at injection site was not reported for ZOSTAVAX. Additional information is not expected.
24 hrs after H1N1 & seasonal flu vaccine administered - felt feverish, sore, achy, then 72 hours later had N/V, diarrhea.
Narrative:  94yo male patient died during inpatient hospice admission. Death was caused by: Acute myeloid leukemia. Pt had received covid vaccines on 1/13/21, 2/10/21, & 12/22/20. This death was not caused by covid vaccines.
6 hours after flu vaccine had severe headache, joint pain, nausea. Lasted app 6-8 hours.
Patient was given vaccine.  I asked if she felt ok?  She stated that she was fine.  Mom was in room with us.  She was standing there as I had turned my back to get paper work to give mom.  Heard a thump as she fell and bumped head on right side forehead.  She came back too.  Vitals were taken, B/P was 100/76, pulse was 80.  She was taken by a wheel chair to lie down.
He started with cyclical vomiting in January.  He has very painful flair ups of stomach pain, vomiting and diarrhea each month lasting for several hours.  I am reporting this as he did not have this condition prior to taking the vaccine.  It happens monthly.   He is scheduled to see a gastroenterologist this summer to find out more information.
Information has been received from a physician concerning a 19 year old female who was vaccinated with unknown how many doses of GARDASIL. On unknown date the patient had positive PAP tests for carcinoma in situ. It was believed that the patient was HPV positive prior to GARDASIL as the patient was sexually active. The patient was in office on 26-MAR-2009. Upon internal review, had positive PAP tests for carcinoma in situ was determined to be an other important medical event. Additional information has been requested.  Follow-up from Merck: On 14-APR-2009, in addition to supplying the above information, a nurse reported that this female pt. was seen initially in their office on 14-APR-2008 because of an abnormal PAP with atypical cells. Another PAP was performed on 14-APR-2008 which detected HPV type 18 and 16 by a molecular diagnostic study.  The physician then performed a specific type test and type 16 was detected.  The final diagnosis was that high grade epithelial lesion (HSIL) could not be excluded.  A colposcopy was performed on 30-APR-2008 along with biopsies at 10, 12, 3, and 6 o'clock with ECC.  The 10 and 12 o'clock positions showed low grade mild dysplasia.  The 3 o'clock position showed high grade mild dysplasia, while the 6 o'clock position showed high grade, carcinoma in situ with ECC High Grade.  A cold knife cone biopsy performed on 16-JUN-2008 showed cervical carcinoma in situ, but no invasive tumor was identified.  Reported that a repeat PAP was performed on 22-OCT-2008 which was negative and benign for changes.  The patient was scheduled for another PAP on 14-APR-2009.    According to the office, the April 14, 2009 pap was negative also.
Mom returned to office - stated "my son passed out" - Found seat belted into passenger seat - eye opened responded by name. Asked what happened "I didn't feel good" mom stated "head fell forward" call by name then opened eyes "drove back to doctor "to get you" I feel lightheaded" - lye seat back - reclined position - color pink, freckles prominent. BP 86/52 Pulse 68 - by 1102. " I feel fine" - cool cloth behind neck - water offered food bar - encouraged to take it easy for a while - eat, drink.
Patient presented to the ED with COPD exacerbation on 4/21/2021. Patient presented to the ED and was subsequently hospitalized on 5/8/2021. These visits are within 6 weeks of receiving COVID vaccination.
This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L048848, expiry date 09-AUG-2018, dose, dose number, vaccination site, route unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19 and still is testing positive..         No concomitant medication were reported.  It was reported that, two weeks ago patient started taking Paxlovid and had a reaction to that one. He doesn't think its from Moderna. and the issue happened with Paxlovid on 21 May 2022.   He tested positive for COVID-19 and still is testing positive.  No treatment medication were reported.  Company Comment: This spontaneous case reported by a patient concerns a male patient of unknown age, with no reported medical history, who experienced the unexpected, non-serious AESI Covid-19, around 1 year and 2 months after receiving a second dose of mRNA-1273.  He was started on Nirmatrelvir/Ritonavir (Paxlovid).  He tested positive for Covid-19 and is still testing positive.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case reported by a patient concerns a male patient of unknown age, with no reported medical history, who experienced the unexpected, non-serious AESI Covid-19, around 1 year and 2 months after receiving a second dose of mRNA-1273.  He was started on Nirmatrelvir/Ritonavir (Paxlovid).  He tested positive for Covid-19 and is still testing positive.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
chills; injection site bump; arm pain/tender in arm; This case was reported by a consumer via sales rep and described the occurrence of chills in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced chills, injection site swelling and pain in arm. On an unknown date, the outcome of the chills, injection site swelling and pain in arm were unknown.   It was unknown if the reporter considered the chills, injection site swelling and pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported, however it could be 65 or 66 years. The case was reported by the retired vaccine representative. The patient was attending a coalition event and approached to the reporter learning was GSK representative.  The patient was wanted to tell her experience with receiving Shingrix injection.  The patient said three months past she received first Shingrix injection.  Within 3 hours the patient had chills, within a day the patient had a significant bump around the injection site and patient arm was tender and hurt.  The reporter don't know when the first shot was given.  The reporter did not know the lot number the second shot was about one month before the reporting date. The reporter did not agree to follow up with GlaxoSmithKline. For tolerance after 2nd dose refer case US2019GSK088801.
Gas pain, 1/10 tenderness RUQ 156/80, 80 16 O2 sat 98%
This spontaneous report was received from a nurse prescriber via a company representative and refers to a male patient in his late 60's. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date (reported as " a couple of months back"), the patient was vaccinated with PNEUMOVAX23 injection (dose, route of administration, anatomical location, lot # and expiry date were not specified) for prevention of pneumococcal disease, at an unspecified pharmacy. On an unknown date, within a few hours of being vaccinated, the patient had a "general reaction" to the PNEUMOVAX23. The patient felt generally ill and was sick for about a week to a week and one half after being vaccinated. On an unknown date, the patient sought medical attention and visited the physician's office. Product quality complaint (PQC) was not involved. The outcome of the event was reported as fully recovered on an unspecified date. The reporter considered the event to be related to the PNEUMOVAX23. Additional information is not expected as there was no consent for further contact.
4/3 vaccination  The day after I got the typical bump in arm Rash all over chest and neck area, both sides, horseshoe. 20 mg of steroid. Reaction to the shot. The skin got pussy. The rash wasn't affected by the steroids.  Getting more spots. Got the spots on my leg and several more down my right arm. Back to the doctor; increased steroids for another round and its finally clearing up. Permanent stain on skin.  *still taking the steroids. Never seen anything like it before. PCM told me it was a reaction to the steroid.  **did have COVID back in 11/2020; maybe 200 days since I had COVID to when I had vaccination
Next day after my vaccine I noticed a lymph node swollen under the injected arm. It lasted about a month. I took Tylenol to help with the swelling.
Mother reported swelling to  R leg after PCV13 vaccine. Mother noted no pain or discoloration. Swelling progressed to the thigh., them mother noted swelling to hands. Went to ER, where lab work done. Pt seen in our office on 5/29/2018,  with swelling to R LE (measurements done).
FLU SYMPTOMS; ACHING BONES; HEADACHE; INTERMITTENT SWEATING; PAIN AND SORENESS IN THE LEFT ARM AT INJECTION SITE; REDNESS IN LEFT ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 214 pounds, and height was 65 inches. The patient's past medical history included lumpectomy of right breast, radiation therapy, and colon resection, and concurrent conditions included breast cancer, non-insulin-dependent diabetes mellitus, asthmatic, second hand smoke, chronic obstructive pulmonary disease, neuropathy, iodine allergy, sulfa allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no history of drug abuse or illicit drug usage. the patient cannot take certain antibiotics because it upsets stomach. The patient experienced bad reaction with colon when treated with prednisone for drug used for unknown indication, and ministroke when treated with midazolam hydrochloride, and blood pressure problems and headache when treated with celecoxib, stomach upset when treated with erythromycin, and blood pressure increased when treated with salbutamol. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 7808980 expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced intermittent sweating. On MAY-2021, the subject experienced pain and soreness in the left arm at injection site. On MAY-2021, the subject experienced redness in left arm at injection site. On 13-MAY-2021, the subject experienced flu symptoms. On 13-MAY-2021, the subject experienced aching bones. On 13-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain and soreness in the left arm at injection site, and the outcome of flu symptoms, aching bones, headache, redness in left arm at injection site and intermittent sweating was not reported. This report was non-serious.
A few hours after getting a flu shot starting getting runny nose and flu like symptoms.  By the next day was significantly worse and said was causing kidney pain and joint pain that prevented from walking.
Patient received the GARDASIL vaccine and was standing approx. 5 minutes later performing a vision exam when she had a syncopal event.
Evening of 5/15, dad noticed left upper arm was red, swollen and painful down to his elbow. He called his physician and he told him to take him to the local hospital's urgent care. The urgent care physician diagnosed him with cellulitis and started patient on a 7 day course of Keflex.
Pt was here for a well-child check-up.  Immunizations were given at the end of the visit.  I inadvertantly used regular diluent from our supply instead of the diluent supplied with the ActHib vaccine.  I've been informed by a supervisor that it's probably OK but the provider will have the choice whether to revaccinate or not.
. Pneumonia due to COVID-19 virus U07.1  This is a 63 year old female with ETOH abuse, whom we are consulted for COVID-19 pneumonia. She was initially seen in this ER on 8/25, with reported generalized weakness. At that time, she was diagnosed with COVID-19. She was recommended to receive Regeneron. She was discharged in stable condition on 8/26. She then re-presented to the ER on 8/29 with difficulty breathing. Of note, she is s/p the Pfizer COVID vaccine previously.   When she arrived in the ER, she was in respiratory distress. She reportedly had a seizure earlier. EMS attempted to intubate her numerous times en route, but were unsuccessful.  She was intubated in the ER.  Afebrile.  WBC 13.9K. GFR 93. SGOT/SGPT: 144/88. CRP 3.9, Ferritin 454. COVID-19 PCR positive 8/25 & 8/29. UDS: benzos & THC. Blood cx from 8/29 pending. ETT aspirate cx from today is pending. CT brain today without acute findings. CT chest PE today: no PE, diffuse GGO infiltrates, bilateral upper nodular consolidations.
Pt describes rash as "pink/red bumps" on upper back. Rash started evening on day of vaccination. Rash lasted approximately 5 days, opened and scabbed over. Pt complained of intense pruritus, denied pain. Denied rash to L arm (location of vaccination). Pt used Calamine lotion and BENADRYL PO for itching. Pt reported event on 12/6/18 (close to 5 weeks after vaccination) when she returned for MMRV2. MMRV2 was not administered.
rash on digits, hands, feet w/minimal edema on trunk lasting 5-6 days;appeared w/in 24hr of vax;2nd & 3rd doses of DTAP, HIB were given;IPV #2 given no rxn was noted;
lots of nerve pain in my upper legs; I lost control of my legs; could not stand; could not even turn and put my feet down on the floor; they are very weak for like a week or more; Booster; This is a spontaneous report from a contactable consumer (patient). This 77-year-old female patient received boost dose of BNT162B2 (Batch/lot number: FE3590, expiration date: Nov2021) on 15Oct2021, at the age of 77 years old, administrated in Right Arm at single dose for COVID-19 immunization. Relevant medical history and concurrent conditions was Arthritis. Concomitant drug was atorvastatin.  Prior vaccination within 4 weeks was No. Historical vaccine was 1st and 2nd dose of BNT162B2.  Patient stated, "I got my booster "the third" Pfizer shot on 15Oct2021 and the next evening I lost control of my legs. I could not stand. I could not even turn and put my feet down on the floor right so I like I made it to bed that night. It is got better in the morning but had lots of nerve pain in my upper legs but I could not even stand night before." Patient stated, "No I did not treatment. I got up to next morning and I could walk down and move my legs but they are very weak for like a week or more and I still have some nerve pain from that." Outcome of the event nerve pain and booster was unknown, for other events was recovering.  Follow-up attempts are completed. No further information is expected.
Nausea; fatigue, chills, - treatment: Tylenol  Outcome:  Systems gone next day by 12pm.  On 3/10/21 - I started itching from by head to the bottom of my feet.    Treatment:  Benadryl (worked temporarily); hydroxyzine 25 mg.  Outcome:  Itching stopped after two days.
Arm soreness; Fatigue; very bad headache; stuff nose; This is a spontaneous report from a contactable consumer (patient). A 72-year-old patient of unknown gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient medical history included obesity and diabetic. The patient concomitant medication was not reported. The patient experienced arm soreness, fatigue, very bad headache and stuff nose. The outcome of the events was unknown.
Diarrhea extreme 12+ times/day, liquid, dizziness, weakness, lack of concentration,  body temp dropped 1-2 degrees below normal. Used Immodium to slow to 5-10 times/day; painful skin areas; face, neck, head, back; shooting pains in ears and neck; painful aching.