chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DISCOMFORT; soreness in the armpit, lymph node area; pain in the injection site started from the top to bottom shoulder / muscle pain at the injection site; A spontaneous report was received from a male patient, concerning himself 68  years of age, who received Moderna's COVID-19 vaccine and Pyrexia, Nausea, Headache The patient's medical history includes Hypertension, cholesterol, Acid Reflux, sleep pattern.   Concomitant product use provided by the patient was Lisinopril, Simvastatin, Prilosec, Ambien.    On 10-Feb-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (024M20A batch number) via intramuscular route for COVID-19 infection prophylaxis and experienced Injection site pain, Axillary pain, Discomfort.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was considered to be unknown at the time of this report.
Pt experienced pain, swelling, itching & a 6cm red zone at inject site 10 to 15 min post vax; Ice applied;
Later in day - aches, (L) arm unable to sleep, lots of aches and pain in my muscles & joints. Had aches, chest pain thru night to my back. No SOB or trouble swallowing. Tues. severe itching took BENADRYL 25 mg 3/28. 3/29 - 50 mg another BENADRYL. By 4/4/11 full resolution.
Feeling sick; Feeling dizzy; Seizure; vomiting; bad Headache; This is a spontaneous report from a contactable consumer. A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in arm right on 12Jun2021 (Lot Number: EN6198) as dose 2, single (at the age of 20 years old) for COVID-19 immunization. Medical history included asthma, attention deficit hyperactivity disorder (ADHD), Blood pressure high; all from an unknown date. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported and inhaler medication for asthma. No prior vaccinations (within 4 weeks). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT#EW0170), via intramuscular administered in right arm on 17May2021 (also reported as 07May2021) as dose 1, single for COVID-19 immunization and experienced no adverse effect. It was stated that it was just when he got the second dose of the COVID-19 Pfizer on 12Jun2021, it was supposed to be on 07Jun2021, but patient didnt go back in. Further stated that patient just started feeling sick just while ago (on unspecified date), but he started feeling dizzy on 13Jun2021. It was reported that patient got his second dose and on 13Jun2021, his vomiting could not stop and having bad headache, he could not stop vomiting. Consumer stated that he was trying to have like seizure or something on 13Jun2021. Reporter stated no treatment for the event. The patient had lab test at a hospital. They were checking out the Vitamin levels. The patient underwent lab tests and procedures which included checking out the vitamin levels: unknown results on 11May2021. The outcome of the events seizure, vomiting, bad headache was not recovered and outcome of feeling sick and feeling dizzy was unknown.
Throbbing arm pain; Fever; Chills; Body aches; Headache; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), intramuscular in left arm, on 18Dec2020 at 09:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history included asthma, chronic back pain (surgery and scoliosis), migraines, systemic reaction to allergy injection, and COVID-19 in Jun2020 (prior vaccination). The patient's concomitant medications included pregabalin (LYRICA), butalbital, ascorbic acid (VITAMINS C), biotin, boron/ calcium/ Cimicifuga racemosa extract/ folic acid/ Glycine max extract/ Magnolia officinalis/ nicotinic acid/ pyridoxine hydrochloride/ riboflavin/ selenium/ thiamine/ tocopherol/ vitamin B12 NOS (ESTROVEN), Linum usitatissimum seed oil (FLAXSEED OIL), paracetamol (TYLENOL ARTHRITIS), and an unspecified stool softener and D (unspecified). The patient previously took amoxicillin and cinnamon oil and experienced allergies to both. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 18Dec2020 at 08:00 PM, the patient experienced throbbing arm pain for 2 days, fever, chills, body aches, headache, and fatigue for 2 days - some of the same symptoms she had when she had COVID-19 back in Jun2020. The events were considered non-serious. Treatment was received for the adverse events including ibuprofen, paracetamol (TYLENOL), and famotidine/ ibuprofen (DUEXIS). Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from "Throbbing arm pain" and "Fatigue" on 20Dec2020, and from the remaining events on an unspecified date.
Nausea, light-headedness, sore throat, pale in appearance.  Pt's feet were elevated and vitals monitered.  Gradual return to normal VS and feeling back to usual within around 15 minutes.
Fine, macular rash to shoulder and trunk which spread to abdomen and face along with fever, body aches and chills.
Vaccine administered via SubQ pinching technique in upper left posterior arm, midway between shoulder and elbow. NOT an IM injection. Site red, swollen and tender. Concern raised for less immune response. No training given to administration staff by hospital clinic.
Patient received 2nd dose of Pfizer COVID-19 vaccine.  She immediately developed diaphoresis and eye tearing.   Diaphoresis worsened.  Patient reported nausea.  Epinephrine administered and transferred patient to emergency department.    ED did not feel epinephrine helped  Patient observed and then discharged.
Initial report received from a consumer on 20 September 2013. A female patient whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD vaccine (Batch number, Route, dose and anatomical site of administration were not reported) on an unspecified date (date reported as : "Friday September"). On an unspecified date, the patient had marble size white raised bumps on her body. One was a domino size, round in shape. Patient also had pain in shoulder and hip. Patient consulted the physician and prescribed her unspecified antibiotics and allergy medicine which patient did not consume. On an unspecified date, some bumps had resolved while some were persisting. It was reported that it might be an infection or an allergy. Patient was not sure whether she had the events before or after vaccination with FLUZINE HD. Laboratory investigations and corrective medications were not reported. As of 20 September 2013, the patient had not recovered from the events. List of documents held by the reporter none.
Client received his Pfizer vaccine and during the post-vaccination wait period in his car, he complained of nausea and lightheadedness. His spouse was in the car with him. Vital signs: BP=143/91. He had no history of allergies and was not on any medications. He was evaluated by the nurse and EMT on site and it was determined he did not require further medical attention. He was instructed to call ?911? if his symptoms returned or he developed additional symptoms and he voiced understanding. He waited a little longer and was driven away by his spouse.
lump the size of golf ball in the arm of the injection; arm was sore last night and all day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump the size of golf ball in the arm of the injection) and PAIN IN EXTREMITY (arm was sore last night and all day) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE (Patient completed series of vaccination on 14 Apr 2021 and details about previous vaccine not provided.).    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE MASS (lump the size of golf ball in the arm of the injection) and PAIN IN EXTREMITY (arm was sore last night and all day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (lump the size of golf ball in the arm of the injection) and PAIN IN EXTREMITY (arm was sore last night and all day) outcome was unknown. Not Provided          No concomitant medication were provided.
TC on Sat 8/7/04 by mother of client. Administrator on call. c/o reddened area at site of injection right arm and legs achy. TC Follow up 8/9/04 by supervisor-stated took daughter to Hospital for swollen area left arm size of quarter, now size of softball, warm and reddened, ache in legs gone. Told rxn to vaccine component but no Tx given. Cold cloths applied. Referred to PP or back to ER as sounds like symptoms persisting. 8/12 TC follow up- mother states area is a little hard but redness gone and better. Did not see pp as advised. Told to ct. pp regarding future additional doses.
Two Rheumatoid arthritis flare up; This is a solicited report from a contactable consumer via a company. (MFR Control No. 21K-163-4101491-00). A 60-year-old male patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), intramuscular on 26Aug2021 (at the age of 60 years old) (Batch/Lot number was not reported) as DOSE 2, SINGLE, the first dose intramuscular on 31Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to 29Jul2021, at unspecified dose, oral from 2021 (Batch/Lot number was not reported) to 25Aug2021, at unspecified dose for Moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. In 2021, the patient experienced two rheumatoid arthritis flare-up while he was paused from taking his RINVOQ in order to get his COVID-19 vaccines. On 30Jul2021 and 25Aug2021, the patient experienced stop taking the RINVOQ when patient had COVID-19 vaccines (Intentional misuse in dosing frequency). The action taken in response to the events for upadacitinib was unknown. The outcome of the event was recovering at the time of report.   Causality for RINVOQ (UPADACITINIB): The reporter's causality for the event(s) of stop taking the rinvoq when patient had COVID-19 vaccines onset 30Jul2021 and 25Aug2021 was not provided. The reporters causality for the event(s) of two rheumatoid arthritis flare-up with RINVOQ (upadacitinib) was no reasonable possibility. Causuality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran): Intentional misuse in dosing frequency - Intentional product misuse. Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Not Reported. Dechallenge: N/A. Causuality:  Rheumatoid arthritis flare up - Rheumatoid arthritis. Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): No reasonable possibility. Dechallenge: N/A  No follow-up attempts are needed; information about Lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the causal association between the event rheumatoid arthritis flare up and the suspect drug BNT162B2  is assessed unrelated.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient developed left lower extremity weakness, numbness & gait disturbance concerning for Guillain-Barree syndrome 1 week after receiving second dose of Pfizer Covid 19 vaccine.
After the vaccine the patient was seated in a chair  for observation and within 5 minutes the patient started to feel dizzy and laid down on the floor and sweat profusely.  He had a good pulse, was severely nauseous and felt like throwing up. We monitored the patient and gave him an ice pack. The patient felt better for a few seconds and then back to feeling nauseous. He did not lose consciousness.  But because he was going back and forth between feeling better and getting dizzy, we called 911.  (Patient insisted  waiting 2 minutes before calling 911) They took care of the patient from there.
Menstrual cycle delayed; This is a spontaneous report 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: EP6955) via an unspecified route of administration in the right arm on 26Mar2021 at 14:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 12:00, the patient experienced menstrual cycle delayed. It was reported that the patient had a very stable cycle of 28 days and was due on sunday 28Mar but as of 02Apr at 03.00, her cycle had still not started. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of menstrual cycle delayed was not recovered.   No follow-up attempts are needed. No further information is expected.
Developed localized reaction 2 days after vaccines administered, then developed hives and diarrhea the following day. Twin sister got same vaccines and developed similar symptoms
im still sick; Sinus infection; loss of taste; headache; sore body; I feel like I have the flu.; This is a spontaneous report from a contactable consumer reporting for herself. A non-pregnant 65-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in left arm on 08Mar2021 15:30, at 65 years of age, (Batch/Lot Number: EN6204) as single dose for COVID-19 immunization. Facility where the vaccine was administered was School or Student Health Clinic. Medical history included allergy to sulfa drugs. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. No other vaccine was administered in the previous 4 weeks. The patient reported that 5 days after the first shot she was still sick (onset unknown). On an unknown date she also had sinus infection, loss of taste, headache, sore body; she was feeling like she had a flu. No treatment was administered. At the time of the report the reported events had not resolved yet.  No follow-up attempts are possible. No further information is expected.
A vaccine administration error occurred. Vaqta was ordered for the patient, but patient was administered Rotateq in error. No adverse outcome for the patient were noted.
2-24-12 Patient received PEDIARIX immunization in right thigh. Had erythema size of a quarter at site - lasting 1 night. Mom noticed hard lump in right thigh at injection site 2 days after injection. 1-18-13 Still has hard lump in right thigh - slightly smaller. No other symptoms.
first dose between 2 and 3 years ago; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose between 2 and 3 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The physician was looking for guidance because his patient who received 1st dose between 2 and 3 years ago. The reporter reported that the patient was not immunocompromised. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led incomplete course of vaccination. The reporter did not consent to follow-up. Note- There is discrepancy regarding age of patient query was raised for the same and meanwhile 68 years was captured as age of patient as narrative.
Information has been received from a nurse for GARDASIL, a pregnancy registry product, concerning an 18 year old female patient who in April 2008 was vaccinated with the second dose of GARDASIL. After receiving her second dose the patient became pregnant and miscarried. the last menstruation period was unspecified. She reported this to office after the event and they followed up with a Pap smear which came back normal. No lot number provided. At the time of report the patient's status was unknown. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.  Date the vial was initially stored in the refrigerator on 10-Sep and freezer were taken out this morning 08-Sep-2021 at 8:00am   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up received contain NNI
Pt accompanied by parent Pediatric pt was inadvertently given an adult dose PFIZER Lot  FJ8762. Adult parents were being vaccinated at same table as pediatric pts. Two pediatric doses and two adult doses were placed on the table, and the two adult doses were inadvertently used for the pediatric vaccinations. Processes of vaccination was without incidence. After vaccination mistake the Medical Evaluator and personnel on site were notified. Parents were notified shortly thereafter by the Medical Evaluator and vaccinator. Medical Evaluator gave parents instructions for monitoring health outcomes for the pediatric pts and contacting their pediatrician if necessary. All parent questions were answered. Pt stayed for a longer waiting period due the Parents vaccination. No adverse reaction was observed during waiting period (approx 30 min).
(R) arm swollen and red down the arm; bruising per pt report. Cold compress and OTC TYLENOL tx.
PAIN AT SITE NEXT DAY HEADACHE, FATIGUE AND INCREASED PAIN WED JAN 6, TH JAN 7, FRI JAN 8 I HAD TELMED SESSION WITH DR, ALSO NEGATIVE RAPID COVID TEST DR CALLED ME BACK AND ORDERED CEFUROXIME AXETIL 250MG;  STARTED FRI JAN 8 2021 AT 900PM RASH HAD SPREAD NOTICED MORNING OF SAT JAN 9, I CALLED PCP AND THEY RECOMMENDED VISIT TO ER/WALK IN.  WALKIN  SAID THEY COULD NOT HELP IF I WAS ON ANTIBIOTICS SO I WENT TO ER AND THEY TRACED SITE AND ASSURED ME TO COME BACK IF SPREAD CONTINUED.  (RASH RESOLVING 01/11/21)
This case was reported by a consumer and described the occurrence of vaccination site pain in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination site pain and muscle pain. On an unknown date, the outcome of the vaccination site pain and muscle pain were unknown. It was unknown if the reporter considered the vaccination site pain and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX into left deltoid. The SHINGRIX administered in retail pharmacy store that had no private rooms. The pain radiated around upper arm and down lateral muscle of abdomen. The patient advised that, SHINGRIX vaccine should be given in large muscle because the patient's deltoid was small. The patient stated, the problem was that if retail pharmacies were to administer SHINGRIX and if it was to be given in a large muscle, at the deltoid should not be listed as site of choice. The patient suggested, perhaps the lateral thigh (the patient could wear shorts). This might have created the further need for Pharmacists to be trained in identifying sites for injection other than the deltoid. The patient reported that the pain was severe. The patient did not want anyone having to deal with this pain and stated that, this pain was not normal, feels as if the muscle were ripped apart.
Numbness on left side, mainly in lips, tongue, face and arm. No treatment sought. Seems to have resolved next day.
Administered on 1/15/07.  Patient had marked lethargy/discontent/fever(100.5) for 2 days and slowly began return to normal feeding/sleep/activity patterns.  However, 2 weeks post immunization, patient still did not seem quite back to normal, (i.e. no talking-jabbering, not rolling over, etc...)  Tuesday (1/30/07) Began projectile vomitting, refused to eat, high level of discontent.  Marked change from normal behavior.  Prior to immunizations, baby was a "perfect" baby.  Ate good, slept good, always (ALWAYS) in a very happy/pleasant mood.  Was very regular, at least 1 stool per day.  Always a good urine output.  Contacted physician, no cause for alarm.  Symptoms continued until Friday (2/2/07) when taken into physician.  1lb. weight loss.  Monitored until Monday (2/5/07) baby taken back in for follow-up, baby had lost additional 1lb.  Doctor advised baby be seen/admitted to Hospital.  ER physician ordered 2-view X-Ray and Ultrasound to rule out intussusception and pyloric stenosis.  Results showed massive amounts of stool blocking almost entire lower GI tract.  Baby extrememly dehydrated and was given IV fluids.  Also received enema to alleviate blockage.  Baby held overnight.  Tuesday (2/6/07) physician ordered Upper GI Fluoro. with barium contrast.  Results negative.  Baby discharged to home.  Wednesday (2/7/07) baby passes barium in stool.  Later that afternoon, baby had 2 massive stools and excessive flatulence.  1 week post discharge Baby continues to slowly improve and has had 2 follow-up appts. with GI specialist and pediatrician.  Baby more responsive and active, however, has still not regained full capacities achieved prior to immunization date. 3/16/07 Received medical records from hospital which reveal patient experienced projectile vomiting, decreased activity & weight loss of 2# over approx 1 week.  Noted to have recent URI s/s after vax on 1/15 which resolved.  Admitted 2/5/07 for IVF, Zantac & fleet enema.  Progressed well & d/c to home on 2/6/07 FINAL DX: vomiting, wt loss & constipation.