chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse event: on 11/17/17, patient reports 3 small bumps on right arm and leg. Does not report pain.  Outcome: Advised patient to follow up with doctor for possible reaction to vaccine.
swollen lymph node; Pain started on Sunday, 17Jan2021. 5/10 pain scale on Sunday.; felt a tickle behind his left ear; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported age was 62 without unit) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were not reported), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During the injection on 16Jan2021, the patient felt a tickle behind his left ear. Pain started on Sunday, 17Jan2021. 5/10 pain scale on Sunday. He stated that "it hurts more after 8 hours of work, in the morning it is good." The patient believes it is a "swollen lymph node." Outcome of the events was unknown.   Information on the lot/ batch number has been requested.
This spontaneous report was received from an office manager, referring to a 63 year old male patient. The patient did not have concomitant medication, pertinent medical history, drug reactions or allergies. On 23-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R002084, expiration date 26-OCT-2019, intramuscular, for prophylaxis (reported as indication: "Over 60 year old"). On the same date of vaccination, the patient "experienced pain and swelling in patient's elbow." Subsequently, "the patient also experienced syncope on unspecified date, therefore, the patient went back to the office on 24-OCT-2018." The office manager reported that "unspecified physician tapped patient's elbow and determined there was high white blood cell count and the patient was referred to the emergency room." It was also reported that the patient was "diagnosed with cellulitis in the elbow and he was hospitalized on 24-OCT-2018." Additionally, the patient received unspecified intravenous (IV) antibiotics in the hospital. The outcome of cellulitis and syncope was reported as not recovered. The causality assessment between cellulitis and syncope and therapy with PNEUMOVAX 23 was not provided. Upon internal review the event cellulitis was determined to be medically significant.
DID NOT TAKE VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report (PVX2019-1925) was received from a pharmacist on 25-Jul-2019. It described a male consumer who "did not take Vivotif according to schedule" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took his first dose on Sunday and missed to take the second dose on Tuesday. The consumer did not take Vivotif according to schedule.   Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.
Extreme diarrhea and vomiting, having bowel movements 10+ times per day for 5+ days now. Started the evening of the vaccinations.
Rt arm site of administered very COLD / Cool to touch; Normal hurt/ discomfort; Nausea; Frontal headache; lightheaded; strange sensation of NUMBNESS started exterior side of right thumb & rt thumb pad. Numbness moved to involve entire rt thumb. Numbness to lesser degree tip to palm of rt index finger rt middle finger, rt ring finger & rt pinkie.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0173) via an unspecified route of administration in the right arm on 04May2021 at 10:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included long term chronic autoimmune diseases and syndrome and on &off sensitive reactions. Concomitant medications included estradiol (ESTRADIOL TRANSDERMAL SYSTEM) and fentanyl (MANUFACTURER UNKNOWN), all for unknown indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153), via an unspecified route of administration in the right arm on 13 Apr2021 at 10:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 10:00, the patient experienced numbness, On 05May2021 the patient experienced nausea, discomfort, frontal headache, lightheaded and feeling cold. It was reported that within few minutes of 2nd Dose administered, strange sensation of NUMBNESS started exterior side of right thumb and rt thumb pad. Numbness moved to involve entire rt thumb. Numbness to lesser degree tip to palm of rt index finger rt middle finger, rt ring finger & rt pinkie. Almost immediately started flexing massaging and moving thumb & fingers Made certain to keep right arm moving/ in motion Rt fingers hand wrist arm flexed massaged moved. On & off for hours. Rt thumb remains semi numb on 05/05/2021. Numbness diminished in rt fingers, but semi numb rt finger tips. Failed to tell. Messaged online care provider & Pfizer on 05/05/2021. NOTE: Rt arm site of administered Pfizer 2 Dose very COLD / Cool to touch for 24+ hours. Normal hurt/ discomfort. Less than 60 after Pfizer 2 started normal/ common side effects...Nausea, frontal headache, lightheaded History of long-term autoimmune disease & syndromes. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of the events of numbness, nausea, discomfort, frontal headache, lightheaded and feeling cold was unknown.  No follow-up attempts are needed. No further information is expected.
A refrigerator malfunction caused the temperature excursion of vaccine which reached -.8 C for 14 hours and 22 minutes and was administered, no AE; Initial information was received on 08-Jul-2020 regarding an unsolicited valid non-serious case from a pharmacist  This case involves a 21 year old female patient who received a 0.5 ml once dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5655AA, Expiry date: 15-Aug-2021) once via intramuscular route in the left deltoid on 01-Jul-2020 for prophylactic vaccination  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. She recently had a baby.   It was a case of an actual medication error due to Product storage error temperature too low (Product storage error).   It was reported that on 01-Jul-2020, a 21 year-old woman came in for an Adacel vaccine as she just had a baby and her doctor was unsure of her immunization history. She received the vaccine, but it was later discovered that the Adacel had undergone an excursion in which the product went to a temperature less than 0 degree Celsius (-.8 C for 14 hours and 22 minutes) due to a mechanical problem. It was reported that she will be reimmunized.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
p/vax pt devel an extreme case of chickenpox lesions;pt whole body was covered & the lesions were also inside the ears & mouth;the lesions were itchy & did not scab over;
The next day I was extremely tired and my arm was sore for about 24-36 hours and after all symptoms subsided
Right arm swollen, red, warm, pruritic circumference 21cm vs 17cm left 15cm (shoulder to elbow) centered posterior arm (No systemic symptoms) (probable site of varicella) Localized site reaction
Menstrual cycle has been irregular since I recieved my first covid vaccine in January. It's been later and later each month and bleeding has been extremely heavy. During my last menstrual period, I soaked through 3 maxi pads within a few hours which is extremely unusual for me.
Body aches; Arm sore; A fever of about 100.3, temperature was up every 3 hours; Swollen lymph nodes; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (Body aches), VACCINATION SITE PAIN (Arm sore), PYREXIA (A fever of about 100.3, temperature was up every 3 hours) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN (Body aches), VACCINATION SITE PAIN (Arm sore), PYREXIA (A fever of about 100.3, temperature was up every 3 hours) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, PAIN (Body aches), PYREXIA (A fever of about 100.3, temperature was up every 3 hours) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown and VACCINATION SITE PAIN (Arm sore) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test negative: negative (Negative) negative (prior to receiving the vaccine).     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 for event included Tylenol and Advil.  Concomitant information not provided.  Company comment:Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
shortly upon waking the next morning, headache, swollen lymph nodes several hours later, blurry/double vision,aura, nausea, dizziness, extreme fatigue above symptoms lasted about 36 hours strong odor and taste in mouth for 48 hours
Tingling, numbness in rt arm; puffy, swelling of knuckles; stiffness & redness in kunckles; wearing braces to bed @ night; pain would wake pt @ night; rx'd Motrin;
No adverse event; 35 patients received a 0.25 ml dose as booster from booster dose only presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial). No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. Vaccination dates reported was between 22-Jul-2022 and 28-Jul-2022. The patient was administered vaccine with a volume of 0.25 ml instead of 0.5 ml. Unknown if patient experienced any symptoms after getting the vaccine.
This spontaneous report was received from a female patient of unknown age (a nurse), reporting on herself. The patient's concurrent conditions and medical history included asthma and allergies/reactions to penicillin (unspecified), CHLOROMYCETIN, clindamycin, NEOSPORIN, DEMEROL. On unknown date, the patient was vaccinated with the first dose of PNEUMOVAX 23 25/0.5 (unit not provided) (dose, lot#, expiration date, route and site of vaccination were not reported). In 2002, the patient was vaccinated with the second dose of PNEUMOVAX 23 25/0.5 (unit not provided) (dose, lot#, expiration date, route and site of vaccination were not reported). In 2008, the patient was vaccinated with the third dose of PNEUMOVAX 23 25/0.5 (unit not provided) (dose, lot#, expiration date, route and site of vaccination were not reported). Concomitant therapies included SYMBICORT, albuterol and unspecified allergies shots. On unknown date, the patient experienced a bronchial infection. At the time of this report, the patient was recovering from the infection. There was no information about product quality complains (PQC) reported. The patient did not seek medical attention. The reporter stated that the bronchial infection was not related to PNEUMOVAX 23 and was viral in nature. Additional information has been requested.
Left shoulder pain with decreased ROM starting evening s/p injection. Rated pain 6-10/10. Patient unable to sleep that evening.
Redness, mild swelling, hot to touch, burning, itching sensation. Symptoms worsened on 3/26/21.
Five minutes after injection patient began to complain of a funny feeling in the throat and chest. Pharmacist called 911 .
severe generalized burning type pain with occasional pruritus in feet, hands, extremities, and occasionally in the abdomen and back; severe generalized burning type pain with occasional pruritus in feet, hands, extremities, and occasionally in the abdomen and back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SLE" (unspecified if ongoing); "other autoimmune diseases" (unspecified if ongoing). Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL] taken for autoimmune disorder; BENLYSTA subcutaneous taken for autoimmune disorder. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "I have had this severe burning pain in my hands, feet, extremeties and somewhat in my abdomen and in my back", "I have had this severe burning pain in my hands, feet, extremeties and somewhat in my abdomen and in my back", "severe generalized burning type pain/I have had this severe burning pain in my hands, feet, extremities and somewhat in my abdomen and in my back", "I have had this severe burning pain in my hands, feet, extremeties", "pruritus in my feet, hands, extremities, & occasionally in the abdomen & back"; Bnt162b2 (Dose 2), for Covid-19 immunization, reaction(s): "had minimal symptoms with the 2nd, 3rd and 4th doses", "had minimal symptoms with the 2nd, 3rd and 4th doses"; Bnt162b2, bnt162b2 omi ba.4-5 (Dose 3), for Covid-19 immunization, reaction(s): "severe generalized burning type pain", "occasional pruritus in my feet, hands, extremities, & occasionally in the abdomen & back". The following information was reported: PAIN (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "severe generalized burning type pain with occasional pruritus in feet, hands, extremities, and occasionally in the abdomen and back". Therapeutic measures were taken as a result of pain, pruritus.  Additional information: With the initial Pfizer vaccine & the 3rd booster dose (modified for defense against the omicron virus), patient suffered from severe generalized burning type pain with occasional pruritus in feet, hands, extremities, and occasionally in the abdomen & back. These symptoms were unresponsive to OTC meds, partially responsive to oxycodone, & usually require short term use of prednisone. These symptoms occurred 6-7 days after the injection on both occasions. Patient reported minimal symptoms with the 2nd, 3rd and 4th doses; these symptoms only occurred with the 1st and the 5th doses.   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.
I don't know for sure that this is related, but would be a very strange coincidence.  My healthy 13 year old son, (who had the chicken pox 1 week prior to his appointment to get the chicken pox vaccine at 51 weeks old) started getting a rash 2 days after we received the second Shingrix vacinne.  He was diagnosed toda, 7 days later, by his doctor with Shingles.
Patient called complaining about a severely sore arm that start a day after his 2nd Covid shot and the soreness has continued to the current date of 8/25/21.  The soreness prevents the patient from using his left arm and he has to rest his arm continually due to the soreness.  The soreness has not gone away.
Pt had hive like rash over trunk, extremities. Assoc with itching. Left wrist soreness, swelling. No fever, no N/V. Headache (mild). Benadryl. To see her own MD also. To F/U with us in one week.
NO ADR, timing error 2nd dose given 49 days after first dose Narrative: No ADR timing ERROR 2nd dose given 49 days after 1st one.
Child received the shot and was walking around and fainted 5 to 10 minutes after the shot was given.  She regained consciousness in 30 seconds.  Walked out of office 15 minutes later.  Stated she "felt fine and was hungry".
one minute after injection, pt started to fall forward in the chair. father caught him and I was immediately called into the immunization room. pt was laid onto the floor and his legs were elevated onto a chair. father stated pt had never had a reaction to a vaccine before. no health conditions. 911 was called..... but then parent decided he didn't want them. pt states his vision started to go black before he briefly passed out... probable vasovagal syncope. we waited for 911 to come since they were already alerted. pt sat in chair but then started to get lightheaded again, so he returned to a position where his feet were elevated in the chair. EMS arrived and monitored him. father and EMS made decision to return pt to home.
Patient reports rash on chest and back starting 1 day ago. Generalized rash on chest, arms, and thighs. 98.1 temp in clinic.
Approximately 15 minutes after receiving injection, patient was sitting in chair and suddenly fell to the floor. According to witnesses, patient hit head first. Patient was wearing a thick winter coat which was immediately removed. Patient was diaphoretic, pale, BP 140/100, P 80. Boyfriend and family member accompanied patient and reported hx of anxiety and fainting with blood draws, NKA, no medications. Patient remained alert, responded appropriately to name, date and even stated time she received vaccine. Only c/o jaw pain. Denied headache, nausea and diploplia. Negative for swelling or bleeding of head and face or hives. Breathing without difficulty. BP taken 10 minutes later 156/90, P90. Activated 911, report given to paramedics, patient was transported by gurney by ambulance, accompanied by boyfriend and family member.
pt recv vax 28AUG95&31AUG95 pt was re-exam because of pain in lt deltoid area,site of inj;pt exp shooting pain down arm s/warmth&tenderness in deltoid area;dec ROM of shoulder was noted;given med for spasm;dx adhesive capsulitis
Vomiting about 24 hours after the second dose (shot); Nausea about 24 hours after the second dose (shot); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Mar2021 (Lot number: EN6198) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot EL9265 , administration date: 12Feb2021, when the patient was 71 years old, for Covid-19 immunization. The following information was reported: VOMITING (non-serious) with onset Mar2021, outcome "recovered", described as "Vomiting about 24 hours after the second dose (shot)"; NAUSEA (non-serious) with onset Mar2021, outcome "recovered", described as "Nausea about 24 hours after the second dose (shot)". Therapeutic measures were not taken as a result of vomiting, nausea.  No follow-up attempts are possible. No further information is expected.
I am 9 weeks pregnant and I just elected to receive the Pfizer COVID vaccine. I got the first shot yesterday.; This is a spontaneous report from a contactable consumer (patient) reported to Pfizer. A female pregnant patient of an unspecified age received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The report received as, I am 9 weeks pregnant, and I just elected to receive the Pfizer COVID vaccine. I got the first shot yesterday. Knowing there is little data on this with pregnancy, I would like to assist with adding to your data if possible, to help other expectant mothers. Please let me know how I may assist. I'm registered to get my 2nd shot on 22Feb. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Amendment: This follow-up report is being submitted to amend previously reported information: Deleted the events off label use and drug use in unapproved population.
Hives-within 1/2 of giving immunization.  Tx with benedryl and kenalog.
Heart stopped, stopped breathing and seizures... Given anti seizure medication and shipped to hospital. Continued testing and medications one week..parenteral nutrition, oxygen therapy... Monitor for seizures and developmental delays upon discharge.
Pt received 2 mos vacc 2/12/07. Pt had seizure active 2/23/07. Saw Dr he felt vacc were not the cause. Saw 4/12/07 for 4 mos vacc pt had seizure activity the same night.