chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain/swelling in left armpit; Pain/swelling in left armpit; Itching and pain at injection site; Itching and pain at injection site; Fever (101.5); Tiredness; Chills; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Single, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 19Oct2022 at 22:30, outcome "recovering"; PYREXIA (non-serious) with onset 19Oct2022 at 22:30, outcome "recovering", described as "Fever (101.5)"; HEADACHE (non-serious) with onset 19Oct2022 at 22:30, outcome "recovering"; VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 19Oct2022 at 22:30, outcome "recovering" and all described as "Itching and pain at injection site"; AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 19Oct2022 at 22:30, outcome "recovering" and all described as "Pain/swelling in left armpit"; FATIGUE (non-serious) with onset 19Oct2022 at 22:30, outcome "recovering", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of axillary pain, swelling, vaccination site pruritus, vaccination site pain, pyrexia, fatigue, chills, headache. Additional information- This report was about COVID-19 vaccine. Patient was not pregnant at the time of vaccination. Vaccination facility type was reported as Pharmacy or Drug Store.  Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient experienced itching and pain at injection site, pain/swelling in left armpit, fever (101.5), tiredness, chills, headache on 19Oct2022 at 22:30. Patient received treatment for the adverse events which included Tylenol and rest. Patient had COVID-19 prior to vaccination. Patient was tested post vaccination which included Nasal Swab test with result as negative on 19Oct2022. Patient was allergic to Sulfa drugs.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 10 year old male patient who on 16-DEC-1998 was vaccinated with one dose of RECOMBIVAX HB. On 18-DEC-1998 the patient developed Tourette's syndrome. No further information is available.
Administration site pain; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 73-year-old female patient received BNT162B2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Mar2021, outcome "not recovered", described as "Administration site pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
left arm rash, itching, pain to injection site  Narrative:  Left arm rash on 01/05/2021 with itching, redness, and pain to injection site.
w/in 1-2 hrs p/vax pt devel flu-like synd, nausea & vertigo which lasted 7 days; fever & myalgia which lasted about 2 days; pt recovered;
Pt. was administered three immunizations, Menactra, Hep B, and Varicella, after administering varicella pt. had immediate itching, burning, and redness at the site.
Information has been received from a physician concerning a 2 year old patient who on 08-JAN-2009 was vaccinated oral with his first dose of ROTATEQ (LOT# not reported).  No adverse effect was reported.  It was not reported whether the patient sought medical attention.  Additional information has been requested.
received the 2nd dose of Shingrix only 3 weeks apart from the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix only 3 weeks apart from the first dose, which led to shortening of vaccination schedule. Also mentioned this was very long before from day of reporting and that if they administer another 2nd dose to the patient that would be a late second dose. The healthcare professional did not have any vaccine data or dates, they were administered at another pharmacy. The reporter consented to follow up.
headache; This is a spontaneous report from a contactable consumer (patient's Grandmother).  A 17-years-old adolescent female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Left Arm on 17Jun2021 as 1st Dose, Single for COVID-19 immunization. The patient's medical history and concomitant medications were reported as no. After the first dose of Covid vaccine, the patient experienced headache ever since. Headache was reported as worsened. She wants to know if her granddaughter can take anything for her headache and if that would be safe. The outcome for the events was not recovered/not resolved.  Information on the lot/batch number has been requested.
Approximately 10 minutes after vaccination patient was uneasy on feet and almost fainted.  After laying down recovered within a couple of minutes.
The pt states she has pain down her (R) arm from her shoulder and a lump up by the clavicle nerve type pain. (Can not work).
After patient received vaccine, seemed ok when leaving the store, but started to pass-out. We called 911. They came and observed her; checked blood pressure and had her sit in a chair for awhile. Then she felt ok to leave the store.
Uncontrollable shivering, despite being at normal body temperature.  Accompanied by uncontrollable rapid breathing and muscle cramps, for approximately 15 minutes.
diarrhea; blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and BLOOD URINE PRESENT (blood in urine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04021A) for COVID-19 immunization.     Concurrent medical conditions included Prostatic disorder and Cholesterol.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea) and BLOOD URINE PRESENT (blood in urine). At the time of the report, DIARRHOEA (diarrhea) and BLOOD URINE PRESENT (blood in urine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported. Concomitant medications were reported for prostate and cholesterol but not specified. Patient wanted to know if he should get second dose tomorrow given the symptoms and prostate treatment.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 67-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 06-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804077 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Pt received COVID vaccine at approx 4:55. Pt waiting in lobby approx @5 pm, reports not feeling well. Rapid response called team on site. Pt c/o dry mouth, tingling. Dr. assessed pt. Pt sweating and c/o CP. BP 165/82 P125. Pt given water, legs elevated, ice pack on neck. Dr. ordered EKG and fingerstick. Pt pulse decreased to 106. Transferred to nursing office. EKG performed and results given to provider. Pt given PO fluids. Dr. assessed pt again and per Dr. since pt is stable, OK to go home with family member as driver. At 5:45 pt was able to ambulate without assistance, pt AxOx4, breathing even and unlabored, not in any form of distress. Pt left clinic with boyfriend and daughter. Pt was given ER precautions for CP, SOB, worsening symptoms.
Received yellow fever vaccine on 7/1/09 no complications. 7/4/09 c/o: nausea, vomiting, severe stomach ache, diarrhea, low grade fever and flat rash to torso, no itching. Lasted about 2 1/2 hours, redness at injection site.
Wed, April 14:  headache, light headed, feeling of going to pass out, blurred vision, very tired, weak, diarrhea.  Thur April 15 ? very light headed, feeling of going to pass out, numb pinky, very weak, very shaky, very tired.  Went to ER after almost passing out they gave me fluids, did a chest xray and ekg, covid test, pregnancy test. They sent me home saying I was dehydrated. ? slept for 4 hours after ER, felt tired, hard to focus, diarrhea then that night slept all night. Fri April 16 ? a bit better in morning but vision still not right, at dinner table felt drunk (did not have any alcohol), very tired, face felt flushed (no fever), hard to focus, headache came on before bed (took 2 Aleve) Sat  April 17 ? tired, went to doctor for additional blood work, slept after appointment, face flush (no fever), vision still not right. Doctor said this is likely vaccine related. Sun April 18 ? felt same as Saturday Mon April 19 ? very tired, vision still not right, hard to focus at work, want to sleep, face felt hot and tingly (no fever)  Tue April 20 ? allergy type symptoms in morning. Sneezing, runny nose, slight headache. These symptoms went away.  From April 21-28 - other symptoms mostly going away except vision issues. April 28th most symptoms went away but vision is still blurry, see floaters, feels like I have Vaseline over my eyes. Going to see an eye doctor ASAP.
Patient is have shooting pains that radiate down her whole arm. There is no redness or swelling at injection site. Patient declined additional medical attention. Taking an OTC pain reliever & will ice/heat arm.
p/vax pt had a sudden onset of abd distension, lethargy, paleness & grossly bloody stools;adm to hosp w/ ? dx of intussusception; child doing well;
patient contacted and denied having any symptoms at this time and verbalized understanding that he received HPV vaccine instead of PCV.
I had soreness in my arm the day after the first injectionbut no other adverse events after the first injection; This is a spontaneous report from a contactable Other-HCP (patient). This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number=EH9899), via an unspecified route of administration on 18Dec2020 14:45 at single dose on the right arm for COVID-19 immunization. The patient's medical history included allergies: Cephalosporin (mild reaction of hives one time after having taken it with no issues for years). There were no concomitant medications. No other vaccine received in four weeks. Facility type vaccine was hospital. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient had soreness in her arm the day after the first injection but no other adverse events after the first injection. No treatment received. Outcome of the event was recovered.
Woke up with a fever and needing to go to the bathroom frequently. Reportedly, patient given second covid vaccine on 11/30/21 with first dose reported by patient's spouse as 11/17/21. Patient reported she was a day away from her two week mark since her first dose. There is no documentation in the state registry or our system a first dose was ever administered.
I got muscle twitches in the left arm where it was injected/it has progressed to twitching over my whole body; severe pain pins and needles electric shocks; severe pain pins and needles electric shocks; severe pain pins and needles electric shocks; feeling like I am wearing Gloves and socks in my arms and legs; My balance is affected; 20% of my nerves are damaged; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration (at the age of 52-years), administered in arm left on 02Apr2021 at 11:00 as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism and high blood pressure, and had allergies to penicillin. Concomitant medications included atenolol, received within 2 weeks of vaccination. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6z06), via an unspecified route of administration (at the age of 52-years), administered in arm left on 15Mar2021 at 09:30 as dose 1, single for COVID-19 immunization and experienced no reaction on previous exposure to drug. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at time of vaccination. On 04Apr2021, It was reported that after the second dose I got muscle twitches in the left arm where it was injected. Now it has progressed to twitching over her whole body. now have severe pain pins and needles electric shocks and feeling like she was wearing, gloves and socks in her arms and legs. Her balance was affected. Her neurologist did a nerve test which was showing 20% of my nerves were damaged. The events were considered as serious (Disabling/Incapacitating) as per reporter. The treatment was not received for all the events. The adverse event result in physician office visit and emergency room visit. The facility where the most recent COVID-19 vaccine was administered was reported as other. The clinical outcome for all the events was reported as not recovered.
Tender to touch under the arm vaccinated. Swollen and warm to touch. Some discomfort in muscle, but swelling happened on the inside of the upper arm.
blood pressure  was too low; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (blood pressure  was too low) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOTENSION (blood pressure  was too low). At the time of the report, HYPOTENSION (blood pressure  was too low) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported that she took the incorrect pill and her blood pressure was already low.  No concomitant medication was reported. No treatment medication was reported.
Tongue swelling; funny taste of mouth; light headed; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue swelling), TASTE DISORDER (funny taste of mouth) and DIZZINESS (light headed) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced SWOLLEN TONGUE (Tongue swelling), TASTE DISORDER (funny taste of mouth) and DIZZINESS (light headed). At the time of the report, SWOLLEN TONGUE (Tongue swelling), TASTE DISORDER (funny taste of mouth) and DIZZINESS (light headed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided    This case was linked to US-MODERNATX, INC.-MOD-2021-090190 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090190:Crosslinked case
April-28-2021 around 9:21am woken up to nauseous headache right side joint pain left arm neck shoulder dizziness weakness heart was beating fast. Been very tired.
PT REPORTS NOSE BLEEDS LASTING AN AVERAGE OF 2 HOURS 4/5/21, 4/7/21, 4/8/21, WENT TO THE ER EACH TIME. HAD AN ADDITIONAL NOSE BLEED ON 4/12/21. UNSURE HOW LONG IT LAST BUT PT REPORTS NOT AS LONG AS PREVIOUS BLEEDS. ALSO HAD NOSE SCOPE WITH ENT ON 4/12/21 AFTER BLEED EVENT.  PT REPORTS DR DID NOT FIND ANYTHING ON THE SCOPE THAT WOULD CAUSE THE BLEED. SAW PCP 4/15/21 AND HAD BLOOD WORK. NO FURTHER DGN OR TREATMENT
Patient presented to pharmacy with a red blister that was raised, inflamed and pussing on right arm that she received J&j vaccine in on 5/2/21. She reports pain started 5/20/21 and blister open overnight. Recommended patient go to urgent care to be seen by a medical doctor right away .
This spontaneous report as received from a healthcare worker refers to unspecified patients. Patients medical history and current condition was not reported. Since an unknown date the patients were vaccinated with improperly stored GARDASIL injection (unknown dose and frequency) (Lot number and expiry date not reported) and sterile diluents. No adverse effects reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
pt felt light headed and felt they were going to black out.  Pt laid down with cool compress and staff checked blood pressure which was slightly elavated.  Pt drank some water and ate some beef jerk and was feeling fine 15 minutes later
Low grade fever, chills, body aches after my 2nd Pfizer covid-19 vaccine
has a rash in both of his armpits that do not itch; This is a spontaneous report from a contactable consumer reported for a male patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Jun2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization.The patient medical history and concomitant medications were not reported. It was reported that both her and her husband received the Pfizer COVID19 Vaccine yesterday. On an unspecified date, her husband had a rash in both of his armpits that do not itch. Caller wants to know if this is normal. Her husband is prescribed Lovenox BID and that did worry her. She states that when she refilled his prescription, she also let the pharmacy know and they advised he should be okay but to follow up with this number as well so that is what she is doing. Patient will be seeing his vascular surgeon this week she states, and they will also make him aware of this reaction/side effect. The event outcome was Unknown.  Caller declined to complete report. Full details not obtained. The caller was provided with phone number and hours of operation, prior to warm transfer.  Information on the lot/batch number has been requested.  Follow-up (23Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient had fever, chills, and frequent urination. She rested and turned heat up in house. She called pharmacy 2 days later and reported events and stated she was feeling better.
Suspected vaccination failure/had both shots for shingles, and getting over them; getting over them; so painful (top of my head, right side and forehead, side of my face, down to eyebrow); so painful (top of my head, right side and forehead, side of my face, down to eyebrow); This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, headache and facial pain. On an unknown date, the outcome of the vaccination failure, shingles, headache and facial pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, headache and facial pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 19-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both shots for shingles, and getting over them , going on six weeks.  The patient stated that so painful (top of his/her head, right side and forehead- side of his/her face, down to eyebrow). The patient stated that no joking, would not wish them on his/her worst enemy, that bad. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Pt is experiencing swollen, hard glands under the armpits. Pt says his lymph nodes are going "nuts."
This spontaneous report as received from a medical assistant (also reported as Registered Nurse - R.N.) refers to a patient of an unknown age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unspecified date in 2013, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot#, and expiration date were not provided). On an unknown date, after he/she received the ZOSTAVAX, the patient experienced neuropathy or an autoimmune disease. There was no product quality complaint involved. The outcome of neuropathy or an autoimmune disease and the relatedness between the adverse events and ZOSTAVAX were not reported. Upon internal review, the adverse event of autoimmune disease was considered to be medically significant. Additional information has been requested.