chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got the flu after the shot; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a patient of unknown demographics who got the flu after the shot (influenza), while the patient received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date) not reported via unknown route in unknown administration site for prophylaxis vaccination.   On an unknown date, (latency unknown) after initiation of suspect drug therapy, the patient got the flu after the shot (influenza).   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.     There will be no information available on the batch number for this case.
Received vaccine and experienced serious stomach cramps and nausea later that day. Physical exhaustion present next day. No symptoms until Tuesday, 1 week after receiving the vaccine. Have begun experiencing hot spots like hot flashes in my right leg and foot. They come and go throughout the day....more occurring when I'm most active at work. Mostly in my right foot and right knee. Today they are also present in my left foot. Skin feels hot to the touch when it occurs. Injection site began itching and experiencing heat yesterday and was showing a red spot on my arm last night.
On 6/22/21 with no advance symptoms right inner ear struck with terrible pain and hearing loss and immediate loss of balance. Approximately 2 weeks later... pain gone with help of antibiotics and prednisone.  Currently (9-12-21) no improvement in hearing loss (90%) and imbalance has not improved despite PT.  Could this inner ear virus been Covid-19?
Pt received a flu vaccination on 10/18/11.  On 11/7/11, stated she did not have any unusual pain after the injection but states over time she has experienced more discomfort and achiness especially when moving in certain directions and when moving heavier objects.  Denies any numbness, tingling, redness or swelling.  Reports she has had flu shots before but no previous reactions.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient).     No concomitant medications were reported.   Treatment information was not provided.
The pt was taken to the ER after the vax. Mother stated the pt did not move or talk for three hours. She said his eyes were open, but he was limp. The MD did not give him any medication. The doctor thought he had a virus. The mother came in on 6/7/01 to received the 2nd dose that is when she told the nurse what happened with the 1st dose.
She was in bed after her vaccine, she had to go to her sisters to get her to sign a will.  She actually slept for 4 days.  Tuesday was the worst day, it got slightly better.  She was just feeling lousy.  She felt fuzzy and weak.  On 2/8/21 her temp was 97.3, she felt well.  On 2/14/21 and it was 97.5, before that she had been in bed and did not take her temperature.  Today she is feeling like a human being, but does not feel as though she is functioning normally mentally.  She is upset about her sister who is dying and plays a large part in how she feels mentally.
SYRING MALFUNCTION, DOSE SPILLED OUT AROUND SYRINGE AND NEEDLE JUNCTION
I did not have any adverse events after the first dose, but about 7 hours after my second dose I experienced chills and aches, which then progressed into fever, debilitating migraines, trouble breathing, bounding pulse, and chest pain, preventing me from standing for nearly 12 hours. The following morning I felt better, but I am still experiencing headaches and body aches, in addition to chest pain.
Vaccine was administered on 2/3/11. There was no pain at time of injection. Pain in the right arm first began on 2/8/11. The shot was given on the Right arm - which has a shooting pain going down arm and into the hand. The hand has numbness and loss of grip.
It all started when I got the first shot on 4/30/21. I immediately got my period and severe cramps.  5/28/21 I got the second shot and got my period immediately and got it twice in the month.  Then twice in June 21, did not get period at all in July and got period twice in August and September 21, with severe cramps, and throwing up.  Prior to vaccines, my period was on a perfect schedule.  I even have an app on my phone to keep track of the periods.
local leg swelling at site of MMR-Varicella (3 x 3 cm erythematous nodule on left thigh) and facial swelling/rash. First noticed when woke out of bed morning after vaccination and gradually improved to when saw the next day to only slight eyelid swelling with continued large nodule.
In Post vaccination area pt stated "throat feels smaller", & "I feel hot". Pt seated in chair, appeared very anxious, pt tachypneic w/short, rapid breathing, diaphoretic, denies allergies to foods & meds, & denies hx of anaphylactic reaction, denies med hx, states no meds.  Pt throat appeared WNL visually, no abnormality seen, pt also able to swallow & speak clearly, RN sat w/Pt to help calm down, used therapeutic nursing, calm voice, & active listening for Pt teaching of vaccine & what to expect post vaccine upcoming days, how to treat & care for common s/e to vaccine, & informed pt when to call dr & when to go to ER & call 911. Pt verbalized all understanding & stated "feel so much better & throat feels fine". States no needs at this time. Please see vitals below.
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Vaccine administered 10/11. She was seen in the office two days later with redness and pain at the vaccine site, bad enough for her to mention it to me.
Swelling lymph nodes in armpit and clavicle; swelling and pain at injection site; swelling and pain at injection site; a little rash in right forearm; This is a spontaneous report received from a non-contactable consumer (patient). A 57-years-old female patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 57-years-old, via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:30 AM (Lot Number: EW0151) as single dose for covid-19 immunisation. Medical history included Diabetes, Hypertension, Neuropathy, Radiculopathy. No allergies to medications, food, or other products. Concomitant medications included metformin hydrochloride; losartan; atorvastatin (LIPITOR); clonidine (CATAPRESS); clonazepam (KLONOPIN). Patient received first dose of BNT162b2, at the age of 57-years-old, administered in Arm Left on 03Mar2021 10:15 AM (Lot Number: EN6207) for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling lymph nodes in armpit and clavicle on 07Apr2021 21:00 with outcome of recovering, swelling and pain at injection site on 07Apr2021 21:00 with outcome of recovering, a little rash in right forearm on 07Apr2021 21:00 with outcome of recovering. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
bad chest pain; her heart is really tight; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 11Aug2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported she received the first dose on 11Aug2021 and since then she had been experiencing really bad chest pain and her heart was really tight. The patient inquired what she should do. The clinical outcomes of the events were not recovered.  The lot number for the vaccine was not provided and will be requested during follow up.
This case was reported by a consumer via call center representative and described the occurrence of fractured hip in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On 10th April 2019, 343 days after receiving SHINGRIX, the patient experienced fractured hip (serious criteria GSK medically significant). On 22nd April 2019, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the fractured hip and shingles were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the fractured hip and shingles to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient's wife. After 355 days of receiving SHINGRIX, the patient experienced shingles on his back and buttocks. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Severe vomiting (4 episodes over 12 hours) and diarrhea.  Severe muscle aches, alternating chills and feeling extremely flushed, temp 101.5 x 24 hours.  Low grade temp 100.6 continued with fever reducer for additional day and then resolved.
This initial spontaneous case, was received from other health professional on 18-Oct-2017, concerning a 67-year-old, elderly, male patient. The patient's historical condition included cholesterol and gout (unspecified dates). The patient's current condition included diabetes (since an unspecified date), high blood pressure (since an unspecified date). The patient's concomitant medications included JANUVIA, BENICAR HCT, glimepiride, metformin, simvastatin and allopurinol for unknown indications. On 28-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 178302A, expiry date: not reported). On 29-Sep-2017, next day after vaccination, the patient's blood sugar level had raised up to 200 mg/dl. The patient's blood sugar level had raised up to 300 mg/dl for about next 3 weeks. The patient was treated with extra tablets of glimepiride for several days. It was reported that, the patient's regular range of blood level would be between 120 mg/dl and 160 mg/dl, but after vaccination the values were quite high than 320 mg/dl. On an unspecified date, the patient's blood sugar reduced to 200 mg/dl (not normal) and he had not experienced this condition before vaccination. The patient had not recovered from the event. The reporter assessed this case as non-serious. Follow-up received on 03-Nov-2017: Gout was changed from current condition to historical condition. The start date was confirmed as 29-Sep-2017. It was reported that the blood sugar was not yet under control. Narrative amended accordingly.
Pt devel t102.8 following immun, given APAP & tepid baths temp still 101.3 24hrs p/event; listless, eyes bloodshot, & s&s of cold; No n,v, no sz;
10-15 mins p/pt recvd MMR vax began vomiting & exp chills; Epi given;
Pt reported that about 1 hour after receiving immunization they did not feel well and went to sleep for 3 hours. upon awakening they stated that their face and tongue felt numb and well as weakness  on left side. Primary care Doctor advised pt. to go to ER to be evaluated for possible stroke. Pt went to ER stated they had MRI and cat scan as well as blood work done. There were no findings of stoke according to patient. Pt, was advised to follow up with a neurologist On 5/26 patient contacted pharmacy to report incident. Still reported left side leg weakness and facial numbness.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 17-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000903:
Anaphylaxis- patient unconscious briefly prior to receiving Epinephrine. After injection, patient slightly arousable- transferred to ED via EMS.
Left arm - Soreness, shoulder pain, shoulder joint pain, limited range of motion in shoulder joint. Exercise, heat and cold packs, ibuprofen, acetamenaphin. Pain still exists after 4 months.
stopped taking Paxlovid on 25May2022. On 01Jun tested positive again for COVID; stopped taking Paxlovid on 25May2022. On 01Jun tested positive again for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9265), in right arm, on 18Feb2021 as dose 2, single (Lot number: En6203), in right arm, on 08Sep2021 as dose 3 (booster) , single (Lot number: Ew0191), in right arm and on 12Apr2022 as dose 4 (booster) , single (Lot number: Fk9895), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "osteoporsis" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: tested positive again for COVID. Concomitant medication(s) included: ADVAIR HFA; ATORVASTATIN. Past drug history included: Erthomycin, reaction(s): "known allergies: Erthomycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "stopped taking Paxlovid on 25May2022. On 01Jun tested positive again for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (01Jun2022) positive, notes: On 01Jun patient tested positive again for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient stopped taking Paxlovid on 25May2022. On 01Jun tested positive again for COVID.
A spontaneous report was received from a pharmacist concerning a patient, unknown age, who received COVID-19 vaccine and the needle coming off the syringe and some of the dose went down the patient's arm. The patient's medical history was not provided. No relevant concomitant medications were reported.  On 04 Feb 2021, the patient received their first of two planned doses (Batch number not provided) intramuscularly in arm for prophylaxis of COVID-19 infection. On 04 Feb 2021, while vaccination the halfway through administration of the vaccine, the needle came off the syringe and some of the dose went down patient's arm. Action taken with response to the event was not reported. The outcome of the event was considered resolved on 04 Feb 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered with no associated AEs.
This is a spontaneous report from a contactable registered nurse for her daughter via a Pfizer sales representative. A 17-year-old female patient received the first dose of TRUMENBA via an unspecified route of administration on an unspecified date, reported as about a year and two months before, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced minor swelling. Outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX and Flu vaccine with an associated reaction of influenza.  In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the erythema of extremities, shingles and swelling arm were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, shingles, swelling arm and pain in arm to be related to SHINGRIX. Additional information was received as follows: This was reported previously to the doctor. The patient received SHINGRIX on the left arm. The patient stated that at the beginning of August 2018, she received the 1st dose of SHINGRIX. The patient stated that later that same evening of vaccination day, she experienced redness and swelling in her left arm. At the injection site, there was red dot that was the size of a thumbtack. Approximately 3 inches below the injection site, there was an oval-shaped reddened area that was swollen and the size of the red, swollen area was approximately 1.5 inches long and 2.5 inches wide. There was a straight line connecting the injection site to the red, swollen area that was 3 inches below the injection site. The patient stated that her left arm got sore every once in a while. The patient stated that she had a case of the shingles a couple of weeks before the reporting date, and it was one spot on her neck. The patient did not wish to provide her physical address.
Pt was given nasal (LAIV) H1N1 vaccine and shortly after pt started to have blurred vision and lightheadedness. Pt given water, fresh fruit and lied down over 20 min and her blood pressure and blood sugar went to normal range.
Patient developed fever, diarrhea, and rash that spread to her trunk. A day later the rash spread to her face, ears, and extremities. There was redness at the injection site, then spread into a rash. Provider prescribed Acetaminophen, cetirizine, and diphenhydramine. Patient came back into clinic 4/25/2019. All symptoms had improved except the rash which was almost resolved at that time.
Soreness at injection site from 6-48 hours after injection; rigors from 16-19 hours after injection; fever from 12-36 hours after injection.
3/10/17 2 days after - neck pain 3/11/17 3 day after - fever, runny nose, congestion and ear pain and rash. Treatment has been self medicated with allergy meds and OTC aids to reduce fever.
FEVER OF 104, LEFT ARM INFLAMMATION AND REDNESS 14 X 10 MM AREA, LYMPH NODES UNDER LEFT INFLAMMED PER DR'S OFFICE
Flu shot provided on 3/22/2016. Facial numbness, facial droop, difficulty speaking, arm/hand numbness, decreased object recognition and processing sensations all right sided on 3/30/16.
A week or so after the booster shot I start getting pain in my stomach.  I assumed it was heartburn issues this continued to get worse and the pain escalated.  By the end of the month I was in the hospital.  I could not eat without pain, I should not sit/stand/lay without immense pain.  The pain was from front to back in the center of my body right underneath my sternum.
PT WAS GIVEN DOSE OF TD BOOSTRIX VERSUS ADULT TDAP. PT CONTACTED.  NO ADVERSE REACTION NOTED.  CDC CONTACTED AND PROVIDED WITH GUIDANCE.
Unable to fully lift arm, intense/sudden pain with no factors causing it, wakes during sleep, OTC interventions not working
Facial jerks and upper body jerks + eyes deviating upward after receiving vaccines 1/16/08.
10 x 12cm area of redness and induration R upper arm surrounding inj site.
Delayed onset swelling/rash at the injection site. Slightly warm/tender/inflammed to touch.
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a 20-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 04-Dec-2011. On 06-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reported causality assessments are not applicable, and the event is considered resolved.