chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 at 12:00 as dose 1, single (Lot number: EN6201), in left arm, on 13Mar2021 at 12:00 as dose 2, single (Lot number: EN6204), in left arm, on 20Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 19Feb2022 at 02:00 as dose 4 (booster), single (Lot number: FJ6369) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "Allergy to penicillin" (unspecified if ongoing); "Allergy to Sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxycilin for Allergy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: After completing Paxlovid I am now at day 11 from my first positive test; Positive, notes: still testing positive and running a low-grade fever. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had not received other medication in 2 weeks. The patient had received, anti viral COVID 19 treatment, on 08May2022, and treatment stop on 12May2022, (Lot number: FY4422) for treatment of COVID-19. Reporter stated, after completing Paxlovid I am now at day 11 from my first positive test, and day 10 since starting Paxlovid. I am still testing positive and running a low-grade fever. Nothing too serious but I'm exhausted and wondering how long I should expect to have it. Adverse event start on 13May2022 12:00 AM, with not recovered outcome and patient had not received adverse event treatment. Patient had known allergies with penicilin, amoxycilin and sulfa.  No follow-up attempts are possible. No further information is expected.
On the 02/09/2021, 3 days after my injection, my injection site  was itchy and the next day I noticed it was red. And the next day  I noticed  it was hot and swollen. I noticed it was hot to the touch. I took an aspirin. By 02/19/2021, it continued to spread  on my arm and it was not getting better . On the 02/19/2021, Dr. diagnosed it as a COVID arm  and  the treatment given was  Fluticasone (Flonase). The  Covid arm resolved after a couple of days.
This spontaneous report as received from a medical assistant (C.M.A.) refers to a female patient of unknown age. On 03-DEC-2012, the patient was vaccinated intramuscularly with her third dose of 0.5 ml GARDASIL (lot # 666598/0786Z) that had expired on 18-OCT-2012. No adverse effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Patient was only given the liquid; Patient was only given the liquid; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's Comments:  The patient was only given the liquid before reconstituted. Additional Supportive Information: The patient was only given the liquid before reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023AMR010183:Same reporter
Extreme itching at the site of vaccine.  Few days later was swelling, warm to the touch, redness and hard muscle at the site.  Itching continued.  Symptoms are subsiding 5 days after initial itching started.
Patient experienced red, raised, warm to the touch, rash about 12 hours after being vaccinated. Rash appeared to grow in diameter over  5 days. The rash has seemed to be resolved on the 6th day following the vaccination.
Patient received vaccine subcutaneously; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 5th May 2022, the patient received Boostrix. On 5th May 2022, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 06-MAY-2022 Reporters comment: The patient received Boostrix vaccine subcutaneously instead of intramuscular. The reporter consented to follow up. Additional supportive information: The patient received Boostrix vaccine subcutaneously instead of intramuscular, which led to intramuscular formulation administered by other route.
Her bones were hurting her; hip was hurting more/ pain in hip; Dental implants and bridge fell out; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar event for two patients. This is the 1st of two reports. A 75-years-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Batch/lot number: EK5730), via an unspecified route of administration on 16Dec2020 at single dose for covid-19 immunization (reported as works with COVID patients on daily basis). Medical history included hypertension, hip replacement from an accident four years before 07Jan2021 in December (Dec2016). The patient was not overweight, exercises, was older, but considered in good health. The patient's concomitant medications were not reported. The past vaccine event included weak after the Flu shot. Couple weeks after first vaccine, before new year (Dec2020), dental implants came out.  The patient clarified she was referring to dental implants had no pain, had a bridge in her mouth on the left lower side. Felt something was bothering her. Noticed her bridge lifted up and her implants fell out. Had to go to doctor's and had it removed. Everything was moving. She was very uncomfortable. Surgery cost her almost $3,000. Surgery was 3 days before 07Jan2021 (04Jan2021) for her implants and bridge. Had to use bone graft. Her bones were hurting her. After COVID-19 Vaccine, her hip was hurting more. She stated the pain in hip beginning up to one week as of 07Jan2021. The had labs in Dec2020 and everything was ok. The event outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021011233 same reporter/drug, similar event with different patients
Notified of condition by the state 5-8-17 Pt states was Dx with cellulitis on 2-9-17 by MD. Was Tx with KEFLEX. States was in (Rd) where received PNEUMOVAX. States did not get better and has been under the care of ortho. States has a torn rotator cuff as a result of the PNEUMOVAX vaccine. States is scheduled to see MD at ortho to have schedule surgery. Health Department has records of MRI/Xrays and cellulitis Tx.
Later that evening I couldn't move my left arm and I was in a lot pain, To tell you that I can't even put my own bra and I can't even dress myself, I need help from my daughter. I think he messed up my nerve because I can't even move it up. Other than that I didn't have any other symptoms but my arm. I haven't been to my provider but now I'm thinking of going to get maybe a X-ray because of the pain.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 1/23/21 and 2/13/21. Admitted 2/23/22 with Covid at local hospital c/b AKI needing CRRT. Transferred to ICU 2/2 renal transplant. Admitted w/acute hypoxic respiratory failure 2/2 Covid PNA and acute encephalopathy. MRI 2/26/21 w/perforated bowel 2/2 right colonic ischemia. Acutely decompensated with a large increase of vasopressor needs and refractory acidosis despite maximized ventilation techniques and CRRT. Transitioned to comfort care and expired on 2/26/22. Treated with vancomycin and Merem at hospital. Treated with vacomycin, cefepime, micafungin, and Cresemba.
Patient received Pfizer instead of Moderna by mistake for her second dose. Patient had no physical or emotional reaction. Patient was made aware.
Pt recv vax on 3/5/98; 15 min post vax pt exp swollen tongue x 20 min
First few days arm was sore, now pain is at 8/10. Can lift arm above head, but not completely. Has tried Ice, Ibuprofen, & Tylenol
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number Z4359, expiry date 19th September 2021) for prophylaxis.   On 7th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In July 2019, less than a month after receiving Shingrix, the patient experienced shingles. The patient was treated with medication unknown. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The patient did not know date of onset of Shingles, but stated that, she went to a medical doctor and was starting on medication to treat the shingles today. The reporter did not consent to follow up.
11:37am Vaccine was administered 11:40am reported numbness of the tongue, lips, sweat on forehead, flush, ringing in the ears, and dizziness. Denied chest pain, denied shortness of bread, and denied difficulty breathing. Immediately the rapid response team assisted the patient along with the provider whom she had a dr's appointment a few minutes prior to receiving 1st moderna vaccine.  11:42am Left arm sitting 1st BP taken; BP:169/48,  P: 88, O2%: 99 11:50am left arm sitting 2nd BP: 168/92, P: 81, O2%: 99 11:52am Right arm sitting 3rd BP: 147/75, P: 84, O2%: 99 12:02pm  was discharged from care. Provider Dx: Zero allergy to moderna vaccine, patient had vaccine anxiety
Patient had odd rash from head to toe for several days and a fever for 4 days. She became very ill. Developed more of an intolerance for eggs. (flu vaccine) began choking on her fluids. Is now on NG tube.
NEARLY DIED; MEDICATION ERROR; FEVER OF 104; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced nearly died, medication error, and fever of 104. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 104, and the outcome of nearly died and medication error was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Had Pain and decreased mobility in left arm after vaccines administered.  Went to Dr. the next day and he gave her Neproxin and Lortab for the pain.  Several days later she was unable to move her left arm and went to the ER where she had a CT scan and was diagnoses with fluid in the Bursa.  She called her Dr. who referred her to a sports medicine Dr. for treatment.
At 4:45 am on 1/28/2021, woke up having body aches, and headache.   At 3:30pm, began having chills.  At 6pm, had 101.9 fever. Continued to have body aches and chills. Took tylenol. Fever broke around 9pm. Body aches contininued until next morning .  Felt back to normal on 1/29/2021 around noon.
i am 5'10" and weigh 145#. Cross country coach. Descent shape.  I am having Heart palpitations since getting shots. Never issue, ever before.
at approximately 11 PM on 7/31, my son started complaining about chest pain. As he was laying in bed he felt chest pain while he was breathing. He described it as a significant pressure causing pain (asked about pain level 1-10, he said 8, he was in pain) being stubborn he wanted to sleep it off, he ended up getting some sleep last night but this morning he is still feeling the pain while inhaling, current level of pain he describes as 4. I checked his blood pressure it was normal but I noticed increased heart rate at 94 per minute at 10 AM on 8/1.
Systemic: Joint Pain-Severe, Additional Details: Pain on left side of body, in hip area. Started following vaccine.
This spontaneous report as received from a healthcare worker (also reported as Certified Medical Assistant (CMA)) refers to unspecified patients (less than 5) of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On an unknown date, the unspecified patients were vaccinated with improperly stored GARDASIL (lot#, dose, route and frequency were unknown). The reporter was at the early stage of identifying how many patients were involved, so she was unable to provide further details at this time. No adverse symptoms reported. The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. It was reported that on 04-DEC-2018, the patient received an improperly stored dose of PROQUAD (Lot # R012416 and expiration date 28-OCT-2019), subcutaneously (dose and anatomical location were not reported) for prophylaxis. The dose of PROQUAD was exposed to a temperature excursion of 11.9 Fahrenheit (F) during a timeframe of 117 hours, which was detected by a digital data logger. The vaccine was reconstituted with properly stored sterile diluent. There were no previous temperature excursions. No adverse event. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1903USA002600: US-009507513-1903USA002596: US-009507513-1903USA002597: US-009507513-1903USA002599: US-009507513-1903USA002598: US-009507513-1903USA001826.
on 12-20-2020 complained of arm soreness, muscle aches, low grade fever and cough for 24 hours.
Narrative: Patient received first dose of Pfizer COVID19 vaccine on 6/4. On 6/5, presented to non facility hospital ED with " a blister under his right arm and a break-out under his chin" . Per patient, received medications in ED (unknown drug/dose) and was discharged from ED.
Received 2nd covid vaccine and by the next morning my left hip began hurting.  Had nausea, fatigue and increased left hip pain on Saturday and left hip and leg pain on Sunday.  On Monday 1/25/21 I developed neck pain and left sided sciatic pain along with the continued left hip pain.  By Wednesday 1/24/21 I was having increased difficulty walking and had to take off work.  On Thursday I had an appointment with my PCP who agreed this was a covid vaccine side effect and recommended rest, heat and Aleve over the weekend.  By Monday 2/1/21 I was able to come back to work but walking was very difficult due to continued left sided pain, particularly in my hip.  Today I am 90% better but I still have altered gait due to leg pain.
The pharmacist applied the bandage first and then gave me the vaccine injection THROUGH the bandage. I have redness and swelling of the injections site. My fear is that a piece of the bandage was injected into my muscle and I will develop an abscess. I AM REPORTING THIS BECAUSE IT WOULD NOT BE BECAUSE OF THE VACCINE ITSELF, BUT BECAUSE OF THE IMPROPER INJECTION TECHNIQUE AND MAY OCCUR TO OTHERS RECEIVING AN INJECTION FROM THIS PHARMACIST. ***********Please call me for details.*********** If you see a cluster of abscesses in the area this may be the cause. (I have saved the bandage.)
Heart palpitations, high blood pressure when standing up, dizziness, chest pressure No treatment taken
Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, severe muscle and joint pain, hypertension, tachycardia, severe skin sensitivity, abdominal epigastric pain and spasms, severe cough, dizziness, lightheadedness. Reaction symptoms were not all immediate and developed over next 3 days requiring evaluation and treatment in the ER. I required decadron injection to stop inflammatory response and was sent home on oral decadron. I am still experiencing symptoms but not as severe. I have to take my albuterol inhaler so I can breathe easier. My monocytes count was elevated.
fever and chills; vomiting, a lot of vomit about 20 times; wheezing; he had stomach ache and sharp pain in his stomach; very, very nauseous; Worse side effects; This is a spontaneous report from a contactable consumer (Reporter Mother of the patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date 2, single dose for COVID-19 immunization. No medical and concomitant medication history were reported. After the 2nd dose vaccine patient had worse side effects, fever and chills, common side effects. It was states she gave him Advil and patient was able to sleep and 4 hours after the Advil he woke up vomiting. Patient had a lot of vomit about 20 times, almost 20 times. In the morning patient started wheezing, had a stomach ache and sharp pains in stomach. Patient was very nauseous. He had a lot of pain in his stomach. Reporter states that the doctor, was no help to her. She was very worried, today patient woke up better, no more vomit, no more stomach ache. She saw on the news, about 1 boy who had the same side effects, inflammation in his heart. Patient was better now but she did not know if patient has Myocarditis now because the Boy in the news had the same side effects as her son and also had vomiting and stomach ache. She just needs to know what she needs to do. Is this a normal side effect. She would just like to know what to do for her son. She canceled her doctor because she told her that her son had no side effects from COVID-19 vaccine. The outcome of the events were unknown.    Information on batch/lot no. has been requested. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021581782 similar report from same reporter
Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 15-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L045953 (dose, route and site and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
severe anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 6 patients. This is 4th of six reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at a single dose for vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced severe anaphylaxis with vaccination on an unspecified date. Outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003207 same drug/event and different patients
Only adjuvant administered; Only adjuvant administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number AB377, expiry date 29th September 2023) for prophylaxis.   On 16th February 2023, the patient received the 1st dose of Shingrix. On 16th February 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter was a nurse. The reporter reported that on 16th February 2023 the patient received only the AS01B adjuvant portion of the Shingrix vaccine. The reporter did consent to follow up. Additional supportive information: Only adjuvant of shingrix administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
CALF CRAMPS; MUSCLE PAIN; NAUSEA; DIARRHOEA; FATIGUED; ARM HURT; ANEMIC; VACCINATION SITE BUMP; VACCINATION SITE RASH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced anemic. On MAR-2021, the subject experienced vaccination site bump. On MAR-2021, the subject experienced vaccination site rash. On 07-MAR-2021, the subject experienced arm hurt. On 08-MAR-2021, the subject experienced fatigued. On 09-MAR-2021, the subject experienced diarrhoea. On 09-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced calf cramps. On 10-MAR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm hurt, fatigued, nausea, diarrhoea, and calf cramps, had not recovered from muscle pain, and the outcome of vaccination site bump, anemic and vaccination site rash was not reported. This report was non-serious.
I have a knee pain; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program support.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported I have a knee pain. At the time of this report, the outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Flu like symptoms stated by patient for 2 wks after 4th shot seen at ship yard March 15,2004. States flu like symptoms increase with each shift. Symptoms-Blemish on right hand side of face. Signs-Blotchy spots (red). Does not itch nor does it irritate. Course and treatment-clinic prescribed Cortizone cream and it started to go away but never completely.