chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fast heart rate, of approximately 137 bpm, with littlemovement; This is a spontaneous report from a contactable consumer, the patient. A 55-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in left arm on 04Mar2021 at 15:00 hours (at the age of 55-years) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809) via an unspecified route of administration in left arm on 09Feb2021 at 15:30 hours as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to Sudafed. Concomitant medications included levothyroxine 112 mg (MANUFACTURER UNKNOWN), Lumigan 0.01 percent (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN). The patient took these medications with 2 weeks of vaccination and exact therapy dates and indication of these medications were not provided. Prior to vaccination, the patient was 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 4 weeks prior to the COVID vaccine. On 05Mar2021 at 05:00 hours, approximately 12 to 14 hours after the second vaccine was injected, the patient experienced a fast heart rate, of approximately 137 bpm, with little movement. The patient was given an intravenous (IV) and baby aspirin. The clinical outcome of the event increased heart rate was resolved.   No follow-up attempts are needed. No further information is expected.
The patient stated that her arm was red and slightly warm to the touch from the injection site to the elbow 1 day after the injection. It was recommended that she go to an urgent care to get it looked at. The patient refused.
Expired Menveo administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA701A, expiry date 28-FEB-2023) for prophylaxis.   On 01-MAR-2023, the patient received Menveo. On 01-MAR-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired Menveo administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 29-MAR-2023 The licensed vocational nurse (LVN) reported that a patient received an expired dose of Menveo. The reporter consented to follow up via email. The patient received an expired dose of Menveo, which led to expired vaccine used.
Allergic reaction, itchy all over, taking Prednisone and Benadryl
Patient said he lost feeling in his fingers. Can't sense hot vs cold, etc. Also, said he lost strength in arm/hand and drops things frequently. He said he got pretty sick the next day, but that the doctor attributed this to possibly having COVID previously.
pt dx w/sz & anemia; pt exp pale, limp, blank staring spell, shallow resp, unresonsive, 02 sat 84%, staring, lt sided sz, rigidness of extremities, BSER showed abn w/lt elliptical discharges present;
Blister, around 2cm diameter, redness around blister. No itching, no pain, no fever, normal BP. Mild HA
Information has been received from a registered nurse concerning a female between the ages of 14 to 21 years old who was vaccinated IM into the deltoid region with a first 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced extreme pain during injection. No medical attention was sought. About 15 to 20 minutes after injection, the patient was improving. No product quality complaint was involved. Additional information has been requested.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Additional Details: pt reported today she develop a blistered like rash at the site of injection for the past 7 days after receiving vaccine and start having tingling at the injection site.
30AUG local react-red swollen, dime size, tender to touch; high pitched cry for 3 hrs; unconsolable; felt warm to touch t99.6 R, nursed poorly; slept 930Pm-6AM (unusual) 930AM; today 31AUG local react the same-irritable-unconsolable;
the patient "reported significant injection site pain in his left deltoid, and significant motor weakness in injection site arm".; the patient "reported significant injection site pain in his left deltoid, and significant motor weakness in injection site arm".; This spontaneous report was received from a physician , concerning a 61-years-old male patient. The patient's concurrent conditions included type 2 diabetes mellitus, hyperlipidaemia, benign prostatic hypertrophy, and blood pressure high. His concomitant therapies were unknown by the reporter. The patient had no known drug allergies.  On 21-JAN-2020, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) injection,  intramuscularly, in left deltoid, as prophylaxis (reported as "age dependent vaccine") (strength was not reported; lot number S005856 has been verified to be a valid lot number for pneumococcal Vaccine, Polyvalent (23-valent) with expiration date: 03-DEC-2020).  On 24-JAN-2020, the patient reported significant injection site pain in his left deltoid, and significant motor weakness in injection site arm (injection site reaction). It was reported that no laboratory diagnostics or studies were performed. However, the patient sought medical attention, and the physician recommended ibuprofen at a dose of 800 mg, three times per day, and if it did not resolve, the physician told the patient to go to urgent care or emergency room. At the reporting time, the patient had not recovered from injection site pain and injection site reaction; and the patient had not required hospitalization due to the events.   The causal relationship between the aforementioned events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not provided.  It was reported that injection site reaction and injection site pain were not cancerous, disabling or life-threatening events.   Physician requested a lot check; therefore a lot investigation has been initiated.
soar arm; Not convinced their was any vaccine in her shot / forgot to ask to see the vile because she was so nervous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soar arm) and NERVOUSNESS (Not convinced their was any vaccine in her shot / forgot to ask to see the vile because she was so nervous) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (soar arm) and NERVOUSNESS (Not convinced their was any vaccine in her shot / forgot to ask to see the vile because she was so nervous). At the time of the report, PAIN IN EXTREMITY (soar arm) and NERVOUSNESS (Not convinced their was any vaccine in her shot / forgot to ask to see the vile because she was so nervous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Pt recvd 3 Engerix-B vax on 0,1,6 mo schedule;17DEC90 titer indicated little response.
Recipient received first dose of Moderna vaccine on 1/20/21 and reported on 1/30/21 site was red, warm to touch and itchy. Recipient contacted her PCP who informed her it was the "Moderna Rash".  No other issues to report.
chickenpox-like rash; rash is pustular and vesicular.; red and itchy along a nerve; itchy along a nerve / comes and goes in waves and in patches; It comes and goes in waves and in patches; "welt" on his right ankle/fingers; This case was reported by a pharmacist via call center representative and described the occurrence of varicella-like rash in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cyst removal (cyst had been presented for years) and bug bite. Previously administered products included Shingrix (received 1st dose on an unknown date).   On 27th May 2020, the patient received the 2nd dose of Shingrix. On 8th June 2020, 12 days after receiving Shingrix, the patient experienced varicella-like rash, vesiculopustular rash, red rash, itchy rash, patchy rash and welts. On an unknown date, the outcome of the varicella-like rash, vesiculopustular rash, red rash, itchy rash, patchy rash and welts were unknown.   It was unknown if the reporter considered the varicella-like rash, vesiculopustular rash, red rash, itchy rash, patchy rash and welts to be related to Shingrix.  Additional details were reported as follows: After receiving Shingrix, the patient developed a chicken pox type rash that was pustular and vesicular in nature, but was not painful.  The rash was red and itchy along a nerve. It came and went in waves and in patches. The patient had bug bites from doing yard work but started to notice that the areas started to appear on his trunk along the areas where shingles usually occurred. The patient also had areas on both legs and arms that seemed to be appeared in waves and go away.  At the time of reporting, the patient had what appeared to be a welt on his right ankle and on his middle and index fingers. The reporter was consented to follow up.
Information has been received from a nurse practitioner concerning a 10 year old female who on unspecified dates was vaccinated with her first two doses of Gardasil (Lot # and route not reported). The patient experienced burning at the injection site during her second vaccination with Gardasil. The injection site became fevered, red and swollen with 2x3" knot after the second vaccination. The patient was treated with and ice pack and MOTRIN. The patient recovered in 4 days. On 05-MAR-2008 the patient was vaccinated intramuscularly in the left deltoid with her third vaccination of Gardasil (Lot # not reported). The patient experienced burning at the injection site during her third vaccination. The injection site became fevered, red and swollen with a 2x3" knot after the third vaccination. The patient was treated with ice pack and MOTRIN. The patient recovered in 4 days. The patient sought unspecified medical attention by calling the office. Additional information has been requested.
Patient had severe discomfort from neck down to shoulder on right side. Did not feel well, and had flu-like symptoms for 4 days after receiving vaccine. Receives flu shots every year - this is first reaction.
slight pain at the site/slight pain in the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 13:30 (Lot number: EN6207) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "had COVID-19 infection", start date: Dec2020 (unspecified if ongoing), notes: Patient's Medical History (including any illness at time of vaccination). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 16Mar2021, outcome "recovered" (16Mar2021), described as "slight pain at the site/slight pain in the injection site".  Additional information: Caller, (withheld) took the 1st dose last 16Mar2021. The 2nd dose will be on 07Apr2021, which was more than 21 days. As per the caller he will have dental procedure for implants on 05Apr2021, and the dentist has prescribed antibiotics prior to the procedure. Adds someone told him that antibiotics might interfere with the vaccine. He was asking if antibiotics will interfere with the 2nd dose vaccine. Mentions the only side effect he had was a slight pain in the injection site that went away that day. Adverse event did not result in Emergency visit and physician office visit. History of all previous immunization with the Pfizer vaccine considered as suspect: none. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. Prior Vaccinations (within 4 weeks): none. Family History: none. Relevant test: none. Prior Vaccinations (within 4 weeks): none. Other Products: No. Investigation Assessment: No.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021368204 same reporter/drug/event, different patients.
Tingling (pins and needles) in bilateral hands, lasted approximately 24 hours, now improving but not resolved No treatment yet
upper resp infection- dry cough, nasal congestion, rhinorrhea, and sore throat
Initial report received from a healthcare professional on 17 September 2013. A 58-year-old female patient had received an intramuscular dose of FLUZONE, (lot number UH894AA) in right deltoid on 10 September 2013. The patient had no illness at the time of vaccination and allergies were unknown. On 12 September 2013, the patient experienced "explosive diarrhea". Laboratory data and corrective medications were not reported. At the time of this report, the patient had not recovered. Documents held by sender: none.
Swelling in armpit hurt to touch. Felt knots and pulling when move. This is my 2nd flu shot & this is the 2nd time this has happen.
Child is experiencing severe headache and neckache along with a fever. This is the second vaccination in the series. She had the same post vaccine symptoms with the first injection but this time she also has a fever. Her chief complaint is neck pain.
Patient received vaccine at 1031a, symptoms started at approx 1040am, started with visual disutrbances and dizziness, progressed to sweats, tachycardia, hypotension and nausea, suggested to patient to go to ER for further evaluation and patient agrees, medics called for EMS transport to ER
Patient experienced onset of symptoms redness, swelling, soreness, injection site warm to the touch starting about 6 hours after administration and lasting through today.  The injection site is surrounded by a demarcated red area of approximately 3" diameter and extends down her arm appearing red and splotchy. Patient also c/o itching at injection site and site feeling painful with movement which was relieved with OTC acetaminophen.  Patient also experienced an immune response following vaccine including fatigue, and "just not feeling well."
Skin blistering and itching beginning as single small blister-like bumps, spread from five lesions to all over the left arm, left leg, upper back and collarbone area; Skin blistering and itching beginning as single small blister-like bumps, spread from five lesions to all over the left arm, left leg, upper back and collarbone area; This spontaneous case was reported by a patient and describes the occurrence of BLISTER (Skin blistering and itching beginning as single small blister-like bumps, spread from five lesions to all over the left arm, left leg, upper back and collarbone area) and PRURITUS (Skin blistering and itching beginning as single small blister-like bumps, spread from five lesions to all over the left arm, left leg, upper back and collarbone area) in a 27-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 12-Dec-2022. Concomitant products included PREDNISONE for an unknown indication.    On 06-Aug-2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On 07-Aug-2023, the patient experienced BLISTER (Skin blistering and itching beginning as single small blister-like bumps, spread from five lesions to all over the left arm, left leg, upper back and collarbone area) and PRURITUS (Skin blistering and itching beginning as single small blister-like bumps, spread from five lesions to all over the left arm, left leg, upper back and collarbone area). At the time of the report, BLISTER (Skin blistering and itching beginning as single small blister-like bumps, spread from five lesions to all over the left arm, left leg, upper back and collarbone area) and PRURITUS (Skin blistering and itching beginning as single small blister-like bumps, spread from five lesions to all over the left arm, left leg, upper back and collarbone area) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: did not show a chronic autoimmune condition. On an unknown date, Blood test: confirmed it is not a viral infection.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       The patient did not experience any additional symptoms/events.  There were no additional lab data/results available.  No treatment medications were provided.
No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 22-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
According to the patient, she experienced severe red and hot rash and hive all over her body. She had discomfort breathing and had to go to ER for treatment. She is currently taking loratadine and Benadryl to help treat the rash.
It gave me Covid symptoms that started about 12 hours after the shot.  Body aches, fever, chills, congestion, exhaustion, nausea & dizziness.  That mostly resolved after 2 days.  Then 1 week later on Saturday, I started having pain in my left leg where I had had RFA of the greater saphenous vein 6 months prior.  Leg swelled up got a hard knot.  I got dizzy & nauseated.  The pain increased, & I went to the ER on 3/21.  They diagnosed it as thrombophlebitis.  The pain & inflammation  has continued  for 3 weeks now despite the use of anti-inflammatory meds & support hose.  I have also had rapid weight gain of 12 lbs and edema not relieved by lasix.  Two weeks after the shot I also started having severe nose bleeds.
I received Gardasil Vac. on August 15, 2008. I received the injection in my upper left arm. A(back side) 30 Days later I went to my Family Doctor for a growth that was right where I recieved the injection. Upper left arm. (back side). September 18 2008, I went to a surgeon September 26 2008 MRI, and then October 3 2008 I had Surgury. October 14 2008 had follow up with surgeon. She told me to tell the doctor who gave the injection to me. I did and they contacted Merck. Now I am telling you because I was told to. 11/12/08-records received for DOS 10/3/08-DX: Left upper arm mass. Left upper arm mass excision with biopsy.
According to his father patient had fever 12AM (high fever), developed a seizure (300AM) (febrile seizure) as per doctor in hosp. 2/5/09-records received for DOS 12/10-12/12/09-DC DX:Fever after immunization shot. Developed fever after immunization given with some shaking and arching of back, rigid, eyes turned backwards.
Erythema & edema developed about 12 hours after injection in RLE.  Positive pain.  Pt seen about 40 hours after injection and diagnosed with cellulitis.  Pt had fever per mom.
Elevated Liver Enzymes 600's; Sensitive Skin (the entire body); Chills (Without Fever); Sore arm; Sore arm; A spontaneous report was received from a consumer concerning a 59-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events achy all over the body, sore arm, chills (without fever), elevated liver enzymes 600's, sensitive skin (the entire body).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 9 Feb 2021, prior to the onset of the events the patient received his first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the events achy all over the body, sore arm , and chills (without fever), sensitive skin (the entire body).   The lab tests included elevated liver enzymes 600's performed on 12 Feb 2021.  Treatment details included Tylenol Extra strength 500 mg every 4 hours.  Action taken with mRNA-1273 in response to the events was not reported.   On 11-Feb-2021 outcome was recovered for achy all over the body, Sore arm, Chills and unknown for Sensitive Skin and Elevated Liver Enzymes.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient was given Varivax(Merck) on 6/5/2007. On 6/6/2007 she developed a circular swelling measuring 7x3 cm on her arm where it was given. It is red and hot. She has no other symptoms.
Myalgia Malaise Narrative: Per supervisor report: "called in sick today, Julys 30 after receiving COVID vaccine. Feeling sick all over. "
7 people had died from Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "7 people had died from Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Age + years/months/days: 50-99. Age Group: Elderly (greater than equal to 65 years). Moderna has proven to be effective against COVID-19; Pfizer is not that effective when the reporter first heard about it. 7 people had died from Pfizer; So that made a change in mind about taking Moderna. Plus, the Primary Care doctor suggested Moderna based of these stories that the reporter heard. The reporter considers the event as caused by the suspect product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300139954 Same reporter/event/drug, different patient;; Reported Cause(s) of Death: 7 people had died from Pfizer
I have had a heart murmur, an irregular heart beat, beginning shortly after the second dose 1/4/2022 and continuing to this day.