chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Feeling unwell; sore arm; Dizziness,; Nausea; Fatigue; Joint pain.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734) via an unspecified route of administration in the left arm on 03Apr2021 at 16:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and allergy to formaldehyde(allergy to chemical). Concomitant medications included topical steroids (unspecified medication) for psoriatic lesions. The patient previously took cephalexin (KEFLEX), amoxicillin, clavulanic acid (AUGMENTIN), sulfamethoxazole, trimethoprim (BACTRIM) and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03Apr2021 at 20:00 within four hours of vaccination, the patient experienced dizziness, nausea, fatigue and joint pain. On 04Apr2021 at 04:00 after 12 hours, the patient experienced headache, fatigue, feeling unwell and sore arm(pain in arm). The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events dizziness, nausea, fatigue, joint pain, headache, feeling unwell and sore arm were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Swelling of bicep area on left arm, redness and itching. Tenderness/tightness when arm is stretched out.  Swelling moved to upper part of forearm.  All within 2 days of shot.
She received the shot on 05/10/2018. She reported a stinging sensation that started on 05/13/2018 on her back. She came to the pharmacy on 05/15/2018 and asked me to look at the spots on her back and her stomach. I looked at the areas and it looked like shingles to me. I advised the patient to see her dr, and she did. Her dr agreed with me and said it was shingles. He started her on a steroid dose pack and valacyclovir.
Patient described mild symptoms of allergic reaction with 1st COVID-19 dose. She states that she did not require an epinephrine pen with her 1st dose. Given concerns for shortness of breath with 1st dose, she had epinephrine pen ready. After her COVID-19 vaccine she went to the bathroom and started having emesis. She also appeared short of breath. She had some visible throat swelling on exam. Given concerning symptoms for anaphylaxis, an epinephrine pen was administered to her left thigh. She immediately felt relief after the epinephrine pen and no longer had any further emesis or shortness of breath. 911 was contacted. Ambulance arrived and she was transported to the emergency room for further evaluation. Told patient she is no longer to have the COVID-19 vaccination due to her adverse allergic reaction.
Pt had COVID-19 symptoms  on 11/15/21 and tested positive on 11/22/21. Pt passed away on 12/24/2021
Patient developed fever, rigors, malaise and fatigue requiring assistance of others. She presented to ED and was treated with fluids and fever reducer. Due to severity of symptoms and underlying conditions, was admitted to the hospital overnight for observation.
On February 13, 2008, patient developed intussusception which was reduced by air enema without complication at Hospital. 3/6/08-records received-DOS 2/13/08-Seen in ED with C/O 12-16 hours of episodic abdominal pain accompanied by crying and bending of his knees up to chest and flexing his body. Emesis. Blood in stool. Decreasing oral intake.
Three days post vax on 09/02/1999 the pt developed a local reaction. One month later, on 10/05/1999, the pt was seen by a physician with an itchy red rash on lower forearm and legs. She was treated with Claritin, Axid and Atarax. Pt was seen by a dermatologist who diagnosed her as having Schamberg's purpura and recommended prednisone therapy which the pt declined. The rash continues but no longer itches. On 03/16/1999 the reporter stated that the pt has had resolution of the intermittent itching and rash that was diagnosed as Schamburg's purpura. These symptoms resolved approximately 1.5 months ago and she has had no further recurrence. The most recent information received reports the condition of the pt is resolved.
Patient received her 2nd dose Pfizer vaccine at 13;30pm and was sitting in observation room when she told staff she felt dizzy nd slightly out of sorts at 1:40pm.Patient continued sitting and VS taken at 1:46pm BP 112/82, HR 78, and O2sat 100%. Patient continued talking and stating she has been anxious coming in. VS @ 1:48pm 135/66, HR 74, O2sat 97%. VS 1:50pm 130/69, HR 74 and O2sat 99%. Patient stating that she is feeling better. VS @2pm BP 124/69, HR 69, O2sat 97%. Patient stated she feels comfortable to go home at 2;05pm.
Developed appendicitis 14 days after first shot; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 31Mar2021 16:00 (Batch/Lot Number: ER8737) (at the age of 16 years old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Facility type vaccine was reported as Pharmacy or Drug Store. There were no known allergies and no other medical history. There were no other vaccine in four weeks and no other medications in two weeks. No COVID-19 prior vaccination. On 14Apr2021 00:00 (12:00 AM), the patient developed appendicitis 14 days after first shot. Event resulted in emergency room/department or urgent care, it was life threatening illness (immediate risk of death from the event). Treatment included appendectomy.The patient received BNT162B2 in left arm on 21Apr2021 16:00 (Lot number: ER8736) at dose 2.COVID-19 test post vaccination was Nasal Swab (PCR) on 21Jul2021 with negative result. The outcome of the event was recovered on unknown date.
This spontaneous report as received from a pharmacist refers to an unspecified adult patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 20-MAY-2015 the adult patient was inadvertently administered a dose of PROQUAD (Merck) (lot number, expiration date, dose strength, route unspecified) (Drug administered to patient of inappropriate age). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 70 year old female patient with unspecified Non-Steroidal Antiinflammatory Drugs (NSAIDS) allergy and tetracycline allergy. On 17-JUL-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot number unspecified). The pharmacist reported that the patient experienced redness, swelling and pain at the injection site on an unspecified date that last 3 shortly after received ZOSTAVAX in July 2012. The pharmacist also reported the patient stated on 24-FEB-2013 that she now had the same symptoms again at the same site, but it was not as severe. The patient had been treated with unspecified antihistamine. No lab diagnostics studies performed. The patient present status was reported as not recovered. The patient had sought medical attention. The relatedness for the events to ZOSTAVAX was unknown. Additional information is not expected.
seizure same day, afebrile, fever on 11/18/2021 100.5F at 8am, received Diastat and 4mg of Versed, loaded with Keppra, resolved
immediately started to vomit after the oral dose of ROTATE was administered; immediately started to vomit after the oral dose of ROTATE was administered; This spontaneous report was received from a nurse practitioner, referring to a 4-month-old female patient. Her concomitant medications included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS) and pneumococcal vaccine conj 13v (CRM197) (PREVENAR 13). No information about medical history and concurrent conditions was reported.  On 05-JUL-2022, the patient was administered dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 2 ml orally, lot # W004504 established to be valid with expiration date 16-JUN-2023, for routine immunisation.  On 05-JUL-2022, right after the dose administration, the patient started to vomit (accidental underdose). The outcome of the event was recovered. Action taken with the suspect vaccine was not reported.  The causality assessment between the events and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not provided.
No adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 065F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 (Expired vaccine used).    Patient age was reported as 71 Year 3 Months.  No concomitant medication was provided.  NDC ID number was reported as 80777027398.   It was reported that also another lot of vaccines lot number O70H21A, was also expired and administered to patient and lot number 065F21A.was administered to patient between 08-Apr-2022 and 15-Dec-2022. Treatment medication was not provided by the reporter.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Lot number: GL2524) at the age of 75 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19 included Paxlovid.
felt hot; sweaty; queasy; 140/106-b/p; This is a spontaneous report from a contactable other hcp.   A 51-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 26Feb2021 15:00 (Age at vaccination 51 years old) (Batch/Lot Number: EN6203) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Penicillin. The patient's concomitant medications were not reported. on 26Feb2021 15:00 the patient experienced felt hot, sweaty, queasy, 140/106-b/p. The patient underwent lab tests and procedures which included blood pressure measurement: 140/106   on 26Feb2021, heart rate: 77 on 26Feb2021, oxygen saturation: 97 % on 26Feb2021. Outcome of the events was recovered on unspecified date of 2021.  No follow up attempts are possible. No further information is expected.
Seven hours after receiving the flu shot she developed SOB that lasted for two hours, also a headache and stuffy/running nose.
pt recv vax; exp severe adverse GI sx w/in 36-72 hr; sx included severe abd cramping; n & v & d;became diaphoretic & flushed prior to v;
Headache  brainfog, brain agitation, fatigue, injection site pain, left eye pain Narrative:
Patient has significant health history  Lung cancer with Mets to the brain. He went to the bathroom had extreme weakness, fell to the floor and had confusion. Went to the ED
Headache, Myalgia, Fever, chills Narrative: Low grade fever, chills, headache, bodyaches. Took Aleve OTC.
periorbital swelling, periorbital itching, low grade fever & nasal congestion/sneezing are reported in pt receiving 1 dose of fluogen vax; pt recvd vax 29SEP93 & on 30SEP93 exp sx;
Numbness that occurs mostly in the extremities of her left side of the body. Bell's Palsy in 11/98, no treatment.
Tired/sluggish, headache, fever, lack of appetite, constant urination, soreness in arm (much more than first shot). Did not have any of these side effects after the first shot in October.
Pt received H1N1 vaccine 02/24/2010, seen on multiple visits the first being 3/29/10 with numbness and tingling hands and feet, had referrals to EMG/NCS, neurology, lab work now to begin plasma electropheresis 5/29/10.
Heart palpitations (fast/fluttering/pounding heart) that lasted for a few hours (3 or 4) until I took medication (D-Hist- a natural histamine) that stopped the heart palpitations.
little tender spot for about a day; Initial information received on 06-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).   This case involved an adult patient of an unknown age and gender who experienced little tender spot for about a day (Rash macular), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site.   On an unknown date, unknown latency, the patient only had a little tender spot for about a day (Rash macular).  No relevant laboratory details were provided.  It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
This case was reported by a nurse via call center representative and described the occurrence of swelling in a 65-year-old female patient who received SHINGRIX. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 3rd May 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced swelling, erythema and pain. On an unknown date, the outcome of the swelling, erythema, pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the swelling, erythema and pain to be related to SHINGRIX. Additional information was reported as follows: The case was reported by contacting a GlaxoSmithKline employee that was a Medical Science Liaison (MSL). The patient was vaccinated with SHINGRIX by subcutaneous route instead of Intramuscular route, which led to inappropriate route of vaccination.
Patient contracted COVID after being fully vaccinated, no booster cough, shortness of breath, chills, congestion, fatigue, fever, anorexia, body aches, weakness
My arm was sore. there was a little itching. It was later in the evening that I felt very tired. I felt warm but I didn't have a fever. I developed chills. it lasted for several hours.
7/20/2022 Sinus congestion and slight cough, fatigue, and fever of 100.2.  Tested positive on At Home Covid 19 test.  7/21 Televist with doctor who prescribed Paxlovid and Azithromycin.  All symptoms continued until 7/30 when the sinus congestions began to diminish. Fatigue continues to linger, but sinus congestion is only noticeable first thing in the morning.
lymphadenopathy left axilla, induration and pruritus at injection site.  Narrative: Per patient: "So I received the injection in my left arm and now have a itchy, sore knot at the injection site. That's not the issue. My nodes under my arm are swollen and painful for which I've been taking NSAIDs with little relief. "Really noticed it Saturday [1/2/21]. Been using a warm compress which helps a little but not much. Haven't seen anyone yet."
Delirium; swelling inside of throat; dizziness; Slurred speech; neck pain; flushed skin; Heart palpitations; Headache; worse throat itchiness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 28Apr2021 15:30 (Lot Number: ER8736) as 2nd dose, single for COVID-19 immunization. Medical history included myocarditis from COVID, elevated BP and known allergies: Cipro and IV contrast dye for CT scans; all from an unknown date and unknown if ongoing. The patient previously took BNT162B2 (lot number: EW0150), 1st dose, on 07Apr2021 04:00 PM in the left arm for COVID-19 Immunization and experienced swelling inside of throat, dizziness, slurred speech and delirium at 56 years old. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had other unspecified medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07Apr2021 04:45 PM, the patient experienced swelling inside of throat, dizziness, slurred speech, delirium, immediate base of neck pain, flushed skin, heart palpitations, headache and worse throat itchiness. The patient did not received treatment for the events. The outcome of the events was recovered on unspecified date.  Information on lot/batch number is available; additional information has been requested.
pt says she developed a rash the day of the vax.  The next day she was having nerve pain from her hip down her leg where the rash was located.  On 4/13/21 she went to her PCP.  She had a culture for Shingles but it came back negative.  She was given a RX for Valtrex and gabapentin.  The medicine helps but within 24 hours of stopping the meds the pain comes back.  Pt states the rash is now gone but she still has nerve pain in the hips and legs.
Patient received Comirnaty on 9/24/23 and was given another dose on 11/2/23 at a vaccine clinic. Patient was offered the vaccine and consented to receive it at the clinic. The daughter then reported to us on 11/3/23 that the patient could not consent for themselves and had previously received the vaccine given. There were no adverse events reported to us.
Rash and red swelling of right arm below injection site. Very itchy.  Injection site painful.  Worse 2 days later.
Allergic skin reaction and mild cellulitis in Rt thigh measuring 12 cm x 12 cm of diameter of cirucular form.
Fever 101 degrees, coughing, aching. 6x4 inch welt at injection site. Very sore and itchy arm.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a patient of unknown age. The patient was vaccinated with MMR II (lot # not reported) on an unknown date. It was reported the patient had an anaphylactic reaction to MMR II but no more details could be provided. Whether the patients sought for medical attention was not reported. The outcome of anaphylactic reaction was unknown. Upon internal review, anaphylactic reaction to MMR II was considered to be an medically significant event. This is one of several reports received from the same source. Additional information is not expected.
Fever of 101d for 2 -3 days.; drop in blood pressure resulting in fall in in bathroom; Arm ache; weak low energy; drop in blood pressure resulting in fall in in bathroom; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:00 as DOSE 1, SINGLE for covid-19 immunisation (Age at vaccination 75 years). Medical history included cardiac disorder, implantable defibrillator insertion/ pacemaker. No other vaccine in four weeks. Concomitant medication(s) included lisinopril (LISINOPRIL); carvedilol (CARVEDILOL); apixaban (APIXABAN); clopidogrel (CLOPIDOGREL). The patient previously took entresto and experienced drug hypersensitivity. No covid prior vaccination. No covid tested post vaccination. On Feb2021 patient experienced fever of 101d for 2 -3 days, drop in blood pressure resulting in fall in in bathroom, arm ache, weak low energy. The patient underwent lab tests which included blood pressure measurement: drop on Feb2021 drop in blood pressure resulting in fall in in bathroom, body temperature: 101 on Feb2021. No treatment required for events. The outcome for all events was recovering.  No follow-up attempts are possible; information about lot/batch number could not be obtained.
A few days after getting both the flu shot and the tdap shot, in the same area of the upper left arm, I began to experience pain at the injection site. My arm had been in pain every day since. It hurts right now as I type this report.
Extreme chills 30-45 minutes long about 8-9 hours after the vaccine was given.
Patient experienced a loss of consciosness after vaccine.Patient was lowered to the floor.  Patient exhibited seizure activity, clonic movements, for a short period of time. Pallor noted to skin.  Patient regained consciousness.  B/P -120/78 Pulse-69 O2 saturation 99%. Patient was helped to chair. B/P was 102/68 in sitting position. Offered water and a candy pop.  Patient again became weak.  Lowered back down to the floor. EMS called.  AED was brought to patient's side. EMS arrived @ 5:15PM. Treatment of glucose check and VS by EMS.  BS was 105.  VS stable.  Standing B/p 120/70.  Mother declined EMS transfer to hospital. Stated she will bring patient to urgent care.  EMS escorted patient to thei car.  Patient fol Patient Follow Up on /1/26/2023- Patient's mother was called in AM.  They did not bring him to Urgent Care.  Patient went home and recovered.  Patient went to school the next moning 01/26/2023.
Patient received vaccination  and complained that  she has been having pain on the shoulder. She too Ibuprofen but the  pain is not letting  up for more than  two weeks now.
pt was given shot at 12:43 and was instructed to wait 15 mins. at the end of 15 mins pt stated that she wasnt feeling well. She stated the left side of her tongue was tingling and had burning in her right arm/hand (injection side) along with a small headache in the rear of the head. At 12:58 pt was given 50mg of liquid benadryl and stated that she immediately felt better. She noticed she had a little bit of pain in between her right neck and shoulder. At 1:13 the pt stated that she felt fine enough to leave. She left with her husband and were instructed to visit an urgernt care or ER if symptoms get worse and to call 911 if anaphylactic reaction occurs.
Large irregular shaped rash at injection site.  It is red, raised, and slightly itchy.  It is about 5 inches high and about 4 inches across.