chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other medical history: None. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
tinnitus; chest pain; weak; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus), CHEST PAIN (chest pain), ASTHENIA (weak), HEADACHE (headache) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus), CHEST PAIN (chest pain), ASTHENIA (weak), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, TINNITUS (tinnitus), CHEST PAIN (chest pain), ASTHENIA (weak), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.
chills, followed by body aches and fever, rash on left arm- continued to develop on right arm and neck/chest
no additional adverse event reported; lots: U015689 and U010395 have been administered to patients since the excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 22-SEP-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number U015689 had been verified to be a valid number; expiration date 18-MAY-2023). The temperature  excursion was at -12.0 degree Celsius (C), for a time frame of 1 hour and 50 minutes. No had previous temperature excursion. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA007144:
shortness of breath; tightness of chest; mild chest pains; This is a spontaneous report from a contactable consumer (Patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0167), via an unspecified route of administration, on 05Aug2021 at 14:30 (at the age of 27-year-old), as dose 1, single in left arm for COVID-19 immunisation at Pharmacy/Drug Store. The patient's medical history included pre-diabetic, alcoholism, and severe dust mite allergy. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Aug2021, after first dose of vaccine, the patient experienced shortness of breath, tightness of chest, and mild chest pains. Patient did not receive treatment for the adverse events. Adverse events resulted in Physician office visit. The patient had no COVID prior vaccination and was tested COVID post vaccination. The patient underwent lab test and procedure which included SARS-CoV-2 test (nasal swab): negative, on 13Aug2021. The clinical outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
pt recvd Hep B vax on 11JAN92; following the vax pt felt warm & lightheaded; tx was not required; sx completely resolved; no further details were provided;
Numb (like fell asleep) in Rt leg and both arms. Repeated vertigo & sharp pain in neck. Itchy left palm.
muscle and joint pain; muscle and joint pain; low grade temp (99.3); chills; headache; tiredness; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non pregnant female patient received first dose of BNT162b2 (COMIRNATY, formulation: solution for injection, Lot number: ENG207) via unknown route of administration in left arm on 12Mar2021 at 10:45 AM (at the age of 78 year old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included losartan, HCTZ, clonazepam (KLONOPIN) and fluticasone taken for unspecified indication. The patient did not receive vaccine in four weeks. On 13Mar2021 at 14:30, the patient experienced muscle and joint pain, low grade temp (99.3), chills, headache and tiredness. On 13Mar2021, the lab data included body temperature was low grade temp (99.3). The patient did not receive treatment. The outcome of the events were recovered.  No follow-up attempts were possible. No further information was expected.
The vaccine was received at approximately 3:45 PM on 3/20/21; that night there was only mild arm pain and chills just before bed. Chills and a fever continued the next day (temperature at one point was 100.2 F). A small redness was found at the injection site. The following day (3/22) I found that the spot was much larger, warm to the touch, and there was a hardened lump if pressing down. I drew a circle around the redness to see if it was growing. On 3/23 there was some brief itchiness and the redness only seems to have expand slightly (this could also have been my husband not being 100% accurate as he traced it in a poorly lit hotel room). The lump is about the size of an orange.
did not feel well; felt like he was trying to get feverish and really wasn't though; tired and went to bed early; This is a spontaneous report received from a contactable consumer.  An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 26Feb2021 (Batch/Lot number: unknown) at the age of 81 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "controlled diabetes" (unspecified if ongoing), notes: on a salt-less diet; "dementia", start date: 2013 (unspecified if ongoing), notes: because of an accident he had; "borderline anemia" (unspecified if ongoing); "seizures" (unspecified if ongoing); "urinating at night" (unspecified if ongoing). Concomitant medications included: VIMPAT taken for seizure; TAMSULOSIN; FINASTERIDE; CIPROFLOXACIN taken for nocturia, start date: 17Feb2021; IRON; FLU SHOT taken for immunisation, administration date Mar2021. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), administration date: Feb2021, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 25Mar2021 14:30, outcome "not recovered", described as "tired and went to bed early"; MALAISE (non-serious) with onset 26Mar2021, outcome "unknown", described as "did not feel well"; FEELING HOT (non-serious) with onset 26Mar2021, outcome "unknown", described as "felt like he was trying to get feverish and really wasn't though".  Additional information: He got first shot at the beginning of Feb2021 (reported as around 03Feb2021, 05Feb2021, or 06Feb2021) and second shot around 26Feb2021 in the afternoon (unknown time), or something. And after that, he waited two weeks and had a flu shot. He was on an iron tablet, but the doctor took him off of it. She added another one after the COVID. No ER or physician's office visit were required.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient admitted with shortness of breath. Patient required up to 4L of nasal cannula oxygen.
Day 6 (Jan 5) after injection painful swollen lymph nodes on left side collar bone Remain swollen as of today 1-16-2021 ,  Physician assessed me on 1-17-2021 during a routine exam and recommended I contact Moderna to find out if I should receive 2nd dose.
The patient (an employee) planned to receive the Moderna booster on 11/18/21. She was given a Moderna vaccine on that day. She later reported a reaction of hives from this booster (unclear onset) to her primary care provider, who identified that the booster dose was given at the 1st/2nd dose amount of 0.5 mL. Moderna booster dose should be 0.25 mL.
brain felt like it wasn't working; Dizziness; mental fog; exhaustion; weak; shaky; upper back neck shoulders and head all hurt; neck shoulders and head all hurt; neck shoulders and head all hurt; neck shoulders and head all hurt; Non-stop pressure behind her neck, forehead, eyes; Injection site arm throbbing really bad; This is a spontaneous report from a contactable patient. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 10:15 (Batch/Lot number was not reported), at the age of 35-years-old as a single dose for COVID-19 immunization. The patient is not pregnant. Medical history included poly cystic ovary syndrome. The patient had no known allergies. Concomitant medication included ethinylestradiol, etynodiol diacetate (KELNOR) for birth control; metformin; ascorbic acid, betacarotene, biotin, capsicum annuum fruit, colecalciferol, collagen marine, curcuma longa, cysteine hydrochloride, equisetum arvense, fallopia japonica, hyaluronic acid, iodine, keratin, lysine, methionine, piper nigrum, selenium, serenoa repens, tocotrienols nos, withania somnifera, zinc (NUTRAFOL); all start and stop date were not reported. The patient had side effects which started within 45 minutes (also reported as within 30 minutes) of injection. Dizziness, mental fog, she felt like she was looking in through someone else's body. She doesn't know how she drove home from appointment. Her brain felt like it wasn't working, chronic exhaustion, weak, shaky, upper back neck shoulders and head all hurt severely. Non-stop pressure behind her neck, forehead, eyes with headache. Injection site arm was throbbing really bad at night. Symptoms lasted 8 days. The events occurred on 26Mar2021 11:00. No treatment was received. The patient had no other vaccine in four weeks. The patient had no prior vaccination and was not tested for COVID post vaccination. The outcome of the events was recovered with sequel.  Information on the lot/batch number has been requested.
Information has been received from a certified medical assistant referring to an unspecified patient of unknown age and gender. There was no concurrent condition and medical history reported. On an unknown date was inadvertently administered a dose of improperly stored ROTATEQ (lot # K023534, Expiration Date 22-MAY-2016, strength and dose not provided, oral). There was no concomitant medication reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Low grade fever for 2 days following injection, red raised itchy area approximately 1" x 2 & 1/2" with a total red area of 3" x 8".
On 9-22-07 large area of redness on L arm where vaccine was given on 9-21-07.In our office on 9-24-07 measured 14cm X 13cm with smaller more red (darker) area measuring 2cm X 3cm with in larger area. Patinet come back to office on 9-25-07 area of redness with still there but with some vading. Parent advised to give Benadryl, Tylenol or Motrin, and to apply cool compresses.
About 22 hours after administration I had chills, headache,blood shot eyes, total body aches and extreme fatigue. I slept off and all day and at 3:00 am 1/13/2021  I woke up and felt much better. chills, headache and body aches all gone. Some fatigue still lingers. I did not have fever at any time.. My arm injection site was less sore than the first vaccine.
Lot # exp date had been extended and vaccine remained frozen until date of administration. Vaccine was given 2 days past expiration date.  Modena consulted and they deemed the vaccine viable so revaccination was not needed.  No adverse side effects were reported by Patient.
Information has been received from a mother concerning her 11 year old daughter who"at the age of 1" (approximately 1997), was vaccinated with VARIVAX (Oka/Merck). On 10-Mar-2008, the patient developed a mild case of chicken pox on her back. It was reported that the patient dose not have a physician. On an unspecified date, the patient recovered. It was noted that a day later, on 11-Mar-2008, her sister developed a mild case of chicken pox on her lower abdomen. A product quality complaint was not reported. Additional information is not expected.
11/09/2005 4pm cellulitis of left arm noted. Shot given 11/08/05 at 10:35 am. MD treating with Benadryl 25 mg at 4PM then Motrin 400mg TID x 2 day. Site red, warm to touch and swollen, 5cm below injection site.
Received Moderna COVID-19 Vaccine EAU. Second round. Fine at time of injection until approximately 00:30 on Feb 3. Woke up restless and stiff. Feel back to sleep around 01:00 and awoke again at 03:30 restless and stiff. Unable to fall asleep. Soreness in back and shoulders began to increase with mild headache. Fatigue began to set in and feel asleep at approximately 07:00 on Feb 3. Work up to chills, muscle soreness throughout, no appetite or desire to drink, and extreme headache at 10:30. Restless periods of sleep while fighting body aches and chills continue through the entire day. Waking periods for remainder of the day occurred between 10:30 - 11:30, 12:30 - 15:00, and 14:00-18:30. Suffered from intense headache, muscle stiffness, no appetite, and chills during all of the waking periods. Upon awakening 05:45 on Feb 4 all symptoms had subsided but low energy due to lack of hydration and low food intake from previous day.
noticed a rash yesterday that started on both arms and has been creeping up on her neck and face; light headed; sore arm; slight headache; physically exhausted; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 05Mar2021 11:30 (Batch/Lot Number: EN6200) (at the age of 30-years-old) as first dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included fluticasone propionate (FLONASE ALLERGY RELIEF); levocetirizine dihydrochloride (XYZAL); fluvoxamine maleate and valaciclovir (VALACYCLOVIR); all taken for an unspecified indication, start and stop date were not reported.  After the first dose, patient stated she went to Urgent Care this morning because she noticed a rash on 06Mar2021 that started on both arms and has been creeping up on her neck and face. Patient stated while at Urgent Care she received a steroid shot. Patient stated on Monday she went running in the same area she always has and she has not used any new products other than the Covid vaccine she received. Patient stated she had a telehealth visit with her primary care doctor yesterday and they instructed her to take Allegra. Patient would like to know if she should receive the second dose of the vaccine. Patient also reported sore arm, light headed, physically exhausted and slight headache on 06Mar2021. The events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the events was recovering. The patient did not have Covid prior to vaccination and had not test for Covid post vaccination.   No follow-up attempts are needed. No further information is expected.
Pt came in for a visit due to back pain and asked if he could get his flu shot. He filled out vaccine consent form and injection was given. Pt came back a little over an hour later and states that he forgot he already received his flu shot 2 weeks ago.
Recieved Hep B shot & later noticed bumps on hand the next day. I broke out with blisters and red bumps all over.
Pt was given vaccine and then mother breast feed baby for about 10-15 min and pt then had hives, no breathing concerns and purpura like rash. BENADRYL was given and referral to allergy.
Gave Influenza vaccine to wrong patient, vaccine was intended for brother who was being seen for a well child exam. When I asked mother if she wanted the patient to get his Influenza and COVID Ped Pfizer vaccine she said yes, and asked if we could also give her other child his COVID Ped Pfizer vaccine. Mother was informed shortly afterwards that the influenza vaccine was for the brother, she was not upset and I apologized, she stated he's just double protected now. There was no adverse reaction of patient 15 min post vaccinations.
I had this swelling under my arm like half of the avocado; the right arm/today I'm getting swelling under that arm; left arm; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation, reaction(s): "No any reaction from the first two"; Bnt162b2 (dose 2), for COVID-19 immunisation, reaction(s): "No any reaction from the first two".  The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Oct2021, outcome "unknown", described as "I had this swelling under my arm like half of the avocado; the right arm/today I'm getting swelling under that arm; left arm"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "Pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Exactly one week later, bumpy redness/rash, itchiness, swelling and tenderness right below injection site. Left upper and forearm started hurting 5 hours after initial symptom was noticed.
PFIZER-BIONTECH COVID-19 Vaccine EUA PFizer 2nd dose taken on 4/13 12:30 PM 4/14 around 11 AM had shortness of breath / cough for 5-10 minutes 4/14 around 11:30 AM started seeing swelling on both left /right top Eye lids like a big sty.
Got a fever and gave him baby Tylenol from 4:45PM and 8:45PM. He was very fuzzy until the mid of the night. His body was really hot. Next morning he was still having fever, so we fed him another bit of Tylenol on 6:45AM.
This spontaneous report as received from a registered nurse refers to a 13 year old female patient. On 19-MAR-2012 the patient was vaccinated with dose 3, GARDASIL (lot#, expiration date and route not reported). On 21-OCT-2011, the patient was vaccinated with dose 1, GARDASIL (lot#, expiration date and route not reported). On 16-JAN-2012, the patient was vaccinated with dose 2, GARDASIL (lot#, expiration date and route not reported). No adverse effect was observed or reported. Additional information has been requested.
Flu; Initial information received on 02-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "The efficacy of the flu shot sucks. It is always a hit and miss as to what strains are out there and it is usually a miss. Covid is a different story. We got that as soon as it was available to us. When my mom had cancer she couldn't have the flu shot so the doctor recommended both my dad and I get one to protect her. 2 weeks after I got the shot, I got the flu. Next year comes around and I told the nurse giving the shots about I had contracted the flu following the shot. She assured me that it wasn't from the shot and that I must have already been infected by the virus before I got it. We laughed about bad timing as she gave me the shot. Two weeks later, I got the flu. Third year came and I was reluctant. Still wanting to be a good daughter and protect my mom, I complied. Two weeks later.... I got the flu! My mom sadly lost her battle with the cancer so the following year I didn't get the flu shot. I was healthy all winter. I haven't had the flu shot since. I have gotten a few colds here and there but for the most part I have been healthy. Haven't had the flu shot in 20 years."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.
4 days course of fever 101-102 R w/relief from APAP; small amt diarrhea; dec fluid intake, poor appetite; 21NOV93 father says completely recovered; no further problems;
feel really crappy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In JAN-2023, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: feel really crappy). The outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The patient got it yesterday (the day before reporting) and felt really crappy, but he/she hear that means a good response from the immune system. The follow-up would not possible as no contact details were available.
Experienced chills 3 1/2 hour after vaccine admin. At 5:30 patient had 103 fever. Continued with flu-like symptoms x 2 days. T-99 degrees the morning of 11/4. Feeling better. Complained of L lower eyelid soreness with redness and drainage. Periorbital swelling continues as of 11/6/09.
Left arm soreness and swelling the next day, post vax. Continued soreness and swelling for 4 weeks, but is better. Had "flu symptoms" next day (ill X 2 weeks). Treated with antibiotics for infection.
Severe anxiety started on 1/26/21 and hasn't resolved 3 weeks later.
Erythema around injection site - much larger on day 3 than 2.  Size of 3 quarters put together.   Very red.  Very hot to touch and raised and swollen.
Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-APR-2018, the patient was inadvertently vaccinated with a dose of VAQTA (lot# N005605, expiration date was 08-APR-2018, strength and frequency were unknown) intramuscularly for prophylaxis (Expired product administered). No adverse effects reported.