chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel severely weak; Sever headache; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 13May2021 13:15 (at the age of 31-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included multivitamins taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient experienced sever headache, nausea and vomiting all on 14May2021 16:00; feel severely weak on 15May2021 08:26. It was reported that the patient took 500 mg of Acetomophine for the event sever headache while no treatment was received for the other events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Queazy, running temperature, extended rash size of 12 inch in length along arm, headache, muscle and joint pain, area of rash is hot to touch.
Red rash about 4 inches long and 3 inches wide forming around injection site. Skin in this area is itchy, swollen, and hot. Muscle is inflamed at location of injection. Only rash is on the injection arm. No other reactions on different body locations have been noted.
Lightheadedness, flushing, sweating, vs taken, observation done, improved, discharge home.
Light headed Vomiting Nurse monitored. Pt improved after 30 mins, water and granola bar.  Date: 3/23/2021  Problem: c/o Dizziness Notes: Pt was being observed after injection and stated she began to feel "dizzy and lightheaded. Provided pt with privacy and began to take VS. BP 166/71 P 72 O2 98% BS 91. Pt stated she previously has felt this way after injections and was anxious before the injection. Pt vomited one time. Pt stated she would just like a drink and snack. Water and granola bar provided per pt request. Pt observed by this nurse for 30 minutes. Pt stated she felt much better. BP 102/63 P75 T97.8 O2 99%. Pt alert and oriented x 4 and left in private vehicle.
I had left lower quadrant discomfort with post menopausal bleeding and then I had a total hysterectomy in December of 2021.  The doctor did genetic testing in August 2022 and found I had a chek 2 variant which is a MRNA thing which is above my paygrade to understand genetics.  I have received chemotherapy and radiation since the hysterectomy.  I was diagnosed with Endometrial Cancer in January 2022.  I am still recovering and have Neuropathy and Colitis due to the treatment that I received.
Patient received the regular Pfizer adult vaccine for the booster rather than the bivalent booster. No adverse effects was reported
bad taste/bitter taste in her mouth; her cheeks was flushed; sinuses were opening; scratchy feeling in her throat like she has a cold; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events bad taste bitter taste in her mouth, her cheeks was flushed, sinuses were opening, scratchy feeling in her throat like she has a cold,  The patient's medical history was not provided. Concomitant medications reported were Metformin 500MG, Actose 15mg, Aspirin 81, Hydrochlorozide, Bystolic 2.5mg, Folic acid, Vitamin D3 5000IU for drug use for unknown indication.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) bad taste bitter taste in her mouth. her cheeks was flushed, sinuses were opening, scratchy feeling in her throat like she has a cold.  Treatment was not taken.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, bad taste bitter taste in her mouth, her cheeks was flushed,sinuses were opening,scratchy feeling in her throat like she has a cold,  was unknown.
I have like the normal pain and stuff; I notice that my heart rate continues to rise like right now I am just sitting on the couch and its 111; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Jan2022 11:00 (Lot number: FL3198, Expiration Date: 30Jun2022) at the age of 58 years as dose 3, (booster dose), single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: Verbatim: Hypothyroid; "High blood pressure" (ongoing), notes: Verbatim: High blood pressure; "Barrett's oesophagus" (unspecified if ongoing), notes: Verbatim: Barrett''s esophagus. Concomitant medication(s) included: ARMOUR THYROID taken for hypothyroidism; ZOLOFT; PANTOPRAZOLE; LISINOPRIL taken for hypertension; VITAMIN D NOS. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "I have like the normal pain and stuff"; HEART RATE INCREASED (non-serious) with onset Jan2022, outcome "unknown", described as "I notice that my heart rate continues to rise like right now I am just sitting on the couch and its 111". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, heart rate increased.  Additional information: Patient taking things like Vitamin D and Multivitamin but no other medicine. On last Monday they draw blood to test pancreas.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 (Lot number: EN6202) at the age of 17 years as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "swollen lymph nodes under his left arm chest area / lymph node swelling under his arm". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: The event started about a week after the first dose of the vaccine which occurred every so often and maybe very briefly for around 5 minutes a day if he was consciously looking at it or touches it. The lymph node swelling was not under his neck, it was under his left chest side. Reporter was wondering if the swollen lymph node was still there after the 3 week period and was querying if it would that lower the effectiveness of the vaccine itself; concerned that the patient still has slightly swollen lymph node glands at the time of the second vaccine administration; asked if there was a possibility at all that the second dose may not be as effective for his son as his son still has side effects from the first dose; queried if there was any reason why somebody should not receive the second dose of the vaccine if that person still has symptoms from the first; clarified that his question is after the second dose and added that the rule was 3 weeks or 21 days to receive the second dose; queried if the patient should have waited longer than the three weeks to have received the second dose. The reporter has not seen anything to be concerned with in regard to being affected if somebody has side effects still from the first dose when that person received the second dose and if the person should still get the second dose. The patient received the second dose of BNT162B2 (Lot: EP7534) on 19Mar2021, 23 days after the first on. The patient received both vaccinations at around 4 or 4:30 pm for both doses. The patient had no additional vaccinations administered on the same day, no prior vaccinations within 4 weeks, no adverse effects following prior vaccinations, no family medical history relevant to adverse events and no relevant tests. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2021331532 Same reporter and suspect drug; similar event, different patient.
This spontaneous report was received from a health professional referring to multiple patients of unknown age and gender. The patients medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with PROQUAD lot number M022401, expiration date: 01-NOV-2017 (concentration, dose, frequency and via were not reported), which was improperly stored at 32.5 fahrenheit degrees for 16 hours. No previous temperature excursion was reported and it was not detected due to a data logger. No adverse effect was reported. Lot number M022401 has been verified to be a valid lot number for PROQUAD. It was also reported the Albumin status as rHA. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received Adacel vaccine due to laceration to her right leg on 11/11/07.  11/12/07 began experiencing chills, headache, fever, swelling at injection site.  Office visit on 11/14/07 showed 10x10cm red, hot, tender area at injection site.
MD notified RN @ clinic of tc from pt's mom 19JUL91 PM reporting "hives" on body; pt recvd immun that AM; Md rx'd antihistamine PO x 1 & hives were completely gone w/in 24hrs of vax;
Fever within 6 hours of the second dose, late menstrual period, and missed menstrual period the month afterwards. Treated by gynecologist and blood work analysis.
This spontaneous report was received from a 66 year old male patient. On 24-FEB-2013 the patient was vaccinated with ZOSTAVAX in the left arm. The patient's route of administration was not reported. On 26-FEB-2013, 3 days after onset of therapy the patient experienced injection site pain and joint pain to the point that he went to the emergency room. He was prescribed 600 mg MOTRIN (frequency not specified) and 50 mg Tramadol (frequency not specified) and sent home the same day. The outcome of injection site pain and joint pain was reported as not recovered/not resolved. The reporter did not provide causality for these events. Additional information is not expected.
Patient received vaccines approximately at 2:30-2:45 pm on 8/15/17. After administration patient felt dizzy and light headed. Patient was kept in the exam room and in supine position for approximately 10 minutes. Nurse checked on patient and she stated she was feeling better. She was sat up on edge of exam table and then to standing position. Patient reported feeling OK. Patient walked to lobby where she lost consciousness and fainted. A Head laceration injury occurred do to her fainting. 2:50 pm Patient was examined by health care professional and at 3:30 treated for her laceration. 4:00 pm Neurological exam was performed and patient was released to home.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: EMS was activated and patient was taken from Clinic by Paramedics.
blotches on hands & arms,sl tightness on breathing approx 30mins p/inj;treated w/epi @ hosp ER w/? other Iv meds;
Six staff members were administered Adacel 0.1mL in the right forearm instead of the TB (tuberculosis) shot, no AE; Six staff members were administered Adacel 0.1mL in the right forearm instead of the TB (tuberculosis) shot, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00636207) and transmitted to Sanofi on 10-Jun-2021.  This case involves 6 patients (demographics unknown) who were administered 0.1ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number not reported via unknown route in the right forearm for prophylactic vaccination on an unknown date (Underdose and Wrong product administered) instead of Tuberculosis shot (TB, not Sanofi's)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to Wrong vaccine administered and Underdose (latency same day).  At the time of report, no adverse event was reported.  Nurse stated that 6 staff members were administered Adacel 0.1mL in the right forearm instead of the TB shot. The nurse asked if there are any side effects/interactions that they should be aware of and if the vaccine was valid. The nurse declined to provide any adverse event (AE) information on all 6 staff members until she could get permission from her boss and the 6 staff members to provide the AE information  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Patient complains of pain upon injection. Continued soreness over the subsequent weeks. The soreness has continued without improvement. Patient claims that she is unable to utilize her arm.
Pt received 1st dose Moderna @ 13:56, pt c/o "throat itchy & I'm going to be sick" @ 14:03. Pt has hx of allergies and brought own EpiPen. Administered pt's EpiPen at 14:05. After administration I noticed pt's EpiPen was expired. Notified NP and RN. 14:06 BP 158/83, HR 93, NP auscultated lung fields CTA. 14:10 pt c/o throat swelling, audible horseness, gave another EpiPen. Pt reported improvement in throat swelling and nausea. 14:26 EMS arrived and assessed pt. Pt refused EMS transport at 14:33. Pt called mother to come pick her up. 14:45 pt c/o itching to back and arms. BP 149/81, HR 88, SPO2 94%. RN gave pt 25mg x2 Benadryl PO. Pt's mother arrived to take pt to ER. Pt left @ 15:00.
I don't think this virus is related to the last booster I received several months ago. But I have had a respiratory virus for 4 weeks. My in-home tests for Covid have been negative, but I'm still dealing with the cough, fatigue, sinus congestion, etc. My Dr. put me on Doxycycline which didn't help, so I know it's a virus. He never mentioned that I might have Covid although he did ask me questions about my testing and sent me for a chest x-ray, which was normal. I just wonder if the tests were not accurate and this is Covid. I want to get the next booster but I'm waiting until I feel well.
Pt received vaccine at 3:11 pm.  Began with itching on neck and hands at 3:25 pm.  Benadryl 25 mg given orally.  Nurse alert called.  Pt declined further eval or observation.  Went home via personal car/picked up.
This is a spontaneous report from a contactable physician, via a Pfizer sales representative. A 67-year-old female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm swelling, fever, and pain on unspecified dates. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.
Information has been received from a mother concerning a her daughter who on 3-JUN-2008 was vaccinated with her first dose of GARDASIL (dose, route and lot number not reported).  The mother stated that after getting first dose, her daughter experienced headache.  Therapy with GARDASIL was discontinued on 3-JUN-2008.  It was not specified if the patient sought medical attention.  Additional information has been requested.
We were advised to give our patients 0.25ml Moderna Bivalent for non-immunocompromised patients. After this vaccine was given, we were told this was changed and patients were to have 0.5ml. Per manager, we were to report for this event.
12/17/2020 at About 2pm pt complained of some blurry vision, slight jitteriness and some queasiness; pt requested water.  Nurse assisted pt to Overflow Observation Room.  Pt A/O x4, Nurse provided pt water, crackers. Nurse continued to monitor pt: Continuous monitoring;  and asked if she need anything periodically/ every 8-10 minutes.  Pt refused any further care or assistance from Nurse; Pt stated she is feeling better and will continue to be in observation ; pt continued to be monitored by Nurse. Pt talked on phone during observation time; A/O x4.  Pt monitored for about 40 minutes.  Pt stated she feels better and fine; pt stated she was going to leave.  A/O X4, denies chest pain, SOB, has steady gait.
On Dec 17 took Moderna covid bivalent booster at local pharmacy. On Dec 23 developed high fever, cold and runny nose On Dec 25 tested positive for Covid-19 and also had shingles On or around January 10 diagnosed with Bell's Palsy
Received flu shot for first time Within 5 minutes had numbness from tip of tongue back to mid-line of tongue. Developed warmth and achiness to deltoid/injetion site. Numbness in tongue lasted 4 days. Inj. site irritation lasted x 6 days.
Pt had normal PE & was given immun; Mom says pt never stopped crying; Returned to clinic @ 2PM; Re-exam was neg, no fever; pt would quiet briefly; Cry not high pitched but was painful rather than fretful;
Delayed hypersensitivity reaction at site of injection.  Red rah approximately three to four inches in diameter with itching.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 30-OCT-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 5 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 152, 30, -1.111111111 and R; 184, 29, -1.666666667 and R; 24, 33, 0.555555556 and R;, 320, 31, -0.555555556 and R; 224, 32, 0 and R. This is one of several reports received from the same source. Additional information has been requested.
One hour post vax, the pt experienced a red, swollen (softball size) leg which was warm to touch. The pt said it was painful. A doctor visit was required. Parent was instructed to use ice packs and Tylenol. Swelling was focal around injection site. No fever, crepitus or drainage was noted. As of 04/04/2000, no follow-up was received.
Pt noticed red "bumps" with raised white centers over back, neck and partially over chest with mild itching, started approx 3 days post Smallpox immunization.
Felt warm all over, sweating, headache, pale, clammy, light headedness.  Given Benadryl 25 mg PO at 3:30 PM.  Cool compresses placed.  Feet raised.  BP 154/88.  Checked by emergency room team.
On day 8 patient developed fever 102 and fever lasted 14 days. On day 14 after vaccines patient developed swelling and pain left knee. On day 22 after vaccine patient developed vesicular rash typical of varicella.
[Pfizer Biontech Covid 19 Vaccine] use for COVID-19 under Emergency Use Authorization (EUA):Pfizer Blontech ] use for COVID-19 under Emergency Use Authorization The patient experienced tingling sensations all after receiving his second dose.
Hives on all of right leg where PREVNAR was given. ("Urticaria" entire right leg).
Pt received vaccine in the am on  10/24/2005. Then per pt report, she was seen in the hospital ER with the following symptoms, fever, severe shaking, vomiting. Pt states the ER Dr told her she was having a reaction to vaccines she received on 10/24/2005. Pt is pregnant and EDC is 01/09/2005.
A huge fever blister appeared on day 2 after vaccine. I haven't had one in; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in  left arm on 05Feb2021 12:30 PM as 1st dose single for an unspecified indication. Medical history included hypertension, obesity, drug hypersensitivity and known allergies: Penicillin. Concomitant medications included Zoloft (sertraline hydrochloride),  taken for an unspecified indication, vitamin C taken for an unspecified indication,  vitamin D (colecalciferol) taken for an unspecified indication. The patient not had covid prior vaccination and post vaccination. On 07Feb2021 07:00AM, The patient experienced A huge fever blister appeared on day 2 after vaccine. Patient stated she haven't had one in years and this one was bigger than ever. Treatment was not reported. The outcome of the event was not recovered.    Follow-up (13May2021): Follow-up attempts completed. No further information expected
Pt vax 3 doses of Recombivax;  found to be non responder.  Booster dose given w/Engerix-B;
Lethargic ( laying still not moving or having any energy)  , temp of 105.5 ( with multiple doses of Tylenol and Motrin given )  , not eating or drinking - dehydration occurred, rash all over body .  Took to local Emergency Room , started an IV to get hydrated again and gave dose of Motrin.
Information has been received from a registered nurse concerning a 4 year old female with no past medical history and no known drug allergies who on 13Dec1999 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. Concomitant therapy that day included a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. In approximately March, 2003, "over the last month or so", the patient developed a mild case of chickenpox. Unspecified medical attention was sought. Follow up information indicated that on 31Mar2003 the patient broke out in a papilovesicular rash on her chest, arms, back, and face. The reporter indicated that her older sister had a similar breakout 1 week prior that was determined to be chickenpox. The outcome was reported as recovered. The nurse also reported that two other siblings developed an allergic reaction to amoxicillin and an ear infection, previously reported as chickenpox and general malaise and developed a mild case of chickenpox and "strep throat". No further information is expected.
Sudden development of redness & itching on face, ears & arms approx 10 minutes after vaccine administration. Symptoms resolved within 20 minutes with 25mg IM BENADRYL.
This spontaneous report as received from a medical assistant refers to a 66 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L018503, expiration date: 16-MAR-2017) (dose and route of administration were not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.