chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 13 year old daughter with penicillin allergy and a history of syncope who on 27-SEP-2010, was vaccinated IM with her first 0.5 ml dose of GARDASIL. On 27-SEP-2010, the patient had syncopal episode, hit her head on a cabinet, and had a concussion in the physician's office. Her appetite was okay though. The patient had x-ray to ensure no fracture. The result of x-ray was negative. It was reported that the adverse event improved on therapy. At the time of reporting, the patient had recovered. It was reported that the patient's mother had a history of syncopy. Additional information has been requested.
Started with normal sore arm and headaches transitioned to diarrhea and fever. Tinnitus set in on Thursday morning and has continued since then. Friday night I experienced a loud pop on the left side of my head - pressure released on the left year slightly followed by numbness and tingling in face along with blurred vision, dizziness and weakness in left leg. Blurred Vision lasted maybe 1-2 minutes, numbness and weakness/dizziness resolved on ride to ER so maybe 10 minutes as we live near the hospital. ER evaluated me for potential stroke. Cat scan and labs done. Nothing odd was noted. Doc decided it was parethesia of left leg and nonintractable episodic headache event. Blood pressure was elevated which is unusual for me along with a high White blood cell count- Doc said this is normal with just having received a vaccine recently. No concerns with platelets or enzymes and electrolytes.  Doc does think it could be vaccine related as that is the only thing new this week. Due to earlier in the week side effects, my PCM did COVID test me just incase since the side effects were hanging around longer than the normal window of time and nasal swab PCR came back negative.
No adverse events   vaccine was opened on 7/6/22, placed back in the refrigerator on 7/6, removed from refrigerator on 7/7 and administered approximately 24 hours and 30 minutes after opening on 7/6
Soreness in Arm for the first few days following injection.  Swollen lymph nodes started the following Monday.  Was sore in armpit and towards left breast for a few days after it had started.
The vaccine reduced the effectiveness of the drug Gabapentin. I experienced an increase in my symptoms and taking more of the drug than usual did not help.
1/26/2022 Woke up and my vision was not right. It changed over a period of a week. It took me a while to get into the doctor. When I got to the doctor's office, they rushed me in for emergency laser surgery and saw a big hole in my retina. They lasered the hole in my eyeball. The doctor said it will take up to 2 years for my vision to improve. It is improving but not up to 100%.
Sore arm; diarrhea; Hamstring muscles weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIARRHOEA (diarrhea) and MUSCULAR WEAKNESS (Hamstring muscles weakness) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIARRHOEA (diarrhea) and MUSCULAR WEAKNESS (Hamstring muscles weakness). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIARRHOEA (diarrhea) and MUSCULAR WEAKNESS (Hamstring muscles weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.    Reporter did not allow further contact
Flublok Quadrivalent from 2019-2020 formula was still in fridge and patient was administered with expired Flublok quadrivalent with no adverse event; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional in the United States.  This case involves a 75 years old female patient who received 0.5 ml once expired of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QSAA1960, expiry date: 30-Jun-2020) via intramuscular route in the deltoid on 17-Sep-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to the expired vaccine used.  At the time of report, no adverse event was reported.  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 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.
Bright red rash on belly and left flank. Did not treat - not resolved. Recommended for patient to talk to her primary.
Redness on both knees 2 red spots on lower right forearm slight redness on lower back.
Left Arm itchy, slight redness around injection site. Vitals stable. Airway clear. EMT will continue to monitor. Vital signs: WNL; Lungs clear =bilateral B.P.=126/84; Pulse=74; Spo2=98% RA Pt.seen by EMT onsite. Patient release at 14:21 P.M. Recorded by RN
No complaints Friday.  Called in and talked to contact Thursday March07, 2006 AM suddenly weak, wiped out, (low grade fever (flu symptoms)-going to MD, stayed home wed.  Phone check in with wife wed-to recall friday 03/10/2006 contact tried three times for follow up and was unable to get any information other than the client had returned to work.
Novartis 2009 H1N1 administered to 3 year old patient.
3:20 R-arm swollen, red, nausea, high fever 102 deg off bus, 4:30-5:00-wheezing, SOB, lethargic. Gave tums, motrin, breathing, albuterol treatment. vomited-improved after that. Dad called ER-told to try treatment.  Vomited during night. Fever decreased. Took total of 3 puffs on albuterol. Stomach virus going around in town.
big yellow circle mark at injection site; various bruising on arms/forearms following 2nd dose; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Optional Information: Diabetes; "Hypothyroidism" (unspecified if ongoing), notes: Optional Information: Hypothyroidism on Synthroid. Concomitant medication(s) included: SYNTHROID taken for hypothyroidism. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious), outcome "unknown", described as "big yellow circle mark at injection site"; CONTUSION (non-serious), outcome "unknown", described as "various bruising on arms/forearms following 2nd dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 12/21/2021 I woke up with a scratchy throat gradually got worse. It felt like it was spreading from my throat into my lungs. I could feel my lungs becoming congested. It felt asthmatic to me. I have had colds but my anxiety was much higher knowing the outcome of this and with my Asthma condition. I had a continuous dry cough but it was also like a scratch/tickle. I was traveling when I came down with the symptom. I drove home on the 21st and it got worse as I was driving. I got home late and the next day it was worse. My doctor was not taking anyone in the office at that time. I went to an Urgent Care 12/23/2021. Prior to traveling, I waited in line for 45 minutes. That was also the day I contacted my PCP before he closed and we weren't sure if I had it yet but he did prescribe medication if I had COVID-19. At that point, he said he could not make a Monoclonal Antibodies infusion appointment anywhere. He prescribed Albuterol Nebulizer twice a day and it did seem that to help and make my breathing easier, also a high dose of steroid, and another medication was an Antibiotic which was also a heavy dose for ten days. I found temporary relief with the Nebulizer and it's possible the Steroid medication also helped that too. I also used 500mg Tylenol twice a day. I also felt very tired and some slight body aches. I did have an episode of Gout in my knee after my third dose and the same doctor prescribed me medication Colchicine for that and I think the combination of that with the Steroid and Albuterol put me in AFib. I do not believe it caused it because I have had Gout once every couple years. I did feel better within the 7th-10th day. I also do Monoclonal Antibody Sotrovimab Infusion on 12/27/2021. I did start feeling better after the treatment but I think I was also already improving.
Patient was receiving the 1st dose and the needle broke away from the syringe; Vaccine leaked on the floor, not sure if patient received any vaccine; A report was received from a pharmacist concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and the needle breaking away from the syringe and vaccine leaking on the floor.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 25 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   The reporter that they vaccinated a patient with the first dose and the needle broke away from the syringe, the vaccine leaked on the floor, and they were not sure if the patient received any vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was considered resolved.; Reporter's Comments: This case a concerns a patient who received the first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection and experienced the needle broke away from the syringe, the vaccine leaked on the floor, and they were not sure if the patient received any vaccine. There we no reported adverse events after vaccine was administered.
-Patient received vaccine -Sat in observation area -Passed out and slumped over, was prevented from falling by wife and pharmacist. -Patient appeared to be sleeping but was roused after a minute or 2. -Paramedics were called and examined the patient, gave fluids and took to hospital -Patient called back and said they were released shortly after (low glucose and BP)
This spontaneous report was received from a consumer via other company (Pfizer) regarding herself a female patient of unknown age. There was no information about concurrent condition, concomitant medication and historical medication. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced a lot of pain, redness and swelling at the injection site. She also experienced fever and muscle aches for several days. The outcome of vaccination site swelling, myalgia, pyrexia, vaccination site erythema and vaccination site pain was unknown. Causality assessment was not provided. This is one of several reports received from the same reporter.
MMR vaccine given on 10/16/10. Pt came into the office with rash on 10/17/10. Doctor describes rash as erythematous maculopapular lesions on entire body...excluding palms, soles & scalp. Most lesions concentrated on the abdomen. Patient is not symptomatic from rash. Parents to observe rash. Approx. 200 lesions noted.
Information was received from a health professional regarding an unknown age and gender patient. Medical history or concurrent conditions were not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) lot # J003539, expiration date 25-MAR-2015, which had been improperly stored. The outcome of the improperly stored vaccination was unknown. This is a corrected report. On 23-SEP-2013, information was received from a registered nurse concerning the unknown age and gender patient. It was reported that VARIVAX (Merck) was exposed to unknown temperatures for 5 hours during interoffice transport. The patient was revaccinated. No adverse symptoms reported. This is one of several reports from the same source. Additional information is not expected.
Nausea woke me up from sleep throughout the night. Wednesday and Thursday wicked migraine and fever of 101.1, chills, fatigue, no appetite
COVID 19; COVID 19; I was vaccinated twice (Both Pfizer and Moderna); This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Feb2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Feb2023 as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "I was vaccinated twice (Both Pfizer and Moderna)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with Paxlovid. Patient was not immunocompromised in any way. Patient was vaccinated twice (Both Pfizer and Moderna) and boosted twice (booster in Feb2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dose 3 caused fever 101f within 18 hours, swollen lymph nodes under left arm, cleared. Hives started 10 days post vaccine on left hand, progressively got worse. Saw doctor, now on prednisone, Allegra, Benadryl, Pepcid, hydrocortisone cream.
I had hot flashes and chills with tiredness like the flu for three days which was not surprising.  But, the hot flashes have continued for over a month.  And, I am having issues with insomnia as well.  I have consulted my doctor about these symptoms and he ordered blood work on Friday, July 30th.  He is seeking results from my immune system and estrogen levels.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN5318) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Statins, notes: She was on statins, but she hasn't been on them. The following information was reported: PAIN IN EXTREMITY (non-serious), HEADACHE (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs". Additional information: Patient received no other vaccines within 4 weeks prior to the first administration date of the suspect vaccine. The reporter reported that, she did travel overseas this past spring and had to have an antigen test. It was all fine and she was able to travel. Primary infection site was Covid-19. Had been on an airplane in front of an unmasked passenger who coughed the entire flight. Took a train to the airport as well. Her and her husband travel a lot and stay in hotels. The reporter wanted to specify Antipyretic Use (around the date(s) of Vaccination). She took Tylenol after the vaccine. Not something she likes to take, but she did. Went through the packet to find a number to call to report her rebound symptoms. Read that rebound happen near 1-10%. She was guessing its more than that.  No follow-up attempts are needed. No further information is expected.
Information has been received from a L.P. nurse concerning a 9 week old male with a history of haemangioma on the face and no allergies who on 19-OCT-2011 was vaccinated orally with a dose of 2 ml ROTATEQ (lot #: 668905/0560AA, exp. : 30-JUN-2012). There was no other concomitant medication. Nurse reported that on 19-OCT-2011 during administration of a dose of the vaccine the patient screamed continuously and made a face that would indicate that the taste of the vaccine was unpleasant. Nurse reported that the patient did not vomit. Nurse reported that the patient's symptoms completed resolved. Nurse suspected a quality issue with this dose of the vaccine because this was one of two patients who received doses of the vaccine from this same lot and expiration (see WAES # 1110USA02941). No lab diagnostic studies perform and no treatment given for AE. The patient was recovered. A lot check has been initiated. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Got a keloid (scar) in the injection spot; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced got a keloid (scar) in the injection spot on 2021. The outcome of event was unknown.    Information about lot/batch number has been requested.
Legs covered in purple and blue splotches 48 hours after vaccine, leg and knee pain, weakness and tingling.
HORRIBLE COLD SORES ALL OVER BODY; This spontaneous report received from a health care professional concerned a 3 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced horrible cold sores all over body. Laboratory data (dates unspecified) included: SARS-CoV-2 IgG antibody test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of horrible cold sores all over body was not reported. This report was non-serious.
Hives(welts) on both legs appeared after the first and second covid shot. Hives were a dime size to pea size around, red and raised. Itched but not out of control itching. First time lasted 2 days. After the second shot they lasted 4 days. Controlled with Benadryl and Epstein salt baths.
shingles, 8 wks to resolve, treated with antiviral medications for 10 days
26 patients received expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 patients received expired dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 patients received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 patients received expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date(s) of administration of vaccine: 09Sep2021 and 10Dec2021  No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
RASH STARTED 4-21-05, IS SPREADING. STARTED ON BACK. FAMILY QUESTIONED ABOUT ANYTHING NEW INTRODUCED TO CHILD FAMILY JUST STATED SHOT ON 4-18-05.
tooth infection; This is a spontaneous report received from a contactable consumer(patient). This 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient inquired if she should get the second dose of BNT162B2 as scheduled and what the maximum time she could wait before getting the second dose was. The patient received her first dose of BNT162B2 and was scheduled to receive her second dose on 25Mar2021. She stated she had a tooth infection, was on amoxicillin 500 mg every 8 hours until 13Mar2021 and was having a root canal on 22Mar2021. She asked if amoxicillin would interact or impact the efficacy of the vaccine. She stated she had no reaction to the first injection of the vaccine. The clinical outcome of tooth infection was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
I had arm soreness for about 36 hours after the initial shot that went away, but today (8 days after my 1st dose), my arm started itching, has some redness, and there's a hard/firm lump under my skin at the injection site. I looked it up and see online that others have reported this issue. https://www.health.com/condition/infectious-diseases/coronavirus/covid-arm-rash-moderna I just took some Claritin and will keep an eye on it, but wanted to report this for the record.
A few days after the booster I got my period for 8 days. I just had my period 2 weeks earlier. My period is always on schedule. Every 30 days 5 to 7 days. Now I have no idea. It was a very scary heavy period I thought something was wrong.
Developed autoimmune arthritic condition that became worse after the 2nd dose of the Moderna vaccine and persists as of this day May 3, 2021.  Over the counter anti-inflammation medications help such as Tylenol, Aleve and prescription NSAID (Meloxicam). This condition did not present itself prior to receiving the two doses of the vaccine.
Received shot at 12pm.  Symptoms started at 2pm and progressed rapidly, within an hour. Headache starting on left side of forehead, moved across forehead to above right eye. Right ear then became plugged, and sharp ear pain in right ear when swallowing. Upper and lower teeth on right side of face began to ache. Right side of face became numb.  Took Aleve and laid down in bed at 4:30pm, and fell asleep.  Woke up at 8:30pm with all symptoms resolved except for the plugged ear (without pain), which was resolved the next morning when I woke up.
Flumist Saturday 11/03/2007 in am at School clinic by Health Department. Monday 11-05-07 104 degree fever, he was crying because of headaches, congestion, cough.  Better 11-09-07 (sister got headache and fever 102 degree, but better within 24 hours.)