chrisvoncsefalvay/vaers-outcomes huggingface dataset:
seasonal allergy; This is a spontaneous report from a contactable consumer (patient) via -sponsored program Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration on 16Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced seasonal allergy on an unspecified date. He was wondering if he can take allergy medication in case his allergy triggers. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
pt recvd 2 doses of Engerix-B & 13AUg92 had h/a & vomiting; lasted aprpox 12 hrs;
Night of shot got chills and body aches. Difficulty sleeping bc of chills and body aches. Next day stayed in bed all day with chills and body aches literally from the tips of my toes to the top of my head.  I had a massive head ache and I rarely even get headaches, loss of appetite. Next day woke up thinking I was doing better and took a shower and almost passed out from extreme fatigue, and breathing difficulties. Spent that whole day in the recliner with no appetite and no energy/strength to get up and do anything. I did make sure I stayed hydrated both days and did have soup the first night (3/5)
After the first shot/vaccine on 4/12/21 I only experienced pain in my right arm for 2 days.  After the second shot/vaccine  I had pain in my right arm. The night of the vaccine I woke up at 11:30 pm  with a fever of 100.7° and muscle aches, joint pain, chills, headache and nausea. I took 2 advil and went back to bed. Then woke up at 2:30 am with all the above symptoms worse than before and a fever is 102.3°. At this point I was feeling very unwell. I took tylenol and had a full glass of Gatorade and headed back to bed. I slept very little that night. 5/4/21 I was extremely tired, still had muscle aches, arm pain and joint pain and a 100.8° fever all day. I got up at 5:30 am. Why back to bed at 8 am slept until 12 pm ate lunch. Went back to bed at 1:30 and slept until 5 pm. Got up had dinner and then went back to sleep at 9:30. Today 5/5/21 I have felt better so far. No Symptoms today.
pt recv vax 28AUG97 & on 29AUG97 pt exp h/a, abd pain, nausea, diarrhea, & extreme weakness;
Ringing in the head; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have a history of allergies to any food or medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date the patient experienced ringing in the head. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in the head was unknown at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 8APR98 10AM & @ noon 9APR mom noted large area of swelling;erythema on lt upper arm surrounding inj site;an exam 6x8c, soft, mildly tender, non indurated, swelling lt upper arm;no axillary adenopathy, T97 ax;
Health Dept. participated in off site clinic at Care Center                                                                                                                                                                                                                                     . Client presented to receive covid 19 bivalent booster vaccine. According to client consent form, client's current covid-19 vaccination card, and record in state immunization database, client is eligible for bivalent booster shot today. Bivalent booster shot administered as planned by RN. Client then states her current last name is not the name she has on her consent form or her covid-19 vaccination card. Client looked up in state database under other last name to find out that she had already in fact received bivalent booster and was not eligible today. Client monitored for extra 15 minutes after vaccination. No s/s distress noted. Client informed to let staff at care center know if she was not feeling well and client verbalized understanding.
I had experience some tightness in my throat with the first dose. But after taking benadryl the symptom went away within 24hrs. I had the same experience with my second dose in addition to tingling of my lips and tongue.  The symtoms started about 30 mins after the vaccine.  Just like with my first dose I took some benadryl in the event that I was having an allergic reaction.  The feeling of tightness went away the same day. However, the tingling of lips and tongue still persist. I continued to take benadyl for 5 days to see if symtoms would go away, it did not help, tingling still continues.
she had pneumonia 6 weeks ago; This spontaneous report was received from a consumer refers to a 91-year-old female patient with chronic obstructive pulmonary disease. The patient did not experience drug reactions or allergies.   The patient's medical history included pneumonia in 2015 and hospitalization, on the same year; it was reported that she was in the hospital during that time for maybe 5-7 days and she could not remember the dates. Concomitant medications include unspecified antibiotics.   In 2016, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in the arm for prophylaxis (dose, route of administration, lot number and expiration date were not reported).         The patient was asking in wanting to know if she should wait to get another pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), because she had pneumonia 6 weeks ago, on 19-JUL-2021 and she was hospitalized for 4 or 5 days. It was stated that she did received antibiotics during her stay. The patient did not know the names of the medication she took but she stopped taking the medication about 4 or 5 weeks ago. The patient stated she also received breathing treatments and had a nebulizer. Moreover, she stated she recently got her lungs checked, on an unspecified date in 2021 and they were completely clear now. However, it was reported that the patient did not perform laboratory test.  The outcome of pneumonia was reported as recovered, on an unspecified date in 2021.        Upon internal review the event of pneumonia was considered to be medically significant.
At 3:30 in morning after receiving shot I became violently ill.  I began having severe chills that made my entire body shake.  Despite 4 blankets, a heating blanket and two corn bags I could not get warm.  The chills brought on unbearable muscle and joint pain. It was excruciating.  My fever fluctuated from 100 to 102. This lasted 24hrs. I had and continue to have a headache, on and off fever and extreme fatigue.
12 hours after injection, I experienced fatigue, muscle aches/tension, headache, a low-grade fever lasting approximately 9 hours. Self-treated with ibuprofen. Symptoms were 100% resolved within 24 hours of vaccination.
Symptoms: Experienced tingling and swelling of throat and tongue about 10 minutes after vaccine. This is a reaction that has never occurred to me with any allergen. I have never needed an Epi-pen before and no allergy test has ever indicated that I have a severe allergy to anything. Treatment: Nurse administered an Epi-pen into left thigh and called 911. Transported to Emergency Department by ambulance. Received IV administration of Benadryl, a steroid, and an antihistamine. Was observed for about two hours and then released at about 3:30 and instructed to take Benadryl for the next 24 hours. Symptoms started to occur again in the ambulance (about 12:40 pm) and again at about 10:00 pm. Emergency Department treatment was after the 12:40 pm occurrence. Took oral Benadryl after the 10:00 pm occurrence.   Outcome: I was fine by the next morning and experienced no other symptoms.
Patient was given his 2nd Moderna vaccine 6 days before the recommended time between the 1st and 2nd dose.   Patient has been notified of the vaccine administration error.
Patient says she experienced headaches, hives, hard time breathing, body aches, joint aches, that lasted for 3 days. Started feeling better on Tuesday 11/14/23
I was hearing crickets in areas where there were no crickets. I made a search online and I noticed that it was a side effect of COVID-19. I went to the doctor, and I was told that I had lost my hearing on the left ear. I work standing up as a cashier, and I can't stand more than 45 minutes. I was feeling really dizzy currently.  I have a hard time with my balance.
Had coughing, sore throat, and congestive.  Had fatigue and a mild fever.  Had loss of aplite.  Sometime the coughing makes feel like he is going to vomit.  These symptom lasted about 5 days now.   He had a PCR COVID-19 test done, positive.  He also had the flu test, negative result.
Neurological response/trigger  - severe leg pain and weakness in both legs. Extremely difficult to walk and not able to climb stairs.  Disrupted sleep (woke up in pain throughout the night). This lasted for a couple of weeks, the worst (debilitating) being 48 hours from initial onset.  I also had difficulty breathing and nausea about 15m after injection which lasted for about 24 hours, then subsided.   I contacted my neurologist, Dr., early next morning, and notified her of what happened and she advised that I increase the dosage of gabapentin until symptoms resolved. After 48 hours, I began to walk without experiencing so much pain and weakness, and it slowly subsided over the course of a couple of weeks. I still experience flares of pain in both of my legs periodically.
Left doctors office two weeks after 2nd vaccine. Does have factors tobacco use, HTN, dilarid and not a ASA. Thymectomy and minimal.
Pt was screened prior to receiving covid 19 vaccine. He received vaccine and was being observed for 30 min. During wait time he informed the observation staff that he had pain in upper R side of chest  his closest to his R axilla. RN was notified and assessed the pt. At time of assessment pt stated the pain stopped after receiving the vaccine. Described pain as an aching, on scale 1-10 was at a 6. BP taken 110/70 LA, P 64, rr 16. No sob, no diaphoresis, no pain at time of nurses assessment. Denied hx of similar pain, cardiac or injury to upper chest. Pt denies feeling anxious prior to receiving vaccine. Not aware of an injury but admits
On 11/15/2019, the patient developed arm pain in the whole arm that had received the PNEUMOVAX injection; a patient received adose of PNEUMOVAX on 11/17/2016 and on 11/14/2019; This spontaneous report as received from a nurse refers to a 65-year-old male patient with diabetes mellitus, hypertension, restless legs syndrome, anaemia, elevated alkaline phosphatase, hyperlipidaemia, obesity, thrombocytopenia, muscle cramps and microalbuminuria. Concomitant therapies included atenolol (TENORMIN), atorvastatin calcium (LIPITOR), glimepiride (AMARYL), hydrochlorothiazide, lisinopril(PRINIVIL), metformin, potassium (unspecified) and pramipexole dihydrochloride (MIRAPEX). The patient had no allergies or drug reactions.  On 17-NOV-2016, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # M026317, expiration date unknown by reporter but established as 11-JAN-2018, intramuscularly for prophylaxis.  On 14-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S018405, expiration date unknown by reporter but established as 23-MAR-2021, intramuscularly for prophylaxis. The patient had also received influenza virus whole virion 3v vaccine inactivated(FLUZONE (INFLUENZA VIRUS WHOLE VIRION 3V VACCINE INACTIVATED)) on the same day but in the opposite arm than the arm that had received pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). On 15-NOV-2019, the patient developed arm pain in the whole arm that had received the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). There was no treatment given for the adverse event. No lab diagnostics/studies performed. The patient sought medical attention - he called a nurse.  The outcome of arm pain was reported as not recovered/not resolved.   The causality assessment between the event of arm pain and the suspect therapy was not provided.
Pt received two different branded vaccines. Pt received Pfizer on 07/22 and Janssen on 08/03/2021
I had a J&J shot at 11am on March 23rd. I woke up at 12am with extreme chills and body aches including major pain around my groin.  About a day later, I was fine but tired. Approximately 3 weeks later on April 9th, I had sharp pain in my lower back when I breathed in and my neck lympth nodes were swollen and sore. I am fine now and the only reason I am reporting this is to document symptoms for your research efforts. Thank you.
This is a spontaneous report from a contactable office manager. This reporter reported similar events in the same patient after the first dose of PREVNAR 13. This is the second of two reports. A 4-month-old male patient received the second dose of PREVNAR 13 on 12SEP2011. Additional suspect vaccines administered on 12Sep2011 included a dose of HEPATITIS B VACCINE, a dose of ROTATEQ and a dose of PENTACEL. Past vaccine history included the first dose of PREVNAR 13 administered on 11Jul2011 (at the age of 2 months) with similar events of respiratory distress, sleep apnea and cyanosis. Relevant medical history included premature, born at 27 weeks. Concomitant medication was not provided. On 12Sep2011 the patient experienced the same reactions as after the first dose: respiratory distress and apnea that was responsive to stimulation and was significant enough to turn the patient blue. The outcome of the events was unknown. The patient was referred to pulmonary for urgent appointment and further appointments will be considered. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
Pt. came in with (L) shoulder red and hot to touch. No hard area noted. Pain is 5/10 on 0-10 scale. Applied ice and advised to take IBUPROFEN and do small stretches.
REDNESS, SWELLING THROUGHOUT CIRCUMFERENCE OF UPPER ARM, PT TOOK BENADRYL AND SYMPTOMS ARE STARTING TO RESOLVE, COULD STILL SEE REDNESS TODAY (2 DAYS POST-INJECTION).
I felt fine but arm got sore, 2-3 hours later I started having a tingling in hands and feet and that was all that I had, it also ran up my legs at one point but that stopped.
Rec'd vaccines 3/8/02. Called office 3/10/02 with red at shot site on R thigh. Dx with cellulitis VS Prevnar redness. Put on Keflex.
Patient has documented Narcolepsy and other heath conditions. Following administration of Moderna vaccine, patient entered REMs cycle and was mildly "asleep" for several minutes following vaccine. The patient's boyfriend was with her and mentioned she has occurrences daily, but feels the vaccine may have prompted her sleep/REMs cycle.  They patient was able to respond to me and speak, but her eyes were closed for several minutes. The patient's boyfriend denied emergency medical attention, and she was able to leave once she gained wakefulness. No allergic reaction, trouble breathing, or hives were observed
Information has been received from a physician concerning an approximately 18 year old female who on an unspecified date was vaccinated with the second dose of GARDASIL vaccine (yeast), IM and experienced aches and fatigue. The patient was "in bed for 3 days" due this. It was unknown if the patient sought medical attention. The patient outcome was not reported. Additional information has been requested.
intense eye pain in both eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 13:00 (Lot number: EN608) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "thyroid cancer", start date: 2008 (unspecified if ongoing); "full thoracotomy", start date: 2008 (unspecified if ongoing). Concomitant medication(s) included: CALCIUM/VITAMIN D [CALCIUM CARBONATE;ERGOCALCIFEROL]; SYNTHROID. The following information was reported: EYE PAIN (non-serious) with onset 22Mar2021 04:30, outcome "not recovered", described as "intense eye pain in both eyes". The event "intense eye pain in both eyes" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of eye pain.  Additional information: The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
I took the booster shot at noon. Beginning of Sore Arm 4 hours later. Next day arm was very sore, but not horrible. Following day, arm is barely sore. Also next day - I woke up to early stage of Oral Herpes. Normal for me is outbreak during time of high stress or bad illness. Outcome is I called the pharmacy to ask if it was OK to take a dose of Valacyclovir to shorten outbreak.  I was advised this was acceptable. Also next day -  I woke up to feeling of fatigue. I rested all day. The next day after the fatigue is still there, but significantly less.
Case-patient had first Pfizer COVID-19 vaccine on 11/22/21, acute covid infection on 12/1/21, second Pfizer vaccine on 12/22/21, and developed MIS-C on 12/31/21 (illness onset).  Case-patient met case definition for MIS-C, with evidence of clinically severe illness requiring hospitalization, with multisystem organ involvement (cardiac, hematologic, gastrointestinal, and dermatologic). The case-patient experience tachycardia, hypotension, conjunctival injection, headaches, abdominal pain & diarrhea, thrombocytopenia, and various elevated inflammatory markers (see box 19 below).  Case-patient was treated with aspirin, steroids, and IVIG and survived after a 5 day hospitalization.
Significant arm  swelling; Significant arm  redness; Nausea; Vomiting; This case was reported by a nurse via sales rep and described the occurrence of swelling arm in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than a day after receiving Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced swelling arm, erythema of extremities, nausea and vomiting. On an unknown date, the outcome of the swelling arm was unknown and the outcome of the erythema of extremities was not recovered/not resolved and the outcome of the nausea and vomiting were recovered/resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities, nausea and vomiting to be related to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Menveo and Bexsero at the same visit in the same arm and experienced significant arm swelling and redness. On the following day after vaccination, the patient developed nausea and vomiting.  The nausea and vomiting had resolved at the time of reporting but the patient's arm was still red. The reporter did not consent to follow-up.
Patient received full dose of pfizer-biontech covid 19 vaccine without it being diluted. Patient reported she experienced headaches, dizziness, nausea, and whole body soreness. Advised patient to continue monitoring her symptoms and seed medical attention if symptoms worsen.
Patient received Flu shot on 01/10/2005 -returned on 01/12/2005 with approximately 2" X 3" red/warm/raised area at location of injection. Seen by doctor who prescribed Benadryl pills and ointment or Amoxicillin 250 mg BID for 5 days.
Vaccine 1/10, 1/31. Admit 3/28. COVID PNA w/hypoxia. Treated w/dexa and zinc. UTD acute or "old" Covid infection per MD note. Still in hospital, palliative care to consult. Pending possible facility placement.
About a month after having my second dose my period started to change and I started to have an increase of weight a year had passed with my period significantly changing going from an a day to a two day and significant weight gain.
Starting 04/12/2021: Headache started at around 3pm; continued to worsen until the morning of 04/13/2021 when woke up at around 9am after falling asleep at around 3am with it significantly improving but still present as of the submission of this adverse event account at 3:40pm, 04/13/2021. Starting 04/12/2021: Stuffy ears started at around 6:30pm; continued to worsen until the morning of 04/13/2021 when woke up at around 9am after falling asleep at around 3am with it significantly improving but still present as of the submission of this adverse event account at 3:16pm, 04/13/2021.Starting 04/12/2021: Fever started around 9pm, 04/12/2021 at 99.3 degrees fahrenheit ( oral temperature); at 11pm worsen to 102.5 degrees fahrenheit ( oral temperature); took 650 mg of acetaminophen (Tylenol) at 12am 04/13/2021; temperature went down to 101.5 degrees fahrenheit (oral temperature) which continued until the morning of 04/13/2021 when I woke up at around 9am after falling asleep at around 3am with temperature at 9:47am 98.5 degrees fahrenheit (oral temperature). Starting 04/12/2021: Body aches started at around 7pm and continued to worsen until the morning of 04/13/2021 when woke up at around 9am after falling asleep at around 3am with it significantly improving but still present as of the submission of this adverse event account at 3:40pm, 04/13/2021. Starting 04/12/2021: Nausea started around 9:00pm, 04/12/2021 continued to until the morning of 04/13/2021 when woke up at around 9am after falling asleep at around 3am with it subsiding.
This spontaneous report as received from an unspecified reporter, refers to a female patient in her 50's with no medical conditions or allergies. In approximately 2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not reported, lot # J011714, expiration date: 20-FEB-2015). It was reported that the recommended dose was given to the patient. On an unknown date in approximately 2014 the patient experienced reactions on her left arm: redness, swelling, warm to touch. She caller her doctor on 17-OCT-2014 and the doctor prescribed her antibiotics (unspecified). The outcome of the events was reported as recovering/resolving (reported as "she is OK now"). Relatedness between the events and PNEUMOVAX 23 was not reported. This is one of several reports from the same source. Additional information has been requested.