chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling, redness and itching starting 9 days after injection. (I also had redness, itching and pain on day of injection but went away two days later then returned a week later) The rash/redness has gotten lighter since I've been taking Benadryl but it has spread a bit more (about half an inch of border)
Within about 30 mins of the shot I became extremely lethargic. Hard to keep my eyes open. The injection site was extremely hot to touch and very sore. While the rest of my body was of normal temperature. Shortly after, I?d say about 45 minutes after injection, came the cold chills. I was freezing cold and shaking  fallowed by a fever. I became very foggy. It was hard to keep a conversation and had extreme waves of nausea. My mouth would salivate like the vomit was coming. I never actually vomited. But that continued  for the next 36 hours. I had to call out of work yesterday. Starting 24hrs after injection. I could not get out of bed. My body was very weak. Aches everywhere, I was freezing cold shaking with chills yet waking up in my bed covered in sweat. I was extremely restless and kept waking up to put a cold towel on my head to try to break my fever. At this point my headache was so severe. Any movement felt like my head would explode.  It?s now 48 hours after the injection my head is still pounding and my body still full of aches. Left arm is still really sore. I truly regret taking the vaccine. And would recommend others to not take it until further testing goes into this product.
cardiac arrest; Initial information received on 27-Jan-2022 regarding an unsolicited valid  serious case received from a consumer/non-health care professional  This case involves a 25 years old and unknown gender patient who had cardiac arrest after receiving  INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) 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 not reported via unknown route in unknown administration site.  On an unknown date the patient had cardiac arrest (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (cardiac arrest).  At time of reporting, the outcome was Unknown for the event cardiac arrest.; Sender's Comments: Sanofi company comment dated 8-Feb-2022 : This case involves a 25 years old and unknown gender patient who had cardiac arrest after receiving  INFLUENZA VACCINE. The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
After the vaccine during the day Sunday I started to feel chills, without fever. During the day a strong pressure on chest, reflecting to upper back. During Monday, 22 November of 2021 during work I continue with pressure on chest. Palpitations accelerated and pain on shoulders and upper back, I tried not to breath hard to not feel pain. I currently do not suffer from anything but these symptoms are new to my health.
Vaccine administered 01/29/2021.  02/05/2021 - complained of itching.  02/07/2021 - Left arm redness.  Treated with cephalexin.  Suspect cellulitis.
itching; itching; swelling; swelling; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE PRURITUS (itching), the second episode of VACCINATION SITE PRURITUS (itching), the first episode of VACCINATION SITE SWELLING (swelling) and the second episode of VACCINATION SITE SWELLING (swelling) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced the first episode of VACCINATION SITE SWELLING (swelling). On 03-Feb-2021, the patient experienced the first episode of VACCINATION SITE PRURITUS (itching), the second episode of VACCINATION SITE PRURITUS (itching) and the second episode of VACCINATION SITE SWELLING (swelling). At the time of the report, last episode of VACCINATION SITE PRURITUS (itching) and the last episode of VACCINATION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
15 minutes after receiving the second dose of vaccine, she felt light-headed and short of breath. She received Epinephrine 0.3 mg IM, solumedrol, and Benadryl. She remained hemodynamically stable.
Received vaccine 10/11/16 - felt jittery and had heart palpations. Went to urgent card on 10/18/16.
Arm pain; Fever; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Arm pain) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
2/10/2021 030M20A 3/15/2021 048A21A 11/14/2021 039F21A 11/27/2022 AS7167B 9/6/2023 - 9/9/2023 (3 days) Discharge Disposition: Home or Self Care admitted with sepsis like picture and a preliminary UA consistent with a UTI. She was also found to test positive for covid but required no oxygen and had no symptoms
Muscle pain / General muscle soreness; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 9DE73, expiry date 6th December 2021) for prophylaxis.   On 1st November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, less than a month after receiving Shingrix, the patient experienced myalgia and fever. On an unknown date, the outcome of the myalgia and fever were not recovered/not resolved.   It was unknown if the reporter considered the myalgia and fever to be related to Shingrix.  Additional details were provided as follows: The patient experienced muscle pain, fever and general muscle soreness.
almost killed me; This case was reported by a consumer via other manufacturer and described the occurrence of near death experience in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself The age at vaccination was not reported. The patient received 1st dose of shingrix and stated that experienced near death experience. The patient also stated that while completing Shingrix series second one was horrible. Almost killed her consider for both dose as it was not confirmed 1st or 2nd dose of Shingrix which almost killed her. No further information available. For further tolerance of 2nd dose refer case US2021AMR063320 reported by same the reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063320:1st dose
fever; Chills; Body ache; arm is really sore; fatigue; severe headache triple this time, much worse; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (Chills), MYALGIA (Body ache), PAIN IN EXTREMITY (arm is really sore) and FATIGUE (fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 11-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced PYREXIA (fever), CHILLS (Chills), MYALGIA (Body ache), PAIN IN EXTREMITY (arm is really sore), FATIGUE (fatigue) and HEADACHE (severe headache triple this time, much worse). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for No adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (Chills), MYALGIA (Body ache), PAIN IN EXTREMITY (arm is really sore), FATIGUE (fatigue) and HEADACHE (severe headache triple this time, much worse) outcome was unknown.            Patient received first dose on 01-FEB-2021 intramuscularly (batch no: 004M20A) and second dose on 02-MAR-2021 (batch no: 025A21A) Patient's side effects from 3rd dose is much worse than from the 2nd dose.
shortness of breath, rapid heart beat; shortness of breath, rapid heart beat; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (shortness of breath, rapid heart beat) and TACHYCARDIA (shortness of breath, rapid heart beat) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017EZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Drug allergy (allergic to ibuprofen.) and Drug allergy (allergic to aspirin.).    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced DYSPNOEA (shortness of breath, rapid heart beat) and TACHYCARDIA (shortness of breath, rapid heart beat). On 27-Aug-2021, DYSPNOEA (shortness of breath, rapid heart beat) and TACHYCARDIA (shortness of breath, rapid heart beat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter.  Treatment medication included albuterol puff and benadry.
Patient got Pneumonia vaccine adult on 12/28/15 at 6 PM (L) deltoid muscle. At 1 AM on 12/29/15, pt c/o pain on (L) upper arm w/redness and swelling and pruritus.
Patient was fine when she left the pharmacy. When she woke up in the morning she was itching under both arm pits and then noticed she had a rash under both breasts and upper back. She took a benadryl 25mg and the symptoms went away.
lost all of her hearing; lost all muscle control; could not even walk; sensation on her skin like there was electricity going through all of her skin and it was really painful, sensation was from the top of her head to her toes; extreme pain in the whole outside of her body; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left (between 1400 to 1500) on 23Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 76-year-old. There were no medical history and concomitant medications. She was one of the healthiest people and before the vaccination she used to walk two miles per day. The patient previously took the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left (between 1400 to 1500) on 02Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 76-year-old. She had one question based on her second Pfizer covid vaccination. When she had the second vaccination, she had several things that affected her severely. She just got the third shot, the booster shot, she was worried that she will have the severe reaction again. After the second dose, she felt ok for 2 days and then 48 hours later (25Mar2021) she lost all muscle control and could not even walk to the bathroom, she called her neighbor to help her. She had a sensation on her skin like there was electricity going through all of her skin and it was really painful, sensation was from the top of her head to her toes. It was an extreme pain in the whole outside of her body. On the third day (26Mar2021) she completely lost all of her hearing, totally. This freaked her out since she has really good hearing.  After she had the symptoms about two days later everything went away, the bad things went away. These events did not result in emergency room or physician office. Patient declined any treatment, and she was told to just wait it out and was recommended to get the booster. Outcome of events was recovered on 28Mar2021.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Rash started on face then spread to trunk and extremities 7 days after administered vaccines.
Severe flu-like symptoms. Skin sensitivity, muscle and joint aches, weakness and lethargy. Fever over 102 even after taking 600mg Ibuprofen. Severe symptoms lasted around 12 hours, next day felt tired, sore, like recovering from a flu. Fully recovered about 72 hours after injection.
This case was reported by a physician via call center representative and described the occurrence of type iii hypersensitivity reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced type iii hypersensitivity reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the type iii hypersensitivity reaction was unknown. It was unknown if the reporter considered the type iii hypersensitivity reaction to be related to SHINGRIX. Additional details were provided as follows: The adverse event was reported via click to chat. The age at the vaccination was not reported. The health care professional asked regarding the data on the effectiveness of a single dose of SHINGRIX. The reporter did not have lot number or expiration date. The reporter could give the patients age and gender but she was concerned about HIPA privacy with initials and date of birth. The reporter was not reporting a severe unexpected adverse reaction. No additional information was provided.
2 expired PENTACEL vaccines were administered with no AE; Initial information received on 26-Mar-2021 regarding an unsolicited valid non-serious case received from other health professional via Medical Information (Reference number- 00537025).  This case involves a male patient (child) who received expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 24th (month unspecified), the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ146AAA, expiry date- 14-Feb-2021) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  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.
Burping; her left ear was hurting; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: EW0217, Expiry date:30-Sep-2021), via an unspecified route of administration, administered in Arm Left on 27Jul2021 13:30 (at the age of 69-years-old) as dose 1, single for COVID-19 immunisation. Medical history included leukaemia , chronic kidney disease ,hypertension ,hearing aid user from an unknown date and unknown if ongoing . The patient had no known allergies. The patient's concomitant medications included Sprycel, Levothyroxine, Amlodipine, Rosuvastin, Clopidogrel, vitamin C, vitamin D. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient got the first dose on 27Jul2021 and after that her left ear was hurting and that went away. The patient experienced burping on 13Aug2021. This started about two weeks after the first shot, or 1.5 weeks something like that. She received the second dose on 17Aug2021, and her right ear started throbbing and it is constant. She stated right now she is "so-so" because her ear is irritating her. The caller stated she is waiting until 8 to see if she can get in to see her doctor.  She asked if this is a known side effect or if anyone has been reporting this. The caller went to urgent care on 19Aug2021 because she couldn't see her primary care provider. The caller was burping and every time she did, it caused the throbbing in her ears. The urgent care provider thought that the caller may be having acid reflux. The burping has gone away but the right ear is constantly throbbing whereas the left ear would come and go. left ear hurting. The outcome of the event burping was recovering and outcome of the other event was recovered on 21Aug2021.
Erythema and swelling on the right upper arm (deltoid region) where MENACTRA and ADACEL were placed. No issues on left arm where GARDASIL was placed. No fever or itchiness. Parent reported it started later on the day of injection and got worse the next morning. I saw pt 2 days after injection. Marked the area and will monitor for now. She has  been applying ice. Will be follow up to see if it gets better tomorrow. If not, will possibly start antibiotics for cellulitis.
I?ve been fevering and shaking since 4am on 04/6/2021 and it is now 8:51 on 04/6/2021. I have dizzy spells, a runny nose, aching joints, a pounding headache, my eyes ache and burn, I constantly feel like throwing up, and I haven?t been able to sleep at all.
According to mother, child vomited for 4 days after receiving Rotavirus vaccine. She did not seek care at the time of the events.
Very sore arm and shoulder not unexpected, but I have had shingles, and the nervous system symptoms afterward are very similar to what I have been feeling for 36 hours all down my left side from my face to my legs. Also weak and dizzy.
Dx: Headache x 10 hrs s/p vaccinations. Temp: 99.1 degrees F, NL PE. Treatment: Analgesics/MOTRIN PRN.
heavy fatigue,  mild nausea,  loss of appetite, soreness in upper arm.  was at worst from about 18-32 hours after getting the vaccine.   took some aspirin for the soreness,  slept much of the day.
No additional AE reported; M-M-R II administered after a temperature excursion; Temperature 9C; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 19-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live 9 (rHA) (M-M-R II) (lot number: T003384, expiration date: 28-JAN-2022; dose and route of administration not provided). The vaccine was stored in temperature 9 degrees Celsius for 5 minutes. There was no previous temperature excursion.  No adverse event was reported.
This spontaneous report as received from a healthcare worker (Certified Medical Assistant) refers to a patient of unknown age and gender. On 26-FEB-2014 the patient was vaccinated with an expired dose of PROQUAD (Merck), lot # H015629, expiry date: 24-FEB-2014, (dose, route and indication not reported). No adverse symptoms reported. The healthcare worker stated the product did not have any previous temperature excursions. It was not reported if the patient had sought medical attention. Additional information has been requested.
Slept for 5-6 hours immediately after vaccination, would not wake up even for feedings despite attempts to wake her up. Cried inconsolably for 1-2 hours and apparently had pain lower extremities to touch a manipulation when woke up.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, patients were inadvertently vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Arm pain, cobstant numbness in right arm/hand/thumb & forefinger. Left arm frequent numbness/pins & needles.
sore arm at injection site.; Nausea; Dizzy; Weak; Feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 08:45 (Lot number: EN6198) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies:sulfa drug" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (medically significant) with onset 01Mar2021, outcome "recovering", described as "sore arm at injection site."; NAUSEA (medically significant) with onset 01Mar2021, outcome "recovering", described as "Nausea"; DIZZINESS (medically significant) with onset 01Mar2021, outcome "recovering", described as "Dizzy"; ASTHENIA (medically significant) with onset 01Mar2021, outcome "recovering", described as "Weak"; MALAISE (medically significant) with onset 01Mar2021, outcome "recovering", described as "Feeling unwell". The events "sore arm at injection site.", "nausea", "dizzy", "weak" and "feeling unwell" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of vaccination site pain, nausea, dizziness, asthenia, malaise.  Clinical Course: Patient received treatment with Epi pen, steroids, Zyrtec, Famotidine. Patient was did not have covid prior vaccination and not tested for Covid post vaccination. No other vaccine in four weeks. No other medications in two weeks.   No follow-up attempts are possible. No further information is expected.