chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse events after my 1st dose (day 0= 01/07/21): Day 1- local tenderness; Day 2- local tenderness + fatigue Day 3-4= felt ok, N/A; Day 5 evening- started to have mild/moderate body aches- took 1 xTylenol in the evening. I was  able to complete my daily activities; Day 6- moderate body/muscle ache, headache and pain in my left armpit (lymphadenopathy)- took Tylenol every 6-8hrs. I was able to complete my daily activities, with moderate fatigue; Day 6/7 over night= Same symptoms as a day 6 plus Moderate/ serve bone -pain woke me up from my sleep. Took Tylenol; I was able to complete daily activities but with moderate/severe fatigue; Day 7/8= Overnight Less pain, localized mainly in upper back. Persistent headaches and lymphadenopathy on my left armpit. Took Advil over night and during the day at q6-8 hrs. Worked from home that day with moderate/severe fatigue. Day 9= No more headache, pain localized upper back, between my arm plates. But new today chest tightness (difficulty breathing) with dry cough. At this time I called the occupational health at the hospital (my workplace) and scheduled a COVID test. COVID PCR Test results were NEGATIVE. The dry cough persisted for a period of time. Adverse events after my 2nd dose (Day 0= 02/04/21): I got my 2nd COVID 19 (Moderna) vaccine at 5.30pm. No immediate reactions post administration. I went back to work and completed the duties until 10pm (a very busy day in the department). Day 0/1: Around 11.30/midnight pm when I went to bed and I started to have chills and tremor like I have never had in my life (the bed was shaking). I could not talk and barely hold my phone in my hand. The next morning I was suppose to give a talk, but when I saw my symptoms I decided to notify the organizers. I barely managed to email them. Please see my reports on the v-safe for  more details. Briefly: presented also with fever, very severe pain at the injection site+swelling. Painful lymphadenopathy on my hight armpit. Headache, muscle and body aches, severe fatigue, nausea (I have never been that sick in my life). Loss of appetite- I couldn't eat anything for >48hrs; I forced myself to keep hydrated. Along all these symptoms I also presented a profuse sweat (for 2 days night and day- at times I changed cloths every 30min-1hr), high HR, and heavy breathing, severe fatigue. I had an oximeter at home and the O2 saturation was below 90% at RT. One of the most alarming symptom that I had was the severe/unbearable headache/eye pain (felt like brain swelling), almost called 911.
Pt received first dose of Pfizer vaccine at 5:38pm and at 5:40pm he stated he had bumps to his tongue and tongue was itchy. Pt vitals: BP 162/97, Resp 14, Pulse 70, O2 99%RA. Pt given 50mg Diphenhydramine HCL PO at 5:42pm. Pt stated at 6:05pm throat began to get itchy. Pt reported to EMS and pt given 10mg Dexamethasone IM. Pt on telemetry. Symptoms all resolved. Pt released at 6:45pm.
Swollen lymph node on armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node on armpit) 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 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 LYMPHADENOPATHY (Swollen lymph node on armpit). At the time of the report, LYMPHADENOPATHY (Swollen lymph node on armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.   Reporter did not allow further contact
12/28/2020  Had cough , shortness of breath, loss of taste of smell and body aches  lasted 12 days  worstern until the  01/06/2021 then became better gradually.  Prescribed Benzonatate 100 mg 3 times a day Covid -19 result as positive  12/29/2020.
At 40 hrs post vaccine I broke out in a red, painful rash located on my trunk from the neck down and the hips up. The rash is prickly, red, somewhat raised and tender to the touch. It came on suddenly at around 8am on 2/14/21.
Severe swelling of arm and itching. Fever for 2 days above 100.
Burned like the booster; Kicked my but; This case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and Flu vaccine. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced burning sensation and feeling abnormal. On an unknown date, the outcome of the burning sensation and feeling abnormal were unknown.   It was unknown if the reporter considered the burning sensation and feeling abnormal to be related to Shingles vaccine and Flu vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The reporter stated just got the shot the other day and wait 2 to 3 month for the 2nd. The reporter stated that not going to lie, burned like the booster plus got the flu shot in the same arm. The reporter further stated that it kicked her but. The follow-up could not be possible as no contact details were available.
Initial unsolicited report received from a nurse on 24 September 2015. This case involves two patients (age and gender not reported) those were vaccinated with a dose of TENIVAC (batch number, dose, route and site of administration were unknown) on an unspecified date in September 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. Concomitant medications were not reported. On September 2015, following the vaccination, both patients had pain at the injection site and unable to move arms. Lab data and corrective treatments were not reported. Both patients were not recovered from the events. List of documents held by sender: none.
Case previously recorded as MA2009-4498.  Initial case report received from a nurse via agency on 20 NOV 2009.  A 3-year-old patient was vaccinated with 0.5 mL of FLUVIRIN 2009/2010 (batch no. 101327) i.m., on 20 NOV 2009.  Administration to a child under 4-year-old is unexpected with S-OIV FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008675.
I started having ringing, a high-pitched sound in my ears apprx. 4-5 days after my first jab.  It's now and has been constant.  It doesn't go away and is very bothersome at night.   I just happened to read Clinic's vaccineologist article about his tinnitis after being vaxxed and thought I should file a report.  *I am unsure of exact time of my 1st jab and what time it was when I first started to notice the ringing.   My 2nd Moderna jab was 12/1/21.  Had I even considered that this constant ringing in my ears was associated with my first jab, I would not have gotten the second.  How does anyone know that the second jab hasn't worsen or prolonged my issue?
Pt had the vaccine around 9:00 am, became tired, and went to sleep from 5 to 7pm, then back to bed later that night. Complained of excessive night mares.  Had fatigue the next day, chills no fever and complained of a headache, all which lasted until noon on Saturday the 20th.
C/o severe pain at injection site going into shoulder. Sudden onset secondary after injection. Still painful 1 1/2 wks later. Treated with heat.
Pt called on 11/7/2013 - Injection of HD FLUZONE given on 10/24/13 complaining of pain in shoulder and upper arm with certain movements started day after shot and is gradually worse and still there.
Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA262537 (same reporter). This case involves a 11 years old female patient who received 0.5ml vaccine MENACTRA lot U595AA, expiry date 27 Aug 2019 and FLUZONE QUADRIVALENT MDV lot UI982AC, expiry date 30 June 2019 via intramuscular route in the left deltoid on 17-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage as it was reported that patient received MENACTRA and FLUZONE QUAD after temp excursion and vaccine unacceptable for use. Temperature: -1.64 Celsius for 24 hours. It was unknown whether patient experienced any adverse reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender - none.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored GARDASIL, (dose and route, lot # and expiration date were not reported). No adverse effects were reported. The patient's concomitant therapies were not reported. This is one of two reports from the same source. Additional information has been requested.
Caller mentioned her husband was not feeling well initially; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Caller mentioned her husband was not feeling well initially".  Additional information:Reporter stated if it would be okay to get the second dose, will it be worse on the 2nd dose. Reporter stated mentioned her husband was not feeling well initially, and afterwards, started to feel bad also.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
About 2 wks post injection, the patient developed numbness both lower extremities followed by weakness that progressed proximally.
About 20 minutes after receiving the vaccination, my left side became numb, especially my face and head. And my left eye was watering.
Mother came to health dept today and reported the following: Client left building where she received IZ "body went stiff, eyes were open x 2-3 minutes." mother caught her & prevented injury from fall. 911 called, taken to ER by ambulance. Mother reports client was told she had a seizure. Referred to neurologist & cardiologist.
Had shingrix in 2020, now have shingles/Suspected vaccination failure; Now have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In September 2022, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK receipt date: 08-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shingrix vaccine in 2020 and now had shingles. The patient was not happy with cost return. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Developed chronic hives with multiple lab tests confirming no medical cause. I have hives every single day, usually accompanied with swelling in my face and hands, and sometimes my feet, making it painful to walk. Treatment only resolves the hives between doses.
Super high fever.  Severe chest pain. Trouble breathing.   Patient taken to emergency room.  X rays taken. Patient was given tylenol
No adverse event occurred. The patient received the booster dose 4 months after completing her primary series. Before administering the injection, she attested that she completed her primary series of Pfizer 6 months prior but did not have her COVID vaccine card with her. We proceeded to administer the injection and a couple of hours later the patient came back to the clinic to get the information added to her COVID vaccine card that she found. At that time, it was noticed that she completed the primary series 4 months prior.
Difficulty breathing approx 30 minutes p/immun; flushing of face followed by hives on upper portion of body; taken to hosp by parents; Adrenalin & Cortisone administered by ER;
Information has been received from a registered nurse concerning a 16 year old female who was vaccinated with second dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient developed a welt at the injection site. Unspecified medical attention was sought. At the time of report, the patient had recovered. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Starting about 8-10 hours after my Moderna Booster injection, I developed urinary frequency, voiding about every 60-90 minutes. This persisted for about 30 hours, then resolved. This had not occured with either of my first two Moderna doses. (I also had the same typical symptoms of fatigue and aching that I had with my second dose.)
Has fluid, swelling, redness and heat in right arm, swollen around elbow of right arm. Started night received immunizations. Told to apply ice and take benadryl 50mg every 6 hours as needed. If not better tomorrow or gets worse at any time, go to immediate care clinic/ER.
On the 22nd after the vaccine, I was working around the house and began to feel lightheaded, my ears sounded as if i was in a tunnel, my vision began to feel like it was rotating and my knees felt like jello.  I felt faint so my spouse helped me to lay down and I had a burning feeling in my stomach.  I tried to lay down but the feeling in my stomach got worse so I sat up with my head down for a while until it eased up.  My head hurt so I reached out the to the ER doctor who told me it was possible side effects and to watch myself and if the symptoms got worse to come in but they didnt.  I laid down until I began to feel better.  I continued to be nausous and have a slight headache for a couple hours after
Information has been received from an approximately 73 year old female consumer with no pertinent medical history, and a swine flu vaccine reaction or allergy, who in 2008 was vaccinated with a dose of PNEUMOVAX 23 (route and lot # unknown). There was no concomitant medication. The patient reported that one day after receiving PNEUMOVAX 23, she developed severe swelling from her left shoulder to her fingers, the swelling was "like a big bag of fluid". No lab diagnostic studies were performed. The patient did not seek medical attention. The patient stated that the swelling resolved in 5 days without requiring treatment. The patient also reported that she experienced severe stiffness of her neck, arms and legs within 3 hours of receiving swine influenza virus vaccine (unspecified), in 1976. The patient stated that the symptoms resolved in a few days without requiring treatment. No further information is available.
Narrative:  Patient has experienced persistent headache and occasional  nausea after receiving first dose of vaccine. it has been 7 days since vaccine and he still reported the headache.
Heavy Menstrual periods every two weeks that last 10-12 days. The symptoms started after receiving my shot. Prior to the shot normal menstrual cycles for my entire life. I also developed fibroids in my uterus. I am opting to have a hysterectomy to stop the symptoms. Other females that I know have had changes to their menstrual cycles as well, all after being vaccinated.
I administered the High Dose Influenza shot meant for her husband instead of the regular dose for 64 years of age and younger.  I realized right away the mix up.  I assured patient that she would be fine.
Information has been received from a registered nurse concerning approximately 3 females (age not reported) on unspecified dates were vaccinated with a second dose of Gardasil. The nurse reported that the second dose hurt more after the injection than the first or third dose of Gardasil. Medical attention was sought. No further information was provided. Additional information has been requested.
Swelling at injection site, turned to itchy rash at day 2 and 3. Now spreading and dissipating. Applied hydrocortisone and took Zyrtec.
left sided facial numbness, feels like her previous symptoms of Bell's Palsy. Bell's Palsy not disclosed at time of vaccination.
bad knees; This is a spontaneous report from a contactable consumer (patient). An unspecified age male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ) via an unspecified route of administration on 21Jul2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, the patient had bad knees. The patient would like to know if he can swim. When he gets cortisone shots to his knee, they tell him not to swim for 3 days. Patient mentioned he wants to make sure with the "corona" vaccine if it is safe to swim. Treatment was received for event. He stated "I just want to make sure, I don't think it affects". The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Extremely high blood pressure.  Near the point of having to go to the ER. Blood pressure was monitored.  Swelling and rigidness in both knees. Severe limited mobility, nearly incapacited. Severe swelling and rigidness lasted 8 weeks. Much improved since 1st or 2nd week of  October.  Had limited mobility, much improved. Still has to be cautious, mainly with stairs.
This spontaneous report was received from a physician via a company representative and refers to a 18 year old female patient. There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications provided. On an unspecified date in 2017, the patient was vaccinated with GARDASIL 9, (dose, route of administration, lot # and expiration date were not provided) for the prevention of HPV. The physician reported that the patient, upon being vaccinated "a couple of weeks ago", passed out. It was reported that the patient was not injured. The office protocol had the patient taken to an emergency room, "to ensure something else was not going on with the patient". The patient was diagnosed with a vasovagal response at the emergency room. The patient's symptoms fully resolved the same day as the vaccination. The relatedness between the events and therapy with GARDASIL 9,was not provided by the reporter. Additional information has been requested.
24 hours after injection she noticed her arm was red, swollen, tender and warm. 48 hours after injection,  her symptoms got worse and the swelling was down past her elbow. she went the the dr and he gave her an anitibiotic and told her she had an infection.
Approximately 10 minutes after receiving vaccine -> pt had white spots in vision and hot flash. A little nausea that lasted approximately 15-20 minutes. No shortness of breath, rash though.
Developed atypical chest pain 1 day following receipt of SPV. Chest pain waxed and waned over next couple of days and patient was seen in ER on 11 April with normal exam. No associated symptoms or radiation. CP described as "little tightness in my chest...not really painful, but more bothersome". Noted burning quality that felt like heartburn, but different from heartburn in duration compared to previous heartburn episodes. No improvement of pain after receipt of IM TORADOL and po MYLANTA in ER. Chest pain did not change with changes in position or with deep breaths. (Patient sought evaluation on at least 2 other occasions for continued chest pain over next several weeks.)
Follow up on 11/17/2003: "Became lightheaded, dizzy, became short of breath-lips, tongue became swollen.  Given O2, Benadryl injection-to ER where she recovered with more medical intervention.  Diagnosis: Anaphalysis.
Started with chills and progressed to severe body, muscle and joint pain, headache, pain in my neck and back.  I was very weak and broke out in a sweat about 2:00 AM.  I was in bed all day Saturday and most of Sunday with pain. My flesh hurt all the way to the bone. The site of the injection was swollen, red and feverish until today, Wednesday. I could not eat for several days.
Onset of symptoms of incomplete transverse myelitis two hours after vaccine administration; MRI of the brain showed lesions consistent with Multiple Sclerosis and follow up spine showed similar lesions at multiple levels; This is a spontaneous report from a contactable physician. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in left arm on 16Jan2021 12:00 (at the age of 32 years) (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. Medical history included S/P gastric sleeve surgery for obesity and hypertension. The patient is not pregnant. Concomitant medications included phentermine and lisinopril. It was reported that the patient experienced onset of symptoms of incomplete transverse myelitis two hours after vaccine administration. MRI of the brain showed lesions consistent with multiple sclerosis and follow up spine showed similar lesions at multiple levels. The events were assessed as serious (medically significant). The patient was treated with intravenous steroids. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on a reportedly close temporal association, the company cannot completely exclude a reasonable possibility that BNT162B2 caused the incomplete transverse myelitis and multiple sclerosis.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Fever 9-18-18 upset stomach, rash developed 9-20-18 itching rash, rash still present 9-24-18.
10 days after shot, developed lump (firm) and redness L thigh. Treated with antibiotics with marked improvement of cellulitis/abscess.
I am a breastfeeding mother and was nervous to get the vaccine knowing there isn't alot of breastmilk testing on it. After receiving the shot my daughter has woken up with a fever that can not lower with medicine. We are now on day 2. My sister also experienced the same thing with her breastfeeding child.