chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 inch lump at injection site  developed within 24 hours and which lasted 2days;  two separate areas of raised red rash on the skin, one over the injection site about 1 1/2 inches in diameter and a second smaller one above it about 1/2 inch in diameter which were first noticed in the morning 1 1/2 days after the injection. I sought medical care at my primary doctor and was seen by a nurse practictioner on the day I saw the redness/rash ( 2/26). She advised me to use a cold compress and come back in if the area increased in size, became more painful, or I developed a fever.  The rash diminished on Friday 1/29/21 as did the lump.
Right upper extremity extremely swollen, reddened and extreme pain. Axilla lymph nodes enlarged and painful. Area hot to the touch.
Patient experienced blood clot on right calf. Blood clot located for DVT from femoral down to ankle. Unknown if related to vaccine, diagnosed 11/1/2021.
Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from other health care professional (Medical assistant). This case involves a 16 years old female patient who received on 17-Apr-2018, injection dose of suspect MENACTRA lot number not reported via unknown route in unknown administration site. On 24-Apr-2013 she also received injection of the same vaccine with an unknown batch number via unknown route in unknown administration site. On 24-Jul-2018 she also received injection of the same vaccine lot U6002AA, expiry date 11 Sep 2019 via subcutaneous route in the left arm due to blood disorder. The patients past history was not reported. The patient did not received any concomitant medication. It was an actual medication error due to extra dose administered and inappropriate route of vaccination. It was unknown whether patient experienced any adverse reaction after the injection. 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 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.
PATIENT HAD A DUPLICATE MCIR WAS NOT DISCOVERED UNTIL VACCINES WERE GIVEN.  PATIENT'S MOTHER WAS CALLED ON 2/26/20--STATED UNDERSTANDING CHILD HAD NO ADVERSE REACTION.
She lost her sense of taste 3 days after the second dose.   She said there is a metallic taste in her mouth and food does not taste the same.  The metallic taste has not gone away and is still very prevelant. Also, she had some breathing difficulties post  covid in april and it seemed to exasperate it.  An inhaler helps her but she still is getting winded more easily than ever before covid and vaccine.
PATIENT RECEIVED A 2ND TDAP WHEN NOT NECESSARY WITHIN THE 10YEAR TIMEFRAME (PREVIOUS ADMINISTRATION DATE 05/26/2021). PATIENT ALSO RECEIVED A 4TH TWINRIX WHEN NOT NECESSARY (PREVIOUS ADMINISTRATION DATE 07/21/2010).
Patient here for 4 month well visit, vaccines ordered (Pentacel, PCV13, rotavirus) but Moderna bivalent booster administered by mistake. Parents informed. Patient observed for 15 minutes, examined and found to be well, in no distress, no reaction noted.
This report describes the occurrence of joint pain in an "older" male of unspecified age who was vaccinated with hepatitis A inactivated & hepatitis B recombinant vaccine (Twinrix) for prophylaxis. This report was received from the subject and has not been verified by a physician or other health professional. The subject's medical history and concurrent conditions were not reported. The subject denied concurrent medications and vaccines. On Feb. 27, 2003, the subject reportedly received his third injection of Twinrix. The subject reported that "a few days" later, he began to experience lower hip, back, and shoulder pain. The subject stated that he was seen by his physician three times. Reportedly, the subject was not working because of his discomfort. The events in this report are considered "persistently incapacitating" because the subject stated that he was unable to work.
Patient called pharmacy today, 9/23/18, around 10:45AM, to report pain and redness at injection site following flu shot. She says that her arm has been sore since the injection was given on 9/21/18 around 10AM. She says she gets a flu shot every year and has never experienced this kind of redness. She said "I am more concerned about the redness than the pain." She reported a red circle "almost as big" as her hand. According to her, this morning was the first time she actually looked at her arm, so she does not know when the redness actually started developing, or if it has become better or worse over time.
12:55- patient recieved first Moderna vaccine 13:30 - patient c/o lightheaded and feeling like she was going to pass out. Patient taken to treatment room 13:34 BP 50/30 Hr 56 down to 40, Sa)2 99% on RA - 0.3 mg epi IM x 1 , patient pale and diaphoretic,  EMS phoned 13:36 BP 110/70, HR 78,99% RA, patient responsive and reported improvement in symptoms. 13:38 BP 100/70, HR 86, 98% RA. Denies any respiratory distress
Chills Fatigue Sensitivity to noises Temperature of 100.3 at started 12 noon (4/11/21)   slight headache
Cough; Tested positive for COVID 19; Fever; A spontaneous report was received from a consumer (physician) concerning a 67-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cough, fever and tested positive for COVID-19.  The patient's medical history included cough. No relevant concomitant medications were reported.   On 29 Dec 2020, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Batch Number Unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient's cough continued since receiving mRNA-1273. On 02 Jan 2021, the patient developed fever and tested positive for COVID-19.  Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event cough was considered not recovered (still having a cough).  The outcome of the event fever was considered recovering .  The outcome of the event tested positive for COVID-19 was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the event of Covid-19 is Unlikely related to mRNA-1273 and a very limited information regarding this event has been provided.  Further information has been requested
broke out in a rash around his ankles, aches and pains throughout his whole body, feeling very run down
Information has been received from a health professional concerning a 7 year old child with no known medical history who on 15-Aug-2001 was vaccinated with a dose of varicella virus vaccine live (lot # 638653/0233L). Concomitant vaccination the same day included poliovirus vaccine inactivated (unspecified) and diphtheria toxoid (+) pertussis vaccine  (unspecified) (+) tetanus toxoid. On 11-Jan-2004 the patient developed chickenpox. The rash began on 13-Jan-2004 and she developed a fever of 103 F. The only treatment was ibuprofen (Motrin) for fever. The chickenpox was described as mild with about 10 lesions on her trunk and legs. There were no lab or diagnostic studies performed. Medical attention was not sought. There was no product quality complaint involved. Follow up information indicated that the office has no record of the child receiving varicella virus vaccine live. They reported that they only got a report of the child having a mild case of chicken pox. They reported that it must have been done in another office, but they do not know who administered it. Additional information has been requested.
Disgusting metallic taste in mouth; very dry mouth I drank lots of water and ate 2 bites of a banana. Metallic taste subsided in 2 hours.  The next evening (1/7/10 @ 7:30 PM I was very tired and had headache & muscle aches, so I went to bed early.  Did not sleep much due to headache, muscle aches, upset stomach.  Frequent urination during the night.  Fri., 1/8/10 did not feel well in morning but went to work (office).  Did not feel well all day.  Left work early and slept from 3:30 PM F., 1/10 thru to next morning S., 1/9 when I awoke at 7 AM and felt normal again.  Took a couple of Tylenol PMs each night for muscle ache.
I have a red and dry itchy rash on forehead, forearm, back, and chest. Later that night it started dripping clear fluid. I went to the urgent care, and they prescribed me doxycycline 100mg for 7 days. It did clear it up the itchy sensation stayed. My rash on my forehead, forearm, back, and chest didn't get any better.
Fever of 102, headache, body ache, sore and painful arm, extreme fatigue
approx 36 hrs p/DTaP/OPV pt exp generlized urticaria & welts, joint pain @ the knees & ankles, c/o feet hurt & as a result was unable to walk; required office visit; dx serum sickness; teatment included a 5 day course of pred & DPH;
Vaccines administered 12/19/2020 and 01/06/2021.  Second vaccine determined to be done in 3rd week of pregnancy (prior to positive pregnancy test). Miscarriage occurred 01/25/2021 at 6 weeks. Otherwise healthy, prenatally-optimized 34 yo woman without personal or family history of miscarriage or pregnancy complications.
severe dizziness; aches; chest pain; palpitations; extremely low blood pressure; fever; shortness of breath; This is a spontaneous report from a non-contactable nurse, the patient. A 38-year-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EK9231; Expiration date was not reported), via an unspecified route of administration in the left arm on 29Dec2020 at 09:15 (at the age of 38-years) as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took cefzil and experienced allergies. On an unspecified date, the patient experienced severe dizziness, shortness of breath, chest pain, palpitations, extremely low blood pressure, fever, and aches. The patient was seen in the emergency department for the events. Therapeutic measures for the events included medications and IV fluids; both not further specified. The outcome of the event severe dizziness, shortness of breath, chest pain, palpitations, extremely low blood pressure, fever, and aches was recovered.    No follow up attempts are possible. No further information is expected.
After the first vaccine I had a soreness in the arm that I got the vaccine in. At first it was sore for a few days and then it was sore with pressure. I have problems with external rotation. I still have symptoms and I cannot reach back. I can?t lay on that arm at night. It has been four months since my shot and my arm is still affected. It seems to a problem with my Deltoid Muscle.
Within an hour of arriving home, pt became fatigued and slept for a good portion of 3 days.
Developed rash, itching, hives to upper arm the day following the immunization. Treated 10 days later with Methylprednisolone.
This case was reported by a healthcare professional and described the occurrence of hepatitis B antigen positive in a 50-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  Concurrent medical conditions included hemodialysis, hypertension and renal failure.  On 1 August 2008, 30 June 2008 and 26 May 2008 the subject received 3rd, 2nd and 1st dose of ENGERIX B (unknown).  On 4 August 2008, 3 days after receiving the 3rd vaccination with ENGERIX B, the subject tested positive for hepatitis B antigen.  At the time of reporting the outcome of the event was unspecified.  The 3rd dose of ENGERIX B was also administered approximately one month too early.  This was considered to be an inappropriate schedule of drug administration.  No adverse events resulted.  Follow-up information was received on 03 September 2008 via a nurse, who reported that the subject received 40 mcg doses of ENGERIX B on 26 May, 30 June, and 01 August 2008.  The healthcare professional considered the hepatitis B antigen positive result to be related to vaccination with ENGERIX B.  On 18 August 2008, the subject tested negative for hepatitis B antigen and the reporting healthcare professional indicated that the event was resolved.  The healthcare professional indicated that the hepatitis B vaccination series was neither discontinued nor delayed, but the subject had not received the 4th dose of the series at the time of this report.
This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on 12Jul2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. On 19Jul2018, the patient experienced redness, warmth and swelling at the injection site. The reporting physician wanted to know if there were reports of delayed local reactions since "he cannot rule out cellulitis". The outcome of the events was unknown. The information on the batch number has been requested. Sender's Comments: Based on the information currently available, it cannot be fully excluded that the vaccination with PREVNAR 13 might play a contributory role for the occurrence of cellulitis at vaccination site. 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.
On 11Feb2021 he stated the headache, nausea, dehydration and fever started and he tested positive for Covid-19; sinus kind of thing; dehydration; This is a spontaneous report from a contactable consumer or other non hcp. A contactable consumer (patient) reported that a 68-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The caller stated he was scheduled to get his 2nd Pfizer vaccine on 27Feb2021. He stated on 08Feb2021 he developed a sinus kind of thing and hadnot been exposed to anyone with Covid-19 and didnot feel like he had Covid. Caller stated he went to his doctor and received antibiotics for a sinus infection diagnosis. On 11Feb2021 he stated the headache, nausea, dehydration and fever started and he tested positive for Covid-19 (five days later tested positive for covid) and received IVs and antibiotics may be. Callers wife loss of sense of smell around the same time he was diagnosed with Covid 19, although she never was tested. He was asking if he could take the vaccine on the 27Feb2021 since he got positive for Covid-19 after his first dose. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Mother reported a knot at the site the night of vaccines and gave Motrin and Benadryl. on 5/2/2023. The knot became bigger with heat/redness. Mother reports that the site continued to grow and the skin started crack and bled due to swelling. Patient came into clinic on 05/03/2023 and patient was gave a steroid shot due to reaction, after receiving the injection the redness started to go down along with swelling, 05/15/2023 mother reports that swelling/redness is still there, but has improved.
large welt in the injection site; sore in the arm; fever (101,5 °F); chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (large welt in the injection site), PAIN IN EXTREMITY (sore in the arm), PYREXIA (fever (101,5 °F)), CHILLS (chills) and FATIGUE (fatigue) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE URTICARIA (large welt in the injection site), PAIN IN EXTREMITY (sore in the arm), PYREXIA (fever (101,5 °F)), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, INJECTION SITE URTICARIA (large welt in the injection site), PAIN IN EXTREMITY (sore in the arm), PYREXIA (fever (101,5 °F)), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.            No concomitant medications was provided by the reporter.  The patient had a temperature of 101.5.     No treatments medications was provided by the reporter.
Symptoms begun on July 17th I tested positive on July 18th I experienced sore throat, body aches, headaches, low grade fever those were the first symptoms I noticed later on I developed a cough I was prescribed PAXLOVID and also prescribed cough medication.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 30-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). On unspecified date, the vaccine experienced two temperature excursions of 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R). No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
02/10/2021- RECEIVED FIRST DOSE OF MODERNA 03/10/2021- RECEIVED SECOND DOSE OF MODERNA 08/13/2021- BOTH PATIENT'S PARENTS TESTED POSITIVE. PATIENT IS LIVING WITH HER PARENTS. PATIENT TESTED NEGATIVE FOR COVID 19 WITH A PCR TEST. 08/14/2021- PATIENT STARTED HAVING COVID LIKE SYMPTOMS 08/15/2021- PATIENT TESTED POSITIVE ON A AT HOME TEST 08/19/2021- PATIENT TESTED POSITIVE FOR COVID 19 WITH A RAPID PCR TEST.
I could feel the vaccine enter my body & feel it move up my arm & spread up across my back & up my neck. I was nauseous instantly.  After 15 minutes I felt dizzy & weak. I started to twitch all over as the vaccine moved through my body. Later that day I had excruciating pain in all my joints & muscles & even bone pain. I got a headache. I felt sharp shooting pains in my chest.  2 days later intense nausea set in. I almost passed out. I am fatigued. I had strange abdominal issues like pressure, bloating, intense cramping, heartburn. I don?t have much of an appetite.  I am fatigued. I had diarrhea.
minor problems after vaccination; sore arm,little sore after other doses; she felt blah; chills for about 2 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (minor problems after vaccination), PAIN IN EXTREMITY (sore arm,little sore after other doses), DISCOMFORT (she felt blah) and CHILLS (chills for about 2 hours) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03121A, 027A214 and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced VACCINATION COMPLICATION (minor problems after vaccination), PAIN IN EXTREMITY (sore arm,little sore after other doses), DISCOMFORT (she felt blah) and CHILLS (chills for about 2 hours). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. In December 2021, VACCINATION COMPLICATION (minor problems after vaccination), PAIN IN EXTREMITY (sore arm,little sore after other doses), DISCOMFORT (she felt blah) and CHILLS (chills for about 2 hours) had resolved.            Concomitant product use was not provided by the reporter.  Also confirmed the email address.
Severe Gastrointestinal Bleeding, bloody diarrhea, first event occurred 10 pm the day after the shot. I had a total of 3 events.
Patient reported "tingling in tongue" and feeling "clammy" ~10-15 min after shot. The clamminess subsided after 5 min. The tingling in tongue did not progress, and it started to subside about 1 hr after initially reported. (Pt sat for monitoring for a while and then shopped before leaving.) Pt said she experiences drowsiness with Benadryl and drove herself to clinic, so she was offered loratadine. She refused an antihistamine and said she would take Benadryl when she gets home. She will continue to monitor for a RXN and seek medical attention if necessary.
Initially pimk  swollen injection spot in left  arm. Heavy feeling arm ,raised pink hive like spot that felt hot to the touch at injection area for the first 4 days. It started to feel a little better day 5.6.7 but  was still red and hot to the touch. Day 8 I woke up to very itchy ,raised pink spot again at injection sight that was bigger,about the size of a nickel. Arm was very hot and burning, and hard to lift over head.I applied ice and hydrocortisone cream. Day 9  I woke up to the same redness, pink raised hive that got bigger like a quarter size and was still hot and heavy. Hive got bigger throughout the day of 10 and on day 11 there is no hive but still blothchy pink.
Pt called call center on 4/23/2021 regarding of covid vaccine side effects. Verified pt with 2 identifiers. Pt reports c/o bad rash on neck, back, the right side of upper leg and hip after covid vaccination. Pt feels dizziness and weakness since this morning. Pt got 2nd vaccination(Moderna) at on 4/22/2021. Pt states she got some rashes after 1st vaccination as well. Pt feels itches, burning sensation and pain with bad rashes. Pt tooke OTC allergy pills but it's not helpful per pt. Noted hx of hyperthyroid and taking levothyroxine. Noted no health issues except covid side effects. Noticed pt to go to ED or call 911 for further evaluations d/t pt shows 2 parts of emergency covid vaccine side effects. Pt is educated of covid side effects. Pt declined the offer to call 911 on behalf of pt but pt states she will go to ED.