chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Participant experienced redness, swelling and itching which started the day after her first and second dose and disappeared within 24 hrs. Then she noticed a pain that started at the injection site and ran down to 2 fingers on her left hand. It occurred after the 1st dose and disappeared 2 days before the 2nd dose and continued after the second dose but was more severe. The pain is still there and has not fully gone away. Participant wrote a message to her doctor after the 2nd dose she was advised to wait for the symptoms to disappear her doctor prescribed Motrin and Tylenol that did not help so she was then prescribed Lidocaine patches that she used for 3 weeks and then stopped because they did not help much.
Janssen COVID-19 Vaccine EAU Severe chill (as to cause uncontrollable trembling), fever, head and body aches for first few hours of symptoms, lessening over the next couple of days
hives with crust on shoulder and arm of injection that spread to neck, face and ears; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives with crust on shoulder and arm of injection that spread to neck, face and ears), FATIGUE (fatigue) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Itchy (Hives in past.).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (fatigue) and PYREXIA (fever). On 03-Mar-2021, the patient experienced URTICARIA (hives with crust on shoulder and arm of injection that spread to neck, face and ears). At the time of the report, URTICARIA (hives with crust on shoulder and arm of injection that spread to neck, face and ears), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
First 3 days I had a sense of minor fatigue, on the 6th day I noticed that the injection area had a circular yellowish green rash. Not feeling any other side effects internet sources said that this was rare enough to report. I did some weight lifting the day before I noticed this.
Erythema, edema around immunization site.  Approximately 1 1/2 in. diameter.
pt recv vax 27JUN95 & p/aspiration vaccine splashed in the eyes;eyes washed w/sterile water for 30mins;same day devel severe h/a which persisted for 3 days;
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On approximately 03-AUG-2015 reported as 11 days ago) the patient was vaccinated with a dose of ZOSTAVAX (lot #, strength, dose and route were not reported). In approximately August 2015 (reported as now) the patient was starting a therapy on a short-term taper dose of prednisone for an unspecified reason (the onset date of adverse event was not reported). The outcome of the patient's events was not reported. The relatedness between vaccination with ZOSTAVAX and the patient's event was not reported. Additional information has been requested.
Febrile seizure 18 hours post vax. Fever noted 1st in ER. Had no other temps.
Patient reports general arm soreness, pain in left scapula, paresthesia descending length of left arm.
My periods are VERY regular.  This was my booster. Received Pfizer for all doses - experienced heavy periods (but at normal/expected time) after my first dose in April and my second in May.  This month, I started my period on 1/11 - expected time, bled a bit heavier, but pretty normal over all. I noticed spotting the evening of 1/24 and have been experiencing a full blown period for the second time this month. Currently On my 3rd day of full bleeding. My period Normally tapers off by third day and have light spotting after on 4th day if anything. Current Bleeding /period has not stopped and more blood clotting ontampons than a normal period for me. I have NEVER had a period and then another 2 weeks later. Very painful cramps and back pain (but that is usual for me). I didn't think I was pregnant and then miscarrying now since I JUST had a period two weeks ago. Not on birth control and trying to conceive. Very fresh red blood on 3rd day.  I don't know if this is related to my booster but this is HIGHLY HIGHLY unusual. Wanted to pass long in case it is related.  I am hoping this restarts my cycle clock and that I don?t have ANOTHER period in 1.5-2 weeks. Periods are always 25-27 data apart. I am due to have an OBGYN appt in a month and will discuss then.
Initial report received on 02 January 2013 from the Investigator participating in post-marketing study under the reference number M5A16. A case of pertussis disease in a 4-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL on 12 February 2008, 28 March 2008, 30 May 2008, and 10 March 2009 (lot numbers, routes, and sites of administration not reported). The subject developed a cough on 22 March 2012, approximately 3 years after the last dose, and a paroxysmal cough with a whoop on 24 March 2012. The subject also developed cold like symptoms on 22 March 2012, and sleep disturbance (start date not reported). Laboratory testing included positive PCR on 27 March 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 March 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 April 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Tested COVID-19 positive by PCR.  Drawn Tues 03Aug and notified positive Thurs 05Aug/Cold-like URI symptoms so far and s; Tested COVID-19 positive by PCR.  Drawn Tues 03Aug and notified positive Thurs 05Aug/Cold-like URI symptoms so far and some body aches; This is a spontaneous report from a contactable other healthcare professional (hcp). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was tested COVID-19 positive by PCR which was drawn Tuesday 03Aug2021 and notified positive on Thursday, 05Aug2021. Patient also had cold-like URI symptoms so far and some body aches. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective / COVID-19 cannot be ruled out.
Swelling of arm in the area where the pneumovax was given.  Mild pain as well
The second dose of the vaccine triggered a moderately severe RA flare lasting from 28 April to 29 April. Significant flu-like full-body joint pain, moderate fever (100.5 F against a normal base of 97.3), and light nausea. Joint pain continues as is usual for such flares, since some light damage likely occurred in my joints. I was unable to take NSAID or Prednisone (as I normally would for a flare) due to the vaccine. Acetaminophen taken but ineffective. NOTE: My RA is being treated with Rituximab, two doses every 4 months. Next dose scheduled 11 May 2021. Prior dose completed 12 January 2021.
Patient's mother put her son's birthday as a different date but his real birthday has been updated. After talking to the mom she implied that she lied on the form to get him a vaccine. He received the 12 and older vaccine but should have gotten the pediatric dose. Mom said that patient had no side effects from the higher dose.
herpes zoster with ophthalmic complications; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On or about 150DEC-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by the physician assistant for herpes zoster with ophthalmic complications. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.  Upon internal review, the event of herpes zoster with ophthalmic complications was determined to be medically significant.
Patient with history of anaphylaxsis - Received Covid Vaccine -  In observation area pt wearing home oxygen.   Pt observed to become short of breath- states "my throat is tightening" - face red - Nurse stat called. Unable to speak - immediately taken to emergency room
Patient complained of Left Breast redness, blisters, burning.  She has a history of a Left breast implant.
Vesicular/papular rash spreading on neck, face, back, chest, abdomen and legs. Not in a dermatomal distribution. Some lesions crusted over.  Temperature of 102. Treated with IV acyclovir and IV immunoglobulin in addition to IV antibiotics for left chest wall cellulitis. Discharge dx: disseminated varicella zoster. She was vaccinated as part of her immigration process.
Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech: dose#1-4, Moderna: dose#5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6202), as dose 2, single (Lot number: ER8732), on 04Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 10Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 76 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Sep2022 at 10:00 as dose 5 (booster), single (Lot number: AS7146B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies : Penicillin" (unspecified if ongoing), notes: Known allergies : Penicillin. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2022 at 10:00, outcome "unknown", described as "Pfizer / BioNTech: dose#1-4, Moderna: dose#5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Covid rebound 4 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient received Vaccine. Patient received other medication in 2 weeks. Antiviral details: Product: COVID-19 Treatment. Brand: Paxlovid. Treatment start date was 11Dec2022 and Treatment stop date was 16Dec2022. Indication: Treatment of COVID-19.
Headache; Stabbing in the back of my right eye; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Sep2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 01Sep2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 26Sep2021, the patient experienced stabbing in the back of his right eye accompanied with a headache. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 24Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events stabbing in the back of right eye accompanied with a headache was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Flu-like symptoms after receiving the vaccination were reported. Concomitant medications were not reported.
2nd shot about 11 am on 4/15. A few hours after shot, arm pain, took one ibuprofen. First night: fever, severe chills, vomit, aches. No treatment. Next morning, symptoms less (no more vomiting), tired,. Took ibuprofen. Gradually most symptoms faded, but felt tired. Soon diarrhea presents. After week and a half, see primary care Rosin. Took stool sample. No treatment, in fact retold not to take anything OTC for symptom.. Advised to eat blueberries and stay hydrated. Test results a few days later rules out all causes. No treatment recommended.
Arm got severe pain where shots were given, next morning area was deep red that evening started getting red whelps and very swollen.
Immunization 8/6/10. On 8/7/10 had small blisters distal to site of Varicella vaccine which became 2 large blisters per mother's report. At clinic 8/11/10 and noted 2 red areas each 1 1/2cm round to Rt arm distal administration site of Varicella. Mother will continue to monitor.
Information has been received from a consumer concerning her 15 month old daughter who on 04/01/02 was vaccinated with a dose of MMRII (Lot # 638706/0745L (also reported as 0745LO)).  The pt's vaccination history was noted to include a dose of DTP, a dose of IPV, and an "RV shot" on 02/27/01, a first, second and third dose of Hib conj vaccine on 02/27/01 (Lot # 638138/1548K (also reported as 1548KO)), 05/01/01 (Lot # 639437/0929L) and 01/09/02 (Lot # 639437/0929L) respectively, a first, second, and third dose of hepatitis B vaccine rHBsAg (yeast) on 08/14/01 (Lot # 640323/0753L), 11/19/01 (Lot # 640323/0753L), and 01/09/02 (Lot # 641449/1230L) respectively, and a dose of varicella virus vaccine live on 01/09/02 (Lot # 638244/0466L). The mother reported that each time the pt "had a shot (any shot)" she experienced a rash around the diaper area and a fever (Hib conj vaccine (WAES # 0401USA01373), hepatitis B virus vaccine rHBsAg (yeast) (WAES # 0401USA01516) and varicella virus vaccine live (WAES # 0401USA01518)).  Unspecified medical attention was sought. The mother was told to "just wait through the fevers". A product quality complaint was not involved. Additional information received indicated that the pt's vaccination with MMRII was not administered by the reporting physician's office. Additional information is not expected. The mother also reported that the pt developed a severe urinary infection after therapy with Hib conj vaccine (WAES # 04/01USA01373).
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 22-AUG-2013 the patient was vaccinated with one dose of ZOSTAVAX rather than VARIVAX (Merck) for the second dose of VARIVAX (Merck) (first dose of VARIVAX (Merck) was administered on 17-MAR-2013) (dose, route and lot # not provided). No product confusion discovered, just a medication error. No adverse event reported. Additional information is not expected.
Soar throat - Hard time swallowing. Like having strep throat. Aching Body - All my joints hurt very bad. No Energy at all - Aching all over Nausea, Felt warm Weak, Eyes blurry & DRY Coughing felt Like having the FLU Full Blown this was 1st time for the high dose - made me very sick
Patient received 3 doses of Moderna COVID-19 vaccine. 1st dose on 3/4/2021, Second on 4/3/2021 and returned requesting second dose on 6/18/2021 when entering vaccine it was noted that patient had already received his second dose. All three were verified in clinic EHR.
The pt's mother noticed that he was napping a little longer than usual. Additional information has been requested. Follow up provided no additional data.
Next day after shot, I started out with body pain all over and mental fatigue,  it is now a month and a half latter and I am still experiencing major inflammation and lower back body pain.
severe pain (8-9/10)in multiple sites over body (myalgia + joint), headache, stomach ache, fatigue + malaise persisting now > 2 weeks unremitting.  5/13/10 Follow up: Unremitting intense pain across multiple body locations. Chronic Regional pain syndrome-disabling.
Beginning next day, patient experienced fever, muscle soreness, sore throat, red rash around injection site.  All symptoms lasted several days; however, rash and muscle soreness lasted 3 weeks.
Information has been received from a pharmacist concerning a 80 year old female patient with no known allergies who on 19-JAN-2009 was vaccinated with a dose of ZOSTAVAX (lot # 663673/1710X). The patient had completed a 16 day course of VALTREX seven days before receiving ZOSTAVAX. On 21-JAN-2009 the patient experienced an outbreak of shingles after receiving ZOSTAVAX. The lesions were located on her waist and down buttocks. The patient had not contacted her physician at the time. The patient's outbreak of her shingles persisted. Additional information has been requested.
Per vaccinator,  while attempting to administer vaccination, needle prematurely retracted into syringe and the vaccine sprayed out. Less than half of the dose was received by the patient. A replacement vaccine dose was administered per Rph  Syringe/needle was different brand
10/23/2008 @ 13:00 2 1/4 cm x 2 1/2 cm reddened slightly swollen, slightly warm to touch @ injection site.  No fever aches/pain.
Two hours after Hep B vaccine patients temp was 101 (axillary) and he was feverish and cold. The next day (28 hrs) his temp was 102 (axillary). The following morning symptoms were resolved.
Pt came by pharmacy on 9/19 and showed arm to pharmacist on duty. She said arm was red with raised rash, warm to touch and she was having difficulty moving her arm.
This spontaneous report as received from a physician via a company representative refers to a 12 year old male patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. The reporter stated that patient received his first dose of GARDASIL 9 (dosing details were not reported) in August 2015 and a 2nd dose of GARDASIL 9 in August 2016 (inappropriate schedule of drug administration). The patient has come to the physician office for his third dose of GARDASIL 9 on 14-NOV-2016. It is unknown whether the 3rd dose of GARDASIL 9 was administered. The lot and expiration dates for all doses of GARDASIL 9 are unknown. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
I received my Covid vaccine on Friday July 23,2021, then Saturday I had a very fast heartrate, getting up to 188,   starting around 2:00 P.M. Saturday and lasting throughout the evening.  I kept drinking water to flush my system.  Things calmed down with my heart by Sunday .  Then a few days later  I had projectile vomiting, not just throwing up it was more forceful.   I really do not want to take the 2nd covid vaccine.
Pt. developed pain, redness; lacy looking rash to right upper arm. Slightly swollen, c/o pain from (R) neck & shoulder radiating to (R) upper arm. Evaluated by Dr. - ? reaction vs shingles. Treated with KEFLEX & VALTREX.
Fever of 101.3 degrees and headache the day following the vaccination.  Fatigue continues after 3 days.
cold sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of cold sores in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 10-AUG-2023, 1 days after receiving Shingrix, the patient experienced cold sores (Verbatim: cold sore). The outcome of the cold sores was not resolved.   It was unknown if the reporter considered the cold sores to be related to Shingrix.     It was unknown if the company considered the cold sores to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-AUG-2023 The patient self-reported this case. She inquired if she could use Valtrex for the cold sore after the vaccine. She was concerned about a potential interaction. The reporter did not consent to follow up.
On 5/2/01, left arm at site of injection had 4cm area of erythema and induration. No pain.
Information has been received from a health professional concerning a female patient who on 09/21/2004 was vaccinated intramuscularly with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine.  Subsequently the patient developed redness, soreness and pain at injection site.  Unspecified medical attention was sought.
Patient Complained of feeling lightheaded 1 minute after vaccine administered. She bent over forward in chair. Observation nurse called over and BP cuff applied. 0957=BP 97/58; radial pulse 60; skin warm dry and pink; 1002=complained of nausea, patient lowered to floor with legs bent; BP 96/60; 1005 nausea gone; epi pen administered in lateral left thigh; 1006 BP 104/70 radial pulse 68; 1008 BP 102/70 radial pulse 80; skin warm dry pink; EMS called and responded; transfer of care occurred at 1020am; patient refused to go to hospital; remained in our recovery area for 30 minutes post epinephrine injection. left with husband at 1040am. Vitals within normal limits.