chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a 5 year old female patient who on 1/12/00 was vaccinated with a dose of varicella virus vaccine live (lot # 632039/1357J). On 5/1/04, the patient developed shingles on her ear and was hospitalized for four days. The patient responded to treatment with Acyclovir with a complete recovery. On 5/18/04 (also reported as 3/18/04) the patient developed another shingles rash in the same area and was again treated with Acyclovir. As before the rash quickly and completely resolved. No other information was available. There was no product quality complaint reported. Additional information has been requested.
No additional AE details or PQC; Patient was administered an expired dose of MMR-II.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding medical history, previous drug reactions or allergies was provided. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).   On 25-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) as prophylaxis (dose, route of administration, and anatomical site of vaccination were not reported; lot number T018892 has been verified to be valid, expiration date reported and established as 02-JUN-2022) (expired product administered).   No additional adverse events were reported (no adverse event).
Swollen; Red; Rash; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swollen), INJECTION SITE ERYTHEMA (Red) and INJECTION SITE RASH (Rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced INJECTION SITE SWELLING (Swollen), INJECTION SITE ERYTHEMA (Red) and INJECTION SITE RASH (Rash). At the time of the report, INJECTION SITE SWELLING (Swollen), INJECTION SITE ERYTHEMA (Red) and INJECTION SITE RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
about 24 hours after 2nd injection, I received tenderness 5 inches around the injection site on the upper arm.  Tenderness lasted for 24 hours.
Hives that come and go, and last 5-10  minutes, relieved with hydrocortisone cream. Hives are random and appear on different parts of my body.  Hives are very itchy.
Discovered extreme soreness, warmness at injection site and red swelling the size of grapefruit
Pt was to receive 0.25ml booster dose of Moderna - SARS - 2, instead received 0.50ml dose. Denies any symptoms.
This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Aug2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 27Apr2022 at 11:00 as dose 5 (booster), single (Lot number: Fk9893) at the age of 44 years, in right arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 06Feb2021 at 14:00 as dose 1, single (Lot number: 012m20A), in right arm, on 06Mar2021 at 11:00 as dose 2, single (Lot number: 016m20A), in left arm and on 16Nov2021 at 13:00 as dose 4 (booster), single (Lot number: 065f21A), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Autoimmune-Sjogren's" (unspecified if ongoing); "Raynaud's disease" (unspecified if ongoing); "positive ANA" (unspecified if ongoing); "vestibular Migraines" (unspecified if ongoing), notes: I have vestibular Migraines. Concomitant medication(s) included: Hydroxychloroquine, start date: 14Oct2019; Effexor, start date: Jun2019. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: Antigen testing negative. Therapeutic measures were taken as a result of drug ineffective, Covid-19 included Paxlovid from 24Jun2022 to 28Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
after my 1st shot I got came a contact to Covid virus and I tested Positive; achiness; head was like really swimming, at time when I stand up I get very light headache; Fever; I was still feeling very light headache if I move too fast; Chills; This is a spontaneous report from a Pfizer-sponsored program. A contactable 56-year-old male consumer (Patient) received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EW0191), dose 1 via an unspecified route of administration on 16Jul2021 as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Other Medication just regular daily Vitamins, don't know D3 (further not clarified, hence not captured in tab). The patient's concomitant medications were not reported. On 27Jul2021, the patient experienced after my 1st shot, the patient got came a contact to covid virus and the patient tested positive, I did another covid check before came in but it tested positive again, on an unspecified date in 2021 fever, chills, achiness, head was like really swimming, at time when the patient stand up and get very light headache, the patient had still feeling very light headache if the patient move too fast. He missed the 2nd Dose and asking if how long he needs to wait to get the 2nd dose, I already gave him the number of the Pfizer medical information department." Therapeutic measures were taken as a result of, headache. Treatment taken in response to adverse events, only thing I took was Tylenol for the headaches may be 200mg, took two. Investigation Assessment Yes. Consumers ask, how long should I wait for my 2nd dose because when they came time for my 3 weeks after the 1st dose, the patient actually contacted Covid, and how long do I wait to take my 2nd shot. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in 2021, sars-cov-2 test was positive on 27Jul2021. The outcome for all events was unknown except headache was recovered on an unspecified date in 2021.
Patient received 1st dose of the Covid vaccine (Moderna) on 9/11/21. When she returned for her second dose on 10/09/2021, she informed me that since her first dose she has had radiating pain from the injection site up to her neck. She also described having swollen lymph nodes on her neck on the same side (left) she received the vaccine. No fever, headache, or other symptoms reported.
Patient received her booster (pfizer) vaccine at 15:10, patient initially received Janssen as her first vaccine. 1512 patient came back to vaccinator's table stated she is having SOB "tightness in her chest", dizziness and light headedness and feeling warm. 1512 initial vitals taken as follow HR80 RR 18 BP 158/97 SAT 100%. 1514 water provided no signs of aspiration, patient still stated she is feeling warm and the feeling comes and goes. 1517 retook VS HR71 RR 19 BP 153/105 sat 100%. pt stated she felt like her throat is closing. 1527 HR 88, RR 18, BP 162/93 SAT 100% 1528 called 911. 1532 hr80, RR 18, BP 174/93 SAT 100% pt stated her thought is closing up again. stated her lips felt dry. 1542 EMS arrived and assessed patient.  1557 patient was taken out by EMS. PT A/O x 4 , ambulatory.
Severe muscle aches, joint pain, dull headache, low-grade fever, nausea, lack of appetite, fatigue; all symptoms lasted about 28 hours, but muscle aches and joint pain lasted about 48 hours. I took ibuprofen at regular intervals to lessen the pain, used a heating pad, drank lots of water, and slept a ton.
NO ADVERSE EVENT; GIVEN PEDS 0.2 mL IM INSTEAD OF THE OVER 12 VACCINE 0.3 mL DOSE
Pt describes a bump on the arm, swollen; redness near the injection site for about 3 weeks.
ON 5/8, this 70 year old man was in his usual state of health when he went to bed. He was awakened with "the worst leg cramping of my life". He states that his right lower extremity tightened up and the cramping extended all the way into the foot. His leg began shaking uncontrollably. Called EMS and arrived in ED for evaluation. Noted to have labored breathing and confusion. Blood alcohol 170. Elevated D-dimer. The patient was given nebulizer treatments without significant improvement. BP 119/68, HR 76, RR 19. oxygen sat 96% on room air. Speaking in short sentences, audible wheezing. CT angiogram with contrast: findings suspiscious for pulmonary embolism, involving segmental branches of both lungs. No large central embolism identified. Patient started on apixaban. No signs of hemodynamic compromise. Plan 3 months anticoagulation.
I smell cigarette smoke, several times a day. No one around me smokes. No one is smoking in my vacinty when I smell it. Sometimes last a few min, other times last  about30 min.
5 minutes after receiving the vaccine approximately 1305, patient has flushed face, tingling in face and throat, tongue feels tingly and numb at approximately 10 minutes after shot. These symptons last one hour. At 1400, pt. feels more flushed and faint. She sits down and calls nurse at the hospital for help. Nurse advises to take benadryl. Patient takes 50 mg of Benadryl and within 15 minutes, she feels better. Later on at 1900, the tingling and numbness starts again on face and in throat. Patient takes 2 benadryl tablets again and was better in 15 minutes. Patient states had no other problems.
Came to ER with syncope, coffee ground emesis, O2 sats in the 80's, placed on O2, admit to ICU, was able to wean O2 was then able to move to general medical floor, consults GI, Cardiology and Infectious disease. Remains in hospital on oxygen.
Notmal injection. Days later large lumps formed on my under arm and rib cage that appear to be lypnodes or something similar. Painful to the touch and persistent over a few days
30 year old white female with hepatitis A and a history of gastritis who on 05/07/2005 was vaccinated intramuscularly in the left deltoid with a first dose of hepatitis B virus vaccine.  On 05/10/2005, 3 days later, the patient developed pharyngitis, low grade fever, swollen lymph nodes, decrease in appetite, irritability, and insomnia.  She was treated with Benadryl.  The symptoms were noted to be gradually resolving.  Unspecified medical attention was sought.  There was no product quality complaint. Follow up information received from the physician indicated that on 05/10/2005, the patient developed fatigue, mild pharyngitis, sensation of warmth, neck pain, axillary lymphadenopathy, disturbed sleep, irritability, and decreased appetite.  The patient was recommended to take Benadryl, Tylenol, and Buspar.  Relevant diagnostic tests and laboratory data included: lead, CBC, and chem 18 = normal results; alk phosphatase = decreased; and urinalysis = positive ketones and glucose.  The patient was feeling better on 05/25/2005, and then left for another country.  Additional information has been requested.
sought guidance on whether they can still receive the second dose, as they are now also past the 28 day interval.; Patient diagnosed with COVID-19 infection after receiving first dose of Moderna COVID-19 vaccine.; sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient diagnosed with COVID-19 infection after receiving first dose of Moderna COVID-19 vaccine.), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and PRODUCT DOSE OMISSION ISSUE (sought guidance on whether they can still receive the second dose, as they are now also past the 28 day interval.) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07862119) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (Fever). On 15-Jul-2021, the patient experienced COVID-19 (Patient diagnosed with COVID-19 infection after receiving first dose of Moderna COVID-19 vaccine.). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (sought guidance on whether they can still receive the second dose, as they are now also past the 28 day interval.). At the time of the report, COVID-19 (Patient diagnosed with COVID-19 infection after receiving first dose of Moderna COVID-19 vaccine.) outcome was unknown and PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and PRODUCT DOSE OMISSION ISSUE (sought guidance on whether they can still receive the second dose, as they are now also past the 28 day interval.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. No treatment medications were reported.
The first day following the injection, aches and muscle pain, fever of 99.5. The following day joint aches and muscle pain and fever of 101.5.
lightheaded, abdominal cramps/ discomfort, Placed in semi fowlers position with legs elevated.  Given gramham crackers and water and patient stated he felt better.
This spontaneous report was received from a Medical Assistant regarding a patient of unknown age and gender. The patient's medical history or concurrent conditions were not provided. On 25-AUG-2015,  the patient was indicated for ZOSTAVAX and accidentally received a dose of (Oka/Merck) VARIVAX instead (dose, route, lot number and expiration date were not provided). No adverse effect reported. Additional information has been requested.
3am woke up freezing cold and shivering. Temp 99.7. 4:30am temp was 101.3. Took 975mg Tylenol. 8:00am fever broke. Headache. Took more Tylenol  2:00pm headache. Took migraine medication. Laid down to sleep. 5:30pm woke up. Temp 100.7. Took 650mg Tylenol. 8pm fever broke. Headache better.  *fatigue and soreness at injection site all day*  Saturday 1/9/21 Feeling much better. No fever or headache so far. 11:30am.
p/vax pt exp swelling, redness; inflammation at inj site; following inj itching; inc T at site;
Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium
Started feeling weak with fever a few hours after injection.  Had fever of 102 and above, chills, headache, body ache, fatigue for two days. Fever went away on third day, but I still have body aches and fatigue.  I have also developed bad vertigo.
Arteriosclerotic cardiovascular disease; Heart issues; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP).  A 64-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as DOSE 2, SINGLE (lot number: EW0162) at the age of 63 years old, for COVID-19 immunization. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose, via an unspecified route of administration, administered in the right arm (lot number: EP7534) as DOSE 1, SINGLE, AE: Bell's palsy 12 hours post vaccination), administration date: Mar2021, when the patient was 63 years old, for COVID-19 Immunization, reaction: "Bells Palsy." Patient did not receive other vaccine in four weeks. Patient was not tested for COVID post vaccination. The following information was reported: CARDIAC DISORDER (death, hospitalization, disability, medically significant) with onset 23Jul2021, outcome "fatal" described as "Heart issues"; ARTERIOSCLEROSIS (death, hospitalization, disability, medically significant) with onset 03Sep2021, outcome "fatal" described as "Arteriosclerotic cardiovascular disease." The patient was hospitalized for cardiac disorder (start date: 2021, discharge date: 2021). The events "heart issues" and "arteriosclerotic cardiovascular disease" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of cardiac disorder, arteriosclerosis which included stents to try and save arteries. It was reported that the patient required 2 stents due to "new heart issues." 23Jul2021 required 1 stent due to "new heart issues." 03Sep2021 Death classified as Arteriosclerotic cardiovascular disease. The patient's date of death was 16Nov2021. Reported cause of death: "Arteriosclerotic cardiovascular disease" and "Heart issues." No autopsy was performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300049978 same patient and product; different dose number and events;; Reported Cause(s) of Death: Arteriosclerotic cardiovascular disease; Heart issues
Patient stated that Sunday 12/16/12 he had a headache, felt nausea, & felt warm & thought he was going to pass out at 10 am.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients' were vaccinated with improperly stored doses of M-M-R II (dose and route not reported) from lot # L026551 with expiry date of 16-JUL-2017 (also reported as 24-SEP-2017), lot # L036853 with expiry date of 24-SEP-2017 and from lot # M002419 with expiry date of 12-JAN-2018. The vaccines were exposed to temperature of 33 Fahrenheit (F) for 116 hours (8 occurrences of 14.5 hours each) and 47 F for 116 hours (8 occurrences of 14.5 hours each). No adverse effects were reported. Digital data logger was not involved. There was no previous temperature excursion. Product quality complaint was not involved. This is one of the three reports received from the same reporter. Additional information has been requested.
severe pain at injection site/tender to touch at injection site; redness at injection site; swelling at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 227FL, expiry date 30th November 2020) for prophylaxis.   On 3rd November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. The patient was treated with cortisone (non-proprietary) (Cortisone Injection) and lidocaine (Lidocaine Patch). On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had injection site pain, injection site erythema and injection site swelling and tender to touch at injection site. The pharmacist reported that the patient went to the emergency room twice, on unknown dates, and received a cortisone injection and lidocaine patch. The reporter consented to follow up. Emergency room visit required. Limited information was provided by the pharmacist.
I have always had some itchiness on my legs, but it's started happening on my scalp. I also now have a wound on knee and it is not healing but it is not painful. I saw my dermatologist and they gave me an appointment and will be following up in about a month for a biopsy.
Diarrhea x 5 days, spitting up, switched to Isomil formula, Kaopectate
p/vax pt exp neuro sx: numbness in both feet, legs, arm, rt hand, abd; also enunciation impediments;dx: "secondary progressive" MS;pt speaking ability challenged considerably diplopia;UTI sx;urinary frequency & urgency;pt depressed
Fever up to 101 for 3 weeks Horrible chest pain it hurt to breathe and cough felt like a broken bone it hurt so bad even on pain medication.  Constant feeling of fatigue but the pain in the chest into right breast was overwhelming.  Drop in blood pressure.  Called pharmacy and Doctors Office non-responsive pharmacy stated to report my antibodies test was high 2.66 done at lab.   I have never experienced such pain in my chest area .  I thought someone would care but idk. I have no idea when this will end and Have not heard back from Doctors Office after about 7 messages.
R leg (received PCV7, Hib, Pediarix) because of vascular abnormality on L side (possible  Cutis Marmorata Telangiectatica Congenita), patient had swelling of right leg overnight and L side was tender at that time.  On exam the following day, the R thigh was normal without any swelling.
This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 27-JAN-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # reported as M023260 with expiration date on 18-AUG-2017) (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced temperature greater than 14 degrees Fahrenheit and less than 46 degrees Fahrenheit for 12 hours. A prior excursion was also reported with the same tmperature aforementioned but for 6 hours. Data logger was involved. No product quality complaint was involved. Lot number M023260 is an invalid lot number for zoster vaccine live. Additional information has been requested.
The morning after being vaccinated I had an elevated temperature of 100.1, headache, and body aches all of which were gone the next morning.  I also experienced a sunburn like rash on the inside of my arms and legs and on my torso front and back.  The rash was painless, not itchy and similar to the rash I get when I take an antibiotic that I am allergic to.  The rash gradually subsided.  The arm I received the injection in was sore for a few days.