chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable Consumer (patient)  A 72-years-old no pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 25Feb2021 15:15 (Batch/Lot Number: Eng6202) as SINGLE DOSE for covid-19 immunisation  . Age at vaccination:72 years. Medical history included diabetes mellitus, chronic obstructive pulmonary disease f , drug Penicillin allergy) .The patient received the first dose of bnt162b2 (brand=Pfizer ;lot number=El9269, administration time=03:15 PM,vaccine location=Left arm, There were no concomitant medications.  The patient experienced dizzy  (non-serious) on 25Feb2021 19:00 with outcome of recovering , fever (non-serious) on 25Feb2021 19:00 with outcome of recovering , fatigue (non-serious) on 25Feb2021 19:00 with outcome of recovering , headache (non-serious) on 25Feb2021 19:00 with outcome of recovering.No treatment received. Additional information:Facility type vaccine : Hospital.No other vaccine in four weeks ;No  covid prior vaccination : No .The patient has not been covid tested post vaccination   No follow-up attempts are possible. No further information is expected.
Syncope with seizure activity and bilat forearm contractures (normal respiratory rate) after smallpox vaccination.  Also had anthrax and typhoid vaccinations before given smallpox vaccine.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with a dose of improperly stored PEDVAXHIB (dose, units, route of administration and lot number were not reported). No adverse effects were noted. This is one of several reports from the same reporter. Additional information has been requested.
Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 17 years old female patient who was vaccinated with a 0.5 ml dose of FLUBLOK QIV (lot number: QFFA1804 and expiry date: 01-Jun-2019) via intramuscular route in the left deltoid on 07-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENACTRA for Immunisation; and TRUMENBA for Immunisation. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: none.
Head cold; Sneezing; This is a spontaneous report from a contactable consumer (patient's husband). An unspecified age (76, units: unknown) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on 03Feb2021, as 2nd dose, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took the second dose of the vaccine. Later in the day, on 03Feb2021, patient started sneezing and today on 04Feb2021, patient had a head cold. Her husband was asking if the vaccine was effective or compromised and what should be done if it is compromised. he was asking how to know it was effective and if the patient need to get a covid test. what can she take for the head cold. The outcome of the events was unknown.    Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected
Bivalent vaccine given too soon. Last monovalent COVID booster vaccine was given on 9/1/2022.
Period has completely stopped since the first dose; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 21Jan2021 at 11:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included Known allergy to Tree nuts, seafood, dust and pollen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received hydrocodone bitartrate; paracetamol (VICODIN) for unknown indication on unknown date and experienced drug allergy. On 29Jan2021, the patient experienced her period had completely stopped since the first dose. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period had completely stopped was not resolved at the time of report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 11Feb2021 at 11:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable physician. This physician reported on behalf of a 67 year old female consumer who received a single dose of PREVNAR13 on an unknown date. Relevant medical history included leukemia from which she had recovered on an unknown date. Relevant drug history was unknown. Relevant concomitant medications were unknown. Vaccine given on the same day was unknown. Vaccines taken with in the last four weeks were unknown. On an unknown date, patient's unspecified titer levels were low. Relevant lab data included an unspecified test carried out on an unknown date which revealed that unspecified titer levels were low. At the time of report clinical outcome of the above mentioned event was unknown. Follow-up (07FEB2013) Follow-up attempts completed. No further information expected.
Increased redness, swelling at injection site, systemic symptoms of chills/sweats, malaise.
Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with GARDASIL vaccine (yeast) and her last PAP smear test came up positive for Human papillomavirus (HPV). It was unknown if the patient sought medical attention. No further information is available.
Events besides flu like symptoms are  arm swelling and palpitations  for 3 days or more. Severe muscle pain with swelling  and hardening with heat in my right upper thigh which continues to linger since the vaccine.   Wakes me up at night when i'm trying to rest, it feels better upon walking around but if I sit down or lay down it bothers me.  Not sure if anyone else has reported this.  I have never had this pain before ( I did get the shingle vaccine 2-3 months prior to this shot so I don't know if it was an interaction).
pt recv vax & exp progressive neurological sx including demyelination; No further details were provided;
This spontaneous report was received from a nurse prescriber referring to a 17 weeks old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-AUG-2018, at age 17 weeks old, the patient was vaccinated with ROTATEQ (Lot: N029670; expiry date: 03-SEP-2019) (Drug administered to patient of inappropriate age). No adverse effects reported.
60 yo M who developed delirium and was in ER 5/7/21 for this. Described by son/boss as difficulty focusing x 2-3 weeks, diffuse body weakness, paranoia, anxiety.  CT head was neg, pt was discharged home. outpatient MRI brain suggested Creutzfeldt Jakob disease CJD. He was seen by neurology, who confirmed CJD by LP, he is now nonverbal and dependent on all ADL's, going into hospice
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated orally with improperly stored doses of ROTATEQ oral liquid (lot# K019371, expiry date 16-JUL-2016 and lot# L004454, expiry date 07-AUG-2016; exact doses were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Got vaccine on 11/4 on right arm around 11am.  Patient reports the next morning she had red dots on her face Red spots are still present. Decribed as painful, warm, and pruritic.  Reported having right arm pain after administration which is now resolved.  No spots are on body. No new creams or lotions. No sun exposure Reports history of acne on face but not significant Has seasonal allergies, but no known allergies to foods No attempted treatment and rash has no resolved.  Denies shortness of breath, fever, palpitations
I ended up with DVT blood clot. Injection was very painful and pain lasted 2 days, expected that. Day 3 woke with bright red rash, itchy,  swollen and lumpy on inside upper arm. Could not get answers, lived on Benydril  for 3 days. Day 4 called CDC, FDA,  Health Dept & Moderna. Moderna was only person that I was able to talk to someone, had no clue. Had to google to find out I had Covid Arm since no one knew anything. Day 5 ..The lump moved or maybe different one to inside my inner elbow and was painful. Did not read pain as a symptom of Covid Arm and went to ER
Missed second dose (37 days); COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19) and PRODUCT DOSE OMISSION ISSUE (Missed second dose (37 days)) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose (37 days)). At the time of the report, COVID-19 (COVID-19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed second dose (37 days)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment drug was provided by reporter.   This case was linked to MOD-2021-314265 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up Received, included updated  Reporter details. Patient details were added and start date of the event was added.
Headache, Myalgia, Arthralgia, Fever, CoughWheeze,  body ache, chills, eye pressure, sore arm  Narrative:   Other Relevant History:
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 46 years old with past medical history of Alcohol dependence and chronic PTSD. Patient was admitted to hospital on 3.15 (alcohol use disorder) and notes says 46 y/o man w/ a PMHX of HTN & seizures and a past psychiatric hx of depression & alcohol use d/o presents requesting "alcohol detox." Drinks 1-2 pints of vodka/day with last drink 2 days ago. UDS +benzos. Ethanol 193. Last note from May 12th said patient was found deceased during wellness check on the morning of 5.12.21. No other information were found.
L upperarm Cellulitis  8CM x 8CM 3CM x 3CM hard nodule
Disseminated zoster- majority of rash in V1 distribution, with other lesions on arms and chin.
Information has been received from a registered nurse concerning her son with no known allergies or past medical history who on 28-JUN-2000 was vaccinated with a first dose of Recombivax HB (lot # 636274/0641K).  On unspecified dates the patient was vaccinated with second (lot # 636477/0812K) and third (lot # "0411C") doses of Recombivax HB.  There was no concomitant therapy.  Approximately one week after the first injection, the patient developed an upper respiratory infection that led to thrush and fever.  The patient was reported to be sick with continuous upper respiratory infections for a year and a half.  It was also noted that the patient developed autism on an unspecified date.  Labs performed included "brain mercury levels", reported to be high.  The patient's autism was being treated by an unspecified specialist and he was "making progress in therapy".  The patient was reported to be recovering.  No further information is expected.  Upon internal review the patient's autism was determined to be an other important medical event.
Rash on left leg at a possible site of injection there seems to be an enlarged redness area and bump that is a little hard it was not there at time of vaccine injection it appeared when rash appeared. Rash all over the body. Did have a low grade fever 4 days prior to rash appearing, no other Sx noted. Appeared 12/25 morning. Provider suggested to try hydrocortisone cream 1%. As mother had already tried BENADRYL and BENADRYL cream with no relief.
Approx 24 hours after vaccination, patient developed noticable fatigue, muscle soreness (injection point and throughout entire body).  Nausea and headache presented at approx. 27 hours post-vaccination.  At 30 hour mark, patient developed fever (99.9) and overall shakiness.  For next 8 hours, all symptoms continued including a fever spike at 102.1.  Patient also exhibited mild hallucinations/dreams that were extremely vivid; difficult for patient to differentiate between real and hallucinations.  After approx. 40 hours past, fever began to break and symptoms slowly subsided.  Headache, minor nausea and low-grade fever persisted.  Patient returned to normal after 48 hours.
Initial misuse report received from a healthcare professional on 06 June 2013. A 4-year-old patient had received a dose of ADACEL in March date instead of DTaP for the firth dose. No adverse event was reported. List of documents held by sender: none.
Warm at the site of the vaccination; Inflammation at the site of the vaccination; Redness at the site of the vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm at the site of the vaccination), VACCINATION SITE SWELLING (Inflammation at the site of the vaccination) and VACCINATION SITE ERYTHEMA (Redness at the site of the vaccination) 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 VACCINATION SITE WARMTH (Warm at the site of the vaccination), VACCINATION SITE SWELLING (Inflammation at the site of the vaccination) and VACCINATION SITE ERYTHEMA (Redness at the site of the vaccination). At the time of the report, VACCINATION SITE WARMTH (Warm at the site of the vaccination), VACCINATION SITE SWELLING (Inflammation at the site of the vaccination) and VACCINATION SITE ERYTHEMA (Redness at the site of the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had redness and warm raised area around the injection nine days after the vaccine shot was noted.  No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.
Dizziness, Fever, arm pain, chills, tingling in face and heavy head feeling Narrative:
first dose 11/11/2020, second dose on 09/21/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 7GM34, expiry date 10th February 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11th November 2020, batch number GM2Y4, expiry date 10th May 2022).   On 21st September 2021, the patient received the 2nd dose of Shingrix. On 21st September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The pharmacist stated that, the patient received 2nd dose of Shingrix later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Left hand had itchy rash: did video visit with walkin clinic on 1/13/21. the rash worsened and became present in right hand after 2nd dose of Moderna COVID vaccine on 2/3/21. red bumps with white in center on palm side of hands, and flat purple blotches of various sizes on nonpalm side of hands, pain. 2/10/21: video visit with Dermatologist and rx'd lidex advised to go to ER if my fingers started to turn black  3/31/21 rheumatology consult: Dr. 4/21 palms of hand start feeling like little thin shards of glass are poking my palms when I make a fist 5/19 Heme/Onc consult w/Dr.  finger and had rashes/symptoms  are fading 7/1/21 Derm consult: Dr.  Dr.  dx'd fingers as Chilblains
This is a spontaneous report from a non-contactable consumer that reported for the son. A 21-years-old male patient received the first vaccination of TRUMENBA, single dose on unknown date. The patient experienced that he had elevated CPK levels. Outcome of the event was not reported. No follow up attempts possible. No further information expected.
Hives developed 1 hr after receiving immunizations. And lasted at least 2 days.
I developed mild injection site pain about 5 minutes after the second dose which didn?t happen the first time so quickly. It shortly progressed to a cold/numb sensation from my deltoid down to my finger tips. This persisted but seemed to transition from more numbness to moderate pain from my left scapula, neck and down to my fingers about 7 hours after the vaccine. I also developed intermittent fasiculations of my forearm muscles on the left arm. This morning I woke up with worsening pain, mild numbness but new weakness in the hand and arm. I have a weak grip and can?t fully grab objects. My wrist flexión and extension are also weak as well as shoulder abduction (I am a neurologist by the way so can?t localize it to any nerve distribution). I?m not weak anywhere else and I only have mild arthralgia and diarrhea systemically.
C/O HA most of the day after injection. Pt has hx of migraine HA's & also minor viral illness coincidentally. Pt advised to f/u with PMD if sx worsen or do not improve.
Narrative:  A 41yo femalw with PMH of Chronic PTSD, Chronic Low Back Pain, Generalized Anxiety Disorder, Migraine without Aura and Iron deficiency without Anemia She received Pfizer' s Covid - 19 vaccine per policy and protocol First dose March 24, 2021 Second dose on April 14, 2021 and had an ADE of weakness, Anxiety and dizziness post the 2nd dose which was reported by the NP as an observed event. Patient went to the ER - was observed and evaluated for vaccine reaction. In the ER, she reported her symptoms improved. No medication was given and she got discharged with instructions to return to the ED if she experiences N/V, diarrhea, tingling in mouth difficulty breathing, Fever, Rash or ulcer....
Relatively severe pain Rt. side lower back, side and moving to front intestine area.  Persistent vomiting until 10:00 pm.  Entire event from 12:15 pm until 10:00 pm.  Mild pain and soreness all day next day (Sunday Feb. 28)
Headache, Diarrhea, Nausea Vomiting, Tachycardia, fatigue, muscle aches Narrative:
One day post vax, the pt developed a rash on upper anterior and posterior chest. Treated with over the counter medications and then resolved.
Pt recvd 3rd dose of vax & OCT92 visited MD who ran test including CBC & LFT's results revealed elevated LFT's & elevated fasting bilirubin; 2 wks later tests were repeated; dx gilbert's type II synd;
This spontaneous report as received from a medical assistant refers to a 13 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 15-JUL-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL.  This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918. 1407USA012919. 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407SUA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012939. 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959. 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989. 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012295, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link).  Additional information has been requested.