chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster; Headaches; right arm pain at vaccination site; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2, lot unknown reason=Unable to locate or read the details), administration date: 26Mar2021, when the patient was 60 years old, for Covid-19 immunization, reaction(s): "covid test date: 16Aug2021 / covid test result: Positive", "covid test date: 16Aug2021 / covid test result: Positive"; Bnt162b2 (Dose: 1, lot unknown reason=Unable to locate or read the details), for Covid-19 immunization, reaction(s): "covid test date: 16Aug2021 / covid test result: Positive", "covid test date: 16Aug2021 / covid test result: Positive". The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "Headaches"; VACCINATION SITE PAIN (non-serious) with onset 17Dec2021, outcome "recovering", described as "right arm pain at vaccination site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, vaccination site pain with  Ibuprofen.  Additional information: Patient did not receive other vaccine in four weeks. prior vaccination, the patient had tested with Covid-19 and post vaccination tested for Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101823145 same reporter and patient, different AE
High blood pressure (180/110, disorientation, did not remember getting a shot, short term memory loss.
Day after the vaccine administer, left deltoid warm and swollen down to elbow - pt checked by Nurse Practitioner and given Tylenol tsp q 4 hours. Recheck/follow up in 1 week.
11/19 redness with edema 7-8cm thigh (Lt) fever 102-103. 11/20 called back and stated area was not as red but had moved towards the side of leg
Constant unilateral  left ear tinnitus, sounds like Morse Code, sometimes like ?flatline?, headaches, fatigue.
Incident Details: Per a local clinic provider's email sent out on 9/1/22-"the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand." The patient,  was seen in office on 9/2/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (pfizer) by *** in error as patients are now only supposed to receive the bivalent booster per Dr.'s email. Pt was due for booster at the time they received it, however the bivalent booster was not yet stocked at the pharmacy.  Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation  of monovalent covid boosters until the pharmacy receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also ?monovalent? and ?bivalent? are new terms that have not previously been used when discussing booster vaccines.
Pt devel deep pain at the injection site and striations of injection radiation from the injection site to the neck and elbow. Pt indicated that he had very tender deltoid pain which was resolved in two days.
body rash, iching 12/11/09 ED Medical records received for DOS 12/08/09. Pt. presented with itching rash on arms and neck following vaccinations. Treated with benadryl and prednisone. Discharged home. DX: urticaria s/p immunizations 12/14/09 Medical records received for DOS 12/09/09. Pt presents to ER for worsening of hives upon awakening.  Also has tightness in throat and dysphagia. Treated with benadryl, decadron, epinephrine. Admitted for observation when rash became confluent and pt. c/o SOB. DX: allergic reaction-allergen uncertain; possible Stevens-Johnson syndrome
Inflammation and edema - 5 x 6 cm  with mild axillary lymph nodes. Temp 100 degrees. Tender to palpation and increased color. There's a small abrasion to the same shoulder 2 cm distal to injection site - no local erythema at injection site. Cannot rule out cellulitis  2 degrees abrasion.  Rx: Cephalexia.
Progress Notes (Physician Assistant) ? ? Family Medicine Cosign Needed Expand All Collapse All                                                                 Date:  1/25/2021                                                                                              Subjective 78 y.o. male who was seen today for his first  dose of the COVID 19 vaccination.    He was given the Pfizer vaccination in the right deltoid muscle.   During his 15 minute waiting period after the injection, the patient began to experience dizziness.  He denied difficulty breathing and difficulty swallowing.   This provider was notified of patient reaction and he was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to hypotension and rapid progression of symptoms.   Patient ate a bowl of oatmeal this morning prior to receiving his vaccine. He has only drank a small amount of diet coke today, no water. He became dizzy when standing up and some while walking. He notes the dizziness resolved on his walk to the medical evaluation bay.   ALLERGY REVIEW OF SYSTEMS:  Patient complains of dizziness   Patient denies chills, fever, facial swelling, chest tightness, shortness of breath, wheezing and headaches         Previous Reactions: Denies    Objective    Vitals Vitals:   01/25/21 1150 BP: 133/86 Pulse: 84 SpO2: 97%       Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic and atraumatic.     Mouth/Throat:     Comments: No swelling or lips or tongue.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: He is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.           Assessment/Plan  Treatment included: water Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Patients symptoms of dizziness completely resolved prior to discharge. He denied dizziness when standing up and walking to leave the medical evaluation bay.    Electronically Signed 1/25/2021 12:02 PM
This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9  (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced drug administered to patient of inappropriate age and no adverse event. This is a non valid case due to lack of patient identifiers.
This non-serious spontaneous case, initially received from other non-health professional on 16-Nov-2017, concerns a 59-year-old, adult, female patient. On 13-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195243, expiry date: 30-Jun-2018, anatomical location: upper left arm and route of administration: not reported). On an unspecified date, the patient had a injection site rash on her upper left arm. At the time of this report, the outcome of the event was not reported. Non-significant follow up received on 18-Dec-2017: The medical communication reference number (SEQ17-5799) was updated in the additional information.
Patient developed a rash on his chest almost immediately after we got him home.  He became listless, started to stare off, stopped looking at us, smiling and ceased talking from that day forward at age 1 and 1 month, until age 7 seven...  He began to have diarrhea from that day forward, several times a day.  He also started to strangely flap his hands and shake his head intermittentely.  His stool sample tested as having NO healthy flora left in it whatsoever.  He is also now allergic to Penicillin.
A physician reported a 7 month old female received Prevnar and Recombivax-HB vaccines on 10/10/00 and on 10/12/00, she developed a maculopapular rash on her arms and lower extremities. She was treated with oral diphenhydramine.
Patient has rash and pruritus on legs and arms the day after receiving the shot. She was instructed by the pharmacist and her doctor to take oral benadryl every 4 hours. As of today (12/21/20), 12 days after immunization, patient's rash in resolving and pruritus is not as bad as it was on 12/10/20.
This spontaneous report was received from a physician and refers to a 1 month old patient of unknown gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On 17-MAY-2017, the patient was inadvertently vaccinated with a dose of ZOSTAVAX lot # M039452 with expiration date 19-DEC-2017 (dose and route of administration were not reported) instead of VARIVAX because ZOSTAVAX was mistakenly ordered instead of VARIVAX. No treatment was given. The patient did not seek medical attention. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA009078:
Information has been received from a nurse concerning her approximately 14 year old granddaughter with no pertinent medical history and no known allergies, and a family history of paternal Aunt with cervical cancer and paternal grandmother with cervical cancer who in late 2007 was vaccinated with the first dose of GARDASIL (lot number not reported). On an unspecified date the patient was vaccinated with the second dose of GARDASIL (lot number not reported). In June 2008 or July 2008 the patient was vaccinated with the third dose of GARDASIL (lot number not reported). There was no concomitant medication. 2 or 3 days after the first dose, the patient started having headaches. The headache increase after the second dose was given. The patient was put on NAPROSYN to help the headache (start date not reported0. The headache was worse after the third dose. On an unspecified night the patient woke up screaming at 2 am because of a headache. The patient was sent to the emergency room. No lab diagnostics studies were performed. The patient was put on PERCOCET (start date not reported). There have been times when the patient was throwing up and couldn't get her head off the pillow. The headaches have gotten worse and worse to the point of making the patient nauseous. It was noted that when the headache gets real bad the patient can't get out of bed. 3 months after the third dose, the patient developed ringing of the ear. The nurse felt that the ringing in the ear experienced was associated with the headaches. At the time of the report, the patient had not recovered. It was noted that the patient's father's sister and the patient's father's mother had cervical cancer. The headache was considered to be disabling by the nurse. Additional information has been requested. 9/2/09 ER records from 2 visits 4/17/09 and 5/2/09 received with dx:  Serous Otitis and Vomiting/H/A. Pt initially presented 4/17/09 with c/o ear pain, ringing  and fullness x 3 days.  Recent ear injury. L TM bulging. Tx: nasal spray. Returned 2 weeks later with c/o H/A level 9/10, decreased appetite, body aches, sinus congestion with green secretions x 1 week, vomiting and difficulty sleeping 2' H/A pain. D/C for outpt f/u with pcp. US for pelvic pain done 11/07.
Fever; headache; body aches; This is a spontaneous report from a non-contactable other healthcare professional reporting for herself. A 34-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231), via an unspecified route of administration on 05Jan2021 14:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (results unknown). The patient experienced fever, headache, body aches an unspecified date in Jan2021. Event outcome was unknown. The reporter assessed the events as non-serious.  No follow up attempts are possible. No further information is expected.
Red spot, knot that grew over the course of 3 days. Fever lasting at least 3 days (still ongoing), vomiting for 2 days. Decreased hunger (has eaten very little for 2 days), decreased thirst, shortness of breath with high fever, chills, shivering, insomnia.
TIREDNESS; SLIGHT FEVER; KEPT ME AWAKE; CHILLS; SORE ARM WHERE SHE GOT VACCINE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 12-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the subject experienced sore arm where she got vaccine. On 12-JUL-2021, the subject experienced kept me awake. On 12-JUL-2021, the subject experienced chills. On 12-JUL-2021, the subject experienced slight fever. On 13-JUL-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from kept me awake, chills, sore arm where she got vaccine, slight fever, and tiredness on JUL-2021. This report was non-serious.
Severe weakening of the immune system: Bronchitis contracted 24 hours after shot, followed by pneumococcal pneumonia and viral gastritis. One illness after the other lasting 2 1/2 months and counting.
PROVIDER ON CALL RECEIVED PHONE CALL AFTER HOURS ON 06/02/2016 FROM MOTHER. MOTHER STATED PATIENT HAD AN AREA ON LEFT DELTOID THAT WAS RED, SWOLLEN HOT TO TOUCH & TENDER. PROVIDER ON CALL SENT THEM TO URGENT CARE FOR EVALUATION & TREATMENT.
Complete unresponsiveness upon waking--stared in one direction while panting, followed by seizure (approx. 3 minutes); Taken to Emergency Room.
02/04/2021 redness, lump in injection site, itching 02/05/2021 redness, lump in injection site, itching and headache that over 12 hours 02/11/2021 redness, lump, itching has returned today
SWOLLEN UPPER LIP; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 09:40 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced injection site pain. On 14-APR-2021, the subject experienced swollen upper lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen upper lip, and had not recovered from injection site pain. This report was non-serious..
Starting 4cm below injection site developed a red,hot, swollen arm with associated tenderness and discomfort with right shoulder ROM. Red area 2x12cm. Temp 99.1 on date 10/26/06 symptoms date 11/01/06. RX Keflex.
This case was reported by a pharmacist via sales rep and described the occurrence of fever in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced fever and injection site muscle pain. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the injection site muscle pain was  unknown. It was unknown if the reporter considered the fever and injection site muscle pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever (101 Degree F) for 3 days and extreme muscle soreness at the injection site that travelled up to her neck. No further information was provided.
Pain radiating down left arm to hand on certain movements. Started about 1 week after vaccination. Still has pain
Delayed symptoms. Received on Friday, no symptoms until Saturday afternoon. Symptoms lasted form Saturday 12pm-Monday morning. Symptoms included: aches, chills, headache, sore arm, nausea, and fatigue. On the Tuesday after symptoms dissipated, a head cold started. Nasal congestion. Could be unrelated, or a result of a weakened immune system.
worsening lymphedema; rash; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (worsening lymphedema) and RASH (rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter. .     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Mar-2021, the patient experienced RASH (rash). On an unknown date, the patient experienced LYMPHOEDEMA (worsening lymphedema). At the time of the report, LYMPHOEDEMA (worsening lymphedema) and RASH (rash) had not resolved.            No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable   This case was linked to MOD-2021-030855 (Patient Link).
no fever, deltoid area has progressing redness, swelling, & warm to touch; treated by MD w/DPH & Amoxicillin x 10 days;
Information has been received on 07/05/2001 from a physician concerning a 41 month old female pt with no known allergies and no significant medical history, including no immunosupression or known exposure to natural varicella, who had not been vaccinated with varicella vaccine. There wee no medications. She had been in contact with ehr 10 year old aunt, playing at each others' homes, who had been vaccinated with a dose of varicella vaccine approximately two-three weeks ago and subsequently developed greater than 100 lesions over her entire body, post-vaccination. Subsequently, on 07/05/2001, five days after exposure, the pt presented to the physician's office with greater than 30 vesicular lesions on her neck, back, buttock, and abdomen. There was no treatment or medication ordered. The pt did not have a fever or other systemic signs or symptoms. It was reported that the attending physician planned to have a specimen collected for PCR analysis. It was also noted that to the physician's knowledge there was not a current outbreak of varicella in the community. Follow-up info noted that the child developed 50+ lesions, but was otherwise asymptomatic and even playful. A capillary tube and a swab specimen taken from several vesicular lesions were both obtained on 07/05/2001. On 07/12/2001, preliminary PCR analysis results indicated that the specimen for this case was positive for vericella. Follow-up info on 07/25/2001 reported that the lab result for the specimen was VZV and the presence of wild-type virus was identified on 08/23/2001, indicated that the pt "recovered uneventfully from her wild-type varicella." No further info is available.
TOOK THIRD DOSE A DAY LATE; This spontaneous case (PVX2019-1260) was received from a pharmacist on 20-May-2019. It describes a female consumer who "took third dose a day late", while being on Vivotif for an unknown indication.  Case report: The consumer took the first and second dose of Vivotif on 14-May-2019 and 16-May-2019, respectively. But, she took the third dose on 19-May-2019 instead of 18-May-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took third dose a day late" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took third dose a day late" was considered as not applicable.
I had nausea and generalized malaise, body aches and pretty intense swelling about 6 inches, distal at the vaccination site.  I put ice, massaged it and tried to break it up. I talked to my doctor who recommended me to apply light pressure massage. These symptoms lasted for 1-2 days.  My left arm is still sore but doing better.  I feel anxious due to the side effects the J&J vaccine is having.   I do not have the lot # with me at the moment.
My left arm was very sore just near the shot site.  It became itchy later that night or the next morning.  After scratching, a small rash appeared and stayed. It's smaller today but still there.
CHEST PRESSURE AND PALPITATIONS, EXTREME FATIGUE X 2 DAYS.  PALPITATIONS ON AND OFF FOR ONE WEEK.
suicidal thoughts; This is a spontaneous report from a contactable other healthcare professional. An 18-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Oct2021 (at the age of 18-years-old) at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient stated that she experienced suicidal thoughts for 1 and 1/2 weeks after her first dose, on 15Oct2021; no prior suicidal thoughts experienced prior to administration of first covid vaccine. It was unknown if a treatment was administered for the event. The patient had recovered from the event in Oct2021.   The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with first dose (Oka/Merck) VARIVAX  dose, route and frequency unknown.  On 10-FEB-2010, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX dose 2, lot# 665413/1128Y. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.