chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 42 year old patient (gender not reported) who was vaccinated (date, route, dosage and site not reported) with pneumococcal 23v polysaccharide vaccine (lot# 658074/0961U). Subsequently, post vaccination, the patient experienced "severe injection site reaction". The patient did receive unspecified medical attention and improved. Additional information has been requested.
Pt's mother reported the pt experienced a red raised area at the injection site, with warmth to the touch. The office applied a topical cream and gave Benadryl. Pt was observed for 30 minutes and the edema and erythema decreased.
On 4/9/01, the pt rec'd a dose of hepatitis B vaccine (manufacturer unknown), as well as, tetanus and diphtheria Toxoids (manufacturer unknown). It was not known whether the pt had rec'd previous doses of either vaccine. Exactly one week later on 4/16/01 the pt developed dizziness (NOS), nausea, vomiting and headache. As of 5/16/01, the reported symptoms persisted, and had prevented the pt from attending school or reading for one month. No information about diagnostic testing or therapy was available. The pt was reportedly scheduled to be evaluated by a neurologist on 5/18/01. Since the pt missed one month of school, the events are considered incapacitating and this report is considered serious.
Patient received a 3rd dose (booster) but she is only 17.  She has not experienced any signs or symptoms
My arm was a little sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm was a little sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable nurse communicated to a Pfizer Sales Representative. The nurse reported similar events for 6 patients, who experienced the same issues over the past 3 months before this report. This is the 6th of 6 reports. An elderly patient of an unspecified age, ethnicity and gender received PREVNAR 13 (Expiry Date and NDC # Unknown) subcutaneous at 0.5 ml, single in arm (unknown of which one) on an unknown date. The patient medical history was unknown. The patient's concomitant medications were unknown. On an unknown date the patient experienced local site reaction which produced cellulitis. On an unknown date the area became hot, hard and red (generally a large portion of the arm, not localized to injection site, a more perfused area). Events outcome was unknown. Laboratory tests performed were unknown. Therapeutic measures were taken: prescribed antibiotics for cellulitis.
Over half of vaccine was lost through loose needle. Dose of vaccine was repeated since over half of original dose was lost.
severe asthma; Vertigo; increased heavy menstrual bleeding; polyps; cysts; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 28Apr2021 as dose 1, single (Lot number: EW0176) at the age of 36 years and on 19May2021 as dose 2, single (Lot number: EW0179) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: BISOPROLOL; FLECAINIDE; ZOLOFT. Past drug history included: Midrin, reaction(s): "known allergies: midrin"; Dialuadid, reaction(s): "known allergies: Dilaudid"; Tramadol, reaction(s): "known allergies: tramadol". The following information was reported: VERTIGO (hospitalization) with onset May2021, outcome "not recovered"; CYST (hospitalization) with onset May2021, outcome "not recovered", described as "cysts"; HEAVY MENSTRUAL BLEEDING (hospitalization) with onset May2021, outcome "not recovered", described as "increased heavy menstrual bleeding"; POLYP (hospitalization) with onset May2021, outcome "not recovered", described as "polyps"; ASTHMA (hospitalization) with onset May2021, outcome "not recovered", described as "severe asthma". The patient was hospitalized for asthma, vertigo, heavy menstrual bleeding, polyp, cyst (hospitalization duration: 2 day(s)). The events "severe asthma", "vertigo", "increased heavy menstrual bleeding", "polyps" and "cysts" required physician office visit and emergency room visit. Additional information: No covid prior vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of vertigo, heavy menstrual bleeding and severe asthma might not be fully excluded, considering the temporal relationship.  Polyp and cyst more likely represent intercurrent medical conditions.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Narrative:  Pt was a 66 YO male with h/o liver cirrhosis in the setting of Hepatitis B, polysubstance dependence, COPD, and psoriasis who presented to the agency ED due to a 2 week history of abdominal pain and swelling. Pt developed shock requiring pressor support and pt continued to decline despite treatment. Family decided to pursue comfort care and the pt passed comfortably in compliance with his wishes. Pt received the Moderna COVID-19 vaccine on 1/29/21, 3/1/21, and 10/7/21. There is no evidence that the COVID-19 vaccine contributed to his death.
Initial case received from a physician on 08 September 2011. It pertains to 1 of a cluster of 2 patients who experienced similar events following FLUZONE vaccination; information for the other patient is found in case number 2011-08443. A female patient was diagnosed with the flu 5 days after receiving FLUZONE (lot not reported) on 02 September 2011. The patient was a nurse in a pediatric health care facility. On 07 September 2011, the patient developed flu-like symptoms and subsequently tested positive for Type A flu (no subtesting done). Outcome was not reported. Documents held by sender: None.
Very sick; Flu like symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced sickness and influenza-like symptoms. On an unknown date, the outcome of the sickness and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the sickness and influenza-like symptoms to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient just had the 1st dose of newest Shingles shot.  The day after 1st dose, the patient was very sick with flu like symptoms that lasts 24 hrs.  The patient said they did not warn the person about that when you get it. The follow-up would not possible as no contact details were available. For tolerance of 2nd dose refer case US2021AMR254585, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR254585:Same reporter.
Tachycardia (racing heart),  fever, chills, severe joint pain and muscle aches, headache, dizziness lasting for 18 hours. Severe pain in left arm and armpit.
1 day p/vax pt devel an inj site rxn characterized by a 1inch by 1 inch area of redness & swelling;seen in ER where was noted to have a fever of 100.3;treated symptomatically & recovered;
This spontaneous report as received from a physician, via a company representative, refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, reported as: "2 to 3 years ago", the patient was vaccinated with a dose of GARDASIL (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. Following vaccination the patient experienced and unspecified anaphylactic reaction to the vaccine. The reporting physician stated that the event was reported to VAERS on an unspecified date. The outcome of anaphylactic reaction was unknown. Additional information has been requested.
PATIENT GOT AN ANAPHALAXIS 2 MINUTES AFTER RECEIVING THE 3 VACCINES. HE ALREADY ATE. HE FELT HOT AND WAS SHAKING AND ROLLING HIS EYE. WE CALLED CODE WHITE AND 911. HE BECAME COMPLETEPY UNCONCIOUSNESS AFTER 1-2 MINUTES. WE TRY TO WAKE HIM UP BUT NO RESPONSE. I INJECTED  EPIPEN IN HIS THIGH. HIS WIFE WAS HOLDING HIM AND FELT HE WAS RESPONDING AFTER THE INJECTION. HE SLOWLY REGAIN CONCIOUSNESS AFTER 1 MINUTES BUT STILL VERY TIRED. I MONITOR HIM UNTIL 911 CAME AND TOOK OVER. PT FELT BETTER AND REFUSE TO GO TO THE HOSPITAL
Pt had acute ischemic stroke involving right vertebral artery  16 days after dose number one of Pfizer vaccine.  She developed sudden dizziness and loss of leg strength, fell to floor.  it took 7 hours until she was found and taken to hospital, so did not receive TPA.  CTA  on 2/27/2021 showed occluded V4 segment of rt vertebral artery.  residual deficits currently include imbalance, loss of lower extremity strength (now in wheelchair), loss of hearing and  discordant occular movement.
a lot of coughing; wheezing a lot; rash in Stomach and back; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (a lot of coughing), WHEEZING (wheezing a lot) and RASH (rash in Stomach and back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bronchitis on 27-Feb-2021.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced COUGH (a lot of coughing), WHEEZING (wheezing a lot) and RASH (rash in Stomach and back). At the time of the report, COUGH (a lot of coughing), WHEEZING (wheezing a lot) and RASH (rash in Stomach and back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information on concomitant medications was provided.  No treatment information was provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Red swelling at site of injection, warm the the touch.  Chills, low grade fever, body and neck aches.
Pt with erythema, increased size, on (L) deltoid. Blanching, slightly raised. No exudate. No crusted. Erythema on (L) SQ surrounding VZV site. Supportive care, Benadryl, Claritin, Motrin, monitor clinically for s/sx impetigo.
Approximately ten hours after injection, woke up with constant chills, fever of 100.1, body aches, stuffed nose (had to breathe out of mouth), and headache. Acetaminophen helped slightly. For the next 12 hours fever stayed between 101 and 102 despite continuing to take acetaminophen, and headache also didn't improve. At 6:15 pm that day (~29 hours post-shot) fever was 103.2, headache was very strong (with light sensitivity). Since acetaminophen hadn't been helping, switched to ibuprofen. About an hour later, the fever finally began to go down and was gone by 10 pm that night. The next day, no fever and minimal headache, but was very weak and lightheaded. At about 51 hours after the shot, symptoms were all gone.
eyes burning; Low grade fever 99.1 degrees F; fatigue; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (eyes burning), VACCINATION SITE PAIN (soreness at injection site), PYREXIA (Low grade fever 99.1 degrees F) and FATIGUE (fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 21-Mar-2021 to 31-Mar-2021. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site) and FATIGUE (fatigue). On 06-Apr-2021, the patient experienced EYE IRRITATION (eyes burning) and PYREXIA (Low grade fever 99.1 degrees F). At the time of the report, EYE IRRITATION (eyes burning), VACCINATION SITE PAIN (soreness at injection site), PYREXIA (Low grade fever 99.1 degrees F) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 99.1 degrees f (Low) 99.1 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications was not provided.
Mom reported fever and listlessness on Friday 10/12/07. He did not go to school. She also noted soreness in arm. She did not look at the left arm until Saturday when she noted his arm was swollen to almost twice the size from shoulder to elbow. It was red and continued to sore to the touch until late Monday (10/15/07). Swelling and reddness is gone as on 10/17/07.
GBS; Initial information received on 23-Dec-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves patient of unknown demographics who had gbs (Guillain-Barre syndrome) while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (formulation, strength, frequency, route, administration site, batch and expiry date was unknown) as prophylactic vaccination.  It was reported that patient had one in over 20 yrs. since then patient had developed GBS (Guillain-Barre syndrome, onset and latency: unknown) and patient doctor told to never get another one, so he/she learned to take better care of himself/herself eat real whole foods keep his/her D3 levels between 50-70. Patient rarely eat sugar and had remained flu free  Action taken: Drug withdrawn  Corrective treatment: not reported  Outcome: unknown  Seriousness criteria: medically significant for Guillain-Barre syndrome; Sender's Comments: Sanofi company comment dated 24-Dec-2021: This case involves patient of unknown demographics with influenza Vaccine (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. Patient's past medical history was unknown. Additional information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Menstrual cycle disruption. Extended period after dose 1 and 2. Heavier bleeding than normal. First period after the 2 disrupted ones was 2 weeks early
Hot flashes two months after vaccine; 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 HOT FLUSH (Hot flashes two months after vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 HOT FLUSH (Hot flashes two months after vaccine). At the time of the report, HOT FLUSH (Hot flashes two months after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided
TRUMENBA vaccine given on 6/26/18. Felt sore right after administered which progressed to deep sharp pain. Patient states unable to sleep that night. Took ADVIL with no improvement with pain of arm. Notices slight swelling and no redness, seen in office 6/29/18 pain and soreness slightly better but not completely resolved.
One day subsequent to receiving the first dose of Engerix B, the pt had a fever for one day which resolved. One day subsequent to receiving the second dose of Engerix B the pt experienced nausea and vomiting for three days which resolved. No treatment was given. The most recent information received reports the outcome of the event as resolved.
Cough; joints were really sore; Headache; feeling really tired; body aches; sore at injections site; This is a spontaneous report from a contactable consumer reported for himself.  A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot FL3302 via unspecified route at the left upper arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications were not reported. The patient had received a flu shot vaccine and he also got a shingles shot in Oct2020. The patient reported that he worked on the military base. On the day of vaccination, he had a slight headache after getting the shot. Toward the evening he began to feel really tired and had bad headache. The next day he was still really tired and developed a slight cough. It was clarified that the slight headache started the day of the shot, 20Jan2021 followed by it getting worse that evening and feeling really tired. On 21Jan2021 he was still really tired and developed a slight cough. On 22Jan2020, he was still really tired, had the headache and cough. He was taking Ibuprofen. The patient stated he also had body aches that started on night 20Jan2020 at the vaccination site, it was not really bad, but it felt like his joints were really sore. The outcome of  the events was reported as not recovered. He was supposed to go back for the second shot on 10Feb2021.
HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.; This spontaneous non -serious safety report, with reference number 02475849 (Interaction number 02475710) was received by a partner on 20-SEP-2023 and forwarded on 21-SEP-2023, from a HCP.  The causal relationship between Vaxelis and the reported event "HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.Temperature:8.74 C, Time frame:35min." was assessed as not applicable due to the nature of the event.  Further information is expected.
The client contacted us after he'd taken the 4th capsule and told us that he'd developed a headache and fever of 103 after taking the third capsule. I advised him to take Ibuprofen  q 4-6 hr and call us if he didn't improve. He also stated that his urine was darker than normal though not cloudy. He went to his family doctor on 4/21/04.
Patient developed indurated injection site approximately one week after immunization administered. Site was pruritic, inflamed and had approximately firm blueberry sized nodule at the site of injection.
Headache; neck ache; didn't get much sleep; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NECK PAIN (neck ache) and INSOMNIA (didn't get much sleep) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (Headache), NECK PAIN (neck ache) and INSOMNIA (didn't get much sleep). At the time of the report, HEADACHE (Headache), NECK PAIN (neck ache) and INSOMNIA (didn't get much sleep) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details include advil and nausea pills. No concomitant medication details was reported.
This spontaneous report as received from a pharmacist via company representative refers to a 40 year (reported as early 40's) old female patient. Pertinent medical history was unspecified by reporter. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (intramuscular, dose, route of administration and anatomical location was unknown). Concomitant medications included influenza virus vaccine (unspecified) (given in other arm, dose, and route of administration unknown). On an unknown date the patient experienced severe swelling at injection site with painful redness. The outcome of the events was unknown. The causality was unknown. No additional information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Patient received a second dose of Pfizer bioN Tech for age (5-11) years instead of receiving  Pfizer bioN Tech for ages 12 and above. no side effects or allergic reactions happened
she is like breaking out in hives; Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 26Nov2021 11:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for covid-19 immunisation. The following information was reported: URTICARIA (non-serious) with onset Nov2021, outcome "unknown", described as "she is like breaking out in hives"; RASH (non-serious) with onset Nov2021, outcome "unknown", described as "Rash".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 30-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of M-M-R II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Unknown COVID vaccine.  Patient did not receive the vaccine at our facility so unable to provide above information.  Patient presented to the ED on 3/3/21.  ED notes as follows  73 y.o. female who arrived to the emergency department for Facial droop.  Patient notes that she got her COVID vaccine on 2/26/21.  States that she noted having a facial droop on 3/1/21 and does note that she's had prior history of Bell's palsy.  States that he feels similar.  She states that she cannot move the left side of her face or close her eye.  She denies difficulty with ambulation numbness weakness or tingling of arms or legs, headache or other acute symptoms.  Diagnosed with Bell's palsy