chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anaphylaxis, treated with IV Benadryl IV fluid bolus and SC epinephrine. 10/05/06-record received for DOS 9/28/06- PE: WNL-assessment prior to immunization: four year old generally doing well, speech articulation issues, innocent heart murmur. Post vaccine office note for DOS 9/28/06-Family enroute to parking lot, mother noted a diffuse rash and the child was very fussy and digging at her skin. She vomited clear mucousy material two or three times. Mother immediately returned to clinic. At the time of assessment she had a diffuse erythematous rash over most of the surface of the body most prominent was the erythema and mild swelling of both hands and feet. She vomited 3 times shortly after arriving into the clinic treatment room, vomitus completely clear except for some greenish material, no blood in vomitus. Peripheral IV started and RX with 10mg of Benadryl IV, appeared to improve over next 5-10 minutes but continued to have gastrointestinal upset and vomited one to two more times. The rash on her back seemed to get worse. Bolus os IV saline approximately 10ml/kg over 20 minutes. BP 70/38. Appeared as though she was going into anaphylactic shock and Epi Pen Jr. 0.15mg administered in left thigh. Also placed on supplemental oxygen as initial pulse ox was 92%. She complained of difficulty breathing but had no stridor or wheezing. Her rash faded within about 30 minutes of administration of epinephrine.  PMH: Significant but localized reaction to her flu shot last year which involved erythema and swelling of the left upper arm. Examination: No swelling of the tongue, lips or pharynx, TM WNL.  Pulse ox normalized at 99% on room air prior to discharge home.  Observed for 3 hours and discharged home on Benadryl and Orapred and provided with an Epi Pen Jr. Follow up visit 9/29/06-No more rash no itching, no coughing drooling or difficulty swallowing. Follow up with Pediatric Allergist. Follow up visit 10/03/06-allergy skin testing was performed with a normal reaction to the histamine control, positive reaction to MMR/Varicella lot number 9758601 for Merck. She did not react to IPV or DTAP. Recommend RAST testing to gelatin.
Muscular pain total body especially chest, back and neck.  Large hematoma at injection site.  Feeling of tightness in breathing.
Soreness in (L) shoulder, moved up to neck and into head, resulting in H/A lasting all day. 1st time pt. recd. flu shot in her life. No treatment sought. Pt is fine now but wanted to report this.
This case was reported by a consumer and described the occurrence of injection site redness in a 59-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included a lot of allergies, such as preservatives and antibiotics. There were no concurrent medications. On 7 October 2009 at 10:30 the subject received unspecified dose of FLULAVAL (unknown, right arm). On an unspecified date the subject received unspecified dose Flu vaccine (unknown). On 8 October 2009, one day after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and injection site pruritus. On an unspecified date, at an unspecified time after vaccination with Flu vaccine, the subject experienced injection site pain. At the time of reporting the swelling injection site resolved on 13 October 2009, injection site pruritus resolved on 13 October 2009, and injection site redness resolved on 14 October 2009. The outcome of the injection site pain was unspecified.
Flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 07Apr2021 (Lot number: EP7533, Expiration Date: 31Jul2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EN6208), for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms".  Additional Information: The patient was asking if he was supposed to be feeling the event. The patient reported was shy 2 days of 2 weeks of the second vaccination, and was thinking why the patient was feeling the effects."  No follow-up attempts are possible. No further information is expected.
Patient started with rash on face 12 days after administration of varicella vaccine. Rash now on arms and chest. Patient to use Benadryl as needed.
About 8 hours after the 2nd dose  my husband became very ill. Uncontrollably shaking, fever,  terrible headache, nausea, etc. for 24 hours.
This was the double dose and caused lump and sharp pain in left upper arm below injection site. Used heat and cold at first, no help, then doctor visit. Throbbing pain radiating to forearm and shoulder muscle, lasting 7 weeks. Still some pain in forearm and shoulder muscle.
"Pressure on the chest/ pinching feeling up to my back.  My left arm goes numb on and off with a little pain.  Headache and dizziness. Vaccine given in the right arm."
Vaccine given on Friday and over the weekend pt developed redness/warmth/tenderness and swelling on Left thigh where the vaccine was administered.  Pt was given ibuprofen, Benadryl and heat/ice/rest.
shoulder pain & stiffness, not @ the site of vax & not immediate in onset; no other joints involved; no hx of trauma to shoulder;
Fever of 102.3, given Acetaminophen.  6:00 AM Fever of 103.2 given Ibuprofen.
Roughly 10 minutes after vaccination patient had fainted in their chair, patient's mother helped daughter remain in char. Patient was given water and an ice pack and felt fully recovered after about 15 more minutes. Patient did not want 911 called and was ready to leave.
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients might have been vaccinated with improperly stored doses of GARDASIL 9 lot # reported as M041213 (doses, route of administration, anatomical location and expiration date were not reported). No adverse effects were reported. Administered doses of vaccine underwent a temperature excursion between -1 degree Celsius to -2 degree Celsius which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician.; Sender's Comments: US-009507513-1703USA014121: US-009507513-1703USA012983: US-009507513-1703USA014120:
This spontaneous report as received from registered nurse refers to a unspecified number of patients of unknown age and gender. Patient's medical history and current condition were not reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) injection 0.5 ml (dose number, lot number and expiry date unknown). No concomitant medications were reported. On an unknown date the unspecified number of patients received improperly stored VARIVAX (Merck) and no adverse events were reported. Action taken with VARIVAX (Merck) was unknown. The outcome of received improperly stored VARIVAX (Merck) and no adverse event was unknown. The reporter considered received improperly stored VARIVAX and no adverse event to be not related to VARIVAX (Merck). Additional information is not expected.
10/03/2005 4:30pm 1st injection baby was crying after 2nd injection baby was crying harder and was holding her breath. her face then turned blue and pt tainted. Pt was examined by Dr and then went to hospital. Pt didn't need cpr she was fine after about 10 sec.  Information received from discharge summary states apnea, allergic reaction. msv
Beginning 12 hours after the shot, I started having chills. My upper left arm (the injection site) was also sore which made it hard to sleep. These symptoms continued through the night. The next morning I had severe fatigue and had to call in sick to work. This continued all day and into the next night (36 hours after the shot). Overnight (40 hours after the shot) I had a low-grade headache. After 48 hours most of these symptoms subsided. Right now (54 hours after the injection) my arm is still slightly sore.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 06-OCT-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L017997, expiration date 19-MAY-2017, dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Received Hep A dose #2/Hep #2 on 3/10/2006 @ 16:30. Pt noted @ approx 17:00 3/10/2006 skin burning on neck, shoulder/ears/face. Denies SOB or respiratory distress. Notified RN on 3/11/2006 @ 08:00 about face/shoulder burning sensation seen by RN @ 16:30 3/11/2006 after returning from ECC.
tested positive also; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (tested positive also) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive also) (seriousness criterion hospitalization). At the time of the report, COVID-19 (tested positive also) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         No concomitant medications were reported. Patient had received previous Moderna vaccinations. No treatment medications were reported.  Company Comment: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the unexpected, serious, event of COVID-19 which led to the hospitalization of the patient and occurred on an unknown date after receiving a dose of mRNA-1273.222 (BA.4/BA.5) Original/Omicron Bivalent Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the event was unknown. The ongoing COVID-19 pandemic remains a confounder. The benefit-risk relationship of mRNA-1273.214 (BA.1) Original/Omicron Bivalent Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the unexpected, serious, event of COVID-19 which led to the hospitalization of the patient and occurred on an unknown date after receiving a dose of mRNA-1273.222 (BA.4/BA.5) Original/Omicron Bivalent Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the event was unknown. The ongoing COVID-19 pandemic remains a confounder. The benefit-risk relationship of mRNA-1273.214 (BA.1) Original/Omicron Bivalent Vaccine is not affected by this report.
Raised localized reaction; lost some balance; Double vision; raised localized reaction that was very painful; welt; she has not had the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Raised localized reaction), BALANCE DISORDER (lost some balance), DIPLOPIA (Double vision), PAIN (raised localized reaction that was very painful) and URTICARIA (welt) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D NOS for an unknown indication.    On 11-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Raised localized reaction), BALANCE DISORDER (lost some balance), DIPLOPIA (Double vision), PAIN (raised localized reaction that was very painful), URTICARIA (welt) and PRODUCT DOSE OMISSION ISSUE (she has not had the second dose). The patient was treated with PARACETAMOL (TYLENOL) on 12-Feb-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Raised localized reaction), BALANCE DISORDER (lost some balance), DIPLOPIA (Double vision), PAIN (raised localized reaction that was very painful), URTICARIA (welt) and PRODUCT DOSE OMISSION ISSUE (she has not had the second dose) had resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received on 26-JUL-2021 : Correspondence contact is Unchecked. Event outcome from Unknown to Recovered was updated.
Inconsolable loud shrieking cries, every time awake for a period of 24 hours following the vaccination. A cry atypical of my daughter, nothing I did could calm her, she is a very calm baby normally. I did administer Tylenol and considered that the crying was a result of her red and swollen legs at the site of injection. I have done further research and concluded that her crying was above and beyond the scope of normal.
Pain in elbow, radiating to upper arm down to fingers.  Worsens with certain movements and uses.  Persistent ache with sharp pain occurring with and after use.
Client received a pediatric dose of Pfizer, when she should have received an adult dose. This issue was identified when the client returned for their second dose in the series. Client's parent was notified. No adverse affects noted.
took shingrix, still got herpes zoster/Suspected vaccination failure; severe herpes zoster; This case was reported by a physician via other manufacturer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included upadacitinib (Rinvoq) tablet for rheumatoid arthritis.   The patient's past medical history included shingles. Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received Shingrix and Rinvoq (oral) 15 mg once daily (15 mg daily). On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant and other: other medically important cond) and herpes zoster (serious criteria other: other medically important cond). The action taken with Rinvoq was unknown. On an unknown date, the outcome of the vaccination failure and herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the Shingrix vaccine for shingles but still got very severe herpes zoster with Rinvoq. It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Rinvoq. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
pt began screaming 20 mins post vax 27APR93 lasted 4-5 hrs; no consoling; MD talked w/mom; no tx given; advised to delete pertussis future doses;
Dizziness, anxiousness, nervousness, generalized weakness. Patient given a bottle of water, seated, encouraged to relax, calm down.
Pt presented to office 10-11-13 to show SN swelling and reddened area on (L) deltoid had a pink-reddish area that measured 16 cm length by 10 cm width which extended down and medial to injection site. Warm and tender to touch. Circumference of arm .6 cm longer than (R) arm.
Severe arm pain in upper arm, weakness in arm, I had parsonage turner syndrome 20 years ago. The pain feels like the onset of PTS when I had it before.
Both legs starting hurting, tingling and was not able to climb stairs without assistance. This started on 3/6/2018 and eased up on 3/8/18 at 4:00am.
Information has been received from a physician concerning a 7 year old female with no significant medical history who on 2/24/98, at 13 months of age was vaccinated with a first dose of varicella virus vaccine live. In November 2004, the patient was diagnosed with an inoperable, malignant brain ependymoma. The treatment plan was to shrink the tumor with chemotherapy, followed by radiation therapy. The patient began chemotherapy in November 2004 and was tolerating it well on an outpatient basis. On 12/28/04 she presented at the hospital with a chief complaint of low back pain and was afebrile with no other reported signs and symptoms. An MRI was done which showed a subcutaneous area of enhancement in the low back; there was no spine, bone or meningeal enhancement. The patient was admitted to the hospital. On 12/29/04, at approximately noon, the patient was noted to have several vesicles on the crown of the head. That same day she was started on IV acyclovir at a herpes simplex dose and was transferred to the ICU. Subsequently a skin biopsy was done and an Infectious Disease consult was requested. As a precaution while awaiting the results of the skin biopsy, the acyclovir dose was increased for varicella. Later in the day on 12/29/04, the patient developed fulminant liver failure, with ALT >6000, AST 3620 and an INR of 5.6. She was given lots of blood and cryoprecipates; however, the liver failure persisted. On 12/30/04 her transaminases were over 13,000. The physician reported that the patient's anti-varicella IgG was negative. On 12/30/04 she developed multi-system organ failure and was intubated. On 12/31/04, life support was withdrawn and the patient died. The physician reported that he did not know if an autopsy was done, but believes that the child died from multiorgan failure resulting from disseminated varicella. He noted that some lesion specimens were sent for PCR analysis. The physician reported that there was no known varicella exposure prior to the child's hospitalization. The physician reported that he felt most certain that this was wild type VZV in an immunocompromised patient. Discharge Summary reviewed stated patient experienced sepsis, hypoxia, respiratory distress and GI bleed.
Heat goes right to her head; Chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Heat goes right to her head), CHILLS (Chills) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Heat goes right to her head), CHILLS (Chills) and NAUSEA (Nauseous). At the time of the report, FEELING HOT (Heat goes right to her head), CHILLS (Chills) and NAUSEA (Nauseous) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment information were not provided.
Patient presented to pharmacy wanting to get the first dose of Pfizer covid-19 vaccine. Pharmacist administered the dose and wrote the CDC vaccine card. However, while reporting this dose to Immunization Registry, it was discovered that patient had already received J&J one dose on 3/11/21, one dose of Pfizer on 10/23/21. Pharmacist asked paient to verify those doses and at that point he disclosed that he indeed had gotten those doses. His explanation was that reading on News about J&J vaccine is not as effective as initially thought so he needed to restart vaccine series with a different vaccine. However, he failed to adequately explain why he got pfizer dose on 10/23/21. Pharmacist asked patient  for his reasons for not being forthcoming despite questions of Consent/screening prevaccination form and he said the news got him all confused and decided to get a new vaccine while ignoring the face that he still needed to report his previous covid-19 vaccinations regardless they were effective or not.
Immediate pain in arm. Still having pain, can not lift arm above shoulder level, tingling in hand. Pain from shoulder to elbow. Can't sleep at night from pain.
patient received VARIVAX that had undergone temperature excursion; No additional AE reported; This spontaneous report has been received from a healthcare worker regarding to a currently 30-year-old patient of an unknow gender. The patient's medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date (reported as before calling), the patient was vaccinated with one improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, vaccination scheme frequency, route of administration and anatomical location were not provided; lot number W003818 that was verified to be a valid lot number with an expiration date reported as 12-NOV-2022, but upon internal review established as 02-FEB-2024) for prophylaxis (product storage error).  The administered vaccine underwent a temperature excursion of 76.1 degrees Fahrenheit (F) with a time frame reported as 322 hours and 15 minutes. There was a previous temperature excursion reported; however, no details were provided.   No additional adverse event (AE) was reported (no adverse event).  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA009412: US-009507513-2209USA009527: