chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got pre-exposure shot on 01Dec2020. She didn't understand to get another one 7 days later; Case reference number US-BN-2020-019902 is a spontaneous case report initially received from a pharmacist via Agency (reference number  USBAV20-0245) on 28-Dec-2020, and concerns a *20-year-old* female patient.  The patient's medical history and concomitant medication details were not provided.  On 01-Dec-2020, the patient received RabAvert (Inactivated Rabies Virus Vaccine, Batch no. *ARBA7318*) at unknown dose for pre-exposure prophylaxis.  On 28-Dec-2020, the patient went back for the second shot as she did not understand that she needed to get another the second dose 7 days after the first dose (inappropriate schedule of vaccine administered).   *At the time of this report it was reported that the patient did not experienced any adverse events due to RabAvert.*  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).   Follow up information was received from a pharmacist on 30-Jan-2021: Information included patient details, batch number, and confirmation that the patient did not experienced any adverse event due to RabaVert.; Reporter's Comments: Inappropriate schedule of vaccine administered is listed by convention. Reportedly, the patient did not receive the second dose of RabAvert on the day when it was actually scheduled which is considered to be inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to the vaccine itself, but to human action.; Sender's Comments: Inappropriate schedule of vaccine administered is listed by convention. Reportedly, the patient did not receive the second dose of RabAvert on the day when it was actually scheduled which is considered to be inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to the vaccine itself, but to human action.
Pain, edema and tenderness in right axilla.  Swollen lymph nodes.  Sore joints in all fingers on both hands.
Patient is a 57 year old female complained of light headedness, dizziness.  Encouraged pt. to relax, stay calm.  Water provided. Fire Rescue arrived to scene for further evaluation.  Vital signs rendered.  Pt. denies any pain, discomfort.  Pt. refused hospitalization.  Pt. recovered from adverse event at 2:06pm with no complaints of lightheadedness, dizziness and left observation via personal vehicle.
Hedheac (headache); This is a spontaneous report from a contactable consumer, the patient. A 43 year old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 at 12:00(at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 13:15 the patient experienced headache. The adverse event did not result in a visit to the doctors or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event headache was not recovered.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Slider#2 reporter was removed since same as 1st reporter 2. in slide#1 reporter, State format updated 3. patient address added in patient tab 4. Vaccine Facility Information added  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient called pharmacy on 2/5/18 to discuss the following adverse event: Patient broke out in widespread rash on arms, legs and back/all over body on 2/3/18 at approximately 12:00AM. Patient said rash itched and appeared as red hives and she went to ER. Patient was prescribed diphenhydramine, hydrocortisone cream and prednisone tablets. Patient started this therapy and rash/hives improved some on arms but as of 2/5/18 has not improved completely on legs. Patient states rash seems to clear up but come back on legs. At the ER patient was told it was contact dermatitis but is still concerned it was event related to vaccine. Patient could not think of any other recent changes in lifestyle that could be attributed to reaction.
pt brought to ED with AHRF with bilateral pneumonia; COVID test positive; admitted to hospital; started on ABX, steroids, bronchodilator, Pulmicort; respiratory status declined; DNR/DNI; transferred to inpatient hospice with comfort measures where pt died
Hives covering body. Started on forehead and has spread and is still spreading 4 days after. I got steroids starting yesterday and was called and told that I am no longer vaccinated since I took steroids.
Information has been received from a physician concerning a 14 year old female, with no medical history, who on 06-DEC-2006 was vaccinated with a second intramuscular dose in the right arm of Varivax (Lot# 655065/1142F). Concomitant vaccine administered on the same day included a first dose in the right arm of Gardasil (Lot# "0916F"). It was reported that, on 06-DEC-2006, the patient's injection site swelled to the size of a golf ball, and had become red and tender but developed no fever. The patient was treated with ice. At the time of the report the patient was recovering. There were no laboratory diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Pt developed new onset vertigo at 2am (approximately 12 hours after vaccine was administered)
*5 hours after injection:  7:30 pm. extreme shivering/chills.  Fever 101.4  major body aches and a moderate headache.   I Took exedrin migraine 200 mg at 10 pm and 250 Ibuprohren tablet at midnight. Fever hovered around in 99.4 to 100 range, throughout night.  Took another Ibuprohren 2:30am.   Took another exedrin migraine tablet around 9am morning after injection.  Frequent urination, throughout first night.  I was up every hour to hour and half.   24 hours after injection.  Temp back to normal.  Fatigued. Butcher body aches and headache have abated. Loss of appetite, lasted several days after injection.
I started feeling nausea, extreme flushing of skin, heat radiating throughout body, vomiting, and swelling in throat within 3 minutes of injection. I started to actively throw up and shortness of breath I could feel my throat closing off and was struggling to breath. Within the first 10-15 minutes, I could not breath, swallow, and my body started to contract. I was given epinephrine, steroids, and other medications and emergency services dispatched. I was in Anaphylaxis
pt recv shots 10AM & 1hr later began screaming-face bright red-lasted 2 days only stopped for intervals of 10-15mins; didn't eat as well as usual; t102.6; legs sore; used APAP & compresses to legs;still fussy the third day then cold sx;
Information has been received from a licensed practical nurse concerning a 17 year-old (pediatric) patient who, on 02-JUL-2013, was inadvertently vaccinated with an adult dose of VAQTA, 50/1.0 U/ml, 1 ml, intramuscularly (lot # reported as J000145, expiry date 25-SEP-2015). This was the patient's first dose of VAQTA. No adverse effect was reported. Additional information has been requested.
20 days p/vax lt gland in node became very swollen; no fever, no rash; c/o discomfort in neck area; next morning it became very swollen APAP given;
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
severe adverse reactions; 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 ADVERSE REACTION (severe adverse reactions) 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 ADVERSE REACTION (severe adverse reactions). At the time of the report, ADVERSE REACTION (severe adverse reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment information was reported.
Vomiting 2x 8:00-10:00 AM, diarrhea, fever, chills, violent shivering; Ibuprofen 200 every 4-5 hours; reduced fever, chills, and shivering. Diarrhea and IBS symptoms continued for 6 days.
Patient's arm became swollen the next day (9/10). On 9/11 the patient went to urgent care where doctor prescribed prednisone. Patient states she is much better today and swelling is almost all gone (today 9/12).
Client was given HPV and varicella vaccines. Approximately 15 minutes later - Mother described her daughter as "felt dizzy, then fell to her knees". Client was noted to have diffuse pink, flat, pinpoint spots on several areas over arms and upper torso, including but not limited to injection sites. No urticaria or edema noted. Vital signs slight elevated. All symptoms resolved within 30 minutes.
Information has been received from a registered nurse concerning a 3-4 patients who on an unknown date were vaccinated with a dose of GARDASIL (lot number, dose and route not reported). It was reported that all patients experienced tonic-clonic seizure in both arms after being administered with a dose of GARDASIL. At the time of the report, the patients' outcomes were unknown. It was unknown if patients sought medical attention. Upon internal review, the tonic-clonic seizures in both arms were determined to be an other important medical event. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Injection site was, red, tender, swollen, itching and painful. Treated w/ibuprofen and BENADRYL, prednisone added.
Information has been received from a licensed practical nurse concerning a 6 year old caucasian male patient with no known allergies and no pertinent medical history, who on 03/29/1999 was vaccinated in the right leg with a first dose of varicella virus vaccine live.  Yesterday, 11/04/2004, the patient presented to another medical office with a maculopapular vesicular rash all over his body, he was diagnosed with chickenpox.  It was noted that the rash onset was 11/01/2004.  The mother stated, the patient had approximately 150.  There were no laboratory tests performed.  Treatment was comfort measures.  The patient had no adverse events following prior vaccination.  There was no product quality complaint reported.  Unspecified medical attention was sought.  No additional information is expected.
Boostrix intra venous administration; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 16-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix (intravenous) and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Pharmacist reported that the patient was administered Boostrix via intravenous instead of intramuscular route, which lead to Incorrect route of vaccine administration. The reporter consented to follow up.
approx 2minutes p/vax pt became flushed, tachycardic & started wheezing;on exam was found to be wheezing in all fields both inspiration & expiratory;pt had full body hives but mostly on chest & abd;improved p/DPH & prelone & 2 albuterol;
19 y/o female complaining of dizziness after COVID-19 vaccine. Pt CAO X4, vitals stable. Pt received w/o treatment.
Headache, Myalgia, Fever, Diarrhea, chills Narrative:
Was fine before the COVID19 vaccine shot. After 15 minutes of observation, I experienced a runny nose which I was told was fine. About an hour later, I experienced slight swelling under my left eye and cheek. A few minutes after, my throat began to have a scratchy feeling and a slight wheezing which was concerning. As soon as I experienced this feeling, I took one Benadryl immediately. After about a half an hour, the swelling under my eye and cheek gradually went down, my runny nose stopped after a few minutes , and my throat itching stopped after about 15 to 20 minutes. I felt fine afterwards.
A non-serious spontaneous report of a nurse cutting her finger on the syringe while administering H1N1, Intranasal has been received from a pharmacist concerning an adult female. Medical history and concomitant medications were not provided. On 21-Oct-2009, the nurse administered H1N1, Intranasal. During administration of the vaccine to a patient, the nurse cut her finger on the syringe. The outcome of the event is unknown.
muscle spasms after the COVID Vaccine; She had soreness in her arm; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously had flu shot on an unspecified date for immunisation and experienced muscle spasms. On an unspecified date, the patient experienced muscle spasms after the covid vaccine. She felt like she did when she gets a flu shot. She had also soreness in her arm. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Itching, tingling and face swelling. Liquid Benadryl resolved the issue.
This 72-year-old female with acute onset of confusion onset yesterday morning.  Upon exam this morning patient was awake alert oriented x4 however was sluggish in her responses.  Patient did arrive with a fever 100.5 Fahrenheit.  Patient had a Covid test upon arrival which was negative.  Patient had third Covid shot on Monday, 9/13/2021.  However chest x-ray revealed  suspicious for Covid pneumonia.  We will recheck Covid status this morning.  MRI of the head with and without contrast has been ordered.  Metabolically patient has a potassium of 3.3, and slight elevation of AST, ALT with known hepatitis C.  Patient's ammonia level is unremarkable.  Therefore neurology impression at this time is transient global amnesia versus other side effect to the third Moderna vaccine or active COVID-19.  Patient's exam did not support TIA.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored dose of PROQUAD injection, lot # L050907, expiration date: 14-JUN-2017 and lot # L051102, expiration date: 17-JUN-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Report 20010248321 describes swelling in the axillary area of a female age not specified who received hep B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not specified. The pt received her first and second injections of Engerix-B 07/06/2001 and 08/07/2001, respectively. "Weeks later" she developed swelling in the axillary area. On 08/27/2001, 20 days following the second injection of Engerix-B, she developed three swollen lymph nodes that were tender to the touch. The pt was seen by a physician and unspecified tests were performed; the results were not provided. Outcomes of the events were not specified.
Parents of patient found him dead the morning of 03/12/2010. Per ER physician, rigor mortis had set in. Per the ER physician, mother mentioned questionable abdominal pain and questionable cold symptoms, but says that child seemed okay.
no adverse events; Administration of an expired dose of PNEUMOVAX23; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 18-JUN-2021, the patient was vaccinated with an expired dose of (PNEUMOVAX23) 1 injection, lot# S024808, expiration date 02-JUN-2021, for prophylaxis (strength, route and frequency were not reported). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S024808; expirationdate: 02-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Itching at administration site within minutes, large area of redness surrounding site in hours. Treated with BENADRYL. Saw urgent care MD, no further treatment necessary.
Big red 3" wide streak across the entire arm, welting at the site of injection, Foggy head feeling, felt like my head was going to lift right off, still to this day not feeling well, dizzy, pain in left shoulder and neck since then.
Chills; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills".  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-2021266103 same reporter, suspect product, different patient, event and dose
Pt was given 0.25 mL of FLUVIRIN in (L) thigh. FLUVIRIN is intended for ages 4 and over. Admin/med error. Consulted with Novartis (manufacturer) - recommended fill out VAERS form.
Information has been received from a consumer concerning her approximately 9 month old son with severe respiratory infection and the worst cold in his life at time of vaccination and with no drug allergy who in 2009 was vaccinated with his first dose of MMR II (lot # not reported). Secondary suspect therapy included his first dose of VARIVAX (Merck) (lot # not reported). Concomitant therapy included another unspecified vaccine and unspecified antibiotics for cold. In 2009, 7 days after vaccination, the patient experienced febrile seizure. The patient was initially evaluated in a local hospital but was then transferred to another hospital. The patient was evaluated in the emergency room and a "spinal tap" was performed which was normal. The patient was hydrated and a diagnosis of febrile seizure was made. The patient did not require admission to the hospital. The reporting consumer mentioned that her son, who was just beginning to say a few words prior to vaccination, did not speak for 1 month after the seizure. Her son had subsequently recovered from the events. Upon internal review, febrile seizure and did not speak were considered to be other important medical events. No further information is available.
Injection site reaction (rash, swelling, red blotches, itchy), headache, and fever. Still one month later has occassional itchy red blotches on waist on side of vaccine and other arm.
Erythema 20 x 20 over (L) arm PCV7 site.
Modern COVID-19 Vaccine EUA Symptom: headache to right right side of head around temple area- started roughly 9:25pm 35 mins later and still accruing.