chrisvoncsefalvay/vaers-outcomes huggingface dataset:
adjuvant was not reconstituted with powder; patient received only  adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number A45FG, expiry date 23rd April 2023) for prophylaxis.   On 13th July 2022, the patient received Shingrix. On 13th July 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-Jul-2022 Reporter's Comments: The nurse reported a patient received only the Shingrix adjuvant (without reconstitution with powder on 13th July 2022 The reporter consented to follow up. Additional Supportive Information:  The patient only received shingrix adjuvant without reconstitution with powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022106155:Same reporter. Patient 2
The 2nd dose of the vaccine was very painful when first injected them a metallic  taste in my mouth followed by numbness and tingling on the left side of my face and dizziness.  Fave numbness subsided and metallic taste subsided after a few hours . However Continuous throbbing and pain  after  continue after 17 days post injection  . Pain is on left deltoid and numbness and tingling , down  the left arm day as he night . Shoulder  pain and  a feeling of numbness on hand . Weakness, numbness and tingling  persists on the left arm to the point of having to stop doing activities . Pain in injection site keeps me awake at night .
tingling numbness in fingers right after injection , swollen under arm/tenderness to touch continued and still exist 3 days after injection
Swollen under left armpit that irradiates to my arm, L+ right side of my chest and L+ neck side. It caused pain and discomfort since last night.
30 minutes after injection, began feeling strange sensation in left side of chest (12 pm Friday).  Sensation continued and became mildly painful Friday evening.  Mild pain began Saturday, with shortness of breath developing Saturday afternoon.  Serious difficulty breathing onset Saturday night.  Car was broken so considered calling 911 for ambulance, but hesitated due to $5k health insurance deductible.  Quickly researched myocarditis, saw treatment included NSAIDs, and took two Advil.  Within one hour, breathing returned to near-normal and went to bed.  Stayed on Advil through Sunday night when symptoms seemed to resolve.  On Monday did telehealth consult with Medstar doctor who confirmed suspected Myocarditis and recommended ER consult to rule out other causes or permanent damage.  Went to ER on Tuesday for chest exam, x-ray, blood panel, EKG, blood marker to rule out blood clot in lung.  ER Dr interpreted all tests as normal and discharged with diagnosis of strange reaction to COVID vaccine and recommended to watch for worsening or resolution of symptoms.  Symptoms returned Thursday, so began taking Advil regularly (1 pill every 4 hours).   Present (10/8/21): Normal breathing can only be maintained by taking 1 Advil every four hours.  If medication stops, breathing difficulty returns, along with chest pain.
Patient had an episode of syncope following immunizations (Fluzone HD, and Prevnar 13). Patient went unconscious, and EMS was dispatched. Patient did have a weakened pulse and was sweating. Patient was put in supine position with feet eleveated and ice pack placed behing neck. Patient was still breathing and had a strong pulse after elevating feet. Within 5 minutes EMS took over and patient sent to hospital. Patient called the following day saying she was okay.
2 days after booster was administered, I started showing rash/bumps on the back of my head at base of hairline. Extremely itchy. I went to the dermatologist on 12/8/2021 to look at rash on back of head/neck. I was administered topical medication. Considered it to be potentially related to shampoo. Rash progressively got worse: extremely itchy red rash raised bumps on both arms, both elbows, upper back, chest and hands. Now on my hip. Extremely itchy. Now using Benadryl as well as topical cream and ointment prescribed. I now believe this was from the 12/2/2021 booster as the problems are continuing, despite stopping shampoo use on 12/8/2021.
21JAN97 pt devel fever of 103-105 approx 6 hr p/vax;pt had t103-105 for 2-3 days @ times would go down to 101;MD was notified of above s/s on 22JAN & 23JAN when pt hosp p/sz;r/o some viruses on 26JAN97;pt now fine rash on head/arms;
3 inches in diameter and continues to grow; injection site swelling; injection site red; injection site warm; scratching that shoulder, it was itching; Arm was sore; Thought that she was dying; hot and cold chills; low grade fever; Fatigued; nausea; A spontaneous report was received from a healthcare professional concerning a 50-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigued, arm was sore/pain in extremity, low grade fever/pyrexia, nausea, thought that she was dying/feeling abnormal, hot and cold chills, scratching that shoulder, it was itching,/pruritus injection site swelling/vaccination site swelling, injection site red/vaccination site erythema, injection site warm/vaccination site warmth, 3 inches in diameter and continues to grow/vaccination site rash.  The patient's medical history was not provided. Concomitant medications reported were losartan, melatonin for unknown indication.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events, fatigued, arm was sore, low grade fever, nausea, thought that she was dying, hot and cold chills.  On 9 Feb 2021, the patient experienced the events, scratching that shoulder, it was itching.  On 10 Feb 2021, the patient experienced the events,  injection site swelling, injection site red, injection site warm.  On 12 Feb 2021, the patient experienced the event 3 inches in diameter and continues to grow.  Treatment details included Topical - Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.  On 6 Feb 2021 the outcome of events, fatigued, arm was sore, low grade fever, nausea, thought that she was dying, hot and cold chills was resolved. The outcome of events, scratching that shoulder, it was itching, injection site swelling, injection site red, injection site warm, 3 inches in diameter and continues to grow was unknown.
Information has been received from a pharmacist concerning a 69 year old female with diabetes mellitus insulin-dependent and chronic obstructive pulmonary disease and whose husband was noted to be waiting for a liver transplant since he has hepatitis B, who on 3/16/05 and 4/15/05 was vaccinated IM with the first and second 1ml doses of hepatitis B virus vaccine (lot #'s 648213/0597P and 647274/0205P, respectively). Concomitant therapy included furosemide, potassium, lisinopril, albuterol, insulin, oxybenzone, and benzonatate. On approximately 4/22/05, the patient experienced nausea, vomiting, jaundice, and was hospitalized. On 4/22/05, laboratory tests showed: total bilirubin 0.5; AST 20; ALT 20; and albumin 3.8. On 5/16/05, laboratory tests showed: total bilirubin 16.9; AST 2178; ALT 2299; and albumin 2.7. At the time of the report, it was unknown if the vaccine was involved with the elevated LFT's. The outcome was reported as not recovered. No additional information was available. There was no product quality complaint. The events were considered to be other important medical events (OMIC) by the reporter. Additional information has been requested.
1 of 3 pts vaxed from the same Tetramune vail who exp extreme irritability described as crying for an extended period following vax; no fever reported;tx w/APAP;pt recovered;No further clinical details available
I got the first shot on 24Jan2021 and I got the second dose on 31Jan2021; I got the first shot on 24Jan2021 and I got the second dose on 31Jan2021; Have a lump on my arm and it's very itchy/lump where they give me the shot; Have a lump on my arm and it's very itchy/lump where they give me the shot; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 31Jan2021 at a single dose on arm for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient received the first dose of BNT162B2 for COVID-19 immunisation on 24Jan2021. Consumer stated, "I took my second Covid shot on Sunday (31Jan2021) and I have a lump where they give me the shot. I have a lump on my arm and it's very itchy. So that's what I wanted to know that is why I have been hold for an hour to find out how you can assist me. I am asking you what you can do for me. I don't think you understand me. I have been holding an hour because my arm has a lump where I got the shot. Are they supposed to give the first shot and second shot in the same arm?" Event start date was reported as "Yesterday, 01Feb2021." The patient did not receive treatment for the events. The outcome of the events was not recovered.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 at 12:00 as dose 1, single (Lot number: EN6202), in right arm, on 23Mar2021 at 13:15 as dose 2, single (Lot number: ER8727), in left arm, on 29Sep2021 at 17:15 as dose 3 (booster), single (Lot number: FF2588), in right arm and on 19May2022 at 17:30 as dose 4 (booster), single (Lot number: FM0173) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure and covid-19 included Paxlovid (lot numberGE4606) from 14Sep2022 to 18Sep2022.  Clinical course: It was unknown that the patient received other medications within 2 weeks to the COVID vaccine. Patient had a COVID-19 rebound and onset of symptoms from 24Sep2022 07:00 AM. Patient did not receive treatment for symptoms and not recovered from symptoms. The patient previously receive a COVID-19 Vaccine.
pt recvd vax; felt "exhausted" & devel back pain; was tx w/ voltaren, however, devel numbness of hands & migrating, gen pains;also devel low grade fever of about 99.3;
small little jelly bean that moves around under her skin; whole area swelled up a lot; more tender; felt a lot of pressure (like a punch and a bruise) that hurt so bad.; it is really puffy up there; she can feel a hard nodule underneath that moves; lymph nodes right above her left collarbone; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes right above her left collarbone), SWELLING (whole area swelled up a lot), LYMPH NODE PAIN (more tender), DECUBITUS ULCER (felt a lot of pressure (like a punch and a bruise) that hurt so bad.) and SKIN SWELLING (it is really puffy up there) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products were not provided.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph nodes right above her left collarbone). On 19-Mar-2021, the patient experienced SWELLING (whole area swelled up a lot), LYMPH NODE PAIN (more tender) and DECUBITUS ULCER (felt a lot of pressure (like a punch and a bruise) that hurt so bad.). On 14-Apr-2021, the patient experienced SKIN MASS (small little jelly bean that moves around under her skin). On an unknown date, the patient experienced SKIN SWELLING (it is really puffy up there) and NODULE (she can feel a hard nodule underneath that moves). At the time of the report, LYMPHADENOPATHY (lymph nodes right above her left collarbone), SWELLING (whole area swelled up a lot), LYMPH NODE PAIN (more tender), DECUBITUS ULCER (felt a lot of pressure (like a punch and a bruise) that hurt so bad.) and SKIN MASS (small little jelly bean that moves around under her skin) outcome was unknown. Not Provided   Treatment products were not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Shortly after vaccine was administered, patient appeared to have vasovagal response and fainted from chair in waiting area. Patient's legs were lifted as to bring blood flow back to the heart, patient started recovering within minutes. Patient did not sustain any injuries from fall.
pt states that on 2/6/2021 that she noticed her arm has a 3X5 red spot below the injection spot.  Pt will contact her PCP to let them know.
A month after the vaccine, I started having abdominal cramps and my period was heavier. Ever since, my period has been irregular and painful.  This is new for me. I am now fatigued.
Initial report received from a health care professional on 05 May 2010. An unidentified patient, with medical history not reported, had received an injection of VF-VAX (Lot number not reported) on 23 March 2010 and developed hives widespread over the body. The hives, which were red, raised and itchy, appeared on the patient's shoulders, hips, and trunk. The patient was seen in the emergency room and had been placed on ZYRTEC with some improvement. Recently the patient reported numbness and tingling in the left hand and left side of face. The patient was being seen by an allergist. The outcome for the events was reported as not recovered. Documents held by sender none.
The pt experienced a 3.5 cm pruritic / sore erythematous rash starting at injection site at left upper arm for 2 days. It has grown 5 cm over the last 4 hours.
11/06 awoke with chills and extreme headache. Very lethargic all day and loss of appetite.  11/07 9 cc diameter red and sligtly swollen area at shot site. 11/08 constant itchiness at site;  various topical lotions have given no relief
Left deltoid region with 7 x 7 cm of erythema and warmth. Treated with ibuprofen, BENADRYL and ice.
pt recvd vax 9NOV94 in AM; pt woke w/fever 102 during noc & c/o nausea; fever down by 10NOV daytime;
No additional AE's; Customer calling to report a temperature excursion on V ARlV AX. Customer does note the vaccine was administered; This spontaneous report as received from a other refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.      On 19-FEB-2021, the patient was vaccinated with first dose varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S025910 and expiration date since it makes match with the autopopulated expiration date 20-AUG-2021) dose 1(indication, route, and anatomical location were not reported) which where stored at temperature excursion. The temperature excursion was 7.1 degrees Fahrenheit for a time frame of 45 minutes, and 6.9 degrees Fahrenheit for 45 minutes, as recorded by a data logger. The previous temperature excursion was 6 degrees Fahrenheit to 14 degrees Fahrenheit for 45 minutes.   No additional adverse events was reported.
felt like someone punched him in the arm; black and blue mark on left arm; This is a spontaneous report received from contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A 57-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: EP6955, Expiration Date: 30Jun2021) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune Condition" (unspecified if ongoing). Concomitant medications included: IMURAN [AZATHIOPRINE] taken for autoimmune disorder (ongoing); PREDNISONE taken for autoimmune disorder. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Mar2021, outcome "recovered" (Mar2021), described as "felt like someone punched him in the arm"; ECCHYMOSIS (non-serious) with onset 2021, outcome "unknown", described as "black and blue mark on left arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: About 12 hours after the first shot, he felt like someone punched him in the arm and completely recovered after 4 or 5 days. When he went to get his second dose, he noticed that there was still a black and blue mark on his left arm from where he had the first shot and this was 21 days later, so he decided to get the second shot in his right arm. The patient was on mild immunosuppressants. Yesterday (19Apr2021), the patient had a SARS-COV-2 IgG antibody test. It came back negative with SARS-COV-2 IgG index of 0.02. Antibody interpretation was negative. The patient wanted to know if that was the appropriate test that was run. He asked if the test that they ran would tell him if he had an immune response. He did not want to run around with a false sense of security.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021438489 Same patient and drug, different dose and events
Patient received shot on Monday and her arm started to get warm and red on Friday morning. Pt said that it got worse overnight and came in pharmacy on Saturday. Her arm was slightly swollen and red. We told her to put some ice pack and gave her 3 BENADRYL to take every night for next 3 nights. And if symptoms get worse then go see MD.
This spontaneous report was received from a physician referring to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored doses of PROQUAD (dose, frequency and route were unknown) lot # R002936 expiration date 29-JUL-2019, lot# R008207 expiration date 16-SEP-2019, lot# R003298 expiration date 31-JUL-2019, lot# R003298 expiration date 31-JUL-2019; for prophylaxis. Other suspect therapies included VARIVAX (dose, frequency and route were unknown) lot # R011809 expiration date 23-APR-2020, lot# R002054 expiration date 22-JAN-2020, lot# N031003 expiration date 03-NOV-2019, lot# N026072 expiration date 20-SEP-2019 and lot# N023957 expiration date 01-SEP-2019, for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent(manufacturer unknown). Digital data logger registered a temperature excursion between 15 Fahrenheit degrees and 46 Fahrenheit degrees along 40 minutes. Other temperature excursion was registered between 6 Fahrenheit degrees and 24 Fahrenheit degrees along 54 minutes.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored VAQTA (lot # K018181, expiration date 04-JUN-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMh significant for nephrogenic diabetes insipidus, cancer of esophagus, prostate cancer, parkinson's disease, dementia, anemia, obstructive sleep apnea, hyperlipidemia, diabetes mellitus, htn, bipolar. Was seen at ER on 4/9 with cc of SOB x 1 week and discharged. Pt fell on 4/21 but not injured. Pt was 72 years of age and deceased on 5/1/2021. No cause of death noted.
Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. On approximately 06/13/03, "within the last week", the pt may have possibly developed zoster. The pt was not treated. No additional information is available at this time. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
administered expired ACTHIB to a 15-month old patient with no reported adverse event; Initial information received on 09-Nov-2021 regarding an unsolicited valid non-serious case received from another health professional and physician via Medical Information number: 00849826.   This case involves a 15 months old female patient who was administered an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE  [ACT-HIB].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 09-Nov-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot number: UJ404AAA and expiry date: 04-OCT-2021 via intramuscular route in the left thigh for prophylactic vaccination. It was reported that the patient did not receive treatment after expired vaccine administration.   It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Swelling and pain within 30 minutes of injection. MD placed Pt on KEFLEX 500 mg for 10 days (4/30/2012). Pt came back into office 5/3/2012. Pt notes that the swelling has went down & her arm feels much better. Pt is noticing some knots still on her right forearm.
Injection site soreness; Muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) and MYALGIA (Muscle soreness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness) and MYALGIA (Muscle soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) and MYALGIA (Muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.