chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received a 0.05 ml invalid dose of Adacel, No AE; Adacel were administered to patient after being exposed to 30 Farenhiet, No AE; Initial information received on 11-Aug-2020 regarding an unsolicited valid non-serious case from the other health professional.  The case is linked to the cases 2020SA209621 and 2020SA210303 (same reporter).  This case involves a 30 years old male patient who received the 0.05 ml invalid dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number and expiration date not reported), after being exposed to 30 Fahrenheit via unknown route in the left deltoid as prophylactic vaccination on 09-Aug-2020.  Medical history, medical treatment and family history were not provided.  No other medication or vaccinations were received on this visit.   It was an actual medication error case due to product storage error temperature too low.  It was also a case of vaccine underdose.  No adverse event reported at the time of reporting.  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 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.  There will be no information on the batch number for this case.
I was sick 4 months later, after covid 19 vaccine, with acute pericarditis.  I had pressure on chest and was in hospital for 5 days.
my left arm still hurts since Friday - dull ache 1or2 out of 10 pain overnight from 09Apr to 10Apr I was woken up in pain around 3a.m.  I was very hot and my body ached all over, my joints and muscles, I also had a bad headache
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Caller mentioned that her brother and sister took the Pfizer Vaccine shot and are both dead now and his best friend". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: No, medical inquiry was not forwarded. 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-202201034250 Same drug, same event, different patient; US-PFIZER INC-202201034251 Same drug, same event, different patient; Reported Cause(s) of Death: Caller mentioned that her brother and sister took the Pfizer Vaccine shot.
infection; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 25Oct2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) via the Pfizer- Sponsored Program. A 80-year-old male patient received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm, in the morning of 05Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE (received at the age of 80-years-old) for COVID-19 immunisation. Medical history included chronic myeloid leukaemia (CML) from 2011 to an unknown date; his cancer (CML) was almost undetectable at time of injection. Cancer count in Feb2021 was 0.01. Concomitant medication(s) included bosutinib (BOSULIF) taken for an unspecified indication, start and stop date were not reported; dasatinib monohydrate (SPRYCEL) taken for CML from 2011 to 2021. The patient had no prior vaccinations. The patient experienced infection on 10Feb2021. The patient stated he had the Pfizer Covid shot and it put him under oxygen. He was on ventilator for 8 days and almost died. Now he is not as strong as he was before Pfizer Covid shot. The patient stated that the doctor and nurse said his temperature and blood pressure were normal. He was told he is in great shape and to take the Pfizer covid shot. When he got the Pfizer covid shot on 05Feb2021, he was 80 Ups and could do 50 push up without stopping. He was in great condition at the time of his first and only Covid-19 injection. Five days later (10Feb2021), he had infection. The patient stated, "Five days later, I was infection". He was in the hospital bed for 9 days on a Ventilator for much of the time. His son drove him to the hospital as he could not drive at the time. The Doctors told him that if his son took him to the hospital 2 minutes later, they could never have woken him up and he surely would have died. He further stated, "I am so Dammed mad that no one warned me about the Danger of the Covid shot!! and that my Doctor urged me to get it." Outcome of the event infection was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.
J96.00 ACUTE RESPIRATORY FAILURE 2/21/2022 ATHEROSCLEROSIS OF AORTA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/22/2022 ATHEROSCLEROSIS OF AORTA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/15/2022 ATHEROSCLEROSIS OF AORTA J96.00 ACUTE RESPIRATORY FAILURE 2/21/2022 ATHEROSCLEROSIS OF AORTA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/22/2022 ATHEROSCLEROSIS OF AORTA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/15/2022 ATHEROSCLEROSIS OF AORTA
10cm x 10cm area of redness, swelling and induration around injection site of DTap.
This 44 year old reported she experienced onset of pain to injection site 24 hours following 2015 and 2016 influenza vaccinations. On 16 Oct 2015, she received FLUARIX (quad preservative free influenza) to left deltoid. She advised this discomfort persisted for one month despite use of TYLENOL or ALEVE prn. She sought medical care 11/2/2015 with 8/10 left shoulder pain and difficulty moving/lifting her arm overhead and was having problems putting on clothes, and some SOB/feeling winded after exercises-difficulty catching her breath (symptoms resolving as of Jan 2016 using asthma meds). She denied any chest pain, fever, n/v, arthralgia (to other joints), headaches, or rash following the flu vaccine. HCP documented left shoulder was TTP and pain elicited on movement with no swelling, erythema, or instability or weakness- had normal ROM. X-ray was normal. Patient advised in Dec 2015 pain to left shoulder had improved. In May 2016 she received PPV23 vaccine to left arm with no documented complaints. She advised her arm pain would come and go 1-2 x/week and she just lived with it. On 27 Oct 2016 she received annual flu vaccine FLUARIX to left arm lot# T44G9 (per note); however pt advised vaccine given in right arm due to past problems with left. She advised 24 hours later her right arm was now painful similar to left. She sought medical care on 12/7/2016 (upon return from family medical leave/holiday season) stating that she had right arm 8/10 sharp shooting pain with occasional loss of grip and could not raise her arm. She was treating with MOTRIN. Providers exam was unremarkable documenting TTP anteriorly to both shoulders - treated with Meloxicam and physical therapy. Patient advised she was not going to physical therapy because "If MD didn't know what was wrong, why go to them". Patient advised since first week of Jan 2017 while on Meloxicam, her pain has almost resolved and she has been pain free for about 1 week. She advised she can dress herself normally, can lift arm over head, and continues with her normal exercise routines. She denies any grip weakness, paresthesia, or pain to bilateral upper extremities. She has no SOB/difficulty breathing/feeling winded or chest pain.
Pain/ache at injection site--tenseness in bicep muscle. Still in pain after 3 days
chest tightness started 9/11, worse and 9/12 and worse on 9/13. Fatigue 9/11-9-13, achy muscles in legs 9/11-9/13.
Facial itching and hives on both cheeks and chest pain. B/P: 180/100, HR: 100, O2 saturation: 100% BENADRYL 50mg capsules given.
Patient Had a severe redness, pain, extending to underarm on the site of Bexero. Fevers, chills x4 days Exam - negative for any other. Redness improved with Zyrtec 10mg QD for 5 days.
This case was reported by a consumer and described the occurrence of a low grade fever in a 55 year old female patient who received hep-B vaccine (Energix-B).  The reporter is the patient.  A physician or other health care professional has not verified this report.    The patient's past medical history was notable for Iga deficiency.    On an unspecified date in 2002, the patient received the first dose of Energix-B in her arm.  Approximately one day later, the patient experienced a low-grade fever, headache, and "felt under the weather."  She was seen at a physician s office and was treated with tylenol.  The events resolved "two to three days after the vaccine" was administered.  On an unspecified date in 2002 the patient received the second dose of Energix-B in her arm.  Approximately one day later, the patient again experienced a low-grade fever, headache and "felt under the weather."  The reporter stated that the events following the second administration of Engergix-B were "milder".  The events resolved "two to three days after the vaccine"  was administered.  The immunization series with Energix-B was discontinued because the patient changed jobs.
Chills,  severe body aches - 11pm thru the next day, nausea - 230 am,  and vomiting - 6am until 9pm, fever - 530pm-939pm , headache and extreme fatigue - all day and into the next day (3/7)
This spontaneous report was received from a physician referring to a 11 year old female patient with asthma and penicillin allergy. Concomitant therapy included MENACTRA. Information about relevant history condition was not provided. On 19-JUL-2018, the patient was vaccinated with a dose of VAQTA (strength, dose detail, lot # and expiration date were not reported) intramuscularly for prophylaxis. In September 2018 (reported as beginning 2 months after injection), the patient experienced hives, uticaria, occasional flares of asthma, hip pain, headache and paresthesia. On 25-SEP-2018, the patient made a visit to a hospital emergency room and received unspecified treatment for headache. On 27-SEP-2018, patient made a visit to the emergency room again and received unspecified treatment for allergies. The patient had laryngoscopy on an unspecified date without any result provided. The outcome of the events was reported as not recovered/not resolved. The causality assessment was not provided. The reporter considered all the events to be serious for the following reason: potentially life threatening.
that he received PNEUMOVAX 23 at age 53 years old and PREVNAR at age 60 years old.; that he received PNEUMOVAX 23 at age 53 years old and PREVNAR at age 60 years old.; no adverse effect reported; This spontaneous report was received from a pharmacist via a company representative, regarding himself, a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.  On an unspecified date, the patient received a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered for prophylaxis at age of 53 years old (route, dose, location of administration, lot # and expiration date were not reported). On an unspecified date, the patient received a dose of pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) (Interchange of vaccine products) (route, indication, dose, location of administration, lot # and expiration date were not reported). No adverse events were reported.   The outcome of interchange of vaccine products and the causal relationship between the event and both vaccines were not provided.
This case was reported by a nurse practitioner and described the occurrence of neck and shoulder pain in a 41 year old male who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt received his first injection of Engerix B (5373B6) on an unspecified date. On 7/03/03, an unspecified time post-immunization, he reported pain in his neck and shoulder. He stated that he "cannot attribute the pain in any activity."
Correct medication & patient, incorrect dosing interval. 3rd dose (initial booster was administered 3/19/2022). 4th dose (2nd booster) was administered today (2.5 months after last dose) in error rather than appropriate time interval of 4 months after previous booster. No adverse effects reported at this time.
Initial report was received from a consumer, who was also the patient, on 16 October 2012. A 79-year-old female patient had received an intramuscular injection in the right arm of FLUZONE HIGH-DOSE (lot number not reported) on 18 September 2012. The next day, on 19 September 2012, the patient had right arm, hand and foot numbness and tingling. She went to the emergency room (ER) and was told she had "parathesia". She went back to her doctor and is waiting for her to call back. The patient had no illness at the time of vaccination, an allergy to penicillin (PCN) and a past medical history of diabetes. The patient had "many doses" of Influenza Vaccine in the past. The patient's outcome was not recovered. Documents held by sender: None.
Headache, Myalgia, Arthralgia & NauseaVomiting  Narrative:
Erythema and wheal formation site of injection few minutes <10 min's of administration of PROQUAD. Left thigh. Rx Diphenhydramine PO in clinic.
50hr p/vax mom reported redness to site of Td inj;54 hr p/vax pt was seen by MD redness was medial to inj site-swelling inc to 5cm x 10cm;hardness, warmth to area-painful to touch & spreadding rapidly;tx w/pred, DPH & keflex-16 hr later;
I can't move my arm/can't bring my arm up to my breast and obviously over my head/this really limits my mobility; it was that upper joint area that was throbbing; couldn't sleep much because it was excruciating; extreme pain in my shoulder/excruciating pain in my shoulder/that top part, that ball and socket was excruciating to move; Vaccine given too high up in my arm/it felt like it was going into my bone at the top; Chills; my whole arm hurt/it's excruciating when I attempt to be mobile; A spontaneous report was received from a consumer (United States) concerning herself, a 72-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273), who experienced the following events: I'm concerned it was given too high up in my arm/it felt like it was going into m y bone at the top/MedDRA PT: inappropriate route of vaccination, that top part, that ball and socket was excruciating to move/MedDRA PT: joint pain, I can't move my arm/can't bring my arm up to my breast and obviously over my head/this really limits my mobility/MedDRA PT: injected limb mobility decreased, chills, my whole arm hurt/it's excruciating when I attempt to be mobile/MedDRA PT: pain in arm, couldn't sleep much because it was excruciating/MedDRA PT: sleep difficult, it was that upper joint area that was throbbing/MedDRA PT: throbbing pain, band ack to the same pain I had after the injection/MedDRA PT: shoulder pain.   The patient's medical history included cancer and child birth x 2. Concomitant medication use was not provided.   On 03 Feb 2021, the patient received the first of two planned doses of mRNA-1273 ([LOT 029L20A]) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Action taken with mRNA-1273 in response to the events was not reported.   The even of  "a couple of patients received their dose at 7 hours" was considered recovered/resolved (date unspecified).; Reporter's Comments: This case concerns a 72-year-old female who had NS unexpected Incorrect route of product administration and NS unexpected injected limb mobility decreased, painful arm, throbbing pain, insomnia and NS expected arthralgia, chills. The events occurred the same day as first dose of mRNA-1273. Treated with Tylenol. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Syncope s/p HPV vaccine, pt was sitting post vaccine administration when she became faint, also had 1 episode of emesis, VS were stable. Pt was advised to lay down, did not have breakfast, once stable, started hydration. Recovered in 15 min.
Pt had fever and cough on 10-30-14, seen in urgent care 10-31-14. No improvement so seen in my office 11-4-14 w/persistent fever and found to have clinical pneumonia. Pt had increased RR and 02 sat 94% RA.
smelling cigarette smoke; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (smelling cigarette smoke) in a male patient of an unknown age 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 PAROSMIA (smelling cigarette smoke). At the time of the report, PAROSMIA (smelling cigarette smoke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  Treatment medication was not provided by the reporter
pt recv vax 18OCT95 & by 19OCT95 230AM pt presented to ER w/a high fever,h/a & generalized maculopapular rash;no further details known as of the date of this report
Urgency and frequent need to urinate.  Felt like I had a UTI but got urine culture at minor emergency clinic  and had no infection.  Another friend happened to have a vaccine the next week and said she had the same symptoms afterwards!  No UTI found for her either!   I think that a lot of people may have this and just not put the two together.  I would not have linked it to the vaccine unless my friend had not happened to have the same symptom!  Please investigate with other people who have Covid vaccine!
She have her first dose of the COVID vaccine; She had a positive COVID test; She have her first dose of the COVID vaccine; She had a positive COVID test; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age reported she received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported she have her first dose of the covid vaccine; and had a positive covid test on 31Dec2020. The patient underwent lab tests and procedures which included COVID test: positive on 31Dec2020. The event outcome was unknown.  Information about lot/batch number has been requested.
numbness & weakness in lt hand x 3 wks p/vax; went to ER & was splinted;
Abdominal pain, chest pain, under left breast pain, shortness of breath, nausea, fatigue, dizziness, feeling faint, vision problems, cluster headaches, upper and lower back pain, numbness in limbs, feeling very cold majority of the time, heart racing/pounding/fluttering, losing my vision when I stand up
severe respiratory issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001225 (Novavax).  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary series of immunization completed, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: RESPIRATORY DISORDER (hospitalization), outcome "unknown", described as "severe respiratory issues". Clinical course: had severe respiratory issues, was hospitalized, and ended up in the ICU (Intensive Care Unit). The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Developed a raised itchy rash on the top of my right foot. Blister type welts, bumps. Went to my doctor and he gave me a cortizone injection to clear the rash and Dovate cream to apply to my foot.  A week later the rash was worse on top of my foot and welt type blisters, itchy bumps formed on my fingers and hands, like warts. Red rash on top of my hands.  A red rash appeared on my stomach and under my arms, itchy and raised rash.  I went to the doctor again and he prescribed Prednisone tablets and Travacort cream to apply and Rupanase antihistamine tablets.
This spontaneous report received from a nurse regarding multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (Merck) lot # L030586, expiry date: 10-FEB-2017 (dose, route and frequency: unknown). No adverse effects were reported. There was no product quality complaints (PQC). This is one of the several reports from the same reporter. Follow up information was received on 30-DEC-2015. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 4 year old male patient. On 11-JAN-2016, the patient was vaccinated with PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient, product, event and narrative were updated.
My symptoms were like hay fever.  I had sneezing, runny nose sore throat, fatigue. I thought because it was pollen season that was the cause. I was scheduled for a procedure at clinic and the did a routine COVID-19 screening. I had symptoms for that entire week before but they were mild.  I was prescribed Paxlovid. I lost my sense of smell right before I started the Paxlovid.
Pain, redness, and swelling at injection site 5cm circumferential area of light erythema, swelling, tenderness on exam. Treatment: MEDROL dose pak and cephalexin 500mg x 7 days.
Information has been received from a physician concerning a 13 month old female who on 02-DEC-2008 was vaccinated with ROTATEQ vaccine. concomitant therapy included INFLUENZA vaccine (unspecified) and POLIOVIRUS vaccine (unspecified). The physical stated that the patient was administered with the third or possibly thee fourth dose as the family went from another practice without accurate records. Additional information has been requested. Follow-up information has been received from a physician concerning the patient who was supposed to be vaccinated with PREVENAR and on 02-DEC-2008 orally received ROTATEQ (LOT #662732/1100X) instead. No symptoms or problems were reported. No further information is available.
Child presented with rash on arms, legs, and face. Rash began on Tuesday 2-19-08, positive for itching.