chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have like hives or rash or something from my elbow down to my hand not solid but there are several spots; This is a spontaneous report received from a contactable consumer (patient). A 66-Year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: EN6201, Expiry Date: 30Jun2021) via an unspecified route of administration on 23Feb2021 (at the age of 66-year-old) as a single dose for Covid-19 immunization in hospital. The patient medical history and concomitant medications were not reported. On 24Feb2021, patient reported that she had like hives or rash or something from elbow down to hand not solid but there are several spots. The outcome of the event was unknown.
GAVE MENVEO AS A 3RD DOSE INSTEAD OF BEXSERO FIRST DOSE; First dose at 11 / booster / prior to / incident / gave the patient a / (third dose); This case was reported by a other health professional via sales rep and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AXMA44A, expiry date 1st March 2022) for prophylaxis.   Previously administered products included Menveo (1st dose received on an unknown date at the age of 11 year old) and Menveo (2nd dose received on an unknown date at a visit prior to the date of the incident, was the booster dose,when they were in high school for the school rule compliance.).   On 3rd August 2021, the patient received the 3rd dose of Menveo .5 ml. On 3rd August 2021, unknown after receiving Menveo, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.  Additional details were provided as follows: The patient received 3rd dose of Menveo instead of Bexsero 1st dose, which led to wrong vaccine administered. The patient returned to get a dose of Menningococcal B at a later visit, but the nurse gave the patient a Menveo (would be their third dose) when she should have given the patient a dose of Bexsero, which led to extra dose administered. The reporter consent for follow up was unknown.
Started as a slight headache and soar arm and increased  to a pulsating headache with so much pressure it caused me to vomit, arm swelled a little with 2 red spots and pain increase quite a bit at spot the shot was given and arm was shaking a bit and hurt to put it straight. Headache persisted for almost 8 hours and felt immense pressure, hurt to keep my left eye open when headache was at its most severe. Took 2-Excedrin  extra strength and a hour later took 4-200mg ibuprofen. The pressure from the headache started to subside and it getting better now. When finally open my left eye again it was blurry and unable to focus for about 5 mins
Myalgia posterior neck stiffness Narrative:  Roughly 25 minutes after receiving the Pfizer Covid vaccination, employee reported posterior neck stiffness while still being observed in the vaccination clinic. She was observed for the full 30 minutes as she had had prior allergic reactions to shrimp and eggs. After 30 minutes, she was escorted to the Occupational Health clinic for further evaluation. Vital signs checked in Occupational Health: HR 85, RR 18, BP 137/79, sats 96% on RA. No shortness of breath, itching, or rash noted.
This spontaneous report was received from a physician refers to a 2 years old patient. The patient was vaccinated with the first and second dose of VAQTA (dose, route, lot # not reported) respectively on 20-MAR-2012 and  28-AUG-2012. It was reported the "2nd dose of VAQTA was administered to a patient 3 week early". There was no adverse reaction. Additional information has been requested.
About 5 hours after receiving the covid vaccine I started to feel flustered.  My chin felt hot and a little itchy.  When I looked in the mirror my chest from shoulder to shoulder was red and it looked almost like a prickly heat rash and was slightly itchy.  About an hour later it wasn't as red on my chest.  My chin still is red and feels irritated (like sunburn).  I don't know how else to describe it.   I tried calling Pfizer and no one answered.  I called CDC but the agent was of no help and didn't have any info that I didn't already have.
Severe vertigo beginning the morning of 3/20 (three days after vaccination). Anomic aphasia on the morning of 3/22. Consulted a doctor; per doctor's advice, went to ER. Aphasia resolved by itself after several hours; it had been progressively improving over the course of the day. Vertigo was treated with diazepam and resolved completely. Admitted to hospital overnight for testing. Discharged from hospital on 3/23; several hours after that, had a severe migraine (with no previous history of severe migraines). Migraine eventually resolved a week later.
10:10 am - Sx onset - dizziness, hand tremors 10 min after vaccination. Placed in supine position BP-130/78, P-96, BS 93. 10:40 no change, general malaise. 50mg BENADRYL given as precaution. 11:30 Sx better. 1 pm - felt nl again.
See attached page 9/28/2020, admitted to intensive care at Medical Center CT - no-acute abnormality MRI with and without contrast - normal Lumbar Puncture - negative EEG on 9/30 - Abnormal COVID 19 - negative CXR - negative labs drawn
None at this time.  However, I do not plan on getting the third injection which was due in August 2008.  Date of first vaccination is estimated.
Hi I finally got my first SHINGRIX vaccine on Wednesday 3/20. I got the expected sore arm and local redness and swelling. I also got fatigue and malaise. What I did not expect was a rash all along my shoulders, neck itching and sensitivity on my upper back like open sores. The rash is gone. The itching persists on my back and is sensitive.
Patient was given a Covid 19 dose that had been at room temperature approx 23 hours.
arm very sore - unable to lift arm. Doctor said infection - fever 100 to 102, chills, severe aching, light headed, heart racing, arm very red all over upper arm.
I received Shingrix (first dose) last Friday (11-Oct-2019). Just 2 hours post vaccination I started feeling very tired and feverish (although temp was normal) and very strong pain at site of injection. 24hrs later the flu-like symptoms worsen as well as the pain. Today (3 days post vaccination) I am feeling better but my shoulder is much more swollen and now I have a very hot, erythematous, and painful lesion that covers almost 12 cm my right deltoid area. I have been taking since Saturday night (>24 hours post-vaccination) Paracetamol 1g + Ibuprofen 200mg every 6 hrs. I will start putting cold patches on my right deltoid area to help decrease the inflammation and continue the anti-inflammatories PO as above.
27 months old received Kinrix; Kinrix instead of Infanrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 27-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix (received 3 doses of Infanrix on an unknown date).   On 9th December 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 9th December 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Dec-2022 Reporter's comment: The reporter reported that a patient inadvertently received a dose of Kinrix instead of being given Dtap (Infanrix) and wanted to know how to proceed.  Details for the adverse event were collected except for the patient's name.  The vaccine information was given. The vaccine administration facility was the same as primary reporter. The call was forwarded to second line. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix instead of being given Dtap (Infanrix) at inappropriate age, which led wrong vaccine administered and inappropriate age at vaccine administration.
Patient came to hospital with shortness of breath and chest pain. She was diagnosed with PE and Covid. She was treated with heparin oxygen and nebulizers. pt discharged home
Fatigue starting around 6 PM on 1/20, chills shortly after.  Extreme chills until about 2:30 AM on 01/21. Dizziness/feeling like blacking out around 5 AM on 01/21. Fatigue/headaches all of 01/21.
The site of the injection, LDT, became warm with a dull ache, and it spread to his neck and mouth. His mouth became tingling, up to his left eye. This lasted for about 20 minutes, and began about 5:00 pm. Later he noticed the whites of his eyes were both red, itchy and watery. He also c/o general malaise, which lasted until the next day. Before patient went to bed he did take 1000mg Tylenol.
Initial night - headache, muscle aches, nausea, arm soreness, and fever. Intense shivering as well as feeling both too hot and too cold. Near inability to sleep. Second day - headache, muscle aches, weakness, fatigue, nausea, arm soreness, fever (101.3 oral), and elevated heart rate (resting pulse of 120 - my normal is 80-90). Sensitivity to temperature but milder than the previous night. Was able to sleep through the night. Third day - most symptoms have subsided or are mild. Mild headache.
Fever and flu type symptoms, aches,  sore throat,  difficulty swallowing & breathing, swelling up of throat, face, and eyes, mucus pouring out of eyes, chills.
09/07/22 presents to ED for "shortness of breath". PMHx of "class III congestive heart failure, TIA, hypertension, type 2 diabetes"
(had a shingles shot in 2015 - no issues) this new shot - extreme temperature and pain to touch at injection site for 5 days / I felt out of it / no energy tired/ slight headache / stomach upset joint aches left side of body / trouble focusing  I have never had a shot reaction like this before in all my years. I have grave concerns regarding getting dose 2 of this vaccine. I need to know why I had such an adverse reaction and if it safe for me to take dose 2. My hope is that others are not impacted as I was and that this medication is analyzed and deemed truly safe for use.
Body Aches , Fatigue, Head Aches, Fever 101.7 until 11/3/2019 AM
I experienced a breakthrough case of COVID-19 with congestion, cough, body aches, fatigue and chills.
No adverese event reported.   It is already reported that the vaccine was used on the same day that the Bivalent Covid-19 Vaccination was stopped. When we informed the staff, this person had been vaccinated.
50 y/o female who received TDAP in her RUE; does not recall anything unusual regarding site administration or technique. Noted soreness, some redness and swelling with onset a few hours post-vaccination, but by 48 hours post-vaccination, she was experiencing significant pain. Area of redness and swelling was about the diameter of a golf-ball; swelling and redness gradually improved and resolved within 1 week post-vaccination. Denies significant systemic symptoms such as fever, generalized body pain, fatigue or headaches. Reports feeling well on day vaccine receipt. Pain at its peak was 10+/10 on pain scale; pain primarily limited to R) shoulder area and upper arm; pain significantly increased with AROM. Patient self treated with CELEBREX with minimal-moderate relief. Pain significantly limited ROM and patient was unable to carry out ADLs. Denies numbness and tingling. No R)UE weakness. No prior history of R)UE injury or trauma; no previous history of R)UE pain. Has had rotator cuff surgery on her left shoulder and does not feel current pain in R)UE is similar to that pain. Exam on 12/23 notes: R)UE - tenderness on palpation of deltoid muscle. Pain elicited by motion of the shoulder with a painful shoulder arc. Shoulders appeared normal; no muscle spasms. No instability of shoulders noted. No shoulder weakness. Pain on active ROM (+ Hawkins) and right bicipital tenderness. Dx - joint pain, localized in R) shoulder - biceps tendonitis vs rotator cuff tendonitis with referral to PT (pending) and CELEBREX prescribed.
The evening of the vaccine andthe  next day, I had the typical symptom of slight headache, sore arm, tiredness that I have had with all my prior Moderna Covid vaccines. (My prior Moderna vaccine was May 2023).   On Day 3, I started getting a terrible throbbing headache that was debilitating.  I also had pain in my shoulder, neck and upper back.   I took 2 extra strength Tylenols and the severe pain improved,  but I still had a low grade headache.  The body aches improved.  However from this day forward until Day 6, the severe headache came back immedialty after the Tylenol wore off.  I was taking Tylenol 24/7 and not sleeping much, waking up with headache pain.  I tried a heating pad on my shoulder, neck and back but that did not help.  On Day 6 (Saturday 10/28), my PCP told me to go to the ER and get a Head CT Scan to see what was going on. At that point I was still taking 2 Extra strength Tylenol every 6 hours 24/7.  I went to the ER and got a CT Scan with and without contract (results below). I was treated with 10mg of Dexamethasone  (Decadron) and sent home.  I have not had a sever hadache and this is Day 7.  Diagnosis-   Migraine without status migrainosus, not intractable, unspecified migraine type
redness 7 cm x 9 cm at site of injection, aching in that arm, warmth to area  Instructed to take Ibuprofen or Tylenol, Benadryl  and apply ice pack
This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown (booster), 0.2 ml single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious), outcome "unknown" and all described as "a dose of orange cap formulation being provided to 1 patient without dilution. 0.2 ml volume provided resulting in a dose higher than intended". Additional information: The reporter classified the event as non-serious. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe pain running from shoulder to thumb,  limited range of motion, for 3 weeks now, Tylenol 8, hot and cold compresses,
Pfizer 6/1/21 and 6/22/21. Positive on 1/13/22
Dizziness described as a swaying sensation. Swollen eyelid. Dizziness/sway has not gone away. Also off balanced and visual axis is now tilted.
11/09/09-second seasonal influenza vaccine administered. 11/13/09-first H1N1 vaccine administered. 11/14/09-lethargic but played in AM. Temp 101.9 axillary at 4:30 AM. 11/15/09-temp 102.4 but walking, later in evening developed febrile seizures and was intubated at hospital. Flown to another hospital and admitted to PICU.
No adeverse event; patient was administered a dose of the Moderna COVID-19 monovalent vaccine instead of the Moderna bivalent vaccine as his booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient was administered a dose of the Moderna COVID-19 monovalent vaccine instead of the Moderna bivalent vaccine as his booster dose) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient was administered a dose of the Moderna COVID-19 monovalent vaccine instead of the Moderna bivalent vaccine as his booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient was administered a dose of the Moderna COVID-19 monovalent vaccine instead of the Moderna bivalent vaccine as his booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient was administered a dose of the Moderna COVID-19 monovalent vaccine instead of the Moderna bivalent vaccine as his booster dose).    No concomitant medications were provided.  A patient was administered a dose of the Moderna COVID-19 monovalent vaccine instead of the Moderna bivalent vaccine as his booster dose. He received the correct dosage of 0.5 mL, but an incorrect product. Patient has not reported any adverse reactions at this time. No treatment information provided.
mom stated pt recv vax 8JUL98 & then fell asleep several hr later;unable to awaken pt for additional 24hr, ate very little;possible hyotonic hyporesponsive episode;
pt recvd vax & w/in 24hrs p/vax exp puffy,swollen,edematous & painful lt hand which had pitting edema;was eval in ER;found that swelling was secondary to lymphatic swelling;Motrin prescribed for pain;also exp flu-sx,myalgia,arthralgia
Approximately 12-24 hrs after receiving flu shot pt experienced swelling/redness/warmness/no bumps/rash at the site (about 2" in diameter)
Ear pain; Vertigo; Facial pain/freezing pain; Ear noise/Tinnitus/continuing sounds like water in right ear; Facial pain -burning; Ear pain and noise -escalating to Migraines; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the right arm on 04Feb2021 at 07:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included numerous autoimmune issues, drug allergy (allergy to versed, codeine, morphine, cymbalta and nitrous oxide) and latex allergy. The patient received unspecified medication for unknown indications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks of vaccination. The past drug history included codeine, versed, morphine, cymbalta and nitrous oxide had taken from on unspecified date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Feb2021 at 09:00 the patient experienced ear pain, vertigo, facial pain/freezing pain, ear noise/continuing sounds like water in right ear, tinnitus, facial pain -burning and ear pain and noise -escalating to migraines. It was reported that the events had resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events included PT (physical therapy) which was ongoing and the patient was referred to specialist. On an unknown date, the patient underwent CT (computed tomography) sinus and the result was unknown. The clinical outcome of the events ear pain, tinnitus, vertigo, facial pain/freezing pain, ear noise/continuing sounds like water in right ear, facial pain -burning and ear pain and noise -escalating to migraines was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
0900 c/o ringing in ears followed by tightness in throat followed by lightheadedness;no wheezing;no noticable diff breathing;pt felt better p/20-30min
Some very bad gout; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On an unspecified date, the patient had some very bad gout. The outcome of the event was unknown. The reporting nurse would want to give the patient indomethacin for the gout, and wanted to know if it will be safe.  Information about lot/batch number is requested.
No additional adverse ffect reported; The patient received one improperly stored dose of VARIVAX; This spontaneous report was received from a nurse prescriber concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions and drug reactions or allergies.     On 06-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # S028920, expiration date 16-SEP-2021 for prophylaxis (dosage schedule, anatomical location and route of administration, were not reported) (product storage error). The sterile diluent was stored properly.   The administered dose of the vaccine experienced a temperature excursion 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.69 degrees Fahrenheit) for 1 second and 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.81 degrees Fahrenheit) for 28 minutes, as recorded by a data logger. There was no adverse effect reported.
Information has been received from a health professional concerning a 5 year old female patient who on 04/19/1997 was vaccinated with a dose of Varivax. On 01/08/02, the patient developed a mild case of papular lesions resembling varicella. It was reported that there were approximately a dozen lesions She was afebrile and no other symptoms were noted. The patient sought unspecified medical attention, but was not seen in the office. Additional information has been request.