chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her daughter, who on 10-JUN-2009 was vaccinated with the first dose of GARDASIL. The patient was not able to received the second dose as required because was sick. The patient received the second dose of GARDASIL on 10-OCT-2009. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. No further information is available.
The plunger component of the syringe was completely stuck. He was unable to push the vaccine through the needle to administer to the patient; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE ISSUE (The plunger component of the syringe was completely stuck. He was unable to push the vaccine through the needle to administer to the patient) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032218) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection (batch no. 3032218) for COVID-19 prophylaxis.    No Medical History information was reported.   On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (The plunger component of the syringe was completely stuck. He was unable to push the vaccine through the needle to administer to the patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE ISSUE (The plunger component of the syringe was completely stuck. He was unable to push the vaccine through the needle to administer to the patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (The plunger component of the syringe was completely stuck. He was unable to push the vaccine through the needle to administer to the patient).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (The plunger component of the syringe was completely stuck. He was unable to push the vaccine through the needle to administer to the patient).    No concomitant medications were provided.  The pharmacist technician was calling about defective dose of Spikevax PFS (with blister pack). Upon administering the dose to the patient on 1Nov2023, the plunger component of the syringe was completely stuck. He was unable to push the vaccine through the needle to administer to the patient. He had to open a new one. The HCP confirmed that he used a different syringe with same lot number (3032218) to administer the dose to the patient. He did not use any of the dose that was in the defective syringe, but he did inject the patient with the needle. He was requesting a replacement for the defective syringe.   The Device problem code for Spikevax syringe include FDA code, agency code which include Defective Device.  The device was malfunctioned, and the malfunction type.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2023: Live Follow up received contains PQC report that includes reference number added.
needle inserted and vaccine leaked out around hub, less than 50% injected. inspected device and needle had not been completely screwed on
Cough; has a metallic taste in her mouth; This is a spontaneous report from a contactable consumer (patient) reported that a 76-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number and Expiration Date unknown) via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation.  The patient's medical history and concomitant medications was not reported.  Patient was getting a cough and has a metallic taste in her mouth in Jan2021. Wanted to know if it was from the vaccine or Covid. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Underage recipient received dose 1 in two dose series. (16 at time of administration)
muscle ache; pain; low-grade fever (99.9 °F); This is a spontaneous report from a contactable consumer (patient) Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 10Feb2021 (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose last February 10th and scheduled for her second dose tomorrow (March 3rd). She tested negative for the Rapid COVID-10 test and no symptoms anymore. On unspecified date, last week, she had muscle ache, pain and low-grade fever (99.9 °F). She was still waiting for the result of her second COVID-19 test. She wanted to know if she can get the second dose tomorrow. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
14 minutes post vaccination the  individual complained of dizziness and itching in her throat.  Vitals signs were obtained, including oxygen saturation,  the individual was assessed my a medical provider and orders were given to administer 50 mg of Diphenhydramine IM.  The individual was monitored for 30 additional minutes. After 30 minutes vitals were obtained,  the individual denied any symptoms. Individual was instructed to follow up with primary care provider.
Day after vaccine administered pt felt swelling & discomfort in (R) axilla & heaviness in (R) arm with tingling of (R) hand.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 30-AUG-2016, the patient received a dose of improperly stored ROTATEQ (lot # M019691, expiry date: 02-NOV-2017). Excursion: 1.3C for 77 minutes cumulatively. Data logger was involved. No adverse effects reports. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Feeling lightheaded and kind of dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling lightheaded and kind of dizzy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Feeling lightheaded and kind of dizzy). At the time of the report, DIZZINESS (Feeling lightheaded and kind of dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
An LVN received a bottle of undiluted Pfizer Pediatric COVID Vaccination in the morning from the RN.  When there were no more doses left after four doses were given, this was report to the RN.  There were no adverse reactions observed or reported in the patient observation area today.  This medication error was reported to me and immediately escalated to our director at 9:15am.  The nursing director advised us to contact the Infectious Disease Physician for next step.  Dr advised contacting Dr, Pedicatric Infectious Disease.  Dr informed that four patients received 0.75mcg instead of 0.3mcg of Pediatric Pfizer vaccination this morning.  Dr consulted:  1. No particular action to be done at this point except to contact the parents and make them aware to monitor for the same potential side effect (fever, headache, etc.).   2. Reassure parent/guardian that their child received a lower dose than a teen or adolescent would have received, even with this extra dose.   3. Patient is at higher risk for these reactions, but he is not particularly concerned from a vaccine standpoint.   4. If patient experiences any significant side effects, have physician evaluate.   5.  Continue with second dose as usual, unless strong reaction from this dose.
The patient stated that the next day the patient had swollen glands, chest pain and nausea. The patient told the doctor at the facility where she works and the doctor prescribed anti-biotics for reaction.
Fever in afternoon, aching during night & into next day. Rash began after second day turning into shingles.
aneurysmal subarachnoid hemorrhage 10/10/22, presented to hospital 10/12/22 IR stent assisted embolization of aneurysm 10/13/22 vasopressors required 10/14/22 for symptomatic vasospasm
Severe case of varicella, with lesions in conjunctive and pharynx. Lasted 10 days with school absences.
DOUBLE DOSE RECEIVED; This spontaneous report received from a pharmacist concerned a 53 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 09-MAR-2021, and dose was not reported. The batch number was not reported and has been requested, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-MAY-2021, the subject experienced double dose received. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of double dose received was not reported. This report was non-serious.
Client reports redness in the lateral lower portion of her right upper arm on 2/14/08 in AM.  Upon observation of the arm on 2/15/08 at 2:45PM, this same area was tender, red, swollen (approximately 6 inches in diameter) and hot to the touch.  Client's M.D. diagnosed Cellulitis and prescribed antibiotics later the same day, per client.  As of 2/20/08, client's mother reports symptoms have subsided and no other problems.
Patient reported pain in arm/shoulder. She stated the pain started in her wrist after getting the vaccination and today her arm hurts. No fever reported.
Significant arm pain that has lasted 3 days now. Tylenol not effective in touching the pain. It is difficult to move my arm.
-swelling and pain in lymph nodes in neck beginning 1 day following first vaccination, lasting about 3 weeks - a couple recurrences of same symptoms every 4-5  months for no apparent reason, lasting about 1 week.  No other symptoms or illness at the time of recurrence.
ITP-  extreme low platelet count.  7k count at Hospital 8-22-2018.   Extreme bruising, bleeding in mouth, petechiae all over (mouth, neck, head, groin)  Bruising happened very quick-24hours
Fever of 101.8 for 18 hours; Chills and body aches for 2 days; Chills and body aches for 2 days; Red around injection site starting at about 5 across. The area is slightly raised and hot to touch. Sore and itches. It is 5 days later and about 3 across now.; Red around injection site starting at about 5 across. The area is slightly raised and hot to touch. Sore and itches. It is 5 days later and about 3 across now; Red around injection site starting at about 5 across. The area is slightly raised and hot to touch. Sore and itches. It is 5 days later and about 3 across now; Red around injection site starting at about 5 across. The area is slightly raised and hot to touch. Sore and itches. It is 5 days later and about 3 across now; This is a spontaneous report from a contactable consumer reported for herself. A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809), dose 1 via an unspecified route of administration, administered in Arm Right on 24Feb2021 13:45 (at the age of 68-years-old) as a single dose for covid-19 immunization. Medical history included sinusitis, immunodeficiency common variable, covid-19. The patient previously took aspirin [acetylsalicylic acid] and ibuprofen and experienced drug hypersensitivity. The patient received pneumococcal vaccine for immunisation on left arm on 09Feb2021 within four weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Feb2021 23:30, the patient experienced fever of 101.8 for 18 hours. Chills and body aches for 2 days. Red around injection site starting at about 5" across. The area is slightly raised and hot to touch. Sore and itches. It is 5 days later and about 3" across now. The patient did not receive any treatment. Outcome of the event fever was recovered on 25Feb2021 17:30; chills and body aches was recovered on 27Feb2021; while rest other events was recovering.  No follow-up attempts are possible. No further information is expected.
head cold; nose running; stuffy; sneeze; This is a spontaneous report from a contactable Nurse. This nurse (patient) reported that the (Age:59; Unit: Unknown) female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient reported that "I got my first Covid vaccine on 21Dec. Today is three weeks and I am scheduled for my second shot.  I have a head cold: nose running, stuffy, and I sneeze. I don't have Covid- I was tested and I'm negative. Its not my allergies. Its just a head cold.  Can I get my second dose?  No one can give me an answer." The outcome of the events was unknown.   Information on the lot/batch number has been requested.
4 hours post injection, swelling and intense pain at injection site (Deltoid muscle) right arm. 24 hours post injection severe diarrhea that was uncontrolled for 12 hours.  24 hours post injection AFIB was present . Very high irregular heart rate and elevated BP. Controlled with Toporol 12 1/2 ml and 30 ml Diltiazan every 20 minutes until normal heart rate returned.
Caught Covid. Symptoms were mild and only noticed because I lost sense of taste and smell. This cured in last week of September 2021.
Patient had vasovagal reaction to vaccination.  Pt was picked up at the vaccination station w/ BP 61/33, HR 40 near syncope.  Patient stable after lying on gurney.  Prior to D/C, BP 126/76, HR 69, RR 18.  patient stable and released from vaccination site.
I initially had to sit down for about 15 min and felt my mouth dry, my tongue was kind of tingling, not swollen. I was checked for anaphylactic shock. I felt like an adrenaline shock, and felt my heart racing, my BP was high - stayed in the ER for an hour for observation. I felt the same kind of sensation when I had COVID in July. This morning, had chills early in the morning around 1AM but it is all gone now.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on arm), PERIPHERAL SWELLING (swelling on arm), HYPOAESTHESIA (numbness all over her body), MUSCULOSKELETAL DISCOMFORT (heaviness on the back of her neck) and LIMB DISCOMFORT (heavy on her feet) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (headache). On 12-Feb-2021, the patient experienced INJECTION SITE RASH (Rash in form of blotches around the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness on arm), PERIPHERAL SWELLING (swelling on arm), HYPOAESTHESIA (numbness all over her body), MUSCULOSKELETAL DISCOMFORT (heaviness on the back of her neck), LIMB DISCOMFORT (heavy on her feet), LIMB DISCOMFORT (wobbly) and ASTHENIA (weakness). At the time of the report, PAIN IN EXTREMITY (soreness on arm), PERIPHERAL SWELLING (swelling on arm), HYPOAESTHESIA (numbness all over her body), MUSCULOSKELETAL DISCOMFORT (heaviness on the back of her neck), LIMB DISCOMFORT (heavy on her feet), LIMB DISCOMFORT (wobbly), ASTHENIA (weakness), HEADACHE (headache) and INJECTION SITE RASH (Rash in form of blotches around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Antibiotics were used on 15-Feb-2021 for the rash.   Reporter did not allow further contact
No additional AE; Practice coordinator calling to report administration of expired RECOMIBAXHB to an adult patient.; This spontaneous report was received from a practice coordinator, referring to an adult patient of unknown exact age and gender. Information regarding the patient's medical history, concurrent condition and concomitant medication was not provided.  On 05-APR-2023, the patient was vaccinated with expired dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) thimerosal free (1 mL, once, lot # T041337, expiration date 25-JAN-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). There was no symptomatic adverse experience (No adverse event). No temperature excursion in product lifetime confirmed.
This spontaneous report was received from a healthcare professional refers to a patient of unknown age. On 25-JUN-2013, the patient was vaccinated with a dose of GARDASIL,(lot # H012973, expiry date 05-MAR-2015, route was not reported) which may have been improperly stored at 8.5 degrees celsius to 9.1 degrees celsius for 720 hours. No adverse event was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
? and slept almost 24 hours and temperature 101. Re-examined 12/6, neuro stable, no infection to explain, suspect vaccine reaction
Client reported vomiting x2 last night.  RT arm red, tender. Swelling rt side of neck and shoulder. Encouraged to see DR.
Moderna COVID-19 Vaccine EUA  body aches, chills, sore throat, cough, fever, running rose
Seems to more easily bleed now. And I don?t not heal easy like I used to.  Harder to stop bleeding.
bad cough, still has mucus coming up; Upper Respiratory Infection; Suspected Vaccination failure; RSV; Sick; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included asthma.   In AUG-2023, the patient received Arexvy. On 03-SEP-2023, between 2 and 4 weeks after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: RSV) and sickness (Verbatim: Sick). On an unknown date, the patient experienced productive cough (Verbatim: bad cough, still has mucus coming up) and upper respiratory tract infection (Verbatim: Upper Respiratory Infection).  The patient was treated with ciprofloxacin (Cipro). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection, sickness, productive cough and upper respiratory tract infection were not resolved.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, sickness, productive cough and upper respiratory tract infection to be related to Arexvy.     It was unknown if the company considered the vaccination failure, respiratory syncytial virus infection, sickness, productive cough and upper respiratory tract infection to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-SEP-2023 Customer was a female patient that received the Arexvy vaccine the 3rd week of August, 2023 (no specific date provided) and reported that she had been sick for a month, beginning 3-SEP-2023 through today had RSV, which was diagnosed by a doctor with an upper respiratory infection, a bad cough, and still had mucus coming up. Customer said she had been debilitated from having RSV, and was taking Cipro twice a day (unknown product information) to keep from getting pneumonia. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming RSV were unknown at the time of reporting.
Moderna COVID-19 Vaccine EUA Booster: Injection site tenderness, swelling and tenderness of lymph nodes underarm in same arm (size of of goose egg), fatigue, muscle ache, joint pain and stiffness, for two days following shot. Third day lymph swelling underarm reduced by 50%, with minimal fatigue and stiffness.
Learned that Moderna had been approved, believed it to be from CDC when i was from a committee however. Patient did reported temporary dizziness. We've called to check on him a few times that day and the day after. Patient said it was temporary , he felt better as the day went on.
8AUG93 @ 1055AM pt fainted p/leaving the vax site; pt stated had never had prev react to any vax; pt was placed in a supine position prior loss of consciousness; Vital signs BP 80/50, P50, resp 18 @ 1110AM BP 80/50, P60, Resp 19;
I was initially sick to my stomach so I went to bed early.  I suddenly received a severe bout of vertigo, which I had never experienced before. My bed seemed as if it was turning and falling, the whole room seemed to spin.  I closed my eyes to try to stop the spinning, but it continued and I felt like I was going to get sick. This happened several times during the night if I turned my head.  I tried not to move during the night.  I do not know if it had anything to do with the vaccine, but since I had taken the vaccine that morning and had never been sick like that from taking the Influenza Vaccine, or any other time,I thought I would report it.  The next day, (today) I am a little dizzy but nothing like how I felt last night.    I did not go to the hospital or doctor and probably won't unless I get another case of the severe dizziness.
Pt recd 2 vaxs (1cc); 1st dose, either May or June, was uneventful; p/2nd dose, either June or July, "developed pain on breathing ('pleurisy')"; no rx given; Pt "got better w/in a few days (?)"; 3rd dose not given; p/2 doses neg Ab test;