chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The initial case was missing the following minimum criteria: Unspecified adverse event. Upon receipt of follow-up information on 26Aug2016, this case now contains all required information to be considered valid. This is a spontaneous report from the Pfizer-Sponsored Program. A contactable consumer reported a currently 76-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on May2015 at single dose for immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced extreme weakness in all muscles like having severe flu was worse for 10 days and extreme pain in muscles on an unspecified date. The patient was not treated for the events. The patient recovered from the events on an unknown date. Follow-up (19Sep2016): New information from a contactable Physician  included: the reporter is not aware of the events experienced by the patient. Follow-up attempts are completed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "heart murmur" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Patient had received Anti-viral medication (Paxloid) as COVID 19 treatment and the treatment was started on 23Jun2022 and stopped on 28Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Symptoms Not feeling right -within 5 minutes Heaviness in appendages-15 minutes little dizziness 20 min Heart Rate increase 25 min Pressure on chest 25 minutes Severe shivers-30 minutes
hurts from the injection site to the shoulder when she tries to push or pull using her left arm; The discomfort /forces her to stop using her arm; Injection site Pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date 18th May 2021) for prophylaxis.   On 15th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced pain in arm and injection site discomfort. The action taken with Shingrix was unknown. On an unknown date, the outcome of the injection site pain, pain in arm and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm and injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The reporter had a consumer that called the pharmacy the next day after receiving the second dose of the Shingrix vaccine and described that the she was experiencing pain at the injection. The consumer recently contacted the pharmacy and indicated that it hurts from the injection site to the shoulder when she tried to push or pull using her left arm.  The discomfort she feels sometimes forces her to stop using her arm and use the other arm.  The reporter was unable to provide additional information.
Mother reports child had a fever as high as 102.5axillary starting on 2/14/2019 with wheezing and chest retractions. Child was seen in the urgent care clinic on 2/16/2019 was tested for RSV and Influenza which were both negative. His O2 stats were okay the mid-level practitioner questioned if the child had croupe. The child was sent home and given Tylenol as needed he was drinking okay but wouldn't eat for approximately 4 days. The mother reports that the child just wanted to be held. After the 4 days the child was fine and has had no further problems.
completely sick again with COVID; depressing; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in 2021 (reported as last Thursday, about 5'o clock) as unknown, single dose for covid-19 immunisation. Medical history included covid from an unknown date to an unknown date. The patient's concomitant medications were not reported. The patient underwent lab tests and procedures which included covid: positive on an unspecified date. It was reported that the patient took it last Thursday about 5'o clock and for 48 hours (2021), patient was completely sick again with COVID, it was just like when patient had it before and patient didn't really understand why this was the case. Patient reported that it was just depressing as patient didn't wanted the shot in the first place and it was just as if patient had it all over again. The outcome of the events "sick again with COVID" and "depressing" was unknown.  Information on the batch/lot has been requested.
101.6 fevers and chills, day 2-5, 99.6, day 7 Neck pain, frontal headaches, severe Blood pressures up 186/106, bp med in teased from 8 mg to 32 mg on day 5.. bps 140/90 by day 7  Bp spike Started on 1st vaccine 01152021, lot 029L20A
Information has been received from a healthcare worker concerning a 13 year old male patient with no allergies or drug reactions and no pertinent medical history who on 18-MAY-2011, was vaccinated with a dose of GARDASIL intramuscularly in the left deltoid (lot number 668554/0306AA, Exp: 10-MAY-2013). There was no concomitant medication. On 18-MAY-2011, within an hour of receiving the vaccine of GARDASIL the patient started experienced shortness of breath, redness of face, achy joints and dizziness "could not get up due to dizziness". On 19-MAY-2011, the mother of the patient called and reported to the healthcare worker's office that the patient was still very dizzy but the shortness of breath was much better. The patient received as treatment for the event ALLEGRA. No laboratories were performed. There was no mention of the status of the achy joints or redness of the face. Additional information has been requested.
I do not have the vaccine Lot number. Not administered at our facility. We treated patient post vaccine.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. on 18-NOV-2014, the patient was vaccinated with a dose of VARIVAX, 0.5 ml, subcutaneous (lot number and expiration date were not reported) that underwent a supported temperature excursion. No adverse experience reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had a grandmal seizure and since have had an ct scan, mri, blood work and spinal tap.
Episode of shortness of breath 4 hours after vaccine, tachypnea, persistent cough.  Tx: Symbicort         Albuterol pumb         Prednisone
24 hours later developed fever of 100. Headache, joint pain.  Lasted one day 48 hours later developed a large (6" by 5") bright red spot around injection site. Very hot and itchy rash. Still there today but fading.
Received injection in R arm, c/o redness, hot, swelling, painful, stiffness with 2 red streaks leading toward her axilla.
Received vax 12/22; 12/23-12/27 dizziness, light headed, fatigue, swollen left arm, left arm tender/warm to touch/red, muscle of injection site swell to x3 of size; 12/27-12/28 muscle/joint pain (felt unbearable to stand), hips/hands/feet/knees achy, hands swollen and hurt to grasp, red bumps appeared that were itchy, painful and turned into a rash over hands; 12/28 noticed same rash from fingers appearing on toes. 1/4 noticed a had lump in my arm; possibly swollen lymph nodes. Muscular/Joint pain has subsided however I still have the rash and my hands are swollen in the mornings/evenings, spots are painful and still have the lump in my arm. I was prescribed a topical steroid by PCP and has the rash is still there.
Sudden onset of hypotonia 2 days after vaccination. CT scan, CSF, tox screen and history negative. Botulinum toxin pending. Received in 2-3 days.
3 days later began to feel very depressed, emotionally volatile, crying a lot.  It has continued with some better days and some awful days, I am now 7 days post vaccination and today was awful.  I have not had any major physical reactions other than some fog and headache.
Pt was given all 3 vaccines at the end of his physical-approx. 10:10 am. He tolerated them well.  He then watched his cousin get her imm and tb skin test. I asked how he was feeling and he said fine. I asked if he had breakfast this morning and he said yes. At about 10:20 the family was at checkout and pt fainted. Pt placed in supine position with legs elevated and BP and pulse taken. He was awake and oriented and able to answer question. He had some blood on front tooth as he hit his forehead/mouth on wall. He was placed in sitting position and vitals taken again-normal. Pt was moved to a room and given apple juice and rested for 10 more minutes. Vital retaken and pt seen by NP who had done his physical this morning and was released to his guardian with instructions to call us if he has any other sx's or concerns.
4th dose administered; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 13-year-old male patient who received HBV (Engerix B) (batch number 333M4, expiry date 7th April 2024) for prophylaxis.   Previously administered products included Engerix-B (received 3rd dose of Engerix-B on 16th August 2022).   On 12th December 2022, the patient received the 4th dose of Engerix B. On 12th December 2022, unknown after receiving Engerix B, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Linked case(s) involving the same patient:  US2022186700   Additional Information: GSK receipt date: 13-Dec-2022 Reporter's comment: The reporter consented to follow-up. The case was linked with case US2022186700, reported by same reporter for different vaccine. Additional supportive information: The patient received 4th dose of Engerix-B, which led to extra dose administered.; Sender's Comments:  US-GSK-US2022186700:Same reporter
Patient vaccinated with COVID vaccine on 12/18/2020. On 12/20/2020 he began having swelling of the left ankle. Patient previously had surgery to this ankle where plates and screws were placed. Patient was seen at Urgent Care on 12/21/2020, who prescribed Antibiotic and followed up with his podiatrist a week later.
He did not have an adverse reaction to the vaccine. He did not show any symptoms prior to testing positive. He tested positive for COVID-19 and RSV on 11/25/2022. He had exposure to COVID-19 from his father and RSV from the day care he attends. We continued his daily regimen of using his inhaler, chest rubs and BENADRYL for his symptoms.
Beginning several hours after vaccine administration to right tricep, patient experienced pain, swelling, and bruising.  By 24 hours after administration, swelling had increased to ~7 x 12 cm area over right tricep with ~2 cm superficial ecchymosis and blotchy erythematous rash at margins of the swelling.  Treatment is symptomatic - motrin/tylenol for pain, ice/elevation/compression for swelling, benadryl for itching/rash.
Patient was administered Bexsero instead of Menveo. When the error was identified by staff, patient and parent were notified. Parent and patient verbalized understanding. They confirmed that they did still want the correct vaccine given that same day. Patient did not have any adverse symptoms.
Pt reports arm feeling itchy, hot, pink, and blotchy. Symptoms presented about a week after vaccination on 4/1/2019.
Got my shot 10/20 woke up Sunday 11/20 with the worst case of flu; Initial information was received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a non-health-care professional.  This case involves an unknown age and unknown gender patient who had got my shot 10/20 woke up Sunday 11/20 with the worst case of flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).      On an unknown date the patient developed a non-serious event of got my shot 10/20 woke up sunday 11/20 with the worst case of flu (influenza) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown.
Shoulder was a little sore; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 27-Jan-2023. Reporter's Comment: This case was reported by a consumer via interactive digital media. Patient stated that shoulder was a little sore for a couple of days. Additional Supportive Information: Follow-up would not possible as no contact details were available.
pt received the Pfizer vaccine 2023-2024 booster dose for the age 5-11 years (10mcg) in error, due to age pt should have received the Pfizer Covid vaccine 2023-2024 6month-4 years (3mcg) at visit
Swollen lymph nodes in left armpit. Noticed 5/7. Had second dose of Pfizer 4/26 lot number EW 0171.
8/16/21: COVID pos presented to ED with cough, clear phlegm, fatigue, weakness 8/18/21: discharged on steroids and told to f/u with PCP as needed
1 1/2 hours after vaccine given he got a rash all over body, itching, fever.  Went to ER and was given liquid to drink and antibiotic to take at home. Once he received liquid, rash and fever went away gradually.  Then no problems.
Myalgia, Fever, Severe pain at injection site (left deltoid), low-grade fever: 99.8F, muscle ache and joint pain. Narrative:
TROUBLE SWALLOWING; CHILLS; TIREDNESS/FATIGUE; DIARRHEA; TINGLING THROUGHOUT BODY/TINGLING FEELING IN HEAD; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included: right mastectomy, and lymph nodes removed under right arm and neck, and concurrent conditions included: cancer, celiac disease, alcohol user, non-smoker, and gluten allergy, and other pre-existing medical conditions included: No drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-NOV-2021, the patient experienced trouble swallowing. On 02-NOV-2021, the patient experienced chills. On 02-NOV-2021, the patient experienced tiredness/fatigue. On 02-NOV-2021, the patient experienced diarrhea. On 02-NOV-2021, the patient experienced tingling throughout body/tingling feeling in head. On 02-NOV-2021, the patient experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, chills, tiredness/fatigue, diarrhea, tingling throughout body/tingling feeling in head, and trouble swallowing. This report was non-serious.
had hip replacement on 17 Nov 2021; This spontaneous case was reported by a patient and describes the occurrence of HIP ARTHROPLASTY (had hip replacement on 17 Nov 2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 025L20A and 011J20A) for COVID-19 prophylaxis.     Patient had no known drug allergies to medications, food and other products.  Patient had never been diagnosed with or tested positive for COVID-19. Patient didn't had acute illnesses at the time of vaccination and up to one month before or any chronic or long-standing health conditions.    On 30-Dec-2020 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021 at 3:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HIP ARTHROPLASTY (had hip replacement on 17 Nov 2021). At the time of the report, HIP ARTHROPLASTY (had hip replacement on 17 Nov 2021) outcome was unknown.      No prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination or at the time of the adverse event were reported.   Reportedly, other vaccines given on the same day as moderna covid-19 vaccine were none. Other vaccines received within one month prior to dose of moderna vaccine were none.  It was reported that on 10 Oct 2021, patient had experienced extreme inflammation in both hips especially the surgical hip and after 5 weeks, the situation persists. Even if it backs down for a day or two it returned with a vengeance and also reported that anti-inflammatories were useless and the hip replacement surgery was performed on 17 Nov 2021.   This case was linked to MOD-2022-672436, MOD-2022-669954 (Patient Link).
Approximately 12 hours post vax, the pt developed redness, swelling, warmth at the site of injection. No complaint of pain. The pt experienced erythema that increased to cover entire anterior deltoid area despite "ice packs". On 1/22, 4 days later, warmth and redness persist. No app, decreased activity or mobility. Has appt with MD.
Received vaccine 9/20/09, admitted to hospital 10/16/09 for viral spinal meningitis.
The injection was very painful when given very high on my left arm.  I have experienced pain every night that wakes me several times and requires ibuprofen to lessen -- usually 6 to 8 during the night. During the day the discomfort is less, but still limits my arm movement.
Same day: fever, chills, headache, severe  pain in unloved arm, fatigue  2 days after: blisters inside of lips
Got flu-like symptoms about 4 days, post vax 1st vaccine on 9/3/00, which lasted about 3 weeks. Got 2nd vaccine on 10/10/00 and got headache and flu-like symptoms back within 12 hours.
Tested positive for COVID-19 virus; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 29Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 05Feb2021, the patient had tested positive for COVID-19 virus. The outcome of the event, 'tested positive for COVID-19 virus', was unknown. The patient would like to know if she could get the second dose on 19Feb2021 as scheduled.  Information of lot/batch number has been requested.
Large reddened area at shot site 15 x 15 cm area mild swelling, increased warmth, itchy.
VACCINE DRAWN UP DAY BEFORE AND GIVEN AT THE 15 HOUR MARK  PATIENT STATES LOW GRADE FEVER X 1 DAY
Full body aches, fatigue, shaking and cold all over, headache, earache, nausea. Ended up taking ibuprofen 2/5 at 10:30am.
Rash on bilateral wrists, left elbow, left temple, pruritus lasting for one day until evaluation and treatment with hydroxyzine.  Persistent lesions until evaluation by this provider 48 hours after initial onset of symptoms.
very high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "very high blood pressure".  Additional information: The caller took the covid vaccine and she has experienced very high blood pressure, it was sky high, and it has never been like this before. The caller wants some data about the trials. Since the caller had the covid vaccine, her blood pressure has seem to have gone high and she doesn't attribute it to a change in diet or anything.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & 4JUL97 pt broke out in spots 7 days p/immunized sibling came down w/chickenpox;
Mother of the patient called our office and stated that she contracted shingles after the child received vaccines.  Her OBGYN stated that this "could be dangerous".
Loss of consciousness x 2 times. Sustained laceration in chin.  Brought to the ER.  Treated with IV fluids and discharged.
A huge rash under the injection site began to develop 7 days after the 1st dose.  It began as 2 bumps around the injection site that were hard, warm, and a little pink. Then a rash became hotter to the touch as the days progressed. It was raised, hot to the touch and sensitive. It was painful and uncomfortable to have; it caused me to not be able to sleep at night. I emailed my PCP, and she recommended: "we are recommending taking Benadryl, it can be oral or the cream and just take Tylenol if needed. Sometimes using a warm compress on the site helps as well." I took Tylenol in the morning and Benadryl at night to help with the rash. I would also use anti-itch ointment to help with the discomfort. The rash lasted for another 5 days before the symptoms started to subside. I felt fatigue and week for roughly two weeks after the 1st dose.
At 1118 patient fainted, had fixed shaking, pale, loss of speech. Once patient reactted he was able to speak and gave Past medical history of Asperger syndrome and no fainting spells before. Patient complained of stomach pain. numb lip, tingling sensation on fingers. Hands began to flexion and tense up.  Vital signs were with in normal range. clinet began to show normalized sign and symptoms. Ems was still called and was taken to hospital for furhter observation at 1153.
Tdap 5/19, 5/20 now lge, red and hard. 5/31 reddened tender swollen 50 x 76 mm.
About a week and a half after receiving a booster vaccine shot, I started to experience signs of Shingles. I went to the urgent care and was confirmed to have Shingles.