chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Allergy with Tetanus toxoid; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves unknown demographic patient who experienced allergy with tetanus toxoid, while received vaccine TETANUS TOXOID.  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 TETANUS TOXOID produced by unknown manufacturer (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious allergy with tetanus toxoid (allergy to vaccine) (Unknown latency) following the administration of TETANUS TOXOID.  (Other relevant tests included no lab data).  Final diagnosis was allergy with tetanus toxoid.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for allergy with tetanus toxoid.  Information on the batch number was requested.  List of documents held by sender: none.
Throw up; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Throw up) in a  patient of an unknown age and gender 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 VOMITING (Throw up). At the time of the report, VOMITING (Throw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
The vaccine was mixed using a multi-dose vial of diluent. The diluent was punctured twice and used to mix two vials of vaccine. The vaccine was given IM and may have been given with a 5/8inch needle.
patient had a Moderna shot 2/1/2021,  Day of injection developed dime sized blister.  Following day developed redness, warmth and swelling approx 4"x4" .  Today 2/12/2021 area is still somewhat erythematous, warm and red.   Shot was given fairly low in the arm.
Injection site reaction; Injection site swelling; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's age group was not reported but captured as adult as per vaccine indication. The patient experienced these injection site reaction having severity grade 3. The events were ongoing.
Patient presented to ED on 01/10/2022 with AMS, the onset was abrupt.  The patient was transferred from small clinic for evaluation and management of a head bleed after a fall, and Covid positive.  CT showed occipital fracture, subdural bleed, bilateral subarachnoid frontal bleed.  Prior to presentation, history of flu like symptoms for the past week.  Patient was admitted to NCCU.  On 01/13/2022 patient presented with worsening neurological exam, extensor posturing, not protecting airway, patient was intubated, repeat CT head with worsening edema and evolving left pica stroke with mass effect.  Patient code status was changed to DNR.  Patient expired on 01/15/2022.
Generalized itching x 1 day, febrile x 1 day, redness swelling & pain at site x 4 day (L) deltoid - No reaction to flu in (R) deltoid administered same time.
Un reconstituted vaccine administered to child. Child was observed for one and a half hours without symptoms of reaction or distress.
Initial report received from a physician on 20 October 2010. This is a case of misuse where the vaccine was administered in an inappropriate site. A 50-year-old female patient had received a dose of ADACEL (lot number unknown) on 18 October 2010 in the shoulder joint area and the following day experienced severe shoulder pain with numbness and tingling. Per the reporter, the patient had nerve complex symptoms of "BPN" (Brachial Plexus Neuropathy). Treatments received, diagnostic tests completed, and recovery status were not reported. The patient's medical history was also not reported. Documents held by sender: None.
Blood clots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clots". Clinical course: Reporter stated, "Why are the vaccines causing blood clots in my girlfriend?".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. c/o feeling light-headed 5 mins after receiving vaccine. She was taken  in a wheel chair to a cubicle in the observation hall and made to lie down for assessment and observation. V/S -b/p 151/97, resp16, H/R 88, O2 96%RA. Pt. was verbal, A&Ox 4. After 15 mins of observation and monitoring, Pt was re-assessed in a sitting position for about 23 mins when she said she felt well and okay to leave. V/S obtained at 10:35 a m was b/p 146/75, resp.14, H/R 80. She also denied pain, respiratory distress or dizziness. She left the observation hall unassisted at 10:38 a m.
Information has been received from a registered nurse concerning a patient who on 30-JUL-1999 was vaccinated with a dose of Varivax. Subsequently, on 16-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
This spontaneous case reported by a consumer, describes the occurrence of headache in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19  immunization. No medical history reported. On Nov 19, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In November 2021, patient experienced headache. At the time of the report, headache outcome: unknown. Patient wanted to know if could take an ibuprofen for his headache. No concomitant medication or treatment information reported. This case linked to MOD-2021-396027, MOD-2021-396028 (patient link).
Onset muscle aches & malaise 30NOV91 @ 1PM fever 102 alternated w/chills & diaphoresis from MN 30NOV through 4DEC91 respiratory congestion, cough & h/a accompanied illness; weakness persisted until 8DEC;
Patient presented to ED with SOB and hypoxia. She stated that this is a chronic problem for her. She had a video conference with her physician who told her to go to the ER. Her O2 saturation was noted to be 87%. She was found to have pulmonary edema and received Lasix. She is also scheduled to have a cardiac cath to evaluate ventricular tachycardia. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
This spontaneous report as received from a nurse refers to a 14 year old female patient. The patient's medical history was not reported. On 30-JUL-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency, route and lot # were not reported). Concomitant medications were not reported. On 17-OCT-2014 the patient was vaccinated with second dose of VAQTA. No adverse effect was reported. No product complaint was reported for VAQTA. This case is linked to case # 1410USA010488 (same patient link). Additional information has been requested.
very lethargic; She was sleeping for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (very lethargic) and SOMNOLENCE (She was sleeping for a couple of days) in a female 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 LETHARGY (very lethargic) and SOMNOLENCE (She was sleeping for a couple of days). At the time of the report, LETHARGY (very lethargic) and SOMNOLENCE (She was sleeping for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided. No treatment medication details was provided.
THIS REPORT IS FOR AN ADMINISTRATION ERROR, NOT AN ADVERSE EVENT. PT RECEIVED A LOWER VACCINE DOSE DUE TO DILUENT ADDITION ERROR.  NO ADVERESE EFFECTS NOTED DURING OBSERVATION PERIOD OR TODAY UPON FOLLOW UP PER PT MOTHER.
on 8JUN95 pt had rt arm redness size of silver dollar marked w/pen, warm to touch & tender; 9JUn sl inc in redness noted had MD look @ it & stated cellulitis secondary to DT
Within 45 minutes of receiving the vaccine - red face with tingling; recipient got "extremely warm". Resolved quickly once patient received Benadryl 100mg.
During the first night (12/13/2021): chills with fever; severe headache; fatigue; night sweats; muscle pain at the injection site. Side effects mitigated by over 12 hours of rest in bed.   Most of the side effects went away after two days (12/15/2021) except: slight headache; night sweats; muscle pain.
Headache, muscle and joint pain began sometime around 1am. It progressively got worse through the night. By morning around 10am Sunday, Sept. 23rd, I had severe headache, nausea, severe joint and muscle pain to the point I could not stand up. I had to lay down. It was so bad, I took a 1/2 of PERCOCET that I had left from my foot surgery in Dec. 2017. (Just for reference, I do not like taking prescription pain medicine. But I was desperate.) I also took a ZOFRAN to help me with the severe nausea. I ended up taking number 3 - 1/2 tablets of PERCOCET throughout the day. I was unable to do anything but use the restroom and laydown all day. This was the most pain I have experienced in years, if ever. Major foot surgery was not this painful. This pain encompassed my entire body. Some places on my skin hurt to touch but you could not see anything there. I was starting to feel some minor relief though that night while sleeping. The following morning I was feeling better but unable to go to work. I remained home all day. I did nothing but rested. Ibuprofen was sufficient now (800mg every 6 hours). I did work the following day, Tuesday, but still did not feel back to normal. I still have sore achy joints. The injection site is still very sore. I am assuming each day that passes, I will feel better. If I had not had my own pain and nausea medication, I would have been forced to go to the local Urgent Care.
Vomiting from 10pm-2:30am with 100.5 fever, aches, stomach pain beginning day of vaccination and fever continued (rose to 100.8) through 5pm the next day
Last flu shot that received made sick.; Initial information received with live follow-up on 05-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case was linked to case 2020SA350877.  This case involves a female patient of an unknown age who made sick (Illness) after receiving INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) last flu shot that received made sick. That was a few years back. Will not take something that causes reactions.   No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Swelling, redness warm to touch and itchy. Rash and itchiness on right upper thigh and back of neck. Patient seen at Hospital and Given ABX: cephalexin (KEFLEX) 250 MG/5ML suspension--Dose: 50 mg/kg/day × 19 kg Route: Oral Frequency: 2 times daily Sig: Take 9.5 mL by mouth 2 times daily for 10 days for antibiotic. Patient re-evaluated in the PCP office on 6/25/2018: Will continue oral antibiotics for 10 days. Discussed natural history of problem. Warm compresses four times daily as needed. Discussed pain management and contagion prevention. Reviewed use of good skin hygiene and protection, including topical hypoallergenic emollient once daily as needed. Continued use of non-scented, hypoallergenic soaps, lotions, detergents, etc. Probiotics given for diarrhea; recommend take it easy on the dairy and BRAT diet. Use probiotics to help while on abx. Push fluids to stay hydrated. Let us know if recurrent off abx. Family informed to call or return to the office as needed if patient's symptoms worsen or fail to improve as anticipated. Risks and possible side effects of the prescribed medication[s] as well as appropriate use were discussed. Family indicated understanding of the information.
pt developed L arm paresthesias followed by left face and left leg paresthesias about an hour after the vaccine prompting him to come to ED for evaluation
fever; chills; headache; injection site pain /sore arm; injection site swelling; muscle weakness; tiredness /extremely tired; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced fever, chills, headache, injection site pain, injection site swelling, muscle weakness and tiredness. On an unknown date, the outcome of the fever, chills, headache, injection site pain, injection site swelling, muscle weakness and tiredness were recovered/resolved.   It was unknown if the reporter considered the fever, chills, headache, injection site pain, injection site swelling, muscle weakness and tiredness to be related to Shingrix.  Additional case details were reported as follows: The patient experienced fever, chills, headache, injection site pain, injection site swelling, muscle weakness and tiredness after vaccination. The patient consented to follow up.   Follow up information was received from the consumer on 20th February 2020: The patient reported that received the 2nd dose and experienced events, refer case US2020AMR044175.
Post vax, the pt developed cellulitis of arm, lymphadema, decreased blood pressure, and whole body flushed.
I had the vaccine on 12/28/20 and I had soreness (which I know is normal), but today, 01/05/21, I noticed that I have a red raised area at the site of the injection; I am a PA and I would describe it as a red circular area of induration that is tender to the touch.I believe this is a common side effect and I have heard from a few other people that have reported this side effect, but I wanted to report it because I am not sure when it started and it has been a week since I got the vaccine. My arm was sore for the first few days after the injection, but then the soreness got better. I hadn't really looked at my arm closely since the day after the vaccine, so I am not sure if it was there before. I was not able to report this on the CDC v-safe website because it has been over a week and I stopped getting the daily check-in links. I am not sure if I will get another link for 1 week. This is why I am sending this here.
one of three pts who was vaxed from the same vial & exp fever, fussines & severe local rxn; pt had a high fever; reporters states vial contains borken glass; no broken glass observed in returned vial per QC;
called 215PM recvd vax 10Am when woke had ringing in ears, h/a, was flushed; noted that rt side of body side vax was given ached;
Nausea; Headache; 100.9 F fever; Sweaty; Her arm hurt all day; Diarrhea; Injection was very painful the day of vaccination; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 28th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 29th September 2019, the patient experienced nausea, headache, fever, sweating, pain in arm and diarrhea. On 30th September 2019, the outcome of the injection site pain, nausea, headache, fever, sweating and pain in arm were recovered/resolved. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the injection site pain, nausea, headache, fever, sweating, pain in arm and diarrhea to be related to Shingrix.  Additional details were provided as follows: The reporter reports his mother received 2nd dose of Shingrix and the injection was very painful the day of vaccination. The reporter the next day on 29th September 2019 she had significant nausea, headache, 100.9F fever, diarrhea, sweaty, and that her arm hurt all day. On 30th September 2019, Today, caller reports his mother was coming around everything was all better. The reporter was consented to follow up. The reporter forgot to ask caller for vaccination facility details.
Client reports that on the second day after the vaccination she developed severe pain and weakness in the right arm where she received the Td injection.  She describes the weakness as so severe that she had difficulty picking up light objects.  She ran a fever of 101 degrees.  She did not seek medical attention.  The symptoms improved over a 4 day period.  No long-term adverse effects remain.
Child developed L-posterior cervical adenitis 2.5 x 2 cm after MMR 04.21.2016.
Extreme fatigue, cough, shortness of breath, coughing up bloody mucus a couple of times
Vaccine went into 2-8 celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022; Vaccine went into 2-8 celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022 at 10:51 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 06-Feb-2022 at 10:51 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient has Ethnicity as private  Its 30 days Expiry date vaccine went into 2 to 8 °C thaw state on or about to 24-Dec-2021, this vaccine administered until its Mfg date of 04-Apr-2022  No Concomitant Medications were provided by the Reporter No Treatment Medications were provided by the Reporter   This case was linked to MOD-2022-542869 (Patient Link).
mom stated noticed pt rt arm was swollen from shoulder rt to elbow, warm to touch, reddened, was seen by MD 30MAY96 PM who recommended APAP or Motrin if needed & will f/u 3JUN96
malaise, myalgias, headache, fever, flu like symptoms severe enough to seek medical attention to rule out flu
I received the Pfizer vaccine on 21 December 2021.  On December 27 I developed a fever, cough and was diagnosed with Covid-19.  About 14 days later I started to get a rash on hands and feet with burning sensation.  I was evaluated and diagnosed with Covid toes.  About 1 week later I developed a fever and was evaluated and diagnosed with pneumonia, pulmonary embolism, and a DVT.  I continue to get worse to include arthritis in hands, wrists, feet and ankles.  I was admitted to the hospital with worsening pneumonia, reactive arthritis and a rash on elbows, knees, hands and feet.  I was in the hospital for about 5 days.  I have been evaluated by rheumatology, pulmonary and dermatology since.  The ongoing theory is I have a reactive arthritis from COVID and may have developed psoriasis/psoriatic arthritis.
Information has been received from a consumer concerning her son at that time approximately 15 month old with no pertinent medical history and no drug reactions/allergies who in October 2003, was vaccinated with the first dose of MMR II (LOT# not reported). There was no concomitant medication. Three days later, the patient experienced delays in development and began "toe walking". The mother stated that her son's speech was not developing as she believed it should be and he had a hearing test completed in February 2005. On 20-SEP-2005 the patient was diagnosed with autism. There was no lab diagnostics studies performed. The patient sought medical attention by office visit. The mother believed that MMR II contributed to her son's symptoms. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 68-year-old male patient 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 EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided.; Sender's Comments: This case concerns a 68-year-old, male patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on unknown date after unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Patient reported heaviness on her head, closed eyes repeatedly, coldness on the face, nausea, paleness, and pain in left arm.
pt recvd vax 20NOV92 & became ill that noc; t101, arm sore & red, body ache;