chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with history of quadriplegia secondary to C6 spinal cord injury. She was brought to the ED by EMS on 12/10 for evaluation of fever, cough, and shortness of breath for the past two days.  Additionally, patient reported concern that she is not getting adequate care and help at home. A COVID-19 PCR test done in the ED on that day resulted positive. Ultimately patient admitted as an observation for COVID-19 infection and concern for inadequate care at present living situation. During admission, patient was afebrile, hemodynamically stable, and satting well on room air. She was admitted 12/10/22 - 12/31/22. Per the discharge summary, her COVID-19 infection resolved during her admission.
pt fell off the chair. He had a seizure for about 5 seconds and then got up. He was very sweaty but he felt better after a few minutes
Injection was given to me on 12/29/20.  On 1/6/21, I noticed a small red area, under the bruise from where the injection had been given. It was about 2 inches by 3 inches in size.  On 1/7/21, the area has increased in size - it's about doubled in size. No itching.  It's soft.  It is warm, but not hot.
Upper arms - sore, aching muscles. Calf muscles - sore, aching muscles.
5/7/21 1:15 pm -  Couple of minutes after my top lip felt swollen and felt tingling with a slight headache.  Had a bit of dry mouth.   5/8/21   7:30 am. -  Heart started racing with elevated blood pressure.  Had a headache and fatigue all day. 5/9/21- headache and fatigue.  Felt an electrifying sensation upon waking throughout my body. 5/10/21 -  left side pressure headache,  fatigue.  Felt an electrifying sensation upon waking throughout my body.  Felt tingling in my face.  5/11/21 -  left pressure headache throughout the day  then at 9:30 pm my left arm went numb and felt left sided pressure headache with tingling in my face. 5/12/21 -  mild headache.  Had metal taste in my mouth. 5/13/21. Mild headache 5/14/21 - heart racing with elevated blood pressure 5/15/21 -  pressure headache
Patient's parent stated that patient is not feeling well before lunch, and after the vaccination. Patient complained about headache, chills, and feeling sick. Patient returned to immunization clinic within two hours after vaccination with above complaint. Patient was instructed to rest on the bed, Vital signs was checked every 5 minute X3. At 1:46 PM-Temperature 100.5, B/p 97/57, Respiration 20, Pulse Oximeter 99%. Patient was later sent to Emergency room for further evaluation.
if she receives the 2nd dose 6 weeks longer from 1st dose; gum  infection; This is a spontaneous report from a Pfizer Sponsored Program. This report is received from contactable consumer (Patient, Self-reported). An unspecified aged female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: unknown), dose 1 via an unspecified route of administration, on 23Jan2021, single for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. The patient received her 1st dose on 23Jan2021 and went for a dental appointment and after that developed a gum infection. She was also on amoxicillin which was prescribed by the dentist. She was rescheduled for the 2nd dose on 26Feb. Original date was 13Feb. She was asking what the percentage protection coverage will be if she receives the 2nd dose 6 weeks longer from 1st dose. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Redness and swelling of injection site that appeared the day after receiving vaccinations. Swelling and redness is slowly resolving over time.
Case number PHEH2011US06971 is an initial spontaneous report received from a health care professional on 10 Oct 2011: This report refers to a female child. She was given only the CYW-135 liquid component MENVEO (batch number: unknown) intramuscularly on 03 Oct 2011. No other adverse event was reported.
dizzy; occasional and pain in the left arm; did not have a dose due to Moderna (COVID-19 vaccine,; tingling in her legs when she lay down at night that lasted couple of; nauseous; fever; chills; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jun-2021 and was forwarded to Moderna on 24-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), PAIN IN EXTREMITY (occasional and pain in the left arm), INTENTIONAL DOSE OMISSION (did not have a dose due to Moderna (COVID-19 vaccine,), PARAESTHESIA (tingling in her legs when she lay down at night that lasted couple of) and NAUSEA (nauseous) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy), PAIN IN EXTREMITY (occasional and pain in the left arm), INTENTIONAL DOSE OMISSION (did not have a dose due to Moderna (COVID-19 vaccine,), PARAESTHESIA (tingling in her legs when she lay down at night that lasted couple of), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, DIZZINESS (dizzy), PAIN IN EXTREMITY (occasional and pain in the left arm), INTENTIONAL DOSE OMISSION (did not have a dose due to Moderna (COVID-19 vaccine,), PARAESTHESIA (tingling in her legs when she lay down at night that lasted couple of), NAUSEA (nauseous), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            Reporter did not allow further contact
p/vax pt devel aches & pains in hands & legs then all over;constant pain saw MD 12/97;ANA test positive sent to rheumatologist;saw MD 1/98 tx for joint inflammation;started having problems w/eyes;recurring episcleritis;still under MD care;
Rash (red, slightly puffy skin) around injection site. It is itchy at times.    I received a paper that said to include ?Moderna COVID-19 Vaccine EUA? if reporting side effects. Hi
The patient woke up with severe pain in his leg, a flare of a previous nerve pain issue he was having. He had taken percocet to help with the pain and went to bed. His wife called and she was informed to have him take ibuprofen 400-600 mg every 6 hours to help suppress an inflammatory response that could be increasing the pain he is experiencing.
pt recv vax & devel fever/ h/a & redness @ inj site, pain @ inj site, swelling @ inj site, warmth @ inj site;muscles aches;pt also exp dizziness, n/v, abd pain, diarrhea, diff breathing;
I was congested in upper respiratory system, fever at 99 degrees, cough, drainage.
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported  No laboratory data was provided.   No treatment information was provided.; Sender's Comments: Based on the current available information a causal relationship cannot be excluded.
The next day my arm was sore and body was hurting i was in a lot pane i had to go the doctors they ran ekg, mri and they thought my health was in danger because i don't have a gallbladder. The doctor didn't give me any medication and did not figure what was wrong with my liver stats.
Flu vaccine was administered with a 5/8  inch needle instead of a 1 inch needle.
At 16 hrs post second vaccine I started to develop fevers, chills body aches and light headedness. At 17 hr post vaccine I had a near syncopal episode, HR 120, temp 101.2 temporal artery scanner.  Took Tylenol, 650mg at 1245 am 1/21/2021, and q 6 hrs x 4. I was at work at the hospital and completed by shift went home and drove back to hospital for ACLS recent. I was back at my home by 1:30pm 1/21/2021. I had fever, chills, diaphoresis and palms. cont Tylenol. I woke up several times in night with fevers, chills. Woke up at 0620am 1/22/2021 and felt ok, fevers gone, chills gone but I then had bilateral periorbital edema and a raise red rash above and below where the injection site is. It is hot red and itchy. I took Benadryl 25mg po x 1 without relief of the rash but the periorbital edema resolved.
Patient and her husband arrived to the mass vaccination clinic to receive their 2nd dose of the Moderna COVID-19 vaccine. First dose in the two dose Moderna series administered on 2/8/21. Patient was inadvertently injected with the Pfizer-BioNTech COVID-19 vaccine instead of the Moderna vaccine at 9:31 am on 3-8-21. Patient denied any adverse effects at the time of the vaccination or during the post vaccination monitoring period. Patient again denied any adverse effects during a provider post vaccination follow-up phone call on 3-8-21 at 3:18 pm.
This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 09-JAN-2017, the patient was inadvertently vaccinated subcutaneously with a dose of improperly stored VARIVAX injection, lot # M025870, lot# 24-MAY-2018 (dose and anatomical location were not reported). No adverse effects were reported. Data logger was involved. The VARIVAX was stored in - 13 Celsius degrees for 46 hours 30 minutes. There was no previous excursion. Additional information is not expected as no consent for further contact was given.
Employee describes fever of 103.2 and nausea on night of vaccination (02/01/21). 02/03 developed blood in urine and body aches, nausea, fever continued.
Information has been recieved from a physician concerning a 11 year old male student with no medical Hx who on 07/07/1995 was vaccinated SQ in the LA with the 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 06/21/04, the pt developed breakthrough chickenpox characterized by approximately 20 vesicles and a temp of 102.5 F. Medical attention was sought and the pt was treated with acyclovir (400 mg PO QID x 5 days). On 06/30/2004, the pt recovered from the breakthrough chickenpox. Additional information is not expected.
At approx. 1757 PT was noticed by his wife that he had slumped over in the driver side of their vehicle.  PT was quickly evaluated by a volunteering EMS paramedic and a volunteer MD. PT presented with pale cool skin color and temp.  PT was quick to come back around and was a able to communicate with medical personnel.   PT stated that his last oral intake was earlier that morning and that he been "straight out all day at his school" where he works.  PT also stated that he had worked out twice earlier in the day prior to his vaccination.  Denies any history of any adverse reactions to any vaccinations in the past.   No interventions were needed from medical personnel on scene                                                                                                                                                          ne.  No EPI pen administration and PT was not transported from scene.
Right arm pain from her shoulder around to her neck; Can hardly sleep; She can hardly get up from the pain. It hurts so bad it seems like paralysis is taking over her body.; Muscle pain all over her body all the time; Joint pain all over her body all the time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm pain from her shoulder around to her neck), INSOMNIA (Can hardly sleep), PAIN (She can hardly get up from the pain. It hurts so bad it seems like paralysis is taking over her body.), MYALGIA (Muscle pain all over her body all the time) and ARTHRALGIA (Joint pain all over her body all the time) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Knee pain.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Right arm pain from her shoulder around to her neck), INSOMNIA (Can hardly sleep), PAIN (She can hardly get up from the pain. It hurts so bad it seems like paralysis is taking over her body.), MYALGIA (Muscle pain all over her body all the time) and ARTHRALGIA (Joint pain all over her body all the time). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Right arm pain from her shoulder around to her neck), INSOMNIA (Can hardly sleep), PAIN (She can hardly get up from the pain. It hurts so bad it seems like paralysis is taking over her body.), MYALGIA (Muscle pain all over her body all the time) and ARTHRALGIA (Joint pain all over her body all the time) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-030007 (Patient Link).
May 26, 2022 I started having a sore throat, headache, head congestion. On May 27, the cough kicked it in, it felt like a head cold with a really bad cough. It wasn't a deep cough, it was an upper cough in my chest. I did a home COVID-19 test early Friday morning that came back faint. Later that day I took another COVID-19 test that came positive. Saturday I got a PCR COVID-19 test at an urgent care, it came back positive. I got a telehealth appointment prescribed MUCINEX. The NP at a pharmacy prescribed molnupiravir, I started feeling better by Sunday, much better by Tuesday.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/21/2022 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/21/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/21/2022 ALTERED MENTAL STATUS, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/21/2022 CHF EXACERBATION, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/21/2022 CHF EXACERBATION, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/21/2022 CHF EXACERBATION, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/21/2022 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/21/2022 ANEMIA
Client became dizzy, pale, and had 5 second loss of consciousness about 2 minutes after vaccine administration. Client stated feeling warm and lightheaded. Cool towels placed on client's forehead and neck. Reported feeling much better about 20 minutes after onset. Vital signs returned to baseline about 5 minutes after onset.
- Positive morbilliform- red blotchy coalescence of lesions > truncal/less on extremities 10 days after vaccine (MMR) given. No fever. No conjunctivitis, No pharyngitis. Observation/ no labs.
Patient developed acute onset episodic abdominal pain 5 days after Rotateq administered in office.  Found to have 1 cm segment of intussusception by abdominal ultrasound; appeared to be small bowel to small bowel segment involved.  Reduced spontaneously after ~ 12 hours.  On day 7 had fever and pharyngitis - ? viral infection. 5/6/08-records received for DOS 04/26-04/27/9/08-DC DX: Small bowel intussusception. Seen in ER with intense crying and screaming with stiffening of lower extremities and upper extremities, no decrease in appetite. Fussy. No vomiting or diarrhea. Rhinorrhea and congestion on day of admission. Admitted for observation.
A spontaneous report was received from a nurse, concerning a 44 year-old patient of unknown gender, unknown race and ethnicity, who received Moderna COVID-19 vaccine (mRNA-1273) and experienced injection site itchy (injection site pruritus), injection site redness (injection site erythema) and injection site swelling. The patient's medical history and concomitant medications not provided. On Dec 29, 2020, prior to the onset of the events, patient received their first of two planned doses of mRNA-1273 (lot# unknown), intramuscularly for prophylaxis of COVID-19 infection. On Jan 5, 2021 (seven days post vaccination), patient experienced injection site redness, swelling and itchy. The treatment for the events included diphenhydramine and unspecified cream. Action taken in response to the events was not provided. The outcome for the events, injection site itchy, injection site redness and injection site swelling not reported. Reporter's comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sudden bloody nose a little less than 2 hours after the shot and it away pretty quickly.
Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old female patient who experienced one inch diameter globule at the injection site and entire leg was swollen after PREVNAR administration. At 2 months of age, the patient received the first dose on 16-Jan-2008. The patient experienced one inch diameter globule at the injection site and entire leg was swollen after PREVNAR administration on 16-Jan-2008. The patient was recovering from the leg swelling. The outcome of the injection site induration was unknown. No additional information was available at the time of this report.
Hospitalization for COVID with previous recent pneumonias on dates 7/12/2022-7/19/2022. Treated with no covid-related medications.
pt recvd vax; pt had hx of feb convuls in may94; when pt had inject at 11am, devel 2 episodes of generalized tonic clonic convuls at 7pm & 10:20am the next day; hosp for 2 days with no more convuls;
Vaccine was mixed with 1.4 ml of diluent instead of 1.8 ml. The mixing error was discovered shortly after administration. The patient was notified immediately (still in recovery area.) CDC was called and I spoke to a pharmacist who said the patient may have more localized reaction (arm pain) as well as fever, body ache, etc.
patient received 2nd dose at 2 week interval instead of 3 week interval no adverse events reported
Rash started on my hands Sept. 28, then I then began breaking out in hives on Sept. 30, which have continued, but are now beginning to subside.
LITTLE TO NO SIDE EFFECTS; This spontaneous report received from a consumer concerned a 7 decade old female. 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, and batch number were not reported) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced little to no side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little to no side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20220361763.
Initially developed redness, swelling, and pain, resolved after 48 hours. Twelve days after immunization painful, red, swelling returned at the site of injection (4 inches x 1.5 inches) blanchable, associated with headache and whole left arm tingling without loss of sensation or motor control.
Diarrhea.    black stools for 7 days after vaccine... still black today...
DIZZINESS AND LIGHTHEADEDNESS; FACIAL SWELLING; TRIPPED; SLIGHT SENSE OF QUEASINESS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced anaphylaxis and drug allergy when treated with macrogol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced dizziness and lightheadedness. On 07-APR-2021, the subject experienced facial swelling. On 07-APR-2021, the subject experienced tripped. On 07-APR-2021, the subject experienced slight sense of queasiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness and lightheadedness on 09-APR-2021, facial swelling on 08-APR-2021, and tripped, and slight sense of queasiness on 07-APR-2021. This report was non-serious.
itch in the lower back / only the itch; This case was reported by a pharmacist and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced an itch in the lower back, after receiving 1st dose of Shingrix.  The reporter also  reported there was no rash associated with the itch, there was only the itch. The reporter felt uncertain that, issue experienced was related to vaccine and said she wanted to reach back out to the patient, before providing any additional information to GSK (GlaxoSmithKline). The reporter did not consent to follow up.
received Kinrix prior to 4 years of age; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2M, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 11th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient received Kinrix prior to the recommended 4 years of age, which led to inappropriate age at vaccine administration. The reporter consented to follow up. This case is linked with US2022027796 and US2022004256, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022027796:Same reporter US-GLAXOSMITHKLINE-US2022004256:Same reporter