chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an office manager refers to a female patient (medical assistant) of unknown age. On an unknown date the patient had RECOMBIVAX HB (lot # H010380 and expiration date 18-NOV-2014) spill on her hands after the plunger rod and stopper fell out of the prefilled syringe. No adverse effects reported. Product quality complaint filed. Additional information has been requested.
Chills onset at around 2:30 AM the next day along with significant dry throat, fever above 100 taken at approximately 8:30 AM, significant dizziness, headaches, and muscle aches in the hours following, dizziness persisted until the next morning and was especially noticeable when moving around
Severe subacromial bursitis in L shoulder limiting arm movement x three months. Followed 1 week later by R middle finger MCP joint severe stiffness with inability to flex finger. Now after second dose I have torn medial gastrocnemius head. I am avid runner and weightlifter and none of these conditions existed prior to vaccine. I am currently on crutches unable to walk.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 56-year-old female patient who received FLUARIX QUADRIVALENT (batch number DX4SN, expiry date unknown). Concomitant products included thyroid medication (nos). On 11th November 2015, the patient received FLUARIX QUADRIVALENT. On 11th November 2015, 6 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema, injection site warmth and injection site pain. In November 2015, the patient experienced nerve pain. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovered/resolved and the outcome of he injection site pain was recovering/resolving and the outcome of the nerve pain was not recovered/not resolved. The reporter considered the injection site erythema, injection site warmth and injection site pain to be related to FLUARIX QUADRIVALENT. The reporter considered the nerve pain to be probably related to FLUARIX QUADRIVALENT. Additional details were received as follows: The patient received FLUARIX QUADRIVALENT in right arm. On 12th November 2015, 25 hours after receiving FLUARIX QUADRIVALENT, the patient experienced nerve pain, which was specific to left foot.
low grade fever; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (low grade fever) 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 PYREXIA (low grade fever). At the time of the report, PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
Redness from right thigh to knee; Hives from right thigh to knee; Blanchness from right thigh to knee; This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Concomitant products included HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL) (PEDVAX HIB), PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) and ROTAVIRUS VACCINE (ROTATEQ).   On 8th June 2020, the patient received the 1st dose of Pediarix (intramuscular) .5 ml. On 8th June 2020, 5 min after receiving Pediarix, the patient experienced erythema, hives and blanching of skin. On an unknown date, the outcome of the erythema, hives and blanching of skin were unknown.   It was unknown if the reporter considered the erythema, hives and blanching of skin to be related to Pediarix.  Additional details were provided as follows: The patient was administered Pediarix in the right thigh and was also administered Pedvax Hib and Prevnar 13 in the left thigh and Rotateq was given orally. About 5 minutes after vaccination patient experienced redness, hives and blanchness from the right thigh down to her knee. The patient described blanchness as redness turning into white area upon touching. No other details were provided.
she did not feel like herself; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she did not feel like herself) 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 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (she did not feel like herself). At the time of the report, FEELING ABNORMAL (she did not feel like herself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-523632 (Patient Link).
Erythemia, induration and swelling of right thigh on the evening of May 19th.  On May 21 patient was brought to office and an approx. 6 inch round erythematous, indurated area was noted over the anterior aspect of the right thigh at the immunization site.  Mom was instructed to use cool compresses, benadryl and Tylenol prn.  Over 24 hours the area was noted to have significant improvement.  Area did remain slightly itchy.  No fever, shortness of breath or rash was noted.  This is the first noted reaction of any kind related to Vaccinations for this patient.  Patient does have an allergy to Amoxicillin.
Information has been received from a registered nurse for ZOSTAVAX a Pregnancy Registry product refers to a female patient of unknown age. It was noted that the nurse could not confirm whether patient had a possible history of ZOSTAVAX administration (lot number, dose, route and indication were not reported). On an unspecified date may have had a prior case of shingles on an unspecified date while pregnant (MARRS 1308USA012075). On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, dose, route and indication were not reported). This patient who was presently immunocompromised and pregnant may also have a diagnosis of shingles on 16-AUG-2013. The LMP and ED were not known. The pregnancy outcome and the outcome of adverse event were not provided. Additional information has been requested.
Had coughing and wheezing. Had difficulty taking deep breath. Had running nose and coughing up mucus. These symptoms lasted for about 3 weeks. Went to the doctor about this. They did a breathing test. Test negative for COVID-19 test.
SIDS.  found unresponsive in crib @ 5:39a 2/23/99
With in 9 hours : dizziness. 10 hours of  rigors, unable to get out of bed for 15 hours and temp 101.4. Joint pain(all over). Frontal headache. Unable to eat or drink for 16 hours.
Adult patient received pediatric dose; Adult patient received pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 23-year-old female patient who received HAV (Havrix pediatric) (batch number ly35f, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2022, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 3rd November 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022184452   Additional Information: GSK receipt date: 8-Dec-2022 Reporter's comment: The reporter reported that a week after the administration of the incorrect dose a full dose was adult dose of Havrix was administered.  Same situation happened with Engerix B and it was reported in related case. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The case was linked with case US2022184452, reported by same reporter for different product. Additional supportive information: The patient received a pediatric dose of Havrix by mistake, which led to underdose and adult use of a child product.; Sender's Comments:  US-GSK-US2022184452:Same reporter
This spontaneous case was initially received on 03-DEC-2015. This case report was received from a(n) Health Professional and concerns a(n) adult female patient. Weight:  not provided, Height: not provided. Linked caseID9s): US-BEH-20150555519 (Same patient, 2015 episode) and US-BEH-2016058106 (Same patient 2014 episode). For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received Flu shot on unknown dates, Batch no: not provided, Route of administration: not provided, Dose: Administered in 2013.  Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting / treatment with Flu shot the patient experienced Joint pain (non serious, outcome: Unknown); Fever (non serious, outcome: Unknown), Chills (non serious, outcome: Unknown), Headaches (non serious, outcome: Unknown). Action taken: Details manually to be entered, Event treatment: Details manually to be entered, Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: n/a.
HAND TREMORS; FEELING OF ELECTRICITY GOING DOWN HER ARMS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced hand tremors, and feeling of electricity going down her arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling of electricity going down her arms and hand tremors was not reported. This report was non-serious.
Pt began complaining of severe pain in her right arm immediately after receiving vaccination. Within 5 minutes she began complaining of difficulty breathing and was treated with 2 Epi-pens, O2, Solu-Medrol and Ranitidine, after she resumed normal breathing. She continued to have pain and reduced movement in right arm.  1/8/08 Reviewed medical records which reveal patient experienced severe pain in contralateral right arm immediately s/p vax.  Difficulty breathing, tachycardia.  Tx w/epi, steroids, antihistamine.  Breathing improved but severe right arm pain & hyperesthesia continued & was unable to move right fingers.  Shoulder edema & curcular deltoid mass.  No reaction on previous anthrax vax x 3.    FINAL DX: anaphylactic shock due to serum
FACIAL SWELLING, HANDS, GIVEN FLU VACCINE ON 9/23/09 10:00 A.M.  WILL BE 23 OBSERVATION AT HOSPITAL FOR TREATMENT.  9/29/09 ED/Hospital records received DOS 9/24/09 to 9/25/09. Assessment Angioedema, Adverse reaction to influenza vaccine. Patient presents with swelling of face, lips and hands. Swelling of cheeks, lips, eyes.
patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) as dose 2; The patient has passed away; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team and a Pfizer sponsored program. The reporter is reporting on behalf of her husband.   A 76 year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose 2, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Dose 1, single), for immunization. The patient had passed away on 13Oct2021. The reporter stated that her husband got a second dose of pneumococcal 13-val conj vac (dipht crm197 protein) when he was in the hospital. He was deceased. The patient's  passing away did not have anything to do with receiving the second dose of the pneumococcal 13-val conj vac (dipht crm197 protein) vaccine as it happened so long after. The patient date of death was 13Oct2021. The reported cause of death was unknown. It was not reported if an autopsy was performed.   The lot number for pneumococcal 13-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified and assessed as unrelated.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: passed away
PT PASSED OUT UNCONSCIOUS FROM A SEATED POSITION 5 MINUTES AFTER RECEIVING HIS SECOND DOSE OF THE COVID SHOT.
11/1 vaccine was administered. That evening started chills - was in bed with aches, pains in joints and headache. All symptoms gone by Friday PM.
1. Severely swollen, very hard, warm to touch injection site.  Within 24 hours of my injection the injection site became severely swollen, extremely hard, red and warm to the touch.  The affected area is approximately 3-1/2" in diameter top to bottom and  side to side.  This continues to the present time which is 9/13/21 at 2pm. 2.  Experienced being extremely cold with chills, very fatigued with body aches all over....within 24 hours of injection lasting 72 hours.
Same day post vax, the pt developed an injection site reaction characterized by pain, heat, erythema, and swelling.
1st vaccine- sore arm with some swelling. Mild fatigue and nausea that day. Felt ok after that.  2nd vaccine- extremely sick 5 hours after vaccine. For 2 days had migraine, low grade fever,  severe body aches, extreme fatigue.  Couldn't stand longer than  3-5 mins.  Right arm was red, swollen and very sore for 3 days. The following week I had fatigue and flu like symptoms.  8 days after vaccine (Feb 21)  the following Sunday i was feeling worse like I had the flu and broke out with a localized rash on the right side of my neck.  The rash worsened and got more painful as the week went on and became pustules filled with clear fluid.  Sunday (Feb 28) I broke out with a rash all over my body. They were clear fluid filled pustules.  Monday ( March 1) I went to my primary care physician who stated i for sure had shingles but did not know what the secondary rash was from since it was all over my body and not just 1 side as with shingles.  The next day (Tues March 2) I went ad saw a dermatologist who  confirmed shingles and a secondary rare virus called disseminated zoster.  He was shocked saying he had only seen ever 2 other patients with this and they were immuno-compromised  and were on immunosupressants. It was been nearly a week since this diagnosis and I am still having nerve pain all over my body and extreme fatigue. The pustules are drying up.
This spontaneous report was received from an office manager and a nurse referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. Since 24-JAN-2017, the patients were vaccinated with an improperly stored PROQUAD Lot # M031945, expiration date: 27-DEC-2017 (strength, dose, frequency and route of administration were not reported) for prophylaxis, with a temperature of >5 Farenheit degrees <14 Farenheit degrees for 84 minutes. Additionally, previous temperature excursions were reported on an unspecified dates: >5 Farenheit degrees but < 14 Farenheit degrees for 6 minutes, >14 Farenheit degrees but < 46 Farenheit degrees for 1 hour and 48 minutes, >46 Farenheit degrees but < 77 Farenheit degrees for 2 hours and 42 minutes. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006115.
appeared the day after vaccination. on injection arm near injection site, not on, is red and hot to touch
08/17/04 - received smallpox vaccine on his left upper arm (3 jabs)- denies any problems. 08/27/04 - onset 0600 while sleeping - bilat chest pain ("dull pressure-like" 5/10) radiating to bilat neck and bilat axillaries (did not radiate down to arms) - constant pain and pressure - denies SOB, palpitations, diaphoresis, or n/v - not pleuritic or positional- Pt. presented himself to ER - pain relieved with GI cocktail - Pt. given dx of "non ST segment elevation MI"-Pt. transferred from ER to ICU 08/28/04 - no cardiac sx's during hospitalization - Pt. discharged from hospital in stable condition. 09/07/04- Pt. placed on temp medical suspension for two months (due to Pt. taking Cardizem). 09/27/04 - states had f/u appt. with Doctor, MD- states all his cardiac meds d/c'ed- no lab/ diagnostic tests ordered by Cardiologist. 10/15/04- patient seen by PCM-"Patient not fit to perform military duties (flight) from 10/15/04 to indefinite pending further notice and AMS" 10/19/04- "Patient deemed to be medically unfit for deployment. 10/26/04- Pt's medical documentation received from MD. 10/28/04- Pt. seen in the clinic by his case manager- states has not had any cp or other cardiac sx's since discharge from the hospital - letter sent to Dr. recommending 6wks cardiac f/u for Pt.- Pt. currently on med hold-scheduled to deploy in near future- Pt. would like to deploy ASAP. 11/01/04 - walk in received a copy of immunization record from Pt-copy of letter written to Doctor given to pt.- states has cardiology appt. in Dec 04 - importance of cardiac f/u reinforced - will reevaluate pt's status after results obtained. 11/02/04- spoke with pt's Case Manager, via phone- above plan of care reviewed. Symptoms: Chest pain start: 08/27/2004. END: 08/27/2004. Symptoms: Chest Heaviness Start 08/27/2004. END: 08/27/2004.  6/23/09 Medical records recieved DOS 8/17/04 11/28/04 Assessment: Probable acute myocarditis temporally associated with the receipt of the smallpox vaccine. Patient presented with bilateral (dull pressure like) chest pain radiating to bilat neck bilat axillaries.   ICD-9 Codes: 272.4 Hyperlipidemia
Paralysis; This is a spontaneous report from a non-contactable consumer. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient suffered from paralysis after he was vaccinated. He has been having issues with the left side of his body from head to toe since receiving the first shot of the Pfizer vaccine. He went to local hospitals where doctors ran every test and can't find anything wrong. He went to a local chiropractor who said he's seen similar issues from the vaccine in about 12-20 patients. The outcome of the event was unknown. The event was assessed as serious-medically significant.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Patient received Moderna Bivalent vaccine on 03-29-203. Upon review of records, the patient had already received a dose of Moderna Bivalent on 09-16-2022. Patient has not reported any adverse events from vaccination.
p/vax pt exp a vesicular rash, flu like sx & a sore throat;vesicle fluid 7 scabs were sent for analysis;lab results of this specimen revealed wild type virus by PCR analysis;
Several lesions back itchy 5-6 erythematous lesions with raised vesicles on back.
high fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (high fever). At the time of the report, PYREXIA (high fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.   This case was linked to MOD-2021-201725 (Patient Link).   Reporter did not allow further contact
I received my first dose of Moderna 12/31/20 (registered nurse) and my second dose around 1/28/21. I received my Moderna booster on 11/1/21. On 11/10/21 I became symptomatic but thought it was due to pregnancy complications (severe shortness of breath and tachycardia with minimal exertion and night sweats without a fever). I?m currently 36wks pregnant (due 12/23/21). On 11/18/21 Myself, my husband, and my 2.5yr old tested positive via PCR for covid-19. My husband has received his Pfizer series and booster (10/4/21). Our contact and exposure risk is low. I have been out on medical leave due to a high risk pregnancy, my husband has been teleworking, and my daughter stays at home with with us.  My husband stayed asymptomatic other than maybe fatigue. I developed severe congestion on the 19th that last 3 days straight. I have also had a covid rash on my left foot, shortness of breath, tachycardia, fatigue, and loss of taste and smell. It?s now nov 30 and I only have a rash and intermittent congestion left. We just had a high risk ultrasound yesterday 11/29 and baby appears fine at this time.
Abnormal soreness in arm and decreased mobility from date of vaccination to present. No treatment as of 11/8/17. Patient will be monitoring and will see a physician if the symptoms worsen or does not improve soon.