chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had immunizations done on 04/21/04 at 14:00.  Her 12 month vaccines were MMR#1 and Hib #4.  Mother stated there have been no reaction to any other vaccines the child has received.  PT come in on 04/23/04 and saw morning who said pt was fine and was her body reacting to her body mixing antibodies.  She was not contagious.
Transverse Myelitis; spastic twitching in thighs; severe back and leg pain; severe back and leg pain; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiration date not provided) via an unspecified route of administration, administered in left arm on 07Jan2021 15:00 as a single dose for COVID-19 immunisation. Medical history includes Hypertension, Gastrooesophageal reflux disease (GERD), prostate cancer and broncholith left lung. The patient has no known allergy. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine, losartan, pantoprazole, hctz, and acetylsalicylic acid (ASPIRIN). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on 17Dec2020 and experienced mild numbness and tingling in arms and legs following first dose of vaccine, followed by progressive weakness in legs. On 19Jan2021, the patient developed severe back and leg pain resulting in spinal fusion surgery on 25Jan2021. Postoperatively, the patient developed spastic twitching in thighs on 31Jan2021. On 07Feb2021, he woke up with weakness and clumsiness in left hand. At post-op check for spinal surgery on 10Feb2021, the neurosurgeon recommended another MRI and mentioned possibility of Transverse Myelitis. Following this MRI on 15Feb2021, he was again admitted to hospital for more extensive work up and was admitted for 6 days. Diagnosis made of Transverse Myelitis and was started on high dose steroid treatment and was discharged to home on 17Feb2021. Since then have had profound leg weakness, right side greater than left, which severely impairs mobility, especially stairs. He completed 5 day course of 1000 mg methylprednisolone per day as an outpatient on 20Feb2021. He is in PT and is unable to predict date of return to work. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Treatment for the events included high dose steroid therapy, PT and exercise. The patient underwent COVID test post vaccination via nasal swab on 24Jan2021 and was negative. The outcome of the events was recovering.; Sender's Comments: Based on available information the reported events are unlikely related to BNT162B2.  These are intercurrent medical conditions.  Case will be reassessed if additional information is received.  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 and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient presented to clinic about 20 minutes after receiving FLUVIRIN c/o throat swelling (mild) described as "cotton throat" no shortness of breath, no facial, tongue, or lip swelling, c/o mild dizziness. No prior reaction to FLUVIRIN. VSS IM Benadryl 50mg. given with significant improvement of symptoms, improved throat. Within 30-40 minutes after receiving Benadryl 50mg x 1 dose, patient reported significant improvement of throat swelling about 75% improvement. Dizziness improved after ate a nutrition/ energy bar and water. Vital signs stable. Ortho-static BPS/HR stable. HEENT/Respirtory/Cardiac and Neuo exam all stable/ normal. Alert and oriented x3 patient discharged in stable condition and advised to call 911 if symptoms recurred or worsened. Patient expressed understanding of plan. Advised to discuss future eligibility for FLUVIRIN vaccine with her primary care provider and inside under allergy skin testing.
pt recvd vax & w/in 24 hrs had sz; symptoms included limbs rigid in extension; tonic/clonic mvts; eyes clenched, head thrown back;
patient described her reaction as welts on left are near injection sight, rash, and swelling. patient treated with Benadryl for the itching.
DRY HEAVES; BODY ACHES; CHILLS; FEVER OF 103; This spontaneous report received from a consumer concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, high cholesterol, non-smoker, and non-alcoholic, and other pre-existing medical conditions included there was no drug abuse or illicit use. The patient experienced keflex allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805408) .5 ml, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced fever of 103. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced dry heaves. On 08-MAR-2021, the subject experienced body aches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 (unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 103, chills, dry heaves, and body aches. This report was non-serious.
With the first shot he was down for a week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (With the first shot he was down for a week) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-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 VACCINATION COMPLICATION (With the first shot he was down for a week). At the time of the report, VACCINATION COMPLICATION (With the first shot he was down for a week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment drugs were reported   This case was linked to MOD-2021-336266 (Patient Link).
Front of right bicep is extremely sore, majority of pain is localized to top, rear area of the deltoid, dull pain reaches down to elbow with occasional finger tingling, great discomfort and tightness when arm is laid on or raised from horizontal or higher, pain increases with pressure. 400mg of ibuprofen taken once for pain.
TINGLING SENSATION IN RANDOM AREAS OF THE BODY, INCLUDING  FEET, ANKLE AND SPECIFICALLY LEFT HAND; NUMBNESS SENSATION IN RANDOM AREAS OF THE BODY, INCLUDING  FEET, ANKLE AND SPECIFICALLY LEFT HAND; FEVER; TWITCHING A LOT IN LEGS; RESTLESS/MOVING LEGS; This spontaneous report received from a patient 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 was not reported, administered on 06-JAN-2022 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On JAN-2022, the patient experienced twitching a lot in legs, and restless/moving legs. Treatment medications included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. On 06-JAN-2022, the patient experienced fever. On 08-JAN-2022, the patient experienced tingling sensation in random areas of the body, including feet, ankle and specifically left hand. On 08-JAN-2022, the patient experienced numbness sensation in random areas of the body, including feet, ankle and specifically left hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on JAN-2022, and had not recovered from tingling sensation in random areas of the body, including feet, ankle and specifically left hand, numbness sensation in random areas of the body, including feet, ankle and specifically left hand, restless/moving legs, and twitching a lot in legs. This report was non-serious.
Temperature 101 degrees Farenheight/high temperature; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature 101 degrees Farenheight/high temperature) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Temperature 101 degrees Farenheight/high temperature). At the time of the report, BODY TEMPERATURE INCREASED (Temperature 101 degrees Farenheight/high temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (abnormal) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter. No treatment medication were provided by the reporter.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot number not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced red rash of the size of palm at the injection site. No treatment information was reported. No medical attention was sought by the patient. The outcome of red rash of the size of palm at the injection site is unknown. The relatedness for red rash of the size of palm at the injection site is unknown for ZOSTAVAX. Additional information has been requested.
The patient had bilateral Pulmonary Embolisms on February 8th. recommended we report this and any major incident a patient might have within 1 month of administering the vaccination.
Urticarial type reaction on deltoid region of several nonconfluent patches, fullness in the right supraclavicular region.
Information has been received from a doctor of pharmacy concerning a male who was vaccinated IM with first dose of Hep B vaccine. Subsequently the pt tested positive to Hep C. It was noted that prior to vax, the pt tested negative to Hep C.  No further information is available.
I ended my last period on April 20th. I got my first Pfizer shot on April 27th. I got my period on May 7th, over a week early than I should have and it is very heavy bleeding, more than normal, with severe cramping and fatigue. I am not on any form of birth control, and I am not sexually active. My period has never come early this far in advance. I also wasn't under any particular stress during that time period, or experiencing any unusual sleep patterns. Today is May 10th and I am still bleeding heavily. I may add another entry if the bleeding goes on for longer than my normal period. I also will be visiting my obgyn this afternoon.
Doesn't feel good; Temperature of 99.2; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Doesn't feel good), BODY TEMPERATURE INCREASED (Temperature of 99.2) and HEADACHE (Headache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING ABNORMAL (Doesn't feel good), BODY TEMPERATURE INCREASED (Temperature of 99.2) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Doesn't feel good), BODY TEMPERATURE INCREASED (Temperature of 99.2) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 99.2 (Inconclusive) temperature of 99.2.         Concomitant products used included blood pressure and cholesterol medications.  No treatment medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: TCR-follow-up received on 15-Jun-2021 contains no new information. Consumer reported everything was fine and declined further follow-up.
Vomiting and diarrhea started 5-4-23. Approximately 4 liquid stools per day. Is able to take oral fluids but sometimes vomits after. Slightly fussy. No fever. Not lethargic. Parent is concerned diarrhea has persisted for 5 days. Parent called Health Dept. 5-8-23 for advice. Advised to call Dr. her PCP and have the baby examined by her today if possible.  If unable to schedule for 5-8 or 5-9 take baby to urgent care clinic. If baby begins persistent crying, fever, distended abdomen, unable to keep fluids down, increase in BMs (more than 6 per day) take baby to ER.
pain to injection site arm; pain to injection site arm, which feels swollen and tender; nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 18Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "pain to injection site arm"; VACCINATION SITE SWELLING (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "pain to injection site arm, which feels swollen and tender"; NAUSEA (non-serious) with onset Apr2021, outcome "unknown", described as "nausea"; VOMITING (non-serious) with onset Apr2021, outcome "unknown", described as "vomiting".  Additional Information: In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (5 microgram/0.5ml (thimerosal free, lot # L007558, expiration date 10-NOV-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for reach time were 40, 34, and R. The storage criteria was refrigerator (R). This is one of several reports from the same source. Additional information has been requested.
(Janssen COVID-19 vaccine EUA ) I became ill a few hours after receiving the shot. The bones in my entire body ache (including my fingertips). I had a bad case of the chills. I spent the rest of the day and night bundled up under 3 layers of blankets. I lost my appetite but continued to drink water as directed by the Pharmacy staff. I felt back to normal when I awoke the next morning.
cardiac arrest; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (cardiac arrest) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack in September 2020. Concomitant products included LEVOTHYROXINE, ATORVASTATIN, CLOPIDOGREL BISULFATE (PLAVIX), CARVEDILOL, ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMIN D3, ALENDRONATE SODIUM (ALENDRONATE), LISINOPRIL and FAMOTIDINE for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criterion hospitalization). The patient was hospitalized on 27-Mar-2021 due to CARDIAC ARREST. At the time of the report, CARDIAC ARREST (cardiac arrest) outcome was unknown.            Cardiac catheterization to be performed on the patient on 31-MAR-2021.  Based on the current available information and temporal association between the use of the product and the onset date of the reported event of cardiac arrest, a causal relationship cannot be excluded. However, patient's recent myocardial infarction may have been contributory.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of cardiac arrest, a causal relationship cannot be excluded. However, patient's recent myocardial infarction may have been contributory.
Nine days, post vax, I developed a severe cold. I had not had a cold for 2 years prior to flu shot.
Infanrix - Administration of an expired dose.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 13-JUN-2023, the patient received Infanrix. On 13-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Infanrix - Administration of an expired dose.). The outcome of the expired vaccine used 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 Information: GSK receipt date: 13-JUN-2023 The health care professional (HCP) asked for information about adverse reactions following the administration of the expired dose. The reporter consented to follow up. The patient was administered an expired dose of Infanrix, which led to expired vaccine used.
This spontaneous report was received from a clinical medical assistant referring to a 4 month old patient of an unknown gender. The patient's concurrent conditions and medical history were not provided. On 06-JAN-2016 the patient was inadvertently vaccinated with a dose of VAQTA, lot # L015460, expiration date on 20-JUL-2017 (route, anatomical location and dose were not provided). Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. Additional information has been requested.
This 7 year old pt was given Prevnar on 1/14/02 due to a history of recurrent pneumonia. That evening he developed a fever of 103.5F and a red and sore vaccine site on his right deltoid. He was seen on 1/15/02 for increased red and sore area. On exam, it was consistent with a local rxn; not cellulitis. The entire area had blanching erythema; not indurated or intense erythema.
At 6pm the day of the injection I began post menopausal bleeding. (I have have not had a period for 4-5 years). I have contacted primary care provider to see if I need to follow up with him. Have not yet heard back from his office. I have  also contacted GYN, and they have scheduled me for an appointment on 7/21/21.
Patient directed to table #1 to receive vaccine. Patient stated that she has anxiety when getting shots but was ok after 1st dose. After administering 2nd dose patient stated she was a little light headed. Nurse encouraged pt. to stay seated and remember to breathe. Patient started drinking her orange juice and stated she was ok. Patient continued to close her eyes and nurse asked if she was ok and patient stated "I feel it coming, I'm about to  pass out." Patient then started to lean in chair and with nurse beside her for safety notified nurse lead and post ob nurses for assistance. This nurse responded to station one to assist. V/S taken immediately. BP94/47 P52 Ox 99% T97.3 RR20 BS85. Patient began to respond appropriately. Assisted patient in to a laying position. Patient continuously monitored following incident for 30 minutes. Remained AOx4. Patient stated she was feeling better. Assisted in to chair by nurses. VS rechecked BP 104/69 P59 O2 98% Pt. was accompanied by mother and released after stabilized.
Sore Arm beginning the moment patient received vaccine.  Pain never improved.  3 weeks after receiving vaccine, pain worsened.  Pain is currently at 7 (on a scale of 1-10).  Patient experiences pain when trying to reach above her shoulder.  Unable to wash hair, difficulty putting on clothing.
Received MENACTRA to left arm on 11-3-15 left deltoid mow with about 5 cm x 5 cm round erythema, hot to touch, painful.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On unspecified dates in 2015, the patient was vaccinated with the first and second dose of GARDASIL as recommended schedule at 0 months and 2 months (dose, route of administration, lot number and expiration date were not reported). Additionally, it was also stated that on 06-JUL-2016 (reported as "a little over a year, since the vaccination series was started"), the patient received the third dose of GARDASIL 0.5 ml, intramuscular, lot # L035105, expiration date 14-MAY-2017 (Anatomical location was not reported). No other suspect or concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Dizziness, lightheadedness immediately after vaccine. Vertigo (spinning sensation) same night and 3 nights thereafter. Numb and painful and swollen left hand and wrist 2 days later. All symptoms have gone except dizziness still present.