chrisvoncsefalvay/vaers-outcomes huggingface dataset:
light headedness; sore arm; chills; headache; nausea; fever; This is a spontaneous report from a Regulatory Authority via contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she experienced side effects after the vaccination. On an unspecified date, the patient experienced light headedness on the next day of vaccination, sore arm on the second day of vaccination and the events chills, headache, nausea and fever on the third day. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Light fever, nausea, body aches, painful aches and ?tight feeling? in stomach/abdomen, night sweats, chills, headache for 3-4 days. Treatment: wait it out, drink fluids, light exercise, extra rest, general self-care. Felt back to normal after 5 days.
Chest pain and Atrial Fibrillation, not heart attack per lab tests, after two weeks of extreme fatigue, finally back to feeling normal.
Pt presented to office with 2 day history of red, papular rash on b/l extremities and torso. Pt previously received varicella 5/28/99.
fever,  diarrhea, screaming, sleep issues, no more eye contact, decrease babble, large golf ball size knot on leg with bruise. tylenol for initial treatment
Information has been received from a Registered Nurse (the director of the facility) concerning a 4 year old female who 15-SEP-2010 was vaccinated with a single 0.5 ml dose of GARDASIL (lot # not reported). The nurse reported that on 15-SEP-2010 the patient was supposed to receive a pediatric vaccine (name and manufacturer unspecified), but instead received a dose of GARDASIL (lot # not reported). No adverse events involved. Additional information has been requested.
Parent/guardian called to report that they had taken child to the doctor due to an allergic reaction after DTap vaccine was administered. She stated the child developed redness/swelling  from elbow to shoulder and a large lump at the site of the injection about the size of "a medium potato". She stated the doctor prescribed steroids and ibuprofen and advised her to call and let us know about the reaction. Advised to follow up with PCP if any changes or worsening and call EMS if signs of severe allergic reaction.
Information has been received from a licensed practical nurse (L.P.N.) concerning a 22 month old male with no medical history and no drug reactions/allergies who on 26-MAY-2009 was vaccinated with the first dose of ROTATEQ (lot # 663842/0068Y, oral). The reporter stated that on 24-FEB-2011 the patient developed diarrhea and rotavirus infection after receiving ROTATEQ and ROTARIX. The patient received the ROTATEQ on 26-MAY-2009 and ROTARIX on 27-AUG-2009. The patient did not get the third dose. No treatment was given for the event. Rotavirus test was performed showed positive. At the time of reporting, the patient was recovering from diarrhea and rotavirus infection. The patient sought unspecified medical attention. Follow-up information was concerning a 22 month male who on 26-MAY-2009 was vaccinated with the first dose of ROTATEQ (lot # 663842/0068Y, oral). Secondary suspect therapy included a dose of ROTARIX (lot #: A41FA850A) on 27-AUG-2009. The reporter stated that on 23-FEB-2011 the patient developed diarrhea, fever and vomiting, the patient was seen in office on 24-FEB-2011. On 24-FEB-2011, Rotavirus stool screen was performed showed positive. At the time of reporting, the patient had recovered. Follow up information was concerning the male patient who on 24-FEB-2011 (previously reported as 23-FEB-2011) came to the office with diarrhea, temperature (previously reported as fever) and vomiting. At the time of the report, the patient had recovered. No further information is available.
Patient developed increase right upper arm pain and redness surrounding injection site, started afternoon of Nov 29 2017. Pt denies right axillary involvement. Place on antibiotic doxycycline, patient states improving discomfort and redness diminishing as of morning of Nov 30 2017.
fever, cough, fatigue, sore throat. tested positive in hospital after being admitted for a fall
Erythma, swelling, approximatley 4 1/2 - 5 inches in diameter, some warmth.
SLIGHT MUSCLE PAIN; SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 15-JUN-2021 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 15-JUN-2021, the subject experienced slight muscle pain. On 15-JUN-2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight muscle pain and slight fever was not reported. This report was non-serious.
Pt. passed out, had difficulty breathing, couldn't feel her left side, and had a seizure before paramedics arrived.
Systemic: Fainting / Unresponsive-Moderate, Additional Details: fainted, hit head, came to quickly, i helped, clinic nurse took vitals and ambulance called, pt walked out of store with ambulance
Patient, pregnant, received Infanrix; Infanrix instead of Tdap; 30 year old received Infanrix; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 30-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Tdap vaccine (received 1st dose on 21st January 2020).   On 30th August 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Infanrix at an unknown time during the pregnancy. On 30th August 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration were unknown. The pregnancy was ongoing.   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: 31-AUG-2022 Reporter's Comment: The health care professional reported that the patient who was 27 weeks and 4 days pregnant received a dose of Infanrix instead of Tdap (Boostrix). The reporter consented to follow up. Additional Supportive Information: The 30 years old pregnant patient received a dose Infanrix instead of Tdap (Boostrix) which led to wrong vaccine administered, inappropriate age at vaccine administration and vaccine exposure during pregnancy. This case had been linked with US2022124956 reported by same reporter.; Sender's Comments:  US-GSK-US2022124956:Same reporter
Black and blue at injection site for 1 week and pain in arm for 1 week.
8 days p/vax pt devel short episodes of generalized tonic sz lasting 1-3min; not associated to fever & w/a short post-ictal state; pt treated w/tegretol by recommendation of pediatric neurologist;
Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 58-year- old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 28Feb2021 at 13:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, diabetes type 2 and shellfish allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 07Feb2021 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced chills and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills and nausea was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Since then I have noticed blood spots on both my right and left forearms.; This spontaneous case was reported by a patient and describes the occurrence of RASH MACULAR (Since then I have noticed blood spots on both my right and left forearms.) 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 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced RASH MACULAR (Since then I have noticed blood spots on both my right and left forearms.). At the time of the report, RASH MACULAR (Since then I have noticed blood spots on both my right and left forearms.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.    Reporter did not allow further contact
pt recv vax 17NOV97 on rt arm & had soreness in that area every since;pt was instructed to f/u w/pvt MD;if the soreness does not demise p/using moist heat & a deep heat rub in the next few days;
Cough  Fatigue  Muscle or body aches  Congestion or running nose
Severe Swelling and Pain at injection site (deltoid muscle), with accompanying headache.  Took 1000 mg ibuprofen orally immediately after vaccine and 12 hours later.  Iced swollen area and continuing to ice 10 mins on/20 mins off.  Swelling and deep pain of deltoid muscle continue at time of report (almost 48 hours after vaccination).
Parent reported that patient had swelling in (R) leg. Parent reported that patient has no fever, rash, respiratory problems, and is playing appropriately. RN advised parent to use cool moist compresses to area.
This spontaneous report as received from certified medical assistant refers to a patient of unknown age and gender. On 06-AUG-2014 the patient was vaccinated with an expired dose of RECOMBIVAX HB (Lot # not reported, exp. date 05-APR-2014) (dose and route not reported). Concomitant therapy was not reported. No adverse event was reported. Additional information is not expected, since the reporter does not wish to be contacted.
Pt recvd 1st dose of Hep B Recombinant AUG92; 2nd dose administered in rt deltoid in approx SEP92; 1mo following 2nd inject pt was seen by MD w/numbness in lt middle & ring finges; devel numbness in rt middle & ring fingers;
pt reports, fever to 102, rash; hives, swelling, warmth to area; arm soreness shoulder to waist; cough;
No additional adverse effects were reported; received improperly stored PEDV AX HIB; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-JUL-2020, the patient was inoculated with an improperly stored 0.5 ml dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PEDVAX HIB) lot # T011167, expiration date was not provided but upon internal validation established as 27-MAY-2022 (route of administration was not reported), for prophylaxis.   The vaccine was stored at the temperature of 62.2 degrees Fahrenheit for 3 hours and 50 minutes. There was no previous temperature excursion reported. Digital Data logger was involved. No additional adverse effects were reported.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-FEB-2015, the patient was vaccinated with improperly stored dose of VAQTA pediatrician dose: 25U/0.5 ml (lot # J014584, expiration date: 16-JAN-2016; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 492 hours, with the lowest recorded temperature of -3 degrees Celsius, second lasting for 336 hours, with the highest recorded temperature of 59 degrees Fahrenheit (15 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient experienced seizure like activity 10 minutes after receiving the vaccine. Patient tensed up and became unresponsive. He was slightly shaking. This lasted for under a minute (RN estimated 20-30 seconds). Has had one seizure in the past as a child. Currently not taking any medications for this.
fever/chills and whole body muscle soreness for about 2 days, gone by third day.
In addition to expected side effects such as nausea, hot flashes and body aches, I experienced severe stomach pain on the second day that could not be relieved.  Lasted about 8 hours.  Both husband and I experienced this, had the same shot, and did not appear to have anything to do with food, as we eat different things.
Covid Positive after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid Positive after vaccination) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01T21-2A) for COVID-19 vaccination.     Concomitant products included DEXAMETHASONE for an unknown indication.    On 10-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2022, the patient experienced COVID-19 (Covid Positive after vaccination). At the time of the report, COVID-19 (Covid Positive after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2022, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.   Patient is taking Dexamethasone twice a day as maintenance dose. No further information given why he is taking that medication.; Sender's Comments: This is a spontaneous case concerning a 42-year-old male patient with medical history of concurrent use of dexamethasone, who experienced the non-serious unexpected AESI event of COVID-19. The event occurred approximately 4 days after the first dose of mRNA-1273 vaccine administration. Causality for the event of COVID-19 was not applicable. The rechallenge was not applicable. The concurrent use of dexamethasone considered as a confounding factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient received vaccine on 10-29-15 with FLUVIRIN shot calling saying red 3 inch circle around inj site. Flu site OK - went to physician told to take BENADRYL and draw bullseye around - think its just a rxn. Pt will follow up if needed. BENADRYL helped rxn gone down.
No additional adverse event reported.; Nurse reported administered ROTATEQ after temperature excursion.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 23-JUL-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter (ml) orally administered (lot number 1676324 which has been verified to be valid, expiration date reported and validated as 21-APR-2021) (vaccination scheme and frequency were not reported) as prophylaxis. The administered dose of the vaccine was stored at a temperature of 8.83 degrees Celsius, during a time frame of 20 hours, as recorded by a digital data logger. There was no previous temperature excursion. No additional adverse events were reported in the patient.
Left arm numbness; Left arm feels heavy; right hand numbness (feels like carpal tunnel on steroids); Left hand numbness (feels like carpal tunnel on steriods); shaky hands; tingling in legs; weakness left hand; Hot flushes; EXTREME SWEATING; FREQUENT URINATION; FATIGUE; HEADACHE; Sore arm; Nausea; Crummy feet and hands; A spontaneous report was received from a physician concerning a 53 year old, female patient who developed a sore arm, fatigue, headache, nausea, frequent urination, extreme sweating, hot flushes, and crummy feet and hands.    The patient's medical history included anaphylaxis. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 23 Dec 2020. On 23 Dec 2020, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot #039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020 the patient had a sore arm, fatigue, headache, nausea, frequent urination, and extreme sweating. The patient also reported that she had hot flushes and started to feel crummy on her feet and hands. Treatment for the event included paracetamol for headache, which subsided. Other symptoms were ongoing at time of the report.   On 07 Jan 2021, the patient reported more symptoms which include Left arm numbness, left arm feels heavy, right hand numbness (feels like carpal tunnel on steroids,) left hand numbness (feels like carpal tunnel on steroids,) shaky hands, tingling in legs, and weakness in left hand. It was also reported that all the original symptoms from 24 Dec 2020 have resolved.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.   The event, headache was considered resolved on 24 Dec 2020. The outcome of the events sore arm, fatigue, nausea, frequent urination, extreme sweating, hot flushes, and crummy feet and hands were reported as resolved.  The events, Left arm numbness, left arm feels heavy, right hand numbness (feels like carpal tunnel on steroids,) left hand numbness (feels like carpal tunnel on steroids,) shaky hands, tingling in legs, and weakness in left hand are reported as not resolved.; Reporter's Comments: This case concerns a 53-year-old female who had NS unexpected pain, pain in extremity, hypoesthesia, tremor, restless legs, muscular weakness, limb discomfort, pollakiuria, hyperhidrosis, hot flush, and NS expected fatigue, headache, nausea. Event onset occurred 1 day after the first dose of mRNA-1273. Treatment included paracetamol. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded
Client vaccinated with second Moderna vaccine @ 11:30 am 3/11/2021. went to waiting room @ 11:33 am for 15 minute observation after injection. At 11:40 RN noticed pallor and hard breathing. Pulse 76, Respirations 36 and BP 142/82. Client stated it felt like his heart was beating fast. Rn applied oxygen by nasal cannula @ 2L./minute @ 11:45am. Pt asked RN not to call rescue squad because he had similar episodes in past. At 11:50 client reports feeling better. Facial color normal. At 11:53am removed oxygen.At 12:03pm after no oxygen times 10 minutes client denies shortness of breath. BP 150/84, pulse 64 and respirations 18. At 12:05pm client stood independently and ambulated to car without any assistance.
developed rash on the injection site; more than a rash it was a big red blotch; started itching on the injection site but that there was nothing there; arm and shoulder pain , minor; arm and shoulder pain , minor; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm and shoulder pain , minor), ARTHRALGIA (arm and shoulder pain , minor), INJECTION SITE PRURITUS (started itching on the injection site but that there was nothing there), INJECTION SITE RASH (developed rash on the injection site) and RASH MACULAR (more than a rash it was a big red blotch) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for an unknown indication.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm and shoulder pain , minor) and ARTHRALGIA (arm and shoulder pain , minor). On 29-Jan-2021, the patient experienced INJECTION SITE PRURITUS (started itching on the injection site but that there was nothing there). On 31-Jan-2021, the patient experienced INJECTION SITE RASH (developed rash on the injection site) and RASH MACULAR (more than a rash it was a big red blotch). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm and shoulder pain , minor), ARTHRALGIA (arm and shoulder pain , minor), INJECTION SITE PRURITUS (started itching on the injection site but that there was nothing there), INJECTION SITE RASH (developed rash on the injection site) and RASH MACULAR (more than a rash it was a big red blotch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Pt developed generalized lesions with increased clusters at the site of vaccination and a fever.  Pt was diagnosed with chickenpox.  Pt was hospitalized for 7 days for IV acyclovir therapy.
Facility Manager reported that she put hospital on hospice on 3/15/21. HCP knew that she wasn't looking well.  Patient was transferred to hospice facility where she is currently.  HCP caled hospice on 3/5 and they came for the tranfser about 3 weeks ago.  Patient has Bone cancer