chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Next day post vax, the pt developed redness and swelling at injection site. She presented to ER with redness in left arm from shoulder 6-8 " down arm with swelling and warm/tender to touch. Treated with Medrol dose pack and Atarax.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot # J006358, expiry 23-MAY-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the (Oka/Merck) VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated (Oka/Merck) VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from  the same reporter. Additional information has been requested.
1/20/21: Headache; slight nausea with flip-flop stomach feeling; no appetite; sore arm injection area 1/21/21: Lingering headache but only slight; sore arm injection area 1/22/21: Lingering sore arm but dramatically decreased
DTAP given 06/15/04.  Injection site how with 10x10cm erythematous, hard, warm, tender area. Augmentin prescribed for cellulitis.
On Thursday 07/22/04 pt's face was really flushed and red. He felt hot. On Friday 7/23/04 he felt his body hurting and ver tired after a high fever of 101-102. Every 4 hours he was given Tylenol. He mostly slept most of both dates.
The pt experienced 6.5 x 4 cm area of redness with increased warmth and itching on right thigh, at the site of injection for 2 days. Treated with Benadryl and cold compresses.
pt recv vax 30SEP96 & 30SEP96 pt devel an erythematous area @ the inj site & a fever;
After administering MMRV and HepA vaccines to patient (while seated), I told him to let me know if he felt lightheaded or nauseous. I turned to enter the vaccines into the registry and he slithered to the floor. His father confirmed that his son was not acting (the boy had a vacant look on his face). I immediately called 9-1-1. Within less than a minute the patient was responding to verbal commands and trying to rise. We kept him on the floor until paramedics arrived to take over care.
Developed routine varicella after the vaccination. 17 days after 1st vaccination. Mild case-about 200 lesion-widely scattered. No fever. No resp sx.
nose hurts; ear hurts; temple hurts; white flashes on the side of her head; loose stools; shoulder pain; bad headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NASAL INJURY (nose hurts), EAR PAIN (ear hurts), FACIAL PAIN (temple hurts), HOT FLUSH (white flashes on the side of her head) and DIARRHOEA (loose stools) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine (Ocular migraines). Concomitant products included PARACETAMOL (TYLENOL) and CAFFEINE for Migraine.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL INJURY (nose hurts), EAR PAIN (ear hurts), FACIAL PAIN (temple hurts), HOT FLUSH (white flashes on the side of her head), DIARRHOEA (loose stools), ARTHRALGIA (shoulder pain), HEADACHE (bad headache) and NAUSEA (nausea). At the time of the report, NASAL INJURY (nose hurts), EAR PAIN (ear hurts), FACIAL PAIN (temple hurts), HOT FLUSH (white flashes on the side of her head), DIARRHOEA (loose stools), ARTHRALGIA (shoulder pain), HEADACHE (bad headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were not reported by the reporter.
Pain, unable to lift my arm. Extreme pain trying to move my arm. Nausea, vomiting. Flu symptoms.
Took him home and put him down for a nap. He had fever and cold symptoms, got vaccinated by nurses at the doctors office and was sent home. I went out of the room and had heard gurgling noises so rushed back in to see my son blue choking on vomit and barely breathing. We quickly picked him up and were able to get him breathing again but everytime we set him back down he turned blue. I took him to the ER and they said it was just reflux and sent us home. He only threw up once and has NEVER had reflux or symptoms. He ran a fairly high fever for three days. And has been sick ever since. He's required several hospitalizations and we usually end up at the doctors once a week or two. He was a perfectly healthy baby up to 4-6 months when vaccinations were forced on us by the pediatrician threatening to "fire" us as patients if not vaccinated. He stopped sleeping and became a very fussy baby, he also started refusing food and started getting allergies and has had skin sensitivities start as well. He's almost 18 months old and has terrible times sleeping and his tantrums are horrible. He isn't autistic but can at times seem like he is by beating his head off things when upset. We are extremely tight on bills, and close to losing our home from all the medical expenses piling up.
Patient reports fever 4 hours after receiving vaccination and shortness of breath the next day which lasted about 4 days.
got sick for about 5 hours/as soon as I took the shot I was sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick for about 5 hours/as soon as I took the shot I was sick) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 011620A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ILLNESS (got sick for about 5 hours/as soon as I took the shot I was sick). In February 2021, ILLNESS (got sick for about 5 hours/as soon as I took the shot I was sick) had resolved.            no concomitant and treatment medications are provided by the reporter.  The patient was on a high risk category. Patient had pre existences. The patient would have a total knee replacement.  3 patients that had the Pfizer's shoot and died from COVID.   This case was linked to MOD-2021-361518 (Patient Link).
Information has been received from a consumer concerning her 18 year old daughter who, on an unspecified date was vaccinated with her second dose of GARDASIL (Lot # and site not reported). Subsequently the patient experienced swelling, pain when being touched or taking a shower, joint pain, muscle weakness, nausea, difficulty breathing, general tiredness, congestion, eye redness, eyes swelling shut. It was reported "the swelling seems to come and go in different places". She has also experienced throat pain, and throat tightness. The mother reports "she hasn't felt well since the second dose  of GARDASIL.The mother also reported that her daughter is still experiencing "hurtful swelling and pain to her arms. She can not stay in school she hurts so bad." No further information was provided. Additional information is not expected.
Magnet stick to the vaccine injection area; 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 VACCINATION SITE REACTION (Magnet stick to the vaccine injection area) 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 VACCINATION SITE REACTION (Magnet stick to the vaccine injection area). At the time of the report, VACCINATION SITE REACTION (Magnet stick to the vaccine injection area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided
Post injection site pain; Left arm feels heavy around injection site; Left arm tingling; This is a spontaneous report from a non-contactable nurse, the patient. A 49-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 20Aug2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 30Jul2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 20Aug2021 at 12:30, the patient experienced post injection site pain, left arm felt heavy around injection site and left arm tingling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events post injection site pain, left arm felt heavy around injection site and left arm tingling was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (lot# K026247, expiration date: 29-JAN-2017), dose and route were not reported. No adverse effects reported. This is one of three reports received from the same source. Additional information is not expected, because there was no consent to contact the physician.
I developed arm pain and headache/nausea at about 11pm after the shot (at 1:30pm). I was nauseous, had body aches, severe arm pain, and a head ache all night and did not sleep well. Then I woke up at 1pm the next day with less arm pain, no nausea, less body aches, and a slight headache. This continued through the day, and then at 7:00pm I started to get a severe headache and arm pain again.
On 8/18 pt started getting back pains at T8 that spread down her spine to sacram.  Also had pain and numbness spreading to the left leg and part of right leg.  Also had pruritis with pain and diffuse petechiae on both upper later/posterior legs and shoulder/upper arms.  On 8/20 was admitted to observation.  Diagnosed with Menactra induced Henoch-Schonlein Purpura.
Redness, swelling, itching of vaccination site.  Swelling of top 1/4 of arm.  No treatment.
immunocompromised patient received 0.25ml dose of booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (immunocompromised patient received 0.25ml dose of booster) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Oct-2021, the patient experienced UNDERDOSE (immunocompromised patient received 0.25ml dose of booster). On 28-Oct-2021, UNDERDOSE (immunocompromised patient received 0.25ml dose of booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  The patient was immunocompromised, but she did not indicate it on her form, so she received 0.25 ml of Moderna booster instead of 0.50 ml third dose on 28-Oct-2021. Two days later, the patient  went back to get another dose of 0.25 ml. The patient received her first two doses of Moderna COVID19 Vaccine on unknown dates.
A large rash (about 8 inch by 7 inch) on the site of injection. Treated with Benadryl PRN and 1% hydrocortisone cream.
Shortness of breath; Rash within the whole body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash within the whole body) and DYSPNOEA (Shortness of breath) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.  On 29-Dec-2020 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced RASH (Rash within the whole body). On 30-Dec-2020, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, RASH (Rash within the whole body) and DYSPNOEA (Shortness of breath) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided.  Treatment for the event included Benadryl (diphenhydramine).   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Contact details provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Knot with swelling, wheal, edema, and tenderness with ring around it, about size of small grapefruit.
Type 2 Diabetic with levels at 544; Sore arm; A little tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIABETES MELLITUS (Type 2 Diabetic with levels at 544) in a 37-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.     The patient's past medical history included Type 2 diabetes mellitus.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIABETES MELLITUS (Type 2 Diabetic with levels at 544) (seriousness criterion medically significant), PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little tired). At the time of the report, DIABETES MELLITUS (Type 2 Diabetic with levels at 544), PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Blood glucose: upto 544 (High) Type 2 Diabetic - sugar level was up to 544, the highest she's ever been is around 350.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Underlying diabetes mellitus is a confounder.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Underlying diabetes mellitus is a confounder.
BLOOD CLOT; STARTED BACK UP ON ELIQUIS AT 7.5 MG BID; This is a spontaneous report received from a contactable reporter(s) (Physician) from License Party. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2022-134774 (Bristol-Myers Squibb Company).  Information was received from a Physician concerning a 68 Year(s) old Male patient, who received Suspect product APIXABAN for Product used for unknown indication (5 milligram(s) 2 every 1 Day); Suspect product COVID-19 VACCINE for Product used for unknown indication, lot number:Unknown. On an unknown date, the patient experienced thrombosis(blood clot) which was considered serious due to medical significance. It is unknown if treatment was provided. The outcome of the event is unknown. On an unknown date, the patient experienced prescribed underdose(started back up on eliquis at 7.5 mg bid) which was considered not serious. It is unknown if treatment was provided. The outcome of the event is unknown. APIXABAN was discontinued. The status of COVID-19 VACCINE medication is unknown. Concomitant medications were not reported. The reporter did not provide a causal assessment for events thrombosis and prescribed underdose to product APIXABAN. The reporter considered event thrombosis related to product COVID-19 VACCINE. The reporter considered event prescribed underdose not related to product COVID-19 VACCINE. Patient had a breakthrough blood clot while taking 5 mg BID of eliquis. He was around 350 pounds. She has also been working with a hematologist after the incident. They tried switching him to Lovenox after clot however he started coughing up blood. They have since started back up on Eliquis at 7.5 mg BID. She was hoping for some guidance on dosage and any information on Eliquis usage in obese patients. She was thinking Covid vaccines/boosters have instigated clotting, his last booster was a few months ago. She also stated her pharmacy team has seen more breakthrough clots in obese patients. The strength of apixaban was 5 mg. Tracking of Changes: 08-Nov-2022: Initial information was received.  Eliquis is under agreement with BRISTOL-MYERS SQUIBB.; Sender's Comments: This patient had blood clot while on therapy with apixaban. Based on the available information, it cannot be ascertained with reasonable possibility that the suspect drug contributed to the reported events and hence is unrelated to suspect therapy.  Pfizer comment: Based on the information provided, there is no information to suggest a causal relationship between COVID-19 Vaccine - (Manufacturer Unknown) and the reported event of thrombosis. Vaccination date and event onset dates were not provide at this time. Case will be reassessed upon receipt of additional information. 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.
Like Bronchiole dry cough/Coughing; Sore throat; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 86-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EP7534; Expiration date: not provided) via an unspecified route of administration on 19Mar2021 in right arm (age at vaccination 86-year-old) as dose 2, single for Covid-19 immunization at the college. The patients medical history included blood cholesterol, gastrooesophageal reflux disease (GERD), blood pressure and allergy. The patients concomitant medication included ezetimibe (ZETIA) taken for cholesterol; omeprazole (PROTONIX [OMEPRAZOLE]) taken for gastrooesophageal reflux disease (GERD); verapamil taken for blood pressure and fexofenadine hydrochloride (ALLEGRA) taken for hypersensitivity. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on 26Feb2021 (age at vaccination 86-year-old) as dose 1, single for Covid-19 immunization. It was reported that the patient got the second one on 19Mar2021 and on an unspecified date in Mar2021, the only reaction that patient had was sore throat. Now on 22Mar2021, 3 days after vaccination patient experienced sort of was getting cough, a very dry cough and wondering. The patient had basically was that night on 22Mar2021, patient saw the cough a lot started yesterday and it was like a Bronchiole dry cough and had it all day. Today patient got up this morning and had the same cough. Patient was just calling to just give you what one of the reaction from the Pfizer shot. Patient thought that just going to call doctor. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient had severe pain radiating from site of injection at shoulder to hand 30 minutes after shot. He also reported numbness & weakness on the right arm, but is able to move arm. Pt took Ibuprofen and pain & numbness were gone 3-4 hrs post injection.
Redness and itching at administration site extending down to elbow. Pt visited PCP and received prednisone per pt report. (visit on  7/28/16). RPH called to check on pt 7/29/16 and learned of PCP visit.
I had my Covid shot. My arm was sore; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (133943).  A 67 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HUMALOG; FLOMAX [MORNIFLUMATE]; CILOSTAZOL; ALBUTEROL SULFATE HFA; CLOPIDOGREL; ANASTROZOLE; TAMSULOSIN HCL; GEMFIBROZIL; WARFARIN SODIUM; LEVO-T; GABAPENTIN; CALCIUM. Past drug history included: Hydromorphone, reaction(s): "Drug allergies: HYDROMORPHONE".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had my Covid shot. My arm was sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse issues or side effects were reported surrounding the administration of the expired; dose of PNEUMOVAX 23 that expired on 07/30/2023; This spontaneous report was received from a medical assistant referring to a 20-year-old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 02-AUG-2023, the patient was vinadvertently accinated with pan expired neumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5mL via injection in the right deltoid, lot # U034712 with expiration date 30-JUL-2023, for prophylaxis (strength and route of administration were not reported). The facility recognized the incident on the same date. The vaccine did not experience any temperature excursions. No adverse issues or side effects were reported surrounding the administration of the expired vaccine. The person who administered the vaccine was an experienced medication aide and the product had been disposed of and was not available for retrieval.
pt recvd vax 2FEB95 & to hosp 13AUG95 w/3 days hx of cough & fussiness;day a/woke up coughing, devel watery stools, dec oral intake & sleeping more than usual;cried all noc;dx bacterial pneumonia;mild-mod resp distress;pale;dx react airway
Patient presented to clinic for appointment. Patient requested HPV vaccine. Provider did not see previous vaccination history in the EMR. Nursing did not check for prior vaccination. HPV vaccination ordered per provider and administered per nursing staff.