chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had significant swelling and redness in left arm after receiving the Arexvy. Said swelled up to lump the size of a golf ball and had redness the size of a tennis ball. Felt tired and feverish that evening. Flu shot injection site had some swelling and redness. Patient took Benadryl and wrapped left arm in a cold cloth when they went to bed that evening. Came in to pharmacy on 9/9 and right arm looked almost fully improved and left arm had some redness still but looked like it had improved a lot since 9/6.
No treatment. Pain/discomfort. Right arm. Soreness in injected arm; increasing with time (since October 23, 2013, or 10/30/13 increasing to today, Feb. 1 2014).
Chest discomfort and SOB since 3/5/21 Non occlusive thrombus to the RUL anterior segment of the pulmonary artery
Pt's arm swelled up to twice it's normal size. Also was very painful, so painful the pt could not move it.
Right hand side shoulder down to about 3-4 inches was really sore, it was down her right arm, it feels like somebody pulled the nerves or the tendons and is suffering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (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: ARTHRALGIA (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Right hand side shoulder down to about 3-4 inches was really sore, it was down her right arm, it feels like somebody pulled the nerves or the tendons and is suffering ". The event "right hand side shoulder down to about 3-4 inches was really sore, it was down her right arm, it feels like somebody pulled the nerves or the tendons and is suffering " was evaluated at the physician office visit. Therapeutic measures were taken as a result of arthralgia.  Additional information: The patient took one to two 200 mg unspecified pain relief medication but didn't help and was a little better only for 3-4 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L026553 expiration date: 16-JUL-2017, (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 15 year old female with a history of reflux as a young child and no known drug allergies, who on 20-DEC-2007 was vaccinated with a first dose of Gardasil. Subsequently, the patient felt nauseous and "not quite right." On 20-FEB-2008 the patient was vaccinated with a second dose of Gardasil. Concomitant therapy included meningococcal vaccine (unspecified). On 20-FEB-2008 after the vaccination the patient almost passed out, was nauseous, diaphoretic, and had a severe headache on the way home from the office. The nurse reported that it was not a vagal response. On 21-FEB-2008 the patient felt dizzy and had tachycardia upon arrival to the emergency room. The patient was treated with one liter of saline (previously reported as IV fluids), and a dose of ZOFRAN. The patient felt somewhat better. The client was then given contrast for the abdominal scan, and was nauseous again. An abdominal CT scan was performed and was normal. A pregnancy test was negative. An EKG was performed and was normal. The patient was not hospitalized. It was reported that the patient had lost 5 to 6 pounds and could not eat or drink without feeling nauseous. The patient's mother reported that she did not think the patient's nausea was related to vaccination with Gardasil. The mother believed that the patient "has something like an acid reflux and the Gardasil initiated it." The patient was seen by a gastroenterologist and started the patient on REGLAN and PREVACID. At the time of the report, the patient had not recovered. No product quality complaint was involved. The nurse considered the nausea, dizziness, diaphoresis, weight loss, and not being able to eat or drink to be other important medical events. Additional information has been requested.
Fever developed on the same day. Then left arm pain spreading across chest on 6/12. Pain improved with benadryl x 2-3 days after patient was seen in ER on 6/16 and left AMA before any work-up was complete. Chest pain returned and worsened, worse with laying down and improved with sitting up and leaning forward. Pain relieved with Toradol, patient diagnosed with pericarditis and started on colchicine at Cardiologist's recommendation. Negative cardiac enzymes.
SENSE OF TASTE GONE; STRANGE TASTE IN MOUTH; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, non-alcohol use, non-smoker, lupus, high blood pressure, and high cholesterol, and other pre-existing medical conditions included: In youth tried several illicit drug usage, now has medical marijuana and vaporizes marijuana on an as needed bases. The patient was previously treated with memantine hydrochloride for high blood pressure, high cholesterol, omeprazole, ezetimibe, tramadol, folic acid, zinc; and experienced hives and swelling when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. Concomitant medications included hydroxychloroquine phosphate for lupus, and prednisone for rheumatoid arthritis. On 12-SEP-2021, the patient experienced sense of taste gone. On 12-SEP-2021, the patient experienced strange taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sense of taste gone, and strange taste in mouth. This report was non-serious.
Initial report received from consumer on 14 Jan 2010: This patient was vaccinated with FLUVIRIN, batch number 97851P1, unspecified dose intramuscular on 16 Oct 2009. On 26 Oct 2009, the patient experienced welts, itchiness and redness in different places each day beginning. On 11 Jan 2010, the patient was diagnosed with Urticaria. The outcome of the events was reported as ongoing. Following internal review of the data on 29 Jan 2010, it was noticed that the manufacturer receipt date of the initial report received on 13 Jan 2010 had been incorrectly presented as 14 Jan 2010. The correct receipt date was 13 Jan 2010.
PATIENT WAS HAVING DIFFICULT BREATHING. PATIENT WAS NERVOUS DURING THE ADMINISTRATION PROCESS
lighteheaded, nausea, felt like passing out, EMS evaluated, pt. refused transport.
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient received pneumococcal 13-val conj vac (dipht crm197 protein) and her arm became swollen on an unspecified date with outcome of unknown. Information on the batch number has been requested.
approx 30mins p/vax mom calls back stating pt breaking out in large red whelps contacted MD dx allergic rxn given Epi & DPH;
Mom states had painful red lesion s/p tetanus shot. Pt says only hurts on deep palpation. Treatment for Cellulitis with antibiotics.
Patient was nauseous and vomited afterwards. She stated that she hadn't eaten or drank anything before coming to the clinic.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an 82-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. No adverse event was reported. Treatment information was not provided.
Patient received vaccine without incident. About 5 minutes into the observation period, the patient began complaining of tightness in the chest that felt like allergic reactions he had experienced in the past. Patient had a history of severe ASCVD.  He appeared calm without any trouble breathing, BP 140/80, pulse 84. Patient did not appear in distress, no clammy skin, no change in outward appearance of any kind. Patient denied chest pain. He stated that is was nothing like what happens when he has ASCVD-related chest pain. He was administered 50mg of oral diphenhydramine. Within 60 seconds of taking the oral diphenhydramine, he stated that he could feel it working and was starting to feel much better. Patient was advised to remain at the pharmacy for further observation but refused (documented). He left with his caregiver.
02/24/2021 11:30 PM Chills Pain at injection site Swelling at injection site Extreme fatigue Nausea   02/25/2021 11:00 AM Continuance of symptoms listed above Fever 100.2
Received second dose two weeks before scheduled date; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose two weeks before scheduled date) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose two weeks before scheduled date). On 13-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose two weeks before scheduled date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.  The action taken with mRNA-1273 with the events was considered as not applicable
I was having right upper quadrant liver pain, my spleen was sore and a little enlarged. I was having GI symptoms.
Patient starting feeling dizzy, malaise, and runny nose approximately 3-4 hours after vaccine, patient was monitored and had normal vitals. Patient stopped feeling dizzy after 15-20 minutes but continued to feel malaise and runny nose.
Severe headache lasting over a month.  4 ibuprofen every 4 hours for the first week.  2-3rd week every 6 hours through the day (none at night).  Headache started to travel down to the face on week four and then slowly went away.
Patient was given booster dose of Moderna bivalent vaccine then admitted to not having had any doses of the primary series COVID monovalent vaccine prior.
9:30 pm patient awoke feverish. mother gave Motrin. Patient while sleeping would jerk spontaneously. 12:30 am on 9/25/2008 patient had generalized seizure activity followed by short period of apnea, lips turned blue and sluggish to verbal and physical stimuli. Patient taken to local ER, temp 101.2 Redness and rash on right thigh at site of injection. Tylenol, Motrin, and Amoxil given
Patient appeared nervous upon receiving vaccine. Patient reported trouble swallowing ( has a history of radiation therapy on throat). When asked if breathing was restricted, patient was able to take long breaths with minimal additional effort. Shortly after, patient appeared to be close to passing out (not completely awake and alert), eyes dilated. The pharmacist who administered the vaccine then administered one dose of the epinephrine (Epi-pen LOT:0FM353/eEXP:NOC 21) while the staff member kept the patient stable in her chair. The facility was instructed to call 911. At 11:49 AM (7 minutes later), symptoms began to improve and the patient became more alert. EMS arrived around 12:00PM to take patient to hospital--patient refused and was back walking around the facility 5 minutes later. No further issues were reported with this patient (pharmacist administering the vaccine left the facility around 1:15PM)
1) About 10:45am July 6, 2021 - Severe Nausea and Diahrea folowing Vaccination 2) Continued Diahrea July 7, july 8, July 9, ranging from watery stool to dark loose stool 3) july 9 at 6am - awoke with NOSEBLEED in Left Nostril, dark red blood with clots 4) July 9 about 7am, NOSEBLEED in Left Nostril, dark red blood with stringy clots 5) July 9 about 8 am NOSEBLEED in Left Nostril, bright red blood with clots 6) July 9 2pm, Was able to see   Nurse Practioner at my Drs. Office who confirmed bleeding in both nostrils and ordered blood testing. 6) July 10 and July 11, continued Diahrea with Black, Dark Stool, with urgency.
No adverse event; patient administered with monovalent Moderna vaccine (0.5 mL) instead of Moderna bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient administered with monovalent Moderna vaccine (0.5 mL) instead of Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 13-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient administered with monovalent Moderna vaccine (0.5 mL) instead of Moderna bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient administered with monovalent Moderna vaccine (0.5 mL) instead of Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient administered with monovalent Moderna vaccine (0.5 mL) instead of Moderna bivalent booster).    Concomitant medication information was not provided.  No adverse event was reported post vaccination.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-661311, US-MODERNATX, INC.-MOD-2022-661318. Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661311:same reporter US-MODERNATX, INC.-MOD-2022-661318:same reporter
9 days post vaccination pt returns to clinic c/o pain and swelling since 2 days ago. Observe tenderness, swelling, redness, that extends 9.5cm x 9.5cm. Blister white with secretions.
Normal vaccine side effects (chills, body aches) for 2 days and then on 6/28/2021 severe loose diarrhea that is still ongoing. She otherwise does not feel ill.
body aches; incredible fatigue; headache; This is a spontaneous report from a contactable  health care professional nurse, the patient. A female patient (nurse) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on unspecified date  as a single dose,  for COVID-19 vaccination. The patient medical history and  concomitant medications were not reported. On an unspecified date, the patient experienced incredible fatigue, and body aches followed with a headache for about 24 hours. The clinical outcome of the events fatigue, body aches  and headache was unknown.   No follow-up attempts are possible; information about lot number cannot be obtained
Pt had large local rxns to Anthrax #1,#2, and #3. Pt had blisters, headache, diarrhea, now resolved.
I am severe chills teeth chattering - then vomit (12-14) times urinated while vomiting. Lasted 3:30 hrs then fever took 24 hrs to recover.
metallic taste in their mouth; esophageal reflux; burning in the throat.; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in their mouth), GASTROOESOPHAGEAL REFLUX DISEASE (esophageal reflux) and THROAT IRRITATION (burning in the throat.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A20A) for COVID-19 vaccination.     Concomitant products included VERAPAMIL for Hypertension.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced DYSGEUSIA (metallic taste in their mouth), GASTROOESOPHAGEAL REFLUX DISEASE (esophageal reflux) and THROAT IRRITATION (burning in the throat.). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse reaction, at an unspecified dose and frequency and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (metallic taste in their mouth), GASTROOESOPHAGEAL REFLUX DISEASE (esophageal reflux) and THROAT IRRITATION (burning in the throat.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-404760 (Patient Link).
10 min after given flushing, nausea, headache, petechia back, came to RN office, redness decrease to chest with hives. Benadryl 50mg IM given, V/S prior 11am 143/76m 78 16 after 11:15 144/82 74, 11:30 pt fine. Returned to class room.
Patients skin raised at injection site. She felt nauseous & had palpitations. She said she also felt cold & her arm was hurting at injection site.
Info has been received from an RN concerning a 30 year old female who on 8/13/02 and 9/18/02 was vaccinated with the 1st and 2nd doses of Hep-B. Concomitant therapy, on 8/13/02, included a dose MMRII. On 8/26/02, the pt experienced pain in the fingers of both hands which progressed to her wrists. On 9/26/02, the pain got worse and traveled into her back. On that same date, the pt went to her physician. The pt had tests performed which showed a positive arthritis panel. The pt was treated with anti-inflammatories and was scheduled to see a rheumatologist. The pt sought unspecified medical attention. Additional inform has been requested.
Pt had hives over face & trunk 3 days p/recvd vax; these were relieved by PO DPH but returned the next AM; no other new meds, soaps, laundry, dets, etc;
no adverse event; received improperly stored vaccine which was administered via unspecified route; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/ allergies and concomitant medications were not reported. On 05-FEB-2020, the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot number S033516 and expiry date 29-JUN-2021 (strength, exact dose and anatomical location were not reported) for prophylaxis (product storage error). The administered dose of the vaccine experienced a temperature excursion total time and highest temperature as follows: above 47 degree fahrenheit/ 9 degree Celsius 47.6 degree fahrenheit and for a time frame of 15 minutes, above 47 degree fahrenheit/ 9 degree Celsius 52.5 degree fahrenheit and for a time frame of 15 minutes, above 47 degree fahrenheit/ 9 degree Celsius 46.7 degree fahrenheit and for a time frame of 15 minutes and above 47 degree fahrenheit/ 9 degree Celsius 47.1 degree fahrenheit and for a time frame of 15 minutes, as recorded by a data logger. The vaccines had previous temperature excursion. No additional adverse event was reported. No product quality complaint (PQC) was reported.
Expired vaccine given to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported by reporter. Treatment information was not provided by reporter.
About 3 minutes after vaccine, the patient got dizzy and fell. His girlfriend was also with him. We helped him to chair. He said he was dizzy and hot. Immediately after that, he stopped communication. His eyes wide open, unblinking, staring into space. Girl friend shook him to get his attention, and he did not respond to our questions. We called 911. A minute later, pt was back to communicating, very white. Paramedics monitored him about 20 minutes and he then was able to get up and walk out. Don't know about any further reaction