chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart palpitations, shortness of breath, lymph nodes swollen. I went to my PCP on 4/14 due to severe shortness of breath. I went to urgent care on 4/15 for severe shortness of breath. At the urgent care the did a chest X-ray and EKG and they were both fine. The doctor prescribed a 5 day course of prednisone to calm the inflammation down in my lungs. After two days of taking the prednisone the shortness of breath was worse.  On 4/19 I went to the Emergency Room because of the shortness of breath and pain in my back and sides. The doctor ordered a CT Scan of my chest and lungs and labs. The test showed no blood clots but the blood test that determines if you have a clot or that will lead a doctor to get a CT Scan was elevated. The doctor said I was basically ok because I did not have any blood clots. She said I was experiencing some type of respiratory issue. On 4/22/21 I saw an allergist to see if I had some type allergic reaction to the vaccine. My allergist said there was no way to test the components in the vaccine but he did test me for other things. On 4/26/21 I followed up with my PCP and he gave me Maloxicam and a pain medication to take if I needed it. I was in so much pain in my sides that I couldn?t put my arms down comfortably. I continued taking two Tylenol?s every 6 hours. On 4/30/21 I saw my pulmonologist to discuss my symptoms and he talked about the prednisone suppressing my immune system so the one shot that I did get won?t really cover me. He changed my inhaler earlier this year and he said he should have left it where it was because of the time of year and my allergies. My allergist put me back on symbicort and my pulmonologist agrees and he want to keep me on it until next year. I started to feel better on 5/1/2021/ . I did not get the second vaccine because I was afraid. I have never been so sick in my entire life and none of the doctors could really tell me what happened.
24 hours later started to develop hives on different parts of the body. Called healthcare provider and took Benadryl and went to sleep. Woke two hours later with hives all over torso and starting to develop on face. When to ER and was given antihistamine and steroids and monitored. Went home after a couple hours as hives subsided. Took steroids and antihistamine prescriptions which helped. Had a few smaller hives the next day before starting prescriptions.
On 8/16/21 @0815, patient was given COVID19 Moderna vaccine dose #1 from vial that was past the beyond use dating (12 hours from 1st puncture).  The vial was initially punctured on 8/15/21 @1034AM with BUD of 8/15/21 @1034PM.   Patient was notified in the afternoon on 8/16/21 regarding the error and did not report any adverse effects.  Patient was referred and has reached out to worker's compensation.  Moderna was contacted on 8/16/21 inquiring if the dose will need to be replaced.  On 8/18/21, Moderna's response was received and recommended that no additional dose is needed to replace the initial dose.
No additional AEs; expired vaccine was inadvertently given to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 04-MAR-2021, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #S012247 which was verified to be valid with expiration date: 10-FEB-2021) in dose 0.5 milliliter as a prophylaxis (dose number, route of administration and anatomical location were not reported). No temperature excursions were reported, no additional adverse events occurred. The outcome of expired product administered was unknown. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S012247; expirationdate: 10-FEB-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
1hr after receiving vaccine, left eye swollen, watery, red.  Patient received Rx antibiotic/steriod drops from private eye doctor. 2 days after completing drops symptoms of red, swollen, watery eyes in both eyes appeared.  Have not cleared to date
The female patient had more localized swelling at the injection site which was on her left arm; Redness, swelling, pain, and a large hard knot at the site; Redness, swelling, pain, and a large hard knot at the site; Redness, swelling, pain, and a large hard knot at the site; This spontaneous report as received from an office manager refers to a 64-year-old female patient. Her concurrent conditions included chronic obstructive pulmonary disease (COPD), heart disease, diabetes and hypertension. The patient was allergic to terbinafine (LAMISIL) and itraconazole (SPORANOX) (reported as SPROANOX). The patient's concomitant therapies included meloxicam (MOBIC), albuterol sulfate (PROAIR), alprazolam (XANAX), atorvastatin, furosemide, glimepiride (AMARYL), lisinopril (manufacturer unknown), tiotropium bromide (SPIRIVA), fluoxetine, metformin and bupropion.  On 06-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # T009744, expiration date 28-JAN-2022, intramuscularly in the left arm to prevent pneumonia. On the same day, on 06-OCT-2020, the patient was also vaccinated with an influenza virus vaccine inactivated (unspecified) (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis.  On 06-OCT-2020, the patient had more localized swelling at the injection site which was on her left arm, she had more redness, swelling, pain, and a large hard knot at the site. The patient did not seek for medical attention. No treatment was given for the events. On 07-OCT-2020, the patient recovered from the events.  The relatedness between the events and the suspect vaccines was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: T009744; expirationdate: 28-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
1-14-06 Had 20 second seizure @ 3am, Temp 102.
Left Arm where injection was administered is red, hot, hard and itchy.   About the size of a silver dollar.  Also looks as if it is alittle raised as if it?s  infected and has a blister or puss
Within 24 hrs after immunization pt experienced disorientation and pain at injection site.  Treated w/Decadron & prednisone.  On 27-MAY-89 developed fever, swollen lymph nodes at inject site, following day a repeat dos of Decadron given.
Headache, Myalgia, sore arm at injection site Narrative:  phone call
Chest pain, shortness of breath, nausea, vomiting, and left arm numbness
Headache 1/10- Redness, swelling, pain/discomfort at the injection site Narrative:
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:01 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 27.50 for dose administered on 15-Apr-2021  Concomitant products were not provided.  On 15-Apr-2021, At excursion time 09:00 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  Vial was stored on cooler 1, on 15-Apr-2021, Excursion duration At 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM: 43, 2 PM : 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported for a 24 year-old female patient of an unspecified race and ethnicity who received in Apr2016 for immunization a single dose of PREVNAR 13, a dose of TDAP, a dose of haemophilus influenza type b vaccine, a dose of recombinant hepatitis b vaccine and a dose of poliovirus vaccine. Medical history included ongoing immunosuppression, concomitant medications were not reported. On an unspecified date in 2016 she had a very robust response to the vaccines with fever. Outcome was unknown. They would continue to hold off on further vaccinations as at the present time the patient remained immunosuppressed in treatment with prednisone and subcutaneous Ig.
Symptoms: Heartburn ; Chest Pain/ Tightness ; Shortness of Breathe; Nausea ; Burning/Tingling Sensation in hands and feet ; Tingling/Numbness in face; Body Ache and Fatigue ; Costochondritis;  Vision ? Had blurred vision, pain in the eyes, and some headache- resolved after 3-5 months; Have to limit physical movement, talking/laughing, diet.   Treatments: Pantoprazole SOD -40mg ? Once a day, before bed (did this for 2 months, no improvement);Famotidine 40mg ? Once a day, before dinner; Baclofen 10 mg- Once a day, before bed ; Amitryptiline 10 mg- Once a day, 6 pm (Briefly switched to zoloft for a month but wasexperiencing extreme nausea, diarrhea, etc so switched back to Amitriptylline); Sucralfate 1GM ? Twice a day ? Morning and evening (stopped after 6 months);  Mylanta and TUMS as needed; Spiriva Inhaler ? maintenance, once a day 2 puffs ;  Levalbuterol rescue Inhaler /Nebulizer? as needed  but often once a day; Xyzal; Montelukast; Nasonex; VOltaren Gel (as needed); Tylenol (as needed)
Pt rcvd immunization on Friday and developed macular-papular rash of arms, legs, torso on third day accompanied by itching.  No change in personal care products.  No ingestion of new foods/beverages/medications.  Rash continues on fifth day. Tx. Benadryl, Calamine, hydration, observation.
The morning after the shot, I had flu-like symptoms including body aches, chills, nausea and pain at the injection site.  By the afternoon, I had a pounding headache and was exhausted.  I got into bed at around 5pm and slept all the way through until Friday morning.  By Friday morning, the symptoms had improved and by Friday afternoon I felt back to my normal self.  On Sunday, I began to have pain in my armpit on my left arm where I received the injection.  The pain under my armpit lasted almost a week, feeling unnoticeable for the first time today (Sunday).
Delayed Extreme urticaria/large welted hive like  reaction on axillae, groin , abdomen and upper arms that lasted for 7 days.  Responsive to antihistamines over the course of 4 days. Rash came and went, especially reactive in evening from 5pm on.
Nurse reports that they inadvertently administered a monovalent vaccine to a patient which was past the published expiration date.; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse reports that they inadvertently administered a monovalent vaccine to a patient which was past the published expiration date.) and NO ADVERSE EVENT (No Adverse Event) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071B22A and 074B22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Not that the HCP is aware of.  Previously administered products included for Product used for unknown indication: MODERNA COVID-19 VACCINE on 07-Feb-2023. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE.   On 07-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse reports that they inadvertently administered a monovalent vaccine to a patient which was past the published expiration date.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse reports that they inadvertently administered a monovalent vaccine to a patient which was past the published expiration date.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported No concomitant medications were reported  Nurse reports that they inadvertently administered a monovalent vaccine to a patient which was past the published expiration date. This would have been the patient's 2nd dose. Lot number 071B22A, expiration date - 12Mar2023 Patient did not report any AE after the administration. 1st dose was administered on 07Feb2023, Lot number -074B22A at their facility. Agree with Safety follow up. Preferred method of contact: email
About 8min after the vaccine I got a severe headache on the top of my head and was at a 10/10 and dropped to a 7/10 after a few moments and finally went away on its on.  I was very flushed and hot.  I was laid down and given ice pack.  Started feeling a littler better but experienced riggers and was transported to the ER where I was given benedryl, fluids and was monitored for a few hours.  I was released but for the next 2 days after I was super tired and laid around and slept for 2 days.  Today I am at work but I feel very tired and fatigued
Patients administered Moderna vaccine while temperature excursion assessment was ongoing; Patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter confirmed that patients had been administered doses while the temperature excursion assessment has been ongoing. No treatment medications were reported.
"On 1/9 felt severe flu-like symptoms (chills, fever, nausea, dizziness, headache), and stayed in bed until 1/10. Felt fine midday, 1/12, then sudden, intense migraine, ear/sinus pressure/pain, dizziness, blurred vision, weakness, tired.  Symptoms improved but were still present the next day."
Woke up the morning after with a racing heart at 100+ BPM and shortness of breath
Fever 104oral, rash? (few red spots), vomiting - flu virus? gastroenteritis (saw MD hosp) ear infection;
onset of chest pressure, tachycardia within 10 minute. hives, swelling of lips and upper extremities, shortness of breath, systemic itching, sore throat and change in voice occurred 20 minutes post vaccination.  epi-pen administered at onset of hives, etc. taken to ED and given more epinephrine, IV solu-medrol and diphenhydramine. monitored for a few hours and then discharged. 5 day course of prednisone prescribed.
Narrative: Patient reported developing headache and high blood pressure following administration of second dose of Pfizer Covid Vaccine. Resolved without intervention.
Temp of 100-102 within 24 hours.  Muscle spasms x5 days now. 4 inch area of swelling around injection site.  Pustule at injection site.  Soreness limiting range of motion.  Nausea, fatigue, vertigo.
Headache, nausea, body aches, slight trembling, skin eruption on forearms, fever blister, loose stool, lethargy, continuing through day five after onset illness.
patient fainted  shortly after receiving vaccinations .  Calle 911 and kept patient calm and applied cool compress to forehead. Ems arrived and took patient to hospital for precaution due to low blood pressure. Patient was released later in day after receiving IV fluids to help raise blood pressure. Patient is feeling fine after treatment
Pt reported rapid heart rate. 2:25 PM: Measured Blood pressure of 160/120 and pulse of 124.  Rechecked Blood pressure at 2:40PM Blood pressure was 162/128 and pulse of 112. No dizziness or other signs or symptoms. Patient stated she felt fine other than rapid heart rate. Discussed with patient recommendation for monitoring due to continued increased blood pressure. Patient left with parent and is being driven to urgent care in town.
Patient reported that 2 days after the injections she had bilateral arm swelling (left more than right, injection was in the right arm) and hand swelling. She had some facial edema around her eyes. No difficulty with breathing, swallowing or tongue swelling. This all occurred at home.
Arm soreness radiating to underside of arm given injection, swollen under same arm, body soreness, headache, fever, fatigue
patient came in for a shingles booster shot and was given a covid booster shot instead. Patient already had a bivalent covid booster in September of 2020.
Had the usual sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "heart trouble" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Had the usual sore arm".  Additional Information: It was reported that, the patient did not have any real problems with first 2, original doses of Covid vaccine. Had a little sore arm but not bad.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201240238 similar report from same reporter;US-PFIZER INC-202201240542 similar report from same reporter;
In about a week and a half after receiving the vaccine, my neuropathy went from just in my feet to going up my leg almost to my knee.
My cycle has been off since receiving the first vaccination. Every period since getting the Pfizer vaccine my period has been either late or early by a week. The first irregular cycle my period started one week early, the second cycle it came one week late. There doesn't seem to be a pattern. It's just not regular like it normally is.