chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fast heart beat; Sore arm; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Fast heart beat), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included Heart disorder (heart condition).    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced TACHYCARDIA (Fast heart beat), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and NAUSEA (Nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Fast heart beat), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Injection site swelling; injection site erythema; injection site warmth Information has been received from a registered nurse concerning a 78 year old female who in 1998 was vaccinated with her first dose of pneumococcal 23v polysaccharide vaccine. On 16-NOV-2005 the patient received an influenza virus vaccine (unspecified) in the right arm. On 18-NOV-2005 the patient received a booster dose of pneumococcal 23v polysaccharide vaccine (651329/1047P) 0.5 milliliters one time in the left deltoid IM. Concomitant therapy included alendronate sodium (MSD), ezetimibe (MSD), and simvastatin (MSD). On 19-NOV-2005 the patient went to the emergency room (ER) because the injection site on her left arm formed a 4x6 inch patch that was swollen, warm and erythematous. The patient did not have a fever. She was given diphenhydramine hydrochloride and acetaminophen (Tylenol) in the ER and was released. The patient recovered in November 2005. Additional information has been requested.
Flu shot 10-31-13, woke next day with hives all over body. Scratchy throat, hoarse voice.
5-7 cm erythema, (L) upper arm, non tender. Tx - OTC hydrocortisone.
PT reports red swollen approx. the size of a racket ball. Since receiving the vaccine she has had diffuse body aches/ no fever but has chills/ and migraine/ pt reports 1 instance of vomiting has taken Zofran and vomiting has stopped. Pt declined overbook appt here today.
it caused an autoimmune disorder to flare up; it caused an autoimmune disorder to flare up; she had a fever; This is a spontaneous report from a contactable consumer. A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 28Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date caller states that she had a fever when she wanted to get second dose, so put it off. Her rheumatologist didn't think it was a good idea to get the second dose, and caller thinks it might put her in the hospital. She is also worried, however, about getting COVID and particularly the Delta variant. Caller said she got 1st dose of the Pfizer BIONTECH Covid-19 vaccine on 28Feb2021, and it caused an autoimmune disorder to flare up. She wants to know if she should get the 2nd dose after that happened. Caller took the first dose of the Pfizer COVID 19 Vaccine and was having auto immune flare ups. Caller wants to know if she can and should get the second dose. The outcome of the event was unknown.  Information about lot/batch number has been requested.
This spontaneous report as received from a licensed nurse practitioner refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose and route were not reported) lot # M026317 and expiry date: 11-JAN-2018. No concomitant medications and no adverse effects were reported. The call was due to a data logger. No further information was available. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
No symtoms until 4-5 days following the vaccine. Severe joint pain, nausea, weakness, muscle pain, fatigue. Blood tests were done which revealed elevated liver enzymes and other concerning levels. I was then diagnosed with autoimmune hepatitis after seeing a hepatologist.  I was around 6 weeks post Partum when I received the vaccine.  And my last blood test with normal levels related to my liver was done in April 2021.
Nausea, dry heaving, felt dizzy at the time of injection. At 09:48: pulse: 98 then 87 Respiration; 16 SPO2: 98%BP: 90/60 Observed and gave water and crackers, at 9:50 she felt much better and discharged home
pain on both sides of the torso; rash and aggravated skin with pain and swelling when injected; rash and aggravated skin with pain and swelling when injected; rash and aggravated skin with pain and swelling when injected; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain on both sides of the torso), INJECTION SITE RASH (rash and aggravated skin with pain and swelling when injected), INJECTION SITE SWELLING (rash and aggravated skin with pain and swelling when injected) and INJECTION SITE PAIN (rash and aggravated skin with pain and swelling when injected) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for an unknown indication and UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN (pain on both sides of the torso), INJECTION SITE RASH (rash and aggravated skin with pain and swelling when injected), INJECTION SITE SWELLING (rash and aggravated skin with pain and swelling when injected) and INJECTION SITE PAIN (rash and aggravated skin with pain and swelling when injected). At the time of the report, PAIN (pain on both sides of the torso), INJECTION SITE RASH (rash and aggravated skin with pain and swelling when injected), INJECTION SITE SWELLING (rash and aggravated skin with pain and swelling when injected) and INJECTION SITE PAIN (rash and aggravated skin with pain and swelling when injected) was resolving.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
UPON ENTERING IN THE VACCINES THAT WERE ADMINISTERED TODAY, I DISCOVERED THAT THE HPV WAS GIVEN BACK IN DECEMBER OF 2009, WHICH WAS A LITTLE OVER A MONTH AGO, WHICH WAS NOT ENTERED INTO SHOTS, THEREFORE THE VACCINE GIVEN TODAY WAS GIVEN IN ERROR.
Became very fussy, hard time to even nurse him, leg became very red and sore to touch, this went on for the whole day, better the next day.
soulders hurt; This is a spontaneous report from a contactable other HCP. A 56-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization; tofacitinib citrate (XELJANZ XR, Formulation: unknown, Lot number was not reported; Expiration Date: 28Feb2023), oral from an unspecified to an unspecified date, at 11 mg, daily for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced soulders hurt. The outcome of event was unknown.   Information on the Batch/lot number has been requested.
Swelling of upper two-thirds of R arm. Outer arm beneath vaccine site 2 days after vaccine.
Another lady said she was sick; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. It was stated that another lady (patient) said she was sick. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sterile water for injection was used as the diluent instead of sodium chloride. Contacted Pfizer and they recommended re-vaccination since sterile water was not used in studies and stability cannot be guaranteed. Parent not willing to re-vaccinate at this time.
temperature was near 100°F; sore arm; chills at night, was very cold, woke up freezing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), CHILLS (chills at night, was very cold, woke up freezing) and PYREXIA (temperature was near 100°F) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 041L20A) for COVID-19 vaccination.     Concomitant products included TICAGRELOR (BRILINTA), MULTIVITAMIN [VITAMINS NOS], ACETYLSALICYLIC ACID (ASPIRIN 81), LISINOPRIL and ROSUVASTATIN for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and CHILLS (chills at night, was very cold, woke up freezing). On 26-Feb-2021, the patient experienced PYREXIA (temperature was near 100°F). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (sore arm), CHILLS (chills at night, was very cold, woke up freezing) and PYREXIA (temperature was near 100°F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable    This case was linked to MOD-2021-028494 (Patient Link).
The patient states that the few days after vaccination were slightly painful in the arm but has gotten progressively worse since then. She reported this information to us on 8/6. She states the pain is in her shoulder and radiating towards her neck. She also states she cannot lift her right arm up completely.
Stomach pain; fever for 101.5; Headache; 14 years patient received the BNT162B2 vaccine; This is a spontaneous report from a contactable consumer (patients Father). A 14-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 07Jun2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2) on an unspecified date (3 weeks prior on Monday) for covid-19 immunisation. It was reported that his son who was 14 years old got the 2nd dose (Covid vaccine) of Pfizer yesterday around noon. So that was around something 17 hours ago, the reporter don't receive any information on how to handle any side effect. He apparently has headache and he has fever for 101.5 right now and he has stomach pain. But you said they were not open right now well that this was not very helpful at this point because its 5 eastern time right now. So where could get information on how to handle or what we should do with him to help him. If the reporter could go someplace for reference and couldnot contact at this point in time. Does not seem appropriate and especially giving that you know, you could do on a certain time. So pretty upset with that the reporter known it was recorded one. So, reporter hope someone on side does something about that because it was not very good practice he would try to find answers elsewhere. The outcome of the events were unknown.  Follow-up attempts are needed; information abut lot/batch number has been requested
"Patient was admitted with Atrial fibrillation with rapid ventricular response which responded to rate control with NOAC for stroke preventions CHADs2 score 3. On the day prior to discharge she was found to be COVID 19 positive she remained asymptomatic. She was pleasant and ambulatory during her stay. Due to her cognitive impairment she tends to "wolf her food down" rapidly and has occ been noted to choke and cough. SLP evaluation early in the year noted same she was placed on a dysphagia 3 level diet. During her hospital stay she was maintained on a puree diet and it is now recommended she remain on the puree diet. Consider giving limited amount of food in sequence during meals."
This spontaneous report as received from a registered nurse refers to a 13 year old male patient. The patient's medical history and concomitant medications were not reported. His concurrent conditions included an idiopathic scoliosis and unspecified seasonal allergies. On 30-JUL-2012, the patient was vaccinated with the first dose of GARDASIL 9 (expiration date 11-JAN-2015, lot # reported as H009745; dose and route of administration were not reported). In March 2013, the patient was diagnosed with Crohn's disease. The patient sought an unspecified type of medical attention and he received the treatment with REMICADE (it was also reported as concomitant medication). On 31-JUL-2013, the patient was vaccinated with the second dose of GARDASIL 9 (expiration date 07-JAN-2015, lot # reported as J003727; dose and route of administration were not reported). On 05-AUG-2015, the patient was vaccinated with the third dose of GARDASIL 9 (expiration date 10-MAY-2017, lot # reported as K016966; dose and route of administration were not reported). The outcome of Crohn's disease was unknown. The relatedness between the adverse event and the vaccination with GARDASIL 9 was not reported. Additional information has been requested.
blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; This is a spontaneous report from a contactable consumer(patient).  The 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 22Jan2021 13:10 at single dose for COVID-19 immunization.  Medical history included ongoing injury to right foot. Concomitant drug included Steroid from 21Jan2021 and ongoing for injury to right foot. There was no prior Vaccinations within 4 weeks. On 22Jan2021, the patient experienced blood pressure skyrocketed and body was really hot touch with outcome of recovering, dizziness and shortness of breath with outcome of recovered on 22Jan2021, headache with outcome of not recovered. Patient went to Emergency Room for all events on 22Jan2021.  It was reported that Patient received the first dose of the Covid-19 vaccine today. Patient had a severe reaction and went to the Emergency Room. Her blood pressure shyrocketed. She experienced dizziness, her body was really hot. You could feel it to touch. She had a headache and shortness of breath. Then She was given Benadryl, Zofran and steroids at the Emergency Room, no physician office. She was released because she was going home and going to bed.  Information about Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Diarrhea from 9:00 pm 01/25/01 until 9:00 am 01/29/21. Fever/chills from 9:00 pm 01/25/01 until 10:00 pm 01/27/01 Body aches from 8:00 pm 01/25/01 until 10:00 pm 01/28/01 Fatigue from 5:00 pm 01/25/21 until  9:00 am 01/29/01
First day after shot Sore arm for 4 days applied pain patch and continual use kept pain under control  First day after shot..Legs swelled from hips down to toes for 7 days.  Painful to touch and painful to walk increased water usage and did massage therapy. Sugar levels were normal during this week (not normal to be swelling)
p/vax pt c/o nausea & being tired;MOC noted pt was unsteady on feet, bumping into mom while walking;c/o dizziness, MOC thought pt might be hungry went to get food mom then turned & pt was on ground, arms, legs, jerking, eye rolling back;sz
Wed. 2/28 @ 5:30 rec'd Hep A#2 in thigh. Fri 3/2 @ 3:45pm noticed hives on bilat calves and left thigh and face.  Instructed mom to call Dr for further instructions.
swollen, red, heat @ inject site, pt cried & was fussy, mom thinks had fever-local reaction to DTP inject site, resolved w/in
24 hours s/p injection pt complained of pain and swelling of left legs. RX Orapred 15mg, 1tsp Q 12 hrs, x 2 days.
Skin rash (pityriasis rosea)? 8/4/17. 8/7/17 Fever - high at 101.0 fussy - rash improving.
Sore arm at vaccination site within 3 hours.  Muscle ache, mild headache, and extreme fatigue the following day.  Spent entire day in bed sleeping most of the time (to 7 PM) .  Sensitive skin (typical whenever have a viral infection since bout with transverse myelitus in 1976.) Still some fatigue the next day (48 hours from vaccination).
Nausea, Dizzy/Lightheaded, then passed out, he was in a sitting position. Held him and tried to wake him by patting back, talking, moving him. He was still unconscious after around 3-4 minutes and looked more pale. Administered Epipen shot to left thigh and called EMS.  He opened his eyes but still groggy. Called his father while EMS was checking him. Father mentioned has fainted before. EMS checked vitals and everything okay.  Child mentioned has fainted twice before. Once when blood was drawn for blood work and again before IV was given for wisdom tooth removal. Child took sips of water while waiting for his father. Father arrived and waited until child felt well enough to walk.
Patient received 2 vaccines in left upper arm: Kinrix and MMRV.  Mother reports that the following day the arm looked red and that by 2 days later, arm was red and swollen.  She called the office was unable to get through to provider and then brought patient to urgent care.  Mother states she was prescribed bacitracin which she has applied twice a day.   Mother feels that arm swelling has improved after 2 days though still feels some warmth to the area and sees some redness.   Mother reports he has had a vaccine reaction in the past in which his skin turned red after a vaccine.   Exam: Left upper arm with area of 5 cm s 4 cm of erythema, 1 cm firmer area palpated, no induration.
Day after immunization pt had 6cmx5cmx2cm red raised area on Lt deltoid. Area stayed red and raised for 5 days.
Shingles type rash on left side of face and arounbd left eye with itching
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity received PREVNAR 13 (NDC number: 0005-1971-02, Lot number: 195216 and Expiration date: Apr2018), via an unspecified route of administration in the arm on 12Sep2017 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist told the patient that her arm was going to get tender because at some point in her life she might have had pneumonia and made antibodies. On an unspecified date the patient arm did get sore and then got better. Then it came back and got a little bit hot and a little bit sore, it was also reported that it felt itchy. These had been completely resolved. It was also reported that on an unspecified date, there was red erythema around the injection site. Everything had been good and then it broke out in the red erythema and other symptoms. The outcome of the event red erythema around the injection site was unknown. The outcome of other reported events was recovered on 16Sep2017.
Menstrual period began 10 days early, then began 12 days late the following month. Both had heavier than normal menstruation. The same thing happened again after my 3rd Covid 19 Dose. (Pfizer-BioNTech)
Mom called at approximately 140 stating child  had been crying/screaming for several hours after vaccines. Child is still trying to cry but has almost lost his voice. Mom gave Tylenol but has almost lost his voice. Mom gave Tylenol seen at 210pm treatment for Tylenol with Codeine given. To call back if no symptoms.
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: numbness, unable to move her arm
arm is red; itching on arm; some swelling on arm; warm arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm is red), PRURITUS (itching on arm), PERIPHERAL SWELLING (some swelling on arm) and FEELING HOT (warm arm) in a 72-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced ERYTHEMA (arm is red), PRURITUS (itching on arm), PERIPHERAL SWELLING (some swelling on arm) and FEELING HOT (warm arm).            Reporter did not allow further contact
Pneumonia booster resulted in flu like symptoms, pain deep in muscle at injection site and upper arm swelling and redness: lasted two days.
Seizures occurred and still occur mostly 2 to 3 hours after sleep; irregular menstrual cycle for a couple of months; lower back disc on nerve (possibly from falling from the jerks).