chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 101.5° f, headache, chills, body ache, joint pain, inner ear pain in both ears and swollen painful lymph node around collarbone on left side. Collarbone areas are visibly different due to swelling. Most symptoms resolved within 36 hours of second dose of Pfizer vaccine. However, swollen lymph node in left clavicle area has continued to get more painful and swollen. Will seek medical treatment if this does not resolve.
Redness, pruritis and swelling on Right Deltoid area Friday evening which worsended on Saturday.  Approx 2 mm fluid filled, raised lesion developed late Sat afternoon with redness/swelling area expanding to upper arm.  Mom took child to ER and child was given one dose of Benadry. Vitals were normal.  Symptoms improved on Sunday with 2 doses of Benadry given and cool compresses.   Mom brought child to North Las Vegas clinic on Monday, 11/9/09.  Swelling and pruritits was minimal with redness decreasing. 2mm lesion scabbed over.  Child denies any SOB at any time.
flu-like symptoms - i.e., body aches, chills, fever, headache, mild nausea, fatigue, and a very sore arm
This case was reported by a consumer via call center representative and described the occurrence of hard to awaken in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 21st March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced feels awful and sickness. On 22nd March 2019, the patient experienced hard to awaken and nausea. On 23rd March 2019, the outcome of the hard to awaken and nausea were recovered/resolved. On an unknown date, the outcome of the feels awful and sickness were recovered/resolved. It was unknown if the reporter considered the hard to awaken, feels awful, nausea and sickness to be related to SHINGRIX. Additional details were provided as follows: The wife of the patient reported that her husband received SHINGRIX at 3:00 PM and he could not get out of bed the following day until 4:00 PM. The patient got up to use the bathroom and he drank 4 oz. of Coke and then went back to bed. Then on Friday, 1 day after receiving SHINGRIX, the patient could not wake up and he was nauseous. Friday afternoon reporter went to the pharmacy to report to them how sick he was. On Saturday 23rd March 2019, morning the patient was still feeling awful until around noon on Saturday and then all of his symptoms resolved.
Patient had shot Tue. eve.2/9. Woke up Sat AM with sever lower back pain to where she could not stand up without help. Specifically complains of pain in her tail bone, especially when she sits. Went to ER on Sun. AM (2/15) . (diag. Lumbosacral Strain). Saw GP (2/17) ordered PT.  Started PT 2/19.   2/23 pain in tailbone gets worse, went to Urgent care, had X-ray of tail bone (OK). Diagnosed with UTI on 3/1, put on Levofixacin 500mg.  Received 2nd vaccine 3/3,  RT on 3/5 patient walking better.  patient on 3/6 complaining of pain getting worse
ADMINISTERED VACCINE AFTER EXPIRED AT ROOM TEMPERATURE; This spontaneous report received from a health care professional concerned 3 male patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced administered vaccine after expired at room temperature. The action taken with covid-19 vaccine  was not applicable. The outcome of administered vaccine after expired at room temperature was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545147.
Expiration for that lot # had been extended and vaccine remained frozen until date of administration but vaccine was given 2 days past expiration date.  Moderna consulted and deemed the vaccine viable so revaccination was not necessary.  No adverse side effects were reported from patient.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-FEB-2015, the patient was vaccinated with an improperly store dose PNEUMOVAX 23 0.5ml, (lot #K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion was 24 hours with the lowest recorded temperature of -1 was exposed to temperature excursion once. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Initial unsolicited report received from a physician on 17 February 2015. A 2-month old male patient, medical history was unknown and concomitant medications were not reported, had received first dose of DTAP manufacturer unknown, (batch number, route of administration, site of administration were unknown) on an unspecified date. It was reported the patient had never received another Pertussis contacting vaccine. On an unknown date after vaccination the patient had 4 hour crying spell and was diagnosed with a possible neurologic reaction to pertussis vaccine. The patient required ER/doctor visit. Laboratory investigations was unknown and corrective treatment were not reported. On an unspecified date patient was recovered from the events. Documents held by sender: none.
patient received Bivalent Moderna COVID-19 vaccine instead of a monovalent; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received Bivalent Moderna COVID-19 vaccine instead of a monovalent) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient received Bivalent Moderna COVID-19 vaccine instead of a monovalent) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received Bivalent Moderna COVID-19 vaccine instead of a monovalent) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (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 received Bivalent Moderna COVID-19 vaccine instead of a monovalent).    No concomitant information provided No treatment information provided
Pt received Jansen vaccine in April. Pt presented to the ED on 09/08/2021 with complaints of AMS. Pt found to have COVID-19 viral pneumonia with hypoxia on supplemental oxygen. Pt started on Remdesivir.
Fever 102, injection site pain, fatigue.  Youth kept overnight in outpatient housing unit and discharged self on 9/15/07 AMA.  Follow up on youth, 9/16/07 "no further symptoms"
some side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (some side effects) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (some side effects). At the time of the report, ADVERSE DRUG REACTION (some side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Muscle pain, joint stiffness, fatigue. constant headache. Swelling, I feel as though numerous bones are going to snap
7 days after the 1st dose, the injection area was itchy & red. 5 hours later the area was still itchy, red & also raised & warm to the touch. The approximate size was 2 inches wide by 5 inches, oval shaped. I applied a topical ointment & took ibuprofen over the next 24 hours. All symptoms were gone within 48 hours.
Fever of 105-106 reported by mother today(5/26/04) when received last DTP vaccine- unsure how long other vaccine given this developed.
2-9-05 mother reported that infant developed fever aftershots given 1/12/05 for three days which peaked "third" day to 104. Infant was taken to ED then transferred to hospital.  Was in hospital 5 days with diagnosis of UTI.  Discharge Summary stated patient experienced UTI, fussiness and sleepiness.
redness where the shot was adminstered, hot to the touch hard when you touch it itchy at sight
This spontaneous report as received from a pharmacist refers to a 67 years old patient of unknown gender with no medical history and drug allergies. On 13-OCT-2014 the patient was vaccinated with PNEUMOVAX23 (injection, intramuscular, dose: 0.5ml, lot # K007824, expiry date: 05-NOV-2015). Other suspect therapies included FLUZONE. There was no concomitant therapy. In approximately October 2014 the patient experienced erythema and swelling of upper arm after receiving PNEUMOVAX23 and FLUZONE (high dose) in the arm. In approximately October 2014 the patient experienced itching and the swelling extended to below the elbow, when seen on 15-OCT-2014 by pharmacist. It was reported that cortisone cream was used as a treatment for adverse event. No lab diagnostics were performed. The patient sought medical attention (saw the pharmacist). The outcome of erythema and swelling of upper arm after receiving PNEUMOVAX23 and FLUZONE, swelling extended to below the elbow and itching was not reported. The relatedness between PNEUMOVAX23 and the events of erythema and swelling of upper arm after receiving PNEUMOVAX23 and FLUZONE, swelling extended to below the elbow and itching was not reported. This is one of several report received from the same reporter. Additional information has been requested.
diagnosed with breast cancer / right breast / 2 cm. in size; received the injection / hurt / as being bit by a Jersey mosquito; This case was reported by a consumer via call center representative and described the occurrence of breast cancer in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced breast cancer (serious criteria GSK medically significant) and injection site pain. On an unknown date, the outcome of the breast cancer and injection site pain were unknown.   It was unknown if the reporter considered the breast cancer and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient reported that she received her first dose of Shingrix and she was diagnosed with breast cancer around the same time. The patient could not recall the exact date of her diagnosis and she couldn't confirm if the diagnosis occurred before or after the vaccination.  The patient claimed that the breast cancer was in her right breast and was 2 cm. in size.   The patient planned to undergo chemotherapy. She also reported that when she received the injection, it hurt which she described as being bit by a mosquito. The reporter consented to follow up.
On day of vaccines the left arm hurt significantly through the evening. Treated with ice, tylenol and motrin. Approximately, 7 am the next day patient experiencing headache, backache, and malaise.  Patient felt chills with mild rigors treated with tylenol. Patient went to school. Around 750 headache as well as pins and needles sensation throughout bidy except head. Between 0900 and 1000 chills returned. 1110 to 1210 patient felt more chilled and noticed numbness in both feet. At the same time the pins and needles sensation increased significantly in the legs up to the waist. Patient also felt very tired. Hands and feet were cold. Patient described anything touching her skin increased the discomfort from the tingling sensation. Around 1215 took motrin. Around 1400 patient felt warmer. At about 1630 temperature noted to be 100.4 F. Tylenol and motrin given. Myalgia, headache and mile tingling continues.
Migraine headache occurred in the day following injection.  Treated with two doses of Excedrin at home, taken according to the dosing instructions on the label.
) Left shoulder symptoms: He got his second Pfizer Covid shot in December 2021. Within a few hours his left arm where the shot was given was very stiff and sore and hard to lift. For the first few days he basically couldn?t use his left arm, and symptoms have persisted this last few months although they have gradually gotten better. He?s worked on exercises, stretching, strengthening and now it?s up to be able to do push-ups dips and planks for 30 to 40 minutes. He got his second Pfizer Covid shot in December 2021. Within a few hours his left arm where the shot was given was very stiff and sore and hard to lift. For the first few days he basically couldn?t use his left arm, and symptoms have persisted this last few months although they have gradually gotten better. He initially could not use that arm for a week. He took advil which did not seem to help much. He had to do range of motion exercise and stretching for a while and it is improving but still; haws symptoms regularly. He?s worked on exercises, stretching, strengthening and now it?s up to be able to do push-ups dips and planks for 30 to 40 minutes. But he does continue to have some soreness and stiffness in his left shoulder and he points to lateral upper arm/deltoid area. He does not have weakness radiation of the pain, numbness tingling or loss of function.
3 days after I received a first doze of Pfizer vaccine on May 13, I found out that I was pregnant, about 5 weeks. I consulted with my OBGYN and also called CDC phone number to consult regarding getting the 2nd doze, and both encouraged me to get the 2nd doze. My bloodwork showed low levels of progestrerone, so I was prescribed it to support the pregnancy.  My 2nd doze was on June 3, and on the next day after the vaccination I've experienced strong vatigue, headache, and overall low-grade fever achy sensations.  On the 4th day after getting vaccinated with my 2nd doze, I got a terrible migrain that lasted for 48 hours; I was unable to keep any food or fluids in, and actually lost 7.5 lbs over the period of 2 days. A couple of days after that, I had a similar migraine that lasted by 24 hours, and I lost another 3 lbs.   Today, June 16, I came in for my 1st 10-week sonogram, only to find out that I had a Blighted Ovum Miscarriage. This is make it my 3rd pregnancy and my 3rd miscarrige. My OBGYN has ordered some blood tests, and we're trying to get as much information about the possible cause on our end.  In the meantime, I felt obligated to share my story in case the vaccine had any hand in this...  I get the flu shot every year, and I am pro vaccination. I've been tested negative for COVID-19; prior to getting teh vcaccine I also checked for anti-bodies, and the result was negative as well.
Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO concomitant drug information was provided.
Right upper leg, red and swollen with a circular area approx. 2 1/2" in diameter. Treated with Zithromax 200/5ml.
Note that this was following my second dose. (dose one on 4/17/2021 had no symptoms aside from mild arm soreness). My second dose, on 5/10/2021 resulted in extreme fatigue that afternoon and remained for two weeks. During that time period I also became quite depressed, which is very rare for me, but I do not know if the depression was a result of the vaccine or the extreme fatigue that came from the vaccine.
Hospitalization: 2/19/2023 - 3/6/2023 (15 days) Presentation to the ED: generalized weakness and difficulty urinating for the past few weeks. COVID + date: 3/2/23 Treatment: dexamethasone Discharge to: SNF EN6198 3/3/2021 ER8727 3/25/2021 FG3527 11/12/2021
ACTHIB vial that expired was inadvertently administered to a patient with no reported adverse event; Initial information received on 10-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient who experienced HIB (PRP/T) vaccine [ACT-HIB] vial that expired was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Aug-2023, the patient inadvertently received an expired dose of 0.5 ml (frequency: once) suspect of standard strength HIB (PRP/T) vaccine powder and solvent for solution for injection (lot: UJ735AA, Expiry date: 07-Aug-2023) via intramuscular route in the left deltoid for Immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Injection site pain ongoing as of today's date; tiredness ongoing as of today's date; muscle pain; joint pain, injection site slight swelling and redness immediately following injections; arm pain ongoing as of today's date
Hospitalized for hypoxemia/acute exacerbation COPD 1/9/22-1/18/22. Treated with dexamethasone, baricitinib, zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily
The next morning after the vaccine I woke up and my arm at the injection site was swollen with a 2" diameter bump and I was very fatigued which lasted about 3 or 4 days and subsided on it own. On 1/4 I developed a sore throat, body aches and was fatigued. I had a runny nose and sneezing and d/t the fact my son tested positive the same day for COVID-19. I went to the VA and had a COVID-19 test performed which was negative at that time. But on 1/8 I took a home test and it was positive and on 1/9 I took another test and it too was positive for COVID-19. I suffer from tinnitus previously, but since I developed the COVID-19 it seems as if the tinnitus has increased in intensity to about a 6/10 where previously it was about 3/10. To date I have persistent inflammation where my body is mildly swollen. And my chest on the left of my breast bone has a lot of pain and tenderness and 1/31 I had an EKG and chest x-ray performed but both were normal and clear but I was placed Naproxen to help with the pain and swelling.
Only reporting this only as a potential side effect of the vaccine or just coincidence. The doctors are not sure what caused the venous sinus thrombosis after my brain tumor (benign) surgery.
This spontaneous report as received from a certified medical assistant refers to a 2 month old patient (gender unknown). No concurrent condition, medical history or allergy/drug reactions were reported. On 07-JUL-2015, the patient was inadvertently vaccinated with a dose (the only dose this patient has received) of GARDASIL injection (lot #  K023432, expiry date 18-JUN-2016) (strength and dose unspecified) intramuscular (inappropriate schedule of drug administration). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Weakness in lt shoulder (deltoid muscle)where vax was injected & followed by skin sensitivity & bad body rash following 3rd inject; Recombivax 3 inject- 1st 7JUN or 9th; 2nd 13JUL90; 3rd 18DEC90;
Third day, severe tennis elbow on right arm; One week later, tennis elbow on left arm; This is a spontaneous report from a contactable consumer, the patient. An unknown gender patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 20Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no allergies to to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021, third day after vaccination, the patient experienced severe tennis elbow on right arm. On an unknown date in Mar2021, one week later after vaccination, the patient experienced tennis elbow on left arm. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measure was taken as a result of the reported adverse events. The clinical outcome of the event severe tennis elbow on right arm and tennis elbow on left arm were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.