chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEVER; HEADACHE; TIREDNESS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 29-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced headache. On 29-MAR-2021, the subject experienced tiredness.  Laboratory data included: Body temperature (NR: not provided) 100.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, headache, and tiredness on 30-MAR-2021. This report was non-serious.
102°fever started 7 hours after shot.  fever lasted over 24 hours.  Severe headache and all over body aches.   No appetite
Rash on face, and itchiness on arms, face, head 2 days after vaccine
Initial report was received from a non health care professional on 02 April 2014. This case is one of a cluster of two identified patients who experienced similar adverse events following administration of ADACEL. The events for the other patient was captured in case 2014SA042582. A 16 year-old male patient with a history of asthma had received on 30 May 2012 an intramuscular first dose of ADACEL, lot number U3554CA and approximately 21 months later developed wheezing, coughing, SOB (shortness of breath), vomiting and fever of 104. The patient's Mother thought it was an asthma attack. The patient was evaluated by a physician on 12 March 2014 and was treated with Azithromycin pack times two. On 27 March 2014, the patient was evaluated by a pulmonologist and was diagnosed with pertussis. Laboratory data included an IgG of 75 (units not reported) and IgM of 1.9 (units not reported). No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
Redness to left shoulder and upper arm, warm to touch. Patient noticed the redness yesterday morning, and stated this morning she noticed it had moved farther down towards her elbow.
a few hours of periorbital swelling, improved with antihistamine that started 2 days after getting the 2nd dose of her vaccine. she was improved by the time she was seen in a virtual office visit.
Information has been received from a consumer concerning her daughter, a female patient, who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, site and route not reported).  On an unspecified date, the patient experienced "auto immune disease and fatigue".  The outcome of the event was not reported.  No further information is available.
Varicella injection site red, warm, painful, felt woozy.  Better by 9-26-07 later afternoon
Information has been received from a medical assistant concerning multiple patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unspecified dates, the patients were vaccinated with VARIVAX (lot #: M025870 with expiration date: 24-MAY-2018, lot #: M010484 with expiration date: 01-MAR-2018 and lot #: M000757 with expiration date: 06-JAN-2018) (dose, dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 5°F but less than 14 °F for 48 hours and at temperature greater than 14°F but less than 46°F for 72 hours without any previous temperature excursion. No adverse effects were reported. Data logger was reported as No. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000248: US-009507513-1701USA013789.
1. Muscle soreness at injection site, lasting 2 days. Currently resolved.  2. Feeling of overstimulation throughout day and evening, and difficulty falling asleep at night. "Buzzing" feeling similar to drinking too much coffee.  Lasting 3-4 days. Currently resolved.
pt c/o hives p/last vax on 14SEP98-hives appeared over hands & arms just hr p/describe large red welts over hands & arms;
Information has been received from a nurse concerning a 7 years old female patient. On 23-JUN-2006, the patient was vaccinated with VARIVAX (Merck) (lot# 652868/0267F) subcutaneously. On 13-OCT-2009, the patient was vaccinated with VARIVAX (Merck) (lot# 665181/1007Y) subcutaneously. No other co-suspects were reported. Concomitant medications included ZONEGRAN and lactase. On 19-NOV-2012, the patient experienced 20 papular chickenpox lesions after receiving VARIVAX (Merck). No treatment information was reported. The patient sought medical attention and saw the physician. At the time of the report, the patient was not recovered from the event of 20 papular chickenpox lesions. The relatedness for 20 papular chickenpox lesions was unknown for VARIVAX (Merck). Additional information has been requested.
Severe Pain/ swelling, brain fog, itching - started at sight next day  and eventually spreading to all over body after 2 days., injection site warm to touch. Pt went to instant care and was treated on 11/18.  Today (11/19) symptoms seem worse; thus, patient will be going to be seen again later today.
Presented to ED s/p ground level fall; Covid + x 4 days PTA; cough, weakness; Dx Covid PNA, UTI;  CXR: Patchy bilateral pulmonary opacities; Labs: D-dimer 2.06; CRP 12.94 Ferritin 564.65; Tx: Rocephin, Remdesivir, Vit C, Vit D3, Decadron, Vit B12, lovenox,  02 flucuated between room air and 2 lpm NC; 2 lpm cont at d/c
2 days of flu-like symptoms and fever consistently around 102° after injection; joint swelling, aches, warmth, stiffness; redness, warmth to touch, and immense tenderness in arm followed by week-long pruritic rash about 4? below injection site; 2-4 minute long attacks of heart palpitations up to 8 times daily about two weeks after vaccination
the vial was initially stored in the refrigerator on 23-Jun-2023 6 and the vaccine was administered on 25-Jul-2023; no adverse event; Nurse reported that a MA gave a vaccine that was past date of expiry to a patient.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse reported that a MA gave a vaccine that was past date of expiry to a patient.), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 23-Jun-2023 6 and the vaccine was administered on 25-Jul-2023) and NO ADVERSE EVENT (no adverse event) in a 58-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     It was unknown whether the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 25-Jul-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse reported that a MA gave a vaccine that was past date of expiry to a patient.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 23-Jun-2023 6 and the vaccine was administered on 25-Jul-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse reported that a MA gave a vaccine that was past date of expiry to a patient.), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 23-Jun-2023 6 and the vaccine was administered on 25-Jul-2023) and NO ADVERSE EVENT (no adverse event) outcome 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Nurse reported that a MA gave a vaccine that was past date of expiry to a patient.) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 23-Jun-2023 6 and the vaccine was administered on 25-Jul-2023).    No concomitant medication was reported. It was reported that dose administered after 30-day Use By Date or after Manufacturer Date of Expiry. The vial size was reported as 2.5 ml. The vial did not undergo any temperature excursions.  No treatment medication was reported.
Right after 48 to 72 hours later when I was feeling fine - had BP shoot up and also had palpitations. The BP settled down after 6 hours to so (took a lot of water and did some breathing). I am not concerned about what happened in the three days or so of the vaccination.  However, I am worried about the continuation of palpitations that seem to happen a few times a week.
This was pt's second Gardasil vaccine on 8/7/07. She developed symptoms 8/14 and was seen at hospital 8/20, 8/21, 8/22/07. She was suffering from myalgias, trismus, "lockjaw" and slight neck adenopathy. Her neck CT was normal.  9/18/07 Received hospital medical records which reveal patient experienced severe neck pain & swelling w/inability to open her mouth.  After 1st vax 6/07 had tenderness in right clavicle & neck area.  Saw pcp & dx w/reaction to vax.  Resolved over approx 1-2 mos.  Received 2nd vax in 8/07.  Approx 1 week later developed severe pain in right neck & axilla w/enlarged lymph nodes.  States pain was so severe that she could not open her mouth.  Saw pcp who again dx w/reaction to vax but referred to ER due to severity.  Exam revealed full ROM of neck w/tenderness & palpable tender lymph nodes of neck & right axillary.  D/C to home.  No improvement & returned to ER on 9/21.  Tx w/IVF, pain med & IV steroids.  Improved in ER & d/c to home.  Returned to ER on 8/22 for repeat labs & recheck of symptoms.  CPK improved but continued w/same symptoms but no adenopathy noted on exam.  Right arm exam WNL but w/increased tone to bicep/tricep area w/good ROM, strength & sensation.  Tx w/pain med & benzodiazapam w/excellent relief.  D/C to home & f/u w/pcp.   Final ER DX: 8/20/07 reactive lymphadenopathy, probable viral illness, ? TMJ syndrome, questionable AE to vaccine. Final ER DX: 8/21/07 myalgias w/extremely low grade rhabdomyolysis & ? serum immune complex type hypersensitivity reaction to vaccine. Final ER DX: 8/22/07 myalgias w/low grade rhabdomyalisis.
fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (fast heart beat) in a 69-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 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced TACHYCARDIA (fast heart beat). At the time of the report, TACHYCARDIA (fast heart beat) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
01/27/04: Pt received 1st Hep B vaccine-couple of hours later with facial rash, some itching.  Took Benadryl that night.  Next morning with blister tongue and lip.  (Facial rash, itching and mouth blisters)
This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (sore  arm), VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE PAIN (Hot arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and VITAMINS NOS for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red arm). In February 2021, the patient experienced VACCINATION SITE WARMTH (sore  arm). On an unknown date, the patient experienced VACCINATION SITE PAIN (Hot arm). At the time of the report, VACCINATION SITE WARMTH (sore  arm), VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE PAIN (Hot arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant product use was cholestrol pills. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: non significant follow up case has  no new information.
Information has been received from a 74 year old consumer regarding himself. Medical history included HPV (human papillomavirus) and HIV (human immunodeficiency virus). The consumer received and completed the GARDASIL Vaccines (dates not provided) (considered inappropriate age of vaccine administration as indication is for boys/men 9-26 years of age). He filled a complaint against his primary and secondary insurance carrier for failing to provide copayments for the vaccine. The consumer noted he was currently having difficulty talking due to recent tongue surgery. No further details provided. Additional information has been requested.
I woke up early the next day 3/10/21 nauseous and with diarrhea.  I was tired and had a mild headache.  My arm hurt moderately where the injection site was, but also on the inside of my upper arm.  I felt lethargic and nauseous the rest of the day.  I did not sleep well.  Then 3/11/21 I woke with a mild headache and some nausea, but also severe pain on the inside of my upper arm.  It was very sensitive all up to my shoulder on the underarm area and somewhat on the side of my ribcage, but then also radiating down to my wrist.  This pain persisted until I am writing this form, approx. 2pm 3/11/21.   It has not subsided at this point.
Pt. received H1N1 FLUMIST. Age greater than age vaccine licensed for. No known complications.
Woke up 0200 on 12/4 with (L) arm hurting clear down to hand, positive chills and headache. Then developed body aches. Denies any fevers. No redness or itching or swelling to injection site. Called patient next day and was feeling better. Thinks it was part of the flu. Denied any other concerns.
Adult Pfizer vaccine was administered to 10-year-old patient. No treatment needed, as there were no reported adverse effects. Guardian was notified of error.
SUDDEN ONSET WATERY DIARRHEA WORSENED OVER TIME. CALLED 911 WHEN IT BECAME IMPOSSIBLE TO STAND OR WALK. HAD SHAKES, CHILLS, SEVERE SHIVERING OVER ENTIRE BODY. RECEIVED 3 IV BAGS, BLOOD DRAWN TWICE, CAT SCAN. NOTHING FOUND THAT WOULD HAVE CAUSE THIS EXCEPT WHITE BLOOD CELL COUNT INDICATING POSSIBLE VIRUS OR INFECTION. ER DOC INDICATED THAT THE FLU SHOT COULD HAVE BEEN THE CAUSE.
Arm pain followed by tingling in the arm/ hand.  She then developed numbness/ tingling on some side face.  Resolved overnight.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case included information of patient 8th out of 100 patients.  No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11 Jan 2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
12 hours after vaccine administered experienced heart palpitations ranging from 140-160bpm at about 1am Sunday Morning.  At 4pm Sunday I was admitted to the emergency room where I was given diltiazem in an IV which did not bring my heart rate down. I was then given another heart medication which brought my heart rate down but I had to stay overnight.
Soreness and redness of arm. Body aches, headache, fatigue, cough, fever, nausea, chills. Bed rest, ice packs and fluids.
Tingling in the face occurred after both doses of the shot. I didn't know it was an adverse effect after the first dose, but my daughter is in medical school and told me that it could be and I should report it
L lateral breast with redness, blotchy macular rash w/o pain or pruritis
Swelling at the left arm , neck and lymph nodes; Redness at the left arm , neck and lymph nodes; lymphadenopathy; A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling at the left arm , neck and lymph nodes, redness at the left arm , neck and lymph nodes.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the event(s) swelling and redness at the left arm , neck and lymph nodes.  No treatment information was provided.  The seriousness criterion for the events was reported as other.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), swelling at the left arm , neck and lymph nodes, redness at the left arm , neck and lymph nodes was unknown.; Reporter's Comments: This case concerns a 71 Y/O F with serious unexpected events of peripheral swelling and erythema. Event onset 26 days after first dose mRNA-1273. Events outcomes not reported. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient stated during the vaccination date that she is unable to get any vaccines in her left arm (pharmacist attempted to do 1 vaccine in L arm and 1 in R arm), therefore patient received both Prevnar13 and Shingrix in the R arm.  Patient stated starting on Saturday 10/24 she was experiencing chills and the area of vaccination was warm/hot to the touch.  Patient reported the event to the pharmacy on Wednesday 10/28 that the warm/hot to the touch has not gone away.  Patient was informed to go to the doctor in order to have the arm looked at.
On 4/11/03, patient reported to Infection Control/Employee Health Dept. with c/o "whelps and itching" occurring on various parts of body.  Digital picture taken and sent to Dr., Rash was not vesicular.  Benadryl 25mg PO given for relief. On 4/14/03, Patient reported back to Infection Control with continued c/o itching whelps and left facial swelling and numbness.  Dr. notified of situation.  Patient referred to E.R. Seen by Dr. Digital pictures forwarded.  Patient treated with corticosteroids and sent home.
This spontaneous report was received from the administrator and refers to a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-JAN-2017, the patient received a dose of expired adult formulation (instead of pediatric) VAQTA lot # L027735 which had expired on 12-JAN-2017 (dose and route were not reported) for prophylaxis. In addition, on 16-MAR-2017, the patient received the second dose too early of VAQTA lot #M030598, expiration date 13-OCT-2017 (dose and route were not reported) for prophylaxis. No adverse effects reported. Additional information has been requested.
MOTHER BROUGHT PATIENT IN WITH COMPLAINTS OF RIGHT UPPER ARM RED AND SWOLLEN (WARM TO TOUCH). ONSET OF SYMPTOMS WERE LATE 3/12/2009 IMMUNIZATIONS WERE GIVEN 3/11/09 PATIENT CAME TO CLINIC 3/13/09 WAS EXAMINED BY DOCTOR HE TREATED HER WITH ZYRTEC AND ICE PACKS.
Just under 24 hours later developed a fever, chills, shaking and a dull head ache. Arm pain at injection sight began within 12 hours but was not sever. Head ache persisted and required 3 aspirin. Head ache continued through the evening into the next day while the fever & chills resolved itself by the next morning. Pain killers were taken over night.  Head ache remained present throughout following day although it was milder and resolved within approximately 36 hrs.
p/vax on 23OCT95 pt had swelling of the inj site, soreness, burning, itching, & redness in color;pt exp no sxs w/1st Rabies vax 10OCT95;