chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects; patient was administered an expired VAQTA; This spontaneous report was received from a consumer and office manager refers 26 month old patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 21-SEP-2019, the patient was administered an expired hepatitis a vaccine, inactivated (VAQTA) (expired product administered) for prophylaxis (lot # R018935, Expiry date: 05-SEP-2019). No adverse effect reported. No PQC involved. No additional information provided.
No additional adverse event; The patient was inadvertently admininstered a dose of PROQUAD, stead of MMR and VARIVAX; The patient was inadvertently admininstered a dose of PROQUAD, stead of MMR and VARIVAX; The patient was inadvertently admininstered a dose of PROQUAD, stead of MMR and VARIVAX; This spontaneous report was received from a medical assistant concerning to a 43-year-old male patient. The patient's concurrent conditions, medical history, concomitant medication, previous drugs reactions and allergies were not reported.   On 06-JUL-2020,  the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), injection, lot # S030210 expiration date reported as 25-MAR-2021, for prophylaxis (strength, dose, route of administration and anatomical site of injection were not reported), stead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (product use issue, wrong product administered and interchange of vaccine products). No additional adverse event. The outcome of the events was unknown.
Seizures became worse and all progress made with development stopped and declined. Her second negative reaction occurred a few months after being dx'd with infantile spasms. We were encouraged to immunize her and within 5 minutes of receiving 4 immunizations, on 3/27/01, the seizures came back worse than before. Her development ceased and the seizures are no where close to being under control. The 1st onset date of adverse events was 12/21/00. The 60 day follow-up states that she has more seizures and her development is further delayed.
Blood clots. Start of week had lower back pain (right side). As week progressed pain spread to shoulder (right) and pectoral (right). Later progressed to lower back (left). Assumed it was pulled muscle, spreading  due to compensating my posture to relieve pain. I had done some minor lifting while torso was extended. Uncomfortable taking deep breaths. Went to urgent care  1/20/23 hoping I could get muscle relaxants (was about to go out of town for work). Dr. correctly diagnosed as Deep Vein Thrombosis, had me take a blood sample and chest X-Ray. Interestingly enough, I sneeze (for all practical purposes) every day of my life. I didn't sneeze for about a 2 week period during and after this.
rash all over her chest; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash all over her chest) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced RASH (rash all over her chest). At the time of the report, RASH (rash all over her chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Follow up received; Patient initial was updated.
Patient presented to urgent care 9/20/2022 with SOB for a week.  Patient had chest xray and chest CT, revealing a mass in his left lung.  Biopsy on 10/7/22 positive for invasive squamous cell carcinoma.
Patient woke up on 2-29-08 with Baseball size red raised area on right arm where injection was given(per patients mom).  Also complains of headache and nausea.
Pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2021, the patient received the 1st dose of Shingrix (intramuscular) 0.5 ml. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient reported case for herself. The reporter reported that she received dose of Shingrix and had since been experiencing pain in her arm. No lot number or expiration date was known for the vaccine. The pain continued and had not resolved. The reporter did not consent to follow-up. The reporter declined to provide HCP information.
irregular period/breakthrough bleeding, cramps, bloating, high fever, high heart rate, muscle aches and pain, nausea, headache,
Patient was given 0.5ml of Moderna vaccine for her booster dose instead of the correct dose of 1.25ml;   Patient notified by phone and states she has not adverse reactions at this time.
Heavier and longer menstrual cycle. Prior to the vaccine, did not have a menstrual cycle since 2/2020 due to breastfeeding and birth control. Prior menstrual cycles lasted 4-5 days with few other symptoms. After the second dose of the vaccine on 2/2/21, my cycle returned on 2/19/21 despite still breastfeeding and no change in birth control. For the next 3 months, my period has been longer (8-9 days), heavier, and with new bloating, low back pain, and cramps.
hives all over her arm, and they were hot to the touch and itched, knee joints were hot; hives all over her arm, and they were hot to the touch and itched; mettalic taste in mouth; felt like a truck had hit me, I hurt all over, and I was so tired that I could barely make it to the couch, and then I fell; knee joints were hot; bumps that itch; but the injection site is still swollen and is more pink vs red; injection site is still swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hives all over her arm, and they were hot to the touch and itched, knee joints were hot), URTICARIA (hives all over her arm, and they were hot to the touch and itched), DYSGEUSIA (mettalic taste in mouth), VACCINATION COMPLICATION (felt like a truck had hit me, I hurt all over, and I was so tired that I could barely make it to the couch, and then I fell) and JOINT WARMTH (knee joints were hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced FEELING HOT (hives all over her arm, and they were hot to the touch and itched, knee joints were hot), URTICARIA (hives all over her arm, and they were hot to the touch and itched), DYSGEUSIA (mettalic taste in mouth), VACCINATION COMPLICATION (felt like a truck had hit me, I hurt all over, and I was so tired that I could barely make it to the couch, and then I fell), JOINT WARMTH (knee joints were hot), VACCINATION SITE MASS (bumps that itch), VACCINATION SITE ERYTHEMA (but the injection site is still swollen and is more pink vs red) and VACCINATION SITE SWELLING (injection site is still swollen). On 31-Jan-2021, DYSGEUSIA (mettalic taste in mouth) had resolved. On 01-Feb-2021, FEELING HOT (hives all over her arm, and they were hot to the touch and itched, knee joints were hot), URTICARIA (hives all over her arm, and they were hot to the touch and itched), VACCINATION COMPLICATION (felt like a truck had hit me, I hurt all over, and I was so tired that I could barely make it to the couch, and then I fell), JOINT WARMTH (knee joints were hot) and VACCINATION SITE MASS (bumps that itch) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (but the injection site is still swollen and is more pink vs red) and VACCINATION SITE SWELLING (injection site is still swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medication not reported.    Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: Follow-up received on 02-Feb-2021 and does not contain any new information.
7 hours later:  chills.  8 hours later:  Fever between 102 and 103.  Next day:  Low grade fever, fatigue.  Continued difficulty with heat regulation (sweating) the following day.
Reportedly, sometime, post vax, the pt experienced pain in her arm at the injection site, left deltoid. From additional info received on 03/12/1999, additional pt, responsible physician and vaccine administrator info were given. From follow-up correspondence received on 04/26/2001, it was reported, "No further info available regarding this pt or this case." This case is closed.
Symptoms started  16 hours after injection. Headache, fever, body aches, chills,  fever about 100.2 for 24 hours from onset of side effects. Noticed Rash on right arm below injection site and on upper chest next day.  Was able to use Acetaminophen for general side effects. Brought temp to 99.2.   Most symptoms resolved except rash within 24 hours of symptoms onset.
Severe swollen armpit on side of injection massive headaches fatigue and breast swelling on side of injection. Slight cough, throat closure feeling
Fever, chills, headache, nausea, vomiting, arm redness and swelling
inadvertently was administered a second FluLaval dose on 30Oct2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 5EK43, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLULAVAL QUADRIVALENT).   On 30-OCT-2023, the patient received the 2nd dose of FluLaval Quadrivalent 2023-2024 season. On 30-OCT-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: inadvertently was administered a second FluLaval dose on 30Oct2023). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-OCT-2023 Medical Assistant reports 17 year old patient received a dose of FluLaval on 11th September 2023 (lot 2MA3K, expiration date 30th June 2024) and then inadvertently was administered a second FluLaval dose on 30th October 2023 (lot 5EK43, expiration date 30th June 20240) which led to extra dose administered. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
This spontaneous report was received from a medical assistant referring an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On unknown dates since 01-AUG-2016, the unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX lot # L033343 with expiration date 13-SEP-2017 for prophylaxis (dose and route were not reported). It was stated that the temperature excursion was between 32 and 36 Fahrenheit degrees for 4 days. No previous temperature excursion was reported. No adverse effect had been reported. A product quality complaint (PQC) was not involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA004138: US-009507513-1701USA001682:
Vaccine TdaP 11/14/08 - felt sick 11/15/08, shaky, sweats, chills - went medical center 11/18/08 - admitted - "acute renal failure" - antibiotics & IV - medical center said not bacterial infection - 3 days in hospital - kidney function returned.  1/26/09 Reviewed hospital medical records of 11/19-11/20/2009. FINAL DX: no d/c summary available.  ER dx: acute renal failure, anion gap acidosis & elevated LFTs. Records reveal patient experienced fever, chills, myalgias, dizzy/lightheaded, abdominal & lower back pain, nausea, anorexia x 4 days.  Had bloody/brown vaginal discharge.  OB/GYN consult done & WNL.  Tx w/IVF & antibiotics. Improved markedly overnight w/fluids & antibiotics.  D/C to home.  .
p/vax pt exp a strange shutter throughout body;also exp pressure @ the base of skull;sx cont the next hr but then pt started to feel weak;also reports feeling uncoordinated, legs feeling like going to buckle & going to fall & feeling heavy
Body Aches for two days Skin irritation at injection site Body hives and generalized itching
ramsay hunt syndrome appeared day 27/28 after first vaccine, which was also the evening of dose #2
patients received half a dose for booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patients received half a dose for booster) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (patients received half a dose for booster). At the time of the report, ACCIDENTAL UNDERDOSE (patients received half a dose for booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-611786 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-611786:Patient 2
Patient states " it feels a little itchy where I got my shot" approximately 15 minutes after immunization. Denies any adverse effects after first 2 doses. Site and surrounding skin assessed and no redness, no swelling,  and no rashes noted. Denies any shortness of breath, difficulty breathing, chest pain/palpitations, difficulty swallowing, throat irriatation, dizziness, or nausea.  Patient remained in clinic for an additional 15 minutes and site reassessed prior to patient leaving clinic with no redness, rash, or swelling noted. No rashes, swelling, or redness noted to other visible parts of skin. Patient states that itching has resolved prior to discharge from clinic. Discussed with patient should she develop any shortness of breath, difficulty breathing, difficulty swallowing, swelling of tongue/throat, chest pain, or dizziness to call 911 as this may indicate a severe allergic reaction requiring immediate medical attention.  Patient alert and oriented x 4 and ambulatory with steady gait when leaving clinic.
Noticed many red dots on both legs all the way to the thighs, more on the left than the right.   Some red dots on the left forearm as well.  They are not itchy and not bumpy, and they seem to be under the skin.  Did not have fever and  did not have other symptoms or discomfort.  Did not use any treatment and the red dots have been fading but very slowly.
Severe Headache, Moderate neck ache, nauseous, very stiff joints. We are on day 3 with no relief from them. Also had on night two rapid heart beat/heart racing.
I received my first dose (Pfizer EN6201) at 3-1-2021 on my left arm. I felt pain and observed swollen on the injection site for two days. Then I did not pay attention to the injection site until last night when I took a shower (3-8-2021, 8 days after first dose). The injection site became rigid, swollen, and a little warmer, but not painful.
Stomach pain (left & right side), and pain scale of 6 out of 10) and feels like its swollen until now because it got worse; Stomach soreness; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain (left & right side), and pain scale of 6 out of 10) and feels like its swollen until now because it got worse), ABDOMINAL PAIN (Stomach soreness) and VACCINATION SITE PAIN (Pain at injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011021A and 025321A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain (left & right side), and pain scale of 6 out of 10) and feels like its swollen until now because it got worse), ABDOMINAL PAIN (Stomach soreness) and VACCINATION SITE PAIN (Pain at injection site). On 24-Jul-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain (left & right side), and pain scale of 6 out of 10) and feels like its swollen until now because it got worse) and ABDOMINAL PAIN (Stomach soreness) outcome was unknown.            No concomitant medication were reported.   No treatment medication was reported.
?Covid arm? - I had no reaction when I got the shot other than a sore muscle for a day or so. Then  8 days after injection I had itching, swelling and redness at injection site. Started as a 1? x 2? welt and grew to 3? x 5? over 3 days. Itchiness was worst the first day and lessened as days went on.  Cortaid had no effect on itchiness but Nupercainol did help.  It is now 6 days later and itchiness is very slight. All you can see is faint outline of red area.
Patient reported to public health nurse a rash beginning at the naval area and extending lateral, described as a "band across my belly". Rash started approximately three hours following the immunization. However patient did not report to public health nurse until approximately 12 hours following immunization. Rash continued through 24 hours and then subsided. The morning following the day of immunization the patient also reports both her right and left upper arm skin felt tight and " maybe puffy" when she woke up and then subsided several hours later. Patient self treated with Benydryl.
neck and shoulder are tight; neck and shoulder are swollen; headache; Shoulder is painful; face, shouilder and leg were numb really bad; numbness in both arms; dizziness; body aches; shot needles pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (face, shouilder and leg were numb really bad), HYPOAESTHESIA (numbness in both arms), DIZZINESS (dizziness), JOINT STIFFNESS (neck and shoulder are tight) and JOINT SWELLING (neck and shoulder are swollen) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure (Taking blood pressure medications), Cholesterol (taking cholesterol medications) and Arthritis. Concomitant products included VITAMINS NOS for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (shot needles pain), PYREXIA (fever), MYALGIA (body aches) and CHILLS (chills). On 15-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in both arms) and DIZZINESS (dizziness). On 16-Apr-2021, the patient experienced HYPOAESTHESIA (face, shouilder and leg were numb really bad). On 20-Apr-2021, the patient experienced JOINT STIFFNESS (neck and shoulder are tight), JOINT SWELLING (neck and shoulder are swollen), HEADACHE (headache) and ARTHRALGIA (Shoulder is painful). On 15-Apr-2021, VACCINATION SITE PAIN (shot needles pain), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, HYPOAESTHESIA (face, shouilder and leg were numb really bad), DIZZINESS (dizziness), JOINT STIFFNESS (neck and shoulder are tight), JOINT SWELLING (neck and shoulder are swollen), HEADACHE (headache), MYALGIA (body aches) and ARTHRALGIA (Shoulder is painful) outcome was unknown and HYPOAESTHESIA (numbness in both arms) had not resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Treatment of the events were not reported.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. ON an unknown date the unspecified number of patients were vaccinated with ZOSTAVAX, exposed to -6C for 2 hours and 30 minutes (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received via a field employee from a more than 70 year old physician with neuralgia from Guillain-Barre Syndrome referring to himself. In summer of 2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were unknown). Around 20-MAR-2016, the patient developed a burning sensation on his forehead. The patient visited his dermatologist, who diagnosed the burning sensation as the beginning of shingles. VALTREX and prednisone (manufacturer unspecified) were given as the treatment. The burning sensation lasted for another week after starting therapy with VALTREX and prednisone (manufacturer unspecified) before it resolved in 2016. The patient said that he felt this would have been a lot worse if he had not received ZOSTAVAX,. The causality was not reported. Additional information has been requested.
Fever, aches, headache,  tender/sore armpit (same side as injection), fatigue,  no appetite
Around 1 hour after shot, dizziness and leg numbness. 4/07/21 Woke to headache, dizziness leg weakness and severe lower back pain. Headache and back continued through 4/8/21.
Nurse gave GARDASIL inj. Almost immediately pt c/o lightheaded, dizzy, pain and numbness in (L) arm. Examined by M.D. Left office with directions to use warm compress at site and use arm. Per mother pain worse along with numbness to across chest to neck & down Rt arm. Parents to take to Emergency Rm. Now c/o pain & numbness to Rt hip.
Arthralgia, NauseaVomiting, fatigue, chills, muscle cramps Narrative:
Experienced slight soreness and swelling at site of injection on the day I received the first shot of the hpv vaccine (08/22/2016). The symptoms subsided on the same day, but I went on to develop significant pain and swelling (about 8.5 cm in length) at the injection site on 08/28/2016.  The swelling and soreness are still present as of 08/31/2016 albeit less than on 08/28.
Fever with T39.2, nausea/vomiting, rash over site of injection.
Patient reports that the day after receiving TDAP vaccine she noticed a large painful swelling under her right arm with that area tight feeling.On examination by RN 4 days later a 15mm swelling tender to the touch was found in rt. axilla.No reddness or swelling noted at injection site(rt. deltoid).Patient was instructed to watch area and if worsens or does not resolve to see PMD.