chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional reefers to a 2 year old female patient. On 05-OCT-2014, the patient was vaccinated with VAQTA (lot # K001792, expiry date: 22-OCT-2015) intramuscular in the left leg (reported as left vastus lateralis (VL)), that had been improperly stored. Number of previous doses administered was not reported. There had been no reported adverse events and no need for revaccination from the time of administration. The staff was still gathering information regarding the reported adverse event of incorrect product storage. No adverse reaction was reported. This is one of several reports received from the same source (MARRS # 1411USA008692, MARRS # 1501USA004614 and MARRS # 1501USA004615). Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 20-JAN-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 11-SEP-2017, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was treated with LYRICA for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX, 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. Additional information has been requested.
Patient was given the Pfizer/Biotech Covid-19 Vaccine on 10/11/2021. It was discovered that the product was dispensed and administered on the 33rd day of being in the fridge.
A spontaneous report has been received 24APR2015 from a licensed practical nurse, who stated that multiple unspecified patients were administered either GARDASIL (Lot # K007828, exp 02MAR2017), Oral ROTATEQ (Lot K009901, exp 08MAY2016) or PEDVAXHIB (Lot K015462, exp 10JUL2017) that had temperature excursion. No adverse events were reported. No further information was available. Additional information has been requested.
achy / aches and pain; didn't feel like himself; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The reporter stated that her husband (patient) received the first dose of the vaccine about two and one-half to three weeks ago and he had some aches and pain but it was not that bad. She was unsure of the exact day or time and does not know which arm. She reported that a day or two after the first dose he was achy and didn't feel like himself. He didn't say much about it. Then yesterday 26Jan2021 he got a major headache after the second dose; he would sleep and wake up and sleep again trying to get rid of the headache. She gave him Tylenol 650mg one by mouth and it didn't help. Outcome of the events was unknown.  Information about batch/Lot number has been requested.
Missed Second Dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed Second Dose) in a patient of an unknown age and gender 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 an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed Second Dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed Second Dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter   Reporter did not allow further contact
temp began approx 36hr p/vax;temp cont x 3 days & ranged from 101 to 104 despite APAP q 4hrs;pt saw MD 8AUG96;checkup revealed no other existing conditions which might account for elevated temp;pt irritable w/periods of screaming, d;
Developed mild headache at 4 hrs after vaccination then rash on forearms and chest after 24 hours. Treated with antihistamines and steroid oint.
Nausea and vomiting the day after the shot. Just lasted about an hour and then I felt fine.
Pt recv vax on 12/7/98; on 12/15/98 pt exp ecchymotic vax site w/ red, indurated/ necrotic & warmth, headache; tx=Keflex & warm compress to site
Arm where received the vaccine was killing her; Arm pit became swollen; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2020, the patient received Shingrix. On 2nd January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. In January 2020, the patient experienced local swelling. On an unknown date, the outcome of the local swelling and pain in arm were recovering/resolving.   It was unknown if the reporter considered the local swelling and pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The ptient experienced injection site swelling and injection site pain after receiving Shingrix vaccine. The patient reported that the arm where she received the vaccine was killing her the day of the vaccine. The patient refused to answer any questions stating that she was not sure that the swelling was caused by the vaccine. The patient will see her doctor and if he thinks it is a side effect, she will call to report it. The reporter did not consent to follow-up. There was a discrepancy between the outcome reported in the structured field and in source document.
No additional adverse events reported.; the administration of PROQUAD to a 17 year old patient; This spontaneous report as received from a nurse refers to a 17-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.     On 11-FEB-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, albumin status rHA (PROQUAD) lot # S031704 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 06-APR-2021 (exact dose, route of administration, anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported.
All started few days after vaccine.  Resolved mostly within 4 weeks: Insomnia (1-2 hours of sleep per night 5 out of 7 days), continuous elevated heart rate (over 160 at one point) Not resolved: Pulsing in abdomen/chest that causes waves of panic. Happens every 5-10 seconds. Usual treatment for anxiety ineffective, feeling of extreme "fight or flight" or impending doom continuous. Constant fidget and inability to sit still. Never experienced before.  Bloating and burping constant, inability to digest foods that could be eaten previously
Patient presented to the ED and was subsequently hospitalized on 3/15/2021. She was also admitted on 4/16/2021. These visits are within 6 weeks of receiving COVID vaccination.
Brachial plexus neuropathy clinically involving the right supra spinatus nerve with right shoulder pain the day after injection and weakness 2 weeks post injection.
The area where the vaccine was administers continues to have muscle spasms/twitches throughout the day/night. It doesn?t hurt but have concern it?s an allergic or neurological reaction and have apprehension about bigger side effects stated by 2nd dose in 4 weeks.
Muscle pain; This case was reported by a consumer and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced muscle pain which still persisted at the reporting date. The patient asked that how long would the muscle pain continue.
Felt tired; Her body ached; She slept a lot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired), MYALGIA (Her body ached) and HYPERSOMNIA (She slept a lot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced FATIGUE (Felt tired), MYALGIA (Her body ached) and HYPERSOMNIA (She slept a lot). On 20-Jan-2021, FATIGUE (Felt tired), MYALGIA (Her body ached) and HYPERSOMNIA (She slept a lot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt states that later that night he had a very sore arm, headache and dizziness that lasted about 24 hours then went away.  About 10 later he developed diarrhea and this has lasted 3 days so far.  He took Pepto Bismol for 2 days but this did not seem to help.  He has an already scheduled appt w/ his Diabetic doctor and will discuss his symptoms with him to see what he suggest he should do about the diarrhea.
Heavy nosebleed two days after each shot. I never had nosebleeds in my life.
Information has been received from a registered nurse concerning a female patient who on an unspecified date, was vaccinated with a dose of GARDASIL.  The nurse reported that the patient had a fainting episode after receiving GARDASIL.  Soon after the vaccination, the patient complained that her arm felt "funny" and lips became numb.  Her skin color turned "dusky" and her hand became "postured".  The patient was then lowered to the floor.  She was sent to an emergency room and determined that she did have a fainting episode.  Additional information has been requested.
Approximately 10 days after 1st dose, complaint about pain running from lower to upper inside of left leg.  Second dose given on 5/19/21.  On 5/21/21 had an ultrasound of left leg.  Acute deep vein thrombosis found.  On 5/22/21, complained of pain in back when breathing.  Hospitalized overnight with acute pulmonary embolism.
I felt like paresthesia which feels like needles sticking me all over & I knew what it was because I had have them before.
Breakthrough case admission after 2 vaccines  Moderna 7/27/21 Lot# 078C21A;  MOderna 9/7/21 Lot# 049E21A
This is a spontaneous report from a Pfizer-sponsored program. A non-contactable nurse reported for herself. A 40-year-old female patient received PREVNAR 13 at single dose in Apr2016 for immunization. Relevant medical history included eye surgery. Concomitant medication were unknown. On unknown date in Sep2016 the patient experienced pneumonia. The patient had cough and nasopharyngitis at the time of vaccination. The pneumonia was diagnosed at Emergency Department and treatment started. The patient had had the another shot of pneumococcal 13-val conj vac (dipht crm197 protein) in 2014 and she had experienced pneumonia in Jan2016. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment.
right breast very tender; nipple was red; Pain in arm; was running a fever; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on unknown date, refer case US2019AMR218952).   On 26th November 2019, the patient received the 2nd dose of Shingrix. On 27th November 2019, 1 days after receiving Shingrix, the patient experienced pain in arm and fever. On 30th November 2019, the patient experienced breast tenderness and nipple disorder. Rechallenge with Shingrix was positive. On 28th November 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain in arm, breast tenderness and nipple disorder were unknown.   It was unknown if the reporter considered the pain in arm, fever, breast tenderness and nipple disorder to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and my arm was so sore and was running a fever. The fever went away but the arm was still very sore. The patient right breast very tender and the nipple was red. The reporter asked could all of this be from the medication in the shot.
Pediatric Pfizer booster given before appropriate time interval. Other siblings were due for boosters. This individual had not received vaccination at the same time as his siblings. Once recorded, the time interval was noticed. No adverse reaction noted.
Progressive more pronounced tinnitus, difficulty swallowing, and new-onset laryngopharyngeal reflux developed about 5-7 days following Moderna shot #1. Both symptoms have persisted for approximately 15 days, and had not resolved as of this report.
Lt. tricep/bicep area - swollen, warm, hard nodule, red 6x8cm started 7/25/19 then fever 99-100 degrees, myalgias, arthralgias, weakness, dizziness and nausea with fatigue about 4pm later that day; symptoms continued through 7/26/19 early evening and resolved except for tender hard nodule at vaccine site.  This Tdap was given through Employee Health.  This patient is a physician on staff.  She had to miss a day of work due to this vaccine.  Another employee who received a Tdap from the SAME LOT NUMBER also had unusually severe reaction (reported separately) and also had to miss work.  This is unusual.  I have given over 100 Tdaps this past year and these two cases are the only rather severe reactions.  Maybe a coincidence??  Just thought I should report.
While in the post-vaccine observation area, while sitting - pt. reported feeling tingly, warm/sweaty, slightly nauseated; hearing decreased -ringing in ears and stated "like I was going to pass out." Patient raised her hand/alerted me. Brought by wheelchair to the exam table: vitals assessed, supine with feet/legs elevated, cool cloth - fluids/gatorade offered. Unable to obtain a BP initially: then 10:45 a.m. 83/49; HR 47bpm; o2 sat% 100%; 10:47 a.m. BP: 107/68 HR 56bpm 97% on RA; 10:51 a.m. 101/64 HR 65bpm; 100% on RA; 11:05 a.m. 103/71 HR 60 bpm; 100% on RA; temp 98.5(temporal) Improved and able to drink Gatorade; sit up and then stand to chair: 11:35 a.m. to walk out of vaccine clinic stable, on own.
Patient with achiness that eventually progressed to severe muscle pain with movement and experienced elevation of CK to 6546 on 2/14 and required hospitalization.
Shivering and sweaty all night the first night. Headache for 3 days, muscle aches 3 days, nausea, and fatigue for 2 days, muscle/nerve prickles and twitches 1 day, lump on arm that was very tender, red, and hot to the touch for 5 days. Swelling in armpit with a large lump in the armpit began on day 3 and is subsiding on day 5.
DTAP given in AM - woke up from nap vomited - starring, strange movements. Gasping for air (as witnessed by grandmother) *Dx: DTAP reaction vs nightmare vs age
Sore Shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore Shoulder) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) 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)) (unknown route) 1 dosage form and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Sore Shoulder). At the time of the report, ARTHRALGIA (Sore Shoulder) had resolved. Not Provided          Patient had all Pfizer vaccinations and boosters except the one for the Omicron booster which was Moderna. Patient never had a reaction to any of them except a sore shoulder for a day or two. concomitant and Treatment medications were not reported.
Breakthrough case of Covid, sx onset 06/02/2022. Sx began on 06/02/2022, I woke up with a sore throat, low grade fever, fatigued and I had not slept well the night before. The sore throat was not getting better. I went to urgent care to get a rapid strep test, which was negative. The rapid Covid test was negative that I took at home. Urgent care recommended a PCR test. Results came back Saturday 06/04/2022. I was extremely fatigued, throat was very sore, fever was 100.5. I have a pulse oximeter and my O2 level was at about 94%. I slept all day Saturday, most of Sunday. I did take some MUCINEX last night before bed and when I got up, I was still a little fatigued and I have not had much of an appetite. I have been drinking plenty of fluids. No other sx currently, my appetite is coming back slowly.
This case was reported by a other health professional via call center representative and described the occurrence of inflammation in a adult patient who received FLUARIX QUADRIVALENT (batch number 29PD2, expiry date unknown). In September 2016, the patient received FLUARIX QUADRIVALENT. In September 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced inflammation, tenderness and swelling. On an unknown date, the outcome of the inflammation, tenderness and swelling were unknown. It was unknown if the reporter considered the inflammation, tenderness and swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The reporter explained that several staff, about 8, who received the FLUARIX QIV vaccine had developed large amounts of inflammation, swelling and tenderness. On the date of reporting, it was the day 4 after injection. No further details were provided. On 30th September 2016 at 3:14 hours, the reporter's office was contacted and got voicemail that they contacted GlaxoSmithKline GMS Quality and found FLUARIX in Lot Locator system. This was one of the 8 cases reported by the same reporter.
pt recvd vax & noticed immed numbness in arm & saw MD next day w/ c/o dec strengthin arm, red welt @ site & on neck, blotchy skin on shoulder; conversation w/MD on exam MD felt this was an extreme local react, not an allerg react;
vaccine that underwent temperature excursions could have been administered to patient; No Adverse Event; vaccine that underwent temperature excursions could have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No Adverse Event) in an 86-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022 at 11:54 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 19-Sep-2022 at 11:54 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient).    Patient received vaccine in deltoid.  No concomitant product reported by the reporter.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. No adverse reactions reported for the patient. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion.  No treatment medication reported by the reporter.
Vaccine on Fri. By Sat. afternoon I was so tired I slept 14.5 hours. Sun. morning my muscles and joints were so stiff and sore I could not walk. Headache. No energy. Gradually improved over the next 8-10 days. Left ankle still very sore. Let elbow so tender I cannot even rest it on a pillow. I've had Covid, boosters, flu & other vaccines, but never had anything hit me the way this RSV vaccine did. Wow!  Q#17 asked for RSV (Abrysvo) or RSV (Arexvy). I don't know which this was, I just picked one.  Q#20 asks for "Yes/No" answer. It's not just yes/no--just very gradual.
Pt. called stating her arm was in severe pain with hot red arm at site of Prevnar.  "Rash" going to elbow. Called pt. today 6/29 pain still present but improving.