chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received a flu shot in my upper right arm on 12/7/2019 (approximately mid-day). I recall thinking that it seemed odd that the pharmacist stood next to me while injecting the shot as opposed to sitting down. I noticed initial discomfort within a few hours, but I assumed it was the normal discomfort that can accompany a flu shot, and so I dismissed the feeling. Sometime within a few days or week of the flu shot, I started expressing to my husband, who is a physician assistant (PA), that my upper right arm was sore. By approximately mid-December, in repeating that my arm was sore, I told my husband that the only thing I could think of that I'd done to my right arm was get a flu shot. By that point, he said he was aware of no reason why a flu shot would cause pain that long after injection. I continued to have pain when rotating my shoulder in certain angles. Between late December and 1/10/2020, two doctors (a former colleague of my husband's and a friend of mine) also said in informal conversations that they were unaware of any conditions related to a flu shot that could cause lasting pain. Over the weekend of 2/8/2020-2/9/2020, I insisted to my husband that something was wrong with my shoulder, and so he researched his medical sources and discovered SIRVA. I then made an initial appointment with Dr. on 2/14/2020 (she is now my PCP). I provided medical documentation of SIRVA to her, as she, too, was unaware of the potential for injection-related injuries. We agreed to try a six-day course of steriods. I completed the course from 2/15/2020 to 2/20/2020 and rested my arm. Afterwards, it was not worse, and may have felt slightly better, but I wasn't sure if that was from not using my shoulder that week. Dr. also provided me with a physical therapy referral for a few items, and I had my first PT appointment on 3/5/2020.  After performing multiple evaluations, PT mentioned that the pain I had with certain tests was consistent with a rotator cuff injury. Following that PT appointment, my shoulder is more sore than it has been since December. I have additional PT visits now scheduled for several weeks into March 2020.
Patient did not report an adverse reaction following dose #1.  Within minutes of receiving vaccine dose #2, patient c/o flushing. VS 131/88, 100% RA, Hr 102, temp 97.5, RR 20, no SOB nor difficulty breathing. About 10 minutes post dose, patient reported feeling anxious, BP 130/87, HR 107, RR 20. Some swelling of lip on inner side. About 20 minutes post dose, patient started coughing and c/o itchy throat. Transported to ED where patient received epinephrine, Benadryl, solu-medrol, famotidine, NS 500mL bolus. Symptoms resolved and after 3.5 hours observation was discharged.  After the patient was transported to the ED, a jar of nuts was found in the vicinity of where the patient was sitting post-vaccination.
1 week after Je-vax (japanese encephalitis) client had the sensation of a pinched nerve at the site of her second J-vax shot. Shortly after she noticed that her thumb on the same are was swollen, felt like a pinched nerve and developed a bruise at the base of the thumb.
Large amount of edema, erythema around injection site for 3 days.  Required patient to be grounded from flight duties.
4/15/2022- Presents to ED via EMS, c/o 1 week history of N/V , SOB , chest pain and decreased PO intake.  Troponin 0.408   Seen by Card: review of EKG no ST elevation or STEMI   chest CT: Patchy peripheral airspace densities subsegmental atelectasis Admit: Acute respiratory failure  Covid 19 and CHF exacerbation. Start remdesivir, Ceftriaxone, doxycyline and heparin. 4/17/2022- Improving, SOb remains. WBC 11. Requiring 1.5 L o2 via NC. VVS BP 103/59. 4/18/2022- Hypotensive event systolic dropped to low 70's. Bolus given  100/62.  4/20/22- BP remains stable 97/60, continues on 1.5 L NC.  4/21/2022- VSS stable.   1.5 L NC 98% sat. WBC 8.9  Discharge to home.
36-48 hours after vaccine had chest discomfort and felt like needed to take deep breaths
Case number PHEH2014US025029, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to an 84-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 31 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
patient was apparantely given a dose of Shingrix with only the reconstituted dose/adjuvant only; patient was apparantely given a dose of Shingrix with only the reconstituted dose/adjuvant only; This non-serious case was reported by a medical representative via call center representative and described the occurrence of inappropriate dose of vaccine administered in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-AUG-2023, the patient received Shingrix. On 16-AUG-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: patient was apparantely given a dose of Shingrix with only the reconstituted dose/adjuvant only) and inappropriate preparation of medication (Verbatim: patient was apparantely given a dose of Shingrix with only the reconstituted dose/adjuvant only).     The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date: 17 Aug 2023 The  patient was apparently given a dose of Shingrix with only the reconstituted dose and provided partial information.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient was apparently given a dose of Shingrix with only the reconstituted dose adjuvant only which led to inappropriate dose of vaccine administered and inappropriate preparation of medication
Within 30 mins of 1st Hep B experienced N/V- face flushed, severe headache, "couldn't see private physician" "unavailable " duration 36 hrs.
Body aches, itchiness all over body, hoarseness and slight cough, edema on the hands.
COVID-19; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.  No Medical History information was reported.  On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In March 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In December 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.     No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt c/o dizziness, clammy UEs.  BP 104/68, HR 88, RR 20 -- > 104/68, 90-105.  Symptoms resolved, VSS, A&Ox3.  Pt stable and released from the vaccination site.
I tested negative on 08/02/2022 and 08/03/2022 I  tested positive. My symptoms were  nasal congestions, runny nose and cough.  I  did a tele health with  a doctor on the same day  they prescribed me with anti viral  medication, Tylenol and I also took over the counter  cough drops. I took the medication  for 5 days.
approximately 6-8 mins. after receiving the vaccine, my upper lip went numb. it started on the left side, then progressed to the entire lip. my lip did not swell up, nor change color. it lasted for about 1.5 hours. no shortness of breath or difficulty in breathing noted.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6198), in left arm, on 30Mar2021 as dose 2, single (Lot number: EP7533), in left arm, on 04Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 19Sep2022 as dose 4 (booster), single (Lot number: FL3198) at the age of 67 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "Ehlers danlos" (unspecified if ongoing); "history of cancer" (unspecified if ongoing). Concomitant medication(s) included: SYNJARDY XR; CENTRUM SILVER WOMEN 50+. Past drug history included: Codein, reaction(s): "Known allergies: Codein"; Mucinex, reaction(s): "Known allergies: Mucinex". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (02Nov2022) Positive, notes: Tested positive again after finishing the Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.
fever to 102 1st 24hrs then to 104-105; irritability, anorexia, vomiting x2;
pt had a recent hospitalization (unsure on date and length of time) with a dx of COVID and GI bleed; general surgery consult said pt did not have a significant bleed and was able to be put back on anticoagulant; was dc'd to home with diarrhea; had been home 4 days before family was unable to reach pt, called for a welfare check; EMS found pt with no signs of life; brought to ED for evaluation; pt pronounced deceased at Hospital
A few minutes after the injection the fingers on my left hand started tingling ,the same with  my bottom lip & the tip of my  tongue  , after letting the pharmacist know I waited an addition few minutes to make sure my lips didn?t swell . Hours later there?s been no change , still feeling the tingling in all stated above
Approximately 5 minutes after vaccine administration, the observer noticed patient wasn't responding. Seated in wheelchair with head hunched over, RN went to PT and found him to be non-responsive to voice and sternal rub. Patient was dead, wife assisted in trying to wake the patient. Sx: Non-responsive, head forward on chest, shallow breathing, color normal, unable to obtain a radial pulse, weak carotid pulse was found, skin warm and dry Checked vital signs, mask removed, EMS responded and cared for PT on-site
Severe Headaches, Dizziness & facial tingling 10 minutes after recieving 2nd Covid Vaccine. Transported to ER for further evaluation / treatment
This spontaneous report was received from a physician referring to a 5-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 14-MAR-2017, the patient was vaccinated with PROQUAD recombinant Human Albumin (rHA) (lot # M038861) (dose, route of administration, anatomical location and expiration date were not reported) for prophylaxis, which was stored in a freezer that was not monitored twice daily for temperature variability. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004: US-009507513-1703USA014463: US-009507513-1705USA007310: US-009507513-1705USA007309: US-009507513-1705USA007311: US-009507513-1705USA010146: US-009507513-1705USA010145: US-009507513-1705USA010142: US-009507513-1705USA010147: US-009507513-1705USA010144.
Information has been received from a health professional concerning a 5 year old Caucasian male with a very small atrial septal defect and a history of hemiplegia at 8 months of age who on 8/10/99 was vaccinated with the 1st dose of varicella virus vaccine live (lot 631067/0447J), SC in the left arm. There was no illness at the time of the vaccination. On 5/7/01, the pt developed a 101F fever which lasted for 2 days. The pt had 15-20 lesions of apparent pox which healed after 6 days. The pt did not experience itching. The only treatment was acetaminophen (Tylenol) during the period of the fever. The pt recovered on 5/13/01. It was also noted that the pt and sibling did not experience any adverse events following prior vaccinations. Additional information has been requested.
Case number PHEH2013US020540 is an initial spontaneous report from the nurse received on 30 SEP 2013 with a follow-up received on 25 FEB 2014. This report refers to a 40-year-old female patient. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308401, expiry date: Mar 2014) at a dose of 0.5 ml via intramuscular route into deltoid on 27 SEP 2013. It was reported that the vaccine which was given to the patient was stored at room temperature during shipment for 72 hours. No adverse event reported following this medication error.  Follow-up received from a nurse on 25 FEB 2014: Site of vaccination updated.
Had 1 seizure Saturday.  Twitching and jerking movements all weekend. 5 seizures on Monday morning
Initally swollen lymph node on left arm. By Sunday (48 hours) swelling in upper left arm with pain radiating to elbow. 68 hours pain still in arm but swelling in lymph node is beginning to subside.
C/O immediately feeling dizzy and felt as if he was going to pass out   he was lowered to the floor by staff to lay on his back, his vital signs were monitored from 11:30 am to 12:10 pm, he was given a juice box
Feeling dizzy; Couldn't sleep; Body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Feeling dizzy), INSOMNIA (Couldn't sleep) and MYALGIA (Body aches) 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 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 28-May-2021, the patient experienced DIZZINESS (Feeling dizzy), INSOMNIA (Couldn't sleep) and MYALGIA (Body aches). At the time of the report, DIZZINESS (Feeling dizzy), INSOMNIA (Couldn't sleep) and MYALGIA (Body aches) outcome was unknown.            no concomitant and treatment drugs were given
Syncopal episode, hypotension. Evaluated by EMS-Transported to Emergency room/department or urgent care.
Reports within several hours after injection she noticed that her eyes were watering, became very reddened, draining clear fluid and a runny nose. She also states she felt like she had to take a deeper breath. Upon questioning she denied shortness of breath, wheezing or any tightness in her throat. She reported that she took a Benadryl 50mg that evening and went to bed. She states that the next morning that her symptoms were resolved. This AM her discharge from the eyes is clear, and 90% of redness is gone.
Information has been received from a physician concerning a 12 year old female with a history of an elbow injury and passing out, who on 02-JUN-2008 was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # 659962/1740U).  Concomitant therapy included a dose of MENACTRA and a dose of DTAP.  On 02-JUN-2008 the patient passed out after receiving the first dose of GARDASIL.  The patient was already in the clinic.  The physician also reported that the patient "might have experienced a minor seizure because her hands were kind of rigid and were tightened up."  No diagnostic laboratory testing was performed.  The physician noted that the patient had recovered.  No product quality complaint was involved.  Upon internal review, minor seizure was considered to be an other important medical event.  Additional information has been requested.
This spontaneous report as received from a registered nurse, refers to 33 patients of unknown age and gender, who on an unknown date, were vaccinated with a doses of VAQTA (doses, routes and lot numbers not reported), that were exposed to 23F for 268 hours. The product was unsupported by in-house stability data for this temperature excursion. No adverse symptoms reported. This is one of several reports received from the same source (related MARRS #1305USA016227, # 1305USA016228). Additional information has been requested.
Very red, swollen, & sore arm. Hard to move. Nausea & vomiting. Headache. Pt had to go to urgent care and got MEDROL dose pack, ZOFRAN ODT, & naproxen.
Experiencing neuropathy in both feet/legs/hands; intense cramping in both calves; nausea; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 19Mar2021 17:30 (Batch/Lot Number: ep75534) as single dose for covid-19 immunization. Medical history included cancer survivor from an unknown date and unknown if ongoing , chemotherapy from 2017 to an unknown date, known allergies: penicillin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced experiencing neuropathy in both feet/legs/hands, intense cramping in both calves and nausea for past 4 weeks on 20Mar2021. No treatment was received for the events. The patient did not recover from the events.
constipation for 3 days following shot. medical treatment; daily fiber drink, suppository. and sttol softner.finally had a movement Sunday, 01/17/2021.  2nd shot on 02/03/2021 had same effect but I was prepared and medicated for it.
Injection with typical sx then progressive swelling, pain, erythema past left elbow. Large local reaction, no systemic symptoms.
April  -  Kidney stones -  Hospital, ER visit - Kidney stones End of May or May 15th, 2021 - Have been diagnosed with a sarcoma in my liver since then.  It was found incidentally - at hospital they did a biopsy.    My lymph nodes - I have had two scans - my left side axilla has been inflamed. It's the side that I was vaccinated on - it's been seven months and it's still enlarged. The other side is normal
Information has been received from a physician concerning a 6 year old male with no history of chickenpox who on 14-DEC-2001 was vaccinated on the left side with a 0.5 mL dose of Varivax (lot # 640072/0791L). No rash occurred at the site of injection or elsewhere within 42 days of vaccination. On 31-MAY-2006, the patient developed herpes zoster. His temperature was not taken but he felt warm. He had no other systemic symptoms. At the time of the report, he still had spots. The physician noted that she would like to submit a specimen for varicella zoster virus identification. Additional information was received from a health professional which indicated that a vesicular lesion specimen was obtained on 15-MAY-2006 and sent to the laboratory for varicella zoster virus identification on 16-MAY-2006. Varicella zoster virus DNA was amplified and the interpretation was adequate specimen, vaccine strain. Additional information has been requested.
This spontaneous report was received from a 71 year old male patient, community health educator with no know allergies. The patient's medical history included hypertension. The patient's concurrent conditions were not provided. On an unspecified date in 2014 (reported as 2 years ago), the patient was vaccinated with a dose of ZOSTAVAX, dose of 0.65 ml, subcutaneously (dose number, frequency, concentration, lot number and expiration date were not reported). There were no concomitant medications reported. On 12-APR-2016 the patient experienced pain in his toes, right knee and back, for which he went to an urgent care on an unspecified date and as a result, on 17-APR-2016, the patient was diagnosed with "shingles" and was prescribed with Acyclovir for 10 days. On an unspecified date in 2016, the patient sought medical attention. On an unknown date the patient experienced headache and general malaise. It was also reported that there was no intervention to prevent serious criteria; significant disability or hospitalization and it was not considered to be life threatening. There was no product quality complaint (PQC) involved. At the time of reporting, the outcome of herpes zoster, headache and malaise was reported as recovering. The primary reporter did not provide the causal relationship between ZOSTAVAX and the events. Additional information has been requested.
Pt vaccinated with HIB/OPV developed red w/white bumps on face stomach back arms, legs, cranky. Pt asthmatic.
Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016293885) on 16-Jun-2016. This case involves a male patient (onset age not reported) who was vaccinated with a dose of TETANUS TOXOID (Tetanus vaccine) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date following vaccination (Latency unknown), the patient experienced allergy to Tetanus Vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (dose and route of administration were not provided; lot # M014304, expiration date: 22-SEP-2017, albumin status:rHA; lot# M037012, expiration date: 21-FEB-2017, albumin status:rHA). The reporting nurse stated, that sterile diluent (manufacturer unknown) (lot# and expiration date were not provided) used to reconstitute the vaccines was properly stored. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 25.7 degrees Fahrenheit for 1.5 hours and 8.8 Fahrenheit for 1 hour. Digital data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1704USA002617.
Severe shoulder pain causing limited range of motion and strength in deltoid. Pain radiated down arm and into hand. After 5 weeks of no relief, went to Dr office and determined bursitis in shoulder (I do have a history of bursitis in that shoulder but was not experiencing pain in shoulder prior to flu shot). Given a steroid injection into shoulder.
Starting like 8 hours later and then lasting 12 hours long, I experienced severe chills, fever, inability to sleep, and muscle soreness.