chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingle in throat; Severe left arm pain; Dizziness; weakness; migraine; This is spontaneous report from a non-contactable other healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration (left arm) on 01Jan2021 10:45 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that immediately after receiving vaccine (01Jan2021), the patient felt tingle in throat, severe left arm pain, dizziness, weakness, and migraine. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  No follow-up attempts are possible. No further information is expected.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns an 80-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 18-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805445 was crossed linked to original cases 201804863 due to same reporter.
noticed swelling from rt elbow to hand around 8PM the evening p/vax;pt came to hlth dept around 10:00 11/4/99 to have nurse look at swelling;referred to PMD for marked swelling rt arm from hand to elbow, redness, denies pain or fever;
On 9/16, pt had a febrile (101 temp) with 4 min generalized tonic-clonic seizure. He was seen at hospital. He was d/ced on Rx DIASTAT which was not available to be filled at 15 local pharmacies. On 9/17, he had a 101.6 temp & an 8 minute feb. sz. He was post-ictal about 45 min with both seizures. Mom spoke to on call doc on 9/17 after sz. No Rx.
pain at the injection site / like " a punch in the arm."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows:  The patient reported case for herself. The age at vaccination was not reported, but it could be 52 or 53 years. The patient stated that within 3 hours of dose 1 she had left arm pain at the injection site. The patient stated it felt like a punch in the arm. The patient shared vaccine experience during meeting to this agent. The reporter did not consent to follow up. For tolerance of 2nd dose refer case US2021047798.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021047798:same patient, same reporter, 2nd dose
Approximately 1 week after receiving the shot my Crohn's disease came out of remission after almost 15 years.  Blood and mucus in stool, malformed stool, diarrhea, blood and mucus bowel movements, bowel movement urgency, physical fatigue.
Muscle pain to slight pressure along upper arm Extreme surface pain on certain days feels like neurological Muscle pain left side of neck
extremely ill; This case was reported by a consumer via call center representative and described the occurrence of unwell in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax.   On 24th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced unwell. On an unknown date, the outcome of the unwell was recovered/resolved.   It was unknown if the reporter considered the unwell to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient felt extremely ill after receiving Shingrix. The patient did not consent to follow-up and did not provide any additional information. This case has been linked to US2019176216, reported for the same patient.
Roughly two days after receiving the COVID vaccine I had a red, warm bump at the injection site.  This went away in roughly 48 hours.  Roughly 9 days after the the first dose, on February 7th, the red, warm welt reappeared.  There appears to be itching with the second appearance.
This case was reported by a nurse via sales rep and described the occurrence of fever in an unspecifed number of adult patients who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not reported. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. It was reported that 2 to 3 patients experienced low grade fever after receiving Shingrix vaccine. This is 1 of the 12 linked cases, reported by same reporter.
Flu type illness for 3 days followed by pnuemonia symptoms and Myocarditis.
Hospitalization for syncopal event and tested positive for COVID on dates 6/29/22-7/1/22.  Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Immediately had tingling in your hand and still having the tingling a couple weeks later pain in the area for a couple days had the fever for 2 days body aches and headaches
Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. Patient had a history of blood infection. No concomitant drugs were reported. No treatment information was reported.   This case was linked to MOD-2021-232889 (Patient Link).
About 24 hours after I felt feverish, fatigued and wanted to cry - hormonal? About 48 hours after I felt very fatigue, almost too exhausted to get ready for work. The following two days I felt nauseated, very fatigued, achy and interrupted sleep patterns - going to bed earlier than usual, waking up between 2-4am. 4 today after still fatigued aches. The 6th day I felt better with energy, then that evening came the headache and by the following morning (7th day) felt fatigued with chills. The head ache woke me up from sleep at 1 am that night and 3:45am the following night. By the Friday 1/15/21 I still had chills, broke out in a sweat walking throughout house, still tired but not as bad and the headache is gone. I felt so bad onvthe 14th I went and saw a Doctor who suggested I was having a severe reaction to the vaccin. He said my vitals were good, performed a covid test to rule out the possibility (turned out negative) and told me to rest. He also warned the 2nd dose could be worse reaction.
It began with a fever of over one hundred and one, it was accompanied by diarrhea, coughing, severe headache and body aches. It lasted over two weeks. Shortness of breath persisted for at least a month, the headaches have lessened but still present.
Narrative:  Patient with breakthrough covid infection. Positive 9/2/21, 2 doses of moderna vaccine previously received. Treated with monoclonal antibody therapy.
Severe pain in extremities, worse in left upper arm that is not remitting and now 1 month out.
Headache, Myalgia, Fever, NauseaVomiting, chills,upset stomach Narrative: Employee treated with OTC meds.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE   OBSTRUCTIVE SLEEP APNEA
10/08/21 She is experiencing cough, sore throat, loss of taste, and SOB with exertion  ED to Hosp-Admission  Discharged  10/10/2021 - 10/14/2021 (4 days)  COVID-19  Principal problem Patient is an 71 y.o. female.   With Past medical history diabetes, OSA, obesity, hypertension was brought to emergency room due to shortness of breath.  Patient has been having symptoms for some days, sore throat, congestion, decreased appetite.  Patient lives alone, EMS was called, patient found to have saturation 88% on room air.  In the emergency room lab work unremarkable, patient was placed on 4 L, saturation improved to 96%.  Patient also admission for hypoxia due to COVID-19 pneumonia   Patient seen and examined be
Urticaria, started on L forearm, then next on R leg where she received shot, and has persisted for 9 days now, coming and going. Worse after nap time or sleep, usually resolves in 30min.
05/21  intermittent breathing issues - full breath hard to take and caused a cough.   happened once every few hours lasted through 05/23 05/22  started feeling warm - low grade temp 98.9  around 4pm only lasted about 4 hours 05/22   body aches  around 6pm -  lasted until 05/23 am 05/23   fatigue - could not fully wake up.  even when up eyes were heavy and felt like closing. 05/24   nausea in the morning.    included vomitting.    brief dizziness when went back to bed 05/22 - 05/23  diarrhea 05/22 - present.    injection site sore / upper arm hurts 05/24 -  midday - muscular pain around midsection - hurts when taking deep breath or twisting 05/22 - 05/23  chills 05/21 - 05/24  just not feeling good
Major Headache. Nausea. Rash around injection site. Lasted for 48 hours. Treatment was sleep and naproxen, lots of water, and some Gatorade.
I received a flu shot on Tuesday, October 2nd. By that Thursday evening, my arm was swollen and I could not move it up and down or extend it. I saw Dr. on Tuesday, October 9th and she advised me believed that the nurse that administered the shot hit a nerve and she gave me an anti inflammatory and steroid shot. Told me to go to the hospital if it got worse. I went to the hospital after work on Thursday, October 11th. They also believed that the flu shot administered was administered incorrectly. They did a sonogram on my arm to make sure of no blood clots and gave me an anti inflammatory shot and a pain shot. I called Dr. on Monday, October 22nd and advised her that the discomfort and pain I was still having. She told me to contact an Orthopedic doctor. I saw Dr. on Tuesday, October 23rd. He took X-rays of the arm and shoulder and administered a cortisone shot. If not better, I will return in 2 weeks.
Clt phoned on 4/29/03 to report adverse events following vaccination. Clt reports she had HA, nausea, and dizziness beginning on 4/27/03.She also reported she had some mild redness near the YF and MMR injection sites. Clt reports she went to the ER where she was given something for nausea and Benadryl. Clt states she has been gradually improving since then. 5/1/03 clt doing better and states she did complete the oral Typhoid series.
LA subcutaneous nodule noted approx 4cm x 4cm sl. erythema.
BLOTCHES OVER ENTIRE BODY NO OTHER SYMPTOMS. TREATED WITH BENADRLY  OBSRVED 30 MIN AND RASH RESOLVED
Systemic: Chills-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Additional Details: A few minutes after receiving vaccination patient complained of feeling hot and cold and also sleepy. Patient dozed off and had decreased responsiveness for a few minutes then recovered. Had patient stay at pharmacy for 30 minutes and seemed to fully recover. Patient took some tylenol and benadryl afterwards.
HEADACHE, MILD FEVER, MUSCLE ACHES, LETHARGY ( GENERALLY FEELING ILL) PAIN, SWELLING AT INJECTION SITE, LUMP WITH REDNESS THAT LASTED SEVERAL DAYS THOUGH PROGRESSIVELY IMPROVING.
Developed pain L shoulder radiating down L arm to hand immediately following administration.  Pain persists L deltoid region despite use of Ibuprofen.  Has pain with elevation and abduction of L shoulder.  Tenderness persists at injection site which is somewhat proximal to the main body of the deltoid. Initiating physical therapy and Celebrex.
Fever 104.5 degrees F (oral), malaise / joint pain, vomiting, headache 48 hours.
About 24 hours after the shot she had experienced flu like symptoms including mild fever body aches and chills for 4 hours in duration then it resolved and symptoms resolved.
Following both doses of Covid vaccine I developed symptoms on 6/24/2021 that were "cold like" symptoms.  Scratchy throat and stuffy nose.  My symptoms worsened over the course of the next 4-5 days.  On 6/27/2021 I began to have chills and body aches.  On 6/28/2021 I had a Covid rapid PCR test and tested positive.  My 13 month old son also tested positive.  On 6/30/2021 my 4 year old daughter tested positive.
On 2/10/00, pt experienced respiratory distress. The respiratory distress and increasing oxygen requirement increased over the next 5 days, and pt was hospitalized for 11 days. Subsequently the pt recovered. The reporting investigator felt that the symptoms were possibly related to study vaccine. No further info is available.
pt recv vax 16MAY97 & on 21MAY97 pt brought to office 97 3/19, multiple pox lesion on head began yesterday meds given;DPH & aveeno bath;Zovirax;
Case number PHEH2016US030704, is an initial spontaneous report received from a pharmacist on 18 Nov 2016. This report refers to a male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1618621, expiry date: Apr 2017) from 18 Nov 2016, at one single dose of 0.5ml, intramuscularly. It was reported that the patient was administered with FLUVIRIN after a temperature excursion at 50F for less than 24 hours/had inadvertent exposure to vaccine. No adverse event was reported following this administration error (Incorrect product storage). The case was assessed as non serious by the pharmacist.
A report was received from a health care professional on 31 October 2003 concerning a 50 year old male vaccine who inadvertently received a double dose of Fluvirin on 31 October 2003.  On 31 October 2003 the vaccine received a double dose of Fluvirin.  The vaccine had experienced no adverse reaction at the time of the report.  No follow-up pending, all information received.  There was insufficient information to determine the reporter's causality assessment.  Update 1, 17 February 2004.  A follow-up report was received from a health care professional indicating that no adverse event had occurred at the time of reporting.
Developed arm numbness; His voice changed; A spontaneous report was received from a consumer concerning himself, of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed arm numbness / hypo aesthesia and his voice changed / dysphonia.  The patient's medical history was not provided. Concomitant product use was not provided.  On 25 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 002A21A) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, the patient developed arm numbness and his voice changed.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event(s), arm numbness and his voice changed was unknown.
pt recv vax & 17 days post vax pt was found to have rt sided Bell's palsy;pt was seen by MD & started on pred;pt was examined by MD 11JUL96;sx had improved somewhat but lt eye droop & facial involvement persisted;
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was unknown. On 03-NOV-2018, the patient was vaccinated with M-M-R II (dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 12-NOV-2018, the patient began experiencing an unspecified rash at the injection site (injection site rash). On the same date, the patient came to the pharmacy to ask about the rash. The patient was given an unspecified antihistamine to alleviate her symptoms, however it was unknown if that alleviated the symptoms. It was also unknown if laboratory diagnostic studies were performed. The outcome of injection site rash was unknown. The causality between the event and therapy with M-M-R II was not provided.
patient passed away on 10/22/2021 due to COVID.  Per doctor's note on ED visit 10/19/2021: Given that her history of present illness, past medical history, physical exam findings and laboratory medic epic results are consistent with an acute COVID-19 pneumonia with hypoxia, I do not believe any further emergent work-up is needed.  I had a lengthy discussion with the patient regarding the benefits of hospitalization, and now she is willing to be admitted.  I gave her Decadron 6 mg IV and remdesivir 200 mg IV for hypoxia in the setting of a COVID-19 infection.  1145: During her evaluation by Dr, she was noted to have a precipitous decline in her mental status and increasing respiratory drive with tripoding, grunting respirations and supraclavicular retractions.  I discovered the patient awake, but not responding in obvious respiratory distress.  Her oxygen saturation was in the mid 70s on a nonrebreather mask at 15 L of oxygen per minute.  She was also placed on a nasal cannula at 15 L/min with no improvement.  I contacted the respiratory technician who placed her on BiPAP and her oxygen saturation improved to 97%, but she remained altered and tachycardic.  With the decline in her mental and respiratory status, Dr.  requested that she be transferred to a facility for a higher level care.  I gave her Zofran 8 mg IV to help prevent nausea and vomiting.  1330: I gave her Toradol 15 mg IV for chronic low back pain.  1255: I had a lengthy discussion with the patient's husband concerning her CODE STATUS via telephone.  He would like her to be a full code, including intubation.  Patient was transferred to Medical Center on 10/19/2021 at 1740.
Seizures, both absence and tonic-clonic. We were admitted to Emergency Dept, and later to Pediatrics. Prescribed Trileptal.
Swelling of optic nerve and hemorrhaging in left eye. Have seen family eye doctor on 04/28/2021 and will see retina specialist on 04/29/2021.
This case was reported by a physician (also the consumer) and described the occurrence of influenza illness in a male subject aged between 80 and 89 years old who was vaccinated with Flulaval (GlaxoSmithKline). On an unspecified date the subject received 1st dose of Flulaval at 1.0 ml. Four months after vaccination with Flulaval, the subject developed a severe influenza illness. This was considered to be a vaccination failure. This event is medically serious according to GSK. The subject experienced a systemic reaction. There was a concern as to whether or not the medication had been properly stored. It was thought that the vaccine was not kept in the refrigerator. This was considered to be a medication error. At the time of reporting the influenza illness was resolved. The physician considered the events were probably related to vaccination with Flulaval. No additional events were reported.
Right upper arm redness and swelling, urinary incontinence lasting 4 days. Went to urgent care to receive doxycycline antibiotic.
patient fainted 3 times in the office; This spontaneous report was received from a physician via a company representative referring to a 14 year old female patient. The patient's pertinent medical history, drug reactions and allergies were unknown by the reporter. No concomitant medications were reported.    On an unknown date, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route of administration, anatomical location, lot #, and expiration date were not reported) indicated for routine vaccination.         On an unknown date after the administration of the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient fainted 3 times in the office (syncope) for which the patient sought medical attention.  It was unknown if a treatment was given for the event and if laboratory diagnostics and studies were performed.   The outcome of syncope was reported as recovered the same day that the event occurred. The causal relationship between syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.       Upon internal review, syncope was considered a medically significant event.
some itch and pain at site initally, then 10 days later large (3cm) raised erythematous plaque
Case number PHEH2014US020153 is an initial spontaneous report from the nurse received on 03 Oct 2014 with a follow up received from nurse on 16 Dec 2014. This report refers to a 39-year-old female patient. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14512P) at a dose of 0.5 ml intramuscularly on 01 Oct 2014. On an unknown date (on the same date of vaccination or on the next day after vaccination) in Oct 2014, the patient's injection site was very hot to the touch and had redness and soreness at the injection site. Further, the patient experienced red hot rash lasting for three to four days. The patient was hospitalized. The reporter stated that no long term reactions were noted in the patient. The outcome of the event red hot rash was complete recovery; outcome of the other events was unknown. The seriousness and causality of the events were not reported. Follow up received from nurse on 16 Dec 2014: updated patient demographics (patient age and gender), new event (red hot rash) seriousness criteria hospitalization and other clinically relevant information in the narrative.