chrisvoncsefalvay/vaers-outcomes huggingface dataset:
History of having had an upper respiratory tract infection 2 weeks ago, for which he was treated symptomatically with over-the-counter medications.  He was immunized with the influenza vaccine on 12/18/07.  Following this, on 12/22/07, he developed tingling/numbness in the fingers of both hands and the toes of both feet.  It gradually progressed to involve his hands the next day, associated with a feeling of weakness in his hands and feet.  He also developed imbalance and felt unsteady when walking.  He does not give a history of shortness of breath, dysphagia, double vision, or dysarthria. There is no history of neck/back pain or radicular symptoms in his extremities. He was admitted, Neurology was consulted in regard to his care. He was started on IVIG. He received 5 days of IVIG and was recommended to continue with physical therapy, occupational therapy. At time of transfer to Rehab, he is about 50% back to his baseline, continues to have some numbness in his hands.  1/18/08 Reviewed hospital medical records which reveal patient experienced progressive foot/hand tingling, weakness, decreased hand grip, difficulty walking x 4 days.  When received flu vax at clinic vs of 12/18 had improving URI symptoms w/dry cough.  Admitted 12/26-12/31/2007.  Neuro consult done.  Tx w/IVIG x 5 w/some improvement.  Transferred to inpatient rehab 12/31/2007-1/04/2008.  Developed right shoulder pain while in hospital & dx w/impingement & rotator cuff tendonitis & was tx by Ortho w/steroid injection w/good results.  D/C to w/continued PT, Neuro & Ortho f/u as outpatient. FINAL DX: Guillain-Barre syndrome; axonal peripheral polyneuropathy, sensory axonal neuropathy; possible right CTS. 1/24/08 Received EMG/NCS of 12/27/07 which concludes mixed sensory/motor polyneuropathy w/axonal & demylinating features.
Hives - itchy head started day of vaccination, then developed hives to chest, back, neck, face the days following. No SOB Also had fever, chills, body aches the day after
hives, vomiting, high pitched scream-3hr;seen in ER: DPH;
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with VARIVAX (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. The case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424 and 1403USA011425 (same reporter link). Additional information has been requested.
Left arm sore at injection site. 2 weeks later, any quick movement or stretching of my biceps results in acute pain that immobilizes me temporarily.
Chills, Fever, headache, body aches, weak, nasua,  Rapid heart beat for 4 hours
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical histories, drug reactions or allergies, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL, lot # M018810, expiration date 28-MAY-2018 (dose, route and site of administration were not reported). There were no adverse effects reported. Administered doses of GARDASIL were exposed to temperature excursion of 31.3 degrees Fahrenheit for 87 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA005338: US-009507513-1701USA005336: US-009507513-1701USA005337:
Information has been received from an unspecified health professional via other company (#64664) referring to a 50 year old male patient. Information regarding relevant medical history and concurrent condition were not reported. On 21-MAY-2015, the patient was vaccinated with PNEUMOVAX 23 (dose and route not reported, lot # K020215, expiration date 31-MAY-2016) at a regular office visit. Information regarding concomitant medications was not reported. The patient called the office on 22-MAY-2015 to report that he could barely move his arm and he was in a lot of pain. This was the same arm he received the PNEUMOVAX 23. It was not swollen or red. The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to an unspecified amount of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (strength, dose, route and lot # unknown) injection, which underwent multiple temperature excursions. No adverse effect was reported.   Follow up information has been received from a medical assistant. Medical assistant stated that between the dates of 12-AUG-2014 through 10-SEP-2014, approximately 12-15 doses of (Oka/Merck) VARIVAX were administered to a population of 23 months old children. The reporter also stated that he lot # for (Oka/Merck) VARIVAX was K003420, expiration date 06-MAR-2016. It was reported that 5 doses had not being administer yet. This is  one of several reports received from the same reporter. Additional information has been requested.
Myalgia fatigue Narrative: 2nd dose received on 1/8 - missed work on 1/11 and 1/12 due to above symptoms
redness and  large swelling of left arm , 8cm/10 cm in size....painful  Not feeling good all day 11/012020 headache and nauseated Taking Tylenol and with to Advil on 11/02.2020  ice on the arm
fever; ache; leg started to hurt; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), PYREXIA (fever), PAIN (ache) and PAIN IN EXTREMITY (leg started to hurt) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025l00a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event). Concomitant products included THYROID for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced NAUSEA (nausea) and PAIN IN EXTREMITY (leg started to hurt). On 18-Jan-2021, the patient experienced PYREXIA (fever) and PAIN (ache). At the time of the report, NAUSEA (nausea), PYREXIA (fever), PAIN (ache) and PAIN IN EXTREMITY (leg started to hurt) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Flushed face, light headedness, shortness of breath, and chest tightness 20 minutes after vaccination. Needed albuterol inhaler and benadryl to stop reaction.   Redness swelling at injection site up to 1/2 dollar in size now, still increasing in size. Even after 3 days since shot
Feels sleepy; Developed itchy mark injection site; Developed red mark on injection site; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Feels sleepy), VACCINATION SITE PRURITUS (Developed itchy mark injection site) and VACCINATION SITE ERYTHEMA (Developed red mark on injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced SOMNOLENCE (Feels sleepy), VACCINATION SITE PRURITUS (Developed itchy mark injection site) and VACCINATION SITE ERYTHEMA (Developed red mark on injection site). At the time of the report, SOMNOLENCE (Feels sleepy), VACCINATION SITE PRURITUS (Developed itchy mark injection site) and VACCINATION SITE ERYTHEMA (Developed red mark on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Phone contact, patient hung up phone.
pt recv vax 01MAY95 & 3MAR95 exp numbness in lips,tingling of hands,feet,legs & arms & soreness in joints;presented to MD who suggest that exp may have been d/t vax;
Pt did not have any previous covid vaccine. This was his first covid vaccine. No adverse reactions.
Shot 3/3/2021 9:05am, headache started around 7:00pm, overnight also had fever and chills. 3/4-Headache and fever continued, also had nausea and vomiting. On 3/5/3021, other symptoms resolved, but woke with double vision due to 6th cranial nerve palsy. This is the fourth acute occurrence of the nerve palsy. As of today, 4/2/2021, the double vision is still acutely present.
Large knot on my arm where injection was given. Also spot is also red. It has gotten larger and redder since it started 2 days ago.
I lost the use of both of my legs, right after I was given the "shingles" serum. I still do not have the full use of my legs!!
I had fever, extreme chills, a terrible headache, super fatigue, upset stomach-loose bowels Sunday into Monday. Fever, extreme chills, a terrible headache, super fatigue lasted until Tuesday.   July 30, 2021 is my estimated date of delivery. I am 19 weeks gestation.
Feeling faint; Light headed; Fatigue; Diarrhea; Nausea; Vomited; Sore arm; A spontaneous report was received from a consumer concerning a 69-Years old, female patient who experienced the events syncope, dizziness, pain in extremity, diarrhoea, nausea, vomiting and fatigue.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included metformin for diabetes type 2, valsartan 25mg for high blood pressure and paroxetine for anxiety and depression.   On 09 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient experienced sore arm. On 11 Feb 2021, the patient felt very bad had nausea and vomited. The patient also experience diarrhea on the same day. On 12 Feb 2021, the patient woke up with feeling faint and lightheaded. The patient reported that she cannot put anything in their mouth and experienced fatigue.  The event syncope was considered to be serious with seriousness criteria - medically significant and all other events were non-serious.  Action taken with mRNA-1273 in response to the events was not unknown.  The outcome of the events syncope, dizziness, pain in extremity, diarrhoea, nausea, vomiting and fatigue was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
PATIENT WAS STANDING AT THE CHECK-OUT AREA AFTER RECEIVING IMMUNIZATIONS, AND FAINTED FALLING BACKWARDS, HITTING THE BACK OF HIS HEAD.  LOSS OF CONSCIOUSNESS WAS ESTIMATED AT APPROXIMATELY 10-15 SECONDS.  PATIENT WAS UNAWARE HE HAD FAINTED BUT WAS ABLE TO VERBALIZE WHERE HE WAS AND THAT HE HAD JUST RECEIVED VACCINATIONS.  HIS COLOR WAS PALE AND HE STATED HE FELT "SICK TO HIS STOMACH."  AFTER LYING FOR APPROXIMATELY 10 MINUTES, PT SAT UP.  HIS CONDITION CONTINUED TO IMPROVE, LOOKING MORE AWARE,REGAINING HIS NORMAL COLOR, AND BECOMING MORE VERBAL.  AFTER APPROX 10 MINUTES OF SITTING, PT WAS HELPED TO A STANDING POSITION.  ALMOST IMMEDIATELY, THE PT STATED HE AGAIN BEGAN TO FEEL FAINT AND COLOR AGAIN APPEARED PALE. HE WAS HELPED TO A LYING POSITION, AND VITAL SIGNS WERE CHECKED.  ALL VS WERE WITHIN NORMAL LIMITS. PT HAD NO C/O HEADACHE, NO VOMITING, NO HEAD LACERATION, NO SEIZURE ACTIVITY, NO C/O NECK OR BACK PAIN, AND VS REMAINED WNL.  DUE TO PROLONGED RECOVERY AFTER FAINTING AND RISK OF CLOSED HEAD INJURY SECONDARY TO FALL, PARAMEDICS WERE CALLED.  PT WAS ULTIMATELY TRANSPORTED TO HOSPITAL FOR FURTHER EVALUATION.
Patient experienced seizure activity and respiratory distress approximately 1 hour after receiving the vaccination. Patient does have a history of seizure activity and physician on site was skeptical as to whether this was due to the vaccination or the patients history. Could also have been a result of change in environment or stress of vaccination clinic day.
My back is very tender it feels as if it has been bnuised; Continued breast pain; lump in my right breast. I have a history of lumps and bumps that came and go. Several of them have enlarged since taking the vaccines; My clothes hurt and the bottom of my feet hurt and so did my shoes and socks.; Tonight pain in my ribs/right side and back.; Tonight pain in my ribs/right side and back.; Neck pain back of head pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 69-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0196, Expiry date: unknown, at the age of 69-year-old), dose 2 via an unspecified route of administration, administered in Arm Left (Vaccination Facility Type: Pharmacy or Drug Store, Vaccine Administered at Military Facility: No) on 19Jun2021 17:00 as dose 2, single for covid-19 immunization. Medical history included ongoing migraine since childhood migraine IBS, muscle spasms from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing, breast mass from an unknown date and unknown if ongoing (lump in my right breast). Patient had a history of lumps and bumps that came and go. Concomitant medications included zolpidem tartrate (AMBIEN) taken for migraine from 2020 and ongoing; cefixime (FLEXERIL [CEFIXIME]) taken for muscle spasms, migraine from 2004 and ongoing; ibuprofen (ADVIL [IBUPROFEN]) taken for pain from an unspecified start date and ongoing. The patient experienced neck pain back of head pain (medically significant) on 06Aug2021. AE required visit to the event neck pain: could not move head. No treatment received for neck pain. The patient experienced tonight pain in my ribs/right side and back on 20Aug2021. The patient experienced my back was very tender it feels as if it had been bnuised (tenderness), continued breast pain, lump in my right breast. Patient had a history of lumps and bumps that came and go, several of them have enlarged since taking the vaccines, my clothes hurt and the bottom of my feet hurt and so did my shoes and socks on an unspecified date. The patient underwent lab tests and procedures which included blood test, chest x-ray and electrocardiogram with unknown results on 23Jun2021 yes, it seemed to reveal nothing unusual. The clinical outcome of neck pain was not recovered and clinical outcome of all other events was unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received from a healthcare professional concerning a patient of unknown age and gender. Information regarding patient's concurrent condition, medical history and concomitant therapy was not reported. On 20-APR-2016, the patient was vaccinated with a dose of PROQUAD (Merck) and a dose of VARIVAX (Merck) (for both vaccine, dose, route and lot# was not reported). No adverse effects were reported. At the time of report, the patient's status was unknown. Additional information has been requested.
This nurse administered the vaccines at 1518, with mom assistance. This nurse left the room to get physical forms for the patient. While retrieving the forms another nurse informed me that pt. was having a possible reaction. When this nurse got into the room and noticed the pt. hands and feet were swelling, he was itching and red all over. This nurse left the room to notify the doctor and another nurse stayed in the room and monitor the pt.. This nurse returned with the doctor and she assessed the pt. and order Benadryl. Administered Benadryl at 1548, continued to monitor pt. and vitals. Administer  prednisone at 1610, Epinephrine at 1613, vitals reassessed at 1620 and famotadine administered at 1620. Hospital transport arrived at 1700 and took the pt. to ED
Case number PHHY2012IT023240 is an initial spontaneous report received a consumer via health authority (reference number 161184) on 15 Mar 2012. This report refers to a 31-year-old female patient whose medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number unknown) on 05 Nov 2009. On 30 Nov 2009 she developed neuropathy (not specified further) and spasticity at upper and lower limbs. After vaccination, she did not receive any further vaccination. The final outcome was reported as condition unchanged. Seriousness criteria for the events was reported as disability. The causality of the events was reported as suspected.
Patient became lightheaded, pale, and was unresponsive for about 10 seconds. Breathing remained normal, injection site appeared normal, pulse was present throughout episode. Patient was approached near pharmacy by family friend who helped him sit. EMS was called. Vitals were normal taken by EMS. Patient did arouse and improve over time. Patient reported bilateral finger numbness.
Information has been received from a registered nurse concerning a 4 year old white male with a history of premature birth (35 weeks) and asthma who on 13MAR2000 was vaccinated SC in the LQ with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. The reporter indicated that on 30DEC2003 the patient's father called the office and reported an outbreak of varicella at his son's daycare. The patient had tow red spots on his chest and complained of itchiness. On 31DEC2003 the patient had a few more spots consistent with varicella. Some had scabbed over. No diagnostic laboratory tests were performed. The nurse indicated that the patient recovered with no incident. No further information is expected.
pt was fussy w/in 2hrs of vax but went to sleep; awoke about 3PM & cried cont for 35mins;mom then brought pt to clinic & was quiet, appeared sl sleepy, leg was red @ DTP/HIB inj site;sl fever & was fussy in evening;
Fine in the 15 minutes after vaccination but had to call out of work around 12:45 pm because of swelling in her arm & being unable to move it. She reported that her joints were hurting all over her body. She said, "her bones were on fire".
Initial report received from a health care professional on 28 January 2011. A 41-year-old male patient received on 27 January 2011 a left deltoid injection (route not reported) of TYPHIM Vi, lot number E0442-1. The patient received on 21 January 2011 an injection (route and site not reported) of DTAP, lot number and manufacturer not reported, and an injection (route and site not reported) of TWINRIX, manufacturer and lot number not reported. The patient had an allergy to penicillin. He had no medical conditions and took no concomitant medications. The patient had no illness at the time of vaccination and no known adverse event following prior vaccination. On 28 January 2011, the patient noted a lump "bigger than a BB, smaller than a marble on the collar bone." The patient noticed the lump the day after the TYPHIM was given and not noted prior to that time. He also had slight left arm soreness. The outcome was reported as unknown. Follow-up information received from a nurse on 11 March 2011. The patient recovered on an unspecified date. The reporter wrote "Reviewed no additional information at this time."Follow-up information was received on 01 April 2011 from a health care professional. The reporter stated the patient had received the TDAP and TWINRIX at a "other" clinic and was unable to provide additional information on the vaccines. The patient only received the TYPHIM Vi at her facility. No further information was available at the time of the report. The patient outcome remained recovered. Follow-up information was received from a health care professional on 25 April 2011. The patient's "lump" resoled after 10 days. No further information was available 20 May 2011 from a health care professional who provided additional patient contact information. No additional new information was provided at the time of the report. Follow-up information was received on 08 June 2011 from a health care professional. Per the reporter, the facility name and address where the TWINRIX and TDAP were administered is unknown. No new medical information was provided. Documents held by sender: None.
9 year old female tested positive for covid-19 approximately one month after 2nd dose of the Pfizer. Pediatric (5-11) vaccine.; 9 year old female tested positive for covid-19 approximately one month after 2nd dose of the Pfizer. Pediatric (5-11) vaccine.; Mild cold like symptoms; low grade fever; This is a spontaneous report received from a contactable reporter (Consumer).  A 9 year-old female patient received bnt162b2 (BNT162B2), administration date 29Nov2021 (Batch/Lot number: unknown) as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "9 year old female tested positive for covid-19 approximately one month after 2nd dose of the Pfizer. Pediatric (5-11) vaccine."; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Mild cold like symptoms"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient was admitted to inpatient level of care on 2-3 for right femoral to posterior tibial artery bypass due to chronic limb threatening ischemia with severe left foot pain
Covid 19 contagion. Muscle aches, fever, sore throat, cough; This is a spontaneous report from contactable consumer (patient, self-reported). A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0186 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 30Jun2021 at 14:30 PM (age at vaccination: 22 years), as a single dose for COVID-19 immunization at Pharmacy or Drug store. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient did not have any known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. The patient reported that on 02Jul2021 at 23:30 PM, she experienced Covid 19 contagion. muscle aches, fever, sore throat, cough. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Jul2021 and sars-cov-2 test: positive on 05Jul2021. The patient received treatment for the event. Outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Pt developed varicella like rash that consisted of about 30 spots on her neck and back. Pt also had a slight fever. Pt was treated with Benadryl.