chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 5/20/07, client stated urticaria on her left upper arm and neck area with itchiness two days after vaccinations were given.  No facial swelling, dyspnea, dysphasia noted.  Advised to report to E.R. if symptoms get worsened.  On 5/25/07, stated urticaria disappeared but rashes with pruritis noted on chest and left upper arm areas.  Advised client for M.D. visit.
Syncope; BP 101/55; HR 67 improved to 121/72; HR 80. RR stable at 18
Initial and follow up information has been received from a physician and emergency room records concerning a 17 year old female student who at 3:45PM on 07-APR-2008, was vaccinated into the right arm with her second dose of GARDASIL (lot# 659964/1978U).  The patient had an upper respiratory infection at the time of vaccination.  On 08-APR-2008 (reported as 2:00PM and also as "in the AM") the patient experienced severe pain in the left shoulder and had a hard time moving her neck.  She was sent to the ER where she received IV fluids.  Follow up information from the physician indicated that the patient woke up in the AM on 08-APR-2008 with a severe spasm of her left neck and left shoulder.  The emergency room records indicated that the patient presented at 14:45 with right side neck spasm which had progressively worsened through out the day.  Torticollis along with palpable muscle spasms were noted in the emergency room evaluation.  There was no known trauma or abnormal activities.  The patient had pain with movement and no systemic symptoms, no fever, no nausea, vomiting or diarrhea.  She denied paresthesia/weakness.  She was reported to have tried heat and BENGAY with relief.  Emergency room diagnosis was neck strain.  The patient was treated with one shot of TORADOL, 30 mg IV and VALIUM, 20 mg IV.  She was discharged to home with instructions to take either ibuprofen or TORADOL, apply heat and follow up with primary physician.  The reporting physician also indicated that patient stayed on TORADOL for a few days and did well.  Further information is not expected. 5/29/08-records received for DOS 4/8/08-DX: Neck strain. ER visit with C/O right side neck pain began morning of ER visit and worsened throughout day. Now with Torticollis. Pain with movement. Denies paresthesia and weakness. URI symptoms recently.  PE: yellow discharge from nose. Palpable muscle spasm neck left neck.
Headache, Myalgia, RespDepression, no appetite Narrative: headache, arm pain, body aches, no appetite, and shortness of breath
Arm sore and hot; rash; Itchy; Red; Arm sore and hot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore and hot), RASH (rash), PRURITUS (Itchy), ERYTHEMA (Red) and FEELING HOT (Arm sore and hot) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore and hot), RASH (rash), PRURITUS (Itchy), ERYTHEMA (Red) and FEELING HOT (Arm sore and hot). At the time of the report, PAIN IN EXTREMITY (Arm sore and hot), RASH (rash), PRURITUS (Itchy), ERYTHEMA (Red) and FEELING HOT (Arm sore and hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Injection site swelled, became red and very sore. She had a fever, stomach upset, headache (rather severe) and fatigue for 7 days.
On 7-28-2022, I started having body aches, chills, feverish at 100.8, fatigue, head congestion and a slight cough. I tested with a home COVID19 test with positive results. These symptoms continued into the next day so I called the doctors office and they called in a prescription for Paxlovid. She recommended Zinc, Vit d3 and Vit C. I started taking the Paxlovid and the doctor recommended medications on 7-30. I am alot better today but still have some fatigue and head congestion. I am reporting a breakthru case of COVID19.
Onset of altered taste 24 hours after flu vaccination, w/o fever, cough, or other URI symptoms.  Onset of numbness in feet 48 hours after vaccination, with progression to numbness from knees down, and in fingers, resulting in hospital admission for possible Guillain Barre Syndrome on 10/28, 5 days after vaccination.  Exam on admission c/w GBS w/ length dependent loss of large fiber sensation in legs up to knees, and in fingertips, with normal strength, and w/ absent reflexes throughout.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (On an unknown date received 1st dose). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm, fever, malaise and pain. On an unknown date, the outcome of the pain in arm, fever, malaise and pain were unknown. It was unknown if the reporter considered the pain in arm, fever, malaise and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe pain in arm but not really unpleasant. For a day after patient's arm was sore, patient was feeling achy, feverish and had malaise. No further information provided.
Pt reported today pain in arm causing discomfort upon use that first occurred after vaccination and has not improved since.  Patient states it is very uncomfortable to use arm.  Condition has not improved at time of reporting.
This case was reported by a consumer via call center representative and described the occurrence of headache in a elderly female patient who received SHINGRIX for prophylaxis. On 6th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 6th November 2018, less than a day after receiving SHINGRIX , the patient experienced headache, fever, nausea, muscle pain, injection site swelling and injection site erythema. On 7th November 2018, the outcome of the headache, fever, nausea and muscle pain were recovered/resolved. On an unknown date, the outcome of the injection site swelling and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the headache, fever, nausea, muscle pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient planned to continue follow-up with her physician on an unknown date. The reporter had consented to follow up.
a "good size red patch" at injection site that is hard, swollen, red.; a "good size red patch" at injection site that is hard, swollen, red.; a "good size red patch" at injection site that is hard, swollen, red.; Red, swollen, itching and kind of arm at injection site on left arm; This is a spontaneous report from a contactable consumer. A 80-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: 9809), via an unspecified route of administration, administered in left arm on 04Feb2021 at a SINGLE DOSE for covid-19 immunization. Medical history included breast cancer. There were no concomitant medications. 08Feb2021 the patient experienced a "good size red patch" at injection site that is hard, swollen, red patient also reported red, swollen, itchy, and kind of hard area at the injection site. 7 days of Cefalexin (antibiotic treatment) was given from an urgent care. The patient stated that she wanted to report a reaction to the first COVID shot. She is due for her second shot on 25Feb2021. The outcome of the events was not recovered.
By 8:00 pm on day of vaccination, chills, headaches, low fever (101 degrees) which lasted until Sunday morning.  Took Tylonol, l tab, the same evening, the following morning and evening.  Feel much better today, Sunday, March 14.
fatigue (1 day), intense headache (1 day, treated with Tylenol), chills (1 day), body aches (lower body ie. legs, 1 day)
Literature report from foreign country on 26 October 2009. Case report: "A 23-year-old previously healthy man received immunization against yellow fever (17-D-204) 2 weeks prior to foreign travel. Three weeks later, he developed fever, nausea, vomiting, severe bifrontal headaches and photophobia, followed by ascending weakness of the lower limbs, paresthesias of his feet, and urinary retention. On examination, he was febrile, had mild nuchal rigidity, and exhibited unsustained horizontal nystagmus on left gaze, discrete left arm dysmetria, bilateral symmetric lower extremity paresis, patellar and ankle hyperreflexia, and impaired sensation to light-touch and pinpick with an ill defined sensory level around T9. Magnetic resonance imaging (MRI) of the brain and spinal cord showed areas of high signal intensity on T2 weighted and fluid attenuation inversion recovery (FLAIR) in the middle cerebellar penduncle, right dorsal medulla oblongata and a multilevel lesion involving the thoracic spinal cord with subtle patchy heterogeneous enhancement after administration of gadolinium. Cerebrospinal fluid (CSF) analysis showed clear and colorless fluid with a normal opening pressure. Cell count was elevated with 62 white blood cells (neutrophils 41%, lymphocytes 46%, monocytes 13%) 17 red blood cells, glucose 54 mg/100mL (serum glucose 154 mg/100mL) and a protein content of 105 mg/dL. CSF cultures were negative. Serum and CSF evaluations for herpes simples virus type 1 and 2, epstein barr virus, varicella zoster virus, cytomegalovirus, human herpes virus type 6, enterovirus, human deficiency virus, human T-lymphocytic virus 1 and 2, rabies virus, arbovirus barthonella quintana, rickettsiae, brucella spp, leptospiras, salmonella, borrelias, myobacterias, treponema pallidum, plasmodium, cryptococcus and myoplasma were negative. CSF myelin basic protein (MBP) was elevated with a level of 618 ng/mL. CSF total IgG level, and IgG index were normal. CSF specific IgM antibodies to YEL levels were elevated with a level of 15.6, IgM and IgG specific antibodies to YEL levels in serum were 4.8 and 1.4 respectively (normal is less than 2.0). The patient received a five-day course of 1 gram daily of intravenous methylprednisolone, with marked clinical improvement. MRI of brain and entire spine showed resolution of previous lesions 30 days after initiation of therapy." Follow-up information received 09 November 2009 from a co-author of the above mentioned literature report. The reporter confirmed that the patient had been vaccinated in another country. The vaccine administered was YF VAX (lot number not provided). No additional information was provided.
Pt received 3rd Gardasil vaccine at 11:00 am on 10/18/07 called office at 12:15 pm with c/o migraine headache with Lt pupil dilation, no other symptoms noted - pt has Hx of migraines and Hx of stroke - pt instructed to treat migraine as she has in past and call her neurologist today 10/18/07, per Dr, PO instructions.
No adverse event, patient received an extra dose of the Pfizer Covid-19 vaccine. Patient received first dose on 1/6/21, second on 1/27/21, and the third on 2/17/21.
4/30 decreased po, fatigue, and holding her leg with knee bent refusing to have it straightened. 5/1/17 extensive subcutaneous RLE inflammation without drainable fluid collection and bacteremia with gram positive cocci in chains. 4/30 blood culture: Final result: Streptococcus mitis / oralis group (Strep viridans group) Treated w: Ceftriaxone and transitioned Amoxicillin Po with plan to complete a 14 day course.
This spontaneous report was received from a physician (the patient's wife) and refers to a 50 year old male patient with multiple sclerosis (MS) from 2010 (reported as for 5 years). The patient's medical history included cerebrovascular accident (CVA) in 2014 (reported as 1 year ago) and unspecified morphine reaction. On 04-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX23 in the left upper deltoid (strength, dose, route of administration, lot # and expiration date were not provided). The patient was vaccinated at a military facility. Concomitant therapies included PLEGRIDY every 2 weeks, intravenously for multiple sclerosis (MS), gabapentin and baclofen. On 05-NOV-2015 (also reported as today), the patient experienced fever of 102.5 Fahrenheit degrees, was achy, had headache and had a localized reaction at the injection site of PNEUMOVAX23. The patient's left upper arm was red and hot, tender to touch. It was unspecified if the patient received any treatment or had diagnostic studies performed. The patient did not seek medical attention. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX23 was not reported. This is one of two reports concerning the same patient. Additional information has been requested.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number K003074 with expiration date 13-MAR-2015 (route of administration and anatomical location were unknown). The sum of hours of the vaccine excursion was 328 hours and the lowest recorded temperature reported was 33 F (0.555555556 Celsius degrees). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Tingling; Linear Unilateral Erythema; Itching in L2 distribution; This case was reported by a physician via call center representative and described the occurrence of erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a month after receiving Shingrix, the patient experienced tingling. On 19th June 2019, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were recovered/resolved and the outcome of the tingling was not recovered/not resolved.   It was unknown if the reporter considered the erythema, pruritus and tingling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced  linear unilateral erythema and itching in L2 distribution.  It took a week to disappear and he never had any blisters.  Late it was clarified as the erythema was almost gone, but there was some tingling. It was reported that,  the patient had just finished a few days earlier on a trip, sleeping in mosquito netting in a hut. The reporter consented to follow up.
Right leg has been numb for a week. From knee to ankle, mainly my shin area. Not asleep with the ?pins and needle? sensation but very very numb.
Pediatric dose of Engerix-B was given to an adult; Underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 25-year-old female patient who received HBV (Engerix B pediatric) (batch number CM294, expiry date 19-APR-2024) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose of Engerix-B was given to an adult) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-MAY-2023 It was reported that a pediatric dose of Engerix-B was given to an adult. The Vaccine Administration Facility was the same as Primary Reporter. The call dropped before transfer could be made. Adverse event information was provided by another agent who spoke with the HCP when she called back. The reporter consented to follow up via postal.
No feeling in feet and ankles in May 2016, referred to Dr. in December 2016. Diagnosed with CIDP and started treatment with GAMUNEX-C.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-month-old female patient who received HAV (Havrix) (batch number YR532, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 13th September 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's comment: Nurse reported that a patient received a 4 days expired dose of Havrix. The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
Fever and chills were horrible but also experienced hallucinations. This lasted from 8pm day of 2nd shot through 6am following morning.
I administered the vaccine to patient. She seemed calm.  I directed her and her mom to the waiting area to keep an eye on her.  A few minutes later her mom brought her back to me and said she (her daughter ) felt weird.  She presented completely tensed up and pale.  I immediately had one of the techs call EMS.  Myself and her mother were able to get her in a seated position until the paramedics arrived.  They took her in to make sure she was ok.  She was alert, drinking water and had a lollipop.   The mom decided to take her to the hospital to ensure her daughter was ok.
Approximately 5 mins after receiving vaccines patient passed out and fell from standing position. First aid treatment was given.
Patient reports receiving Tdap at local ER and presented to this clinic 7 days later with reports of arm pain.  She reports shortness of breath and "throat closing" on 10/10/2020, no medical evaluation.  Reports remaining symptoms of arm pain.  Seen in clinic today with no objective skin or deltoid abnormalities.  No objective systematic abnormalities.
39 yo female scheduled for COVID vaccine. Reports only incident of anaphylaxis d/t pineapple allergy 4 years ago; medication allergies limited to migraine s/s, not anaphylaxis. Denies possibility of pregnancy. Tolerated injection well. Upon standing ~5 min after injection, pt began experiencing lightheadedness and warmth/diaphoresis. Pt's monitoring and care transferred to clinic.  Pt given Benadryl 25mg, famotidine 20mg, 1000ml NaCl IV, Solumedrol 125mg IV.  Pt symptoms resolved and sent home with  Epipen 2-Pak, Loratadine 10mg, prednisone 20mg, Benadryl 25mg/
Injection site became very itchy and started to swell. I think I had started noticing it being itchy earlier, but by 6:00 PM it was extremely itchy and slightly raised.  I had heard about this possible reaction via Facebook, so I took some benidryl prior to bed. This morning it is slightly red, but no longer raised. The area of my upper arm feels slightly warm.
I started having like a bit of pain in different areas of my body. Kind of like a painful twitch. It lasted for quite some time. Then it disappeared and it popped up a couple more times. It popped up again recently during covid-which was 10 days ago.
Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Arm hurt). At the time of the report, MYALGIA (Arm hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up received on 09-Jun-2021 contain significant information: Outcome of the event changed from unknown to recovered,
Interchange of vaccine products; Covid positive/ It was instantly positive; Covid positive/ It was instantly positive; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022, outcome "unknown" and all described as "Covid positive/ It was instantly positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2022) Instantly positive; (10Jul2022) Negative; (15Jul2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Summary: Patient received the original Pfizer 2 shots, the first booster was Pfizer and second booster was Moderna. She did not have batch and lot numbers for these immunizations. She developed fever within 15 minutes on 04Jul around 8:00. She was certain that she was COVID positive, having been contaminated at the meeting. Being all alone at 5000 feet in the withheld mountains, with little supplies and no test kit was pretty worrisome. Her physician partner from withheld called withheld pharmacy in withheld just as soon as they opened, and she get the last box of Paxlovid (batch number unknown) there were no kits to be purchased in withheld. She had received Paxlovid treatment from 05Jul2022 to 09Jul2022. However, word went out on our mountain that she was needful and one was dropped off. It was instantly positive. She was waiting for the Tylenol to give a little relief, she drove the 25 miles to withheld.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.