chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a physician under reference number PVX201606-000542 on 24 January 2017. This case involves a 12 years old female patient who was vaccinated with a dose of MENACTRA (batch number, expiry date, dose and dose in series were not reported) and VIVOTIF (batch number, expiry date, dose and dose in series were not reported) in an unknown site on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, unspecified time following the vaccination, the patient had developed Persistent cough, Soft tissue swelling on MENACTRA injection site, Slight cold that got worst very fast, Decreased appetite, Fever, Nausea, Headache, and Diarrhoea. Laboratory investigations were not reported. No corrective treatment was reported. The outcome of the event was not reported. List of documents held by sender: none.
I was given shot in the fatty part of my arm near my elbow. It was not inserted into my deltoid muscle or any other muscle! I?m afraid my vaccination is not going to be effective
Sore Left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Left injection site arm   ) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pneumothorax spontaneous and Marfan's syndrome.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore Left injection site arm   ). At the time of the report, VACCINATION SITE PAIN (Sore Left injection site arm   ) 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.   This case was linked to MOD-2021-299769 (Patient Link).
her arm was more sore than after the first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Feb2021 09:15 (Lot number: EM9810, Expiration Date: 30Jun2021) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes 2" (unspecified if ongoing), notes: The caller takes pills and watches diet to control it. The caller was diagnosed over 10 years ago.; "Blood pressure high" (unspecified if ongoing), notes: The caller takes pills to control it. The caller was diagnosed over 10 years ago. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was more sore than after the first shot".  Additional information: There were no additional vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events did not result to physician and emergency room visit.   No follow up attempts are possible. No further information is expected.
I was having daily headache behind my eye, I was nauseas and had dizziness, a lot of ringing on both of my ears, the most significant was the pain behind my eyes. I went to see an eye doctor where I was diagnosed with Papilledema, he said it meant I had too much pressure in my scull and on my brain and for some reason my spine was surrounded by too much fluid, I don't know if that was related to this vaccination. I'm a very healthy individual and I was referred to the lab and I had Spinal tap and brain scan, they pulled all the extra fluid that was behind my brain, they tested the fluid to make sure it wasn't a tumor or bleeding into my brain. I went to Neurologist, and I've been having follow-ups, they keep checking on the pressure on my brain and they said that the fluid is still too high, and they will monitor to make sure there is no more fluids. My next appoint is scheduled. I was also prescribed Diamox twice a day. I am still having the same issues. It hasn't gotten any better.
I have had joint pain in my shoulders for six weeks straight and then  intermittently for weeks after that. The pain is bilateral, and I have never had joint pain before. I had also had right upper quadrant pain in the two weeks after the second dose that is still bothering me on occasion. I am constantly nauseated, and my reflux was out of control. That seems to be resolved. I got tested after I experienced chest pain and my Potassium was very low. My EKG indicated a heart problem. That was seven weeks after my shot. Now my fingers turning white on both hands. I also had an issue with late periods. I was one week late after the first shot and two weeks late after the second shot. I have chronic migraines and since my vaccines I have had long lasting migraines that have lasted up to ten days. I have had multiple visits to the Urgent care and my primary care doctor. I have a GI scope scheduled 04/26/2021.
Patient did not have any adverse reactions to covid vaccine. Patient was vaccinated with incorrect covid vaccine, he was 3 years old when he received a covid vaccine for patients ages 5 years to 11 years.
Fever of 101.5 Chills Body/muscle aches Headache Fatigue Itchy and burning mouth Itchy skin
bumpy growths all over my chest and abdomen; warts; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INDURATION (bumpy growths all over my chest and abdomen) and SKIN PAPILLOMA (warts) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced INDURATION (bumpy growths all over my chest and abdomen) and SKIN PAPILLOMA (warts). On 14-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, INDURATION (bumpy growths all over my chest and abdomen) and SKIN PAPILLOMA (warts) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) "way high" both times and was hard to control but stabilized after 24 hours..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment drug were not reported.   This case was linked to MOD-2021-049848 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up information received : Skin papilloma and Induration events are added.
Incident occurred from possible inviable covid-19 pfizer-purple dose (booster) being administered to the patient. Patient's parent reported no adverse events other than typical ones from covid vaccine. Patient's parent will consider the offer for a replacement booster dose.
evening of inj arm painful, swollen from elbow to shoulder & skin warm to touch;hardened area noted @ entire upper lt arm;8NOV96 swelling & pain minimal;
severe myalgia 10/10 entire body affected; Hyperesthesia; violent chills/rigors; injection site pain (worse than prior dose); This is a spontaneous report from a contactable physician (patient herself). A 35-year-old female patient received second dose of PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (left arm) on 05Jan2021 at 11:45 a.m., at a single dose, for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD) and allergic rhinitis. Concomitant medications included loratadine (CLARITIN), methylphenidate hydrochloride (CONCERTA), fluticasone propionate (FLONASE), and montelukast sodium (SINGULAIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 17Dec2020 for COVID-19 immunization and experienced injection site pain; and isoniazid and experienced rash. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 06Jan2021, at 12:00 a.m., the patient experienced severe myalgia 10/10 entire body affected, hyperesthesia, violent chills/rigors, and injection site pain (worse than prior dose), peaked approximately 12 hours after dose. Patient has no fever. It was reported that first dose side effect of moderate 6/10 injection site pain in Dec2020, responded well to naproxen. The patient did not receive treatment for the events. Patient did not seek medical care, because she and her husband are both intensive care unit (ICU) physicians. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 05-JUL-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (llot#  N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Patient details received.
9 patients received an expired dose of Fluzone Quadrivalent vaccine with no adverse event; Initial information received on 07-Oct-2020 regarding this unsolicited valid non-serious case from a consumer/non-healthcare professional (Practice manager)   This case involves 9 patients of an unknown demographic who received a dose of  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot number- UT6695KA, Expiration date- 30-Jun-2020) via an unknown route in unknown administration site (expired product administered) for prophylactic vaccination on an unknown date.  The patients medical history, medical treatments, vaccinations, concomitant drug and family history were not provided.  It was a case of an actual medication error due to expired vaccine used (Latency: Same day).  At the time of reporting, patient had no adverse event.  Reporter wanted to know if the patient should revaccinated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Wrong Route of Administration; pain left arm; left arm warm to the touch; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. In June 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and skin warm. On 26th June 2019, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the pain in arm and skin warm were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the pain in arm and skin warm to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The registered nurse stated that, she administered a Shingrix dose to the patient subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. The patient was experienced pain in the left arm and his left arm was warm to the touch. There is a discrepancy between the outcome reported in the structured field " recovering/resolving" and the outcome reported in the sender's comment " not recovered/not resolved."
COVID-19 Breakthrough case. 8/24/21: presented to the ED for evaluation of fever, fatigue, and weakness that started today.  Patient went to dialysis today and was able to complete session but on return to nursing home she was noted to have fever and confusion and EMS was called.  COVID rapid antigen PCR test run 8/24 was positive. admitted on 8/24/21. Note: previously received Pfizer Covid-19 vaccines on 3/18/21 & 4/6/21.  Diagnosed and treated for acute hypoxic respiratory failure, Covid infection and sepsis.  Improved and discharged 8/26/21.
Mild intermittent fever, 99.1--100.8, severe joint aches, from evening of vaccine 3/19, til morning of 3/21.  Large local cutaneous reaction at injection site soon after administration -- major swelling, redness and rash, inflamed lymph node in arm; tenderness in nodes under arm. Gradual reduction in swelling over 5 days, still slightly swollen, itchy and sore.
numbess in hand of injection arm; The N and T is intermittently continuing; stiff at injection site; I have injection site pain and expected that; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPOAESTHESIA (numbess in hand of injection arm), PARAESTHESIA (The N and T is intermittently continuing), MUSCULOSKELETAL STIFFNESS (stiff at injection site) and VACCINATION SITE PAIN (I have injection site pain and expected that) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stent placement (CAD, stent) on 04-Sep-2021. Previously administered products included for Shingles: shingix on 15-Oct-2021. Concurrent medical conditions included Cardiovascular disorder since 04-Sep-2021, Diabetes since 11-Apr-2021 and Fibromyalgia since 2011. Concomitant products included PREGABALIN (LYRICA), BUPROPION HYDROCHLORIDE (WELLBUTRIN), DULOXETINE HYDROCHLORIDE (CYMBALTA), ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL TARTRATE, ROSUVASTATIN and PANTOPRAZOLE for an unknown indication.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced VACCINATION SITE HYPOAESTHESIA (numbess in hand of injection arm), PARAESTHESIA (The N and T is intermittently continuing), MUSCULOSKELETAL STIFFNESS (stiff at injection site) and VACCINATION SITE PAIN (I have injection site pain and expected that). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 06-Nov-2021, VACCINATION SITE HYPOAESTHESIA (numbess in hand of injection arm), PARAESTHESIA (The N and T is intermittently continuing), MUSCULOSKELETAL STIFFNESS (stiff at injection site) and VACCINATION SITE PAIN (I have injection site pain and expected that) had resolved.            No treatment medications were reported. patient has taken shingles vaccine on 15-OCT-2021 patient takes Brillanta 90 mg BID   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow-up document received, included Reporter information, treatment medication, concomitant medications and  historical vaccine  updated.
On 2/26/2021, I had a soaking night sweat and a few other symptoms.  After 72 hours, (3/1/2021) labile blood pressure rose; lymph nodes left neck, breast and spleen were enlarged and tender;pain/tenderness cont'd down left side lymph nodes. General ache and pressure across back (kidney area). After 2-3 days, lymph nodes on right side became tender. Labile blood pressure requires medication (generic norvasc) but still fluctuates. Pain in joints and slight "bloating" overall. Sinus mucosa completely dry (nasal). These symptoms continue as of 3/9/2021.
The patient had some numbness and tingling in the shoulder and redness in the area of the vaccine. The doctor put the patient on Xyzal for the reaction.
My son experienced after the Pfizer vaccine and by the next day he had extremely left sore arm, by the evening he developed a fever of 101.F. The next day he still had with the fever of 101F getting some fatigue, then his fever was going up to 102.4F, on Tuesday, Wednesday and Thursday of that week. He also got chills, with the fever and then on one on the nights, Wednesday he had extreme sweat profusion, his clothes were drenched.  We saw his doctor on Wednesday of that week, cheek his vitals, lab work, his WBC was low and platelets were low.   On Friday 05-21-2021, his fever was 99.0F  and then by the afternoon then he was fever free and started to feel better. His doctors did a second lab work, WBC, was normal and his platelets went form 1129 to 373.  His due for his second vaccine on 06-05-2021.
Having chills like she was convulsing; Arm felt unusable; Disoriented; Felt like she was hit by a bus; Extreme body aches; Temperature range of 102-104F that lasted around 24 hours; Chills like she was convulsing; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Having chills like she was convulsing) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No recorded medical history).    On 04-Jan-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 SEIZURE (Having chills like she was convulsing) (seriousness criterion medically significant), LIMB DISCOMFORT (Arm felt unusable), DISORIENTATION (Disoriented), ILL-DEFINED DISORDER (Felt like she was hit by a bus), MYALGIA (Extreme body aches), PYREXIA (Temperature range of 102-104F that lasted around 24 hours) and CHILLS (Chills like she was convulsing). At the time of the report, SEIZURE (Having chills like she was convulsing), LIMB DISCOMFORT (Arm felt unusable), DISORIENTATION (Disoriented), ILL-DEFINED DISORDER (Felt like she was hit by a bus), MYALGIA (Extreme body aches) and CHILLS (Chills like she was convulsing) was resolving and PYREXIA (Temperature range of 102-104F that lasted around 24 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included Ibuprofen and cold showers to relieve her symptoms.  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.; Sender'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.
Worsening joint pain, numbness (left leg/hand), leg coldness, and stroke after AVA #4: 06 Jan 2003 AVA 1 w/o AE.  AVA2 was given 23 JAN 2003 with complaints of mild joint pain (bilateral knees, ankles and shoulders) that increased to a deep 6/10 ache within 8-12 hours similar to preexisting foot pain but now shoulders hurt, lasted 2 days.  AVA3 on 03 March 2003 - 24 hours later he awoke with 10/10 bilateral ankle, knee, hip, and shoulder pain.  He described the pain as if his joints were being "crushed or as if they were going to burst".  TYLENOL and ADVIL provided only minimal relief (6/10 pain scale).  He reported no restrictions in ADL and was able to work.  Was in physical therapy for chronic lower back pain but stated this discomfort was different.  Duration was 3 days.  9/29/2004 AVA #4 and TYPHOID vaccine w/minimal increased in his chronic joint pain - was on TRAMADOL for chronic back problems.  02 Dec 2004 c/o left leg suddenly went cold and numb w/a sharp jolt of pain after pushing in a clutch.  (on GABAPENTIN and MELOXICAM for pain.)  03 December 2004 (day 64 post AVA #4) he awoke complaining of a sharp pain to left leg, left hand numbness, and inability to drive.  Three days later (6 Dec 2004) he presented to ER for 4/10 chest pain and shortness of breath X 3 days.  He also complained that the left 1/2 of his body, hand, face, chest, abdomen, LUE, LLE were weak (subjective) and numb.  His exam was normal with normal EKG, MRI brain, and lab studies.  He was diagnosed with left paresthesia and C/L spine disc disease.  Follow up evaluation 19 April 2005 with PCP documented he "did not have history of a stroke but had left side numbness due to possible viral infection".  His sensation to touch was normal although he complained of a sensation of numbness.  He reported that his facial numbness took 12 months to fully resolve.  Symptoms:  Joint pain, multiple joints.