chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccination failure; This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 29-year-old female patient, who was referred to hematology for severe neutropenia. The patient had a history of cardiovascular malformation (ventricular septal defect) surgically repaired at the age of 5 and recurrent skin and oto-sinopulmonary infections (sinusitis, otitis media, and pneumonia) since childhood resulting in progressive hearing loss and chronic bronchiectasis. The patient also reported anosmia and recurrent blisters of the philtrum, likely herpetic lesions, although no such lesions were present at the time of our examination. Additionally, her HSV-1 antibodies were positive on serology. Her family history was notable for brother with recurrent infections. The patient also underwent a bone marrow biopsy to evaluate incidentally discovered neutropenia and the biopsy showed a largely normal marrow with trilineage hematopoiesis, erythroid hypoplasia, and plasmacytosis without light chain restriction. On the day of presentation to the hematologic clinic, her laboratory examination was notable for bicytopenia with a total white blood cell count of 2.1 10^3/uL, absolute neutrophil count of 1.1 10^3/uL, absolute lymphocyte counts 0.7 10^3/uL, absolute monocyte counts 0.3 and hemoglobin of 7.9 g/dL. Additionally, it was reported the patient immunoglobulins were high: IgA 523 mg/dL, IgG 1804 mg/dL, IgM 185 mg/dL and IgE 260 mg/dL. The patient's vaccine history included vaccination to diphtheria, tetanus, mumps, and rubeola.  On an unspecified date, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) for prophylaxis (formulation, concentration, dose, route of administration, anatomical location, lot number, and expiration date were not reported). However, the response to this vaccine was suboptimal (vaccination failure).  The outcome of vaccination failure was unknown.  The causality assessment between vaccination failure event and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) was considered related.  Literature Report. A copy of the published article is attached as further documentation of the patient's experience.
bad cramp in her arm that was painful; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (bad cramp in her arm that was painful) and VACCINATION SITE PAIN (arm soreness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CELECOXIB (CELEBREX) for Knee replacement.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm soreness). On 23-Mar-2021, the patient experienced MUSCLE SPASMS (bad cramp in her arm that was painful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (bad cramp in her arm that was painful) and VACCINATION SITE PAIN (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included ice.
On the 9th day after vaccine, a rash appeared at the injection site along with soreness and heat.  It is currently the second day of the rash along with soreness and heat.  (10 days after vaccination).
At the end of the 15 minute observation period the client reported slight chest discomfort in the observation area at 2:46 PM. The client denied any other symptoms. Vitals obtained at 2:40 PM were as follows: BP 122/76, HR 96, O2 98%. The client stated that she felt anxious prior to receiving the COVID vaccine Janssen and drank water. Repeat vitals obtained at 2:50 PM were as follows: BP 126/79, HR 86, O2 98%. The client stated the chest discomfort was getting better. At 2:55PM the client stated she has experienced the same discomfort in the past related to her anxiety. The client was educated on s/s of anaphylaxis and when to seek EMS. The client voiced understanding of this education. The client drove herself to the vaccination site and stated that she was "good to drive myself home." The client ambulated unassisted with a steady gait out of the observation area at 2:55PM.
Administered a Moderna COVID-19 vaccine to a 16 year old; A spontaneous report  was received from a healthcare facility staff member concerning a 16-years-old patient who received Moderna's COVID-19 Vaccine and experienced Moderna's COVID-19 vaccine was administered to a 16-year-old.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 31 Dec 2020, the patient received their planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection at the age of 16-years-old. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, Moderna's COVID-19 vaccine was administered to a 16-years-old, was resolved.; Reporter's Comments: This case concerns a 16 year old patient who received their planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. There were no reported adverse events in this case of  product administered to patient of inappropriate age
pt recvd vax on 2APR92 & on 20APR92 noted a petechial rash from neck to toes; had no fever or itching; seen by MD; sx persisted for 8 days & then remitted; No further details were provided;
Local Reaction pain in left arm.   palpitations, started 45 seconds after shot and lasted 20 min.  Facial numbness and tingling began on left side of face started an hour after vaccine administration, spread over entire face over a few hours, remained that way for 6 hours, then subsided but some residual numbness sensation for an additional 18 hours.
Their arm swelled; Their arm had red welts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Their arm swelled) and URTICARIA (Their arm had red welts) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Their arm swelled) and URTICARIA (Their arm had red welts). At the time of the report, PERIPHERAL SWELLING (Their arm swelled) and URTICARIA (Their arm had red welts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.     This case was linked to US-MODERNATX, INC.-MOD-2021-106873, US-MODERNATX, INC.-MOD-2021-106720, US-MODERNATX, INC.-MOD-2021-106972, MOD21-087005 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106873: US-MODERNATX, INC.-MOD-2021-106720: US-MODERNATX, INC.-MOD-2021-106972: MOD21-087005:Crosslink
Within 30 minutes of receiving both vaccines I had numbness in back of tongue and throat. Similar to feeling I used to get whe I took Imitrex (sumatriptan) for migraineswhen I was younger. The feeling lasted a few hours and went away. It caused no other symptoms
Chills, fever up to 100.8, body aches, left arm pain, mild nausea, weakness, rash
Received vaccine 4/8/21. Presented to hospital 4/14 with worsening dyspnea and chest tightness. Found to have bilateral pulmonary embolism. Unclear if the vaccine is a true precipitant here but wanted to report.
His arm was sore; Felt fatigued; Him and his wife both got their 1st shot of the Pfizer covid vaccine last week at pharmacy/they got a call from pharmacy that it was not stored at the right temperature; Him and his wife both got their 1st shot of the Pfizer covid vaccine last week at pharmacy/they got a call from pharmacy that it was not stored at the right temperature; This is a spontaneous report from a contactable consumer. Patient reported about him and his wife. This is report 1 of 2. A 32-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and expiration date: Unknown), via an unspecified route of administration on 07Mar2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received vaccine which was not stored at the right temperature and patient stated he was given a bad vaccine and offered a new appointment for a good vaccine. Patient reported his arm was sore, felt fatigued for 2 days, but now although him and his wife feel okay. The outcome of arm was sore, felt fatigued was recovered and other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Hypertension, with systolic numbers that have increased from 132 to 152 over the course of the months after the first doses, and after the 3rd dose on 11/11 the numbers remain between 145-152, diastolic has remained around 89-95. Also, my heart beat feels stronger, I can feel it more consciously now.
Patient admitted to hospital with positive COVID test after being fully vaccinated.  Patient admitted to hospital on 06/15/2021 with right sided facial droop and right sided weakness.  Initial admission test was "NOT detected."  Patient with chronic cough since April.  Was tested for COVID (NOT detected) on 04/20/21, and chest X-ray completed unremarkable for infectious process.  Cough continued, patient seen again by PCP on 06/10 for cough.  No further COVID testing at that time.  Patient is fully vaccinated (Pfizer 1/18/21 and 02/08/21).   No new or worsening symptoms during hospitalization related to COVID.  Discharged to rehab (PT) facility once out of potential infectious period.
Daily muscle twitches, as well as palpitations and chest pain. My doctor is doing tests currently to figure out what?s wrong. Been happening since around June
Since February 2021 to October 5, 2021, I have lost 14 pounds:  going from 112 lbs. down to 98 lbs. for no unexplainable reason.  I have a very good appetite, 3 meals per day, plus 3 snacks (mid morning, mid afternoon, and evening).  I am down to being a skeleton covered with skin.  There is no known reason for this great amount of weight loss during this period of time.
Rapid pulse, heated and flushed feeling. Red face, dizziness.   Was evaluated in ER. Was monitored for 4 hours at the hospital. Felt flushed and dizzy off an on for about a week.
About 14 hours after patient received booster dose (0.25ml) of Moderna Covid vaccine, he developed severe pain in all joints of his body.  He also reports his nerves were "on fire" and that there was noticeably increased numbness in extremities.  The pt went to his primary physician who prescribed a high dose prednisone taper.  This course of treatment did little to relieve nerve symptoms.  Pt also states that he is in as much pain as he was in before his recent back surgery even though, prior to the booster dose, he was experiencing positive healing and improvement.  He has additional follow-up appts to further address the pain and discomfort.
Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: passed out for 3-5 seconds-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: she passed out for 3-5 seconds, came to. Was very pale, maybe 5 minutes later threw up. Then she regained some color and was less confused. She was very anxious about getting the shot prior to getting the injection.
A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicating that a 11 month old female vaccinee was inadvertently administered Fluvirin IM on 15Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200805, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.
Patient received vaccine and sat on the bench waiting for his wife to get hers.  Approximately 5 minutes later, he got dizzy then his eyes rolled back and he past out started seizing.  EMS was called immediately and patient was laid on his side.  He came to in approximately 30 seconds.  He was noticeably sweating but did not lose any bodily fluids and said he felt better than he did right before the incident.  I checked his blood sugar while waiting for EMS to arrive and it was 99.  Patient has no previous medical history of fainting or seizures and was taken to hospital via ambulance to get checked out.
This case was reported by a other health professional via call center representative and described the occurrence of injection site discoloration in a 5-year-old female patient who received KINRIX (batch number 3425B, expiry date 17th April 2018. On 15th April 2017, the patient received KINRIX .5 ml. On 15th April 2017, immediately after receiving KINRIX, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved. The reporter considered the injection site discoloration to be almost certainly related to KINRIX. Additional details were provided as follows: The case was reported by nurse practitioner student. The patient received KINRIX in the left deltoid and a few seconds after vaccination (immediately) experienced discoloration at injection site. The discoloration had lasted for a month and the patient's parent said that the discoloration was becoming more prevalent.
Upon receiving the vaccination, pt experienced immediate pain that continuously got worse. She underwent surgical exploration and treatment and has been diagnosed with nerve and neurological damage with scarring and impairment of the (L) arm.
Severe Chills Fever Full body ache - joints/muscles Lost Balance - fell twice Incoherent  Confusion ulcers  in mouth and on tongue Swollen lips no strength - could not stand up on my own dehydration
joint pain; fever; headache; chills; This is a spontaneous report from a contactable consumer (patient)   A 66-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 06Mar2021  at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included Prostatomegaly. Concomitant medications included tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]). The patient received first dose of BNT162B2 on 10Feb2021 at 11:30 on left arm. On 06Mar2021 at 23:00 the patient experienced joint pain, fever, headache and chills.  No treatment was received. The patient recovered from the events on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:44 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:44 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 44.83.  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 3-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient came back in to office 4 days after receiving TD vaccine. The area was slightly swollen, slightly warm, may have been a hematoma. No fever or any other reaction, no redness. Ibuprofen suggested as well as ice/heat.
arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jul2021 (Lot number: EW0181) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "PTSD" (unspecified if ongoing), notes: PTSD; "Thyroid" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Muscle Relaxer" (unspecified if ongoing), notes: Muscle Relaxer. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder, start date: 2021 (ongoing); PAXIL [PIROXICAM] taken for post-traumatic stress disorder (ongoing); ROSUVASTATIN taken for blood cholesterol, start date: 2021 (ongoing); METFORMIN taken for diabetes mellitus, start date: 2021 (ongoing); ALPRAZOLAM taken for anxiety, post-traumatic stress disorder, depression, start date: 2014 (ongoing); TRIAZINE taken for hypotonia (ongoing); VITAMIN D3, start date: 2021 (ongoing).  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm pain". Therapeutic measures were taken as a result of pain in extremity.  Additional information: Patient also takes Tylenol for pain every day.   No follow-up attempts are possible. No further information is expected.
As soon as I received my second dose of my Pfeizer shot I felt like an electric current run through my left  arm where I received the vaccine. I also experienced blurry vision up to 20 mins later. And a week later I still feel a little tired.
Started feeling weak and lethargic. Chest felt very tight, and I used my asthma inhaler 5-6 times over the course of an hour to clear out mucous. Coughed up about 1/2 C. clear mucous over the next hour, which at times nearly choked me. By 9 PM I had to go to bed with severe chills, shaking, feeling very cold. Shaking was paroxysmal and all my muscles were clenched, jaws clenched. By 10 PM my head hurt and felt like tremendous pressure inside my skull and like my eyeballs would explode. Neck very stiff. Couldn't find the thermometer so I can't tell what my temp. was. I was delusional; having nightmarish thoughts about a circular saw, crawling out the back door of my house, etc. Literally crying and screaming for help through my teeth, though I could not move during this time due to the paroxyms. (I live alone). Knew I should call ambulance but couldn't formulate in my mind how to get to the phone. Very frightening. By 11 PM I was able to go to the bathroom, drink a glass of water, then went right back to bed. Awoke again around 2 AM the next morning feeling somewhat relieved but exhausted. It was the worst night of my entire life. Horrifying. The feeling of being unable to move, or respond appropriately in my own best interest, was horrifying.
A consumer report has been received. The report concerns a child, consumer of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL), 0.2 ml. FLUMIST (INTRANASAL) started on 19-Dec-2015. The patient experienced BEEN SICK AFTER RECEIVING FLUMIST. The outcome of the event of BEEN SICK AFTER RECEIVING FLUMIST is unknown. The report was considered to be non-serious.
Pregnancy: 24 weeks at time of vaccine, estimated due date: 7/27/2021. Second pregnancy but no prior live birth.  Adverse effects: Woke at 2:30am the next morning with chills, low grade fever throughout the next 24 hours (99 degrees F), severe muscle and body aches, extreme fatigue, slight nausea.  Outcomes: Completely resolved by the following day (4/9/2021). Pregnancy is uncomplicated with baby in 25th %ile for EFW. Baby healthy and active. No issues with cervix or placenta.
Both shots a year ago, I have them right now/suspected vaccination failure; I have them right now, awful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 02-MAR-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had both shingles shots over a year ago but he/she had shingles right no awful. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.