chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2044US004271 is an initial spontaneous report received from a consumer on 27 FEB 2014. This report refers to a 13-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5 ml on an undetermined date in DEC 2013, two weeks before holiday. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 27 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Severe Arm pain lasting 3 days; heart palpitations that lasted about 4 hours the day after; Dose number 3/ booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 16:30 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "known_allergies: Amoxicillan". Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), administration date: Apr2021, when the patient was 39 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), administration date: Apr2021, when the patient was 39 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 16:30, outcome "unknown", described as "Dose number 3/ booster"; PAIN IN EXTREMITY (non-serious) with onset 10Dec2021, outcome "recovered" (Dec2021), described as "Severe Arm pain lasting 3 days"; PALPITATIONS (non-serious) with onset 10Dec2021, outcome "recovered" (Dec2021), described as "heart palpitations that lasted about 4 hours the day after". Therapeutic measures were not taken as a result of pain in extremity, palpitations.  Additional information: Reason for batch/lot number was Unknown as not available/provided to reporter at the time of report completion. Patient did not receive the any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive the any other medications within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Covid Vaccine appeared to be interfering with antidepressants.  On 2/16, at 9:00 AM, began experiencing brain shocks and very pronounced tics, as well as confusion and extreme depression.  Symptoms the same as when decreasing or eliminating sertraline from medication regiment.  Went away by 11:00 PM on 2/16.
Stuffy nose, cough, loss of taste, loss of smell, fever. My smell and taste has not fully recovered to date 05/10/2022 since my Pfizer Booster shot on December 2, 2021.
3/14/03 8:25 - Report of vaccinee via Spanish interpreter, and client reports awoke 3/12 a.m. with dizziness and itchy "rough rash" on belly, arms, back of hands, elbows, knees, can feel it not see it. Also dizzy. Worked 3/13/03 When went to work 3/14 supervisor advised her to call. 3/14/ Tx by Kitinkers Saw Medral PCP as as urticaria (hives)
Diabetes; Arthritis/set off her arthritis really bad; Allergy; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4467544-00.  A 76-year-old female patient received BNT162b2 (BNT162B2), as dose number unkown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "Diabetes"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Arthritis/set off her arthritis really bad"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergy". The action taken for upadacitinib was unknown. Clinical course: Solicited report by a consumer of an elderly female with events of non-serious allergies, diabetes and Covid vaccine effected Arthritis or storm effects Arthritis with RINVOQ (UPADACITINIB). On unknown dates, the patient experienced Allergies, Diabetes and Covid vaccine effected Arthritis or storm effects Arthritis. Pfizer BioNtech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient had allergies really bad. She had diabetes. She had the covid vaccine and it set off her arthritis really bad. When it storms it really bothers her arthritis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's assessment of the causal relationship of "diabetes" and "allergy" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "arthritis/set off her arthritis really bad" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Alternating sweats and chills Headache (6 days) Fever 5 days Back pain Joint pain  Blotchy torso 2 weeks post injection Dehydration Loss of appetite
8 to 9 days post vax, the pt developed a rash on chest, arms, and back; then began running a 105 fever. Taken to pediatrician and dx with ear infection. Placed on antibiotics and was ok within 3-4 days.
Patient is experiencing redness, inflammation, itchiness in the arm she received both vaccines in. The areas on the arm that are affected are at the inject site (deltoid) and also from above the  elbow to below the deltoid. She has tried to hydrocortisone cream for the itching and inflammation which has given her some relief but nothing else yet.
No symptoms or adverse events occurred. Vaccine was discovered to be non viable d/t temperature excursion and patient will have to be revaccinated. DPH consulted.
Hives all over body within 4 hrs of vaccine; improved with OTC Benadryl oral q6 hrs as needed - took it for 3 days - and rash resolved
Respiratory, can't smell hardly anything, food has no taste. This all started the day after I received my 1st shot. As of this date, all symptoms are the same.
pt says the next day after taking the vax his arm was a little sore but when he stood up he had a hard time moving around, he was hyperventilating and he felt very exhausted.  He got a severe pain in his left hip.  He said the pain was so intense he could barely move so he took a low dose pain killer.  He was in so much pain he curled up in a fetal position and rock back and forth.  He says he was crying and in a hallucination state for about an hour.  After that the he said the symptoms seemed to be getting better but was completely exhausted.  His eyes were red and had trouble with his vision.  On 6/4/2021 he still has some pain and has an ache inside the bone, gets winded w/ moving around but says his symptoms seemed to be improving.
I had a fever, chills, body aches, and fatigue. I took 2 at-home COVID-19 tests on 08/06/2022 which both came back positive for COVID-19. I ended up developed long-haul COVID-19 which triggered more issues with my POTS that I was diagnosed with. My doctor didn't want to prescribe me PAXLOVID due to underlying condition so I was told to only take TYLENOL for treatment.
A report has been received   from a Pharmacist concerning a female subject who had  been receiving FLUMIST Quadrivalent. started on an unknown date. The patient experienced itching which started on 13-OCT-2014. The outcome of the event of itching is unknown. The report was considered to be non-serious.
No additional adverse events were reported; improperly stored Gardasil 9 and VAQTA administered on 09-SEP-2022; This spontaneous report was received from a Licensed Vocational Nurse (L.V.N.), who was also an office manager/ administrator and refers to a 15-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 09-SEP-2022, the patient was vaccinated with an improperly stored (temperature below 36 Fahrenheit [F] degrees [29.8 F] for 17 hours, 0 minutes and 0 seconds, there were no previous temperature excursions) dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 2nd dose, lot #1780878 was found to be valid, expiration date: 02-DEC-2023, administered in left deltoid for prophylaxis (strength and route of administration were not provided) and influenza vaccine inact sag 3v (FLUCELVAX), lot# 348359, expiration date: 30-JUN-2023 administered in right deltoid (strength, formulation, route of administration and indication were not provided) (product storage error). The patient experienced no adverse event (no adverse event).  This is one of several reports from the same reporter.
SEVERE CRAMPING, THROBBING, ACHINESS IN ALL JOINTS AND MUSCLES IN LEGS HIPS CALVES AND FEET ALONG WITH A BURNING ITCHY FEELING INSIDE MY LEGS AND HIPS.
Body aches/muscle pain; Headaches; Joint pain; Chills; Fever; Fatigue and tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches/muscle pain), HEADACHE (Headaches), ARTHRALGIA (Joint pain), CHILLS (Chills) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atopic dermatitis. Concomitant products included LOSARTAN and NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced MYALGIA (Body aches/muscle pain), HEADACHE (Headaches), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue and tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (Body aches/muscle pain), HEADACHE (Headaches), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue and tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial 48 hour period showed little to no reaction. Then chills and  fever of 101 followed by more chills and low grade fluctuating fever going on over 48 hours.  The unusual event is  that this reaction occurred 8 days after vaccination beginning on 3/7/21. Has not resolved completely yet as of 3/9/21. Because of the delay, I took a covid19 pcr test which was negative.
Unknown adverse events; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 53BF4, expiry date 14th August 2021) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, less than 4 months after receiving Boostrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Boostrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient identifiers details were unknown. The patient had injection site reactions to Boostrix. The reporter reported adverse reactions to a specific lot number for the product. The adverse event details were unknown. The reporter did not have any further details for any of the patient. The reporter gave permission to follow up. This case had been linked to the case US2019145738, reported by same reporter.
Client received first dose of TWINRIX. After 5-10 minutes post injection she said she began having a headache and some dizziness. (Before the injection, she told me that she had developed, the day before at work, a rash around her neck after crawling out of a crawlspace under a house. She wasn't sure why she had developed it, other than that was the only area not covered by her has-mat uniform. At the time of vaccination she still has a slight amount of pale redness on the front of her neck. She was advised to stay seated and drink fluids (She did not want to lie down). She continued to have a headache after a duration of one hour. She was advised that she should notify her medical provider and advise them of her current symptoms. (She said she would do it TUES when she took her child to his doctor appt. It was advised that she should not go to work and go home and rest. She went to work and her boss sent home after receiving our recommendations. She was advised to talk to her medical provider regarding receiving further vaccine for Hepatitis A and B.
A very pleasant 18-year-old female who lives at home with her parents.  Her history is pertinent for chronic right leg pain due to complex regional pain syndrome, postural tachycardia syndrome (POTS), and questionable mast cell degranulation.  She has been in her usual state of health.  She is looking forward to going to The University of New England for college this fall.  They require COVID vaccination.  Family considered their options.  They opted to choose the Johnson & Johnson vaccine as it is a single shot and the patient has had adverse reactions with prior vaccines according to the mom.  The patient had her J & J vaccine early in the morning.  It was given at approximately 9 a.m.  The patient went home.  Shortly thereafter she started feeling very tired, in fact had to take a nap.  She felt hot, but when the temperature was measured at home, she was afebrile.  Then later evening she started developing significant pounding in her chest.
Facial palsy started afternoon of 12/14, pt went to ER-not sure of Tx there, received Rx's for prednisone and VALTREX to treat Bell's palsy.
About 7 hours after, I developed a fever of 103 that lasted about 12 hours. On 5/25, I woke up with a rash/hives that covered my chest, stomach and back, which I still have. I went to the urgent care and was given steroids, Benadryl and Pepcid. The meds stopped them from spreading, but they didn't go away. On 5/31, I went back to urgent care due to it spreading more onto my neck, bottom and starting to do down my thighs. It looks like little burns all over my body. They are thinking I got it because my body was trying to fight off the vaccine due to my deficiency. I was put on 12 days of steroids to prevent it from continuing to spread, the inflammation and itching. She diagnosed it as Pityriasis Rosea. She said that I will have this rash for approx 4-8 weeks.
When I wake up my hands are swollen with joint pain. Painful to bend fingers. My feet are the same way.  Nausea, vomiting diarrhea.
Information has been received from a third party claims administrator regarding a case in litigation concerning a female consumer. At a pharmacy, on 07SEP13, the patient was vaccinated by injection with 3 vaccines, 2 in the left arm AFLURIA (lot # 08849211A) and PNEUMOVAX (lot # H020684) and the third one BOOSTRIX (lot # AC52B099BA) on the left hand. The patient sustained on her left arm, redness, swelling, pain and her arm felt hot and fever. The patient was admitted to the hospital and was hospitalized due to a cellulitis in left arm. Additional information has been requested.
Experiencing heavy hair loss to the point; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Experiencing heavy hair loss to the point) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included Essential thrombocythemia (Had ET for 16 years). Concurrent medical conditions included Hair loss (Significant hair loss at the beginning but it let up after the first year.).   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Experiencing heavy hair loss to the point). At the time of the report, ALOPECIA (Experiencing heavy hair loss to the point) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: Staying between 700 to 900..         Patient was on HU for 14 years. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Information has been received from a pharmacist concerning a patient who last week, on approximately June 08 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Now, the patient presents to the ER with cellulitis at the injection site. The patient was not admitted, but was placed on oral anitibiotics and sent home. No product quality complaint was involved. No additional information was available.
headache on left side of head, swollen lymph nodes in neck, sore and stiff neck on the left side.  Duration: approx. 9 days Treatment: Tylenol 500 mg; Motrin 200mg
We had patients who were administered the vaccine that underwent temperature excursion; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:42 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.  No treatment medications were provided.
Approximately 2 hours after administration of vaccine, the patient became fatigued.   The feeling of overall fatigue has continued until the present time (10-8-21).
This spontaneous report was received from a medical assistant and refers to a 75-year-old female patient. The patient was allergic to sulfa. No information regarding the patient's medical history was reported. On an unknown date in May 2017 (reported as "on 01-MAY-2017 or 09-MAY-2017"), the patient was vaccinated with PNEUMOVAX23 lot# N005096, expiration date: 22-OCT-2018 (dose, route of administration were not reported). Concomitant therapies included omeprazole, loratadine (manufacturer unknown) and probiotics (unspecified). On an unknown date in May 2017 (reported as "on 02-MAY-2017 or 10-MAY-2017" and "the day after"), the patient experienced cellulitis on the back of her left arm. The patient sought medical attention and was treated with unspecified antibiotics. There was no lab diagnostic studies performed. The outcome of cellulitis was reported as not recovered. The causality between PNEUMOVAX23 and cellulitis was not provided. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009128: US-009507513-1705USA007145:
Patient stated his blood sugars have been fluctuating, and he has thinning hair on his scalp. It was a couple weeks after the vaccine the hair loss started. His blood sugar was closer in proximity to the vaccine with a day or so. Patient came in today and discussed the vaccine. He stated his doctor was informed of the issues, but didn't know if there was anything he could do about it. Patient decided to try an over-the-counter vitamin for hair loss. Patient monitors blood sugar at home for diabetes.
Patient received 1st dose of moderna vaccine 1 week prior to 2nd dose, making it 3 weeks too soon. Patient reported no adverse events. Will follow up with patient over the next couple of days.