chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; headache; lower back pain; She is having a hard time moving around; back started hurting the day after she received the Covid 19 vaccine/back is hurting like she's lifted something heavy but she hasn't lifted anything; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Apr2021 14:00 (Lot number: EW0158, Expiration Date: 31Jul2021) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious) with onset 07Apr2021, outcome "recovered" (08Apr2021), described as "body aches"; HEADACHE (non-serious) with onset 07Apr2021, outcome "recovered" (08Apr2021), described as "headache"; BACK PAIN (non-serious) with onset 07Apr2021, outcome "not recovered", described as "lower back pain"; DYSKINESIA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "She is having a hard time moving around"; BACK PAIN (non-serious) with onset 07Apr2021, outcome "not recovered", described as "back started hurting the day after she received the Covid 19 vaccine/back is hurting like she's lifted something heavy but she hasn't lifted anything". Therapeutic measures were taken as a result of pain, headache.  Additional information: Her mother has been taking Tylenol but it doesn't really help. The Tylenol is 500mg and she takes 1 tablet at a time. Tylenol Lot# SSA101 Expiry Oct2022. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) none. No additional Administered Vaccines If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect. No any AE Prior Vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Left deltoid (site of injection0 red, inflamed, tender to touch. treated with erythromycin 333 TID for 5 days.
Day 1,2,- mild headache, sore arm at injection site Day 3 - dizziness, vertigo Day 4, 5, 6 - slight fatigue Days 7,8,9 : Intermittent Fever 100.1 to 100.5 Constant Headache Exhaustion Heavy lung sensation when taking a deep breath Body aches Hot flashes Brain popping/electrical sensation in skull Day 10 - symptoms stopped.
He has had vertigo non stop shortly after first dose vaccine and he's been on Meclizine with Sudafed to control the spins, he falls if doesn't take the meds.  After second dose, 3/29/21 he still had the spins, but he was healthy.  His wife became ill a week a go and after mothers day around 12/13 she died in her sleep on the 19/20th at night.  She had been sick and did not go to the hospital. Two days later my dad came through with breakthrough covid on Saturday 5/22/2021 after receiving both vaccines. He was admitted into the hospital after testing positive for Covid. on the 26th he was moved to a skilled nursing unit for covid patients.
Myalgia, Arthralgia,  Injection site soreness  Narrative:  Day 1: Fatigue, injection site pain Day 2: Fatigue, injection site pain-hurt to move arm. Symptoms resolved by day three
Severe pain in right hip and down right leg.  Started at 7:00 a.m.  Could not put weight on right leg. Started to subside around 4:00 p.m.  No pain in right leg after 4:00 p.m. but had minor pain still in hip area.   Took Aleve and used heating pad to ease the pain.
New onset latex allergy; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955) in the right arm on 02Apr2021 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) in the right arm on 23Apr2021 both (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced new onset latex allergy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event new onset latex allergy was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was inadvertently vaccinated subcutaneously with her first dose of GARDASIL 9 (exact dose, frequency, lot # and expiration date were not reported). On an unknown date, the patient developed bruising and swelling at the injection site. The patient was advised, by an unspecified provider, to apply a cold compresses to the site. The outcome of bruising and swelling at the injection site was unknown. No causality assessment was provided.
Swelling at injection site began early morning of 07/03/16 and is continually worsening. Currently 2 inches by 3 inches large. Painful at the site.
patient contracted COVID and went to the hospital and got monoclonal antibodies; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on 13 Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 20Mar2021, patient contracted COVID and went to the hospital and got monoclonal antibodies. Lab test included SARS-CoV-2 antibody test positive on 20 Mar 2021. Outcome of the event was unknown.  Follow up #2(07May2021) This is a spontaneous report from a contactable consumer (patients wife) in response to trail mail sent included: the correct name for the wife provided over the call is withheld and the name for the husband (withheld) mentioned in the document was not spelled nor clarified.  Follow-up needed. Information about batch/lot number has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm and on 09Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Elevated cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CIALIS, start date: Sep2022; ROSUVASTATIN, start date: May2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive; (15Mar2023) Positive; (20Mar2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Arm at injection site starting hurting a bit then by nighttime hurt a a lot and whole body hurt a lot. Could barely stand up and walk. Chills-felt cold in 82 degree room. Stomach pain. Headache, achy joint pain. No appetite. This morning feel a like a severe hangover.
While RN was injecting vaccine part of it came out of the syringe.  Patient did not receive the full dose.  Contacted facility and they advised not to give another vaccine and report to VAERS.
Psoriatic arthritis aggravated; Skin disorder; Warts; Localized itching; Vaccination adverse reaction; 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-163-4433179-00.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 2002 (Batch/Lot number: unknown) at 40 mg (40 mg, (cf)), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION REACTION (non-serious) with onset 2021, outcome "unknown", described as "Vaccination adverse reaction"; PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "Psoriatic arthritis aggravated"; SKIN DISORDER (non-serious), outcome "not recovered"; SKIN PAPILLOMA (non-serious), outcome "not recovered", described as "Warts"; PRURITUS (non-serious), outcome "unknown", described as "Localized itching". The action taken for adalimumab was unknown.  Clinical Course: it was unknown if patient was enrolled in a covid-19 vaccine trial.  Causality for Humira: The reporter's causality for the event(s) of warts/blemishes around waist and back/they itchy unknown onset and warts/blemishes around waist and back/they itchy unknown onset with Humira(Adalimumab) was no reasonable possibility and for the event vaccination adverse reaction, localized itching, skin disorder, psoriatic arthritis aggravated was not provided at the time of this report. Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran): The reporter's assessment of the causal relationship of "psoriatic arthritis aggravated", "skin disorder", "warts" and "localized itching" 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 "vaccination adverse reaction" 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: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
lump under my neck; I think it's like swollen lymph node; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on Jun2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she received the vaccine about a week ago, and the fifth day, she had a lump under her neck. She thinks it's like swollen lymph node on unspecified date of Jun2021. The outcome of the events was unknown.  Information about lot/batch number is requested.
Pt devel persistent high pitched screaming, unconsolable crying for 8 hrs; t102;
This is a spontaneous report from a contactable consumer. A 62-year-old male patient received PREVNAR 13 via an unspecified route of administration on the right arm at single dose for immunization and FLUARIX, intramuscular at 0.5 ml, single for flu shot, both from 23Oct2018. Medical history included Herniated disc since 2015, Open heart surgery and Heart attack in 2004, cardiac stent in 2015. There were no concomitant medications. Her husband received a PREVNAR 13 injection on 23Oct2018. He also received a flu shot at the same time in different arms and started to get pain in his lower back that radiated down the legs. She described the pain like burning or hurting. It did not get any better over time. On 29Oct2018 they had to call an ambulance and he was transported to the hospital. He had a MRI that did not find anything wrong. He does have a herniated disc which occurred prior to receiving the PREVNAR 13. They gave him a steroid injection and sent him home. He saw a neuro surgeon on 02Nov2018. They did not find anything wrong. As of today he is still not any better. He was worse than he's ever been. He was using a couple of canes to walk. Caller adds that her husband was very upset and is in pain. Caller adds that her husband had blood work and X-rays that didn't show anything. Stated her husband was supposed to see a pain management doctor. Her husband has tried muscle relaxers. They didn't do anything for him. Caller adds it seemed so strange. When he got the injection, the needle was so long and it seemed to take forever and her husband hurt so bad afterwards like the needle went to the bone. She states her husband has never experienced anything like this before. She was not sure how long the needle was supposed to be but states it was long. The doctor said their hands were tied too. Operating will not relieve this and the doctor does not know want to do. He will be set up with pain management for epidural injections. The outcome of the events pain in the lower back and down the legs and walking with canes was not recovered while unknown for the other events.
Patient reported 4 days post-immunization that she had developed a rash around and below the injection site with itching beginning 2 days post-immunization. On day 4 she indicated it seemed to be getting better, but was not resolved. She also indicated that she also had fever blisters that had formed on her upper lip in a greater quantity than she normally has seen.
Pfizer Dose 1 7/21/21 (EW0179) Pfizer Dose 2 8/18/21 (EW0179) COVID Positive 1/8/22  1/8/22: This is an 87 years old gentleman who presented to the emergency room today because of confusion  Patient has a history notable for CVA, alcohol dependence, type 2 diabetes mellitus  He is vaccinated against COVID 19. The last dose of vaccine was within the past 6 months.  He tested positive for COVID-19 today.  Patient drinks about 2-3 beers per day per his daughter.  His last intake was 3 days ago. Never with history of alcohol withdrawal seizure. Daughter was concerned when patient woke up yesterday did not know where he was a needed to be re-oriented.  There was report of darker appearing urine as well.  He has not been eating and drinking normally but did have some chicken soup prior to coming to the ED.  The patient currently denies any respiratory difficulties, abdominal pain, chest pain, nausea or vomiting.  He is currently saturating well on room air.  Chest x-ray without acute finding.  He did get Rocephin and azithromycin in the ED prior to being admitted to the hospitalist service for further evaluation and treatment  1/15/22: Acute encephalopathy? Possible Wernicke's encephalopathy  Expressive aphasia.  Initial MRI of the brain suggest no stroke but a repeat MRI done just before discharge showed a probable tiny lacuna infarct in the right periventricular area.  I went back to patient's room to explain the findings of the repeat MRI but the daughter has already taking the patient home.  I called the daughter at home and explain the probable finding of a lacunar infarct and she was satisfied. COVID-19 infection  Type 2 diabetes mellitus with hyperglycemia  Hypophosphatemia  Alcohol use disorder  History of CVA currently on daily aspirin  Uncontrolled Hypertension.  Patient prescribed nifedipine XL 30 mg p.o. daily in addition to continuing with carvedilol for BP control. Obesity
Patient experienced anxiety regarding possible swelling related to the vaccine. Administered Benadryl 25 mg PO x1 dose at patient request. No swelling noted at injection site 15 min and 30 min after vaccine administration. Patient left after waiting ~30-45 min.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 23-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 (dose and route were not reported, lot # J007060, expiration date 28-AUG-2014). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Panic attack induced by throat, soft pallet, tongue swelling causing shortness of breath and inability to sleep due to fear. Did take aspirin and ibuprofen to attempt to reduce swelling and monitored for approximately 12 hours before feeling relief
I immediately got itchy throat and itching under skin, then chest tightness started.  That same night 9/29/21 I had a 101 fever.  On 10/1/21, I had a severe headache, flu like symptoms and my hands and feet went numb.  As of today 10/3/21, I still have the numbness in my hands and feet.
Symptoms:  Circular swelling 3"x3", redness, vomit, itchy. Treatment: Rocephin Inj. 500mg.  Instructions to parent: Warm compresses to area.
Initial and follow up information has been received from a registered nurse in a physicians office as reported by a patients mother concerning a 2 year old male with milk allergy. Illnesses at the time of vaccination were unknown. On 3/8/2004 the patient was vaccinated subcutaneously with the first dose of varicella virus vaccine live (previously reported to have received measles virus vaccine live (enders Edmonston) + mumps virus vaccine live (Jeryl Lynn) + rubella virus vaccine live (Wistar RA 27/3). On 4/1/2005 at 9:00AM it was reported that the patient broke out with < 50 bumps just red dots. It was reported that there were no crusting or blisters. The patients mother reported to the physicians office that not many itch. The patients mother felt that the patient had developed chicken pox. The registered nurse further reported that the patient was diagnosed with break through chicken Pox after receiving the varicella virus vaccine live vaccine. It was reported that as the child was only 2 years old, he had not received MMR as he was not old enough and therefore did not have a reaction to the vaccine. The mother of the patient was to treat the patient with over the counter medications for itching if necessary. At the time of this report the patient had recovered (date unknown). No further information is available.
Information has been received from a 29 year old female with sulfonamide allergy and a history of ear infection who on 3/10/05 was vaccinated IM with a first dose of hepatitis A virus vaccine inactivated (lot # 648239/0814P). Concomitant therapy included ciprofloxacin hydrochloride for an unknown indication. On 3/10/05, the patient's arm swelled up and she went into anaphylactic shock. Unspecified medical attention was sought. No laboratory or diagnostic studies were performed. At the time of the report, the patient had reportedly not recovered. Arm swelled up and anaphylactic shock were considered to be immediately life threatening and disabling. Additional information is not expected.
Initially she had some swelling and redness of the right side of her face.  This was the morning after the immunizations.  By the morning after that she developed a rash on her right and left lower abdomen that looked like hives but with papular lesions mixed in.  She has papular lesions with significant surrounding erythema on her arms, left arm greater than right, and on both thighs again left greater than right.  She also hsd some similar lesions on her left calf.  These appeared more like a contact dermatitis with a linear orientation but there was no history of any contacts.  These lesions were somewhat pruritic.  She had no breathing problems.
A non-serious spontaneous report of a 8 month old got a dose of H1N1 LAIV was received from a physician concerning an eight-month-old female. The patient did not have medical history and was not taking any concomitant medications. The patient was a normal birth. On 23-Nov-2009, the patient received a dose of H1N1, Intranasal. There was no adverse event associated with this medication error; therefore treatment and reporter causality assessments were not applicable and the event was considered resolved. Additional information was received on 08-Dec-2009 and incorporated into the narrative: Information about medical history and concomitant medications.
L arm swelling and erythema. Began 8 days after injection. Patient has not yet treated but will treat with applying ice and taking antihistamine.
I received the vaccine around 10:30AM. Around 4:00PM that day I started having severe dizziness. About 40 minutes later I had severe pain in my neck, back, and shoulders. I have had 3 herniated discs in the past and the pain from this was much worse than that pain.  About the same time I felt a headache coming on that just got worse as the night went on. I decided to go to bed and try to sleep, however, the pain was so great that I could not lay down flat or sit up. I spent the night walking the floor. During the night I vomited several times. I also developed jaw pain, earaches, and a sore throat.  But the worse part was that during the night I started to feel the sensation of pins and needles being thrust into my legs, ankles, arms, and hands. I never did however have a fever. I finally was able to fall asleep at about 5AM and slept for several hours. When I woke up the pain was mostly gone and I was just left with no energy at all so that I could hardly lift my head off the pillow. I stayed in bed the entire day and the next day I was fine.
I started with slight headache, nausea feeling, dizziness, extreme tiredness and all symptoms lasted up to 36 hours (From Friday at 10:00 am to Sunday Morning.  I called in sick for work on Saturday.  When I woke up on Sunday, I had no more symptoms.   I've had no symptoms since.
fatigue; myalgias; Mild nasal congestion; Headache; This is a spontaneous report was received from a contactable physician (patient). A 61-years-old male patient received 2nd dose bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3246), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 as single dose for COVID-19 immunization. The patient medical history included BPH. The patient had received unspecified concomitant medications. The patient had no history of allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 in right arm on 18Dec2021 at 8:00 for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications the patient received within 2 weeks of vaccination. On 09Jan2021 at 11:00, 28 hours after injection, the patient developed fatigue, then myalgias, lasted about 44 hours, mild nasal congestion, and headache briefly. The patient did not take treatment for the adverse events. The outcome of the fatigue and myalgia was recovered on 11Jan2021 while for the events headache and mild nasal congestion was recovered on an unspecified date in Jan2021.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.