chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm hurt but it didn't bother me; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt but it didn't bother me) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome (Her lupus in 20 years hasn't progressed too much but it has now; it has gone to her lungs.), Drug allergy (Aspirin), Pneumonia, COPD and Non-tobacco user. Concomitant products included BIOTIN for Dry skin, AMLODIPINE for Hypertension, HYDROXYCHLOROQUINE for Lupus syndrome, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Stomach discomfort, COLECALCIFEROL (VITAMIN D3), METOPROLOL, ESTRADIOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MONTELUKAST SODIUM (SINGULAIR) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt but it didn't bother me). At the time of the report, VACCINATION SITE PAIN (Arm hurt but it didn't bother me) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) 3-4 times per week as the disease progresses. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment medications were reported.   This case was linked to MOD-2021-341062 (Patient Link).
pt inadvertently recvd a dose of DTP 2JUN92 & on 3JUN exp a fever, rigors, light-headednedd & swelling @ inject site; on 4JUN was feeling better but chills persisted;
Left arm erythematous non tender 1 3/4 x 2 in. area. Rx: Keflex, Benadryl, Tylenol PRN.
3 weeks after my 2nd vaccination, I developed chronic hepatitis B. I required a liver transplant in August, 2021
PAIN IN LEFT SHOULDER AND ARM WHICH LAST FOR 2 DAYS. 5 DAYS LATER  I HAD ACHES IN MY MUSCLES AND JOINTS THAT LAST FOR 4 DAYS.AFTER THAT I WAS COUGHING UP MUCUS FOR 3 WEEKS. NOW FOR THE PAST 3 DAYS I HAD A RUNNY NOSE AND A DRY COUGHT.
This case was reported by a consumer via call center representative and described the occurrence of fainting in a 80-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOVAX 23 for prophylaxis. On 17th April 2019, the patient received the 1st dose of SHINGRIX and the 1st dose of PNEUMOVAX 23 .5 ml. On 17th April 2019, 12 hrs after receiving SHINGRIX, the patient experienced fever, shivering, fatigue, nausea, discomfort in joints, influenza-like symptoms and pain. On 18th April 2019, the patient experienced appetite lost. On 20th April 2019, the patient experienced fainting (serious criteria GSK medically significant). The patient was treated with paracetamol (Tylenol), nutritional supplement nos (Ensure) and antiemetics and antinauseants (Nausea Medication (Nos)). On 19th April 2019, the outcome of the shivering and nausea were recovered/resolved. On 20th April 2019, the outcome of the fainting, fever, discomfort in joints, influenza-like symptoms and pain were recovered/resolved. On 21st April 2019, the outcome of the appetite lost was recovered/resolved. On 26th April 2019, the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the fainting, fever, shivering, fatigue, appetite lost, nausea, discomfort in joints, influenza-like symptoms and pain to be related to SHINGRIX. Addtional details were provided as follows: The patient received 1st dose of SHINGRIX on left arm. In the evening of vaccination day, the patient experienced fever of 101. 8 degree F, shivering, fatigue, nausea, joint discomfort or achy flu-like symptoms. One date after vaccination, the patient experienced loss of appetite. Three days after vaccination, in the morning, the patient passed out in bathroom because, the patient went to bathroom to use commode but woke up on floor. Fatigue lasted about a week after seeing doctor. Consented to follow up.
Interval between doses greater than 6 months; Feels miserable/ worse than ever; Cannot move/ cannot drive; Cannot move/ cannot drive; This case was reported by a pharmacist via call center representative and described the occurrence of feeling miserable in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 5cE5S, expiry date 23rd September 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd November 2021).   On 22nd August 2022, the patient received the 2nd dose of Shingrix (intramuscular). In August 2022, less than a week after receiving Shingrix, the patient experienced feeling miserable, mobility decreased and activities of daily living impaired. On 22nd August 2022, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the feeling miserable, mobility decreased and activities of daily living impaired were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the feeling miserable, mobility decreased and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comments: The reporter stated that the patient received Shingrix shot (and also received Fluzone) in the left deltoid at the same time. Less than a week after receiving Fluzone, the patient called the pharmacy to report that he felt miserable, worse than he had ever felt before, he could not move, he could not drive, and he did not know what was causing it. The reporter stated that there was inappropriate schedule of vaccine as interval between dose 1 and dose 2 of Shingrix was greater than 6 months. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended schedule, which led to lengthening of vaccination schedule. Fluzone was not captured in product tab as it was unclear if was a vaccine or other product.
Pt reports an localized injection site reaction. Localized redness, warm to the touch and slightly itching.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna, vaccine dose number=3; vaccine brand=Pfizer / BioNTech, vaccine dose number=2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9264), in left arm and on 25Feb2021 as dose 2, single (Lot number: EM9809), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19May2022 as dose 3 (booster), single (Lot number: 054A22A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The patient was taking various vitamins until 11Feb2023. The patient has no known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19May2022, outcome "unknown", described as "vaccine brand other=Moderna, vaccine dose number=3; vaccine brand=Pfizer / BioNTech, vaccine dose number=2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Negative, notes: positive test after two negatives 48 hours apart; (Feb2023) Negative, notes: positive test after two negatives 48 hours apart; (Feb2023) Positive, notes: positive test after two negatives 48 hours apart. Therapeutic measures, Paxlovid from 11Feb2023 to 15Feb2023, were taken as a result of drug ineffective, covid-19.
PT SAID SHE HAS EXPERIENCED PAIN SINCE SHE GOT THE SHOT.
Flu-like symptoms, vomiting within 3 hours of administration. One episode of vomiting following morning, symptoms began to resolve late that morning into early afternoon.
Herpes; fever; lethargy; muscle weakness; This is a spontaneous report from a contactable consumer (patient herself). A 42-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 14Apr2021 10:00 (age at vaccination: 42 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history were not reported. There were no concomitant medications. The patient had no known allergies. The patient did not have any other vaccine in four weeks not received ant medications in 2 weeks. On 15Apr2021, the patient experienced herpes, fever, lethargy and muscle weakness. The adverse event resulted in physician's office visit. The patient received Advil as treatment for the adverse event was advised to rest. The patient had no prior vaccination for covid nor was tested post vaccination. The outcome of all the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever.  Hypoxia.  SOB.  Hospital admission diagnoses:  Aspiration, right lower lobe pneumonia, hyponatremia.
Pt recvd Hep B dose on 19MAR92 & on 10APR92 & devel herpes zoster in the lumbar area; lesions were painful; described as a prickly feeling along lumbar sacral area; tender to touch; devel red macules, clear papules & vesicles;
On 17SEP92 2AM pt woke up screaming & was difficult to console, t105 R; pt went to clinic 17SEP in AM; APAP & Pediaprofen were being given to keep temp down; screaming was less; 18SEP92 fever broke & pt back to nl;
Severe body aches, constant headache, nausea, sore arm, sore arm pits, slight cough
Received 2nd dose vaccine on 1/22/21; woke up on 1/23/21 with mild headache by later in afternoon with generalized body aches.  By early evening left arm tightness radiates to shoulder/shoulder blade/left chest and arm tingling sensation (as if pulled muscle) requiring icing area and Motrin; felt tired and lethargic; woke up Sunday with headache, ate breakfast and went back to bed till 2pm.  Felt better as day progresses Sunday.  Wednesday 1/27/21 left arm sore as if I received injection that morning.  as day progresses soreness radiates to the shoulder and chest area, tingling resumes and by evening with numbness and nausea.  Thursday 1/28/21 still with the tingling sensation and whole left upper arm and shoulder area tight with some weakness.
Numbness in the area of the ulnar nerve. Numbness resolved 24 hrs after vaccination. Still C/O pain.
Redness at the injection site; Golf ball size swelling at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) (batch number Z4G59, expiry date 7th July 2023) for prophylaxis.   On 2nd August 2022, the patient received Shingrix. In August 2022, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the injection site swelling was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Sep-2022 Reporter's comment: The registered pharmacist called and stated that the patient received Shingrix and experienced redness at the injection site.  The registered pharmacist stated that about two weeks later the patient experienced golf ball size swelling at the injection site that was unresolved.  Adverse events was filed.  Outside phone number for GSK Medical Information given for future reference and warm transfer provided.  The consent to follow up was granted. Additional Supportive Information: Less than 2 months after vaccination the patient had injection site erythema.
Flu like symptoms; Chills; Sweats; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "Chills", "Sweats", "Flu like symptoms", "Fever"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "Chills", "Sweats", "Flu like symptoms", "Fever"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "Chills", "tired", "Very bad headache", "Sweats", "side effects to both the second shot and both boosters; flu like symptoms", "Fever". The following information was reported: CHILLS (non-serious) with onset Oct2023, outcome "unknown"; PYREXIA (non-serious) with onset Oct2023, outcome "unknown", described as "Fever"; INFLUENZA LIKE ILLNESS (non-serious) with onset Oct2023, outcome "unknown", described as "Flu like symptoms"; HYPERHIDROSIS (non-serious) with onset Oct2023, outcome "unknown", described as "Sweats".  Additional Information: Concern: reporter stated that  they had the Pfizer 2 weeks ago and every time they get it. Patient had every shot, every booster including the last booster. Except for the very first dose, they had side effects on everyone. Where patient have had flu like symptoms fever, chills, sweats the hyper thing that last about 24 hours and then patient was fine, but they have had them with every injection other than the first one and they just wanted to make aware of that.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200550445 same patient/product, different dose/event;
Information has been received from a registered nurse concerning a 60 year old male patient with drug reactions or allergies to morphine, penicillin and tetanus who on 11-JUN-2012, was vaccinated with a dose of PNEUMOVAX 23 vaccine, 0.5 mL, subcutaneously (lot number 672962/0025AE, expiration date 11-OCT-2013). There was no concomitant medication. On 12-JUN-2012, the patient developed redness and swelling at the injection site after receiving PNEUMOVAX 23 vaccine. BENADRYL was given as a treatment for redness and swelling at the injection site. At the time of report the patient's outcome was recovering. No laboratory tests were performed. The patient sought unspecified medical attention, contacted office. This is one of several reports received from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 672962/0025AE in question were satisfactory. The lot met the requirements of the agency and was released. Follow up information was received from a registered nurse concerning the 60 years old retired male patient with hypertension, hyperlipedemia, allergies to "MS" morphine sulphate, penicillin and tetanus, history of ulcer and no illness at time of vaccination, who on 11-JUN-2012 at 15:26 p.m was vaccinated subcutaneously in his left arm with the first dose of PNEUMOVAX 23 (Lot# 672962/0025AE, Exp. Date: 18-OCT-2013) at private doctor's office/hospital with private funds. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 11-JUN-2012 (previously reported as 12-JUN-2012) at 17:00 p.m the patient began to get redness, swelling and heat at injection site and pain area. Symptoms increased by 12-JUN-2012 and on 15-JUN-2012, the patient recovered. The patient did not seek medical attention. The relatedness for redness at the injection site, pain area, heat at injection site and swelling at the injection site was unknown for PNEUMOVAX 23. Additional information is not expected.
Started having a fever with flu symptoms and took a home COVID-19 test and was negative. Then 2 days later tested positive. Contacted doctor and decided to just rest and quarantine.
Pt. is 33 weeks GA in pregnancy. When administering the Tdap vaccine, the needle popped off halfway through administration. 1/2 of the normal dose was then administered in addition to the approximately half dose that was injected prior to the needle popping off.
Information has been received from a physician concerning a pt who on 12/01/1996 was vaccinated with a dose of varicella virus vaccine live. On 05/16/1998 the pt experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought. but there was no tx and no hospitalization. The pt recovered. No product quality complaint was involved. This is one of 40 reported. Thirty nine other cases ( WAES 0407USA01446 and 0409USA01855 thriugh 0409USA01879 and 0409ISA01881 through 0409USA01893) experienced bredakthrough varicella after vaccination with varicella virus vaccine live. Additonal information has been requested.
I had a really runny nose but wasn't really stuffy. I had extreme fatigue and a little back pain and body aches but it wasn't awful. I felt worst after than I did during having COVID-19
Firmer; Itchy; Bruising; a lot of pain in her arm; red circle on arm; A report was received from a pharmacist concerning a 37-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced pain, red circle,  itchy, firmer and bruising on her arm.  The patient's medical history, as provided by the reporter, included Hashimoto's disease and rosacea. Concomitant medications reported included levothyroxine.   On 24 Dec 2020, hours prior to the onset of the events, pain in her arm and red circle on arm, approximately 7 days prior to the onset of the event, bruising, and 8 days prior to the onset of the events itchy and firmer, the patient received her first of two planned doses of mRNA-1273 (LOT number 011j20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Dec 2020 around midnight, the patient noticed she had a lot of pain in her arm and had a red circle, which grew over the next few days. On 31 Dec 2020, she noticed bruising. On 01 Jan 2020, the patient noticed a wider red oval on her arm that measured 3 inches long and 1.5 inches tall, and was itchy and firmer. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Immunizations given on 04/21/2005. On 04/22/2005- Rt thigh began to redden with swelling. Increasing throughout the day until seen at office @ 3:00PM with Erythema and induration measuring 10cm in diameter. Does not appear infected. Advised to apply cool packs. Was also on Omnicef- started on 04/21/05 for UTI.
Since I had the shot my arm hurts. It was given to me 9/26/18 and 6 months later I still have pain. I wake up at night in pain. I have trouble lifting up my arm. And I am in very good shape, work out so this is very frustrating for me.
Fever, Death  2/12/08 Received vax record from reporter/provider & confirms as reported.  4/11/08Reviewed autopsy report which states COD as SIDS. Autopsy also states patient was 32 wk preemie & developed fever 104 next day tx w/antipyretic & seen in ER.  Patient found cold, breathing arrested & unresponsive on 1/31/08 while co-sleeping w/parents.  EMS coded & taken to ER in cardiopulomonary arrest where resuscitation unsuccessful.  Accidental overlay could not be completely ruled out.
rash-blotchy red sl raised often confluent into large red blotches on face, arms, trunk;
dizziness, weakness, feeling loops tightness in face/upper chest (waves) rash on left upper torso started about 25 minutes after vaccine: lasted about 4 hours  -loaded up wit zyrtec & pepcid for treatment 4 doses 10mg q6hr - 10mg BID x3
Itchy rash appearing on left hip, right shin, left wrist, right ankle, outside navel, both inner elbows.
It's warm to the touch; Redness; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It's warm to the touch), ERYTHEMA (Redness) and PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE WARMTH (It's warm to the touch), ERYTHEMA (Redness) and PRURITUS (Itching). At the time of the report, VACCINATION SITE WARMTH (It's warm to the touch), ERYTHEMA (Redness) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details was not reported by the reporter. Treatment details was not reported by the reporter.
extremely tired; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FATIGUE (extremely tired) in an 84-year-old female patient 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 FATIGUE (extremely tired). At the time of the report, FATIGUE (extremely tired) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications reported   Reporter did not allow further contact
Patient presented to the ED around 10pm on 4/21, ~one week after her J&J COVID vaccine (exact date of initial vaccination not confirmed but was reportedly 1 week prior) with abdominal pain and headache. She was found to have thrombocytopenia (Plt 38) on presentation as well as renal and ovarian vein thrombosis. CT head showed a large right frontal intraparenchymal hemorrhage. She was taken for urgent craniotomy on 9/5 with EVD placement. Brain tissue was noted to have bleeding spots unresponsive to cautery and requiring local hemostatic agents. Repeat imaging showed worsening infarction. She had continued elevated intracranial pressures, so was taken back to the OR on the morning of 9/6 for bilateral EVD placement to help relieve pressure. Given her thrombocytopenia, thrombosis, significantly elevated D-dimer, low fibrinogen, and +HIT Ab test, she was diagnosed with vaccine-induced thrombocytopenia and thrombosis (VITT). She was started on IVIG 1g/kg daily  x 2 days,  bivalirudin with supportive transfusions to maintain goal plts >50K, fibrinogen > 150. Despite this, her neurologic status deteriorated due to elevated pressures, clotting off of her EVDs, and ultimately was declared brain dead in the afternoon on 9/7.  Family withdrew supportive care and patient passed at 3:57PM on 9/7/21.