chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLU LIKE SYMPTOMS; ACHES ALL OVER BODY; VACCINE KNOCKED DOWN FOR 3 WEEKS - DID NOT FEEL GOOD; BLACK DOTS IN BOTH EYES ALL OVER LIKE BUGS WERE POPPING UP; SEVERE HEADACHE LIKE HEAD WAS POPPING OFF SHOULDERS; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included: coronary artery bypass graft surgery (cabg), and covid-19, and concurrent conditions included: penicillin allergy, anxiety, and alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-MAR-2021, the patient experienced severe headache like head was popping off shoulders. On 05-SEP-2021, the patient experienced black dots in both eyes all over like bugs were popping up. On an unspecified date, the patient experienced flu like symptoms, aches all over body, and vaccine knocked down for 3 weeks - did not feel good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from black dots in both eyes all over like bugs were popping up, and severe headache like head was popping off shoulders, and the outcome of flu like symptoms, vaccine knocked down for 3 weeks - did not feel good and aches all over body was not reported. This report was non-serious. This case, from the same reporter is linked to 20210913090 and 20210913421.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Event: numbness in left arm was reported as worsened; feeling tingling and numbness in my left arm; feeling tingling and numbness in my left arm; This is a spontaneous report from a contactable consumer (reporting on herself). A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot number and Expiry date was not reported) via an unspecified route of administration in Arm Left on 02Feb2021 as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient got her Pfizer shot on 02Feb2021 (last Tuesday) in her left arm. 4-5 days later, on 07Feb2021 patient feeling tingling and numbness in her left arm. Is this a normal side effect. Patient dose not see it listed in the Pfizer vaccine information. Numbness in left arm. Event: numbness in left arm was reported as worsened. She was experiencing numbness in her arm that she got the injection in. She has not received treatment or seen a doctor. She was a medical sales rep, and she got it be-cause they fit patients for power wheel chairs. She was in and out of nursing homes and rehabs.  The outcome of the feeling tingling and numbness in my left arm was not recovered and for event numbness in left arm was reported as worsened was unknown.  Follow-up attempts completed. No further information expected.
Starting at around 6:00 PM and lasting until around 9:30 PM patient screamed and nothing would help him calm down.  He had no appetite.  He started zoning out and staring at one spot and wouldn't respond to voices or loud noises.  Then at around 9:30, on the way to the hospital, his breathing became very irregular and he was gasping for breaths.  Everything seemed to straighten itself out on it's own though.
Severe soreness in arm where shot was administered.; Severe chills; mild body aches for 24 hours after shot was administered; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration (left arm) on 21Dec2020 16:30 at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included multivitamin (unspecified) daily and thyroid medication (25 mcg). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 (20:00), the patient experienced severe soreness in arm where shot was administered, severe chills, and mild body aches for 24 hours after shot was administered. There was no treatment received for the adverse event. The outcome of events was recovered on an unspecified date in Dec2020. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  No follow-up attempts are possible; information about lot/batch number has been obtained.
a 9 week-old boy received ActHIB vaccine that had expired on 5/21/2022 with no reported adverse event; Initial information received on 18-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 9-week-old boy who received HIB (PRP/T) Vaccine [ACT-HIB] vaccine that had expired on 21-May-2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 13V (CRM197) (Prevnar 13) and Rotavirus Vaccine Live Reassort Oral 5V (Rotateq) both for Prophylactic vaccination (Immunization).  On 13-Jul-2022, the patient received a 0.5 ml dose once total of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot: UJ472AA & U6940BA; expiry date: 21-Jul-2022; strength: standard) via intramuscular route in the right thigh for Prophylactic vaccination (Immunization).  On 13-Jul-2022, a 9 week-old boy received HIB (PRP/T) vaccine that had expired on 5/21/2022 with no reported adverse event (expired product administered) (latency: same day).  It was unknown if there were lab data/results available.  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
day following vax pt c/o headache, body aches, temp 100.4, redness, soreness, edema @ inject site. treated w/tylenol
Chills, fever, nausea, head ache, tired, body aches, joint aches 24 hours
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 02Apr2021 as dose 2, single (Lot number: EP7533), in left arm and on 24Oct2021 as dose 3 (booster), single (Lot number: 30155BH) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sesame Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of covid-19.  Clinical course: Paxlovid treatment was started from 01Jul2022 to 06Jul2022.
3 hours after receiving the COVID-19 vaccine, Patient started to experience severe muscle spasms in both of her legs, largely focused in her calves and foot. These muscle spasms lasted for 4-5 hours and she took Tylenol and tramadol to help with the pain she began to experience. The spasms stopped after 4-5 hours and she did not experience them again since the first vaccination.
High blood pressure spikes, shortness of breath, shaky,  dizziness and weakness started exactly one week after 2nd vaccine shot. Had fever of 102 for 3 days after vaccine.
On an unspecified date, the pt received the 1st dose of Lymerix and 1 day later, he experienced generalized muscle aches. Outcome: resolved. On an unspecified date, the pt received his 2nd dose of Lymerix and 1 day later, he experienced muscle pain in his arms and back. Outcome: resolved. On an unspecified date, th pt received his 3rd dose of Lymerix and 1 day later, he experienced a high fever. The reporter stated that since her husband had received Lymerix, he has had intermittent "illnesses" (NOS). No treatment was given. The most recent information, received on 6/8/00, reports the condition of the pt as unknown.
This spontaneous report as received from a physician as a part of Market Research program refers to a 67 year old male patient. The patient's medical history included an unspecified cancer. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported). On an unknown date, the patient experienced post herpetic neuralgia (PHN) and blistering rash. The reporter stated the it was the worst case of post herpetic neuralgia the reporter ever seen. The outcome of post herpetic neuralgia was reported as not recovered (the patient was still on medications) and the outcome of blistering rash was unknown. The primary care physician considered PHN to be related to suspect product and the relatedness between blistering rash and ZOSTAVAX was not reported. The events post herpetic neuralgia was considered to be medically significant by reporter. Additional information is not expected, as the reporter did not wish to be contacted.
Caller received first dose yesterday and noticed "baseball" bruise on right calf after shower/ a co-worker that works security indicated a parallel AE where keys on belt hit body; This is a spontaneous report from a contactable consumer. This consumer reported for a 29-year-old male patient. A 29-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received Hepatitis C shot and experienced stiffness arm. On an unspecified date, after the vaccination, the patient noticed "baseball" bruise on right calf after shower. Indicated that he works for the city of (Withheld) and a co-worker that works security indicated a parallel AE where keys on belt hit body. Stated that he has not experienced any injury or pressure to the area. He stated everything was fine. Vaccination was voluntary, deals with the general public. He did research and indicated that the Pfizer was the best one. The outcome of the event was unknown at the time of this report.   Information on the lot/batch number has been requested.
Second pregnancy, due date of November 6. 3 hours after having the second dose even though I took a pain killer (tylenol) and remained hydrated ,I had extreme headaches, body ache,fever,joints pain,running stomach and kept throwing up. The symptoms lasted 24h. I
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Medium, Systemic: Shakiness-Mild
Patient has had continuous fever, body aches and headaches 10 days out from vaccination that are interfering with daily activities of living.  Influenza test in office was negative.
Right leg edema, erythema, warmth from hip to knee .Resolved in 5 days with warm compresses and Benadryl
Became very ill on Sunday July 25th, lasting through the next weekend (6-7 days).  Started as fatigue in the afternoon, then escalated to fever and vomiting in the evening/overnight (after eating dinner). Monday and Tuesday I was almost exclusively in bed from fatigue and fever. Vomiting stopped Monday morning/early afternoon.  A COVID test on Tuesday July 27 came back negative. On Thursday night I was able to receive a Z-pack of antiobiotics, and by Friday morning I was beginning to feel much better.  I think I was coming down with something (not COVID) on Sunday, and then my Sunday dinner might have given me food poisoning on top of that. I do not believe this was a reaction to the vaccine.
Prevnar shot became indurated 2 cm by 24 hours. At 48 hour generalized confluent erythematous papular rash on neck, chest and abdomen. Child fussiness than usual but sleeping and eating normally.
Patient admitted with chief complaint of abdominal pain for 5 days. Pneumococcal injection was given 07/15/2008 at 0900 in left arm. Patient now has fever, redness near injection site with pain and swelling. Tenderness and redness located in left upper arm in area where injection was given and distal from that. Ice was applied. Blood cultures were drawn. Vancomycin and Levaquin antibiotics ordered and administered. Received orthopedic consult on 7/16/2008. Per ortho musculature is compressible and has zero evidence of compartment syndrome. They see mostly superficial swelling and musculature tenderness. Attending MD insisted on reporting this due to how quickly this occurred after injection and the size of the swelling and pt's pain after injection.  09/02/2008 MR received for DOS 7/14-17/2008 with D/C DX:  Sickle Cell Crisis.  Painful hemolytic crisis.  Left arm swelling, reaction to pneumococcal vaccine.  Tobacco abuse.  Pneumonia.  Pt admitted for sickle cell crisis related abdominal pain. Given Pneumovax in hospital and subsequently developed L arm pain and swelling. Compartment syndrome r/o. By d/c pain and swelling much improved.
This spontaneous report as received from a vaccine coordinator and refers to an unspecified patient of unknown age and gender. Information on medical history, past drugs, concurrent conditions were not reported. On 24-JUL-2017, the patient was vaccinated with M-M-R II, (lot # M047302, exp date: 30-NOV-2018, dose, frequency not reported) for prophylaxis. Concomitant therapy included sterile diluent (Merck injection, lot number: N006322, Exp date: 11-JUL-2019). No adverse effects were reported. All adverse event fields apply to the patient. Temperature was 11 degree Celsius (C), (incorrect product storage). Time frame was for a duration of 46 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. The outcome of events was unknown. This case is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA011025: US-009507513-1707USA011026.
Left thigh warm to touch, redness and inflammation noted at site of injection. Doctor prescribed Benadryl and advised to apply ice.
This spontaneous report as received from a nurse (L.P.N.) refers to a patient of unknown age. On 28-NOV-2011, the patient, who was intended to receive ZOSTAVAX, was inadvertently administered VARIVAX (Merck), (lot # E008889, expiration date 08-SEP-2012), 0.5ml, subcutaneous. No adverse effects reported. Additional information has been requested.
The 2nd day I stumbled and fell forward 4 different times that day but did not fall down. Today I was ok and no symptoms
diverticulitis aggravated by added bile in digestive tract.; diverticulitis aggravated by added bile in digestive tract.; agonizing pain; dehydration; constipation; sweating profusely; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 14Apr2021 13:15 (Batch/Lot Number: ew0169) as SINGLE DOSE for covid-19 immunisation, at 60 years old. Medical history included diverticulitis and recurring atypical pneumonia from an unknown date. No other vaccine in four weeks and no other medications in two weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient has no known allergies. There were no concomitant medications. On 16Apr2021 23:45, the patient experienced diverticulitis aggravated by added bile in digestive tract. Spent entire night in agonizing pain and sweating profusely. Perhaps aggravated by dehydration/constipation. Reporter stated he suggests that people with this condition completely avoid nuts or other lipid/fatty acid foods as much as possible. Treatment was not given for the events. The events recovered on an unspecified date in Apr2021.
I believe I got it around midnight 11/12, I felt like my skin was on fire. I was able to go back to sleep after a while and then I woke up and throughout the day I was having congestions and coughing. I then took a test for COVID-19 it was negative. I kept feeling worse than next day I tested again and still negative. I went to the doctor about a week later and was positive. They gave me no medication and sent me on my way. I did isolate from everyone for the next 5 days. It took about 6 weeks to completely recover. I developed a cough so bad that I was almost inconstant. I didn't start to recover until Dec 5. I felt like I was fighting Mono. Something else that was strange was that I started my cycle all over again and it lasted for weeks. I did reach put to my OBGYN and was told that COVID does throw off cycles.
Patient reported feeling feverish, fatigued and pain in left axilla with node inflammation as well as pain at injection site left deltoid within 3-4 hours of injection.
On 5-24-04 pm: Mother brought child into clinic for assessment of right leg. Large red area of right thigh noted with heat, noted; slightly raised from surrounding skin. No induration noted. Mother was instructed to call private MD. She called back on 5/25/04 saying she had taken child to ER. Treatment given there. Went to ER for treatment.
10x14cm red raised, hot area to left deltoid, per Mom Benadryl given 2 1/2 hours prior, ice applied.  Patient scratching at site.  Per doctor, Augmentin 400mg chewable tabs 2 times a day for 7 days.
On 04/29, 9 days after shot, my left arm suddenly swelled.; Experiencing light pain, itching and swelling around the injection site.; Experiencing light pain, itching and swelling around the injection site.; Experiencing light pain, itching and swelling around the injection site.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 20Apr2021 at 13:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included ascorbic acid (VITAMIN C) taken from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 08:00, nine days after shot, the patients left arm suddenly swelled. The patient was also experiencing light pain, itching and swelling around the injection site. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events on 29Apr2021 at 08:00, nine days after shot, left arm suddenly swelled; experiencing light pain, itching and swelling around the injection site was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
2 x 21 cm localized reaction looks like cellulitis in a diabetic patient. Warm compresses x 3 a day ibuprofen for pain & discomfort. Placed on Cephalexin 250 mg caps 4x day x 7 days.
Severe headache; Muscle and body aches, general achiness; Joint aches; Tired; Chills; 101 Fever; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HEADACHE (Severe headache), MYALGIA (Muscle and body aches, general achiness), ARTHRALGIA (Joint aches), FATIGUE (Tired) and CHILLS (Chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MYCOPHENOLATE MOFETIL, METHOTREXATE SODIUM (METOTREXATE), APREMILAST and LEVOTHYROXINE for an unknown indication.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (101 Fever). On an unknown date, the patient experienced HEADACHE (Severe headache), MYALGIA (Muscle and body aches, general achiness), ARTHRALGIA (Joint aches) and FATIGUE (Tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 31-Jan-2021, CHILLS (Chills) and PYREXIA (101 Fever) had resolved. At the time of the report, HEADACHE (Severe headache), MYALGIA (Muscle and body aches, general achiness), ARTHRALGIA (Joint aches) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 101 (High) 101 fever.. On 29-Jan-2021, Body temperature: 103 (High) 103 fever that lasted 24 hours. On 31-Jan-2021, Body temperature: 101-102 (High) fever, 101-102 until 31Jan2021..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 29-Jan-2021, at 3 AM the patient woke up with teeth chattering chills, she never experienced before and a 103 fever that lasted 24 hours. She continued with fever, 101-102 and chills until 31-Jan-2021.
Red patch at injection site of increasing size that is hard, itchy and warm to touch. Tried treating with benadryl cream and benadryl. Spole to doctor on 1/17/20 and a steroid was prescribed.