chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a 46-year-old male with no known past medical history who initially presented complaining of headache and neck stiffness with onset the morning of 04/03/2021.  The patient states that his headache was initially gradual in onset and eventually decreased in severity on 4/5 however, on 04/06 after a day at the beach the patient developed a severe headache with rapid onset that he described as the worst headache in his life.  He did try to medicate himself at home with 600-800 mg of ibuprofen every 6 hr with minimal decrease in his headache pain.  As result he presented to  urgent care for initial evaluation who sent him to the emergency department for possible brain bleed.  On arrival to the emergency department the patient had a head CT which showed trace subarachnoid hemorrhage in the basilar cisterns likely due to ruptured cerebral aneurysm.  He was transferred to  for continued workup of the subarachnoid hemorrhage with CTA and possible IR intervention.  At time my evaluation patient was resting comfortably in the bed.  He continued to complain of severe headache and neck stiffness.  He additionally notes that light and loud sounds make his headache worse.  He denied any focal weakness, paresthesia's, numbness, speech difficulty, visual changes, or any other concerning neuro symptoms.  Patient was hypertensive during my evaluation despite being on a Cardene drip.  Patient's mother was at bedside and was able to assist with history.
today its relatively itchy; had a rash that got pretty large about 3 inches long and 2 inches wide, going up and down her; At the injection site, it was excessively itching; has like a rash all around on the arm; spot where it was injected started to get a little bit itchy; It was really uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (spot where it was injected started to get a little bit itchy), MALAISE (It was really uncomfortable), PRURITUS (today its relatively itchy), RASH (had a rash that got pretty large about 3 inches long and 2 inches wide, going up and down her) and VACCINATION SITE PRURITUS (At the injection site, it was excessively itching) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PRURITUS (spot where it was injected started to get a little bit itchy), MALAISE (It was really uncomfortable), RASH (had a rash that got pretty large about 3 inches long and 2 inches wide, going up and down her), VACCINATION SITE PRURITUS (At the injection site, it was excessively itching) and VACCINATION SITE RASH (has like a rash all around on the arm). On 22-Jan-2021, the patient experienced PRURITUS (today its relatively itchy). At the time of the report, PRURITUS (spot where it was injected started to get a little bit itchy), MALAISE (It was really uncomfortable), PRURITUS (today its relatively itchy), RASH (had a rash that got pretty large about 3 inches long and 2 inches wide, going up and down her), VACCINATION SITE PRURITUS (At the injection site, it was excessively itching) and VACCINATION SITE RASH (has like a rash all around on the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information include Cortisone cream.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: Informations added.
Patient is a 30 year old male A & O x4 with chief complaint of dizziness.  10 minutes after receiving the vaccine patient stated that he felt shaky and dizzy.  Patient placed in a seated position, vital signs obtained and EMS called.  Vital signs stable.  Negative medical history, allergies or medications.  Patient stated that the symptoms resolved and he felt much better.  Negative chest pain, SOB, weakness, dizziness, numbness, tingling, with no signs of stroke or allergic reaction.  Patient denied any other complaint.  Fire Dept Medic Engine and ambulance  arrived on scene and assumed patient care.  Patient signed AMA and went home via private vehicle.
ipol (opened) was exposed to a temperature excursion ,total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes with no reported adverse event; was administered to the patient post excursion with no reported adverse event; Initial information received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from physician.  This case involves a 4 years old male patient who was administered vaccine IPV (VERO) [IPOL] (opened) that was exposed to a temperature excursion, (total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes) 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 measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.  On 30-May-2023, the patient received 0.5 mL dose of suspect IPV (VERO), Suspension for injection (batch number: V1A021M; expiry date: 27-Feb-2024) via intramuscular route in unknown administration site for Immunization that was exposed to a temperature excursion, (total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes) with no reported adverse event (poor quality product administered) (same day latency) (product storage error) (unknown latency) following the administration of IPV (vero).  Human error: Yes  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
LEFT ARM PAIN, SHOULDER.NECK AND SHOULDER BLADE PAIN.  expanding  REDNESS AND WARM TO THE TOUCH WHOLE DELTOID
4/26- second dose; 4/27- fever, chills, back pain, nausea, diarreah,  fatigue, pain when moving or touched; 4/29- symptoms seemed better but some joint pain; 5/8 - chest pain left side hard to breath in; 5/11- severe.back pain left side- painful to touch; 5/12- morning rash on my back left side by 4 pm rash had spread to left side breast and armpit; 5/12- urgent care visit diagnosed with shingles; Prescribe valtrex 3x per.day, steroid cream and been taking motrin for pain
for 5 minutes after injection, i felt slightly light headed and nauseous but that went away after 5ish minutes. Slight shoulder pain right of the day, with a headache starting after 30 min. Later that night around 10-11pm i woke up with a splitting headache, chills, cold sweat and had a fever of 100.7. Took tylenol, woke up feeling better.  Mild headache lasted 3 days, when headache stopped heaviness/pain started in my left armpit - huge swollen lymph node (injection side). Was painful for 1.5 wks, this past week the lymph node is still swollen but not painful. I tried to go for a run 3 days after injection, I was short of breath and legs felt heavy (usually walk 2 miles daily with dogs, run 3-4 miles 3-4x/wk) figured that went along with swollen lymph node. Today is the first day I was able to run without difficulty catching my breath and my legs don't feel as heavy (2 miles, slow jog vs run).
Excessive lethargy w/somnolence & vomiting w/in hrs p/shot; pt admitted to hosp for observation & evaluation of excessive somnolence, irritability w/vomiting;
Soreness and swelling at site of the injection. Symptoms supposedly associated with 1 out of 3 Zostavax recipients.
Exact date not known- patient said sometime after her vaccination she developed weakness and pain in that arm (right arm) from shoulder to elbow. It has lasted from that time (1/21/15) until now (2/9/15).
Information has been received from a consumer concerning her daughter in her "late teens" who on an unspecified date was vaccinated with a dose of GARDASIL. The consumer reported that her daughter became very sick after she received a dose of GARDASIL, she fainted and experienced vomiting and uncontrollable shaking among other unspecified symptoms. At the time of the report, the patient had not recovered. No further information is available.
Left arm where was vaccinated became red and swollen at site. Dr. told her fluid filled.
Pt. states that after receiving the 1st dose of Pneumo 10/07/2021, started experiencing symptoms that evening 10/07/2021of pain in the left arm, difficulty raising arm, nausea, vomiting, loose stool, chills, and fatigue. Urgent Care visit 10/08/2021 recommended Observation and Ortho.
pt recvd vax 24NOV95 & on evening of 26NOV95 pt exp a h/a & fever;28NOV95 devel over 75 lesions, primarily on his head, neck, arms & torso w/approx 12 lesions on thighs;
RED, BUMP AT THE INJECTION SITE WITH ITCH. ADVICED TO CONTINUE MONITOR THE SYMPTOMS. PATIENT DOES NOT EXPERIENCE ANY OTHER SYMPTOMS BESIDE THE BUMP. ALSO ADVICED TO TAKE BENEDRYL IF ITCH AND TYLENOL IF FEELING PAIN. IF THE BUMP SPREADS OR HAVE ANY OTHER SIGNS/SYMPTOMS THEN REPORT TO PHARMACY OR DOCTOR.
Low grade temps 99-100. Maculo-papular erythematous rash. Seen on day 3 of rash. Rash on face, neck, chest and abdomen. Lungs clear bucal mulosa-clear, TM's-nl no adenopathy.
Injection site reaction (erythema) and fever for 24 hours - treated as cellulitis with 1 dose vancomycin and cefazolin  discharged on cephalexin
Dapt given LD 7-25-06. Mom called and reported a 3/4 cm firm reddened area around.
Client c/o numbness in hand, and hand felt "heavy." Also c/o of being sweaty. Vital signs WNL. She left site at 2:15pm unassisted and with a family member.
Got a shingles shot in September. 2 days after started with bumps on arm that spread all over. Still present but better, Is on insulin. Dermatologist said it is Psoriasis, she thinks it was from insulin-switched insulin type. Is on an antibiotic - bumps are better.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. It was reported that on an unknown date the patient was given 1st and 2nd doses of GARDASIL (lot number and expiration date not reported) (dose and route not reported), 11 days apart. Concomitant therapy was not reported. No adverse event reported. Additional information has been requested.
Light sensitivity, eye discomfort, blurred  and double vision, started immediately when I walked outside to go home. Very hard to focus on anything, everything blurred and doubled, hurt to have my eyes open.  took a  30 min. nap so I could keep my eyes closed, symptoms totally disappeared about 10 min after waking up from nap, total time lasted was 4 hours.
MILD FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18052025, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild fever on 16-MAR-2021. This report was non-serious.
I had all my Pfizer shots and boosters (Unspecified Shot); I took a test and I was positive; I had all my Pfizer shots and boosters (Unspecified Shot); I took a test and I was positive; 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, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Feb2023, outcome "unknown" and all described as "I had all my Pfizer shots and boosters (Unspecified Shot); I took a test and I was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient stated, "I just have a question. So, for the first, I had all my Pfizer shots and boosters (Name of Shot was not clarified over the call, hence captured as Unspecified Shot) and all and today I took a test and I was positive. So, my doctor called in Paxlovid for me and I took one, I misunderstood but I took it at 12:15 this afternoon and then 8 hours later, I took at 8 O'clock tonight, 8.15 and then I am worried that, I found out after the first there should be 12 hours between. Should I be worried or what should I do?." Patient again stated, "Yes, so it's been 8 hours, I misunderstood."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Per documentation, pt states pain started immediately after receiving her 2nd COVID-19 vaccine, The nurse who administered the shot went very high up in the arm just below the bone of her shoulder. Area is very tender to touch. First 3 days after injection pain was excruciating.
This spontaneous report was received from a physician refers to an unspecified patients. There was no information regarding the patient's medical history, concomitant medications drug reactions and allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, (lot# N015475, expiration date 18-MAY-2019; lot# N020686, expiration date 27-JUL-2019) for prophylaxis. Other improperly stored vaccines involved included RECOMBIVAX HB (lot# M035487, expiration date 23-FEB-2019; lot# M044032, expiration date 03-JUL-2019), VAQTA (lot# M039202, expiration date 30-JUN-2018; lot# N008823, expiration date 26-MAY-2018), GARDASIL 9 (lot# M040412, expiration date 30-JUN-2019; lot# N010497, expiration date 15-JAN-2020), PNEUMOVAX 23 (lot# M042324, expiration date 10-JUN-2018) and ROTATEQ (lot# M040269, expiration date 28-APR-2018; lot# M041184, expiration date 31-MAY-2018). Sterile diluent used for VARIVAX reconstitution was stored properly. Doses of VARIVAX was exposed to -14 Celsius degree to-10 Celsius degree for 48 hours. Doses of GARDASIL 9, ROTATEQ, PNEUMOVAX 23, RECOMBIVAX HB, and VAQTA were exposed to temperature below 0 Celsius degree for 1 hour, 0 Celsius degree to 1 Celsius degree for 2.5 hours, and 9 Celsius degree to 25 Celsius degree for 82 hours. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. Follow-up information has been received from the physician on 23-JAN-2018 referring to a female patient. The physician stated her freezer vaccines were not an issue and were found to be "ok to use" after a discussion with MNSC and the vaccine stability data. Specific lot numbers or dates of vaccination were not available at this moment. The following initials are patients who received vaccines that were stored in refrigerator and these patients were being contacted to be re-vaccinated. This is one of several reports received from the same source. Sender's Comments: US-009507513-1801USA010003: US-009507513-1801USA010004: US-009507513-1801USA010005: US-009507513-1801USA010006: US-009507513-1801USA004018.
she was in bed with cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (she was in bed with cold symptoms) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A, 010A21A and 077C21B) for COVID-19 vaccination.     Concurrent medical conditions included Menopause. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced NASOPHARYNGITIS (she was in bed with cold symptoms). At the time of the report, NASOPHARYNGITIS (she was in bed with cold symptoms) outcome was unknown.            No treatment was received.   This case was linked to MOD-2021-406538, MOD-2021-406647 (Patient Link).
Patient reported dizziness, lightheadedness, had progressive symptoms of diffuse flushing of the skin, fatigue.  He was given 25 mg of Benadryl and placed on a caught to rest for about 30 minutes.  After the dose of Benadryl and with time, his symptoms progressively improved. No itching of the throat, skin, no SOB or CP.
Beyond the fatigue, I experienced dizziness that began decreasing two months after onset.  It is still not fully resolved.  It made teaching online a challenge.
Stomach ache; Guts hurts; Fatigue; Massive pain; Could not eat; Could not function; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Massive pain), HYPOPHAGIA (Could not eat), IMPAIRED WORK ABILITY (Could not function), ABDOMINAL PAIN UPPER (Stomach ache) and GASTROINTESTINAL PAIN (Guts hurts) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A. and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis and Arthritis.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On 11-Mar-2021, the patient experienced PAIN (Massive pain), HYPOPHAGIA (Could not eat), IMPAIRED WORK ABILITY (Could not function) and FATIGUE (Fatigue). On 02-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache) and GASTROINTESTINAL PAIN (Guts hurts). The patient was treated with BENZALKONIUM CHLORIDE, SODIUM CHLORIDE (ALIVE) at an unspecified dose and frequency and HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) at an unspecified dose and frequency. On 18-Feb-2021, PYREXIA (Fever) and HEADACHE (Headache) had resolved. On 14-Mar-2021, FATIGUE (Fatigue) had resolved. On 16-Mar-2021, PAIN (Massive pain), HYPOPHAGIA (Could not eat) and IMPAIRED WORK ABILITY (Could not function) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache) and GASTROINTESTINAL PAIN (Guts hurts) outcome was unknown.            Concomitant product use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-067545 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067545:Same patient, 1st dose
Joint stiffness, muscle weakness progressively worsening. Doctor visit on 3rd day. Overall body weakness 10-29-09. Seen by neurology 10-30-09.
This case was reported by a physician and described the occurrence of arthralgia in a adult patient who received FLUARIX QUADRIVALENT (batch number LY2F5, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was unknown. It was unknown if the reporter considered the arthralgia to be related to FLUARIX QUADRIVALENT. Additional information: Physician updating previous report of shoulder arthralgia in 10 patients following vaccination with FLUARIX QIV, with lot number and expiration date info. He was unable to obtain more information on the patients, though he states that they were all adults.
Left upper arm swollen with redness. Hot to touch. Two days lapse from initial shot. Sent to ER given Keflex 500 QID. Recheck in two days. Dx: cellulitis.
Complaints of fatigue, no energy and "feeling ill" since injection on telephone call and appointment was scheduled.  At  1/8/2009 visit to provider noted red streaks, skin erythema and tenderness 3 x 4 inches.  Patient complains of headache. Dr. diagnosed a cellulitis and Rx Keflex which was switched to Augmentin 24 hours later due to increase in induration.
No treatment as medical people dismiss anything related to the vaccine. ? it can?t be vaccine related ?
Intense tinnitus (ringing) in left ear.  I've always had occasional tinnitus (notice it a few times/yr).  After my second shot, I quickly began to experience a substantially louder (maybe by a factor of 5) ringing in my left ear whenever I was in a quiet area (e.g. working from home).  This was constant, and it continued for approximately six months until November 2021.
scratching so much that his bone got sore; itch got wider, side to side but still around the injection site; arm is a little sore; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (scratching so much that his bone got sore), PRURITUS (itch got wider, side to side but still around the injection site), PAIN IN EXTREMITY (arm is a little sore) and VACCINATION SITE PRURITUS (itching at the injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003021A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site). On an unknown date, the patient experienced BONE PAIN (scratching so much that his bone got sore), PRURITUS (itch got wider, side to side but still around the injection site) and PAIN IN EXTREMITY (arm is a little sore). At the time of the report, BONE PAIN (scratching so much that his bone got sore), PRURITUS (itch got wider, side to side but still around the injection site), PAIN IN EXTREMITY (arm is a little sore) and VACCINATION SITE PRURITUS (itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that His pharmacist used latex to cover up the shot site so he thought the itching could be from that. The patient reported that the itching started second week after the shot.  He stated that the pharmacist at CVS told him to use itching relief cream which he said was just like Benadryl but CVS brand.  The patient reported that the cream helps a little but the itch comes back.  The pharmacist also recommended him to put ice on it which he said he had not done it yet.  He was asking if this was normal and if it lasts this long.  The patient was also concerned about getting the second shot.   This case was linked to MOD-2021-138543, MODERNATX, INC.-MOD-2021-138543 (E2B Linked Report).