chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; left arm soreness onset evening of vaccine for about 1.5 days; This is a spontaneous report from a contactable nurse (also the patient). A 51-year-old female (also the age at vaccination) patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248), via an unspecified route of administration at the left arm on 07Jan2021 14:40 (also reported as 02:45 PM) at SINGLE DOSE for Covid-19 immunization. The patient was vaccinated at a Hospital. The patient is not pregnant at the time of the report. Medical history included Environmental allergies: some trees and grass (also reported as Known allergies: No). The patient had no COVID prior to vaccination. Th patient was not COVID tested post vaccination. No other vaccine in four weeks. Concomitant medication included (reported as Other medications in two weeks) bupropion hydrochloride (WELLBUTRIN), loratadine, pseudoephedrine sulfate (CLARITIN-D), montelukast sodium (SINGULAIR), diphenhydramine hydrochloride (BENADRYL), vitamin d nos (VITAMIN D NOS) and MVM (exact meaning unspecified). It was reported that: "Administration time on my paperwork was documented incorrectly; I received 07Jan2021 dose at 2:40pm and not the 1:40pm time that is documented. I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration (reported as 5:30 PM), lasting about 2 hours and resolved; left arm soreness onset evening of vaccine for about 1.5 days." The patient was not treated for the events. The outcome of the events was recovered.
patients had symptoms of body aches, low grade fever and cough which resolved within 2 days; patients had symptoms of body aches, low grade fever and cough which resolved within 2 days; patients had symptoms of body aches, low grade fever and cough which resolved within 2 days; Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 64 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZINC; VITAMIN C [ASCORBIC ACID]; SEROPHENE; TRULICITY; METFORMIN; ROSUVASTATIN; JARDIANCE; OMEPRAZOLE; VITAMIN D NOS; ECONAZOLE; LISINOPRIL; ASPIRIN (E.C.). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "recovered" (2022) and all described as "Covid-19"; PAIN (medically significant), PYREXIA (medically significant), COUGH (medically significant), outcome "recovered" (2022) and all described as "patients had symptoms of body aches, low grade fever and cough which resolved within 2 days". The detail information was reported as due to being diagnosed with covid 19 on 02Jan2022. Patients had symptoms of body aches, Low grade fever and cough which resolved within 2 days. Reporter seriousness for COVID -19: Medically significant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My booster felt like either a shark bit off my arm/brutal pain/Unbearable; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (My booster felt like either a shark bit off my arm/brutal pain/Unbearable) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Pregnancy (2 births).  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (My booster felt like either a great white bit off my arm/brutal pain/Unbearable). At the time of the report, PAIN IN EXTREMITY (My booster felt like either a great white bit off my arm/brutal pain/Unbearable) outcome was unknown.      No concomitant medications were reported. It was reported that patient's booster felt like either a great white bit off arm (not being dramatic) with no anesthesia or someone took a chainsaw to it with no anesthesia. Patient had felt worst pain in the entire life including two births and did not get covid ore vaccine in august of 2011 and have not had since. So, she would never known if it was worth that level of excruciating pain and the pain level with booster was bad. Patient first shot made bed ridden sick for a week and no pain. Patient stated that can handle the sick part, but the brutal pain of booster was unbearable. No treatment medications were reported
Patient was immunocompromised and received a 1st shot of the primary series, a 1st booster and a 2nd booster dose of the Moderna COVID-19 Vaccine; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received a 1st shot of the primary series, a 1st booster and a 2nd booster dose of the Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant. Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received a 1st shot of the primary series, a 1st booster and a 2nd booster dose of the Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received a 1st shot of the primary series, a 1st booster and a 2nd booster dose of the Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            The concomitant medication included steroids (unspecified).  On an unknown date, the patient received the 1st booster dose and 2nd booster dose. The patient did not get 2nd dose and 3rd dose of the primary series as for immunocompromised people. The reporter was confused because did not understand if her husband should get another shot to be fully protected.  It was unknown if patient experienced any symptoms or if any treatment was given.
74 year old receiving her second dose, reported she had wheezing within 15 minutes of first dose, and took her albuterol and the wheezing cleared.  Stated she was told here she had wheezing, but transported to ER, and lungs were clear, told in ER no wheezing, noted, no albuterol given, no meds or treatment given, work up negative, and was discharged with diagnosis of possible anxiety or possible asthma.  I debated whether to hold vaccine based on the Interim clinical considerations, but since I had no documentation of wheezing and ER visit reported as no wheezing or respiratory problems, I made decision to proceed with pretreatment.  At 25 minutes she developed stridor, wheezing and trouble breathing, no facial tongue swelling and no urticaria.  No hypotension.   Prior to immunization BP was 189/105, Pulse 89, 02 sat 96% ra,  25 minutes after vaccination, Audible stridor, coughing, diffuse tight wheezes with decreased air movement.  Epi 0.3 given.  157/92, 105, O2 sat 98%.     Almost immediately after epi stridor improved, although her wheezes persisted, her air movement improved significantly.  She did not developed hypotension, and she did not lose consciousness.   She was transferred to the hospital.   We pretreated her with benadryl and her albuterol
Left arm and left leg numbness. While I can do any activities normal, my left arm and leg feel different to my right side. I haven?t had any pain.
Redness, "knot" at site of injection, 101 fever, felt run down x 5 days.  Patient called and does feel better, we let him know to make an appointment if he feels worse (noted in patient chart)
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with VAQTA (dose, route, lot numbers and expiration dates were not provided), that were improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
gave an expired dose of Tenivac vaccine to a patient/ no AE; Initial information was received on 06-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional via Medical Information (Reference number- 00349245) and transmitted to Sanofi on 06-Nov-2020.  This case involves a 52-old male patient who was vaccinated with 0.5 ml dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6101AA expiry date 23-Oct-2020) via unknown route in the left deltoid on an unknown date for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  No other vaccinations or medications were given at that visit  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  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 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.
Pt given Td in L arm. Had local discomfort in deltoid 7 days w/ induration w/ heat. No edema or redness. 1/2 Felt like arm went to sleep, a little tingley w/ stabbing severe pain in entire L arm, felt numb. Sx better, fingers still numb.
Information has been received from a health professional concerning a health professional concerning a 14 year old male who on 21-JUL-2002 was vaccinated SC in the right arm with a first dose of Varivax (lot # 639778/0981L). On 29-SEP-2006, the patient developed 20 scattered scabbed papules on mostly the anterior and posterior trunk. There were very few on the upper extremities. No medical attention was sought. The patient's outcome was not reported. No further information is expected.
Patient came to our drive thru Covid 19 vaccination clinic to receive her second dose of Moderna.  Pfizer vaccine was given inadvertently to patient.  Patient denies any reactions.  Dr. phoned the patient the next day and patient is fine, still no reaction.
Child became ill on 10-24-07 (AM) with backache, pain in legs, arms, and knees.  Had feeling of "being hot".  Muscle and joint pain severe enough to limit walking and school attendance - out of school until Monday, 10/29 per MD.
Headache the night of and entire next day. The Day following T and L spinal  pain, flowed by organ pain, mainly what felt like kidneys, and slight shortness of breath.
Patient was given the 1st dose of shingrix at his doctor's office on 2/1/19, then came to our pharmacy and received a 2nd dose on 2/28/19.  Patient then went back to doctor office in the 2-6 month window for his 2nd dose with office, then came back to us on 6/29/19  for 2nd dose with us .  This was not discovered that the patient had 4 doses of shingrix in a 4 month period until 4/14/21 at a office visit.  No adverse events were reported.
Severe edema of left deltoid, tender, hot to just above the elbow and severe erythema.
Information has been received from a physician concerning an adult female patient who "within the last 2 months" in approximately October 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 643249/0358M).  Subsequently in approximately October 2002, the patient developed very sore arms, redness and swelling that went from her shoulders down her entire arm.  The patient sought unspecified medical attention and was treated with anti-inflammatory agents (unspecified).  Subsequently, all of the patient's symptoms resolved.  The physician indicated that in his "many, many years" of experience with vaccinations, he had never seen such "an inordinate amount of reports" of "severe reactions" to pneumococcal vaccine 23 polyvalent as he had recently.  He requested a lot check of Lot # 643249/0358M.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The physician also mentioned that 2 other female patients (WAES # 0211USA00016, 0306USA02608) a male patient (WAES # 0211USA00320) had experiences following vaccination with pneumococcal vaccine 23 polyvalent (Lot # 643249/0358M).  Additional information has been requested.
Sudden sensorineural (?inner ear?) hearing loss  Moderate to severe hearing loss.  Words sound fuzzy.  Some things I can't hear.  Onset a few days after 1st shot.
I experienced immediate arm pain that increased as the day went on. (This was much more painful  than any routine shot, like a flu shot.) Within an hour I felt fatigued. Within 4 hours, I went to bed with body aches, severe fatigue, and fever. It felt like I had the flu. These flu-like symptoms lasted for two full days. By the third day, I felt better, but still fatigued. My arm remains sore on the third day.
Reported 12/28/01, a bruise 2" X 2". The center of the bruise, on the left arm where needle was inserted, blanched area about the size of a pencil eraser. It is very tender to touch but gradually improving. Did not seek medical attention. No treatment.
I had a little pain the arm after receiving the vaccine for about two days. On 02/14/2023 I started having chest pains and I went to the emergency room. I wasn't kept in the emergency room for observation, but they recommended following up with a cardiologist. I had test and everything was fine. As of today, no more episodes of chest pain.
This case was reported by a physician and described the occurrence of multiple focal seizures in a 5-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included poliomyelitis vaccine inactivated (non-gsk); Sanofi; unknown; unknown given on 3 December 2012; seasonal influenza vaccine (non-gsk); Sanofi; unknown; unknown given on 3 December 2012. On 3 December 2012 at 15:00 the subject received 5th dose of INFANRIX (.5 ml, unknown route, left thigh). On 7 December 2012 at 03:00, 4 days after vaccination with INFANRIX, the subject experienced multiple focal seizures ("multi focal seizures") and fever. The subject was hospitalised and the physician considered the events were disabling and life threatening. At the time of reporting the outcome of the events of multiple focal seizures was unresolved. The physician reported that "the seizures were not under control yet." The subject "remains in the hospital at the time of the report." At the time of reporting, the outcome of the fever was unknown. The physician considered the event of seizures was probably related to vaccination with INFANRIX. The physician considered the event of fever unrelated to vaccination with INFANRIX.
No adverse effects seen thus far (24 - hours after incident). Patient received double dose of inactivated polio vaccine (KINRIX + IPOL).
I felt a little dizzy after 30 mins of vaccine administration and started feeling chest tightness and loss of appetite all day
At about 9:40, hives, redness, clammy hands, sore throat, lightheadedness, low grade fever, and headache began. At 11:30, I took benadryl and within an hour the symptoms started to subside.
This spontaneous report was received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 13-MAR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius)for a total of 144 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
onset of inc t104, throat congestion, body aches w/sore inj site, flushed face (very red)
She reported: severe hives, severe pain, golf size red raised area at injection site, fever, and feeling very sick for over a week.
Patient was treated previously with antibodies around 30 days prior.  Patient experienced diarrhea the morning after receiving her booster shot.  Patient symptoms resolved on their own, discussed with the pharmacy about a week later and reporting followed.
liver failure; receiving two shots of the booster.; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC FAILURE (liver failure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic liver disease (chronic liver disease).   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEPATIC FAILURE (liver failure) (seriousness criteria death, hospitalization and medically significant) and EXTRA DOSE ADMINISTERED (receiving two shots of the booster.). The patient died on an unknown date. The reported cause of death was Liver failure. It is unknown if an autopsy was performed. At the time of death, EXTRA DOSE ADMINISTERED (receiving two shots of the booster.) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment medication information was not provided by the reporter.  Reporter stated that a girl with chronic liver disease went into liver failure and had jaundice and also died in hospital after receiving two shots of the booster.  Company comment: This is a  spontaneous case concerning a  female patient of an unknown age  with concurrent medical condition of Chronic liver disease who experienced serious, unexpected event of hepatic failure. Vaccination dates and start date of the event were not provided. Reporter stated that a girl with chronic liver disease went into liver failure and had jaundice and also died in hospital after receiving two shots of the booster. Date of death was not disclosed. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information has been requested. Concurrent medical condition of Chronic liver disease remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a  spontaneous case concerning a  female patient of an unknown age  with concurrent medical condition of Chronic liver disease who experienced serious, unexpected event of hepatic failure. Vaccination dates and start date of the event were not provided. Reporter stated that a girl with chronic liver disease went into liver failure and had jaundice and also died in hospital after receiving two shots of the booster. Date of death was not disclosed. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information has been requested. Concurrent medical condition of Chronic liver disease remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Liver failure
Patient presented with scratchy throat .Conscious , alert and oriented X 3. No problem swallowing or speaking . Given water to drink , blood pressure and pulse ox monitored for thirty minutes. B/P 126/85, P:81 , O2 97to 98 percent room air . Given two tabs of 25 mg  Benadryl. Released  in care of husband.
44 y/o MALE doctor with no hx of allergic reaction with previous vaccination was brought to the ER from the vaccination area, patient stated he become tachycardic, dizzy and nauseated 10 min after the vaccination shot was given. Patient denied rash, SOB, wheezing or Swelling of the face and the tongue. Benadryl & Zofran given 1.Adverse Reaction to Vaccination-resolved
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient was giving Covid vaccine bivalent 1st booster. Patient was asked to wait 15 minutes. During this time, patient started feeling drowsy/lightheaded. Patient lie down on bed, feet up, vitals checked, blood sugar checked, which were all normal. NP gave patient Gatorade to drink. Purse lip breathing and smelling of alchol swab to patient directed. Patient started to feel better and was able to go home with husband after event. she denies SOB or chest pain.
Information has been received from a consumer concerning her 14 year old daughter with purple cornflower allergy and no pertinent medical history, who in August 2008, was vaccinated with 0.5 ml of the third dose of GARDASIL. Concomitant therapy included birth control (unspecified). On 25-FEB-2009 the patient experienced hives all over her body and swollen hands, feet and lips. She was taken to emergency room and given prednisone 10 mg and "hydroxydine" 25 mg. On 26-FEB-2009 she was taken back to the hospital where she was admitted over night and released on 27-FEB-2009. She still has not recovered completely and still had break outs. Additional information has been requested.  3/13/09-records received from PCP severe allergic reaction to gardasil vaccine, on 2/18/09 hives, 2/22/09 seen in ED and again on 2/23/09 for 24 observation . Follow-up 3/8/09-when antihistamine wears off spots occur mostly on arms hands feet and thighs, rash is less and less. 4/6/09-records received for ED visit 2/22/09-C/O skin rash 3 days ago, generalized, urticarial rash. Assessment:allergic reaction-acute secondary to vaccine. 4/8/09-records received for DOS 2/23/09-ED Observation, C/O generalized itching times 5 days. DX:acute allergic reaction. Follow-up: Pt has had 2 additional breakouts since this report. 1. NOV 17, 09 > Broke out in hives all over body. 2. Sept 20, 09 > Broke out in hives all over body. Susceptible to allergic reactions since the vaccine not before.
1. Arm sore when I woke up the next day and sore the rest of the day.   2. Woke up with a little headache and feeling a bit wiped out.  As the day progressed my energy lessened to the point where I slept the rest of day and through the night.  My chest also felt a little heavy (like after swimming all day).   3. I woke up the next day feeling better and with more energy but still not myself.   4. On the following day I felt good.  However, I tried to run (I run a few times a week) but it felt like I was running for the first time, heavy legs.   5. I woke up feeling good and able to run.