chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 78 year old white male with hypothyroidism (stable), elevated cholesterol (stable), cardiovascular disease (stable), hypertension, allergies to penicillin and clopidogrel bisulfate, and a history of mild cerebrovascular accident (found on MRI) and mild myocardial infarction who on 11/24/04 was vaccinated in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 647681/0986N). Concomitant therapy included levothyroxine sodium 0.1ml daily for hypothyroidism, dipyridamole 25mg daily for hyperlipidemia, simvastatin 40mg daily for cardiovascular disease and baby aspirin 81 mg daily. On 11/26/04 the patient returned to the clinic with a cellulitis of left arm from fingertips to shoulder. The patient was treated with moxifloxacin hydrochloride 400mg daily, warm compresses, and elevation. The patient received pneumococcal 23v polysaccharide vaccine in October 1999, and stated that he did not recall a reaction at that time. The reporter indicated that on 11/24/04 the patient's wife also received pneumococcal 23v polysaccharide vaccine from the same vial, and had a mild local reaction (WAES0412USA00799). The reporter stated that other patients also received pneumococcal 23v polysaccharide vaccine from the same vial, and did not experience adverse symptoms. On 12/1/04 the patient returned to the office, and although his condition was improving, therapy with moxifloxacin hydrochloride was continued for an additional 10 days. Follow up information indicated that the patient returned to the office on 11/24/04 with left arm pain and swelling. He was diagnosed with cellulitis in the left arm characterized by redness, induration, warmth, and swelling from fingertips to shoulder. It was reported that the patient was treated with moxifloxacin hydrochloride 400mg daily for 7 days, with elevation, and warm compress twice daily. The patient returned to the office on 12/1/04 and the moxifloxacin hydrochloride was continued for 4 more days. The swelling and redness resolved with some mild tenderness in the left elbow. It was reported that the patient recovered. No product quality complaint was involved. The reporter considered cellulitis of left arm from fingertips to shoulder to be an other important medical event (OMIC). Additional information is not expected.
Swelling, redness, induration of right upper thigh noted approx 12 hrs after immunization
Pt received his first dose of pfizer. During observation he became dizzy. He was escorted to the floor where he was maintained safely. Pt did not lose consciousness or hit his head. His VS were taken and were wnl. He was given something to eat and drink. He was observed for an additional 30 mins . At time of discharge he was well and in no distress. His friend drove him home. Pt states similar incidents have occurred  in the past when he gives blood.
Initial soreness  and swelling at injection site lasting a couple of days, then croupy  wet cough leaving a  metallic taste in mouth started  3 days after injection and lasted about 2 days, and the 8 days after injection red raised itchy hives at injection area about 2x3 inches and arm sore and swollen at injection site and warm to the touch.
Sore arm/should at injection area. Ice, rest, home exercise, monitor. Long term impact unknown at this time.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/28/2022 ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE
Initial misuse report received from a healthcare professional on 27-Aug-2013. The case was received on 21-Mar-2014 at the agency. This is an invalid case as individual patient identifiers are not reported. The patient had received unstable PENTACEL on an unknown date. The reporter stated that the nursing staff gave only the DTAP/IPV part of PENTACEL. No adverse event was reported. (No information was provided regarding the patients). List of documents held by sender; none.
Fever, body aches, swelling of Rt arm w/ heat to touch took 6 day to get over.
Swollen supraclavicular lymph note occurring on right side (same side as injection) persisting nearly two weeks post-vaccination
Rash on arm, swollen and itchy in ring shape. Dry cough , muscle aches.
Approx 36 hrs p/recvd the DTP vax, pt became flaccid, vomited-fever had tremuous spells;
This study case was received from the investigator on 22 February 2012 with additional information received on 28 February 2012. A 23-year-old male subject had received the following vaccinations: On 29 April 2011, an injection of ACAM2000 (lot number not reported) and ANTHRAX (manufacturer and lot number not reported). On 01 May 2011, the subject's ECG was normal. On 17 May 2011, the subject had an abnormal troponin I of 00.12. The subject was diagnosed with other, chest pain on 17 May 2011. The subject had a medical history of chest pain and chest pressure. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
This spontaneous report was received from a pharmacist, concerning a 23 year-old female. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of VARIVAX (dose, frequency and route of administration were not reported) lot # M043582 with expiration date of 28-OCT-2018, for prophylaxis. The temperature excursion of the VARIVAX was of 41°F for a time frame of 8 hours. No previous temperature excursion occurred. Data logger was involved. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA009376.
Pfizer-BioNTexh COVID-19 Vaccine EUA On the evening of my 2nd vaccine my lips and face began to itch. Within an hour my whole body was itching. I don?t see hives or a rash. It continued all night and is still itching just as bad today.
Patient received the sub-q vaccines first.  The Adacel was administered and then the Twinrix.  Patient was talking immediately prior to the Twinrix being given and during administration she began to make a strange sound.  After administration was complete, patient then became unconscious and fell out of  her chair.  She was unconscious for at least 1 minute.  She was moved to her back.  She did have a bloody nose and was still not talking normal and had released her bladder. She was pale.  Paramedics arrived and took her blood pressure and pulse.  They put her back in the chair.  They were going to perform her blood pressure again and were unable because the patient began to seize. The paramedics took her to the ER.
soreness of arm, cloudy vision in lt eye,loss of vision in rt eye,mild stroke
Patient received expired vaccine.  Office to call Pfizer for stability data. Will revaccinate if recommended.
KINRIX was administrated to a 10-year-old boy; This case was reported by a other health professional via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a 10-year-old male patient who received DTPa-IPV (Kinrix) (batch number B75MY, expiry date 15th June 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 10 years old patient was administered with Kinrix, which led to inappropriate age of vaccine administration. No additional adverse event was reported. No Product quality complaint was reported.
Left shoulder pain, potential frozen shoulder, and lost range of motion by 50% in left shoulder.
administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number unknown, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 21st October 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was office manager. The patient received an expired Flulaval shot inadvertently. The reporter consented to follow up.
Pt described her sx as "heart racing', fatiqued, hot, small red rash on face.   B/P 118/62 P 84 ossat 97%.  Urgent care doctor examine patient, had her wait in office for observation and then okay'ed her to go home.  Office called the following day and patient reports that sx improved, just tired.  No SOB, itching, rash...
increased fussiness; Inappropriate age at vaccine administration; wrong vaccine administered; This case was reported by a nurse via call center representative and described the occurrence of irritability in a 11-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2439H, expiry date 25th April 2020) for prophylaxis.  On an unknown date, the patient received Kinrix. On an unknown date, unknown after receiving Kinrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.  Additional details were provided as follows: The nurse called to report that Kinrix was inadvertantly administered to children less than 4 years of age, rather than Pediarix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. There may be more patient, they are researching it at the time of reporting. This case linked with US2019133766, reported by same reporter.   Follow up information received from Nurse on 26th August 2019: The patient's demographic details were updated. On 19th December 2018, the patient received the 2nd dose of Kinrix 0.5 ml intramuscularly. The patient's mother reported increased fuzziness. She was out of town and her husband was taking care of patient so she is not exactly sure of specific symptoms. It was unknown if the reporter considered the irritability to be related to Kinrix. The VAERS details were updated.
pt states arm was itchy and sore after the injection.  On 2/3/2021 she had severe chills and fatigue.  Pt states she is feeling better today 2/3/2021  and has a regular appt w/ her PCP on 2/5/2021 and will discuss her symptoms.
NUMBNESS IN THE ARMS AND LEGS; TINGLING OF LEFT ARM; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: 07-AUG-2021) dose was not reported, administered on 06-JUL-2021 15:15 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced tingling of left arm. On 06-JUL-2021, the subject experienced numbness in the arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in the arms and legs, and the outcome of tingling of left arm was not reported. This report was non-serious.
On 12/7/99, the pt presented with herpes zoster on the right side of his thorax. The lesions were described as being vesicular in nature. The child's physician did not treat him with antiviral medications because he was handling the zoster well.
Local reaction area red, warm 09/07/2005 evening ice applied. Take Benadryl PN.
Stomachache pain, vomiting, diarrhea, chest pain, headache, confusion and death
Patient received first Moderna vaccine on 1/15/2021. Delayed injection site reaction which was warm and erythematous 1 week after vaccination on left arm for which was seen by PCP and prescribed Bactrim for 10 days. On 2/3/21 patient experienced itchiness in hands and feet with pins and needles sensation. Seen by PCP on 2/4/21 and was started on Medrol Dose Pack for pruritis and paresthesias. 2/10/21 presented to ED with progressive sensory motor polyneuropathy and early gait dysfunction. Patient started plasmapharesis treatment for suspected Guillan-Barre Syndrome on 2/11/2021.
He had COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (He had COVID) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced COVID-19 (He had COVID). At the time of the report, COVID-19 (He had COVID) outcome was unknown.            No concomitant drug were reported.   Patient last booster was 7-8 months ago from the date of reporting.   Patient had COVID last month from the date of reporting.  No treatment drug were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-664540 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-664540:wife case
Received H1N1 vaccine, within hours had itchy, blotchy red areas, fine rash, facial swelling, and slight discomfort with swallowing but no respiratory distress.
Sore arm; Headache; Mild body aches; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 19Apr2021 at 15:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. 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 4 weeks prior to the vaccination. On 19Apr2021 at 18:00, the patient experienced sore arm, headache and mild body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment paracetamol (TYLENOL). The clinical outcome of the events sore arm, headache and mild body aches were unknown.  No follow-up attempts are needed. No further information is expected.
G62.9 NEUROPATHY 1/10/2022 I82.411 ACUTE DVT OF RIGHT FEMORAL VEIN 5/19/2022 G62.9 NEUROPATHY 1/10/2022 I82.411 ACUTE DVT OF RIGHT FEMORAL VEIN 5/19/2022 G62.9 NEUROPATHY 1/10/2022 I82.411 ACUTE DVT OF RIGHT FEMORAL VEIN 5/19/2022
Patient under 16 years old administered booster (3rd) dose. Last (2nd) dose received on 05/19/21. Informed mom, that boosters are not currently approved unless immunocompromised. No adverse reaction at @ vaccination clinic. Mom denies any adverse reaction from prior doses. Reminded mom to sign up for V-Safe and monitor for adverse reaction as done with previous doses.
Sore throat; Headache; Low grade fever; Malaise; Lower leg/back pain; Lower leg/back pain; This is a spontaneous report from a contactable pharmacist, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 31Mar2021 at 13:00 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 10Mar2021 at 12:00 (at the age of 37-years-old), as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 01Apr2021 at 14:00, the patient experienced sore throat, headache, low grade fever, malaise, lower leg pain and back pain. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatments for sore throat, headache, low grade fever, malaise, lower leg pain and back pain. The clinical outcomes of the events sore throat, headache, low grade fever, malaise, lower leg pain and back pain were resolving at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I am having severe pain at times at the site of the injection and extending outward (block of pain in my top arm).  I have to move my arm around in circles to try to bring relief to the pain & discomfort once it starts.
This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot #: L035878, expiration date on 11-AUG-2018 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. It was noted that the PEDVAXHIB was expose 256 hours to "anything" below 36F temperature and 10.5 hours to a temperature of 30.2F. No adverse events were reported. No product quality issue was involved. Additional information has been requested.
I got the shot on Friday then had a low grade fever on Saturday, was fine until Tuesday, 3/30, when I had a cardiac arrest event and my heart stopped beating.  I needed CPR to be revived.
Patient was given the shot in one of the exam rooms. He was then sent back to the lab for blood work. As he approached the lab he became very nauseous. We led him to the restroom where he fainted. One of the lab techs caught him and laid him down.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/23/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/23/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART
headache; swollen arm; rash/rashness; This is a spontaneous report from a contactable nurse (patient). An 86-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM 197 protein, solution for injection in pre-filled syringe), and tetanus vaccine toxoid (TETANUS VACCINE [TETANUS VACCINE TOXOID]); both via an unspecified route of administration on an unspecified date (reported as some years ago) (batch/lot number was not reported) as single dose for immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, ongoing genetic / chromosomal abnormalities (not specified), ongoing endocrine abnormalities (including diabetes), obesity. The patient's concomitant medications were not reported. The patient previously took flu vaccine from unspecified date for immunization and didn't react. On an unspecified date, the patient experienced headache, swollen arm, rash/rashness. The patient informed that she did react to pneumonia vaccine and tetanus vaccine with a headache, swollen arm and rash/rashness. The patient informed that her body didn't want any more vaccine. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
cold toes changing color from blue to red in her both feet/blue and cold toes in both feet; cold toes changing color from blue to red in her both feet/Blue and cold toes in both feet; Also her toes are red; This is a spontaneous report from a contactable physician. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 11Feb2021 as dose 1, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced cold toes changing color from blue to red in her both feet/blue and cold toes in both feet and also her toes are red on 14Feb2021. The patient underwent lab tests and procedures which included PCR and rapid test on an unspecified date and results were negative. Outcome of events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial report received from non-healthcare professional on 30 September 2014. A female patient, whose date of birth at the time of event and concomitant medications were not reported, had received intramuscular dose of FLUZONE ID (batch number and anatomical site of administration were not reported, dose number was unknown) eight years ago on an unspecified date. The patient has asthma and no known allergies. The patient's illness at the time of vaccination was unknown. It was reported that 8 years ago on an unspecified date, after receiving FLUZONE ID vaccine, the patient experienced an exacerbation of her asthma. The patient had to be on steroid pack as a corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was recovered. Documents held by sender: none.
Delayed hypersensitivity. Large  (5x5 cm)  erythematous raised tender and pruritic lesion over injection site occurring on day 8
pt recvd vax & 48 hrs post vax exp erythema nodosum & a muscle ache over body;pt was treated w/oral steroids;sx resolved;It was suggested to pt that discontinue the series;
Immunizations 8/11/03. Returned to clinic 8/13/03 with pain, swelling at immunization site (thigh). Noted 4cm x 4cm tender indurated erythematous mass. Tx with Zithromax. Pt also with URI. The symptoms (per mother) resolved.
tired and headache started at 2:30pm. I slept all afternoon/evening. I had a fever of 102.3. I had body aches. I'm still tired and achy.
Lymph node swollen under right clavicle less than 48 hours after immunization, supra clavicular space. Resolved by 11/20.
High fever up to 39.6C for entire night same night after injection; shivers, migraine headache, body aches, pain in the joints including neck, spine, hips, knees, swollen joints of fingers, sensitive skin all over, dry mouth.