chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 1/19/2021, I felt a burning sensation on the top of my head. When I scratched my head, I felt a hole or indentation about the size the of the pad of my index finger. When I pushed on it, it was squishy, and it made me lightheaded, nauseous, and dizzy. The left side of my body twitched uncontrollably. The soft spot was located where part of the sagittal suture is. I have never had any head injuries, so I don't know what else could have caused this. I went to the doctor, and she was also mystified.
Pt developed swelling at injection site, puffiness under eyes and a stuffy nose. Symptoms lasted for 2 hours.
Sore throat; increased nasal mucous; coughing; vomiting of mucous. Began with sore throat and symptoms increased until about 10 PM on 01/15/2010. Symptoms seem to be decreasing at the moment.
I was sick for a period of 4 days following the vaccine. Temp was 101.6 for several days following.  I had fever, chills, diarrhea, headache and bodyaches.  On the 2nd day following the vaccine I had a horrible breakout on my lips and gums. I felt as of my lips and gums were swollen.  I had white sores on my gums and tonsils.  This made swallowing difficult. This last for a period of 3 days.
5 yr old was in office for back office visit to receive pneumococcal 23 vaccine per recommendations of the hematologist   The vaccine was given in the right deltoid   I was called into the room as patient begin becoming flushed, red in the face, sweaty and diaphoretic.   Pt. was coughing and gagging, no throwing up Breathing ok, in no distress Coughing and gagging continued for 1-2 minutes   Benadryl elixir ordered - 12.5 mg/5 mls - 7.5 mls given orally   The coughing and gagging resolved with in 1-2 minutes No further distress   Pulse ox thru out time was 96-97%   Patient was able to verbally reply "I am feeling better"   Patient was moved from sitting position on exam table w/ Mom standing next to her to the chair and was then sitting on Mom's lap   Continued to say she was feeling better   No coughing No gagging Breathing comfortably   Very pale and peaked looking   Continued to monitor and disc w/ mom sleepiness that may occur w/ the benadryl and need for close monitoring next 4-8 hours   Patient continued to be pale but comfortable and decision made to call EMS- to have child transported to ER for further evaluation and observation   Paramedics arrived and information regarding above given Vitals stable in office   Pt. able to stand up and walk to gurney where she was held by Mom for transport to ER   Asked which ER preferred   Patient left w/ paramedics about 5 pm
A few days after 2nd vaccine,  she experienced on and off neck pain which was treated with massage, exercise and pain medication. On Feb. 28, still woke up with pain and personally massaged neck and head. Immediately experienced diziness - room spinning, a minute later had nausea and vomiting. Relieved for a few minutes and restarted.  Called 911 due to severe weakness.  At ER in the evening, she experienced right side weakness.  CT head was done with negative result. She was transferred to core hospital due to intractable hypertension. Neuro saw her at another hospital and MD declared she had a stroke. It was verified via head MRI: cerebellar and medullary. Stayed in neuro ICU for 6 days in which PT (next page)
Redness across back and upper torso. Warm to the touch, no itchiness or pain.
1st Day- Arm Neck Pain 12/31/2020 Loss of Appetite, Dizzy-current
68 year old male patient received two shots of Fluzone HD in the same day with no reported adverse event; Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious case from a pharmacist via Medical Information (Reference number- 00824268).  This case involves a 68 year old male patient who received two shots of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in the same day (extra dose administered).  The patient's medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included Varicella Zoster Vaccine Rge (Cho) (Shingrix) for Immunisation.  On 13-Oct-2021, the patient received a 0.7 ml two doses of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ702AB and expiry date: 30-Jun-2022) (Frequency: once) (Solution for injection in pre-filled syringe) via an intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency on same day).  It was reported "Pharmacist reports consumer got two shots of Fluzone HD in the same day. He received one injection at the HCP (health care professional) office and one at pharmacy about a half an hour later. He denied he had gotten the Fluzone HD, however, his HCP office confirmed. She asks for any information regarding. Additional Description of event adverse events: Pharmacist reports consumer was given Fluzone HD at pharmacy and then it was confirmed that he had received it 30 minutes prior at HCP office".   At the time of report no adverse event was reported.  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.
p/vax pt exp inj site & rt arm pain, edema, rash immobility, warm to touch;pt arm was described as being taught;f/u from pt adverse exp resolved as of 10/20/98;
pt recvd vax & exp flu-like sx & inc weakness; No further details were provided;
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 88-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 06-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Patient given expired vaccine in LD.  No S/S of adverse reaction.  Unexpired vaccine repeated in RD.
Left arm has become red and hot to touch Low grade fever 99.9 Extreme fatigue Nausea Muscle aches Congestion *** These symptoms did not start until 03/27/2021 - no redness in the week following the injection, only previous symptoms were arm pain in the days  immediately following injection and headache***
pt recv vax & 20min p/vax pt devel hive-like lesions all over body;pt presented to MD & was treated w/DPH;
had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant).  This case is linked to cases 2019SA166192, 2019SA166193, 2019SA166194, 2019SA164978 and 2019SA166196, same reporter.  This case involves a 48 years old patient (gender unknown) who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given.   On 04-Jun-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6141AB, expiry date 15-Dec-2020 via intramuscular route in the left deltoid.  It was an actual medication error due to incorrect product storage.  It was reported that had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Received MMR vaccine on 8/18/2014 at 2PM. Patient noticed localized swelling, redness, and itching at injection site at 8:30 PM on 8/18/14. Patient also started itching  "all over" at 8:30 PM. Symptoms completely subsided by 8/20/14.
Today his arm is swollen; Swelling in the injection site; This is a spontaneous report from a contactable consumer. A male patient [reporter's husband] of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on 08Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on 19May2021 as single dose for COVID-19 immunization and had no reaction. On 09Jun2021, one day after second dose of vaccination patient experienced swelling in the injection site and arm was swollen. Reporter asked what patient can apply on his arm. Outcome of the events were not resolved.  Follow-up attempts are possible. Further information is expected.
No Adverse Event occurred.  Minor at 16 years old received Moderna vaccine - Consent signed by both mother & father who are physicians and authorized vaccination of Moderna dose #1 and dose #2 to their son. Witnessed by the facilities  Medical Director.  NO ADVERSE EVENT OCCURRED
immunocompromised patient; immunocompromised patient; tested positive for COVID/nasal congestion; tested positive for COVID/nasal congestion; This is a spontaneous report from a contactable physician. A 65-year-old female patient (nurse) received bnt162b2 (Pfizer BioNTech COVID 19 vaccine), via an unspecified route of administration, the first dose on an unspecified date and the second dose on 14Jan2021, at single dose for covid-19 immunisation. The patient's medical history included immunocompromised. Concomitant medications were not reported. The immunocompromised patient received her second dose of Pfizer vaccine on 14Jan2021. On 20Jan2021, she developed nasal congestion and her son became sick the same day. Both tested positive for COVID. The physician asked would you consider giving the monoclonal ab to her? Physician knew the expectation was mild disease not severe but would you consider giving her the monoclonal? Outcome of the events was unknown.  Information about lot and batch number had been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "tested positive for COVID".
Very sharp pain in the pelvis area; Very very slight little sensation enough to know that there is something; Left arm very sore; Lethargic,like a zombie; very tired; Red area; itchy; Pain in chest; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red area), PRURITUS (itchy), CHEST PAIN (Pain in chest), PAIN IN EXTREMITY (Left arm very sore) and LETHARGY (Lethargic,like a zombie) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced CHEST PAIN (Pain in chest). On 01-Jan-2021, the patient experienced ERYTHEMA (Red area) and PRURITUS (itchy). On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Left arm very sore), LETHARGY (Lethargic,like a zombie) and FATIGUE (very tired). On 02-Feb-2021, the patient experienced PELVIC PAIN (Very sharp pain in the pelvis area) and DISCOMFORT (Very very slight little sensation enough to know that there is something). On 05-Jan-2021, ERYTHEMA (Red area) and PRURITUS (itchy) had resolved. On 29-Jan-2021, FATIGUE (very tired) had resolved. On 02-Feb-2021, PELVIC PAIN (Very sharp pain in the pelvis area) and DISCOMFORT (Very very slight little sensation enough to know that there is something) had resolved. At the time of the report, CHEST PAIN (Pain in chest), PAIN IN EXTREMITY (Left arm very sore) and LETHARGY (Lethargic,like a zombie) outcome was unknown. Not Provided          No concomitant medication was provided.  Treatment information included CBD oil.
SHORTNESS OF BREATH; SHARP PAIN IN LEFT ABDOMEN; SHARP PAIN IN UPPER THIGH; HARDNESS AT INJECTION SITE; TENDER ARM; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus, fibromyalgia, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced hardness at injection site. On 29-MAR-2021, the subject experienced tender arm. On APR-2021, the subject experienced sharp pain in left abdomen. On APR-2021, the subject experienced sharp pain in upper thigh. On an unspecified date, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: hydrocodone bitartrate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp pain in left abdomen, and sharp pain in upper thigh on 15-APR-2021, and had not recovered from tender arm, hardness at injection site, and shortness of breath. This report was non-serious.
very Frantic; episode of psychosis; Delusional; Dizzy; Headache; malaise; big knot there [injection arm]; itched; Could not stand up staright; had 17 or 18 falls in 2 days; slept so much after the vaccination; A spontaneous report was received from a pharmacist concerning a 70-year-old age female patient who received mRNA-1273 vaccine and experienced very frantic/delirium, episode of psychosis/psychotic disorder, Delusions/delusional perception, dizziness, Headache, malaise, knot on injection arm/vaccination site mass, itch/pruritis, could not stand up straight/dysstasia, 17 or 18 falls for 2 days, slept so much/Hypersomnia.  The medical history was anaphylactic reaction like iodine. Concomitant medications were not provided by the reporter.  On 17 Mar 2021, prior to the onset of events, the patient received the first dose of two planned doses of mRNA-1273 (Batch number: 045A21A) via Intramuscular route in the right deltoid for prophylaxis of COVID-19 infection.   After the first dose of vaccination, on an unspecified date, the experienced delusional, dizzy, and go through an episode of psychosis and was very frantic and got better and patient never had this before, had headaches and malaise, slept so much, had a big knot in her arm, itched, hard, could not stand up straight, 17 or 18 falls in 2 days. The event delirium worried about was medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event frantic was resolved. The outcome of the events episode of psychosis, delusions, dizziness, headache, malaise, knot on injection arm, itch, could not stand up straight, 17 or 18 falls for 2 days, slept so much were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt presents with large localized erythematous patch on left thigh 9cm x 5cm, warm and edematous.
HEART POUNDING; CHILLS; PAIN IN ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included pre-diabetic, and hbp, and concurrent conditions included seasonal allergy, and other pre-existing medical conditions included high blood pressure under control, medicated. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced heart pounding. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart pounding, and chills on 11-MAR-2021, and was recovering from pain in arm. This report was non-serious.
allergic reaction on skin around injection site, large red breakout, in addition to pain there, lasting for several days
None known -suicidal ideation denied at visit 4/26 - known chronic depression she elected to stop her medications when she turned 18. Committed suicide 04/28/11. Hung herself.
There are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: SARCOIDOSIS (medically significant), outcome "unknown", described as "There are 5 published case reports on patients developing sarcoidosis in close time proximity to COVID-19 mRNA vaccination".; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event SARCOIDOSIS and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300165539 same article/drug/event and different patient;US-PFIZER INC-202300319561 same article/drug/event and different patient;US-PFIZER INC-202300319562 same article/drug/event and different patient;US-PFIZER INC-PV202300165539 same article/drug/event and different patient;US-PFIZER INC-202300319563 same article/drug/event and different patient;US-PFIZER INC-202300319564 same article/drug/event and different patient;
no additional AE; VARIVAX was administered to a patient after it experienced a TE.; This spontaneous report has been received from a pharmacy manager referring to a 31-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, and drug reactions or allergies were not reported. Concomitant mediations included sterile diluent (manufacture unknown).  On 19-APR-2023, the patient was vaccinated with the varicella virus vaccine live (oka/merck) (VARIVAX) injection (0.5 milliliter (mL), lot# W031811, expiration date 05-OCT-2024, strength, route and anatomical location were unknown) for prophylaxis after it experienced a temperature excursion (TE) (product storage error). It was reported that the suspect vaccine was underwent temperature excursions at 46 degree Fahrenheit (F) for 168 hours. There were no previous temperature excursions. No additional adverse event (AE) was provided (no adverse event).  This is one of the two reports received from the same reporter.
Severe body aches; Nausea; Severe headache; Food tastes weird/bitter; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 10:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included HX breast cancer (remission 3y), fibromyalgia, migraine and gastroesophageal reflux disease (GERD). The patient had no known allergies to medications, food or other products. The patient had no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 29Mar2021 at 13:00, the patient experienced severe body aches, nausea, severe headache and food tastes weird/bitter. The patient did not receive any treatment for the events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events general body pain, nausea, headache and taste bitter were recovering at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained.
Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown patient (age and gender was not reported) who received only the diluent portion of ACTHIB, but not the Lypholized Powder portion of ACTHIB of vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to inappropriate reconstitution technique. It was reported the patient only received diluent portion of ACTHIB (lot number of diluent: UU6110AA Expiry date: 21-Jan-2020) but not the powder portion of ACTHIB (Lot number of powder: UI945AA, Expiry date 01-Dec-2018). It was not reported whether the patient had any 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. List of documents held by sender: none.
Injection site very sore continues  ; injection site swollen continues; extreme muscle ache throughout body; sore throat the morning after injection; temperature 101 first day after; second day 99 (normal 98.4); third day 98.9.