chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster vaccination 2-9-10-left arm red and warm. 2-9-10 visited after headache-local reaction -Tx with Motrin. 2-10-10 Left arm still red warm-area hard approx golf ball size-visited ER placed on antibiotics-red. 2-13-10 info improvement spoke with mom. 2-12-10 improvement noted-area smaller-less red-seems better still itching. Child received vax 2/8 in left arm, arm became sore and warm to touch. Child was take to Urgent Care twice and then finally taken to ER on 2/10 where he was put on antibiotics.
Pt. experienced syncopal episode with loss of consciousness and appearance of seizure for less than 1 minute. Pt. then regained consciousness and was sweaty and light headed. Squad was called. pt. assessed, became lightheaded again and laid on the floor. Pt. refused to go to the ER by squad, would like to go by car with his wife who is with him.
Initial reaction - rash emerged at injection site.  Started as red, then more raised/pronounced and itchy.  Spread above and then down injection site with blistering down to tips of fingers - left arm only.  Experienced pain that felt initially like electric shocks, then alternated with extreme burning sensations.   Saw dermatologist who confirmed SHINGLES.  Had  antiviral prescribed which lessened further blistering but the pain continued unabated.   Was prescribed Gabapentin to handle nerve pain - still taking .
Post 15min observation, pt was feeling dizziness and nausea.  Pt assisted to medical bay via wheelchair.  Pt notes no PMH.  Pt is currently on her menstrual cycle and on birth control medications.  Pt given water and juice.  20mins post vaccination BP 88/44, HR 51, RR 20 -- > 7mins later 101/60, 63, 20.  Pt stable and released from the vaccination site after symptoms resolved.
Severe pain and edema localized at injection site. Unable to lift arm, unable to touch arm or put pressure on arm or sleep on left side x 72hrs.  Generalized severe body and joint aches, fatigue, and lack of energy x 72hrs.  Would have missed 2 workdays if this would have happened on a weekday vs. a friday.
Approximately 4 hours post vaccination started scratching her neck, increased mucus production and swollen eyes. Parent gave benadryl and symptoms abated. Report to complete and encouraged parent to discuss with primary care provider next steps to vaccinating or if medical exemption is needed.
Patient is a 93 y.o. female patient of MD with history of Alzheimer Dementia, Anemia, Seizure disorder on Keppra, CKD 3a, CAD, and HLD  presented on 8/29/2023 with SOB. Agency consulted by Hospitalists, Generic for medical management.    Acute respiratory failure with hypoxia Covid 19 PNA Multifocal PNA Pneumonia DNR CC Presented with weakness, SOB CXR 8/26 showed no acute cardiopulmonary process CXR 8/29 showed bibasilar airspace opacity CTPA 8/29 show bilateral lower lobe pneumonia AF, WBC normal, CRP 308.4, PCT 6.14, Blood culture NGTD, MRSA detected, Urine Ag negative ID and Pulm following; was needing HHF but now on RA since not keeping NC on  Resumed remdesivir (Stop 9/2), dexamethasone (stop 9/9) Rocephin and azithromycin stopped, now po Pt's mental status is waxing and waining Palliative care consulted, DNR CC, All labs, IV have been discontinued Plan to discharge to SNF then home   Acute toxic encephalopathy Likely d/t COVID and pneumonia with dementia baseline UA without infection Continues to wax and wane   Generalized weakness Decreased oral intake Likely secondary to COVID and pneumonia PT/OT/CM   History of seizures Continued home Keppra   Dementia Holding home Remeron due to hypersomnolence and AMS   Hyperlipidemia Holding home statin   History of CVA Continue home aspirin; holding statin since risks outweigh benefits
Patient reported history of fainting/getting woozy when receiving injections.   Vaccinator offered for patient to lay down for injection but he refused.  After the vaccine was administered the patient remained in the vaccinator's chair for a few minutes.  Patient denied feeling woozy and walked to the observation station.  Vaccinator informed the greeter at the observation station notified of history and that they should closely monitor him.   1700   BP 132/92   Pulse 74   Resp 16.  Patient sweating.  continued to be monitored.  no medication administered. 1705   BP 132-80  Pulse 74  Resp 14 1710   BP 162/90  Pulse 82  Resp 16  Patient offered a breakfast bar.  states "feeing fine" 1715   162/108  Pulse 78  Resp 16  Patient returned to chair (had lowered himself to the floor).  No sweating.  Denies SOB and difficulty breathing.  1725   BP 162/80  Pulse 64  Resp 16.  Patient states he "feels OK and doesn't feel "funny" 1732   BP 144/110  Pulse 78  Resp 16   Patient denies SOB   States feeling "OK"   temp 97.3   Ate a cookie  1742   BP 178/106  Pulse 76  Resp 16   Patient denies HA or lightheadedness 1753  BP 172/106  Pulse 74  Resp 16   Reports he "feels normal".   Patient was advised to seek medical attention.  Declined EMS call/evaluation.  Patient released to self.  Call placed/message left for follow up on 3/26.  No return call received.
Second Dose Outside of Time Window; "Not feeling well"; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose Outside of Time Window), MALAISE ("Not feeling well") and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose Outside of Time Window), MALAISE ("Not feeling well") and CHILLS (Chills). On 06-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose Outside of Time Window) had resolved. At the time of the report, MALAISE ("Not feeling well") and CHILLS (Chills) had resolved.            Treatment information was not provided.  Concomitant medication were not reported.; Sender'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.
Within 1st hour after shot pt symptoms were high fever 102 to 103, pale, lifeless, body hurt all over, dizzy, hoarse, cough, breathing difficulty, vomited.
Pt has 100mm area of slight erythema and induration that is slightly uncomfortable. Pt describes numbness and tingling in area.
Lower back pain; This case was reported by a consumer via interactive digital media and described the occurrence of back pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2019, the patient received the 2nd dose of Shingrix. On 18th December 2019, 1 days after receiving Shingrix, the patient experienced back pain. On an unknown date, the outcome of the back pain was unknown.   It was unknown if the reporter considered the back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided, but selected as an adult as per vaccine indication. The day before reporting, the patient received dose of Shingrix and on the day of reporting in the afternoon had major lower back pain. The pain was like somebody plunged a knife. The patient asked, if any side effect connection with Shingrix vaccine.
After giving the Pfizer vaccine, were notified that the vaccine had experienced a temperature monitoring event outside of our facility.  The patient and his family were called and informed of the recommendations.  The patient came in to receive an addition vaccine on 10//12/2022.
Case number PHEH2014US022371, is an initial spontaneous report from a medical assistant received on 05 Nov 2014. This report refers to a 12-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with MENVEO (batch number: M14056) that reached 50 F for 30 minutes intramuscularly at a dose of 0.5 ml on 03 Nov 2014 without any reports of adverse reaction.
Very weak after 2nd dose; Chills after 2nd dose; Very high fever after 2nd dose; Threw up a lot after 2nd dose; Shivering after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Very weak after 2nd dose), CHILLS (Chills after 2nd dose), PYREXIA (Very high fever after 2nd dose), VOMITING (Threw up a lot after 2nd dose) and CHILLS (Shivering after 2nd dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.    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. On an unknown date, the patient experienced ASTHENIA (Very weak after 2nd dose), CHILLS (Chills after 2nd dose), PYREXIA (Very high fever after 2nd dose), VOMITING (Threw up a lot after 2nd dose) and CHILLS (Shivering after 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Very weak after 2nd dose), CHILLS (Chills after 2nd dose), PYREXIA (Very high fever after 2nd dose), VOMITING (Threw up a lot after 2nd dose) and CHILLS (Shivering after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103 Fahrenheit.         Concomitant medications like Diabetes medication, Thyroid medication, High blood pressure medication, Cholesterol medications were included. The treatment also include  liquids and  Cool rags.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information was received on 13-May-2021 does not contain any new information. On 06-Aug-2021: TCR attached and contains no significant information.
Starting at 4:30pm (about 8 hours after vaccine) I started feeling fatigue.  Followed by intense chills from about 5:30-9:00pm.  Recorded fever of 102.4 around 9pm.  Took tylenol around this time.  Fever to reduced to 99.7 by ~10:30pm.  Headache & fatigue most of the night and into next day, but fever is gone.
Red area on her right jaw that was very itchy; Red area on her right jaw that was very itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red area on her right jaw that was very itchy) and PRURITUS (Red area on her right jaw that was very itchy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced ERYTHEMA (Red area on her right jaw that was very itchy) and PRURITUS (Red area on her right jaw that was very itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 mg. At the time of the report, ERYTHEMA (Red area on her right jaw that was very itchy) and PRURITUS (Red area on her right jaw that was very itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. The event occurred one hour after the vaccination.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
the arm is swollen and painful; the arm is swollen and painful; stomach pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (the arm is swollen and painful), PAIN IN EXTREMITY (the arm is swollen and painful), ABDOMINAL PAIN UPPER (stomach pain) and CHILLS (chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (the arm is swollen and painful), PAIN IN EXTREMITY (the arm is swollen and painful), ABDOMINAL PAIN UPPER (stomach pain) and CHILLS (chills). At the time of the report, PERIPHERAL SWELLING (the arm is swollen and painful), PAIN IN EXTREMITY (the arm is swollen and painful), ABDOMINAL PAIN UPPER (stomach pain) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.1f (High) 100.1F.         No concomitant medications or treatment reported. Patient denied to give any other information regarding events or first dose.
Fever; Aches and pains; Fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced fever, pain and fatigue. On an unknown date, the outcome of the fever, pain and fatigue were unknown.   It was unknown if the reporter considered the fever, pain and fatigue to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient just got Shingles vaccine 3 days ago from the date of reporting and had reaction fever aches and pains and fatigue. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Two hours after injection got hives on right palm of hand.  Next at exactly the same time was upper arm and armpits, both arms.   Inner thighs then got hives,  back of leg. I am allergic to Benedryl but had no choice to take it.  This morning I had hives on my left wrist and in between all of my fingers.   Afternoon: hives on both wrists,  inner thighs,  and thumbs.  Taking Benedryl currently.
This is a spontaneous report from a contactable consumer (patient). A male patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date: unknown), via an unspecified route of administration,  on Mar 31, 2021, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. On Apr 1, 2021, patient had a sore throat, fever, muscle aches/muscles hurt everywhere all over his body and feeling kind of sick. Patient would like to know if it is okay for him to take Tylenol or if there are any other treatment recommendations. Patient also wanted to know if he can take ibuprofen or something else. Pfizer is unable to make treatment recommendations for individual patients and unaddressed medical questions referred or forwarded to medical information. No treatment received for the events. The outcome of the event: not recovered as caller stated he is still the same. No follow-up attempts needed. Information about batch/lot number cannot be obtained.
Mid-September he began having sinus issues like everyone else does this time of the year, he progressively got worse. His immune system could not fight off a simple sinus issue. The first doctor visit was 10/4/2021 and he was first diagnosed with strep throat, then diagnosed with sinus infection, then diagnosed with sinus infection with migraines, then diagnosed with sinus infection and possible vertigo. Spent the night in the ER to be observed, the next morning they diagnosed him with Mono and was sent by ambulance to the hospital on 10/14/2021 to check for Spinal Meningitis where he was diagnosed with Guillain-Barre Syndrome. He spent 9 days in the hospital receiving IVIG treatment.  The GBS affected him from the waist down.  He has been going to physical therapy 3 times a week since being released from the hospital on 10/22/2021 to get him walking again and his balance issues.
Flushing, shortness of breath. Diphenhydramine 50 mg once.
Pt. Received another initial Peds Pfizer dose instead of Pfizer Bivalent dose. No adverse reactions reported. Pt. mother notified.
This is a spontaneous report from a contactable consumer who reported for her husband. A male patient of an unspecified age received PREVNAR 13 on 23Oct2018 at single dose for immunisation and a flu shot (influenza vaccine) on 23Oct2018 for immunisation. The patient medical history and concomitant medications were not reported. On 24Oct2018 patient started having lower back pain and then it progressed to where he could not even hardly walk: he had pain, burning, shooting pain down the back of his legs and he could not walk. On 29Oct2018 the ambulance was called and patient went to the hospital. Patient was hospitalized on 29Oct2018 due to the events. He was checked for everything and anything and just the pain was 'surrounded': he was given steroidal injection, a pain injection, a narcotic pain reliever and a steroid injection. He saw a neurosurgeon who did not really see a reason why he would have such severe reactions like this burning, shooting pain down the back of his legs; it was getting progressively worse and before this he was absolutely fine, no problems whatsoever and he has gotten to the point now where he had to use two canes to lean on just in order to walk, when he tried to get out of the house. The final outcome of the events was unknown. Information on the batch number has been requested.
1am to 10am  woke up freezing - chills fever body aches, skin was sore, headache, nausea and even vomited! Just like the flu.  Body aches were awful!
FLU LIKE SYMPTOMS; LOSS OF APPETITE; NAUSEA; This spontaneous report received from a consumer concerned a 48 year old male. 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, and batch number: 206A22A expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 07:20 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021 18:00, the subject experienced flu like symptoms. On 13-APR-2021 18:00, the subject experienced loss of appetite. On 13-APR-2021 18:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, loss of appetite and nausea was not reported. This report was non-serious.
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Patient developed abdominal pain approximately 4 days prior to hospital admission and approximately 1 day after receiving the vaccination for herpes zoster (SHINGRIX). The pain was not relieved by lying down or worsened by eating. Ultrasound showed some sludge in the gallbladder but no evidence of stones or inflammation. Pancreatic enzymes were elevated. Patient has improved with IV fluids and supportive care.
pt recvd vax 2NOV93 & 4NOV93 started w/malaise; c/o severe pain in rt hip on 5th remained in bed 5th & 6th; c/o nausea, vomiting & diarrhea on 6th admitted to hosp 7NOV w/severe dehydration w/elevated tem; dx pneumonia;
pt recvd vax & 1 hr later devel a fever of 102 & shaking chills; 20 mins later t103 & chills stopped; pt had nausea & vomiting; treatment DPH;
Expired vaccine used; 0.3ml given as booster; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), ACCIDENTAL OVERDOSE (0.3ml given as booster) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 008C21A and 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus since 2019, Neuropathy since 2019 and Dyslipidemia. Concomitant products included ATORVASTATIN from 20-Nov-2021 to an unknown date, FISH OIL from April 2021 to an unknown date, GLIMEPIRIDE from April 2021 to an unknown date, PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZON) from June 2021 to an unknown date and METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) from August 2021 to an unknown date for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3 milliliter. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), ACCIDENTAL OVERDOSE (0.3ml given as booster) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), ACCIDENTAL OVERDOSE (0.3ml given as booster) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) to be not related. No further causality assessments were provided for ACCIDENTAL OVERDOSE (0.3ml given as booster) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered).    No treatment information was provided. The patient stated that he had no known allergies. No adverse reaction was reported.
Chills, whole body pains, nausea, headache, chemical aftertaste after ingesting food (only ate soup), chemical smells toward food and other things that contain odor.
soreness in chest; like pleurisy; when take a deep breath, hurt in chest, sore; no fever; 7FEB95 pt talke w/MD who said in all probability flu shot had nothing to do w/illness; recent infect not cleared; MD put pt on Floxin starting 7FEB;