chrisvoncsefalvay/vaers-outcomes huggingface dataset:
head felt like a ocean; got sick; diarrhea; very very dizzy; arm hurt; nauseous; headache; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (head felt like a ocean), ILLNESS (got sick), DIARRHOEA (diarrhea), DIZZINESS (very very dizzy) and PAIN IN EXTREMITY (arm hurt) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064L21A, 0466210, 038A21A and 024M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack and Stroke. Concurrent medical conditions included Asthma and COPD. Concomitant products included ATORVASTATIN, DABIGATRAN ETEXILATE MESILATE (PRADAXA), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), LURASIDONE HYDROCHLORIDE (LATUDA), ASPIRIN [ACETYLSALICYLIC ACID], SENNA ALEXANDRINA LEAF (SENNA [SENNA ALEXANDRINA LEAF]), DOCUSATE SODIUM (COLACE), CLONAZEPAM (KLONOPIN) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (head felt like a ocean), ILLNESS (got sick), DIARRHOEA (diarrhea), DIZZINESS (very very dizzy), PAIN IN EXTREMITY (arm hurt), NAUSEA (nauseous) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (head felt like a ocean), ILLNESS (got sick), DIARRHOEA (diarrhea), DIZZINESS (very very dizzy), PAIN IN EXTREMITY (arm hurt), NAUSEA (nauseous) and HEADACHE (headache) outcome was unknown.            Patient was taking two blood pressure medication as Concomitant Product.  The last one patient got was the Pfizer because patient was hoping she would not get sick but did get really sick.
short of breath; lightheaded; Pain right arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, 7 minutes after vaccination, patient experienced short of breath, lightheaded, pain right arm. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Meningococcal was given instead of MMR. No adverse events known at this time.
On 5/22/10 approximately around 2:00 PM in the afternoon, patient was running a very high fever (105-106) and was developing a rash all over her body.  Her rash spread quickly and her fever did not go below 103 for days even when medicated (alternating Tylenol and Motrin every 3-4 hours). Her rash quickly became more severe.  Her entire body was covered in reddish/purple welt like spots.  After two separate trips to the emergency room, patient was diagnosed with Erythemia Multiforme.
Post vax, 1st dose of Hep-B, 11/3/00, developed severe migraine-like headache and nausea, URI with bronchitis (seen by attending physician). Symptoms began 2 days, post vax. After 2nd dose on 12/15/00, developed severe migraine-like headache and nausea (again began 2 days, post vax), 2+ days duration.
Severe, red, painful, ichy rash on stomach, chest, all over both arms, sides, lower back, hips tops of both legs amd buttock
Malaise, fever, muscle pains, headache, fatigue. Pain, swelling, hardness and itching at injection site.
UNEXPECTED THERAPEUTIC BENEFIT/BP WENT DOWN, NO NECK  AND LEG PAIN, NO ERECTION PROBLEM, NO FREQUENT URINATION; BLOOD PRESSURE WENT DOWN TO 120/79; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included leg pain, neck pain, erection problem, and frequent urination, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included patient took medicine for frequent urination or bathroom use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAY-2021, the subject experienced unexpected therapeutic benefit/bp went down, no neck and leg pain, no erection problem, no frequent urination. On MAY-2021, the subject experienced blood pressure went down to 120/79. Laboratory data included: Blood pressure (NR: not provided) 120/79 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unexpected therapeutic benefit/bp went down, no neck and leg pain, no erection problem, no frequent urination and blood pressure went down to 120/79 was not reported. This report was non-serious.
RECD ANTHRAX #4 ON 10/22/03, ON 10/25/03 ARM SWOLLEN, HARD RED, HOT, PRURITIC FROM ARM PIT TO ELBOW. ARM WAS ALSO PAINFUL 5/10. WNET TO ER AND WAS GIVEN MOTRIN, BENADRYL, AND VICODIN. FOLLOWING MORNING SOMEWHAT RESOLVED. NOT COMPLETELY RESOLVED AS OF YET 10/28/2003.
2330: had a headache, large joints became painful By 0400, I felt like I was crawling out of my skin. Unable to sit still. Headache and joint pain continued. After going home, I was able to take Benadryl 25mg. This eased the "crawling" feeling but it did not completely go away. Had to continue Benadryl every 6 hours until Friday night (09/10/2021). At that point the crawling out of my skin feeling eased up. The joint pain continued for an additional 3 days.
fever, diarrhea first night. then following week, extreme headaches,  very stiff neck.  Could not sleep, leg weakness.  8 days later, patient went to ER.  Foot numbness.
aches all over after taking the first dose; she has arthritis and her pain is worse than she had before; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 1 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. The concomitant medications were not reported. The patient experienced aches all over after taking the first dose on an unknown date. It was reported that patient had arthritis and her pain worsen than she had before. The patient asking if she can take Tylenol. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Running nose, sneezing-face burning, similiar to when you have a fever; has had flu shot for 10 yrs never had this type of adverse event;
(1) patient developed -Bilateral inguinal lymphadenopathy 11 days after with localized cellulitis at the sight of injection (2) Admitted to MC on 5/9/19. Dx with Viral Exanthema. See labs attach
Minor change - cotton mouth at some point in every day since starting 1 hour after vaccination, including slight difference of tongue feeling thicker as in slightly thirsty and dry.  MAJOR CHANGE - 12 hours after vaccination, like a faucet turning on menstrual cycle break-through heavier somewhat clotted bleeding starting 4 days early which NEVER happens - convinced is due to the vaccine.  Flow for 12 hours then stopped for 12 hours, going on since but now into the regular week.  Want to know why.  VERY CONCERNED about girls such as 13-year olds and what the vaccine might do to their female bodies and ability to have children and to have normal cycles.
Bexsero administered instead of Menveo; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a male patient who received Men B NVS (Bexsero) (batch number ABXC06AA, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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 Information: GSK Receipt Date: 12-OCT-2022. Reporter's Comments: The reporter stated that a dose of Bexsero was given to a patient who was supposed to receive his first dose of Menveo.  The patient had never received a dose of Bexsero prior to this. The reporter did not ask about follow-up. The vaccine administration facility is the same as primary reporter. Additional Supportive Information: The patient received Bexsero instead of Menveo which lead to Wrong vaccine administered.
Felt typical flu like symptoms and fatigue late evening and all day the 23rd. Slept most of day, arm very tender and painful at injection site, unable to left left arm.  On the 24th significant pain, redness, hot to touch, itching and swelling which got progressively worse through the day and into the 25th. I contacted my Dr on the 26th and was told to go in right away. She told me it was what is called COVID arm and put me on 5 days of 2 per day steroids, 15 days of twice a day Famotodine and 30 days of Allegra. Swelling, pain and redness improved over next 4 days. Itching was more tolerable but I still itch in the same area today.
Initial syncope, followed by nausea w/repeated dry heaves & vomiting, then severe h/a; Also poss of having been given Amyl nitrate as opposed to NH for her syncopal episode;On exam bit pale;...SEE WORM
12AUG94 3PM pt recvd vax & 530PM broke out in a raised red rash on extremities & was nauseated; not feeling well;
Hep B #2 (L) Deltoid 6/18/18 at 3pm administered. 11pm, Patient woke with low grade fever and total body hives, including ears/mouth. No respiratory distress.
Patient stood up to leave the room because she did not want to see her sister get a shot. As she walked out the door she fainted. Came to quickly. No treatement required.
This spontaneous report as received from a female consumer of unknown age refers to herself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number not reported). Other suspect therapies included influenza vaccine (manufacturer unknown) (dose, route, lot number not reported) (reported by the patient as given concomitantly). On an unknown date, the patient developed "little" red bumps in a "tiny, small area" and felt "itchy". The outcome of the adverse events was unknown. It was not reported whether the patient sought medical attention. Additional information is not expected.
Achiness, minor headache, sleeplessness,  Tiredness, night sweats,
First shot one year ago, second one yesterday; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose almost (exactly) one year ago).   On 7th March 2022, the patient received the 2nd dose of Shingrix. On 7th March 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2nd dose of Shingrix day before the reporting after a full year, later than the recommended interval, which led to lengthening of vaccination schedule. The patient asked that the vaccine would work or did he/she need to start over. The follow-up could not be possible as no contact details were available.
Myalgia, NauseaVomiting,  chills, malaise Narrative: Per patient report: "I received my 2nd dose of the COVID vaccine yesterday. I am presently experiencing chills, myalgias, malaise, as well as GI upset." One dose of tylenol yesterday with partial relief. Has not taken any meds today.
I caught Covid by my husband. On Sunday night I started to feel like I was getting a cold. Then Monday morning, I was very stuffy, coughing but not too terrible. I tested for Covid Monday morning and it came back positive. Yesterday was the fatigue that took over.
Extreme fatigue starting the evening of the second shot.  Low grade fever x 1 day, headache entire time since shot.  Brain fog.
No reaction to vaccine, only running nose, congestion, fatigue, no fever. I did the COVID-19 home test and a PCR and both were Positive. I have not recovered yet.
8-9 cm area of swelling, redness in left medial thigh appeared 2 days after given DTaP #5, PV #4 in left anterior medial thigh.
LEFT upper arm swollen, erythematous, tender to the touch. Painful, rashy area overlying vaccine injection sites and extending distally to just above elbow. Gradually resolved over time and was completely gone by office visit on 12/5/19.
Underdose; Received a pediatric dose of Engerix B; Drug dose administration interval too short; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 18-year-old female patient who received HBV (Engerix B pediatric) (batch number EM9E4, expiry date 17-DEC-2025) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B ADULT).   On 31-JUL-2023, the patient received the 2nd dose of Engerix B pediatric. On 31-JUL-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose), adult use of a child product (Verbatim: Received a pediatric dose of Engerix B) and drug dose administration interval too short (Verbatim: Drug dose administration interval too short). The outcome of the underdose, adult use of a child product and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-Aug-2023 The Medical assistant reported a patient received an adult dose of Engerix B and next day received a pediatric dose of Engerix B.  The reporter asked if there were any safety information The vaccine administration facility was the same as primary reporter. The 18 year old patient received a pediatric dose of Engerix B, which led to underdose and adult of a child product. The patient received an adult dose of Engerix B on July 30th 2023 and on July 31st 2023 received a pediatric dose of Engerix B, which led to shortening of dose schedule. The reporter did not consented to follow up.
NO SIGNS OR SYMPTOMS.  PATINET WAS GIVEN TD ON 1/28/09 THAT HAD EXPIRED ON 1/19/09.  INSTRUCTED TO REPORT TO VAERS.
On 06/21/2000 the patient developed 4 chickenpox lesions and a muculopapular "base" rash on his trunk. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information is expected.
25JUN96 tonic-clonic sz lt arm, partial loss of consciousness, 4min long;occurred 7th day p/1st DTP 18JUN96;followed by similar sx 27JUN96 & 28JUN96;25JUN96 sz self relieved;pt irritable p/;18JUN crying >3hr;T100-101;diff nursing;bump @ sit
No additional AE reported; Patient received first dose of GARDASIL 9 in 2015, second dose 18FEB2021 and will be getting a third dose soon; This spontaneous report was received from a registered nurse referring to a female patient of unknown age. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.   On an unspecified date in 2015, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, dosage, route of administration, anatomical location, lot number and expiration date were not reported), then on 18-FEB-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, dosage, route of administration and anatomical location were not reported; lot number 1687290 and expiration date 06-SEP-2022) and the reporter stated that the patient will be getting a third dose soon (inappropriate schedule of product administration). No adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Dizziness & UrticariaPruritus Hx of Guillan Barre with prior influenza vaccination. Anxious regarding hives. Transferred from observation area to ED (located within 50 feet from observation area). Treated with IV Benadryl, IV Solumedrol.
This case was reported by a other health professional via call center representative and described the occurrence of transmission of an infectious agent via a medicinal product in a female patient who received RABAVERT. On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, an unknown time after receiving RABAVERT, the patient experienced transmission of an infectious agent via a medicinal product (serious criteria GSK medically significant). On an unknown date, the outcome of the transmission of an infectious agent via a medicinal product was unknown. It was unknown if the reporter considered the transmission of an infectious agent via a medicinal product to be related to RABAVERT. Additional details were provided as follows: The reporter stated that the RABAVERT came with a non-safety needle for administration of the vaccine. The reporter understood the rationale of using a non-safety needle as a drawing up needle, but not for the one to be used for administering the vaccine to the patient. Recently, there was a blood borne pathogen exposure involving this device. Therefore the reporter requested to exchange the non-safety needles in the RABAVERT kit with safety needles for the safety of their healthcare professionals.
had my first shot on 2/12/2019 and the second dose on 10/11/2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 81-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th February 2021).   On 11th October 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: This case was self reported by the patient. The patient received second dose later than the recommended interval, which led to lengthening of vaccine schedule. The patient reported that the doctor said good but site says second dose should be within 6 months. The patient enquired should he/she get a second dose now as my pharmacist suggested.
Fever/lassitude started approximately 14 hours post injection  with climbing temperature until  Day 1 peak temperature 101.1 was reached approximately 18 hours post injection??-compared to baseline 96.6 - 97.6 (7 am/9pm readouts)  With Tylenol temperature reduced,  but only to 100.1 Day 2 temperature 99.0 most of the day  First dose (3 months prior) more modest effects (slight fever approximately 26 hours post injection), not reported
Rash, red splotchy and scaly bumps. Beginning on day 5 I had a rash that was mainly consolidated around my torso. Most dense from hip to armpit. For a the next few days it spread to arms, legs and up my neck. The rash never had a forced itch type of feeling but certainly felt itchy yet could will myself to not itch. As mentioned, appears scaly, red and irritated. My wife, doctor contact provided, is a GP and we've just been monitoring the rash as she thinks it will resolve itself and looks like some form of Pityriasis rosea although this would a first of that for me.
Sore throat that progressed to a respiratory infection, coughing up stuff, difficulty breathing, fever after day 3, sinus infection after day 3.  Rattling of lungs when breathing.  Doctor prescribed antibiotic.  Have had to breathe in steam to help breathing but may yet have to visit emergency room.
PHARMACY INFORMED BY PATIENT ON 9/8 OF POTENTIAL REACTION.  PATIENT DESCRIBES HAVING ITCHY RED BUMPS ON HER ABDOMEN AND LEGS. SHE STATES SHE DID NOT CHANGE HER DETERGENTS, SOAPS, OR DAILY HABITS.  SHE DOES NOT STATE THAT IT IS SPREADING FROM THOSE AREAS OR ANY OTHER COMPLICATIONS (BREATHING ISSUES/SWELLING/EDEMA). PATIENT INSTRUCTED TO APPLY CORTISONE TOPICALLY AS NEEDED FOR ITCHING AND TO TAKE BENADRYL 25 MG AT BEDTIME.  PATIENT INSTRUCTED TO FOLLOW UP WITH PHARMACY IF THE AREAS DO NOT CLEAR.
Patient's first dose of Moderna was reported in electronic records as given on 04/02/2021 and second dose reported in electronic records as given on 04/22/2021. This makes the patient's second dose given too early and therefore invalid. Unable to make contact with patient for notification.
experienced a sore arm after 1st dose of the COVID 19 vaccination; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a sore arm after 1st dose of the COVID 19 vaccination. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Pfizer booster shot was given 10 days too soon. 2nd dose was given on 06/17/21 and Pfizer booster shot was given on 12/07/21. Patient has not reported any adverse reactions