chrisvoncsefalvay/vaers-outcomes huggingface dataset:
one patient received ACT-HIB after the diluent had expired with no adverse event; administering to a patient who is outside the approved ages of 2 months through 5 years with no adverse event; Initial information received on 27-Apr-2022 regarding an unsolicited valid  non-serious case received from from a other health professional.  This case involves a 18 years old male patient who received act-hib after the diluent had expired with no adverse event and administering to a patient who is outside the approved ages of 2 months through 5 years with no adverse event ,while receiving vaccine Hib (Prp/T) Vaccine [Act-Hib].  The patient's past medical history included Bone marrow transplant. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Tdap); Hepatitis B Vaccine (Hepatitis B Vaccine); Pneumococcal Vaccine Conj (Pneumococcal Conjugate Vaccine); and Polio Vaccine (Polio).  On 04-Apr-2022, the patient received a  dose of suspect Hib (Prp/T) Vaccine Powder and solvent for solution for injection( lot U6901AA and UJ423AA , expiration date: 07-Mar-2022 and 20-May-2022) at a  dose of 0.25ml via intramuscular route in the right deltoid as prophylactic vaccination.  On 04-APR-2022(latency: same day),  the patient received act-hib after the diluent had expired with no adverse event (expired product administered) and administered vaccine who is outside the approved ages of 2 months through 5 years with no adverse event (Product use issue).   Action taken:  not applicable.  It was not reported if the patient received a corrective treatment for the events .   At time of reporting, the outcome was Unknown for both events   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.
pt recvd vax;immed p/dose 2,exp inject site swelling which subsided;rash on arm,neck,face;felt "funny";24-48 hrs later exp ha,tx w/ darvocet;sxs tx w/dospack,orudis,dph,ice pack to lt arm;migraine;BP 150/96;rash at site;site tender,edematou
Had a slight cold when received vaccine; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8733), via an unspecified route of administration in the left arm on 28Mar2021 at 12:30 hours (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included crohns disease and osteoporosis and the patient had a history of allergy to dairy and gluten. The patient received unspecified other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient experienced a slight cold. On 02Apr2021, 5 days after the vaccine the patient underwent lab tests and procedures which included SARS-2 COVID (nasal swab) test and the result was positive. The patient did not receive any treatment for the event. Adverse event resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the event slight cold was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
patient had allergic reation; Initial information received on 10-Feb-2021 regarding an unsolicited valid non-serious case from non-healthcare professional.  This case involves patient (unknown demographics) who had allergic reaction (hypersensitivity), after receiving vaccine INFLUENZA VACCINE.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity) (Unknown latency), following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the  outcome is unknown for hypersensitivity.
started with just an achy arm at the injection site. By the next morning, the inside of my right arm (towards the armpit) hurt a lot. I'm assuming a lymph node. Then the lymph node under the right side mandible was swollen and painful. That lasted for about 2 weeks. About a week after symptoms went away I felt a stabbing pain under my right mandible and severe throat pain. Once again, my lymph node felt swollen. That lasted about 3 or 4 days.
Information has been received from a physician and a nurse concerning a 9 week old (8lb., 15 oz.) male with gastroesophageal reflux and prematurity with apnea and bradycardia (on monitor when sleeping) who on 19-MAR-2008 was vaccinated PO with his first 2.0 ml dose of ROTATEQ (lot# 657980/0106K). There were no concomitant vaccinations. Concomitant drug therapy included PREVACID and ZANTAC. Upon vaccination, the patient "Stopped breathing." The patient sought medical attention in the physician's office. Lab diagnostic studies included a chest x-ray that was within normal limits, a heart rate which was 44-150 bpm and oxygen saturation results of 98-99% room air. The patient was also treated by stimulation and the patient was suctioned with a bulb syringe. It was noted that therapy with ROTATEQ was discontinued for the second and third dose. Subsequently, the patient recovered. There was no product quality complaint. Stopped breathing was considered to be immediately life-threatening by the physician. Additional information has been requested.
Very severe pain, aching, throbbing, stabbing, burning on whole upper arm shoulder area. It is still very intense and is almost 4 weeks now. Doctor recommended heat and Tylenol. Didn't help. Stronger pain killers do not help. Doctor gave Bextra samples to try.
Diarrhea; Upset stomach; A spontaneous report was received from a consumer concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, upset stomach and diarrhea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, upset stomach and diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, upset stomach and diarrhea was unknown.
3 days after vaccination, I had chills, fever above 102, and headache which lasted about 5 hours and subsided after taking Advil.  I took Advil and the fever broken and the headache lessened.  This repeated again the next day and again was better after taking Advil.
I had a severe rash for three weeks after I took the Covid vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "the patient had a severe rash for three weeks after the Covid vaccine. She was not sure if it due to her recent biopsy or caused by the Covid vaccine. She would like to know if there was a trial for skin reaction(s) to the Covid vaccine". Outcome of the event was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Patient received her 1st dose of the COVID vaccine and during the observation  she began to feel throat swelling and tongue swelling.  She also noticed some pressure in her chest with shortness of breath.  She was assessed by staff in the area and was given IM epinephrine 0.3mg  for an allergic reaction and was transported to the emergency room for further treatment and observation.  given diphenhydramine 50mg IV, famotidine 20mg IV, methylprednisolone 125mg IV.
The patient stated that she experienced increasing redness and swelling around the injection site beginning after she received the vaccine. She developed red bumps that a physician family member told her look like cellulitis. I advised her to follow up with her PCP for diagnosis and treatment.
3/30/04 left upper arm with erythema, warmth, swelling- upper deltoid to 3/4 of upper arm
Having fatigue, chills, alopecia, arthralgias, N/V, diarrhea, intermittent rhinorrhea and nasal congestion, lower back pain, neck pain for the last 2 weeks
Fever, Muscle Aches, Headache, Swollen/Painful Lymph Nodes,
Enlarged lymph node under arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Enlarged lymph node under arm) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Enlarged lymph node under arm). At the time of the report, LYMPHADENOPATHY (Enlarged lymph node under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Pt. cried, inconsolable x several. hr. Leg swelling, redness @ vaccine site.
Nauseous after receiving vaccine; but then the feeling went away after about an hour Restlessness Irritability Hallucinations - seeing people that are no longer living (grandparents)  I have reached out to (and will be seeing) my neurologist on Friday, May 14th.  She put me on Clonazepam (.50 mg) - with instructions to take either a half or full tablet nightly.  They are helping, as I have had my second night's dose and was able to sleep through the night without being restless and without the hallucinations.  While I miss my grandparents, I don't wish to see them this way.
moderate amount of redness and swelling at site area: started 02/17/2020 started 02/18/2020: fever and chills, sweats, body/muscle aches, nausea, increased redness and swelling to site 02/19/2020: same symptoms as 02/18/2020
Itching; Painful; Vaccination site erythema; Vaccination site swelling; redness below the injection site; swelling 2 inches below the injections site; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itching), PAIN (Painful), VACCINATION SITE ERYTHEMA (redness below the injection site), VACCINATION SITE SWELLING (swelling 2 inches below the injections site) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness below the injection site) and VACCINATION SITE SWELLING (swelling 2 inches below the injections site). On 12-Jan-2021, the patient experienced PRURITUS (Itching), PAIN (Painful), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 09-Jan-2021, VACCINATION SITE ERYTHEMA (redness below the injection site) and VACCINATION SITE SWELLING (swelling 2 inches below the injections site) was resolving. At the time of the report, PRURITUS (Itching), PAIN (Painful), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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.
INCORRECT STORAGE OF VACCINE (MORE THAN 6 HOURS IN FRIDGE AFTER OPENING); OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-SEP-2021, the patient experienced incorrect storage of vaccine (more than 6 hours in fridge after opening). On 17-SEP-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect storage of vaccine (more than 6 hours in fridge after opening) and out of specification product use was not reported. This report was non-serious.
Diarrhea; Cramping; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and MUSCLE SPASMS (Cramping) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). 22-Mar-2021, the patient experienced MUSCLE SPASMS (Cramping). On 25-Mar-2021, DIARRHOEA (Diarrhea) was resolving. At the time of the report, MUSCLE SPASMS (Cramping) was resolving.            The patient received Imodium AD as treatment drug. The action taken for the second dose of Moderna COVID-19 vaccine is not applicable.
Received vaccine at 2:30 PM on 9/23/09.  Developed Fever at 8:00 PM on 9/23/09.  Fever peaked at 103 degrees at 10:00 PM, was treated with TYLENOL.  Experienced severe chills and body aches.  Remained febrile at 100 degree F on 09/24/09.  Awoke 9/25/09 asymptomatic and feeling fine.
Mother stated raised rash for one week to right side and underneath right arm.  denied fever, itching or pain.
Itching in arm both arm pits, along inside of left arm, and under area where bra stopped.  Checked in mirror and upper body was red with raised marks.  Went to Facility.  Rash had spread down left arm and along inside of right arm just above elbor area.  Doctor at Patient First told me that I had hives and prescribed two medications that I was to begin immediately upon arriving home.  By the time that I arrived home, rash covered entire torso (front and back) and was beginning to spread to thighs and private areas.  Neck and head were beginning to itch.  Over the next three (3) days rash spread down my entire body, including my hands and feet.   Body was hot and itching was severe. Relief through cold showers and compresses.  Called my Primary Care Physician's office on 10/30/23 and made an appointment for Tuesday, 10/31/2023.  My PCP confirmed hives diagnosis and told me to report adverse reaction.    Told me to take a Claritin daily for 30 days after prescribed medication was finished.  Told me, also, that it is not unusual for hives to come back after cessation of medication.  Still have episodes where body parts are itchy.
Everytime end up with a flu; Initial information was received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media (under reference number US-SA-SAC20211027000252).  This case involves a patient of (unknown demographics) who every time end up with a flu (influenza) when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious every time end up with a flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Why every time I end up with a flu anyways stopped taking once I found out it contained MERCURY."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome was unknown for the event (influenza).  There will be no information available on the batch number for this case.
Patient c/o body ache, weakness, pain in left arm, behind shoulder and left upper chest. Pain and discomfort with ROM.
pt recv vax & 6 to 8 wk p/vax devel mononucleosis;
beyond use date for vaccine 09/07/2022 vaccine given 09/15/2022
Within a couple weeks of the 2nd COVID-19 vaccine I developed tinnitus in both ears which is chronic, mild and has persisted since the onset
Redness and warmth at injection site (left deltoid), beginning approximately 13 days s/p injection
Extreme muscle pain in legs.  Occasional tingling in feet. Pain is ongoing has not subsided. Taking Advil multiple times per day,
mom brought pt to ER c/o twitching & questionable sz & crying spell; t100; no neurological abnormality;
Patient called 1 week after receiving vaccine with localized reaction at injection site. Site where vaccine was given was itchy, red and swollen. Pt afebrile, eating, drinking, stooling, voiding fine. No other changes noted.
Left upper arm was indurated, hot and red to touch. Shot was given with a biojector not with conventional syringe.
inappropriate schedule of; fever; shivering; headache; itchy bumps on stomach; rash at injection site; flu-like symptoms; itchy bumps on stomach; This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on 17th January 2019, refer linked case US2019197555).   On 20th August 2019, the patient received the 2nd dose of Shingrix. On 20th August 2019, less than a day after receiving Shingrix, the patient experienced itchy rash, injection site rash, papular rash and drug dose administration interval too long. On an unknown date, the patient experienced fever, shivering, headache and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, shivering, headache, itchy rash, injection site rash, influenza-like symptoms and papular rash were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the fever, shivering, headache, itchy rash, injection site rash, influenza-like symptoms and papular rash to be related to Shingrix.  Additional details were provided as follows: Less than 3 months after receiving Shingrix, the patient experienced flu-like symptoms, fever, shivering and headache. The patient experienced rash at injection site and  itchy bumps on stomach. These resolved after 5 days. The reporter consented to follow up.
Rapid onset of blurred vision and partial blindness, confusion, inability to form complete or coherent thoughts or sentences.  Started with blurred vision around 5:45pm. I immediately sat down on the couch, and tried to explain to my wife what was going on. However, I was unable to complete the thoughts I was trying to form. Eventually I began confusing words (such as saying "king" when I wanted to say "kind" or "kite") and was unable to produce more than one word every 1-2 seconds with great difficulty. Then a headache came that was both extremely painful and somehow "painless," as if I was observing myself having the pain as a bystander. All of this happened within one minute of onset.  I laid down and after about 10 minutes from onset the difficulty speaking subsided and I could make complete sentences, although with some difficulty. After around 20 minutes from onset my vision had fully returned.   I called 911 out of concern for stroke-like symptoms. The dispatcher sent an ambulance, and I was taken to the Hospital Emergency Department for treatment.  Around three hours after the onset of the incident I was diagnosed with a complex migraine and discharged.
patient received on 27Jun2022 a dose of Boostrix that had expired on 21Jun2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3E52S, expiry date 21st June 2022) for prophylaxis.   On 27th June 2022, the patient received Boostrix. On 27th June 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.    Additional Information: GSK Receipt Date: 30-Jun-2022 Reporter's Comments: Medical assistant reported a patient received a dose of Boostrix on 27th Jun 2022 that had expired on 21st Jun 2022.  Conset to follow up was granted. Additional supportive information: As patient received expired vaccine which led to expired vaccine used.
On Saturday night I was sitting and had chest pain felt like an elephant was sitting on my chest, I could hardly breathe. My husband took to me to hospital. They ran test. I had to wait in emergency room until Monday waiting for a bed to be admitted. On Monday I was admitted to a room. The hematologist saw me. I was immediately put on Lovenox. I'm in progress of recovering. They also found a UTI while I was in the hospital with the clot in my lungs. I have an appointment with my hematologist coming up.