chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Terrible reaction / swollen arm; Arm / red; Hot to touch; Arm / very sore; This case was reported by a consumer via(Facebook) interactive digital media and described the occurrence of swelling arm in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced swelling arm, erythema, feeling hot and pain in arm. On an unknown date, the outcome of the swelling arm, erythema, feeling hot and pain in arm were recovered/resolved.   It was unknown if the reporter considered the swelling arm, erythema, feeling hot and pain in arm to be related to Meningococcal B vaccine.  Additional details were reported as follows: This case was reported by the patient parent for his son. The age at vaccination was not reported. The patient received MenB vaccine and had terrible reaction to it swollen arm, red, hot to touch and very sore for over a week.
Side effects: redness, swelling, upper arm pain (but inferior to injection site), nausea, fatigue, arthralgias.
Initial and follow up information has been received through the Merck pregnancy registry for GARDASIL via an obstetrician and a 20 year old white female on methadone maintainence for opiate abuse with a history of an adverse drug reaction to REGLAN, herion abuse, panic attacks, frequent urinary tract infections, pyelonephritis (2002, normal urology on follow up) and one previous pregnancy with first trimester spontaneous abortion. On 23-JAN-2007, she was vaccinated with a first dose of (Lot#655165/1425F). On 27-MAR-2007, she was vaccinated with a second dose of GARDASIL (Lot#655503/0012U). Concomitant therapy include methadone HCl 80 mg daily. Last menstrual period was 30-MAR-2007 (previously reported as LMP 05-APR-2007) and estimated dates of delivery was 04-JAN-2008. On approximately 31-MAY-2007, the patient was informed that she was pregnant. Subsequently, the patient experienced hyperemesis and was treated with ZOFRAN 8 mg prn and TIGAN 300 mg prn. On 07-AUG-2007 the patient had an ultrasound at 18-20 weeks with a result within normal limits. On approximately 01-DEC-2007, the patient's pregnancy was complicated by preterm labor at 35 weeks. On 05-DEC-2007 urine drug screen results were positive for methadone and opiates. On 13-DEC-2007, at 36 6/7 weeks from LMP the patient had a "technically, a pre-term delivery" with a 6 lb. 11 oz. male infant. Apgar score was 9/9. The outcome of the hyperemesis, pre-term labor and pre-term delivery were unknown. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose number unknown, single (Lot number: 30145ba) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Palaxovid from 23May2022 to 28May2022 for COVID 19 Treatment.   Follow-up attempts are completed. No further information is expected.
3 episodes of sz-like activity 530PM, 7, 830PM & brief head shaking; No fever
Otitis Media - A medical assistant reported that a 2 mo rec'd Prevnar, Tripedia (Aventis Pasteur), Comvax (MSD) and IPOL (Aventis Pasteur SA) vaccines on 11/15/00. On 11/17/00, the infant developed crying and irritability. She was seen in an ER and diagnosed with otitis media. A copy of this report has been forwarded to Merck Sharp Dome and Aventis Pasteur., manufacturers of the concomitantly administered vaccine. Follow-up info received on 06/12/2001 indicated that the infant recovered.
Phone call from patient's daughter on 06/07/21 - patient saw doctor last Friday for a complete physical. Order sent to pharmacy  for Tdap vaccine. Patient went to pharmacy and received COVID vaccine. Pharmacy staff thought patient requested COVID vaccine. Tdap order was not yet received at pharmacy. Patient had already gotten COVID Pfizer vaccine on 01/28/21 and 02/18/21. Pharmacy states patient did fill out a general consent for vaccine - questions such as do you have a fever or feel ill today? Have you had a reaction to any vaccine before? Consent was not COVID specific. Phone call from Pharmacy staff on 06/07/21 acknowledging  wrong vaccine was given.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 at 09:00 as dose 1, single (Lot number: 012a21a), in left arm, on 28Mar2021 at 09:00 as dose 2, single (Lot number: 028a21a), in left arm, on 24Oct2021 at 09:00 as dose 3 (booster), single (Lot number: 026d21a), in left arm and on 01Apr2022 at 09:00 as dose 4 (booster), single (Lot number: fic4894) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "depression" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Pollen" (unspecified if ongoing). The patient's concomitant medications were not reported. It was unknown whether the patient received medication with in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of suspected covid-19
PMH: Reaction to Covid Vaccine #2  Vaccinated: 10:28 Reaction: 10:33 Pt reported dizziness.  Vitals: 97/45, 65, 20 Pt stable and released from the vaccination site
lost color directly p/vax became listless would not eat or drink or play;MD believes maybe onset of pre existing viral synd;
After the vaccine in November, 2021, sometimes I felt itchy on the body with red hives, but don't know what are the reasons.  On Nov. 20, after eating lobster and clam chowder, about 2 hours after, my body was itching (back, abdomen, inside part of joints) with red hives; it was back to normal on the day after.  Then on Nov. 21, after eating fish and seafood soup, my body itched again with red hives.  Then on Nov 21, after eating the seafood soup around 7pm, very severe itch occurred on legs, back, abdomen, armpit, and inside of thigh around 11pm, hard to sleep, had to use antihistamine medication (I only had Sleep Aid diphenhydramine HCL) available at the time.  From all these, I believer I am allergic to seafood.  On Nov. 27, I had itch and hives occurred after I ate roasted sunflower seeds, which never happened before.   I never had any allergy to any food in the past of my life.  I eat seafood and like seafood regularly.
FELT TIRED; FEVER; This spontaneous report received from a parent concerned a 50 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, batch number: Unk) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 07-APR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and felt tired was not reported. This report was non-serious.
few hrs p/vax crying noc a/next day longer; red welt rash, shaking inside body; personality change, loss of appetite lasted about 12hs;
my arm was swollen, hot and had a red rash. I took Ibuprofin.
Information has been received from a physician's office concerning a 20 month old female pt who was vaccinate with a 2st, 2nd and 3rd dose of Hep-B vaccine. On 9/5/98, 10/6/98 and 03/10/99. It was noted that the pt received the Hep-B vaccine series because of family history of Hep-B. The pt had received a Hep-B immunoglobulin shot a birth. On 5/11/00, the pt had blood work done which indicated the pt contracted Hep-B. The pt sought unspecified medical attention. Additional information has been requested.
Rapid heart rate. My heart heart rate goes as up as 202. I have chest pain, I feel very tired all the time. I feel dizzy, nauseous. I have a hard time remembering things. I have a hard time focusing. I feel hot at times. This has been happening since 1/27/2021.
three days after vaccination the patient died; This spontaneous report was received from a nurse practitioner via a company representative and refers to a healthy female patient of unknown age. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), (unidentified Merck hpv vaccine administered; name, dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, reported as three days after vaccination, the patient died. The cause of death was unknown. It was unknown if an autopsy was done.   The relatedness between the patient's death and suspect vaccine was not provided.
upset stomach; she felt restless; Chills; fever; Nausea; Vomiting; diarrhea/Loose bowels; Fatigue/woke up tired; Achy; sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm at the age of 75-years, on 04Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot number: EJ1686), via an unspecified route of administration in left arm at the age of 75-years, on 14Jan2021 at a single dose for COVID-19 immunisation. The patient received 2nd dose on Thursday (04Feb2021). The patient began experiencing symptoms/side effects Saturday night (06Feb2021): chills, fever, nausea vomiting, diarrhea, fatigue, and achy. The patient said she got her second shot of vaccine on Thursday (04Feb2021). She said after she got the second dose of the vaccine, Friday (05Feb2021) she felt fine other than the sore arm and then yesterday on 07Feb2021, she woke up tired with chills, fever, and nausea. She says she would like to know if someone can show symptoms later after getting the vaccine. She says she is feeling ok today, but yesterday was horrendous. She says anyway, she is not doing anything but drinking water now. She says she felt fine the second day after the vaccine so she can't understand why she felt this way later, and doesn't know if it could be the second dose of the vaccine or something else. The patient said that that she had her shot on Thursday at noon, then Friday through Saturday night she was fine then she woke up yesterday morning (07Feb2021) with an upset stomach that caused her to throw up. She said she was up through the night (Saturday night) because she felt restless and knew something was wrong. She said her treatment was that she laid on the sofa under blankets and sipped ginger ale and water all day yesterday. She says besides throwing up the one time, she had loose bowels all day long Sunday and then today too, but she doesn't have anything on her stomach today other than a half a piece of toast. She said she felt better today, and had no chills or fever. The patient said she attempted to take her temperature, but she couldn't read her thermometer. The outcome of the events chills, fever, and nausea was recovered on an unknown date in Feb2021, and it was unknown for other events.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) 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. It was reported that date of refrigeration was 5/7/2021.   This case was linked to MOD-2021-365006 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 31Jul2021 at 11:00 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient had no other medication in 2 weeks. Patient received treatment for covid-19 with anti-viral product brand was Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a registered nurse refers to a one year old patient. The patient who was one year of age was vaccinated with dose 1 of GARDASIL (dose, route, lot number not reported) on 23-MAY-2008 and with dose 2 of GARDASIL (dose, route, lot number not reported) on 11-JUL-2008. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. Additional information has been requested.
p/vax pt started sneezing & rubbing eyes/nose, child had loud wheezing, eyes started watering, cheeks flushed, welts forming on legs & body;child weight 25#, given DPH referred to private MD for further eval;
No adverse effects; 0.7 mL were administered; Caller is a nurse who reports an expired dose of VARIVAX was inadvertently administered to a patient today. No adverse effects or symptoms from the administration. No temperature excursions. Vaccine was not supported per post-expiry memo. No other AE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 02-MAY-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.7 milliliter (incorrect dose administered), lot number S028923, expiration date 16-SEP-2021 (expired product administered) for prophylaxis (route of administration not reported). The vaccine was reconstituted with 0.7 millilter of sterile diluent. No adverse event was reported.
Client received immunizations on 11-26-18. Mother called on 11-30-18 and reported that on 11-28-18 client broke out with a rash to his whole body, but it is more pronounced on client's legs. Mother denied the rash bothering the client. Mother reported a mild fever off and on that started on 11-30-18 at 1 am. No other symptoms reported.
delirium; swelling inside of throat; dizziness; slurred speech; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EWO150), via an unspecified route of administration, administered in arm left on 07Apr2021 at 16:00 (at the age of 56-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included myocarditis from COVID, elevated BP and allergies to IV contrast dye for CT scans, all from an unknown date and unknown if ongoing. Concomitant medications included other medications (unspecified). The patient previously took cipro and experienced allergies. For both shots, the patient experienced swelling inside of throat, dizziness, slurred speech and delirium on 07Apr2021 at 16:45. There was no treatment received for the events. The outcome of the events was recovered on an unspecified date.
Patient fainted approximately 3 minutes after receiving his vaccine. He was in a monitoring chair and rested his head back. Pt did not fall or incur any injuries as a result of fainting. Pharmacy staff noticed it happening and gave him attention immediately. He revived right away. Patient was moved to counseling room floor and laid on floor with legs up for 15 minutes. Patient drank some apple juice and was monitored for a total of 30 minutes. Pt confirmed he felt ready to leave at that time and was advised to report any other symptoms to us immediately.
Started as small purple dot, got bigger over time Grew to over 1inch in diameter, turned purplish black, looked like a bruise (see reverse side)
Cardiac arrest witnessed by family. Pt became SOB at home and became unresponsive. CPR was started by family. Pt was in asystole, intubated, given two rounds of epinephrine in the field. Pt was on autopulse and ROSC was achieved around 0125. Pt was seen at ER and was transferred to Hospital.
This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional, concerns a patient of unspecified age and gender. On 10-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). It was reported that, after piercing the vial, when turned upside down upon injecting air, vial was dripping from the rubber seal (explicitly coded as product leakage). The nurse could withdraw only 7 doses from the vial. The patient was administered with full dose. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration was coded. Narrative amended accordingly. Non-significant case correction received 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
HPI -  41 year old in usual state of health until after returning from a trip when she developed a rash on lower back.  She did swim in the river.  She also came home wiht a new dog.  She thought it might be an allergic reaction so started 1% HC cream.  It progressed and continued to itch.  She quit this cream yesterday and the rash seems to have worsened.  Somewhat pruritic.  She admits one lesion started well before the others.     ROS -  (Pertinent positives noted in HPI.) CONSTitutional: No fever, sleep change, activity change. EYES: No eye redness, d/c, swelling, known vision problems, or pain. ENMT: No HA, neck stiffness.  No ear pain, d/c, hearing loss.  No congestion, rhinorrhea, sinus pain.  No ST, voice change. RESP: No cough, wheezing, diff breathing, apnea, cyanosis.  CV: No heart problems, murmur, or chest pain. GI: No vomiting, diarrhea, GERD, constipation, change in po intake, or abd pain.  GU: No change in urine output, frequency, hematuria, or dysuria.   MS: No joint problems, weakness, extremity pain. INTEG: No rashes, hx skin infections, or bruising. NEURO: No loss of consciousness, weakness, numbness, or seizures. HEM/LYMPH: No bleeding, anemia, jaundice, swollen glands.  Patients documented allergies No Known Allergies    MED - reviewed list  PCP -  Provider   PMHx - reviewed list, notably healthy FMHx -   No pertinent medical illnesses. SHx - no ill contacts.  PE - BP 115/65 | Pulse 80 | Temp (Src) 98.2 (Temporal) | Resp 14 | Ht 5' 2" (1.575 m) | Wt 206 lb 14.4 oz (93.849 kg) | SaO2 98% GEN - alert, interactive, and in no acute distress DERM - back with about 2 dozen maculopapular lesions, some a few mm up to a few cm.  One lesion R lower back wtih a collarette.  Lesions are in a tree pattern.    LAB/XRAY RESULTS - Not indicated  CLINICAL COURSE - Not applicable  ASSESSMENT - pityriasis rosea  PLAN -  1) apply skin cream as directed for the next 10 days.  Benadryl as needed for itching.   2) Return to Urgent Care or follow-up with primary care provider if new concerns, no better in 2 months.  Received handout with instructions as  noted in chart.   3) Pt understands, agrees with this plan, and has no further questions.
It was reported that an 18-year-old male received the TD vaccine on 8/23/99. At some point following the vaccination the patient experienced redness, swelling, and a hardness surrounding the injection site. From follow-up received on 5/15/01, it was reported, "no further information available regarding this patient of this case. " This case is closed.
patient presented with dizziness. evaluation was completed and patient was observed. approximately ten minutes after the patient complained of chest tightness and developed urticaria on her neck and chest. she stated that it felt like her throat was closing. one dose of 0.3 mg of Epinephrine was administered to the left anterolateral thigh. immediate relief was noted.