chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FELT LIKE SHE WAS ON ACID TRIP/HER PHYSICAL BODY WAS FUNKY/WAS BIZARRE; CHILLS; FEVERISH; NAUSEA; HALLUCINATION; MORE SEVERE HEADACHE; This spontaneous report received from a consumer via company representative concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included concussion. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  It was reported that, after vaccination the patient experienced chills, feverish, headache, and nausea. On 10-APR-2021 (in the middle of the night), the patient started hallucinating with a more severe headache and she felt like she was on an acid trip and her physical body was funky. The patient felt like she wanted to stretch her muscles but felt like she did not have control. At the time of this report, the patient said it was bizarre. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from more severe headache, and hallucination, and the outcome of feverish, chills, nausea and felt like she was on acid trip/her physical body was funky/was bizarre was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: covid-19 vaccine ad26.cov2.s-Hallucination. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
sore arm which lasted overnight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm which lasted overnight". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Tired, weak, hot/cold throughout the day of vaccine, and felt like she was having a fever. Rash and increased pulse.
A non-serious spontaneous report of administration of FLUMIST to a 55-year-old female was received from a nurse. The subject's medical history and concomitant medications were not provided. The subject received FLUMIST on 08-Oct-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessment are not
RECEIVED EXPIRED DOSE OF VACCINE; TEMPERATURE EXCURSION ISSUE; This spontaneous report received from a health care professional concerned a 66 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced received expired dose of vaccine. On 24-MAY-2021, the subject experienced temperature excursion issue. The action taken with covid-19 vaccine was not applicable. The outcome of the received expired dose of vaccine and temperature excursion issue was not reported. This report was non-serious.
pt recv vax 4NOV95 & devel urticaria @ inj site w/itching;pt has not recovered as of the reporting date;
Information has been received on 14-JUN-2017 from a lawyer and a female patient of unknown age regarding a case in litigation. It is complained and alleged that the patient was inoculated with ZOSTAVAX (dose, route, lot number and expiration date were not reported) on or about 17-SEP-2009 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-JAN-2014, the patient was treated by a nurse practitioner for a vesicular outbreak that was diagnosed as severe shingles. On or about 02-SEP-2015, the patient was treated by two physicians at a Medical Center for ongoing and worsening outbreaks of herpes zoster. The patient was prescribed gabapentin, hydrocodone and valacyclovir (VALTREX) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a 50-year-female patient who received SHINGRIX. The patient's past medical history included fibromyalgia. Concurrent medical conditions included herpes simplex and multiple myeloma. Concomitant products included ZYRTEC, Aspirin, biotin, Levothyroxine, omeprazole, Valacyclovir, Venlafaxine, ATIVAN, LYRICA, ZOCOR, ZOFRAN, buspirone, meloxicam and topiramate. On 23rd April 2018, the patient received the 1st dose of SHINGRIX. On 24th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site tenderness and injection site erythema. On an unknown date, the outcome of the injection site tenderness and injection site erythema were recovered/resolved. The reporter considered the injection site tenderness and injection site erythema to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient experienced tenderness and erythema adjacent to the injection site after receiving SHINGRIX vaccine on the left arm. The erythema resolved after 7 days, and the tenderness resolved after 10 days. The physician stated that, the patient received the vaccine at a pharmacy, and did not have lot number, expiry date, or certainty of route of administration. No medical intervention was taken, according to the physician.
no additional adverse events reported; first dose of gardasil 9 on 6/5/2020 then 2nd dose was administered on 7/15/2020; This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 05-JUN-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown). Then, on 15-JUL-2020, the second dose was administered. No additional adverse events were reported.
Redness, warmth, elevation 30mm appearing within 24 hours and disappearing 48 hours later
I had pain radiate down the back of my left leg. It started at my buttocks and ran down into my foot, then quit.; Fifteen minutes after my shot, on the arm of the injection, I developed numbness in two of my fingers on my right hand.; This is a spontaneous report from a non-contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EN5318) via an unspecified route of administration in the arm right on 26Mar2021 at 08:45 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, hypothyroidism, ovarian cancer stage III survivor, penicillin allergy and sulfonamide allergy. Concomitant medications included lisinopril dihydrate (LISINOPRIL) and levothyroxine sodium (SYNTHROID) for unknown indication from an unknown date. The patient previously received epinephrine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 26Mar2021 at 9:00 fifteen minutes after the shot on the arm of the injection, the patient developed numbness in two fingers of right hand. The numbness lasted six hours. Also, an hour after the shot at 09:45, the patient had pain radiating down the back of left leg that started at buttocks and ran down into foot, then quit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events numbness in two of fingers on right hand, pain radiate down the back of left leg and pain started at buttocks and ran down into foot then quit was recovered on 26Mar2021.  No follow-up attempts are possible. No further information is expected.
Injection site was warm to the touch on 12/31/2020. There is also a small knot felt under the skin but nothing shows on the skin. Intermittently, the entire muscle itches but there is nothing to scratch. After a few (3-4) ?scratches? the feeling subsides.
Patient developed a case of shingles. Rash on shoulders. Treated by physician with antivirals. Patient continuing to recover.
Client stated syncope episode 1hr after receiving vaccine at home. Since  first dose, client reported 4 additional syncope episodes. Per client went to urgent are are emergency room where she had a normal head CT, normal EKG and normal chest X-ray. No medications given. Client states currently following up closely with primary doctor. Recently diagnosed with type 2 diabetes and takes Metformin. Allergy to Oxycodone.
Itchy, swelling, painful, red, warm to the touch at administration site. Approximately 2 centimeters long. Took ibuprofen to relieve symptoms.
Patient presented to clinic c/o possible vaccine reaction. Received RZV immunization, series #2, on 7/3/18 R deltoid. States later the same evening he noted a red, burning, itchy area over R deltoid and mid upper arm which has gotten larger. Area is hot to touch, sl swollen, approx 4x3 inch. Denies rxn to series #1. Denies any insect bites, injury to area, or any exposure to new detergents, soaps. Denies breathing difficulty, throat swelling, facial swelling. Full AROM to arm and shoulder. VSS, afebrile. Advised to take TYL or MOTRIN and BENADRYL per OTC instructions, to apply cold packs x20 intervals, to report to ER if any difficulty breathing, throat or facial swelling, and to call the clinic on Monday if no improvement. Patient verbalizes understanding and agrees to plan.
Pt was given Hib shot in Sept 1998. She then became sick; she was hospitalized and lost her hearing & became paralyzed on one side.  She was dxed w/ bacterial meningitis. As of this date, she is fully recovered and is fine today. 60 day follow-up dated 6/30/00 provided no addtional data.
patient had received 0.5ml of Menactra instead of the Mem B12 vaccination, no AE; Initial information received on 21-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old male patient who received 0.5ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6522AB, expiry date: 29-Jan-2021) via unknown route in right deltoid administration site instead of MENINGOCOCCAL VACCINE B on 21-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  It was a case of actual medication error due to wrong vaccine administered.  It was reported that sixteen year old, male patient had received 0.5ml of Menactra instead of the Mem B12 vaccination he was supposed to receive.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Two days after shot, got a few raised red bumps on trunk, numerous "bumps" below diaper from thighs to ankles. Larger papules formed scabs present luk later (10/19/09). No itching noted, one on bottom of 1 foot. Did not see MD.
irritable & fever 9hr p/vax bulging fontanelle noted 16hr p/vax;
Severe nausea, vomiting beginning after 12 hours accompanied by fever, chills, muscle and joint pain. Nausea worsened through hour 36. At hour 40 frequent vomiting occurred lasting for 8 consecutive hours accompanied by migrane. Dehydration ensued.
Patient received TRUMENBA vaccine on 02/25/19 in our office, she was fine immediately after the vaccination. Child was seen next day in our office. Mom reports that she called our office that evening but she hung up rather than requesting answering service to connect to the doctor on call. She never called again that evening or night as child was doing better. She called next day and was seen immediately. Visit note from DOS 02/26/19 Mom reports that in the evening after few hours of vaccination, she started c/o pain in the left arm and felt very cold and chills. She also felt pain on her left side of body and back. It was associated with headache and dizziness and she felt very tired. Mom reports that she saw the patient's both hands turning purplish for few minutes. Mom gave her blanket and warm towel and immediately her hands became normal, after sometime she felt a little better but kept c/o pain in the left arm which is still there but less than yesterday. Still c/o mild dizziness and headache. No vision changes, no fainting, no vomiting, no chest pain, no palpitations, no abdominal pain, no weakness of any part of the body, no breathing difficulty. Injection site is hurting today when touched but pain over left side and back is much better. She noted swelling and redness over the injection site yesterday night which slightly increased today. Orthostatic BP normal, pulse ox normal in both upper limbs, neurovascular examination is normal, patient is well looking, no distress, no weakness will consider augmentin if not better Motrin as advised Observe closely for additional symptoms, call office/go to ER if worsening symptoms, any skin color change,any cyanosis/blue or purple discoloration, difficulty breathing, any fever, increasing redness or swelling, lethargy, persistent dizziness or headache, any vomiting, vision changes, chest pain/palpitations/persistent or worsening pain/tingling or numbness,any weakness. Call office immediately if any new concern or persistent symptoms. Mom and patient verbalized understanding will f/u tomorrow via phone call.
Following day or day after DTAP and Hib administered in left arm, a simple motor tic (left shoulder shrug) begin and so far is continuing.
my niece was diagnosed with Covid and I had a lot of contact with her in the week before she was tested; feel bad; This is a spontaneous report from a Pfizer-Sponsored program Pfizer.com. A contactable consumer of unspecified age and gender reported that he/she received  second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he/she got second shot  3 weeks ago. His/her niece was diagnosed with Covid and patient had a lot of contact with her in the week before she was tested (she had no symptoms). On an unknown date patient felt bad, but it could have been from the weather. Also patient's mother started having chest pains and asked patient to take her to the hospital and it was Covid. The patient wanted to ask if he/she should get tested again for records sake or not. The outcome of all events was unknown.  No follow-up attempts were possible, Information about lot/batch number could not be obtained.
Pt had lethargy, body aches, chilled and slight increase of temp. no appetite.
This is a spontaneous report from a contactable consumer, the patient. A 50 years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 21Mar2021, (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was allergic to shrimps. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications (unspecified) within two weeks of vaccination. On 21Mar2021 at 09:00, the patient experienced tingling in left arm, left side of face and head and partial numbness of left side of face, mild rash at injection site and nausea. These events lasted for the day of vaccination and the next day. No therapeutic measures were taken for adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events tingling of left arm, left side of face and head, partial numbness of left side of face, mild rash at injection site and nausea was resolved on 22Mar2021. No follow-up attempts are needed. No further information is expected.
many lymph nodes under his armpit; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "many lymph nodes under his armpit".  Additional Information: The patient had many lymph nodes under his armpit and they lasted a month. He had no other symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash/skin redness, similar to sunburn on neck, chest, back, sides, stomach, and upper legs/groin areas; Rash/skin redness, similar to sunburn on neck, chest, back, sides, stomach, and upper legs/groin areas; Rash/skin redness, similar to sunburn on neck, chest, back, sides, stomach, and upper legs/groin areas.; Some parts are blotchy.; Rash/skin redness, similar to sunburn on neck, chest, back, sides, stomach and upper legs/groin areas. Some parts are blotchy. It is a little warm(3/10).; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 320398D) via an unspecified route of administration in the left arm on 28Oct2021 at 14:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included fexofenadine hydrochloride/pseudoephedrine hydrochloride (ALLEGRA-D 24 HOUR), colecalciferol (VITAMIN D3) and triamcinolone acetonide (NASACORT 24 HOUR); all for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 24Mar2021 at 14:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 15Apr2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. On 30Oct2021 at 12:30 AM, the patient experienced rash/skin redness which was similar to the sunburn on neck, chest, back, sides, stomach and upper legs/groin areas, some parts were blotchy and it was a little warm (3/10). It was reported that it did not itch and was not painful. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash/skin redness, similar to sunburn on neck, chest, back, sides, stomach and upper legs/groin areas, some parts were blotchy and it was a little warm (3/10) was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
throwing up for a few days; arm soreness; migraine right when I finished waiting; felt a gland in my throat swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (arm soreness), MIGRAINE (migraine right when I finished waiting), LYMPHADENOPATHY (felt a gland in my throat swelling) and VOMITING (throwing up for a few days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 01-Jul-2020 and Allergic reaction NOS. Concomitant products included SUMATRIPTAN SUCCINATE (IMITREX DF), ATENOLOL, VALPROATE SEMISODIUM (DIVALPROEX) and ACETAZOLAMIDE for Migraine, TRAMADOL, LEVOTHYROXINE, FUROSEMIDE (LASIX [FUROSEMIDE]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), MIGRAINE (migraine right when I finished waiting) and LYMPHADENOPATHY (felt a gland in my throat swelling). On 30-Apr-2021, the patient experienced VOMITING (throwing up for a few days). At the time of the report, PAIN IN EXTREMITY (arm soreness), MIGRAINE (migraine right when I finished waiting), LYMPHADENOPATHY (felt a gland in my throat swelling) and VOMITING (throwing up for a few days) 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.   Treatment information was not provided.   This case was linked to MOD-2021-177302 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up information  received on 30-Jun-2021 contains No New Information.