chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K006960, expiration date 19-FEB-2017, strength, dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
FEELING TINGLING IN RIGHT LEG AND LEFT KNEE/ TINGLING MOVED TO THIGH AREA, STOMACH AND CHEST; FEELING WEIRD AFTER EACH EPISODE OF TINGLING AND WEAKNESS; FEELING WEAKNESS IN RIGHT LEG AND LEFT KNEE/ WEAKNESS MOVED TO THIGH AREA, STOMACH, AND CHEST; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pre diabetes, and other pre-existing medical conditions included he had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced feeling tingling in right leg and left knee/ tingling moved to thigh area, stomach and chest. On MAY-2021, the subject experienced feeling weird after each episode of tingling and weakness. On MAY-2021, the subject experienced feeling weakness in right leg and left knee/ weakness moved to thigh area, stomach, and chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tingling in right leg and left knee/ tingling moved to thigh area, stomach and chest, feeling weird after each episode of tingling and weakness, and feeling weakness in right leg and left knee/ weakness moved to thigh area, stomach, and chest. This report was non-serious.
On 7/20/11, pt received 1st MENACTRA. On 2nd day, deltoid started to swell & turn red - "the size of a softball" per mother. It limited use of shoulder. By 7/23/11 it started to improve.
Brain fog/felt like there were "holes" in my memory.  Couldn't think of my son's middle name. Unaware that I ate something.  Lasted 2 days.  Unrelated to normal "forgetfulness" due to age. Vaccine received in morning, arm increasingly felt stiff and sore until bedtime.  Worried it would get worse overnight (felt much better in the morning).
8/19/11 Swollen and tingling lips after 1st injection - did not administer 2nd injection. No Tx or Rx needed after reaction. Also mild headache all symptoms resolved by morning.
expired vials were used to provide 38 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) 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 some that received the vaccine during dates given and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.Reporter stated that no excursion had occurred and the Moderna vials were taken out of the freezer. It was also reported that on 11-Nov-2021 all vaccines were administered within 1 hour.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Non Significant FU appended with Second reporter Information updated in case.
No additional AE reported; A dose of PROQUAD was administered after a temperature excursion; This spontaneous report has been received from a Physician referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 31-AUG-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot number: W017570 with expiration date: 29-NOV-2023, administered for prophylaxis (strength and route of administration not provided) (product storage error) , which had temperature excursion between 5.7F for 0 hours 30 minutes and 0 seconds, 6F up to 14F (9.1F} for 1 hour 6 minutes and 0 seconds.
HYPOTENSION ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/23/2023  --  PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE
I had common side effects such as nausea, sore arm, swelling from the injection site, fatigue, and headaches. All has gone away since then except for the headaches. I?ll get a handful of headaches a day from bending over, laughing or sometimes breathing deeply. Before my vaccine headaches were not this common for me.
A legal complaint was received from an attorney alleging that a female child (birth date not specified) received Hib-TITER vaccine on 4/4/01. According to the legal complaint, as a result of exposure to thimerosal in the vaccine, the child "sustained neurological injuries and as a result of those injuries has been diagnosed with autism and as a result of those injuries has been diagnosed with autism spectrum disorder (OMIC)." No additional info was available as of the date of this report.
pt recv vax 19APR94 & MD stated that pts mom mentioned @ a later date pt had exp tightness in chest & an asthmatic rxn the noc of the vax; allergy testing for yeast was neg;
Initial case was received from a healthcare professional on 14 November 2013. A patient whose age, gender and medical history were not reported had received a dose of ACTHIB on an unspecified date (anatomical site, dose and batch number not reported). Patient had not reported concomitant medication. It was reported that patient had received vaccine which was incorrectly reconstituted. No adverse event was reported. At the time of event the outcome was unknown.
Swelling, redness, fever, pain...a period of 5 or 6 days.
abnormal period approximately 1 week after 1st vaccine on 20Feb2021. Period was not due for another 3 weeks. Very heavy clotting and flow.; TThis is a spontaneous report from a non-contactable consumer (patient). This 46-year old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9266) at single dose via an unknown route in left arm on 11Feb2021 17:15 for Covid-19 immunization. Medical history was not provided. Patient had no covid prior vaccination. Patient was not pregnant. Concomitant drugs administered in two weeks included estradiol and escitalopram. There was no other vaccine in four weeks. Patient experienced abnormal period approximately 1 week after 1st vaccine on 20Feb2021. Period was not due for another 3 weeks. Very heavy clotting and flow. No treatment received for the event. Covid test post vaccination included nasal swab which was negative. Outcome of the event was resolving.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pruritus and rash over much of body.  Prolonged dermatographia. Ongoing at 48 hours since onset.   No other obvious symptoms.
Received vaccine Monday on 01/21/02, had slight soreness in that arm- no other reaction. today, Thursday, 01-24-2, has  stomach ache and has "blacked out' X 2. Advised to call own physician.  No other symptoms.
patient recieved fluzone quadrivalent instead of fluzone high dose, no AE; Initial information received on 04-Nov-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA312206 (same reporter).  This case involves a 77 years old female patient who recieved  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020 (wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was a case of actual medication error due to wrong vaccine administered (Same day latency).  At the time of report 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 holder's 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.  There will be no information on the batch number for this case.
23OCT91 screamed throughout night p/vax 1 1/2 hrs @ a time; t101; 24OCT91 still fussy-temp 101 APAP given;
Two people got covid after receiving the first shot; Two people got covid after receiving the first shot; This is a spontaneous report received from a non-contactable consumer. This consumer reported similar events for 2 patients. This is the first of two reports.   A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that two people got Covid after receiving the first shot. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021065167 same reporter/drug/ae, different patient
Rashl beginning on pack and spreading to other areas over several days.  Received second vaccination on 2/10/21.   Went to ER on 2-12-21 for treatment.  Condition now resolved.  Meds: Epinephrine, Claritin, Prednisone.  CBC blood test.
Pt was lethargic, described blurred vision, tingling in both arms, sweaty, felt cold to the touch, BP at 7pm was 70/42, contacted EMS for help. EMS followed the pt home (came to pharmacy with his father), his BP had risen to 119/88 per call with father at 8:38pm. Father stated his symptoms had resolved and he was resting.
I got the usual cold-like symptoms the next day. I took a nap and woke up and felt pretty much fine after that. After the 1st, I started getting waves of dizziness. I would lay on ground and I couldn't get up. After a couple of days, I could do stuff but would get random waves of dizziness and would have to sit down until it went away. My doctor told me to take Allegra and I just kind of lived with it. It didn't help with symptoms. It started affecting my work because I'm a CNA and I couldn't be having dizzy spells at work. I went to ER - on January 10th. They sent me to Hasboro because they were to busy at ER. The nurse said I had Vertigo - and they discharged me with Meclizine while I was in ER and it didn't help. I called me doctor a couple of days after. She told me to combine the Allegro with the Meclizine and that didn't help with either. I called my doctor back and she said that there is nothing else I can do because my bloodwork came back normal.  I'm not currently taking anything and I'm still getting random dizzy spells. I have returned to work and so I just have to take breaks at work when it happens.  I got the second vaccine on the 19th of January.
vaccine overdosage administered to 4 patients; A spontaneous report was received on 09 FEB 2021 from a healthcare professional concerning an unknown age, unknown gender patients who received Moderna's COVID-19 vaccine, higher dose than 0.5 ml.  The patients medical history was not provided. No relevant concomitant medications were reported.  On unknown date, four patients received their one of two planned doses of mRNA-1273(Lot number: unknown), for the prophylaxis of COVID-19 infection.  The healthcare professional reported that four patients were given a higher dose than 0.5 ml of Moderna's COVID-19 vaccine at their office. Treatment for the event was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event, vaccine over dosage administered to 4 patients, was considered recovered/resolved.; Reporter's Comments: This report refers to 4 cases of accidental vaccine overdose, administered for mRNA-1273, lot # unknown with no associated AEs.
10/07/2021 Since my booster vaccine, I have been having a flare up intermittently of back pain very frequently. This pain has radiated from my back down to my leg and ankle. It is excruciating pain into my knee 10/10 on pain scale. There are times where it flares up to an unbearable pain. I have needed to use a walker to walk around when I am feeling okay to walk. It has decreased my quality of life by a lot. I've gone to my primary where he recommended going to a pain specialists I have received steroid injections. With the second injection I have seen improvement and if I sit in a chair for more than 20 minutes my pain comes back. I am waiting to speak with my pain management specialist to see about another injection and possibly talk about an ablation of nerves in my knee.
fever/low grade fever; runny nose; This is a spontaneous report from a contactable consumer (parent). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever/low grade fever, runny nose on Mar2021. Reported as, reporter stated her son also experienced a fever after receiving the vaccine and took Tylenol. Reporter son had a low grade fever and a runny nose that cleared up with Tylenol. Therapeutic measures were taken as a result of fever/low grade fever, runny nose. Outcome of all the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient returned for second Twinrix, and stated that after her last immunizations given on 1/24/08, her right arm developed redness and swelling and was warm to touch.  She then stated she developed a rash that lasted 2 weeks.  Did not seek medical attention at the time of the symptoms.
Sore arm at the injection site; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment for the event is unknown.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt recv vax & reported exanthem;reporter felt it was contact dermatits but parental concern of rash;pt referred to dermatologist who felt it was a Gianotti Crosti synd secondary to hep B vax;
Chronic left eye twitching, began approximately 1 Week after vaccine administration, occurs multiple Times throughout the day, no treatments Currently
expired Act-Hib vaccine was administered to a patient, no adverse event; Initial information received on 06-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA125940 (case for female patient).  This case involves a 15 months old (16 months as reported) male patient received expired 0.5ml fourth dose of HIB (PRP/T) VACCINE [ACT-HIB] lot UI735AA, expiration date: 07-Nov-2017 via unknown route in unknown administration site on 08-Nov-2017.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included was MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and INFLUENZA VACCINE (FLUVACCINE) on same visit.  It was an actual medication error due to expired vaccine used. Expired Act-Hib vaccine was administered to a patient.  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.  List of documents held by sender: none.
Widespread dysesthesia from scalp all the way down to the feet.  Began 3-4 days after receiving the vaccination.  Began in the feet and spread upwards to the scalp. Referred to a neurologist.  All bloodwork and neurological tests done in the doctor's office were normal.  Prescribed a steroid pack and gabapentin.  Symptoms still remain one month later.
gastrointestinal problems; nauseous; diarrhea; This is a spontaneous report received from a contactable reporter (Consumer).  A female patient received BNT16B2 (BNT162B2), administered in arm left, administration date 15Apr2021 13:15 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Vaccine Location: Left arm, Time: 01:15PM.), administration date: 25Mar2021, for Covid-19 immunisation. The following information was reported: GASTROINTESTINAL DISORDER (non-serious) with onset 17Apr2021, outcome "unknown", described as "gastrointestinal problems"; NAUSEA (non-serious) with onset 17Apr2021, outcome "unknown", described as "nauseous"; DIARRHOEA (non-serious) with onset 17Apr2021, outcome "unknown", described as "diarrhea". The events "gastrointestinal problems", "nauseous" and "diarrhea" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of gastrointestinal disorder, nausea, diarrhoea. Additional Information: The patient's age was reported as 50 (units unknown). The patient did not receive other vaccine in four weeks and has not received other medications in two weeks. The reporter and the patient got both of their vaccines at the same time/place. On their second dose they had normal side effects that went away after two days, but they have had gastrointestinal problems since, going on two weeks now. They were both nauseous and eating anything beside the BRAT diet made them feel even worse. The patient has also had diarrhea as well and they were contacting their doctor tomorrow to check it out. The patient has not been diagnosed with COVID prior vaccination and has not been tested for COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reports having swollen lymph nodes, went to ER with fever, headaches. Whole body had aches.
open sore; red rash on her skin; mild headache; This is a spontaneous report from Pfizer sponsor program. A contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced open sore, red rash on her skin and mild headache. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initially ill that night and all of next day. April 30th Went toClinic for fever, spots feet, hands and face. Dr. prescribed Mupirocin Ointment, Keflex (which I didnt take) and Hydroxyzine. -- physician thought possibly Hoof & Mouth Disease.  Then went to  Clinic on 06/10 for hives and feeling unwell was prescribed Zyrtec and Kenalog -Dr thought bug bites.. Hives continued and felt unwell on 06/13 was prescribed prednisone - Dr. thought bug bites. More hives, feeling unwell, sore throat, fever and  joint pain went to  Urgent Care prescribed more prednisone (which helps some) and Doxycycline (thought possibly Lyme Disease). July 22nd met new primary  seen given more prednisone and hydroxyzine. Had blood tests, went to Dermatology 3 times and given biopsy for skin legions. Currently waiting on Gastro authorization while taking hydroxyzine, colchicine and betamethasone DP.
After patient was given vaccine he sat in waiting area for observation. He started to sweat and turn pale. He was given cool water and ice pack. He said he always has this happen after he sees a needle or gets a shot. He recovered after 5 minutes.
Itching; covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE REACTION (covid arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE REACTION (covid arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE REACTION (covid arm) outcome was unknown.            On concomitant medications provided. Other treatment included using Vaseline to help with the itching.    This case was linked to MOD21-035615 (Patient Link).
Patient slept from 4:30 PM on October 19 until 7:00 AM on October 20th. When she woke up this morning, we noticed a rash on her face and stomach. It is not on her arms and a little bit on her legs. It seems to be itchy. It is a red spotty rash.
patient was given adult Pfizer for  booster dose instead of Pfizer 5-11 yr old vaccine no adverse events reported