chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle pain; muscle cramps; chills; had terrible pain in her foot; severe pain in her heel and arch; swelling; This is a spontaneous report received from a contactable consumer or other non hcp. An 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9810) via an unspecified route of administration on 06Feb2021 (at the age of 87-year-old) as a single dose for COVID-19 immunization. Medical his-tory included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included allopurinol (ALLOPURINOL) taken for an unspecified indication, start and stop date were not reported. The patient experienced had terrible pain in her foot, severe pain in her heel and arch, swelling on 10Feb2021, and muscle pain, muscle cramps, chills on an unspecified date. Additional information she received first dose on 6Feb2021 and 4 days later had terrible pain in her foot. The swelling and pain were still ongoing.  Any information if this was a side effect and how long it will last and also seeking information how much protection with just first dose. She had such a bad time with her foot. She had muscle pain, muscle cramps and chills she had all of that she had and expected all of those. She went to bed fine, but when she went to get up the next morning, my right foot was swollen and couldn't put any pressure at all. She has lost the use of her right foot. she can't make the steps to her bedroom. She has been down on the couch since the 10Feb2021, the pain isn't as severe as it was early on. It was unbearable pain, 10 out of 10 pains, you couldn't touch the foot at all, pain of a gout, even a blanket hurt. It has lessened gradually little every day hoping it goes away completely. she was wondering how long it would last and when can she get use back of my foot because she was very active person before and it's not easy. she still has pain from the arch into heel of the foot. If she doesn't put a sock on it then the toes will fall on each other. (The big toe will go over to the little toe). she doesn't want to subject myself. she can't even put a shoe on to go to the doctors. she stays in the house anyway. The clinical outcome of the event terrible pain in her foot, severe pain in her heel and arch, swelling, muscle pain, were recovering and other events was unknown.  No follow up attempts are possible. no further information is expected.
Information was received from a medical assistant, who reported that on unspecified dates, an unspecified number of patients (demographics unknown), received improperly stored dosages of VARIVAX (lot # M002064, expiration date 12-JAN-2018 or lot # M005973, expiration date 02-FEB-2018) (dosages and route of administration not provided). No adverse effect reported. No further details provided. Additional information has been requested.
Stiff neck, high fever, nauseous, headache, weak, loss appetite. Admitted - 1/19/10. Discharge 1/21/10. Went to ER. Behavior issues, skin rash on right hand (swelling) no strength in this hand.
ARM SORENESS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced arm soreness, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, arm soreness and headache was not reported. This report was non-serious.
Left buttock red, swollen, indurated.  It is somewhat sore and pruritic.  Occurred same day as shot.
a bad reaction; high fever; her whole body hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (a bad reaction), PYREXIA (high fever) and PAIN (her whole body hurts) in a female 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.    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 VACCINATION SITE REACTION (a bad reaction), PYREXIA (high fever) and PAIN (her whole body hurts). At the time of the report, VACCINATION SITE REACTION (a bad reaction), PYREXIA (high fever) and PAIN (her whole body hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This case was reported in a literature article and described the occurrence of Stevens Johnson syndrome in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed Stevens Johnson syndrome. Serious criteria included GSK medically significant and other: serious per reporter. The outcome of Stevens Johnson syndrome was unknown. It was unknown if the investigator considered the Stevens Johnson syndrome to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of Steven Johnson syndrome in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed Steven Johnson syndrome. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of Steven Johnson syndrome and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cases in the same literature article.
pt recv 1 dose vax in 2/97 then on 3/98 pt devel breakthrough varicella w/20-30 pink papules & vesicles over body. m.d. confirmed.
RN contacted pt DOB verified. PT reports delayed reaction. Pt reports 4x2 inch  red, warm "lump" on 01/23. Pt received vaccine on 01/15. Pt believes this is a  delayed reaction. Pt denies any difficulty breathing, swelling of face or throat  or systemic rash. Pt reports icing area and applying anti itch cream with relief.  Pt reports swelling has improved. Pt intends on finishing series. RN will reports  rxn to VAERS.
pt recv vax & 1 hr p/vax pt exp h/a, malaise, & fatigue; rxn abated p/1.5 days; In f/u MD reported that did not administer pts vax & did not treat the pt for rxn; pt recovered; No further details were provided;
Client called PHN today reporting that she started feeling ill yesterday morning.  Had aches in legs and neck, but was able to work.  Reports that she felt worse this morning.  Feels like her legs are constantly twitching, which makes it difficult to walk.  Continues to have aching around neck and general body aches.  No fever.  Also reports having episodes of diarrhea.  This was client's first flu shot.  Client reports that if she does not feel better tomorrow, she will go into the clinic.  Encouraged client to seek treatment earlier if necessary.
COVID vaccine 2nd dose on 2/11/21 Pt with COVID symptoms on 6/29/21 - testing COVID + on 7/1/21 Regeneron given on 7/6/21
After receiving the vaccine, the patient ended up with a mild case of Bell's palsy.  Symptoms include: mild numbness up to the maxillary bone, and a weak smile (doesn't go up on the right).  Her Smile is asymmetrical.
Sunday Right arm ached with muscle spasms in thighs, calves and toes. Spasms continued through Monday slowly subsided. Left arm also was achy with muscle spasms. Sat. client had a strenuous kickboxing class.
Pt presented to office with red raised areas at injection sites of recent immunizations. They were not fluctuant and did not require I&D, but was placed on antibiotics.  He presented to office 10/13/2009 with frank abscesses to both thighs at injection sites- total of 3 wounds
Dosing error ( 2nd dose schedule more the recommended dosing interval); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error ( 2nd dose schedule more the recommended dosing interval)) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error ( 2nd dose schedule more the recommended dosing interval)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error ( 2nd dose schedule more the recommended dosing interval)) 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.
Case number PHEH2014US071306 is an initial spontaneous report from a medical assistant received on 26 Aug 2014, with a follow up received from physician on 29 Sep 2014. This report refers to a 13 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml of MENVEO (batch number: A14022) intramuscularly into left arm on 25 Aug 2014 at 04:00 PM. On the same day after vaccination, he experienced swelling and mass of baseball size at the injection site that was warm to touch. He called on 26 Aug 2014 and stated he was feeling better. The final outcome of the events was completely recovery on an unknown date. Seriousness and causality was not reported. Follow up received from physician on 29 Sep 2014: updated patient demographics, time of vaccination, batch number, event onset dates, outcome of the events and other clinically relevant information in the narrative.
Severe chills nausea severe stomach pain and lower back pain , diarrhea.  At times felt like throat closing but kept clearing throat and okay, then drinking water  Lasted Over 48 hours
Tingling in lower legs- neuropathy like; Fever 102.9; Tingling in lower legs- neuropathy like; Severe cramping in hands and feet; Severe bone pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the first dose of bnt162b2 (COVID-19 vaccine) lot no: EL0140, via an unspecified route of administration in left arm on 18Dec2020 15:15 at a single dose for COVID-19 immunization. Medical history included acid reflux and known allergies to PCN, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of report. Concomitant medication included omeprazole (PROTONIX), ibuprofen (MOTRIN). No other vaccines were administered in four weeks. On 19Dec2020 at 14:30, the patient experienced fever 102.9 "normal for vaccines i know", tingling in lower legs neuropathy like, severe cramping in hands and feet, and severe bone pain. The patient recovered from the events in Dec2020. The patient did not receive treatment for the events. The events were reported as non-serious. The patient didn't have COVID prior to vaccination and was not tested post vaccination.; Sender's Comments: A possible causal association between administration of bnt162b2 and the onset of neuropathy like cannot be excluded, considering the plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
pt  LMP 26NOV97;estimated date of delivery is 2SEP98;the pregnancy was confirmed by a blood test;pt exp itching, swelling, & pain @ inj site x 1wk;pt found to have trisomy 21;pt elected to terminate pregnancy
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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2022 at 14:30 as dose number unknown single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid on 20Nov2022 to 25Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a female in her 60's with suspected immunodeficiency who received a dose of pneumococcal vaccine 23 polyvalent in approximately 1998. She received a second dose in November 2001 to assess the immunity response to the vaccine; results were equivocal. In December 2001 the patient received a third dose of pneumococcal vaccine 23 polyvalent. Subsequently the patient experienced an injection site reaction with redness, induration and warmth. No details were provided concerning duration or treatment. No adverse symptoms were reported after the first and second doses. Unspecified medical attention was sought. Additional information has been requested.
Client did not have an adverse reaction. Client received his 2nd dose of Moderna 2 days before scheduled due date. Also, client doesn't have an email address.
missed the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the 2nd dose) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Patient received a booster dose ( 0.25ml) instead of the 1st dose ( 0.5 ml).  Notification of error occured 24 hours later. Patient was notified. Pharmacy waiting to see what the CDC advises regarding giving additional 0.25ml dose.
Accidental dose given to 3 year 8 month and 3 day with no reported adverse event; Initial information received on 02-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 year 8 month and 3 day old male patient was accidentally given a dose of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 15-Aug-2022, the patient received accidentally 0.5 ml dose (5th dose of Dtap and 4th Dose of Polio) of suspect  diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection (lot C5862BA: Expiration Date; 01-Apr-2023) via unknown route in the left vastus lateralis for Immunization with no reported adverse event (inappropriate schedule of product administration) (latency; Same day).  Action taken : not applicable.  Outcome : Unknown.   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.
Patient called pharmacy 11/10/18 to report she had around a 4" red slightly swollen spot at injection site.
Uncontrollable shivering, deep muscle aches, trembling limbs, cold and could not get warm. Symptoms hit in early evening and lasted a few hours; took 2 Advil and mercifully fell asleep at about 11 PM; exhausted the next day but better.
Patient has a seizure, was evaluated in our office by two Pediatricians who advised the step to take to make sure patient was ok.
a little swelling of her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2)  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), for COVID-19 immunization.  The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "recovered", described as "a little swelling of her arm".  Follow-up (08Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
approx 12-13 hours after administration, pt reported cramping in abdomen and radiating cramping down legs with bilateral leg numbness, all resolved within 24 hours, unclear if this is related to vaccine or not
PARESTHESIAS OF DORSUM OF FEET AND SHINS OCCURRED APPROX 4-01-90.  UNSURE OF RELATIONSHIP BETWEEN THE TWO.  F/U FROM MFR 05SEP90:  MD REPORTED PT REC'D 3rd DOSE W/O COMPLICATIONS.  PT NOT HAVING INITIAL DIFFICULTIES DESCRIBED.
Information has been received from a physician concerning a 13 year old female who in 2008 was vaccinated with GARDASIL. The patient completed the series of GARDASIL in 2008 and was recently diagnosed with Autoimmune Thyroiditis (2009). The patient sought her pediatrician. At the time of the reporting, the patient had not recovered from the event. Follow up information received on 06-OCT-2009 from a physician via medical records indicated that the patient was female student, with no medical history, known allergies or illness at the time of vaccination. The patient's family history included hypothyroidism and polycystic ovary syndrome (mother), aniridia (brother) and hypothyroidism (paternal grandmother). On 26-NOV-2008 the patient was vaccinated with a third dose of GARDASIL (lot # 650557/0072X), intramuscularly into the left arm. Secondary suspect vaccination given on the same day included a third dose of FLUZONE, (lot # U2760AA), intramuscularly into the right arm. The patient presented with her mother in the physician's office on 19-MAY-2009, complaining of feeling tired, muscle aches and requiring long naps. She has been experiencing these symptoms for the last couple of months (end of school year). The myalgias were generalized and most pronounced in her knees, hips and shoulders. TYLENOL helps some. She has been sleeping well-getting 8 hours of sleep without significant interruption. She generally feels well rested in the morning. She has not been short of breath and she denies fever, chills, night sweats, nausea, vomiting. She started her menstrual periods last July and they have been irregular. Her mother noticed that the fatigue and body aches were more pronounced just prior to her most recent menstruation. She had no urinary problems and she denied increase thirst. She grew approximately 2 inches in height in the past year. The physical exam was within normal limits. The patient developed hypothyroidism diagnosed on 19-MAY-2009 with symptoms beginning in March 2009 (approximate). The patient had a complete blood cell count, comprehensive metabolic panel and serum thyroid-stimulating hormone test drawn. All were normal except for serum thyroid-stimulating hormone test of 12.060 UIU/ml (high), normal 0.400-5.100, done on 19-MAY-2009. Patient's mother was notified and instructed to make an appointment with a child endocrinologist to evaluate hypothyroidism. The patient was not in any thyroid medication. On 30-JUL-2009, the patient was evaluated for hypothyroidism. There was no goiter. The patient's mother reported that the symptoms have somewhat improved despite no treatment. Patient scheduled for additional blood tests to evaluate need for her to start taking Levothyroxine. The reporting physician considered the hypothyroidism to be an other important medical event. No further information is available.
Significant reaction, seizures, overnight hospitalization. Annual follow up states fine motor skills and speech significantly delayed.
Observed severe local reaction on left arm below injection site with induration, redness, and fever down to just above antecubital area. Referred to Dr 3/31/06 client was given antibiotic and told by MD site was infected.
Inferior Vena Cava thrombosis with Pulmonary embolisms and severe left and right leg swelling and pain