chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very bad headache lasting 12 hours; chills; fatigue requiring complete bedrest for 24 hours.
pt recv vax 5MAY97 & 29AUG97 pt exp mid-upper chest discomfort & followed up w/MD;subsequent ultrasound of liver & gallbladder & stress test were all nl;liver function test were elevated;no tx was given & condition of pt unk;
PT arrived at Clinic setting at the (Recreation Park) for her first dose of Moderna COVID vaccine. The clinic was set for boosters doses of Moderna (half doses), with the requirement that registration staff pull aside those individuals arriving requesting 1st, or 2nd dose (full doses) of Moderna for the quality assurance staff memeber staff to draw up a full dose of Moderna and assist them thru the vaccinator lines to ensure they receive the full dose. The registration volunteer member did not notify anyone that patient was on site for a 1st dose and she received a booster (half dose). It was caught before she left the building and a second (half dose) was administered to ensure her 1st dose was accurate (full dose) but she did get a second shot to obtain the appropriate dosing.
She got her vaccine, had a sore arm.  Three days later she started having bouts of diarrhea and then watery diarrhea that continued for an entire month, and just got rid of it 4 days ago.   She also has brain fog, every now and then she has a dizziness feeling and then feels like her brain is doing a flip flop, something pulling elastic tight and letting it go, not normal as she was before the vaccine.  A mushy feeling in her head.  No memory issues though.   She did call her doctor and did a stool sample that was negative, and her blood work was normal and was put on multiple anti-diarrheals and finally it has quit.    She has a question of why does everybody get the same amount of the vaccine no matter what your weight is.   She is a small person 120 #, and the man behind her was large and around 300#, and he got the same amount and wonders why that is.
Patient developed a 3 - 4 inch red, hard, hot raised area around the injection site. She is applying ice and taking Benadryl. She is contacting her physician to see if further treatment is needed.
MMRV given to 28 year old. Age range is 12 months to 12 years old. Vaccine mistake. Contacted Merck and was indicated per recommendation "if MMRV is given to a person 13 years or older it can be counted as completion towards MMR and Varicella series." No need for patient to come back in, but patient was still notified. Vaccine mistake still reported to facilities safety team and VAERS. Patient had no adverse reaction to vaccine.
or unknown reason (not documented in chart) patient received the first Moderna COVID-19 Vaccine dose on 08/03/21, the  second dose of Moderna COVID-19 Vaccine on 08/31/21 and the third/booster dose on 12/16/2022 which is earlier than the required 5 months and outside of the 4-day grace period. There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Cluster of Hive like eruptions around the site of the vaccination. Arm was extremely painful and stiff to move during first two days after Vac.
BODY PAINS; SNEEZING; RUNNY NOSE; FEELING OUT; SORE ARM; EXTREME TIREDNESS; MILD NAUSEA; MILD FEVER; HEADACHE; This spontaneous report received from a patient concerned a 38 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: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: diphenhydramine hydrochloride, and pseudoephedrine hydrochloride. On 09-APR-2021, the subject experienced body pains. On 09-APR-2021, the subject experienced sneezing. On 09-APR-2021, the subject experienced runny nose. On 09-APR-2021, the subject experienced feeling out. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced extreme tiredness. On 09-APR-2021, the subject experienced mild nausea. On 09-APR-2021, the subject experienced mild fever. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme tiredness, and feeling out, and had not recovered from headache, body pains, mild fever, mild nausea, sneezing, runny nose, and sore arm. This report was non-serious.
Information has been received from a health professional concerning an 8 week old male with a history of a skin allergy, who, within the past week, on approximately 8/23/06, was vaccinated with a first oral 2ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live. There was no concomitant medication. It was reported that after the vaccination, within the past week, on approximately 8/23/06, the patient was crying, seemed uncomfortable, and didn't seem himself. The patient was brought to the emergency room and was hospitalized overnight for observation. The patient was released the following day. It was reported that the patient recovered the day after receiving the vaccine. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Caller would like to know if he is still okay to receive his second dose following this exposure to COVID-19.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that he was scheduled to receive his dose of the Pfizer BioNTech COVID-19 vaccine on 06Apr2021 but reports that last Thursday he was around someone who ended up testing positive for COVID-19 on Saturday. He mentioned that that person had their shots already but because his wife had it, he wanted to get tested as well, despite showing no symptoms. Patient also reported that he himself had gotten tested but had not gotten the results yet. Patient would like to know if he was still okay to receive his second dose following this exposure to COVID-19 on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test not gotten his results on unspecified date has not gotten his results yet. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Edema & tenderness left axilla, - no adenopathy or erythema x 2 days given CLARITIN q day & cool compresses.
pt recv vax;no local rxn;pt acted as  if did not feel well;on 22aug95 red rash on abd & rt leg became swollen;rash progressed to back;to MD who stated allergic rxn to vax;no fever; on cytroheptad;
This spontaneous report as received from a nurse refers to a 47 years old patient (gender unknown). On 25-MAR-2014 the patient was vaccinated with PNEUMOVAX 23, injection, lot # H014196, expiry date 19-MAR-2014, dose (unknown), frequency (unknown), route of administration (unknown). No concomitants were reported. On 25-MAR-2014, the patient received an expired dose of PNEUMOVAX 23. No adverse effect has been observed or reported. Action taken with respect to PNEUMOVAX 23 was not applicable. No product quality complaint was involved. Outcome of events was unknown. Additional information has been requested.
Client's arm became swollen 11/9/02. School nurse reported on 11/13/02 that client's R arm was swollen from elbow to ? Arm was hot to touch and hard. Client had been itching her arm. School nurse advised ice packs. Spoke to client later in Monday. Said her arm was getting better. Advised warm compresses, Ibuprofen, and not to get Td for 10 yrs.
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 68-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments No concomitant medication was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses. The vial did not undergo any temperature excursions.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received and included no significant information.
Caller reports still feeling "off' and "out of it" the next morning; Caller reports experiencing body shudders, uncontrollable shaking, nausea and a pounding headache.; nausea; head pounding/ pounding headache; This spontaneous report was received from a 36-year-old female patient reporting on herself. There was no information about the patient's concomitant medications, concurrent conditions or medical history provided.  On 10-APR-2021, she was vaccinated with SARS-CoV-2 vaccine (unspecified) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 27-APR-2021, the patient was vaccinated with a first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injected into upper left arm (exact dose, route of administration, lot # and expiration date were not reported). Indication reported as first annual appointment since the expanded age indication. On the same day, she experienced body shudders, uncontrollable shaking, nausea and pounding headache. On 28-APR-2021 in the morning, the patient was still feeling "off" and "out of it". On the same day in the evening, she recovered from the events. It was reported that she did not sought medical attention.  Causality assessment was not provided.
Arrived in office 1 week post injection. C/o decreased ROM, shoulder and neck pain, shoulder and neck swelling.
pressure in chest, shortness of breath, rapid/irregular heart beat, light headedness.  Started afternoon of June 13 and continued to 6/15.
Red blotchy, itchy rash on hands, arms and trunk. Treatment of antihistamines.  diagnosis of Erythema Multiforme.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 09:00 as dose 4 (booster), single (Lot number: GH09702) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pulmonary fibrous" (unspecified if ongoing). There were no concomitant medications. There was no known drug allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19; patient received Paxlovid.  No follow-up attempts are possible. No further information is expected.
Right shoulder pain that increasingly worsened. Decreased range of motion. date of onset 06/01/23
Client moved her L arm away abruptly during vaccination and vaccinator was unable to successfully vaccinate the client. Lead RN determined that less than half of the vaccine was administered to the client due to the amount remaining on client's arm and in the syringe. RN wasted the remaining vaccine dose and instructed the client's mother that we can attempt to vaccinate on the opposite arm if she is able to help provide assistance with stabilizing the client's arm. Client's mother verbalized understanding and RN provided the vaccinator with a new pediatric dose of Pfizer COVID vaccine. Client received 1st dose of pediatric Pfizer COVID vaccine (lot# FK5618) in the R deltoid at 1605. No adverse reactions were reported by client's guardian during observation. Client left the site at approximately 1620 with a steady and symmetrical gait.
Pt developed pyloric stenosis 10/30/2006, vomiting, diarrhea.  MR received from pediatrician which included hospital H&P of 10/30/2006 and various diagnostics. Two month well baby visit of 10/26/2006 WNL with mother's c/o infant being "gassy" and constipated. Vax. including Rotateq given.  F/U exam on 10/30/2006 reveals multiple episodes (up to 20/day) of forceful vomiting and spitting up, as well as dehydration. Questionable olive-shaped mass in upper abdomen upon palpation.  Admitted to hospital with dx. of vomiting of bloody emesis and dehydration.  Surgery-pyloromyotomy on  10/31/06.  Discharge DX: 1) Pyloric Stenosis, s/p pyloromyotomy.  2) Rotavirus, acute gastroenteritis.  Second admission one week later for vomiting and GERD s/p pyloromyotomy.Feedings were resumed which the infant tolerated well and he was d/c'd with a  Discharge DX: Vomiting s/p pylorotomy, pylorospasm versus GERD.
Client returned to clinic within one hour after receiving flu vaccine. She experienced a hot feeling head to toe & presented with red splotches on face, neck, arms & legs. She was lightheaded & clammy. No itching or problems breathing, alert & oriented. BP 130/70 P-100 Reg. 911 call. Fireman arrived. Pulse at 88. EMT's arrived. Took client's vitals. Determined client should go to hospital. Client stated she had IV BENADRYL & fluids & then when tongue swelled in ER she was given Prednisone. Discharged with 3 days of Prednisone.
On the above-listed date, a vaccination clinic was held for staff to receive the COVID-19 booster vaccination.  On this day we had Bivalent Moderna Booster dosed vials on hand to be given to those requesting the booster dose.  At the time of the clinic, the vaccinator was operating on incorrect information that the Moderna Booster vaccination for the Bivalent vaccine was 0.25 mls rather than the new dosage of 0.5mls.  The error was not noticed until the end of the clinic.  Immediately the error was communicated to those affected.  All patients requesting so were vaccinated with the remaining 0.25 mls within 24 hours in line with the FDA and CDC recommendations for this specific error.  Two patients were contacted but requested the full dosage of the booster vaccine in the coming weeks.  Three patients were contacted and chose not to be vaccinated further.  There were no reactions noted upon follow-up.  All patients were advised to communicate with their primary care doctors and follow up with them should there be any adverse reactions.  The entire department debriefed and confirmed all new information and rehabilitated the draw-up and delivery of SOPS for all vaccinations in the future. This error was taken very seriously and all means of ensuring this is to not happen in the future were implemented.
- Redness & warmth heat at injection site reported 11/12/12 7pm. -Better after cold compresses 11/13/12.
Complete loss of muscular control; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced complete loss of muscular control.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03-Feb-2021, prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 04-Feb-2021, next day after receiving the vaccine, the patient developed a complete loss of muscular control which lasted for eighteen hours. On 5-Feb-2021, forty-eight hours post-vaccination, the patient became fully functional.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.  The event of complete loss of muscular control was resolved on 05-Feb-2021.; Reporter'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.
dry heaves; fever; headache; joints and muscle aches; joints and muscle aches; chills; vomiting; slight diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), PYREXIA (fever), HEADACHE (headache), MYALGIA (joints and muscle aches) and ARTHRALGIA (joints and muscle aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced RETCHING (dry heaves), PYREXIA (fever), HEADACHE (headache), MYALGIA (joints and muscle aches), ARTHRALGIA (joints and muscle aches), CHILLS (chills), VOMITING (vomiting) and DIARRHOEA (slight diarrhea). On 06-Feb-2021, RETCHING (dry heaves), PYREXIA (fever), HEADACHE (headache), MYALGIA (joints and muscle aches), ARTHRALGIA (joints and muscle aches), CHILLS (chills), VOMITING (vomiting) and DIARRHOEA (slight diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Nurse drawing up Moderna doses drew up and administered 0.3mL doses instead of 0.5mL. Patient was notified 10/06/21 and offered to received the additional 0.2mL to receive the full dose.
The vaccine was given past it?s refrigeration expiration date, the date on the vial was still within date.
This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and 24 hours later, became unbelievably sick on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A, 026B21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) had not resolved.            Concomitant information was not provided.   This case was linked to MOD-2021-420951 (Patient Link).
Severe cramping in both calf muscles; Cannot sprint, jog, or run; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 03Mar2021 at 16:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to 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. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. On 07Mar2021 at 15:00, 4 days after the vaccine the patient suffered severe cramping in both calf muscles while playing basketball. The patient was playing basketball every day and now cannot sprint, jog, or run since March 7th. 24 hours a day, the patient had constant muscle spasms in calves. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with physical therapy with no positive result. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe cramping in both calf muscles and now cannot sprint, jog or run was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
7/24--7/27 26y.o. G1P0 at 38w3d by L = 8 wk US presenting to triage with c/o contractions. Patient is here visiting for a wedding. She started to feel contractions about midnight and they are coming closer together so she came in for evaluation. SVD healthy baby. Discharged and went back home.