chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When putting safety needle on the luer lock, the entire thing broke apart; This is a spontaneous report received from a contactable reporter (nurse).  A patient (no qualifiers provided) ready to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Lot number: EN8811, Expiration Date: Sep2023) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported.   The following information was reported: DEVICE MATERIAL ISSUE (non-serious) with onset 11Jan2022, described as "When putting safety needle on the luer lock, the entire thing broke apart".  Additional information: One of the medical assistants was putting the safety needle on the luer lock of the vaccine and the whole thing broke apart. They were not able to give that particular vaccine.  No patient received the affected vaccine. The patient did receive the vaccine, they had to use one from their private stock.  No follow-up attempts are possible. No further information is expected.
coughing up green mucus; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (coughing up green mucus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 PRODUCTIVE COUGH (coughing up green mucus). At the time of the report, PRODUCTIVE COUGH (coughing up green mucus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt experience swelling in forearm, pain radiating to fingers, and soreness in hand. She stated she was not able to use her hand on 10/9 still. Pt was to follow up with MD on 10/10.
Started with uncontrollable chills  that lasted 1 hr , Fever.  The next day ( saturday)tiredness , headache joint pains , muscle pains , chest pains and  nausea as well as Fatigue .  I started taking Tylenol 500mg po q 6 hrs and that improve the sxs. The  site of the injection was extremely red and swollen as well as lymphadenopathy underneath the left arm ( site of injection). The next day ( sunday) I noticed a swelling underneath the axilla going on top of the bra with blood exudate and looked as  if I had bumped an object.   The weakness continued during the next week and slowly the tiredness got better ( TOOK AT LEAST 7-10 DAYS).
took 2nd capsule then devel chills, fever & was aching; no appetite, no nausea, no diarrhea; will take 3rd capsule because fever is down to 99
Itchy rash over arms, back and legs. Resolved after couple days. Reported 1 week after vaccine given.
Chills, nausea, vomiting; Red, sore  3" diameter circle at injection site
Nausea; some aches; swelling and redness on the site; swelling and redness on the site; tiredness; not feeling well; This is spontaneous report from Pfizer-sponsored program from a contactable consumer (patient). A 90-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date on an unspecified date on Thursday 10:30 AM as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine includes BNT162B2 on an unspecified date for COVID-19 immunization and experienced no adverse event. On an unspecified date, after the second dose, the patient experienced Nausea, some aches, a little bit of swelling and redness on the site, tiredness and not feeling well. Outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Pt states that he felt "sick and had very dark stools.  He went to the hospital and had to get blood transfusions.
I have my first dosis of Moderna last april 18th; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I have my first dosis of Moderna last april 18th) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I have my first dosis of Moderna last april 18th). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I have my first dosis of Moderna last april 18th) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided by the reporter. No treatment medications were reported by the reporter. .
She got her vaccine, it was pain and her knees were the worse.  At night when she gets up to use the restroom she has to walk the bed and hang onto it, and then has to grab the wall.  She feels like an old lady.  They just ache and the more she walks the more they ache.  Yesterday she did a lot of shopping and tries not to walk as much due to the pain.  She has messaged her providers on medical records and was taking Advil and was told OK.    She did not have any reactions with the other vaccines.  She was surprised by the this.  She went to her pulmonologist and was told by him that it was probably a reaction from the vaccine.  Yesterday she picked up her BP medicine at Pharmacy and she asked him about it, and was told to contact the Pharmacy as they were keeping track of reactions, and she called them this morning and they gave her our # to report it.
Seizure activity and headache activity increased. Had not had any seizures for over 9months. Had been controlled with medication. Seizures activity now is not controlled and also now experiencing memory loss and absent seizures
light headed; body has severe aches; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed), MYALGIA (body has severe aches) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (light headed), MYALGIA (body has severe aches) and HEADACHE (headache). At the time of the report, DIZZINESS (light headed), MYALGIA (body has severe aches) and HEADACHE (headache) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported No treatment drugs were reported   Reporter did not allow further contact
Patient required hospitalization due to breakthrough infection. Patient received J&J vaccine on 06/03/21. Patient was hospitalized from 09/28/21 - 09/30/21. Below is copied from discharge summary:   Sepsis 2/2 COVID 19 PNA: - meeting sepsis criteria based on fever and tachycardia - O2 at 96% on RA - chest Xray showed atypical PNA - CRP 165 - O2 as needed; pulse Ox-> ordered home O2 eval > no O2 required - DVT ppx with eliquis - Hold Decadron IV, no benefit in view of no hypoxemia - Remdesevir for borderline benefit given AKI and >10 days of symptoms onset->discussed risk and benefits with pr who agreed to get it. > received 2 doses - On statin   Thrombocytopenia: - 130 > 113s in the setting of COVID 19 - Monitor as outpatient   AKI vs CKD: - 2/2 dehydration - Cr 1.6 > 1.9 > 1.4 , follow up as outpatient - Renal US: Bilateral echogenic kidneys noted, which may reflect medical renal disease. No evidence for hydronephrosis.    Hypothyroidism: -Resume synthroid   HLD: -Resume statin   HTN: - Controlled - metoprolol tartrate 25 mg PO BID - IV BP meds prn   Chronic Afib on AC: - Rate controlled - Resume eliquis BID 2.5 mg  - Resume BB   BPH: -Resume terazosin   Patient is discharged in stable condition with stable vital signs. All questions rearding hospital course and plan of care after discharge have been answered to satisfaction. Prescriptions for medications needed to be taken after discharge have been given to patient. Patient has been instructed to follow up with PCP, MD within the next 7 days after discharge. Patient verbalizes understanding all given instructions and has no further doubts regarding discharge.
Redness, heat and swelling in large area around injection site - 9 days after vaccination
Non immunocompromised patient got full third dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Non immunocompromised patient got full third dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Non immunocompromised patient got full third dose). At the time of the report, ACCIDENTAL OVERDOSE (Non immunocompromised patient got full third dose) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.  The patient was non-immunocompromised. The patient had received 3 full doses of Moderna vaccine.  The patient wanted to know whether the fourth booster dose would be the same as the first 3 doses or not.   Reporter did not allow further contact
Dilutent injected without mixing; Dilutent injected without mixing; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number Z3H93, expiry date 07-JUL-2024) for prophylaxis.   On 26-APR-2023, the patient received the 1st dose of Shingrix. On 26-APR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Dilutent injected without mixing) and inappropriate dose of vaccine administered (Verbatim: Dilutent injected without mixing). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 26-APR-2023 The registered pharmacist asked what was the recommendation if only the Shingrix diluent was injected without being mixed with the powder. The reporter confirmed that only the Shingrix adjuvant was administered to a patient.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. The patient received only Shingrix adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
15 mins following MMR pt c/o rash on neck & stomach, swollen & red face; c/o itchy throat & coughing; mom gave DPH;
Employee states h/o receiving influenza vaccination 0900hrs 5 Sept 2013, then at approximately 1100hrs she began experiencing a mild pruritis of the skin of her back, then at approximately 2100hrs her pruritis had become severe, with noticable hives and a sensation of her throat closing, at which time she proceeded to the ER. At ER she was evaluated, diagnosed and treated for anaphylaxis/allergic reaction and after stablization she was released from the ER at 0200hrs 6 Sept 2013 with rx's of Benadryl, Medrol dose pak, Atarax, Claritin, and Epi-pen.
A non-serious spontaneous report of "18 month old received a second dose of H1N1 with no complications", was received from a registered nurse/health professional concerning an 18-month-old male. Neither relevant medical history nor concomitant medications were reported. On an unknown date, the patient received first dose of H1N1, Intranasal and on 24-Nov-2010, the patient received second dose of the vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Patient administered an expired vaccine.  Pfizer recommend revaccination. The patient was contacted to schedule an appointment.
p/vax 4/28 in AM red area to lt arm where vax was injected. later stiffness to neck& extreme pain. went ER next day with swollen lymph nodes at back of neck & under arm lt swollen & sore. To see MD for eval.
10-15-10 Flu-like symptoms including muscle weakness. 10-23-10 ER visit. S/S: muscle weakness, difficulty swallowing, difficulty walking, "pill-rolling" hand motion, tingling in feet, difficulty getting up and down. Discharged to home with Dx of TMJ and hydration problems. 10-29-10 direct admission to hospital, with s/s altered mental status. Discharged after 3 days on Parkinson's medication. 1st Week of November Office to Dr. S/S: increase in severity of all previous symptoms and the addition of partial lower extremity paralysis and right foot drop. Dx: possible GUILLAIN-BARRE and referral to Neurologist. 12-13-10 Office visit to Dr. Performed neurologist tests and physical exam. Dx: probable GUILLAIN-BARRE. Prescribed PT 3x/week for 1-2 months. Received nursing care by Home Health Care 2-3x/week and Physical therapy at home 2-3x/week. 12-24-10 to present Hospitalized in hospital. S/S: increased severity of all previous symptoms and the addition of difficulty breathing and bedfast. Urinary catheter, IV tx, O2, respiratory Tx.
2 lives flu given at same time - FLUMIST and Swine FLUMIST - Called 800 - CDC - INFO
Swelling of top and bottom lip and hives on back. There was no airway obstruction or wheezing. Patient arrived at the clinic, was seen by a provider and given Benadryl.  He was also given methylprednisolone 4mg for 7 days.  Follow up was provied by provider and nursing staff following the treatment.  Patient recovered with no other issues.
next day p/the flu shot had dizziness, h/a, pain all over & no appetitie;
Vaccine on 6/22/2010, redness and swelling 6/23/2010, increased redness and swelling with pain 6/24/2010 with hot flashes. No other lesions.
Immediately after administration it was very painful, unlike any she's had before, felt like an electric shock or a deep burn.  Over 2 weeks the pain has shifted to a dull ache that is deep steady and worse with use of the shoulder. Hurts to sleep on it, hurts to lift and reach behind/above her head. No history of shoulder problems before.
Dizzy, difficulty walking due to loss of balance. Husband drove me to clinic where my blood pressure was above 214. Dr advised immediate trip to ER possible TIA. At ER in Hospital I was greeted by a nurse at the curb with a wheelchair. .
This spontaneous report was received from a 60 year old female patient with seasonal allergies reporting on herself. Patient declined to provide any medical history. On 10-OCT-2014, the patient was vaccinated with ZOSTAVAX in the left arm for shingles vaccination (route, lot number and expiration date were not reported). Concomitant therapies included paroxetine and levothyroxine sodium (manufacturer unknown). On 10-OCT-2014, the patient had some kind of rash in the injection site. On 13-NOV-2014, the patient began having nausea, itching and pain. The outcome of pain, nausea and itching was unknown. The patient also reported that the rash feeling had been continuous. Patient did not received any treatment for the adverse events. Patient sought unspecified medical attention. Additional information is not expected, because the patient did not want us to contact the physician.
Swelling of (L) upper arm at vaccine site. Hard and itchy. Erythema.
Case number PHEH2013US021455 is an initial spontaneous report from the pharmacist received on 11 OCT 2013, with a combined follow-up received on 03 DEC 2013. This report refers to a 56-year-old  male patient. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309301( at a dose of 0.5 ml intramuscularly into left arm on 11 OCT 2013 at 09:30 AM. It was reported that the FLUVIRIN received by the patient was left at a temperature of 47 F overnight because the refrigerator was not closed properly. Patient was doing well and had no adverse event following this medication error (incorrect storage of vaccine).  Follow up was received on 03 DEC 2013: Vaccination information (time, site and dose) and information that patient had no adverse event were updated.
Started with a headache; pulsatile tinnitus; arm and legs would suddenly twitch; This is a spontaneous report from a contactable consumer reported for a female patient who experienced same symptoms as her daughter. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route on an unknown date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced symptoms started with a headache, pulsatile tinnitus (as which also her daughter as experienced) which in your ear you could hear your heartbeat constantly for 2-3 weeks and when subsided went down to her face, her sinus to her neck and her left arm that then tingle. Which is now down to her legs, just her touching her legs would hurt and that her arm and legs would suddenly twitch. The clinical outcome of the events was unknown.  Information on batch/lot number has been requested.
Severe arm pain in muscles, light fever and chills, some nausea on day one.
Muscle pain, headache, shivering, nausea, muscle cramps/spasms in lower hanstrings on both legs
swollen face; swollen tongue; swollen throat; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swollen face), SWOLLEN TONGUE (swollen tongue) and PHARYNGEAL SWELLING (swollen throat) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced SWELLING FACE (swollen face), SWOLLEN TONGUE (swollen tongue) and PHARYNGEAL SWELLING (swollen throat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. On 10-Mar-2021, SWELLING FACE (swollen face), SWOLLEN TONGUE (swollen tongue) and PHARYNGEAL SWELLING (swollen throat) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received on 05-Aug-2021 and contains no new information.
Woke on 3/6 congested and coughing.  Thought it was allergies.   Lost my taste and smell on 3/7.  I did a Covid home test.  It was positive.   Contacted GP via email.  He prescribed an antibiotic and a 5 day steroid.  Instructed to rest & quarantine for 10 days.  Had cough & congestion  for 14 days, had great fatigue for same.   Could not taste or smell for a month.  It returned but was inconsistent for several weeks.  Returned fully approx 4/15.
24 hours, post vax of school shots, pt complained of painful lips and marked edema of bilateral lips and bilateral hands and wrists and all 4 eyelids. Presumed recovery.
Headache, UrticariaPruritus, Injection site pain, Chills Narrative:  All events lasted 24 hours after vaccination  Other Relevant History:
I developed a pneumonia after receiving the 2nd dose.  Symptoms included: fever, chills, sweats, cough, rash, diarrhea shortness of breath.
This is spontaneous report from a contactable Pharmacist. A female patient of an unspecified age received PREVNAR 13, Lot # X13847, Expiry date Jul2020, NDC # 00005197102, UPC # 300051971022 via an unspecified route of administration at single dose on an unspecified date in Feb2019 (might be a week before this report) for immunisation. Medical history included pain. Concomitant medication included Tramadol, it has histamine release but she has been on that one, for pain. The patient has not taken anything since she got the vaccine. On an unspecified date the patient experienced redness all over her body, patches of rash and redness (these red bumps all over her body, they are pretty red), itching really bad, maybe she is allergic to one of the ingredients or something. Skin reaction is raised above. The outcome of the events was unknown. No treatment given by the reporter. Course of events: Pharmacist had a patient come by like 5 minutes before this report and gave her the PREVNAR dose may be a week before this report and the patient said she had these red bumps all over her body and Pharmacist looked at that them they are pretty red. She was itching really bad and but that was about a week, might be a week before this report. Pharmacist was not sure about the itching but the skin reaction was raised above. Causality: Pharmacist spoke to the patient and asking her for anything changed in her diet, if she started taking any other medications over the counter besides the one in the pharmacy. She said no and she said they were all over her body and she received the vaccination on the 16th so to me it has something to do with it, maybe she is allergic to one of the ingredients or something.
SWELLING,REDNESS THAT RADIATED TO LOWER ARM RIGHT AFTER SHOT THAT CONTINUED FOR 2 DAYS.SWELLING MOVED DOWN ARM THE NEXT DAY.PATIENT HAS BEEN PUTTING ICE ON IT AND USING CATAFLAM FOR SWELLING.NO PAIN REPORTED
Swollen lymph nodes under both arms, around both sides of neck and in groin; Swollen lymph nodes under both arms, around both sides of neck and in groin; Swollen lymph nodes under both arms, around both sides of neck and in groin; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm left on 16Apr2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 10Mar2021 at 13:30 as a single dose for COVID-19 immunisation. The patient previously received DTaP vaccine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced rash and severe lymph node reaction (not specified). 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 17Apr2021 at 09:00, the patient experienced swollen lymph nodes under both arms, around both sides of neck and in groin. The clinical outcome of the events swollen lymph nodes under both arms, around both sides of neck and in groin were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Inconsolable crying 72 hrs p/vax; apnea spells observed by mom about 80 hrs p/vax; projectile vomiting 48-72 hrs p/vax;