chrisvoncsefalvay/vaers-outcomes huggingface dataset:
caught covid; caught covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "caught covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of covid-19. Clinical Course: It was reported that patient had triple vaccinated however last week he caught covid and was prescribed with Paxlovid. He is to travel next month and he would like to know if the Paxlovid would have any effect on his natural immunity. Would it lower his natural immunity from the covid infection that he just had (when you get an infection from Covid you body produces natural immunity, would this paxlovid lower that amount of immunity).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient to the ED with c/o numbness of his face, buttocks with breakout of Shingles shortly after Vaccine. Patient received Vaccine on 4/22/2021 and broke out and just recovering from Shingles.
Seen 9/16/10 for rash that appeared to be break through varicella. Vesicular with dry crusting and appeared in crops at varied times.
Patient c/o arm pain for a few days after vaccination, then it resolved, then returned again and has been continuing for multiple weeks. Pt says it "feels like [she] fought with a boxer. Claims no visible skin effects, just muscular pain that wakes her at night. I recommended she follow up with her physician, since she is currently taking opioids for pain but cannot take anti-inflammatories d/t liver issues.
diarrhea; joint pain; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FATIGUE (feeling tired) and ARTHRALGIA (joint pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included POTASSIUM, METOPROLOL and LOSARTAN for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced FATIGUE (feeling tired). On 31-Mar-2021, the patient experienced DIARRHOEA (diarrhea) and ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Mar-2021, FATIGUE (feeling tired) had resolved. On 31-Mar-2021, DIARRHOEA (diarrhea) and ARTHRALGIA (joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also includes, lupus pill, thyroid pill, water pills and thyroid medication.
Itching/redness at injection site; Itching/redness at injection site; Itching/redness up neck; Itching/redness up neck; This is spontaneous report from a contactable pharmacist. A 39-year-old female patient (unknown if pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in the Left arm on 06Jan2021 at 08:15 PM (at the age of 39-years-old) as a single dose for COVID-19 immunization, lot number: EL0142. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included anxiety and depression, coronary artery spasm, hyperlipidemia. Known allergies included latex allergy (anaphylaxis). Concomitant medications in two weeks prior to the vaccination included atorvastatin 20mg, isosorbide mononitrate 60mg extended release (ER), multivitamin, omperazole 20mg, sertraline 50mg and tizanidine 2mg for muscle spasm. On 06Jan2021 h 08:15 PM patient experienced Itching/redness at injection site and up neck. Oral (PO) diphenhydramine hydrochloride (BENADRYL) 50mg was given to treat the events. Rapid Response called and observed for 30 min. Discharged to husband's care. It was unknown if, since the vaccination, patient has been tested for COVID-19. Outcome of the events was unknown.
In 1999, the pt received her 2nd dose of DTPa vaccine. "A few days later", she experienced hives. As of 10/23/00, the outcome of the event is resolved.
Left arm swollen, approximately 14 1/2, inflamed area on inner aspect approximately 2x2, entire arm painful.
Chills and flu-like symptoms for 48 hours. Baseball size local reaction for 7 d. Rash from shoulder to elbow days 2 -> 7.
Muscular soreness in upper arm traveling up to shoulder and back of neck.  No swelling or rash but it's too the point where I can't lift my arm.
Soreness in the arm of the injection (Left arm); Pain under arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm of the injection (Left arm)) and AXILLARY PAIN (Pain under arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm of the injection (Left arm)) and AXILLARY PAIN (Pain under arm). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm of the injection (Left arm)) and AXILLARY PAIN (Pain under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information and concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Email ID received.
soreness at injection site; headaches; Low fever; tired; bumps on my neck, arms and hands, extremely itchy, don't know if i'm allergic; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2022, the patient received the 1st dose of Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced injection site pain, headache, fever, tiredness and itchy rash. On an unknown date, the outcome of the injection site pain, headache, fever, tiredness and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, headache, fever, tiredness and itchy rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comments: The patient self-reported this case. The patient said he/she had been having headaches, a low fever, tired, soreness at injection site and had bumps on his/her neck, arms and hands that were extremely itchy. The patient did not know if he/she was allergic or if itching was a normal side effect.
This spontaneous report as received from a physician refers to a currently 35 year old female patient. Medical history, drug reactions or allergies were not reported. On 13-MAR-2014, the patient was vaccinated with an expired dose of RECOMBIVAX HB 5/0.5mcg/ml, lot # 669599/0231AA, thimerosal free, expiration date: 14-OCT-2013 (also reported as 04-OCT-2013) (dose number not reported) because of a low titer (less than 5) after completion of three doses of Hepatitis B vaccine (manufacturer unknown, dates of administration unspecified, administrated previously at another unspecified facility). Concomitant medication was not reported. The patient received expired dose of RECOMBIVAX HB instead of receiving an adult dose of this vaccine due to medication error, no product confusion discovered. No adverse event reported other than low titer. The outcome of all events was unknown. The causality was not reported. Additional information is not expected.
Within 7 hrs of receiving vaccines pt developed localized cellulitis with red dermatitis of fluid filled blisters.  This occured in the area where the DTaP vaccine was administered.
CHIEF COMPLAINT/REASON FOR VISIT Headache and Sore Throat     HISTORY OF PRESENT ILLNESS  20-year-old female with a past medical history significant for spina bifida with hydrocephalus s/p VP shunt placement and partial vocal cord paralysis presents to the ED for evaluation of a sore throat and headache. Patient states that she has been in her normal state of health until two days ago (Saturday) when she developed an intermittent sore throat. Yesterday afternoon (Sunday), she was playing a ball game when she was struck in the back of the head with a volleyball. She did not lose consciousness or have immediate pain. Yesterday night, she had an onset of intermittent pain located in the posterior right side of her head, near the site of impact. She states that the pain comes and goes and does improve when she sits upright. Her pain was most severe this morning and was an 8/10 for severity. Given her history of a VP shunt, she now presents to the ED for evaluation, though states that her pain has since resolved. Patient notes that her father was recently ill but had a negative COVID test. She denies any known COVID exposures. She endorses an intermittent cough, but attributes this to her GERD. Patient also denies any recent fever, chills, diaphoresis, congestion, rhinorrhea, vision changes, chest pain, shortness of breath, abdominal pain, nausea, vomiting, bowel changes, urinary symptoms, or neurological changes. She is vaccinated against COVID-19. Patient is G-tube dependant and reports that she has been able to tolerate her feeds without difficulty. There are no other complaints at this time.
Patient reports that she developed redness and soreness around the injection site. She also had trouble lifting her arm. This lasted about 2 weeks. Now completely resolved.
little fever about 100.3; joint and muscle pain; joint and muscle pain; headache today; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (little fever about 100.3), ARTHRALGIA (joint and muscle pain), MYALGIA (joint and muscle pain) and HEADACHE (headache today) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (little fever about 100.3), ARTHRALGIA (joint and muscle pain), MYALGIA (joint and muscle pain) and HEADACHE (headache today). At the time of the report, PYREXIA (little fever about 100.3), ARTHRALGIA (joint and muscle pain), MYALGIA (joint and muscle pain) and HEADACHE (headache today) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 100.3 degree Celsius High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Treatment details included not provided
I contracted COVID-19 on 05/03/2022 with symptoms of cough, sore throat, congestion and fatigue. I was not prescribed any medication when I went to the urgent care on 05/04/2022. My symptoms began to improve after 3 days of illness, and were fully resolved by day 4. I have no lingering symptoms.
Sore injection site right arm, right arm muscle weakness, hard to move right arm, redness at injection site. This continued on for over three weeks after the shot and still on an off to this day I still have muscle weakness and arm pain.
Initial unsolicited report received from Consumer on 06-Oct-2015. This case involves a 70-year-old male patient who was vaccinated with a sixth dose of FLUZONE HD (batch number was not available, expiry date and route of administration were not reported) in left deltoid and first dose of PREVNAR 13 (manufacturer: Pfizer, batch number was not available, expiry date and route of administration were not reported) in right deltoid on unspecified date in Sep-2014. Patient had not received any other vaccinations four weeks prior. It was reported that patient had no illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On unspecified date in September immediately after vaccination, patient had swelling of his left arm with redness warmth and pain it extended down to his mid forearm. He also had expected side effects of temp of 100.5F and body aches. It was reported that both PREVNAR 13 and FLUZONE HD were given on the same day and the patient was not sure which arm the vaccines were given and felt that the Pharmacy may have them mixed up. No Lab test had been performed. Patient was treated the swelling and pain with ice and OTC medications. On unspecified date, patient gradually got better and was recovered from the events in a week or so. Documents held by sender: none.
Initial information received on 02-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old male patient who was vaccinated with 0.5 ml  ACTHIB (lot number: UI904AA) in intramuscular route in left thigh on 01 Aug 2018. The patients past medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included VARIVAX II for Immunisation. It was an actual medication error due to wrong solution used in drug reconstitution (product preparation error) as box of diluent confused and mixed the hib with sterile water instead of the diluent. It was unknown if patient had adverse event. 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.
This spontaneous report was received from a physician, and refers to a 2 month old patient of unknown gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On an unspecified date in 2017 (reported as recently), the patient was vaccinated with a dose of ROTATEQ, orally, for vaccination, (dose, frequency, lot number and expiration date were not provided). On an unspecified date in 2017 (reported as at an unknown point in time after receiving the dose),  the patient began to experience bloody diarrhea. The patient sought for medical attention on an unspecified date. No product quality complaint (PQC) was involved. The outcome of diarrhoea hemorrhagic was reported as not recovered. The causal relationship between ROTATEQ and diarrhoea hemorrhagic was not provided. Upon internal review, the event diarrhoea hemorrhagic was determined to be a medically significant event.
No additional AE reported.; Caller is a nurse who reports that a dose of ROT ATEQ was administered following a temperature excursion.; This spontaneous report has been received from  a Licensed Practical Nurse and refers to a patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 19-JUL-2021, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number T028132, that was verified to be valid with an expiration date reported and established as 22-FEB-2022) (concentration, dose number and vaccination scheme frequency were not provided). It was reported that this vaccine was administered after experienced a temperature excursion of 49.69 degrees Fahrenheit during a time frame of 1 hour with 24 minutes and 0 seconds, which was detected by data logger (product storage error). No previous excursions were reported. No additional adverse events were reported.  This is one of several reports received from  the same reporter.; Sender's Comments:  US-009507513-2107USA006147: US-009507513-2107USA006252: US-009507513-2107USA006361: US-009507513-2107USA006509:
Vaccine injected into blood vessel; Vaccine injected into blood vessel with bleeding occurring; I felt dizzy and lightheaded; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 03Jun2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 03Jun2022, outcome "unknown", described as "Vaccine injected into blood vessel"; DIZZINESS (non-serious) with onset Jun2022, outcome "unknown", described as "I felt dizzy and lightheaded "; VACCINATION SITE HAEMORRHAGE (non-serious) with onset Jun2022, outcome "unknown", described as "Vaccine injected into blood vessel with bleeding occurring".  Additional information: The patient was without pre-existing conditions. The patient took the 1st Pfizer dose on 03Jun2022, 2 days ago. The vaccine was injected into blood vessel with bleeding occurring. The patient felt dizzy and lightheaded during waiting period. She was concerned and worried and wanted to know if the vaccine would be effective and whether the lightheaded feeling would go away and what was the possibility of blood clots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Fever, pain can not move left arm, fever, chill and headache Narrative: day 1 - pain to injection site; day 2 can not move left arm, fever 103, chills and headache; day 3 symptoms from day2 continue; day 4 no symptoms noted from this point forward
The pt experienced a local reaction to the right deltoid with redness / erythema and warmth. Treated with Benadryl and ice pack.
Severe and incapacitating arm pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received dose on an unknown date and experienced severe and incapacitating arm pain, refer case US2021AMR266528).   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm (serious criteria disability). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter needed to speak to someone about serious issues being experienced following Shingrix shots. The patient experienced severe and incapacitating arm pain followed the Shingrix shots almost immediately and had gone on for months. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR266528:Same reporter
Patient reports chills and severe right arm pain started around 5 pm the day she received vaccine (Friday).  On Saturday, her hands swelled up and she couldn't turn her head right or cross her right shoulder.   By Sunday, the only remaining symptom was the swollen hands.  On Monday, (the day of this report ) she said her hands were 50% better and she had no further concerns.
3d post 3rd anthrax vacc pt c/o arthralgias, fever and generalized erythematous corticoid-typd rash. Sent home on ?, increase fluid, NSAIDs, HIb and opopiocids for ? pain.
(L) arm red, swollen, hot to touch, non tender around injection shot. Rx - Keflex.
I had a rash below the injection site; It is red rash and warm to touch; It is red rash and warm to touch and below the injection site and not on the injection site..; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ep6955) via an unspecified route of administration in the left arm on 11Apr2021 at 00:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as no. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ew0151) via an unspecified route of administration in the left arm on 19Mar2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 12Apr2021 at 12:00, the patient experienced a rash below the injection site a day or two after the 2nd dose. It was red rash and warm to touch and it was below the injection site and not on the injection site. It was  red at the time of report after noticing it after a day from the vaccine. Therapeutic measures were not taken as a result of the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events rash below the injection site, red rash and warm to touch was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
GARGLING/HOARSE VOICE; This spontaneous report received from a consumer concerned a male 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. the batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced gargling/hoarse voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of gargling/hoarse voice was not reported. This report was non-serious.
Burning and irritated eyes, similar to when I contracted COVID in August 2020 and following second vaccination shot in April 2021.  My eyes are not debilitatingly sore, but are very annoying.  Furthermore, I've not regained my full ability to smell since contracting COVID and have had reduced energy for over a year.  I'm unable to detect certain odors, such as sulfurous scents,  but can smell some very strong odors according to others.  For example, I cannot smell malodorous kitty litter or similar objectionable odors (lucky, I guess).  But, I couldn't smell the odor of a closed fireplace flue when a fire was going.  Others in the house detected that odor and threw open the windows.  You can imagine my concern that I can't smell smoke.