chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe muscle aches, hot and cold sweats. Stomach pains, restless. This lasted for 48 hours.
delayed shingrix dose, received first dose in jan 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The reporter stated that patient received the 1st dose of Shingrix and asymptomatic, delayed for the 2nd dose of shingrix , which led to incomplete course of vaccination . No further information was reported. Reporter consented to follow up.
Patient received Moderna booster dose 01/09/22 at 01:40PM. 15 minutes after administration, patient stated that she felt "flushed in the face" and erythema was noted on the forehead and cheeks of patients. Patient reported no hx of any other medical conditions and NKA were noted. Vital signs initiated and cold compress and water were provided to client. Vital signs Q5m; stable and WNL. 2 x 12.5 chewable tablets of Benadryl were administered to the patient prophylactically for any adverse allergic symptoms. Patient was further observed for 15 more minutes and vital signs were monitored. Symptoms resolved shortly after medication administration and relief from cold compress. Patient was seen leaving vaccination site alert and with steady gait.
Narrative: Patient received her second COVID vaccine on 3/30/21 and per notes on 4/1/21 she went to a non facility with c/o hives. NO scanned records from that facility are available. Reaction was not reported ot the facility until 10/4/21. She received her first vaccine on 3/2/21 and had no reported reactions. No prior history of reaction to an vaccines per records. No documentation of what treatments, if any, were given to treat her hives.
High fever; Couple chills on and off; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever) and CHILLS (Couple chills on and off) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 016M20A) for COVID-19 immunisation.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PYREXIA (High fever) and CHILLS (Couple chills on and off). At the time of the report, PYREXIA (High fever) and CHILLS (Couple chills on and off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Pyrexia: 100.6 (High) 100.6.         Treatment information was not provided.  Concomitant medication use was not provided by the reporter.
Couldn't lay down to sleep; Numbness in forehead; Pain in left side of face; Oyster like bubbles in his eye and halfway up his forehead; Splitting headache; Shingles; 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), in Nov2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "Shingles"; HEADACHE (non-serious) with onset Nov2021, outcome "not recovered", described as "Splitting headache"; INSOMNIA (non-serious), outcome "unknown", described as "Couldn't lay down to sleep"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Numbness in forehead"; FACIAL PAIN (non-serious), outcome "not recovered", described as "Pain in left side of face"; CONJUNCTIVAL CYST (non-serious), outcome "unknown", described as "Oyster like bubbles in his eye and halfway up his forehead". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: In early Nov2021 he got his COVID-19 Vaccine shot and woke up with splitting headache for 5 or 6 days. On 5th or 6th day he woke up with shingles up on forehead and up and down his back. Had shingles for 7 and half months. Worst was first 5 months. Had a headache a 9 out of a 10. Couldn't lay down to go to sleep had to go from one easy chair to another. When the pain did subside he fell asleep easily. Lucky to get an hour or two of sleep a night. After a few months his pain finally got down to a 2 or 3 to get a few hours sleep and continued throughout 7th or 8th month he had shingles. Asked his HCP about the numbness in his forehead and pain in the left side of his face and his HCP said just to work with it. Then after he got his first shingles vaccination, clarified he got the first shot and then the second shot, then got diagnosed with COVID-19. His headache still remains and half of forehead is still numb. Has pain shooting from his left eye socket corner to his nose. Has had 2 or 3 MRIs, couple of CAT scans, and the they told him there is nothing to do. He can't live with it. His headache was caused by COVID-19 Vaccine shot he got. The pain was constant and never quits but he did get it down to a 2 or 2 and half on the scale. Got the COVID-19 Vaccine shot and got the severe headache the next day then had the severe headache for 4 or 5 days and then had shingles. forehead. Aware the 4 to 5 days are discrepant as caller previously provided time frame of 5 to 6 days. Documented as provided by the caller. There is a product complaint to report, Description of complaint includes that Had the COVID-19 Vaccine and was diagnosed with COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Right upper arm very red to elbow 9-10 cm slightly indurated and swollen. Dx'd with cellulitis. Treatment Rocephin.
5/12/09 PC received from guardian that child complained of headache leg aches, vomiting x 3 and fever (felt hot to touch) did not check temp after receiving vaccines- 8 hour later- 5/14/09-student had fever body aches x 3 days-no vomiting. 1st day= decreased appetite x 2 day- Eating decreased, Better 3 days after vaccines.
Heart affected; breathing difficulty long hauler; energy was affected; This spontaneous case was reported by an other health care professional and describes the occurrence of CARDIAC DISORDER (Heart affected), DYSPNOEA (breathing difficulty long hauler) and ASTHENIA (energy was affected) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Heart affected) (seriousness criterion hospitalization), DYSPNOEA (breathing difficulty long hauler) (seriousness criterion hospitalization) and ASTHENIA (energy was affected) (seriousness criterion hospitalization). At the time of the report, CARDIAC DISORDER (Heart affected), DYSPNOEA (breathing difficulty long hauler) and ASTHENIA (energy was affected) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported the patient stated Moderna reaction nearly made patient hospital inpatient. Treatment information was not provided.  Company comment: This spontaneous case concerns a female patient of unspecified age with no reported medical history who was hospitalized due to the unexpected events of cardiac disorder (described as heart affected), dyspnoea and asthenia which occurred at an unknown interval after receiving a dose of mRNA1273. The events in this case may be related to each other.  Further details regarding the clinical course, hospital admission, other diagnostic or imaging test done, concomitant medications and treatment were not provided. Information regarding other COVID-19 vaccines were not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient of unspecified age with no reported medical history who was hospitalized due to the unexpected events of cardiac disorder (described as heart affected), dyspnoea and asthenia which occurred at an unknown interval after receiving a dose of mRNA1273. The events in this case may be related to each other.  Further details regarding the clinical course, hospital admission, other diagnostic or imaging test done, concomitant medications and treatment were not provided. Information regarding other COVID-19 vaccines were not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
NEUROLOGICAL PROBLEMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced neurological problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neurological problems. This report was non-serious.
patient presented with headache, memory loss, and extreme weak legs within 72 hrs of receiving vaccine.  Treated with 3 days of high dose steroids and IVIG.  patient recovering, semi-resolving neuro deficits will require rehabilitation as outpatient.
Pain, after the shot,  fever, body ache , dizziness , until now  my hands  felt warm , no fever.
sneezing; runny nose after getting the first dose of Pfizer COVID-19 vaccine/her nose was just running and dripping; I have allergies but never have one like that; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9263, NDC number and Expiry Date: Unknown), via an unspecified route of administration in Arm Left on 02Feb2021 (Tuesday) at 14:30 as a 1ST DOSE, SINGLE for covid-19 immunisation (age at vaccination was 77 year old). The patient's medical history included allergies. Concomitant medications included montelukast 10mg at bedtime she had been on it a while and fexofenadine hydrochloride (ALLEGRA), 180mg in the morning (It is over the counter. Count Size: 70 tablets. Lot number: 20F211C, expiry: Nov2022), both were taken for allergies. She didn't take Allegra Tuesday morning when she went to get the vaccine, but she did take it yesterday (on unknown date). History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional Vaccines was Administered on Same Date of the Pfizer Suspect. Prior Vaccinations within 4 weeks and AE) following prior vaccinations was None. On 02Feb2021 the patient experienced sneezing and runny nose after getting the first dose of Pfizer COVID-19 vaccine. "her nose was dripping, dripping, dripping quiet a lot but this morning it's better but she was still sneezing (On 02Feb2021). She had allergies but never have one like that on an unspecified date in Feb2021. Patient wanted to know if she can receive the second dose of the vaccine. Upon follow up patient reported that, she got her shot on 02Feb2021. That night she started sneezing. Then her nose was just running and dripping. It is a lot better this morning (date unspecified). It just drips a little. She wanted to know if that mean she is allergic to COVID 19 vaccine and she should get the next one or not. She called the doctor because she was going to ask him because she took allergy pills. She had never had that reaction before where her nose runs and runs. The sneezing and the nose running and dripping has improved. She had only sneezed once this morning. It is not running as bad today (date unspecified). Events did not require a visit to Emergency Room or Physician Office. Outcome of the sneezing and runny nose after getting the first dose of pfizer covid-19 vaccine/her nose was just running, and dripping were recovering, and she had allergies but never had one like that was unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received from a 55 year old female patient referring to herself. The patient had breast cancer approximately 14.5 years ago and she had no drug reactions/allergies. On 18-NOV-2015 the patient was vaccinated with ZOSTAVAX (lot # L012039 with expiration date July 2016, 0.65 ml) in her left arm. No concomitant medications were provided. On 19-NOV-2015, the patient experienced shingles. The shingles was located on her right side around her waist. The patient visited office to seek medical attention. No lab diagnostics studies were performed. Her physician prescribed an unspecified cream, prednisone and acyclovir for the treatment of the event. The outcome of the event was reported as not recovered. Additional information has been requested.
It started out with mainly a minor sore throat. It got worse a couple of days later. The sore throat got a little more painful. By Thursday night, I had body aches, muscle pain, chills, and a lot of mucus and congestion. I didn't have a fever though. On Saturday night, I started taking Paxlovid. The dosage was for 5 days. During those 5 days, the symptoms gradually got better. In the meantime, I also took Tylenol and drank a lot of water. I gargled with salt water. After taking the Paxlovid, the body aches and muscle pain got better. The sore throat eventually got better. The only thing that stayed for a while was the irritated throat from the mucus. It's been a little over two weeks and I still have that.
Patient was immunocompromised and received a booster dose of moderna of 0.25 mL for their third shot rather than the correct 0.5 mL third dose.
Minor nausea; Mild Headache; Tiredness; Chills; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), via an unspecified route of administration in the left arm on 18Dec2020 07:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a facility. Medical history included histoplasmosis, degenerative disc disease, and penicillin allergy. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included diclofenac sodium, methocarbamol, diphenhydramine hydrochloride (BENADRYL), and atorvastatin (LIPITOR). The patient did not receive other vaccine in the last four weeks. On 18Dec2020 16:00, the patient experienced minor nausea, mild headache, tiredness, and chills for about 18 hours. The patient did not receive any treatment for the reported adverse events. The outcome of the events was recovered on 19Dec2020 10:00. The report was considered non-serious.
The patient developed a fever with convulsions consistent with a febrile seizure. The patient had 1-2 shorter subsequent events and then vomited. We are currently monitoring him.
he woke up feeling a choking sensation; dyspnea; neck pain; falling asleep; increased secretions; Injection Site Pain; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING SENSATION (he woke up feeling a choking sensation), DYSPNOEA (dyspnea), NECK PAIN (neck pain), SOMNOLENCE (falling asleep) and INCREASED BRONCHIAL SECRETION (increased secretions) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung upper lobectomy (s/p left upper lobectomy). Previously administered products included for Neck pain: cortisone (spinal injection). Past adverse reactions to the above products included No adverse event with cortisone. Concurrent medical conditions included COPD and Lung cancer (lung cancer of unknown cell type).    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, the patient experienced CHOKING SENSATION (he woke up feeling a choking sensation), DYSPNOEA (dyspnea), NECK PAIN (neck pain), SOMNOLENCE (falling asleep), INCREASED BRONCHIAL SECRETION (increased secretions) and INJECTION SITE PAIN (Injection Site Pain). The patient was treated with OXYCODONE at a dose of 1 dosage form; HYDROCODONE at a dose of 1 dosage form; LORAZEPAM at a dose of 1 dosage form and OXYGEN at a dose of 1 dosage form. At the time of the report, CHOKING SENSATION (he woke up feeling a choking sensation), DYSPNOEA (dyspnea), SOMNOLENCE (falling asleep) and INCREASED BRONCHIAL SECRETION (increased secretions) had resolved and NECK PAIN (neck pain) and INJECTION SITE PAIN (Injection Site Pain) outcome was unknown.            No concomitant medication was reported. Treatment medication included IV rehydration. Patient drank vodka with cranberry juice of unknown amount. Patient received O2 by nasal cannula.
Patient noticed swollen & red area at (L) deltoid 5-19-12. She used TYLENOL and BIOFREEZE at home on this day. Area was also hard. 5-21-12 She reports some itching and redness is less. Provided her today with topical BENADRYL. Redness is size of baseball.
Patient received vaccine and while walking around the store began to feel lightheaded/dizzy and fainted. Her parent caught her and brought her to the ground where she began to have a seizure. Paramedics were called and took over care of the patient. She was conscious and breathing after her seizure
inadvertent administration of just the HIB portion of the Pentacel vaccine to a child/no AE; Initial information received on 29-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 years old male patient who was not administered the other part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] 0.5 ml dose intramuscularly in left thigh on 27-Jan-2020 and reconstituted the HIB with sterile water/no AE (product preparation issue) for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  This is a case of actual medication error due to Inappropriate reconstitution technique.   It was reported patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.  Information on the batch number was requested.
Itching, redness (3 inches wide by 4 inches long), soreness, hot to touch.
covid test result=Positive; covid test result=Positive; Fever 103; chills; muscle ache; joint pain; nausea; extreme headache; injection site pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 20Jan2021 08:45 (lot number: E18982) as single dose at the age of 54 years old, for COVID-19 immunisation. Medical history included interstitial cystitis, palpitations, high cholesterol and covid-19. The patient was not pregnant at the time of vaccination. Concomitant medications included pentosan polysulfate sodium (ELMIRON), metoprolol, oxybutynin, rosuvastatin and Vit (unspecified); all taken for an unspecified indication, start and stop date were not reported. The patient previously took levaquin and experienced allergies. No other vaccines received four weeks prior to COVID vaccination. On 11Feb2021 02:30, the patient experienced fever 103, chills, muscle ache, joint pain, nausea, extreme headache, injection site pain, and tiredness. No treatment was given for these events. On 18Mar2021, the patient's COVID-19 test (nasal swab) was positive. The patient recovered from fever 103, chills, muscle ache, joint pain, nausea, extreme headache, injection site pain, and tiredness on unspecified date. Outcome of the COVID-19 test positive was unknown.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "covid test result=Positive" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.
Tightness in chest, causing shortness of breath. Pain when I inhale deeply. Muscle aches and pains that aren't alleviated with rest, exercise, manual therapy, or stretching. I saw an orthopedic surgeon who said it's not a bone issue.  My oncology physical therapist is concerned.
I was having abdominal pain in the area of my reproductive system. I had severe cramping and like a twisting feeling. It was in the first week of December. I went in and explained to my Gynecologists. I got an ultrasound done and It showed an excess amount of fluid which it typical of a ruptured cyst. It was the first time in my life I have experienced something like that. There were no medications that was prescribed. They told me to take Tylenol for pain management. There is no continued treatment for it. This lasted for about a month and then the pain started to come back in the beginning of March 2022.
stiffness, sore, pain in muscles, legs, arms, back side;14JAN99 soreness;
Severe dizziness started day after FLUZONE HD administered. Treated with MECLIZINE.
Received HPV and VARIVAX in left arm on 11/9. Mild redness around HPV site the next day but yesterday developed swelling over back of arm which has increased. No pain. No fever. Itchy.
First dose almost 3 year ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose with batch number: 24359, almost 3 year before reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-Apr-2022 Reporter's Comments: The reporter was looking information if a non-immunocompromised patient received Shingrix first dose almost 3 year before reporting in other Pharmacy. The reporter consented to follow up via personal e-mail. Additional Supportive Information: The patient had not received the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination.