chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 63 year old female with no known drug allergies and who was first diagnosed with herpes zoster ophthalmic in 2005 who on 20-FEB-2009 was vaccinated SC with a dose of ZOSTAVAX (Merck) (dose reported as 0.6mg, lot number 663895/0135Y). Concomitant therapy included simvastatin (manufacturer unknown), VALTREX and aspirin. The physician reported that when the patient was vaccinated, her current medication VALTREX was withheld for two weeks post vaccination. A week after being vaccinated (on 27-FEB-2009) the patient experienced a flare-up of herpes zoster ophthalmicus of her right eye. She was treated with "two courses" of VALTREX for 14 to 20 days with no improvement noted. The physician was consulting an ophthalmologist. No lab studies were performed. At the time of reporting the patient had not recovered from flare-up of herpes zoster ophthalmicus. Flare-up of herpes zoster ophthalmicus was considered to be disabling by the reporting physician. Additional information has been requested.
7 year old child received a dose of Daptacel for their second dose with no reported adverse event; 7 year old child received a dose of Daptacel for their second dose with no reported adverse event; Initial information received on 28-Apr-2022 regarding an unsolicited valid non-serious case received from other health professional.   This case involves a 7-year-old patient of unknown gender who received a dose of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] for their second dose with no reported adverse event.     The patient's past medical history and family history were not provided.  The patient received no concomitant and additional medication.      On an unknown date, the patient received a dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine form:Suspension for injection, lot number not reported via unknown route in unknown administration site, drug structure dosage: na, drug interval dosage: once, drug treatment duration: na; for Immunisation.     On an unknown date Office manager reported that a 7-year-old child received a dose of daptacel for their second dose with no reported adverse event (inappropriate schedule of product administration) and (Inappropriate age at vaccine administration) (unknown latency). Caller asked if it would cause a problem. Caller declined to provide her address or information on the patient. Batch/lot number requested, not available at the time of call. Caller refused follow-up. This is reported as a potential Adverse Event because of a medication error (inappropriate use). To be evaluated by Reporter relationship : HCP Product used : Used First time product used : Yes Still using product : No.   Action taken was not applicable.  Outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine stored in fridge starting on 10/20/2021. According to the manufacturer it is good to be stored in the fridge for 31 days. The expiration date of 31 days was on Saturday,  11/20/2021. The dose was drawn up and given. After dose was given and paperwork was being filled out, the vaccine administrator realized that the dose was technically past the 31 day mark. Patient notified and told that they would be contacted about next steps or if a repeat dose would need to be given once the manufacturer was contacted. Pfizer was contacted and advised that they had no data related to this type of event and that we shouldn't do anything until a form was filled out and a representative from Pfizer contacted us. We are currently waiting on that information.
Glands in neck started hurting which got worst everyday after. Headaches and Joint pain, fever and dizziness
Patient reported the tip of his tongue feeling "tickly" 10 minutes post injection. Denied any other complaints or concerns. At 20 minutes post injection, he reported it was starting to get better. Denied any other complaints or concerns at that time as well. Drank some water at this time and felt it was improving. Patient reported at 30 minutes post injection that the "tickly" feeling on his tongue was gone and requested to leave. Patient alert and oriented, no other signs or symptoms, denied any breathing concerns. Left clinic ambulatory. Encouraged to report to urgent care if symptoms returned or worsened. Agreed to plan and verbalized understanding.
injected in his joint; Horrible pain; This spontaneous report was received from a physician, who was also a 62-year-old male patient, who received the Moderna COVID-19 vaccine (mRNA-1273) and experienced injected in his joint and horrible pain.   The patient's medical history was not provided. Concomitant medications were not reported. The facility where the vaccine was given was not provided.  On 31 Dec 2020, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 for COVID-19 prophylaxis. He believed he was injected in his joint instead of the muscle of his left arm. He was in "horrible pain" and went to see his physician. Treatment for the event included a steroid shot, ibuprofen, and paracetamol for pain.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, horrible pain, was not reported. The outcome of the event, injected in his joint, was resolved on 31 Dec 2020.; Reporter's Comments: This report refers to a case of a 62-year-old male patient who experienced non-serious of injected in his joint (Vaccine administered at inappropriate site) and horrible pain for mRNA-1273, lot # unknown), Exp date unknown. Injection site pain is consistent with the known safety profile of the vaccine, hence, based on the information provided, a causal association between the administration of the vaccine and the event of horrible pain cannot be excluded.  The event of injected in his joint is assessed as not applicable.
Cough, SOB, rash evaluated at ER. Tx with Nebulizer, IV SOLU-MEDROL, CXR.
11/19 6:15PM pain and swelling in the area of the injection on the right arm; administered ice compact throughout the evening. 11/20 6:00AM - still sore and swollen; 2:00PM - developed hives on the inside of the arm which spread to shoulder, slight headache and extreme fatigue; Advil and Zyrtec were taken. 11/21 hives, pain, and swelling remained; no treatment. 11/22 symptoms diminished; no treatment.
She has 102 fever; she is felling worried; This is a spontaneous report from a contactable consumer (patient's son). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 29May2021 as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 for COVID-19 immunisation. On 30May2021, the patient experienced she has 102 fever and she is felling worried. She was getting worried because she has 102 fever. So she want to know if she need to go to the doctor or she need to do something. The consumer further asked that was it normal, he need to know everything because the patient was feeling worried about all that. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
pt finished Ceclor 29SEP92 evening; small rash started 29SEP92; 30SEP92 pt had huge red welts & joint swelling (lt knee was 1st affected then progressed to all joints); tx w/Pred & atarax;
Patient presented to the ED and was subsequently hospitalized for a fall, generalized weakness, ketoacidosis, lung cancer metastatic to brain within 6 weeks of receiving covid vaccination.
2nd dose administered as half dose (0.25ml) instead of full dose (0.5ml); 1st dose: 23Mar2022 ,2nd dose: 27Apr2022 .36 days; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (2nd dose administered as half dose (0.25ml) instead of full dose (0.5ml)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 23Mar2022 ,2nd dose: 27Apr2022 .36 days) in a 100-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 027L21A and 083J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 27-Apr-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .25 milliliter. On 27-Apr-2022, the patient experienced ACCIDENTAL UNDERDOSE (2nd dose administered as half dose (0.25ml) instead of full dose (0.5ml)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 23Mar2022 ,2nd dose: 27Apr2022 .36 days). At the time of the report, ACCIDENTAL UNDERDOSE (2nd dose administered as half dose (0.25ml) instead of full dose (0.5ml)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 23Mar2022 ,2nd dose: 27Apr2022 .36 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Patient received expired 1st Moderna Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired 1st Moderna Booster) 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 04-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired 1st Moderna Booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired 1st Moderna Booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.
Lump, redness, warm to touch, patient concerned, affected area is larger than a 50 cent piece.
hives; This case was reported by a nurse via call center representative and described the occurrence of hives in a child female patient who received DTPa (Infanrix) (batch number HY2G7, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, unknown after receiving Infanrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Infanrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse stated that patient developed hives after receiving 3 immunizations in one day, one of which was Infanrix. The reporter had not expiration date. It was unknown if the reporter considered the hives to be related to other 2 vaccines (unspecified). The reporter had consented to follow up.
Eye started to swell.  Saw eye Dr. and she said it was a stye.  The eye continued to swell and was completely closed in 4-5 days.  Saw eye Dr. again and was immediately sent to the ER. Was hospitalized for 8 days with multiple scans of the eye, head and body. Diagnosis was damage to the 3rd cranial nerve.  No treatment. It may get better in time. Eye can not be opened and pupil is not straight.  There is double vision when examined. Also weakness and nausea since flu shot. Oddly, I also had eye shingles after a flu shot 2 years ago.
Good smells become bad; Slight taste changes; Shortness of breath; Sense of smell has gone completely off the charts; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Good smells become bad), TASTE DISORDER (Slight taste changes), DYSPNOEA (Shortness of breath) and ANOSMIA (Sense of smell has gone completely off the charts) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAROSMIA (Good smells become bad), TASTE DISORDER (Slight taste changes), DYSPNOEA (Shortness of breath) and ANOSMIA (Sense of smell has gone completely off the charts). At the time of the report, PAROSMIA (Good smells become bad), TASTE DISORDER (Slight taste changes), DYSPNOEA (Shortness of breath) and ANOSMIA (Sense of smell has gone completely off the charts) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was  not applicable HCP information documented. Provided consent to follow-up.
12:26.  Abupt onset of heart "palpitations". Evaluated by onsite EMS and NP.  12:28 BP 156/85; HR 98; R 20. 12:38. Palpitations have stopped VS 136/88- 78- R 16.  Stated she felt better. Discharged home at 12:40
Patient received PNEUMOVAX and within 12 hrs had redness, swelling and pain at injection site.
On 02/25/2021 at 6:00 am I awoke with raised itchy urticaria on both lower arms. By 12:00 noon the urticaria spread to upper arms with intense itching. By 9:00 pm the urticaria spread to upper chest. I self-treated with OTC oral diphenhydramine 50 mg and local application of hydrocortisone 1% cream. Itching became worse by 02/26/2021 at 4:00 am. Took another dose of diphenhydramine 50 mg. During 02/26/2021 and 02/27/2021 urticaria spread to neck and lower torso, lips swelled, voice became hoarse. Felt fatigued and had occasional chills, but no fever. I took diphenhydramine 25 mg every 4 hours for relief. By 02/28/2021 all symptoms subsided and felt better. I notified my Primary Care Physician.
Drug ineffective; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 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: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "recovered" (2023); DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "recovered" (2023). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: New positive test after two negative tests 48 hours; Negative, notes: New positive test after two negative tests 48 hours; Negative, notes: New positive test after two negative tests 48 hours. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 01Jun2023 to 05Jun2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, 'Drug Ineffective and Covid19 were assessed as related to the suspect product due to a plausible temporal association.,Linked Report(s) : US-PFIZER INC-202300219515 same patient, different drug, different event;
migrating arthritis & arthralgia for 3wk;rt middle finger lt index & middle finger lt knee;bilat ankles & great toes;lt 3rd metacarpal; gave Lodeine then 2x oral prednisone;
3 days p/vax pt had low grade fever, pt began to vomit p/feeding, appetite was off, fussy at times, diarrhea, looked like pt was gassy, colicky at times.
onset of rashes noted on both cheeks & neck;feels hot;no resp problems;no itching;given DPH;P80;RR 22;
Information has been received from a nurse practitioner concerning a "few" patients (ages and genders unknown), who, on an unspecified dates, were vaccinated with doses of GARDASIL. Subsequently, when the patients were returning to receive another dose of GARDASIL the patients had redness in the :shape of a band aid" at the injection site. At the time of the report, the outcomes of the patients were unknown.  This is one of two reports from the same source. Additional information has been requested.
Patient received 0.3 mL of undiluted dose of Pfizer vaccine on 9/21/2021. This was his first dose of the series which equated to ~4 doses. Patient stayed in the pharmacy for 15 minutes for observation and appeared fine with no reactions. Contacted patient's mother and father and informed them of the situation. Followed up with call over the next 2 days to monitor any symptoms. Mother has stated that he had not experienced any symptoms of headache, chills, fever, or fatigue on 9/22 or 9/23. Also contacted patient's PCP and left a message about the situation as well.
temperature 109 F; dizzy; she feels nauseous; arm is hurting; A spontaneous report  was received from a consumer concerning a 73-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced the events body temperature 109F, she feels nauseous, arm is hurting, dizzy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) for prophylaxis of COVID-19 infection.    On 03-FEB-2021 the patient experienced the events body temperature 109F (medically significant), she feels nauseous, arm is hurting, dizzy.   Treatment information included paracetamol (Tylenol).  Laboratory data included body temperature which was 109 F.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events body temperature 109F, she feels nauseous, arm is hurting, dizzy was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
A rash started developing about within a day or two of the vaccination. By day 4 or 5, the rash was spreading and appearing in other areas including scalp. By day 6, I was in complete distress. Saw Dermatologist on Day 6 and was prescribed Prednisone and increased antihistamines up to the day of the second injection scheduled for Feb 5, 2021. By today, Day 10, the rash has mostly receded while I continue meds prescribed. I believe that I had Covid early on starting March 28 accompanied by sudden fatigue, nausea, fever, chills, body aches, no appetite, for the first few days, then developed hives all over face and head until my eyes were swollen shut. My doctors, both derm and primary, didn't want me to be tested or come in or go to the hospital, perhaps because so early on in the pandemic, little was known and they feared if it wasn't Covid, I would contract it in those circumstances. They again prescribed creams and antibiotics and prednisone.  I don't remember how the rash side effects lasted but I continue to have scalp problems since. I did not have a cough, but did experience instances of shortness of breath 7 to 10 days after the onset. The fatigue, body aches and brain fog continued for  months. I was feeling much better by the time I got the vaccine and then returned to the rash symptoms I had had before.
Enlarged erythematic, warm, indurated area 16 X 12 cm Right arm, treament includes Keflex as well as Benadryl
Parent brought patient into clinic on 5-13-04 complains of pt's arm (left) being hot, red from receiving a vaccination of DTaP # 4 on 5-11-04. This reaction was noticed on 5-12-04. 3 attempts to follow-up were unsuccessful on 5-14-4. 1 attempt on 5-17-04 to follow up was unsuccessful.
Pain began in upper right arm and radiated down to wrist for first week. Upon slightest movement around arm, pain ensued even worse as is and did not allow sleep. Pain has  limited shoulder mobility for 2 weeks. Received Hydrocodeine-acetiminophen and Ibuprofen at ER on Monday January 25 for 3 days. Then, upon follow up with PCP, medication for pain relief was prescribed as followed: ibuprofen 800 mg and Gabapentin. Pain has subsided but remains upon slight movement of shoulder.
Temperature was mid-40s. I was wearing gloves (not heavy) and had an episode of Reynaud phenomenon in my R index finger. The distal phalanx was white, cold and painful for about half an hour. It resolved spontaneously. I had never had a previous episode, and it has not recurred since then.
Injection site pain, inflammation, and erythema (days 1-4). marked upper arm pain (shoulder to elbow; day 1-3). low-grade fever and marked fatigue (days 1-3).   Injection site palpable, superficial, swelling with development of bruising (days 2-4; bruising has consistently gotten larger; Present day ~0.5 inch x 2 inches) .  Headache/migraine (days 1-3)  Have taken 400 mg ibuprofen x 5 doses from day 1-3 with icing L arm
pain in her right wrist/pain in her left wrist; This is a spontaneous report from a contactable consumer (reported for herself). A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 intramuscular, administered in arm left on 19Jan2021 (at the age of 78-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines on the same day of vaccine vaccination. The 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. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in Jan2021, the patient experienced pain in her right wrist/pain in her left wrist. Therapeutic measures were taken as a result of event with included treatment with Tylenol and Tylenol arthritis. Dose 2 was scheduled on 09Feb2021. The outcome of the event was not resolved.  Description of Product Complaint: Description of complaint: She said that she had the first vaccine, and she plays tennis and had a pain in the right hand and wrist. She was getting it in the left wrist too playing tennis. She said that she wondered if it was arthritis. She said that she took Tylenol and Tylenol arthritis, and it was not really doing anything to help it. She stated that the pain was not alleviated with the Tylenol for arthritis. By process of elimination, she thought it was the vaccine. , Lot, or expiration date for the Tylenol or Tylenol Arthritis. She thinks she bought it a year ago and said that it all should've been ok.   Follow-up attempts are completed. No further information is expected.
Shivering, muscle pain, heart raced 97-100bpm.  Initial symptoms began about 4 hours after vaccine given and worsened throughout the day/evening.  Elevated heart-rate began about 9pm and lasted several hours. They resolved on own. Pt did not seek ER care. Today patient reports  headache and fatigue. .