chrisvoncsefalvay/vaers-outcomes huggingface dataset:
? Weakness - Generalized ? Dry Mouth Patient is an 62 y.o. female  who presented to the ED for evaluation of 1 week history of progressively worsening shortness of breath generalized ,weakness, fatigue, dry cough , chills,and vomiting associated with abdominal pain, and she was found to have COVID-19 viral pneumonia in the ED.
5:08pm - vaccine administered  Approx. 5:20pm - 50 mg of Benadryl taken for itchy throat, need to clear throat, and difficulty swallowing  Approx. 5:40pm - symptoms worsened: 1 adult EpiPen administered and 911 called  At hospital: antihistamine, Pepcid, and saline administered vis IV drip (unsure of dosage or time).
Burning sensation in left abdomen; Hives; Blister; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date in 2021 as a single dose for COVID-19 immunisation. Medical history included breast cancer survivor and high blood pressure since unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) and metoprolol tartrate (MANUFACTURER UNKNOWN); from an unknown start date, for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200 ) via an unspecified route of administration in the right arm on 16Feb2021 as a single dose for COVID-19 immunisation and also received hydrocodone (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 30Mar2021 at 21:00, the patient experienced burning sensation in left abdomen, hives and blister. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.. The clinical outcome of the events burning sensation in left abdomen, hives and blister was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt rec'd 2 days after injection of Menactra and Gardasil c/o increased redness, swelling and area warm to touch. S/B Dr-dx with localized reaction-Benadryl and ice compresses c/o return in AM.
they gave a couple of people doses of the vaccine 30 minutes and 1 hour past 6 hours in the syringe; they gave a couple of people doses of the vaccine 30 minutes and 1 hour past 6 hours in the syringe; arm muscle pain; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 2 patients. This is 1 of 2 reports. A 64-years-old male patient received bnt162b2 (BNT162B2 Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: FA7484; Expiration Date: Sep2021) as dose number unknown, single (at the age of 64-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced they gave a couple of people doses of the vaccine 30 minutes and 1 hour past 6 hours in the syringe on an unspecified date and arm muscle pain on 29Jul2021. Therapeutic measures were not taken as a result of arm muscle pain. Outcome of the event arm muscle pain was not resolved and rest of the events was unknown.  Additional Information: It was unknown if patient had prior vaccination and relevant tests.   Follow-Up (06Aug2021): Follow-up attempts are completed. No further information is expected.  Follow-up (16Aug2021): This is a follow up-spontaneous report from a contactable pharmacist. This pharmacist reported for the patient in response to HCP letter [sent to physician] via follow-up letter which included newly added event (arm muscle pain).   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100971103
Gave MMRV vaccine instead of MMR. Separate Varicella vaccination also given. Patient did not have any adverse effects
The patient described the following adverse reaction to her first Pfizer dose. Swelling of left arm up to neck and down the lefts side of back with pain, throbbing, and numbness. She had severe back and arm pain for 3 weeks. Her gait and movement were impacted. She reported a headache that lasted four days that was focal behind her left eye. 8 weeks post-injection, she still has numbness and some aching pain in her back and neck. She sought care at a doctor's office.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 4/12/2021 and 5/3/2021. Presented to ED on 1/1/2022 with complaints of shortness of breath and diarrhea, with reports of positive COVID test. Saturation on room air 80% on presentation. Started on remdesivir, dexamethasone,  baricitinib, ceftriaxone and azithromycin. Continued to decline requiring intubation on 1/4/2022, and vasopressor support x3. Patient expired on 1/4/2022.
administration of improperly stored vaccines to unknown patients after the temperature; no adverse event; This spontaneous report has been received from an office manager (vaccine coordinator) concerning a patient of unknown gender and age. The patient's drug reactions or allergies, concomitant therapies, medical history, and concurrent conditions were not provided.   On 20-JAN-2022, varicella virus vaccine live (Oka/Merck) (VARIVAX), first dose (formulation, strength, dose vaccination scheme, route of administration, and anatomical site of vaccination were not reported, lot Number U020244, which has been verified to be valid, expiration date reported and validated as 28-JUN-2023), for prophylaxis; underwent a temperature excursion. The vaccine administered was stored at temperature of -14 degrees Celsius (C) during a time frame of 7 hours. It was unknown if a previous temperature excursion occurred or if a data logger was used.  On an unspecified date in 2022, an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (Improper storage of product in use) was administrated to the patient. No additional adverse event was provided.   This was one of eight reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA004997: US-009507513-2205USA005067:02167774 US-009507513-2205USA005084:
My shoulder was sore for several days after the injection. The soreness and tenderness has gone away for the most part. I now have a somewhat limited range of motion and my shoulder aches and becomes stiff. I am not able to move my arm up or back as far as my right arm. It is difficult to put a jacket on.
One week after 2nd dose of Pfizer COVID-19 vaccine, I woke up with severe dizziness which caused nausea vomiting. Symptoms persistent into Friday so went to Emergency Department. CTA of head and neck performed which showed a posterior fossa hemorrhage. MRI confirmed a hemorrhage in the IVth ventricle near the cerebellum.  Per imaging, there is concern for a small cavernous sinus malformation there. Per neurosurgeon, unsure what triggered this bleed.
Initial information received on 10-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves two months old female patient who received 0.5 ml dose of ACT-HIB (batch number, expiry date) intramuscularly in the left leg on an unknown date. Concomitant medications included PREVENAR (lot number U1822AA and expiry date 02 June 2019). It was actual medication error due to Wrong solution used in drug reconstitution as nurse administered the ACTHIB vaccine, but used the diluent for the MMR vaccine. 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 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. Documents held by sender: none.
Narrative:  Patient reported headache following administration of 1st of Moderna Covid vaccine. Patient required no intervention and was able to depart home with no trouble.
615PM on 2FEB93 pt was fussy & crying; pt became extremely pale then turned blue & stopped breathing for about 30 seconds; mom stimulated pt & then began hyperventilating; taken to MD t100; no treatment; mom told was react to pertussis;
Fever cough rash body aches over the past 2 days. I have been using ibuprofen to treat.
I had underlying issues wasn't aware after vaccine now I noticed. I was experienced severe left neck pain and shoulder blade went to  doctor now being treated for degenerative neck disease. In March 2021 experiencing irregular heart beats now I'm on medications. I'm started having episodes of irregular heartbeats was seen by a Cardiologist in June 2021.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 65 years, in left arm 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: "some preexisting gi issues" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No vaccine was received. No other medication in 2 weeks given. Anti-viral details includes Paxlovid, treatment started on 23Jan2023 and stopped on 28Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID  19 and BNT162B2.
red sores all over scalp; scalp hurts; hair is falling out where the spots are; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red sores all over scalp), PAIN OF SKIN (scalp hurts) and ALOPECIA (hair is falling out where the spots are) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ERYTHEMA (red sores all over scalp), PAIN OF SKIN (scalp hurts) and ALOPECIA (hair is falling out where the spots are). At the time of the report, ERYTHEMA (red sores all over scalp), PAIN OF SKIN (scalp hurts) and ALOPECIA (hair is falling out where the spots are) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up received and contains no new information .
16 pts recvd 3 doses of Engerix-B; 6 out of the 16 did not seroconvert;
Information has been received from a female consumer concerning her 12 year old daughter with allergic reaction to antibiotics (amoxicillin) and no pertinent medical history reported who received the first dose of GARDASIL vaccine "3 years ago", in approximately April 2007. It was reported that the patient had all three doses of GARDASIL vaccine (dates not specified). According to the reporter "2 and a half years ago", on approximately November 2007, the patient experienced temporary paralysis from the waist down, migraines for three months straight that progressively got worse. She was tired all the time and went from an active person to someone who could barely get out of bed. The patient also bruised easily, was shaky, sometimes had no feeling in her arms and legs and had high fevers. The consumer stated that the doctors said that "it was all in the patient's head". The patient was going to see a neurologist, possibly in July 2010. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. No diagnostic tests were performed. Upon internal review temporary paralysis from the waist down was determined to be another important medical event. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination, lot numbers, dates of events. Additional information has been requested.
Had chill and headache at gum at school. The nurse checked tempter and have a fever of 100.2. Went to an urgent care for a Covid-19 test, negative results.  Was fine the next day.
Headache, Arthralgia, Fever, Flu-like Symptoms Narrative: Fever 101
Mother reported that pt's "tongue, lips, eyes, throat and penis swelled." "They gave him liquid steroids."
Initial and follow-up information has been received from a certified medical assistant concerning a 9 year old female with no known allergies or pertinent medical history who on 02-OCT-2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 638244/0466L). There was no illness at the time of vaccination. On 16-APR-2007 the patient experienced chickenpox with 10 to 15 vesicular lesions on her trunk, arms, neck and back. Unspecified medical attention was sought. There was no product quality complaint involved. Subsequently, on an unspecified date the patient recovered. No further information was provided. Additional information is not expected.
Fever and chills; Fever and chills; This is a spontaneous report from Pfizer sponsored program. A contactable consumer reported for a male patient (Son).  A male patient of an unknown age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) via an unknown route of administration in Mar2021 as dose 1, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced fever and chills. The consumer reported that her son has experienced fever and chills after getting the 1st dose a week ago. She cannot remember the exact date of the first dose. Caller wants to know if it is safe for her son to take the 2nd dose. The outcome of the events was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
December second 2022 I had a slight headache and a slight dry throat on the fourth of December 2022 I had a slight dry throat and headache then in the evening around eleven PM I tested positive with a COVID-19 antigen test. On the fifth of December I had a 102 degree fever and a more severe sore throat with a bit of phlegm and blood that I produced through my nose, after some sleep my fever reduced to 100 degrees, the same day my doctor prescribed PAXLOVID which I started that evening and I mostly had the same symptoms with the fever gone and then the next few days after that I stayed at home from work resting and hydrating with symptoms improving.
Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 10-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L041206 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 64-year-old female patient who received Shingrix (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. On 24th April 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced blister and vesicular rash. On an unknown date, the outcome of the blister and vesicular rash were recovered/resolved. It was unknown if the reporter considered the blister and vesicular rash to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on the left arm. In 2018, the patient developed blisters on the neck area. As per the pharmacist it looked like the patient developed shingles like symptoms. A definitive diagnosis of shingles was not made. The patient had completely recovered from the blisters. No further data was provided.
sore throat, congestion, runny nose, fatigue, headache, cough, chills, diarrhea. starting 1/3/22
it's very itchy; redness at the injection site; swelling at the injection site; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PRURITUS (it's very itchy), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site). On 06-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (it's very itchy), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PRURITUS (it's very itchy), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   The patient received treatment with Benadryl cream.
Information has been received from a licensed practical nurse concerning a 13 month old female who 05/04/01 was vaccinated with a first dose of MMRII in the left leg. There was no illness at the time of vaccination. The licensed practical nurse reported that on 05/18/01, the patient presented to the office with an erythematous maculo-papular rash on her face, back and legs, which "blanches with pressure, 1-4 mm diameter". The patient was treated with diphenhydramine hydrochloride, (Benadryl). The patient recovered from her experience. No further information is available.
ARM SORENESS, DIFFICULTY SLEEPING, SEVERE WEAKNESS ON AWAKENING, INABILITY TO WALK 10 MINUTES, BARELY ABLE TO WALK, ANOREXIA, SPEND THE NEXT 5 DAYS IN BED ONLY ABLE TO MAKE IT TO RESTROOM AND KITCHEN FOR LIQUIDS, DIFFICULTY THINKING, ABDOMINAL PAIN, CONTINUED WEAKNESS AND ANOREXIA, WEIGHT LOSS NOW AT 17 POUNDS WITH LITTLE TO NO APPETITE AND CONTINUED ABDOMINAL PAIN. NOW I HAVE TO MAKE MYSELF EAT CARBS TO NOT LOSE MORE WEIGHT, STILL HAVE ABDOMINAL PAIN. I HAVE BEEN ABSOLUTELY MISERABLE TAKING NUMEROUS MEDICATIONS AND STILL CANNOT EAT DUE TO ANOREXIA AND ABDOMINAL PAIN.
swollen/painful left axillary lymph nodes and cervical lymph nodes; swollen/painful left axillary lymph nodes and cervical lymph nodes; Max temp 101F 24 hrs after receiving vaccine; bruising at injection site; muscle soreness; general fatigue; moderate-severe headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 13:30 (Lot number: FF8841) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Reynaud's Syndrome" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; ADDERALL. Vaccination history included: Bnt162b2 (Dose 2, Single, Lot number: EL3246, Dose administration time: 09:45AM, vaccine location: Left arm), administration date: 19Jan2021, when the patient was 27 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, Single, Lot number: EK9231, dose administration time: 09:45AM, vaccine location: Left arm), administration date: 29Dec2020, when the patient was 27 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 07Oct2021 17:00, outcome "recovering" and all described as "swollen/painful left axillary lymph nodes and cervical lymph nodes"; PYREXIA (non-serious) with onset 07Oct2021 17:00, outcome "recovering", described as "Max temp 101F 24 hrs after receiving vaccine"; VACCINATION SITE BRUISING (non-serious) with onset 07Oct2021 17:00, outcome "recovering", described as "bruising at injection site"; MYALGIA (non-serious) with onset 07Oct2021 17:00, outcome "recovering", described as "muscle soreness"; FATIGUE (non-serious) with onset 07Oct2021 17:00, outcome "recovering", described as "general fatigue"; HEADACHE (non-serious) with onset 07Oct2021 17:00, outcome "recovering", described as "moderate-severe headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain, pyrexia, vaccination site bruising, myalgia, fatigue, headache.  Additional information: The patient received AE treatment as Tylenol. Patient did not have covid prior vaccination and covid was tested post vaccination. The patient underwent Nasal swab test (PCR test) on 26Jan2021, 29Jan2021, 12Jul2021 and 15Jul2021 and tested negative each time.  Follow-up attempts are completed. No further information is expected.