chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in received second dose Pfizer vaccine at 3:00pm and reported she had burning sensation in top of mouth, throat, chest area at 15:03. Patient stated this reaction had also occured after first dose and lasted 3 days.  Patient vitals were 99% O2, pulse 82, BP 122/82, Resp. 18 at time of reaction. Patient has no s/s of shortness of breath, n/v, dizziness, swelling, hives.  Patient was given 25mg of PO diphenhydramine and monitored for 30minutes. No increase in symptoms. Patient left with symptoms starting to resolved. Patient educated by provider on site to take famotidine and continue diphenhydramine PO as needed every 4-6 hours. If s/s increase to report to the emergency department.
Nurse administered too much vaccine.  Per mother, patient has headache, nausea and vomiting.  Advised to notify nurse tomorrow if symptoms not improving.
No additional AE information; temperature excursion; Information has been received from an administrator referring to a 14 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 24-MAR-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 1.48 degree Celsius. The time frame was 0.35 hours on 01-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
Pt reported that about 1 week after her second covid vaccine she experienced severe arm weakness in the side she received the shot (left). The weakness and muscle tenderness spread across her chest and up through her neck on the opposite side (right). This lasted for about 2 weeks and has since resolved
Pt had burning sensation of stabbing and tightness.  PT feels this was muscular in nature and perhaps irritated the tendon.  she had limited ROM at injection site and had Physical therapy to increase range of motion and decrease pain.  This has taken approx 3 months.
Erythema deltoids bilat without edema/adenopathy/fever, pain or pruritus.
Pt complained of fever, temperature not taken;felt dizzy and could not concentrate for 3-4 days post vax.
Patient has experienced tingling and numbing sensation in his left arm since the date he was given his booster shot. He said that he also feels the tingling and numbness in his index finger and thumb of his left hand.
TIREDNESS; UNEXPECTED THERAPEUTIC BENEFIT; FEVER; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included sensory neural hearing loss, tinnitus, and inner ear sepsis, and concurrent conditions included hearing aid user.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.8 F. On 12-APR-2021, the subject experienced unexpected therapeutic benefit. On 14-APR-2021, the subject experienced tiredness. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative, and Hearing test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 12-APR-2021, was recovering from tiredness, and the outcome of unexpected therapeutic benefit was not reported. This report was non-serious.; Sender's Comments: V1: Medical Assessment Comment not required as per standard procedure as case assessed as Non serious.
Anaphylactoid: throat itching and swelling; loss of voice; nausea; diarrhea.  Throat itching began within the first 5-6 minutes post vaccine; nurses in attendance gave me 25mg Benadryl within first 10 minutes and a second 25mg dose after the next 15 min...the diphenhydramine didn't take effect.  The nurse took my BP and attached a device to monitor my oxygen level.  After another 15 minutes, I felt disoriented, my voice became hoarse and I could barely talk...the nurse told me that my oxygen saturation was still good.  I began to feel nauseated and had stomach cramps and bowel urgency.  At that point, the nurse in attendance brought a wheelchair and took me to the ER, allowing me to stop to use the restroom.  ER physician gave me famotidine 20mg and oral prednisone and watched me for 2+ hours.  When I felt more oriented, they allowed me to go home.  I did not require epinephrine, but the ER physican told me that I should NOT take the second dose.  I followed up at home with  Benadryl 25mg bid for 4 days.  My voice returned in 6 days. I followed up my primary care physician, on Jan. 23rd...she also told me not to take the second dose.  My primary care also advised me NOT to take the second dose.  Please note:  ran a basic  blood panel as a part of my annual physical on Jan. 27th.  The results came back with all my levels totally off the chart!!   She had the test repeated on Feb. 16th and all my levels were back to normal.  She noted that the discrepancy must have been a result of my reaction to the Pfizer vaccine and suggested that she would let her patients know NOT to have bloodwork done within 14 days of their COVID vaccine.
got the Pfizer Covid vaccine/4 years old male; Went to (name withheld) yesterday for their flu shot but instead got the Pfizer Covid vaccine; fever; body aches; head ache/Head hurting; stomach ache; arm pain/Arm hurt; This is a spontaneous report from Pfizer-sponsored program from a contactable consumer (patient's father) via medical information team. This is report 3 of 4 reports.     A 4-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 04Oct2021 at 16:00 (at the age of 4 years old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Patient had no medical history and there were no concomitant medications. The reporter and his wife with 2 children all went to get the flu vaccine, but were given doses of the Pfizer Covid 19 Vaccine instead. Both of the children were given full adult doses of the Pfizer Covid 19 Vaccine. On 04Oct2021, the patient started experiencing fever, body aches, head ache, stomach ache and arm pain. The reporter stated that the patient received the vaccine around 16:00. About 3 hours later the patient began to have a fever, body aches, head hurting. The patient's temperature at the time was 99.8. Reporter states they gave the patient fever reducer, Ibuprofen, and were told to take him to the hospital if the fever persisted. He states that the patient's fever lowered, he woke up at night and it was back up to 99.8 and he was complaining of a stomach ache and that his arm hurt. Reporter stated the patient's symptoms were all persisting. They were alternating Tylenol and Ibuprofen. The patient underwent lab tests and procedures which included body temperature: 99.8 on 04Oct2021. Therapeutic measures were taken as a result of fever, body aches, head ache/head hurting, stomach ache, arm pain/arm hurt. The clinical outcome of fever, body aches, head ache, stomach ache and arm pain was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 11:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 11:43 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 27.03.  No concomitant medications were reported.  The vial was initially stored in the fridge on 08-Jan-2021, moved to clinic on 11-Jan-2021 and proposed beyond use date was 07-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On the date of administration, at 09:00 A.M, the temperature recorded was 34 degree Fahrenheit and at 02:00 P.M, the temperature recorded was 35 degree Fahrenheit, that has been reached by the vial.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Dime-sized, not raised, red spot, distal (L) of injection site. Hard upon palpation.
red rash at injection site rectangular in shape 1 by 2 inches; A spontaneous report was received from a consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red rash at injection site rectangular in shape 1 by 2 inches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 051L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 7 Feb 2021, the patient experienced the event(s) red rash at injection site rectangular in shape 1 by 2 inches.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), red rash at injection site rectangular in shape 1 by 2 inches was unknown.
When I first started having issues, it was a runny nose rhinitis and a cough, it increasing started to feel worse and more frequent. On Friday I tested myself at home and was negative but the condition got worse. I purchased a test from the drug store and it tested positive. I called my provider and he called in a prescription for Paxlovid. The doctor told me to not take the Silodosin and Advair while taking the Paxlovid. The cough is painful. I have a sleep machine that I was unable to use due to excessive coughing. I'd believe I am improving.
Local puffiness, redness. Patient to apply hydrocortisone. Reaction may possibly be from bandaid.
10/16/2010-shot given no pain or rxn 10/17/2010-tiny bruise seen at site 10/18/2010-2"x2" red, raised, hot area in a.m. and viewed by me at 5 p.m.
PT  HAD FEVER AND INJECTION SITE REACTION; SWELLING ON LEFT ARM. RECOMMENDED TO USE TYLENOL AND IBUPROFEN OTC; BENADRYL,25 AT BEDTIME AND CORTISONE CREAM.
Mild case of varicella zoster reactivation (Shingles) accompanied by lymphadenopathy.
This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown ages and genders. On unknown dates the patients were administered with GARDASIL (lot#, route and dose not reported) that were stored improperly. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Chronic diarrhea/Diarrhea since 1st dose/He stated that 7 months later they are still taking medications (anti-diarrheal treatment); This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Chronic diarrhea/Diarrhea since 1st dose/He stated that 7 months later they are still taking medications (anti-diarrheal treatment)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DIARRHOEA (Chronic diarrhea/Diarrhea since 1st dose/He stated that 7 months later they are still taking medications (anti-diarrheal treatment)). The patient was treated with LOPERAMIDE HYDROCHLORIDE (ANTI-DIARRHEAL) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Chronic diarrhea/Diarrhea since 1st dose/He stated that 7 months later they are still taking medications (anti-diarrheal treatment)) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Reporter stated that 7 months later they are still taking medications (anti-diarrheal treatment). Before they had diarrheal episodes 6-7 times a day but now it is 2-3 times a day.
Covid Arm. On 2/23/21 I had a swollen, red, itchy painful arm at the injection site after no symptoms for several days.
These conditions are still ongoing over a year later. They were the worst the first seven months and got somewhat better but still battling these everyday. The dizziness and  extreme fatigue waxes and wanes. Dizziness, extreme fatigue, tinnitus, achiness, eyes aching, anxiety, weakness, insomnia, hair loss, nerve pain.
very bad headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "very bad headache".  Additional information: First Name: withheld (Further not appropriately clarified hence captured Unknown in tab; Initial of First name clarified as I hence Patient Initials captured as withheld in Initials tab) Concern: Consumer stated, "I got the Pfizer booster (Further clarification unknown hence suspect captured as Unspecified Product) yesterday and I have a very bad headache and I must looking on there to see if I can take some Tylenol but they are saying that I cannot (Further clarification Unknown). All day (Incomplete Sentence)." When probed if patient has any query: Consumer further stated, "No, I just need to find out and see what I can take?" Consumer was informed about the role of the Pfizer Drug Safety. Consumer was informed about the Medical Information Department. Consumer stated, "Can you transfer me to that department?" Consumer was provided with the Pfizer Medical Information contact # as withheld and requested to press Option#3 and informed about timings from 9 am to 8 pm. Consumer stated, "This is so 'hard' for me, just please transfer me." The call got disconnected while transferring the call to Pfizer Medical Information department. Further probing could not be done. Transfer Incomplete. Product details (LOT#, Expiration Date, NDC# and UPC#) and Pharmacy details could not be probed. Hence limited information available over the call.  QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 68 year-old female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (Lot number: EW0151) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PNEUMOCOCCAL VACCINE. The following information was reported: FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "very tired"; DIZZINESS (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "dizzy"; VOMITING (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "threw up".  Additional information: Patient who received the first dose of the Pfizer BioNTech COVID-19 vaccine a couple of weeks ago on Friday 9APR2021 and reported that she went to the doctor this week for a check up and received her pneumonia shot. She states that she was scheduled to receive her second dose of the vaccine this coming Wednesday but has heard from other people that she can't get it now because she received the pneumonia vaccine. She would like to know if it is safe for her to receive her second dose. She states her sister went to get her COVID-19 vaccination and was told by her doctor that you cannot do two at a time. Caller reports she has also spoke to her doctor and pharmacist who instructed her to call Pfizer for further information.  Patient also reported that with her first dose of the vaccine, she woke up the following Saturday and felt "very tired", dizzy, and states she threw up. She states that these symptoms were the same as "having the virus" and states that these symptoms went away after 24 hours.  Patient was to HCP (health care professional) for further guidance.  No follow-up attempts are possible. No further information is expected.
Urticaria type reaction on upper left arm consisting of 5-10 hives with well defined borders. Hives were not itchy or irritating in behavior, but were dry and scaly in nature. Rash appeared sometime overnight follow vaccine administration and was noticed the following morning.  Wheal and flare type reaction appearing on both thighs just above the knee. Presentation was more severe on the left leg with swelling causing noticeable elevation of the area from the skin. Flare-up was itchy and reasonably bothersome.  Adverse events were regarded as relatively mild with minimal symptom management needed. Treatment consisted of only an application of Desonide to the areas on the legs which relieved the itchiness and mild burning sensation.
Information has been received from a pharmacist concerning a 75 year old male patient who on 16-DEC-2010 was vaccinated with ZOSTAVAX (Merck) (lot # not reported) by another pharmacy. In December 2010 (also reported as on an unspecified date), the patient started to experience right leg pain from his hip to his shin. The patient was given PERCOCET for pain at night. At the time of reporting, the patient's right leg pain from his hip to his shin persisted. The patient had sought unspecified medical attention. Additional information has been requested.
the hair was completely white grey and now is starting to have black hair; started grow it's hair back / a new follicle on my bald area; This spontaneous case was reported by a consumer and describes the occurrence of HAIR COLOUR CHANGES (the hair was completely white grey and now is starting to have black hair) and HAIR GROWTH ABNORMAL (started grow it's hair back / a new follicle on my bald area) 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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAIR COLOUR CHANGES (the hair was completely white grey and now is starting to have black hair) and HAIR GROWTH ABNORMAL (started grow it's hair back / a new follicle on my bald area). At the time of the report, HAIR COLOUR CHANGES (the hair was completely white grey and now is starting to have black hair) and HAIR GROWTH ABNORMAL (started grow it's hair back / a new follicle on my bald area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Information was not provided by the reporter.
Information has been received from a physician concerning a 16 year old female patient who was vaccinated IM with the first dose of GARDASIL vaccine (lot number not provided).  Subsequently the patient experienced fainting in the waiting room of the physician's office.  At the time of this report, the patient recovered.  The patient sought unspecified medical attention.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 2/13/2009. Follow up information was received from a physician concerning a 16 year old female who was vaccinated IM with the first dose of GARDASIL vaccine. Subsequently the patient experienced syncope. The patient recovered within five minutes. No lab diagnostic studies were performed. No other adverse events were noted. The patient did not seek medical attention. Additional information is not expected.