chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAIN IN ARM; This spontaneous report received from a patient via a company representative concerned a 70 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. No adverse event reported post primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced pain in arm (dose number in series 2). The pharmacist suggested patient a to take Motrin. The patient inquired about risk, as patient don't want to have stroke or heart attack (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in arm was not reported. This report was non-serious.
Patient went to ER complaining of chest pain x 2 days, this was 10 days after smallpox vaccination.
This spontaneous report refers to a consumer concerning a 62 year old female patient as other company letter. Concurrent condition included: heart disease (RA). On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot # L014876, expiry: 13-JAN-2017) in the right arm. On an unknown date the patient experienced cellulitis in the right arm. The outcome of cellulitis was unknown. Causality assessment was not reported. Additional information has been requested.
FATIGUE, MUSCLE ACHES, JOINT PAIN, LOW GRADE FEVER 99.8
Pfizer on 2/3 and 2/24. Positive on 8/24 admitted on 8/31 to current
This is a spontaneous report received from a contactable consumer or other non-HCP (parent). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FK5127), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient (reporter's daughter) developed urticaria (hives on her stomach and legs) and had hypersensitivity (allergic reaction to the vaccine), with outcome of unknown. No follow-up attempts possible. No further information expected.
the sensation of swelling of posterior tongue and lower pharynx swelling like an allergic reaction but tongue not visibly swollen about 30 minutes after administration of 1st dose. Took oral anti-histamine, and symptoms resolved after 1 hour.
I got the  vaccination shot I started to itch all over and severe headache develop with nausea and could not hold down any food,  the next day I went to the ER where I received IV fluids, I was discharged they suggested Benadryl and prescribed medicine for nausea.  The ER physician encouraged me to get second dose ,  I received second dose two weeks later,  I began to itch all over immediately and a rash developed right after the 15 minute waiting period.  While driving my face began to swell, my eyes swelled closing them and impairing my vision went back the ER no treatment at that time because the situation did not worsen.   A week later I went to a ( Urgent Care )  they prescribed me cream for the rash, three days after I reported to my primary care physician for three visits the swelling remained for over month,  these symptoms did not subside until mid- August.
Initial and follow up information has been received from a procurement officer and a Registered Nurse concerning a student patient with no pertinent medical history who on approximately 25-JAN-2011, two weeks ago was vaccinated with one dose of PNEUMOVAX 23. "Two weeks ago" the patient had a rash adverse reaction to the PNEUMOVAX 23 injection. The nurse reported that the rash was actually a large, local infection and the student presented with a fever as well. It was unknown if the patient sought any medical attention. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
8 hours after shot, fever, headaches, chills, body aches, nausea symptoms resolved completely- 4 pm 4/28/09
I started to develop deep chills, fatigue, and generalized muscle soreness at 9 pm. Then I developed a101.6 oral temp on 2/28/21 around 155 am. I took 1 gram of Tylenol at that time. As of this am my temp is 99.4 and I still have the chills,fatigue, and soreness. Thank you.
Pt vacc. HIB 31AUG90 9AM later that day developed severe headache, fever, body aches, sore throat.
Approximately 4 mins after receiving Spikevax Covid vaccine; patient is seen  grabbing his chest when asked if he was ok,  patient is hardly able to speak;  asking if this is normal after the injection.  Patient  is complaining of  "feeling funny, Tightening  of chest and throat".  Wheezing noted.  Nurse mgr.  called to assist.  Oxygen level noted to 76% on RA. Emergency kit opened and Epi  Pen Auto Injector of 0.3mg given at 1125am in the Right thigh while Nurse Mgr.  called emergency services. BP: 214/79 HR 73.  5 min post EPI: BP: 190/90 HR 66  Pulse OX 97%;  Patient reporting feeling much better. Breathing was unlabored and no wheezing  noted. 10 mins post Epi: BP: 183/84 Hr 68 Pulse Ox: 97%  Ambulance arrives at  1145 and transfer of care given. Patient notified not to receive any additional  doses of the COVID Vaccine.
Swelling 5cm X 7cm, redness, warmth and tenderness. Office visit 8/15/02. Symptomatic treatment.
pt states that she since the day after taking the covid vax that she has been having heart burn and constipation.  She has been using drinking Prune juice, taking anti-acids and taking probiotics to help. Pt will call her PCP if her symptoms continue.
1640 male here to receive school vaccines Bexsero, HPV and Menquafi. Child was accompanied  by his mother. Patient was very anxious prior to vaccine administration. RN gave child phycological reassurance. After child received 3rd vaccine (HPV), without warning  he fell to the floor, hitting his face forward  to the floor. The chair fell  on top of the child. After the child hit the floor, he convulsed for 5 secs. RN and mother attempted to raise his head of off the floor. RN and mother held the  child and yelled out for assistance. Tech took child's vitals. 106/64 - 78 RN and  mother was able to get child in sitting position.  Child vomited x2 C/O nausea. Cool wet compress applied to child's head, along with ice pack to back of his Neck. Clerk called emergency services. Fan turned on to cool child due to C/O feeling hot. Observed a reddened area about  a half dollar sized circle to child's forehead.  0 hematoma or lump noted. Child was alert and talkative after in sitting position. Patient stated his Name, date, day of week and  location correctly. Child denied dizziness or  any weakness or headaches. EMT arrived @ 1:50pm. Vital Signs taken by EMT staff.  EMT assisted child off of floor to standing  position where his BP was taken again.
Approximately two hours after receiving Janssen Covid19 vaccine, patient experienced swollen hands, tingly lips, eyes, face. Patient feel better after administer liquid benadryl
pt fainted 5 min after administration of the flu shot , with possible seizure . she was seating down. we called 911..she was taken to ER.
Moderate fever, joint aches, chills, body aches, headache. all but the fever were severe and i was in bed aprox. 24 hrs.; Moderate fever, joint aches, chills, body aches, headache. all but the fever were severe and i was in bed aprox. 24 hrs.; Moderate fever, joint aches, chills, body aches, headache. all but the fever were severe and i was in bed aprox. 24 hrs.; Moderate fever, joint aches, chills, body aches, headache. all but the fever were severe and i was in bed aprox. 24 hrs.; Moderate fever, joint aches, chills, body aches, headache. all but the fever were severe and i was in bed aprox. 24 hrs.; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 01Apr2021 at 13:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The patients medical history was reported as no. The patient had no known allergies to food, medicine or other products. The patient had taken other medications (unspecified) within two weeks prior to vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 11Mar2021 at 13:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 02:30, the patient experienced moderate fever, joint aches, chills, body aches, headache. All but the fever were severe and the patient was in bed approximately 24 hours. No therapeutic measures were taken as a result of the events. The clinical outcome of the events moderate fever, joint aches, chills, body aches, headache, all but the fever were severe and patient was in bed approximately 24 hours was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Information has been received from a 51 year old female registered pharmacist with no past medical history or drug allergies, who on Sept 21 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (first lot # 647635/0864N, second lot # not available) from two different vials that were combined into one syringe. On Sept 21 2004 the patient developed a fever above 100F. the patient took diphenhydramine hydrochloride (Benadryl) and ibuprofen. She also developed a raised spot that was bigger than her hand, The spot was red and hot. At the time of this report, the patient had not contacted her physician. On Sept 25 2004 the patient recovered. There was no product quality complaint involved. Additional information has been requested.
started haveing swelling on 10/24/09, that progressively got worst with reddness, swelling down the arm past the elbow, and eventually all the way around the arm.  Becames worst each day with pain and swelling, small blisters at the injection site.  Went to ER on 10/29/09. Gave a shot of Rocephin and 2 RX for antibiotics.  Dx. of Celluitis.
Waited 10-15 minutes after shot then returned to class. After being in class about 20 minutes, teacher states patient arched back, eyes rolled back & fell out of chair. Awoke oriented. Taken to E.R. M.D sts ? dizziness & tiredness per Mom.
developed covid-19 virus in early Sep; developed covid-19 virus in early Sep; 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.  An 83-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (2023) and all described as "developed covid-19 virus in early Sep". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: Treatment of Covid-19/ Caller had the covid virus in early Sep and took 5 days of therapy with Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caller had the covid virus in early Sep and took 5 days of therapy with Paxlovid and now felt completely fine.  He wanted to know if it was okay to get the newly approved covid-19 vaccine given his past medical history. Caller stated that he previously had covid-19 initial series and "all boosters" with the Pfizer vaccine and recently developed covid-19 virus in early Sep.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
3 wks post vax pt devel swelling of joint, joint pains, h/a, pain occurring in hands back, knees like true arthritis; pain on ankles;
FATIGUE; This spontaneous report received from a patient concerned a 4 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from fatigue. This report was non-serious.
itching and swelling at site of injection for 2 days.  Zyrtec and Singular taken for itching and swelling. Recovered after 2 days.
red splotchy raised spot set in 8 days after injection.  Slightly itchy, tender.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 30-MAR-2009, patient received improperly stored VARIVAX dose 1, from lot # 661445/0525X expiry date 27-MAR-2010. On 20-MAY-2009, the patient received VARIVAX from lot # 663710/0219Y expiry date 13-FEB-2011 (dose # unknown) which was improperly stored. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Mom states patient had several ulcers in the mouth after rec. 1st and 2nd dose of the HPV vaccine.
Joint pain in ankle; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain in ankle) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 15-Jan-2021, the patient experienced ARTHRALGIA (Joint pain in ankle). At the time of the report, ARTHRALGIA (Joint pain in ankle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
I was woken up by stabbing pain in my left shoulder, it went down into the left forearm and up the left side of my neck. The pain would come in waves depending on how I moved my arms, it would be worst and then sometime less but it did not go away. I saw the physical therapist on 05/13/2022, so for the whole week, I was taking all kinds of pain meds as well as heat packs, and electric massager, I had to take the whole week off of work. The therapist did manual therapy,  stretch work and trigger point therapy. I had significant reduction of pain because of the therapy and I have another appointment on 05/18/2022.
Patient completed Pfizer COVID vaccine series 4/15/2021 and 5/10/2021. Patient received 3rd dose of Pfizer vaccine on 7/31/2021 as documented on this report.
According to physician ER reports patient received immunizations on 3/5/13 at app. 11:00 AM. That evening she apparently had a low grade fever that responded to TYLENOL. She subsequently had an uneventful 48 hour period. She was seen in the ER on 3/9/13 at 10:00 for vomiting and fever. Was d/c home in "good" condition after receiving ZOFRAN. She was seen again in ER at 22:47 that day for "persistent" vomiting and was transferred to the main hospital where she was eventually diagnosed with "meningoencephalitis, most likely viral etiology" and "sinusitis". Discharged home in good condition on March 20, 2013.
This spontaneous report was received from a nurse, refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, pertinent medical histories, drug reactions or allergies provided. On 04-DEC-2018, the patient was vaccinated with an improperly stored dose of PROQUAD, subcutaneously in the left arm, lot# R017629, expiration date 18-DEC-2019 (dose and dose number were not reported) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccines experienced the temperature excursion of -14 Celsius degrees to -10 Celsius degrees for 70 minutes and -9 Celsius degrees to +8 Celsius degrees (-8.49 Celsius degrees) for 35 minutes. Previous temperature was reported as -14 Celsius degrees to -10 Celsius degrees for 60 minutes and -9 Celsius degrees to 8 Celsius degrees for 40 minutes. Data logger was involved, detecting this storage error.
C/O upper lip feeling numb & swollen x 4 days (since vaccine).  Denies any other factors, possible allergy triggers or other symptoms.  Recommended antihistamine - ZYRTEC as directed & call if not resolved.  Clinically - no rash, swelling no alteration of facial movements or symmetry.  No sensation loss.
This spontaneous report as received from a consumer refers to his 15 years old daughter. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # not reported) on 30-JUL-2012 at 10:00. No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on 30-JUL-2012, the patient was experiencing fever of 102 degrees and chills. The patient had injection site swelling, the size of a softball and was sleepy. The patient did not receive treatment for the adverse events. The patient's parents called the health care professional. At the time of the report, the patient had not recovered. The relatedness for fever for 102 degrees, injection site swelling and chills was unknown for PNEUMOVAX 23. Additional information has been requested.
felt as though couldn't swallow food, low fever, swollen glands under ears, very excessive secretion of saliva;Now @ 2mos just starting to eat fairly nl;lost 8pounds since onset & could not eat any solids x 6 wks;
Four hours after vaccination developed severe headache, jaw pain, dizziness. BP 190/90 lasted 2 days. Saw PCP and occ med still having headaches off and on.
blood pressure 140/80,; fever day and a half; sluggish but fine; Caller has recently been diagnosed with "severe" carpal tunnel in right hand; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "blood pressure 140/80,"; PYREXIA (non-serious), outcome "unknown", described as "fever day and a half"; SLUGGISHNESS (non-serious), outcome "unknown", described as "sluggish but fine"; CARPAL TUNNEL SYNDROME (non-serious), outcome "unknown", described as "Caller has recently been diagnosed with "severe" carpal tunnel in right hand". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was also reported that the patient was basically in good health and stated he had taken two vaccines plus the booster, 3-4 months ago. Caller stated he had a little bit of a reaction, fever day and a half, sluggish but fine. Caller stated his most recent blood pressure 140/80, and six months ago after second shot, it was 150/85-88.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Light Headed, muscle ache, abdomen and lower back pain. Patient recovered fairly quickly and left the store apprx time 10:15 AM.
Presented to ED w/ worsening SOB & cough; tested positive  9 days prior to arrival; tx w/abx, steroids, mag, zinc; dc'd home w/ O2
very sick; a huge fever; couldn't even move; This is a spontaneous report from a contactable other hcp (patient). A female patient of 68 years old received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Batch/Lot number was not reported; Expiry date: Not Provided), dose 2 via an unspecified route of administration on 27Aug2020 as dose 2, single for covid-19 immunization (at the age of 67 years old ). Family history included minor surgery of her husband. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced very sick, a huge fever, couldn't even move. The patient underwent lab tests and procedures which included body temperature: 102.9, she had a huge fever of 102.9. Treatment was provided for the events. The patient was in the original clinical trial as well as the booster clinical trial for the Pfizer BioNTech COVID19 vaccine. She asked about getting clinical trial doses and booster dose put in the (withheld) database. she had the booster because she was very sick. She was sick after dose two and the booster dose. She was so sick she called the hotline for clinical trial adverse events and he took the information down and called the clinical trial people. the doctor called her and told her to take more Tylenol. She reported that she has already reported this to the clinical trial people after the first time when she got sick with second dose. she was an Oncology Nurse. About six hours after she had a huge fever of 102.9 and couldn't even move. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.