chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in jaw; Popping in jaw; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 07:45 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included temporomandibular joint disorder (TMJ), hypersomnia and anxiety. The patient's concomitant medications included methylphenidate (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN), multivitamins (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all from unknown dates for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took BIAXIN in the past and experienced drug allergy. 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 22Mar2021 at 10:00, the patient experienced pain and popping in jaw. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcomes of the events pain and popping in jaw was recovered with lasting effects.   No follow-up attempts are needed. No further information is expected.
Aseptic Meningitis & Thrombosis of the Superior Sagittal Sinus in Brain 2 days p/vax; Annual follow-up dated 9/22/00 provided no additional data.
Friday night developed serve arm pain, shooting all the way to fingers in L arm. Severe pain last 24 hours and is now just an ache. Also, have a sore lump around collar bone.
Sick, tired, nasuea, headache, body ache chills etc.  Bad reaction is that the lymph node under the left arm swole to the size of a large orange or grapefruit about 3 days after the injection.
This spontaneous report as received from a patient's mother via a registered nurse refers to an 11 year old non-pregnant, female patient. The patient had no history of drug reactions or allergies. The patient's pertinent medical history and concomitant medications were not reported. On 12-FEB-2015, the patient received first dose of GARDASIL, lot# K005881, (route and site of administration and expiry date not reported). On 17-APR-2015, the patient received second dose of GARDASIL, lot# K005881 (route and site of administration, expiry date not reported). On 12-AUG-2015, the patient was vaccinated with GARDASIL 9, lot # L004741 (route and site of administration and expiry date not reported), last dose in the series. Patient's mom reported to nurse that, in approximately 2015, the patient experienced cold-like symptoms, fever and tiredness after first GARDASIL shot. Weakness, lethargy and fever after second GARDASIL shot (approximately in 2015) and depression, anger, lethargy, vomiting, and abdominal pain after last dose of GARDASIL 9 (approximately in 2015). Since approximately January 2016, also reported as in the last three months, patient lost a lot of weight and went from a happy, chubby child to skinny and depressed one. On an unknown date, the patient had blood work done which showed very low iron and vitamin B12 level. In approximately March 2016, also reported as last week, the patient visited the nurse in the office and was given intravenous vitamin called "Myers cocktail".  At the time of this report, the patient did not recover from the adverse events. The relatedness between the events and suspect therapies was not provided. This is one of two reports received from the same reporter. Additional information has been requested.
no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 29-MAY-2019, the patient was vaccinated with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015745, expiration date 02-DEC-2019; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
Left arm swelling, itching.  Went to urgent care next day after vaccine and was given steroids and benadryl. Better now.
Blood in urine and  slight back pain on left side (kidney area?). Noticed change in urine around 7 pm on 9/24/23. On morning of 9/25/23 urine extremely dark brown, then gradually during the day it lighten up to pink/light red.
Swelling, ecchymosis, pain at injection site with in 24 hours. Pt reports a dime size nodule still present 4 weeks after vaccination. Date of vaccination 3/9/06. Pt received Hep A and Typhoid vaccine at same site - left deltoid.
Infanrix was administered on 8/6/07.  Mother notified us on 8/7/07 p.m. that member had 104 oral temp and pink area approximately one inch in diameter around injection site with slight swelling, denied pain at injection site.  Mother denied other worrisome symtpoms at that time. Mother was instructed to give Children's Tylenol and Motrin alternating q3hours, cool compresses to injection site.  Child flew to West Coast on family vacation on 8/8/07, mother called in afternoon to report continuing fever to 102, arm not painful, pinkish area remains and warm to touch, not increasing in size, no streaking or drainage noted. Advised to continue Tylenol/Motrin, cool compresses, seek medical attention if fever continued, arm became inflamed or painful, other worrisome symptoms occurred. Mother has not called back with status report at this time.
Very bad pain and limited movement night of administration. Iced the area and rested arm. Yellow, purple bruising and discoloration. Still has some pain. Getting better
Within minutes of receiving MMR II and VARIVAX boosters patient had hives from head to toe, HR 145, O2 sats 90%. Not true anaphylaxis, BENADRYL given with improved clinical status in 30 minutes. Required doctors visit.
At approx. 3:40AM on April 9th I was awakened by a load sound as if a fire alarm was going off.  When I stood up I realized it was not an alarm but very loud ringing in my ears.  The ringing (tinnitus) in my ears has not stopped since that time.
Patient received Zoster vaccine on 11/18/15 as part of her office visit. She called the office on 11/20/15 as was seen for (L) arm redness and pain which started the day after injection was administered. No fever, chills, sweats, no fatigue. Started on KEFLEX 500mg every 6 hours. Count 40 seen 11/23/15 for c/o continued pain and itchiness in (L) arm. Erythema and swelling better compared to 11/20/15. KEFLEX continued.
Anaphylaxis Patient was vaccinated and within just a few minutes of vaccine administration began to feel throat tightening, difficultly getting air, tachycardia, and dry mouth. Admitted to a past history of anaphylaxis with shell fish and endorses similar symptoms. Employee was treated with an epi pen and taken to the emergency room for additional monitoring and treatment as needed
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L030871, expiration date 10-JUN-2016, lot # L042835, expiration date 19-AUG-2018; dose and route were unknown. No adverse effects was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA  Injection site pain, mild fever, joint pain, muscle pain, fatigue, headache.
vomiting; diarrhea; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a social media consumer.  This case involves patient (unknown demographics) who experienced vomiting and diarrhea (diarrhoea), while being treated with INFLUENZA VACCINE.  Past vaccination included INFLUENZA VACCINE (every year).  Medical history, medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious vomiting and diarrhea (diarrhoea) couple of times (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not reported.  There will be no information on the batch number for this case.
Received Td and Flu on 11/08/06 right arm. On Fri 11/10/06 in the evening one noticed 50 cent hard deep lump, on outer back of right arm. A couple inches from the shot area warm to touch slight discolored skin, lump seems to be resolving and is less hard. Enc to Seek medical attention if increased redness and swelling.
Initial misuse report received from a healthcare professional (nurse) on 25 October 2013 and the case was received on 21 March 2014 at GPV. 2 patient (date of birth and gender was not provided) had received dose of expired FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Right upper arm pain at injection site with neuropathic pain radiating to right distal arm and hand.
Patient in for well check physical. Required 3 immunizations. Tetanus booster 0.5 ml given IM in left deltoid. MENVEO vaccine 0.5 ml given in Lt deltoid. Patient reports redness and swelling from injection site down to lft elbow.
Started itching; Kind of swelled up like when first received the vaccine; Lump in the injection site; Swelled up like when you get a flu shot; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump in the injection site), VACCINATION SITE PRURITUS (Started itching), VACCINATION SITE SWELLING (Swelled up like when you get a flu shot), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Kind of swelled up like when first received the vaccine) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Jan-2021, the patient experienced VACCINATION SITE MASS (Lump in the injection site), VACCINATION SITE SWELLING (Swelled up like when you get a flu shot) and VACCINATION SITE ERYTHEMA (Red). On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Started itching) and VACCINATION SITE SWELLING (Kind of swelled up like when first received the vaccine). On 14-Jan-2021, VACCINATION SITE MASS (Lump in the injection site), VACCINATION SITE SWELLING (Swelled up like when you get a flu shot) and VACCINATION SITE ERYTHEMA (Red) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Started itching) and VACCINATION SITE SWELLING (Kind of swelled up like when first received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        Concomitant medications are not reported.  Treatment information include Benadryl.
Fainted immediately after administration of vaccine. C/o severe (L) sided headache; pain from (L) shoulder to (L) arm, burning sensation in nostrils & sinuses. Treated with Ibuprofen. Did not seek medical care.
Swelling, pain and hardness of the lymphatic nodes of the same arm of injection. Pain started happening about 4 hours after injection. Swelling area is about 1.5 inch diameter, no redness and was discovered by the patient (self) about 28 hours after injection. No compromise of movement, just pain and discomfort from the volume of the lymph. This issue did not happened with the previous doses, both of them Moderna as well. Patient as well felt tired  and had  sore muscles (post extenuating workout alike) in all her body the next day 18 hours after the injection. Patient took 500 mg of acetaminophen 19 hours after injection and haven't taken any more medication.
Patient was seen in ER and treated for Bells Palsy.  Patient had received flu shot 10 days prior.  From notes it appears that symptoms of facial droop began on day of injection. 10/26/2009 hospital records for ED visit 10/11/2009. Presenting sx of rt facial droop, confirmed per PE. Tx: Acyclovir, Prednisone and eye gtts. DC DX: Bells Palsy
Immediately after injection patient had a raised lump of about 1 inch, no redness,  around injection site. Localized reaction, no other symptoms.
7 x 7 erythematous, tender, pruritic local reaction on left posterior arm. Treated with NSAID'S and antihistamines.
Within 15 min. the site started swelling, turning red, was hot to the touch and felt like it was on fire. Within a half hour, my arm from my left deltoid to the bend of my elbow was swollen, hot, red and painful. I also felt like I was going to pass out. I got a cold sweat, and my heart felt like it was beating hard and fast. I returned to the place I had the injection; they put ice on the injection site and monitored me until I was able to walk without feeling dizzy. They recommended I make appt with my provider, but I was unable to get appt that day and they told me not to worry that they will not be giving the H1N1 vaccination again next year. After I went home I also noticed a few hives across my chest and arms. I also developed a cough that produces a metallic/chemical taste/smell.
Tested positive for COVID-19 after two shots and two boosters; Tested positive for COVID-19 after two shots and two boosters; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (COMIRNATY), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID-19 after two shots and two boosters". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for COVID-19 after two shots and two boosters - all Pfizer. Clinical course: Patient showed signs of sweating, aching, drooling, cannot keep eyes open and very lethargic.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Around 3:15 in the afternoon, I began experiencing severe aches and muscle pains, combined with a growing migraine. Not realizing what it may be related to, I took two ibuprofen and I've acetaminophen.  By the time I around home around 6:30, I could barely hold myself up. I ate dinner, which only helped minimally, and by 8 pm felt like death. My husband notice I looked red and felt my forehead, immediately going for the thermometer. I had a fever of 100.5.  We eventually got me into bed after downing a lot of water, but the pain would not ease up. The pain was too excruciating. At 10:30 my husband came to bed and we took my temp again which was 101.6. To help me sleep I took another Tylenol. At 5:45 my work alarm went off and I checked my temp again; still 101.6. I got a cold pack for my migraine and went back to sleep. Slowly throughout the day my fever dwindled, until it finally broke in the early afternoon. By 4:15, as I am writing this, all that's left is done tiredness, thirst, and a small bit of achiness.
Approximately 5 minutes after giving the vaccine I was called because someone had either passed out or was about to pass out. When I got there the patient was very pale and feeling dizzy.  She was still fully conscious so I got her a bottle of water to sip and went to get the pulsoximeter.  Her initial reading was O2 of 95% and heart rate 68.  She progressively got worse, saying her stomach hurt and she felt like she was going to throw up, she kept closing her eyes, and not talking coherently. The pulsoximeter started to beep showing her heart rate was in the 40's. I quickly went to get the epipen and another pulsoximeter to double check the reading.  That monitor was also reading in the 40's and then to 39 for heart rate. By this time the patient lips and cheeks had turned blue and she was barely conscious.  I told my technician to call 911 and I administered an epipen.  After just a minute or two her stats came back up to heart rate 56 and then to the 69-72 rate with 100% oxygen.  She was fully conscious and talking but complaining of dizziness.  When she was talking she told me how she remembered during the episode that she couldn't hear anymore and everything had gotten black. I stayed with her until EMS came to take her and they said good job.  The girl was ok when I handed her off.
first day pain inj arm;3-4 days later flu like sx, exhaustion, sleeplessness, arthritis wandering from joint to joint;joint pain;still continuing in tremendous pain;
Patient experienced lightheadedness and shortness of breath. Pt was given 2 - 25 mg capsules of diphenhydramine. Paramedics also administered oxygen and pt was taken to hospital for observation. Pt released 2 hours later.
Indurated site of DPT inject; recvd vax 14SEP93 vax given too soon;
Was not a booster, but it was 3rd shot; Second dose on 17-FEB-2021 and third dose on 23-AUG-2021; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Was not a booster, but it was 3rd shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 17-FEB-2021 and third dose on 23-AUG-2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0PF2D21A, 023M20A and 032L2(Z)1A) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer (It became aggressive this last fall (2020) before receiving the Moderna vaccine.) since 2017.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Was not a booster, but it was 3rd shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 17-FEB-2021 and third dose on 23-AUG-2021). At the time of the report, OFF LABEL USE (Was not a booster, but it was 3rd shot) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 17-FEB-2021 and third dose on 23-AUG-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient stated that he recently had a hormone shot to keep the cancer from growing.  Treatment information was not provided.
Patient came to several clinics for Moderna Bivalent second dose even though the patient had already received second dose at another clinic and did not require or meet the criteria for any more COVID vaccinations. It is assumed that the patient's parents/ guardians took advantage of an incentive program for patients that receive COVID vaccines. Pt was given unnecessary Moderna Bivalent booster and asked to wait the required 15 minute wait period, after the 15 minute wait period patient's parents stated that the patient was doing fine and did not complain of any effects from vaccine prior to leaving clinic.
Client's spouse verbalize that client started posturing a minute after receiving vaccine.  Client seen and assessed by EMT.  VS: BP 120/76, HR 100, O2 99. 12led EKG shows sinus tacky, upon observation no sign of posturing.  Noted client able to verbalize need and denies any other symptom.  Client advised to seek further evaluation and cleared to go.
Pt returned to clinic x 1 week post vaccination to report a 4cm red circular area lt deltoid where the yellow fever vaccine was administered. Reports area red, sore, slightly warm and itchy x 3 days. Dx local allergic reaction vs infection. TX warm compresses, ASA or Tylenol prn. Call back if worse or not improving.
Severe pain and stiffness in shoulder where injection was given, doctor diagnosed tendonitis in left shoulder, SIRVA.
2 patients under 18 years of age got a booster dose from Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 patients under 18 years of age got a booster dose from Moderna) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (DOSE-2) and PFIZER BIONTECH COVID-19 VACCINE (DOSE-1). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 08-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 patients under 18 years of age got a booster dose from Moderna). On 08-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 patients under 18 years of age got a booster dose from Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients had previously received the 2 doses of the Pfizer vaccine and moderna as booster dose No concomitant and treatment information were reported by the reporter
This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 injection (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The temperature of the GARDASIL 9 was of 19 °C for a time frame of 11 hours. Previous temperature excursion occurred; however, the temperature information was unknown by the reporter. No data logger was involved. No adverse effects were reported. This is one of five reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA007283: US-009507513-1705USA008600: US-009507513-1705USA008602: US-009507513-1705USA008605.