chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dry cough; Joints pain; red spots in the whole body; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: ER8737, expiration date was not reported), via an unspecified route of administration, administered in left arm on 06Apr2021 17:00 (at the age of 47-years-old) as dose 2, single for covid-19 immunization. The patient medical history was none. Concomitant medication included isotretinoin (ACCUTANE) taken for unknown indication from an unknown date. Other medications the patient received within 2 weeks of vaccination included Accutane. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6204, expiration date was not reported), via an unspecified route of administration, administered in left arm on 16Mar2021 12:00am (at the age of 47-years-old) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient does not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. It was reported that, on 06May2021 the patient experienced joints pain, red spots in the whole body, fatigue, dry cough. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included RT-PCR (sars-cov-2 test): negative on 08May2021 Nasal Swab. No treatment was received for the adverse events. Device date: 03Jun2021. The reporter assessed the seriousness as non-serious. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Body aches; restless; no sleep; headaches; chills; This is a spontaneous report from a contactable other health professional reported for herself. A 34-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 24Jan2021 14:00 at single dose at left arm for covid-19 immunization. The most recent COVID-19 vaccine was administered at Hospital. Medical history included high blood pressure. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 03Jan2021 at Left arm 14:00 for covid-19 immunization. No other vaccines received within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Body aches, restless, no sleep, headaches, chills on 25Jan2021 12:00 AM. The outcome of the event was not recovered. No treatment received for the adverse events.  Information on the lot/batch number has been requested.
Within 30 minutes after Flu shot she experienced ipsilateral neck pain that lasted 1 week. Treated with Naproxen.
PT REPORTED TINGLING IN HANDS/FEET/AND LIPS. DID NOT HAVE DIFFICULTY BREATHING OR SWELLING OF TONGUE/MOUTH. DISPENSED LIQUID BENADRYL TO PT FOR ADMINISTRATION AS SOON AS SHE GOT HOME AS SHE INTENDED TO DRIVE AND IT MAKES HER TOO SLEEPY.
I had an underlining cardiac arrhythmia prior to receiving any of the vaccines. My current arrhythmia have gradually  worsen, after receiving the vaccines.
Developed hives  approximately 6 hours after injection. Hives present on both upper thighs near bikini line and underside of both arms. No reaction at injection site. Hives still present on 11/2
This is a 73y.o. female   Patient has a past medical history of CHF CAD diabetes hypertension myocardial infarction PE seizures and DVT which the patient comes in secondary shortness of breath 4 days in duration the patient called EMS the patient had a pulse ox 93% the patient was placed on non-rebreather at that time the patient was transferred to the hospital the patient is found to have COVID-19 viral pneumonia the patient was tachypneic tachycardic the patient presented with sepsis on admission the patient was placed on high-flow nasal cannula CT protocol ruled out a PE
Information has been received from a physician concerning a 11 week old male with no pertinent medical history or drug allergies, who on 23-AUG-2007 was vaccinated with his first dose of Rotateq. There was no concomitant medication. On 11-SEP-2007 the patient developed a 102.3 F fever, vomited once and produced a large stool greenish color. Medical attention was sought by contacting the physician's office. On 12-SEP-2007 the patient was admitted to the hospital due to a high fever. The patient also vomited one more time at the hospital. Lab diagnostic studies performed a rotavirus test and it came back positive. The patient's recovery status was unknown.  There was no product quality complaint. Additional information has been requested.
10mm duration around inj site of DTAP;arm is raised 4mm c/o pain to lt deltoid no loss of ROM per MD;
severely fatigued; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 11:00 (Lot number: ER8727) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "bee sting allergy" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE. Past drug history included: Hydrocodone, reaction(s): "Drug allergy: Hydrocodone"; Levaquin, reaction(s): "Drug allergy: Levaquin". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "severely fatigued"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information : The first dose I had only a sore arm but, a couple of weeks later, was severely fatigued. With the 2nd dose my arm became red and swollen the next day. I also experienced chills muscle ache, headache, racing heart and total exhaustion. After 4 days, my arm is still red, swollen and itchy. Still exhausted with racing heartrate. If Covid prior vaccination reported as No and if Covid tested post vaccination was reported as No.  No follow-up attempts are possible. No further information is expected.
they gave a 5 month old QUADRACEL with no reported adverse event; Initial information received on 30-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 months old and unknown gender patient who was given Quadracel (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation, strength, route: unknown) lot number not reported in unknown administration site as Immunisation. The patient used the product for the first time.  On an unknown date the patient was given quadracel with no reported adverse event (off label use) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.
This spontaneous report as received from a pharmacist refers to a 78 year old female patient. Concurrent condition included, Diabetes mellitus and a "possible neuropathy", drug reactions and allergies were reported as none and no medical history was provided. On approximately 22-MAY-2015 (reported as about a week ago), the patient was vaccinated with ZOSTAVAX (Lot # L006380; Exp date 28-MAY-2016 (also reported as 25-MAY-2016)) in the ar (Dose, route of administration, dose number and concentration were not provided), for prevention of shingles. Concomitant therapies included LYRICA. Since the administration of ZOSTAVAX on approximately 22-MAY-2015, the patient experienced "tingling" in the injection arm. At the time of the report the outcome of injection site paresthesia was reported as not recovered. The patient sought medical attention and called the pharmacy but no treatment was given for the event. It was also reported that there were no laboratory diagnostics studies performed. Additional information has been requested.
Annual Flu Vaccine, unaware of type, brand, or lot number - Painful lymph node in armpit on left side, same side as injection site.
Diabetic patient did not administer her insulin before coming to get her COVID 2nd dose vaccine.  She became lightheaded and nauseous shortly after being given the Moderna COVID vaccine.  The paramedics checked her blood sugar at 493mg/dl and the patient administered her own dose of insulin (type unknown).  Patient was transported to the hospital and only IV fluids were given by the paramedics.
Lower back/hip  pain down through left leg all that night  Fatigue  next morning  into evening
Headache, NauseaVomiting, CHILLS, SHAKING, CHEST PRESSURE, MALAISE, WEAKNESS, L ARM SWOLLEN Narrative:
day after vaccine was received pt developed fever and rash to her arms and legs.  next day fever resolved but rash spread further and had eyelid swelling and rash to her lower lip
This spontaneous report as received from a Healthcare worker reported that GARDASIL were exposed to unspecified temperature conditions during a power failure for an unspecified period of time, were then administered to unspecified patients on unspecified dates. The indication, dose, route and lot # of the vaccine was not reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Slight to increasingly worse dizzy spells. Still not as bad as vertigo so I tried to wait it out for a couple of months. When it was often and bad enough to keep me from walking I decided to see the doctor. In August, went to my doctor and was determined that PT was needed. After PT it only got worse and at that time, 10/30 MRI for Lumbar, Carotid Artery, Spine, and Head (w/ and w/o contrast) which turned out all normal. I also had a concerning result in my blood work and was referred to Rheumatoid Arthritis doctor. There on 11/17 a new set of blood work was done and was returned recently 12/8. Confirmed Rheumatoid Arthritis and was discussed what treatment options and courses of medicine I could take.
Breast feeding; A spontaneous report was received from a consumer concerning female patient of an unknown age who received Moderna's COVID-19 Vaccine, and who experienced maternal exposure during breast feeding.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Batch number unknown) on 07 Jan 2021 intramuscularly in the for prophylaxis of COVID-19 infection.  On 07 Jan 2021, the patient reported maternal exposure during breast feeding. Treatment for the event was not provided.  At the time of the report no additional information was provided.   Action taken with mRNA-1273 in response to the event was unknown.; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Patient (DOB 03-10-1987)received the 2nd COVID vaccine (Pfizer, lot # EW0187 use by 07/15/21) at 1322 in the left arm by LVN. The client was vaccinated in the anti-gravity chair, checked on the client at 1330 and she stated, " I'm feeling a little dizzy." EMT immediately placed the client in a semi-Fowler's position and RN was notified. RN assessed the client who was A & O x 4 and offered her Benadryl, the client declined Benadryl. while vital signs were taken by EMT BP- 142/86, HR-87, RR- 12, oxygen saturation- 98%. The client denied any headache, lightheadedness, chest pain, difficulty breathing, or swallowing. The client last ate about an hour and a half ago, and was offered Gatorade or water, but declined both. The client had no known drug allergies, had type II diabetes mellitus, hypertension, and history of seizures. Reported currently taking Metformin and an anti-hypertensive medication. The clients vital signs were taken at 1336, BP- 140/86, HR-76, RR-12, oxygen saturation at 98%. RN advised the client to stay for an additional 30 minutes from the start of her feeling dizzy. EMT took vital signs at 1341, BP- 138/86, HR-80, RR-12, oxygen saturation- 98%, the client stated, " The dizziness is gone." The client denied shortness of breath, chest pain, difficulty swallowing, difficulty breathing, or lightheadedness. RN educated the patient to follow-up with her primary care provider if the dizziness returns or worsens and also educated the client about V-safe and emergency room precautions. The client left AMA, prior to the 30 minutes advised, at 1345 and had an even and steady gait when ambulating to her car.
Parent was present. Child had not eaten prior to vaccination and parent and child insisted she would be fine. I did proceed to vaccinate her in a chair. Client was seated and received 3 vaccines. She collapsed after the HPV which was the third. She was not injured as she collapsed in the chair and I was able to support her. She regained consciousness in 10 seconds and was alert and oriented to person, place and time. BP 96/70. I assisted her to a supine position, gave her some juice and she remained supine for 20 minutes. BP was again 96/70. They remained in the waiting area for another 10 minutes and child was acting normally.
Pt c/o pain, redness, tender and warm to touch at covid vaccine injection site since 5/17/2021 as she got her 2nd dose covid 19 vaccine Moderna on 05/17/21. Denies any  loss of sensation on affected arm, Can able to move her arm. Pt speech clear, comfortable. AO X3. Also denies emergency sx at this time. Advised to monitor her sx and also home management. scheduled urgent care telephone f/u appt on 05/21/2021
Pt reported an episode of erythema and warmth of entire upper arm lasting 2-3 days.
Intense pain on her right thigh where the Femoral Artery goes; Having sleep disruptions; Can't get more than 5 hours sleep; Muscle cramps have intensified; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Intense pain on her right thigh where the Femoral Artery goes), INSOMNIA (Having sleep disruptions), INSOMNIA (Can't get more than 5 hours sleep), MUSCLE SPASMS (Muscle cramps have intensified) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cramps (Patient reported having cramps before Vaccination).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced INSOMNIA (Having sleep disruptions), INSOMNIA (Can't get more than 5 hours sleep), MUSCLE SPASMS (Muscle cramps have intensified) and FATIGUE (Fatigue). On 04-Apr-2021, the patient experienced PAIN IN EXTREMITY (Intense pain on her right thigh where the Femoral Artery goes). On 04-Apr-2021, PAIN IN EXTREMITY (Intense pain on her right thigh where the Femoral Artery goes) had resolved. At the time of the report, INSOMNIA (Having sleep disruptions), INSOMNIA (Can't get more than 5 hours sleep), MUSCLE SPASMS (Muscle cramps have intensified) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment medication was not provided by the reporter. The patient stated that she is determined to take second dose and then her Cardiologist would Scan her to monitor what's going.   Reporter did not allow further contact
Within 24 hrs of vaccine pt developed redness, pain and swelling at injection sties (L thigh). 48 hrs after vaccine pt was seen in ER and treated with cephalexin and BENADRYL and ibuprofen.
I had nausea/stomach aches, followed by diarrhea for two days.  I was also extremely tired for 3-4 days.
Seconds after receiving vaccines patient had an episode of syncope. Her B/P was 98/52, she was given water and crackers. I checked her B/P 10 minutes later and it was 100/68, and the same 5 minutes later. Her color returned, she stated she felt well and she left with her grandmother and returned to school.
This child presented with diabetic ketoacidosis on 12/01/00. He has recovered but he has juvenile diabetes. On 10/24/00 the patient was given a Prevnar vaccine. On 11/22/00, the patient returned for a visit because he was listless, urinating excessively, and constantly thirsty. He was prescribed Amoxicillin. He was brought back to the doctors office on 12/01/00 because his just described symptoms persisted and had become worse. At this point he was diagnosed with diabetes and taken to the hospital. For the following reasons, the parents suspect that their son's diabetes was caused by the Prevnar vaccine he received : At the time he received the injection he was in good health. There is no family history of diabetes in either of the patient's parents. Diabetes in a toddler as young as the patient (then 18 months) is said to be rare. During the patient's stay at the hospital, one nurse remarked that the patient's hemoglobin count was very low for a diabetic and that the disease had not been with him for very long. According to the Prescribing Info posted by Wyeth-Ayerst Laboratories on its Prevnar web site (www.prevnar.com), diabetes was ascertained as an adverse reaction during efficacy trials of Prevnar. Therefore, the parents request that (as per the National Childhood Vaccine Inquiry Act of 1986) a report be filed with Vaccine Adverse Event Report Covering what happened to their son (a copy of the VAERS form is attached) The parents would like a copy of the filing and all attachments thereto. Kindly confirm.
Pain to left side of abdomen. Urgent care visit for pain and rule out of kidney stone & ovarian torsion. Follow up apt to PCP and was determined to be hemorrhagic cysts to the left ovary. 2 menstrual cycles per month since 2nd dose. PCP stated this was from immune response to vaccine.
Woke up this morning and suddenly felt nauseous and dizzy, nearly fainted and started to sweat profusely. Lasted about 5-10 minutes, and have felt worn down with a mild headache the rest of the day. I wouldn?t think it?s vaccine related, but this has never happened to me before.
React strongly to the second dose; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (React strongly to the second dose) and VOMITING (Vomiting) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (React strongly to the second dose) and VOMITING (Vomiting). At the time of the report, ADVERSE REACTION (React strongly to the second dose) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was reporting their own adverse event and states that they read online that women react strongly to the second dose of the vaccine.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-118427, MOD-2021-073217 (Patient Link).
Pt recvd 3 doses of Engerix-B; found to have no detectable titer;
Patient's son came to pharmacy to pick up antiviral medication a few weeks after their 2nd dose of Shingrix. Son stated that mother had mild/moderate shingle like rash across mid section of body sometime after receiving the 2nd vaccine. Reporter informed patient's son that while no therapy is perfect, that this is not a typical outcome, and that this information would be reported to manufacturer through due processes.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 3:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 66.98    Concomitant products were not provided.  On 03-Nov-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 06 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Infant had a choking episode, vomited suddenly went limp and eyes rolled in back in head.  He was "breathing funny" with rare gasping breaths and long pauses for 2 min, then stayed limp and unresponsive for about 5 min until paramedics arrived.  7/31/2008 VAERS report submitted with MR attached for DOS 5/10-11/2008 with D/C DX: Choking episode vs seizure resolved. Left acute otitis media, conjunctivitis and cough resolving. Pt with recent hx of otitis media and conjunctivitis received vax at PCP's office 5/9/08. Presented to ER 5/10/08 after an episode of limpness, eyes rolling back, breathing difficulty and arrested breathing following a choking episode with coughing and vomiting. Pt was limp and unresponsive for ~5 minutes.  Had been having loose, mucusy stools. Upon arrival in the ER temp was 99.2'F and pt had a red, dull L TM and a harsh cough. Slight color change noted after blood draw. Pt tx's with IV abx and had no further episodes.