chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 20 June 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of Pertussis disease in a 3-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3288AA received on 24 June 2009, lot number C3363AA received on 04 September 2009, lot number C3363AA received on 27 October 2009 and lot number C3552AA received on 08 September 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 07 May 2012, approximately one year and eight months after the last dose. On 10 May 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 17 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on  17 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 24 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # L039066, expiration date 19-MAR-2017, dose and route not reported). The doses of vaccine were improperly stored at 48.9 degree Fahrenheit for 8 hours. No adverse effects were reported. This is one of two reports received from same reporter. Additional information has been requested.
Case number PHEH2015US018517 is an initial spontaneous report received from a health care professional on 17 Sep 2015. This case refers to a 26 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1514501) at a dose of 0.5 ml intramuscularly on 14 Sep 2015, which was left out of refrigerator from Friday until Monday morning. It was reported that the vaccines were delivered on Friday and it stayed out the fridge in the original packaging for the weekend. When the reporter called, she was informed that a temperature excursion was permitted for up to 72 hours and the excursion did not exceed this time frame. No adverse reaction was experienced by the patient following this medication error. The reporter declined further follow up contact. Follow up information received from the health care professional on 27 Oct 2015. Clinical notes updated.
Pfizer-BioNTech Covid 19 Vaccine EUA  Dizziness, Lightheaded, tingling in face and back of throat and tip of tongue, face flushed and high blood pressure Treatment: epinephrine(11:44am), steroids(11:46am), Benydryl(11:44am), pepcid(12:30pm), Zofran (11:12am)
Lump at the injection the side; Sore at the injection the side; Red at the injection the side; Swelling at the injection the side; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump at the injection the side), VACCINATION SITE PAIN (Sore at the injection the side), VACCINATION SITE ERYTHEMA (Red at the injection the side), VACCINATION SITE SWELLING (Swelling at the injection the side) and PYREXIA (Slight fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump at the injection the side), VACCINATION SITE PAIN (Sore at the injection the side), VACCINATION SITE ERYTHEMA (Red at the injection the side), VACCINATION SITE SWELLING (Swelling at the injection the side) and PYREXIA (Slight fever). At the time of the report, VACCINATION SITE MASS (Lump at the injection the side), VACCINATION SITE PAIN (Sore at the injection the side), VACCINATION SITE ERYTHEMA (Red at the injection the side), VACCINATION SITE SWELLING (Swelling at the injection the side) and PYREXIA (Slight fever) outcome was unknown.            No concomitant medications reported by reporter.  Treatment medication not reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
Pt recvd Engerix-B on 26APR90, 23MAY90, & 23OCT90 subsequently found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Phone call from mom on 03/06/2012 reporting that patient started with a temp. the day after she rec'ed vaccines on 03/01/2012-temp. was 102F, gave her fever reducer-mom reports that the temp. went up to 102.2F-monitored her and the temp. was normal the next day.  On Sunday 03/04/2012-mom reports that patient started with a cold and ear infection and on 03/06/2012 she broke out with hives on the back of her head, back and thighs-mom took her to the dr. on 03/06/2012 and was informed by the dr. that patient was having an allergic reaction to the vaccines she rec'ed on 03/01/2012.  Mom reports that the dr. only started her on an allergy med. (Atarax 10/5 1/2 teaspoon 3 times a day) due to the hives-may start an antibiotic later.
The pt experienced a severe local reaction, redness, and swelling from elbow to shoulder on left arm 24 hours post vax. Pt experienced tenderness at the site also.
Fever to 103, approx. 10 pm, taken to ER had seizure at ER.
Within 5 minutes of pt receiving vaccines, pt noted to be diaphoretic and pale. Pt states she "lost vision" and "became sweaty/weak and couldn't move" for a period of time less than one minute. Pt states she hadn't ate prior to appt and that she was "nervous" prior to receiving vaccines. Pt provided with bottle of water. BP and Pulse WNL. Pt provided with cold washcloth. Pt's sx improve after an additional 15 min of monitoring. Pt leaves ambulatory with driver. Pt went to work later that day.
Pt given vaccine about 11 o'clock, Ate lunch about noon. At approx 1 PM reported, diarrhea X 2, severe nausea, feeling faint. Placed in recliner IV fluids given - ZOFRAN - hydrated X 2 hrs.  VSS. Home with spouse.
really sick; bad cough; achiness; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick), COUGH (bad cough), PAIN (achiness), PYREXIA (fever) and FATIGUE (fatigue) in a 40-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick), COUGH (bad cough), PAIN (achiness), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, ILLNESS (really sick), COUGH (bad cough), PAIN (achiness), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.             No concomitant medications were reported.  No treatment medications were reported.
increased redness and warm to touch to right arm, pruritic rash with elevated bumps at injection site (right arm). Patient has taken Benadryl with some relief, recommended anti-itch cream to be applied to right arm as directed. In addition, see provider if symptoms worsen.
Patient started feeling nauseous and felt? like her heart was racing? and anxious Patients vitals were stable and was given snacks and gatorade Boyfriend will be driving patient home  Patient refused medical transport and signed AMA form
pain in the same arm of injection; Tenderness; Vaccination site pruritus; real red  at the injection site; Vaccination site swelling; warm to the touch  at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with CORTISONE at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Treatment medication included antihistamines for 24 hour.
I had sinusitis, it felt like I was getting a head cold and went to bed. I woke up and it was worse than a head cold. I took a COVID-19 test and it was positive. I did not have a fever; I had been taking ADVIL for muscle strain. I had a runny nose, a slight headache. I called my insurance company and advised me to call my primary care offices. I spoke with the nurse, she ended up prescribing PAXLOVID. I took it and I was feeling run down and after about 26-36 hours I started feeling a lot better. I isolated. Day 4 I tested again I was negative, and I tested at day 5 and was positive.
12/23/20: within 2 minutes of receiving the vaccine I felt pulsing in my left wrist and weakness in my left hand, within 30 minutes my left ear felt like it needed to pop, I had the normal/expected side effects for the first 1-2 days (very sore arm, headache, achy, fatigue, mild joint pain) 12/24/20: weakness/numbness/cold feeling in my left lower leg and foot, fullness in left ear continued 12/27/20: same sx as 12/24, plus weakness/numbness in left forearm, pinky and ring finger 12/28/20: same sx as above, plus fullness in R earned weakness/numbness in right forearm, pinky, and ring finger 12/30/20: same sx as above, plus weakness/numbness on the left side of my face, no drooping 12/31/20: same sx as above, now with weakness/numbness/cold sensations on both sides of face (although only one side at a time), in both legs, both arms down into pinky and ring fingers (weakness noticed when typing and writing). Both ears still with fullness feeling (only one side at a time). I can still walk/run, these symptoms are still present as of today 1/3/21.
Pt recvd vax 30NOV93 & had itching all over body where covered by clothing 122-14 hrs p/inject; started breaking out w/hives on trunk & limbs about 24 hrs p/inject; Had some SOB; seen in ER & took PO DPh;
Muscle aches, Chills, Fatigue, Fever of >102oF beginning about 16 hours after administration and continuing for about 24 hours past time of onset. Visible redness, heat, and swelling at injection site of approximately 4x8 cm beginning about 24 hours after injection, fading over the next several days.  Sore arm lasting from 4 hours post injection until 4 days post injection.
I woke up this morning with my left arm pit swollen. I'm guessing the lymph node is swollen.
8/14/14 got oral ROTATEQ #2; 2d later with blood in stool; fussy.
Fax last time I got the flu was when I got the shot; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient). This case involved an adult patient of an unknown age and gender who fax last time I got the flu was when I got the shot (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date, unknown latency, the patient Fax last time that patient got the flu was when patient got the shot.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment. Outcome of the events were reported as unknown.  There will be no information available on the batch number for this case.
Hand deformity; Bladder infection; SWELLING AT INJECTION SITE AFTER COVID-19 VACCINATION SHOT; This spontaneous case was reported by a consumer and describes the occurrence of HAND DEFORMITY (Hand deformity), CYSTITIS (Bladder infection) and VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE AFTER COVID-19 VACCINATION SHOT) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Bladder operation in 2020. Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE AFTER COVID-19 VACCINATION SHOT). In August 2021, the patient experienced CYSTITIS (Bladder infection). On an unknown date, the patient experienced HAND DEFORMITY (Hand deformity). At the time of the report, HAND DEFORMITY (Hand deformity) had not resolved and CYSTITIS (Bladder infection) and VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE AFTER COVID-19 VACCINATION SHOT) had resolved.            No Concomitant medication were reported.  There was no reported medical history.  The reporter's causality for the event(s) of Bladder surgery and Bladder infection with Humira was no reasonable possibility. The reporter's causality for the event(s) of Hands deformity with HUMIRA was a reasonable possibility. The reporter's causality for the event(s) of Swelling at injection site after Covid-19 Vaccination shot was not provided.  No Treatment medication were reported.   This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in
Vaccinator inserted the needle in the client's arm and depressed the plunger to administer the vaccine in the client's arm. Upon removing the syringe and needle from the client's arm, the vaccinator stated the syringe disconnected from the needle hub. The vaccinator noted some liquid present in the hub of the needle. The vaccinator did not note any liquid dripping on the client's arm.
2 hours after injection I had a syncopal  episode . This was new onset . I never had one before . Also BP was extremely high immediately following . I went to ER and BP was 220/112. I also have no history of high BP . BP remained high yesterday 4/9/21, but less so than injection day.
Started getting hives; This is a spontaneous report from a non-contactable consumer (patient). A patient an unknown age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unknown date as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient has the Pfizer first dose, the vaccine on Sunday. About an hour after the patient received the vaccine and started getting hives on an unspecified date and started taking Benadryl (treatment) and it helped. The patient just doesn't know, is that something should be concerned about for the second dose. The patient stated no and just need to talk to someone, don't want to follow up, just want to somebody to tell the patient what if going forward (sentence incomplete). The patient doesn't want to be the part of any survey. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
About 5 minutes after MENVEO administered, patient stated she began to feel nauseous. She stumbled on way to bathroom (although told not to get up if she felt ill) and fell faint on the way, falling and hitting her arm.
This is a 44 M with NIDDM, HTN, HLD, Schizophrenia here with c/o fever and generalized body aches for about 7-8 days. Says was having body aches for about 8 days, had COVID 19 vaccine first dose on 5/14/21. Since then, had worsening body aches and also started having fever(not sure how much). Urine color changed to brown in the past week. No change in appetite or nausea or vomiting prior to admit as per him. No new medications and does not consume recreational drugs. Not an alcoholic, no recent trauma, does not work out and was not exposed to extreme heat or cold recently.               In ER, patient was found to having AKI, shock liver, CK level which is too high to be calculated, had 1 episode of high-grade fever.  He was therefore started on IV fluids and admitted for further management of rhabdomyolysis.  Overnight had no urine output and having poor urine output since this a.m..  Had 1 episode of nausea and vomiting this morning.  No more fever since on the floor.  Complaining of epigastric pain that woke him up from sleep this afternoon.
Patient's daughter came in to find out when he received Covid vaccination because he just had a stroke. It occurred exactly 4 weeks after receiving his second dose. Patient's daughter is trying to get him into a rehab facility that would not accept him without his vaccine card.
10/26/09-received Flu Shot (TIV) at elementary School. Client was feeling fine no illness on day of vaccination. 10/27/09- Came to school and went to health Room to talk to Health Aide. Advised Health Aide she was sick with a sore throat, cough, headache, body aches, and chest tightness, no fever. Health Aide recommended to follow up with PCP. 10/30/09- Went to PCP for scheduled 6-months appointment. Advised PCP that she had received a flu shot on 10/26/09. Stated her ribs hurt, no fever. PCP scheduled appointment for next 6-month visit. No further action concerning current symptoms subsequent to flu shot. 10/31/09- Went out during the evening. That night she had chills, fever (does not have a thermometer, but said her nightgown was wet), her right side hurt, and her urine was orange. She was well hydrated, but was not eating. Her daughter whom she lives with wanted to take her to ER. Client refused. 11/04/09- Went back to PCP. Had EKG, X-ray. PCP wanted to admit client hospital. Client refused and advised she was able to care for self, comply with medication regimen, and had her daughter to assist her at home. Given antibiotics, LEVAQUIN 500mg, 10 day course. 11/06/09-Returned to PCP: diagnosed with pneumonia (type unknown). Still on antibiotics until 11/12/09. After completing course of antibiotics, she is to contact PCP to schedule another X-ray within one month. Per client, PCP advised blood test run previously showed high potassium. She was put on Klor-con (may have misunderstood whether her K was high or low). Note: There is some confusion concerning dates of ER visits and what was done in ER due to telephone calls to client from two PHN's. Stories differed somewhat. The above is the information obtained from the last telephone call with client.
This is a spontaneous case, initially received from other health professional (nurse) on 17-Jan-2018, concerning a 50-year-old, adult, female patient. The patient's current condition: wears braces. It was reported that the patient was healthy. On 17-Jan-2018, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 1720901 and expiry date: 31-May-2018). On the same day, immediately after receiving the vaccine, the patient experienced metallic taste. On 18-Jan-2018, the patient completely recovered from the event metallic taste. The reporter considered the event metallic taste as non-serious. Follow up received from other health professional (Nurse) on 09-Feb-2018: The reporter confirmed that, the patient had recovered completely from the event (metallic taste) on 18-Jan-2018. Narrative amended accordingly.
She states that on 4/2 she developed a rash to her right forearm (had vaccine in her left arm). States that it has "spider veins" and peeling skin. She went to the Urgent Care and was provided a Rx for topical steroids.
MMR shot given with VAR + HA-on 3/17/10 came to office on 3/9 for 4cm + 8 3/4cm red, hard mass to right thigh. Not warm to touch, no fever.