chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial pregnancy report received from a healthcare professional on 09 September 2014. A 29-year-old female patient, had received an intramuscular fifth dose of FLUZONE QIV (batch number-UI171AB, expiry date-30 Jun 2015, site of administration was not reported) on 09 September 2014. The patient current pregnancy history was reported as healthy, some swelling and no risk factors. The last menstrual period was reported as 01 May 2014 and estimated date of delivery was reported as 10 October 2014. The patient did not receive any treatment for infertility. At the time of vaccination the patient was pregnant. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none. Follow up information received from health care professional on 17 September 2014. In this follow up no new information was reported.
sore arm; dizziness; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HEADACHE (slight headache) and VACCINATION SITE PAIN (sore arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Hypertension.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (dizziness) and HEADACHE (slight headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, DIZZINESS (dizziness), HEADACHE (slight headache) and VACCINATION SITE PAIN (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-279444 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up received on 6-AUG-2021: Second dose information, Patient gender and initials were added On 06-Aug-2021: Reporter details, patient details and events added
In the evening after the immunization was administered, patient developed pain, swelling and reddness at the site.  No c/o fever.  Patient went to ER and was put on antibiotic and Benadryl.
Patient noted eyes (both) puffy, swollen and vision blurry approximately 24 hours after shot, also sluggish. No injection site reaction or other symptoms. Following day only right eye affected. Patient tried allergy eye drops and reports better on 2/24.
Nausea, dizzy and then vomited within minutes of receiving the vaccination, resolved quickly after she vomited, applied ice to face/neck, she lay on the floor for recovery, sipped water.
08-13-2009 during well child visit to clinic patient given 6 vaccines. Parent states onset of symptoms 8-19-09. Hives all over body - torso, bilateral arms, legs. Parent treating with otc BENADRYL - parent instructed by nurse practioner to continue with otc BENADRYL. Parent states reaction resolved 08-22-09 with out further intervention.
Patient lymph node in right armpit began to swell starting 48 hours post receiving vaccine; This is a spontaneous report from a contactable pharmacist (patient). A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 intramuscular, administered in Arm Right on 15Jan2021 12:00 (Batch/Lot Number: EL3248) as dose 2, single (Age at vaccination 30-year-old) for covid-19 immunisation. Medical history included from an unknown date. There were no concomitant medications. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 24Dec2020, intramuscularly administered at 12:00 PM, lot number EL1284 for covid-19 immunisation. Prior to 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. Patient did not receive other medications within 2 weeks of vaccination. No known allergies. The patient was not pregnant at the time of vaccination. The patient experienced patient lymph node in right armpit began to swell starting 48 hours post receiving vaccine on 17Jan2021 07:00. Patient lymph node in right armpit began to swell starting 48 hours post receiving vaccine. Swelling lasted one week. The outcome for event was recovered on an unknown date in 2021.   Follow-up attempts completed. No further information expected.
Fever, Rash, loud cry for hours. Glassy eyes and  dazed. Sleeplessness. Doctor said this is normal. How can such  serious side effects be normal??
Excessing crying (screaming) x 2 hrs; no fever, no redness; pt is alert just screaming;
Information has been received from a physician concerning a 34 year old female with no known allergies and a history of tonsillitis who on 04/18/2001 was vaccinated IM in the deltoid with a first dose of varicella vaccine. There were no concomitant medications or current illnesses. On 04/18/2001, sometime in the PM, the pt experienced local aching and pruritus which resolved in a few days. On 04/27/2001, the pruritus returned with a 2cm round area with redness, firmness and tenderness at the injection site. Approximately two weeks after the injection, the pt experienced a sore arm, fever, headache, four large welts on her body, lethargy, neck ache and was itchy all over. The pt presented to the physician's office on 05/01/2001. It was reported that these effects lasted 5 to 6 weeks and that the pt recovered in May 2001. No further info is available.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 25-NOV-2013 at 7:45, ZOSTAVAX (Lot # J008434) was exposed to -12 degrees C for an estimated total time out of range of 42.75 hours. On 02-DEC-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # J008434, expiration date 11-OCT-2014) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
felt bad of pain above left knee for few hours; right hip was painful; diarrhoea; right sided jawpain; gums inflamed for a bottom; Chest pressure; chest pain; This is a follow-up spontaneous report from a contactable Physician reporting in re-sponse to HCP follow-up letter sent in a cross-reference case for DOSE 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).A 65-Years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: not reported) on 06Mar2021 intramuscularly in right arm as DOSE 2, single for covid-19 immunisation (age at vaccination: 64-Years-old).The patient previous medical history included: Allergic to Biaxin, Vicodin, Penicillin. Patient was not taking any medications, did not receive any recent vaccines for any other conditions, did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech Covid-19 vaccine prior to the event being reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech Covid-19 vaccine vaccination. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: not reported) on 06Feb2021 intramuscularly in right arm as DOSE 1, single for covid-19 immunisation. On 06Mar2021, after second shot the patient experienced chest pressure within 5 min and 1 hour later she had chest pain which lasted for 8 hours. She keeps on experiencing the Chest pressure for couple of days. She also felt bad of pain above left knee for few hours, and the next day right hip was painful. She had diarrhoea. 1 week later she had right sided jaw pain and gums inflamed for a bottom. The patient Laboratory test included: CBC performed on 20Mar2021, and the result was normal. CMP performed on 20Mar2021, and the result showed Blood upper 109, NA+ 135.The patient was started on antibiotic by dentist. The outcome of the event felt bad of pain above left knee for few hours was resolved on an unspecified date. The outcome of the events right hip was painful, diarrhoea, right sided jaw pain, gums inflamed for a bottom, Chest pres-sure and chest pain was unknown.  It was reported that the patient required medical intervention: cardiac evaluation. The patient was not seen in the emergency department, nor hospitalized and was not sent to Intensive Care Unit. It was unknown if the patient Capillary refill time was greater than 3 sec or her central pulse volume was reduced.  No follow up attempts are possible. Information about lot/batch number cannot be re-quested. No further information is expected.
1. Macular edema OS; patient reports  reduced vision , patient reports symptoms started 24 hours after vaccine, macular edema first observed at exam 20 days after vaccine (4/21/21) when  vision reduced from previously 20/20 to 20/40; treated with Avastin injection left eye 5/7/21 and 06/21 (exact date unknown); as of 7/26/21 condition has not resolved and best corrected vision is 20/40 in left eye. Note that patient has known risk factor of diabetes with moderate non-proliferative diabetic retinopathy but had negative eye exam 1/25/21 without macular edema. Patient is also pseudophakic in left eye. Patient feels that symptoms started after vaccine and patient feels that vaccine contributed to macular edema.  Practitioner feels that diabetes is the most likely risk factor for macular edema in left eye. 2.  Numbness in left hand and fingertips, symptoms started 24 hours after vaccine and resolved 72 hours after symptoms started.
Diarrhea; Dizziness; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and ASTHENIA (Weakness) 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 DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and ASTHENIA (Weakness). At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and ASTHENIA (Weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The events started about several days after vaccination.  No relevant concomitant medications were reported.  No treatment information was provided.
My forearm got very red , hot and itchy.  This is 8 days after the shot where my arm had only been sore at shot site.  The redness spread down my arm towards my elbow about size of softball. At first thought it was a spider bite and put lavender essential oil on it. The itching stopped but redness and heat continued for 3 more days.  Day 3, I spoke with my holistic health coach, and I energetically  took Benadryl.  The redness and heat are half of what it was this morning will wait and see.  will call my PCD Monday if no improvement.
patient experienced swelling, redness, hot to the touch and pain above elbow in right arm after injection of flu shot the day of and the day after administration. She said it is getting better each day.
W/in 3 min p/receiving MMR pt laid head down on the table & then proceeded to go into sz-like (tonic-clonic movements of arms & legs); Pt transferred to Hosp; Pt became oriented w/in 1 min & admitted to Hosp;
This spontaneous report was received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and historical drugs were not reported. On 02-MAY-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot number M035142, expiration date 03-AUG-2018 (dose and route were not reported) for prophylaxis. The concomitant medication included sterile diluent. The temperature involved was between -9°C to 8°C, with time frame of 2 hours, 30 minutes. There was no previous temperature excursion, and a data logger was not involved. No adverse effects were reported. Additional information has been requested.
Mom brought child in with red swollen and not to touch left upper arm deltoid area. Advised her to take him to the doctor's office. Dr stated that it was a reaction to the DTaP.
pain in the arm on all doses; feeling tired on 1st 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the arm on all doses) and FATIGUE (feeling tired on 1st 2 doses) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm on all doses) and FATIGUE (feeling tired on 1st 2 doses). At the time of the report, VACCINATION SITE PAIN (pain in the arm on all doses) and FATIGUE (feeling tired on 1st 2 doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) normal.         Concomitant products also included  Steroids.  No treatment medication provided. RT-PCR test which came back negative.   This case was linked to MOD-2021-316580, MOD-2021-316515 (Patient Link).
pt recv vax 6DEC96 & 1 or 2 days later 8DEC96 it was reported that pt devel a fever, rash on back & gen malaise;etiology has yet to be determined because it was reported that this was a first time vaccine recipient;
Severe headache, nausea, vomiting, chills, fatigue, generalized weakness and lethargy.
100.9 fever Chills Violent shakes   Nausea  Arm pain
Within 30 seconds of receiving vaccines, patient was walking towards mom and stated "she felt funny." She then appeared as though she was going to faint but Medical assistant caught her from behind before she fell. Patient went rigid for a few seconds in Medical assistant's arms but then within 15 seconds had improved and returned to baseline. When she went rigid, her face and front side was not visualized. She was briefly examined by another provider who asked her a few follow-up questions and everything was normal.
This spontaneous report was received from a licensed practical nurse regarding a 12 year old male patient. His medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On 01-FEB-2018, the patient was accidentally vaccinated with 2 doses of GARDASIL 9 (lot # M044717 and expiration date: 19-JUL-2019) for prophylaxis. No adverse events were reported. No product quality complaint was involved.
Worsening inflammation/dermatitis 10 days following Moderna Covid-19 vaccine injection.  First mild/moderate pain  around injection site a couple days after injection (2.5 X 4 cm).  By day 10 post-injection the inflammation and aching (mild-moderate) sensation increased.  Inflammation around injection site expanded to 8 X 6.5 cm..  Sought medical care at this point and given diagnosis of unspecified dermatitis.  Have been prescribed antibiotic cefadroxyl 1 GM tablet - 1 day and Medrol Dosepack 6-day course.  Treatment starting 1/25/2021. Suspect possible cellulitis, and poor location of injection (back of right arm not positioned in deltoid muscle.)
Facial Tics- opening eyes wide, and jerking of the neck to the side.  All day, every day.
Bell's palsy 4 days after injection.  Given Prednisone (60 mg/day) and Valacyclover (3 gm/day) for 1 week.  Dramatically improved  at 10 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 34-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 34 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Post concussion syndrome" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE oral. Past drug history included: Known allergies: sucralose, reaction(s): "Allergy", notes: Known allergies: Sucralose. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: had positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details, Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 16Jul2022, Treatment stop date: 05Jul2022, Indication: Treatment of COVID-19. Had mild rebound symptoms and had positive antigen test for COVID 4 days after completing the 5 day course of Paxlovid. He initially tested negative after completing his course of Paxlovid.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Reddness and swelling RL and Knot at injection site. Advised to apply cool compress and Tylenol PM.
Mild wheezing worse with laying down. Nasal and throat dryness. Pain at injection site radiating to neck.
Pt. given pneumonia vaccine and had an immediate reaction of redness in the arms, face and sob. Lungs did have wheezing throughout the lung fields (they were clear during the exam) thus I will classify this as an adverse reaction/allergy. Pt. given a nebulizer treatment --> and wheezing cleared about 90%. Pt. felt much improved. Plan: Rx for prednisone 40 mg for 3 days will be sent to pharmacy. Pt. to RTC or the ER for any return of allergic like reactions including worsening asthma, SOB, wheezing, swelling, rash or other problems. Pt. agrees.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild
Patient triaged prior to vaccine administration. Mother informed nurse that pt. had allergy to milk, eggs and soy and peanuts. When asked about reaction type when child eats eggs, mother stated, "I don't know, but she doesn't like eggs." Mother stated child had no hx of serious reaction to any vaccine in the past. No hx of any respiratory problems including asthma reported by mother. Approx. 30" following vaccinations mother called PHN to report that child was having difficulty breathing  and was wheezing. Instructed parent to call ambulance and go to emergency dept.
Headache, Myalgia, NauseaVomiting, FATIGUE Narrative:
PATIENT REPORTED HE NEEDED HIS SECOND DOSE. PROOF OF VACCINATION CARD ONLY LISTED FIRST SHOT. PATIENT RECEIVED 0.5ML DOSE AS A RESULT. AFTER ADMINISTERING THE VACCINATION, IT WAS DISCOVERED THROUGH IMMPRINT RECORDS THAT PATIENT HAD ALREADY RECEIVED THE SECOND DOSE ON 7/19/2021. THE 12/3/2021 VACCINATION SHOULD HAVE BEEN ADMINISTERED AS A BOOSTER DOSE OF 0.25 ML ON 1/15/2022 OR AFTER. PATIENT WAS NOTIFIED AND  DID NOT REPORT ANY ADVERSE SIDE EFFECTS.
slight headache; Tiredness; Joint pain; Chills; hands were shaking; Fever; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration on 28Jan2021 at 15:00 as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient said he was calling about the Pfizer shot that he got yesterday (28Jan2021) at about 3pm. He stated he experienced some of the stuff they have on the list. He got the shot around 3PM and around 7PM that evening he started having chills, his hands were shaking really bad so he covered himself up really good and once he got some warmth to his body and about an hour later the chills calmed down and he started getting a fever his temp, the highest it got was 101.3 and it did come down after all night. He had a cold rag on his head the whole night. He had some joint pain, headache and tiredness, the headache was not severe. He had some diarrhea he does not know if that is associated with that or not. He did have some food, he ate that so he doesn't know if that is the cause of the diarrhea but it would not have caused all the other symptoms. He didn't have any redness where they gave the shot at all everything was fine on that end but he figured he better call to report it since he seen these are on the list. It was reported that slight headache was pretty mild now and it was not severe, he could just feel it in there but it is pretty much gone right now. Diarrhea went through the night and in the morning. He went 3 different times but now he thinks he is cleared out and needs to get some food back in him. His card says Pfizer COVID 19 vaccine. He does not see an NDC number or expiration date. He saw healthcare clinic site. Patent received vaccine because wants to be protected like all the other seniors. He went through night and that was pretty bad but he was starting to feel better now. He was tired it drained him he still feels pretty out of it but he is starting to feel better. He asked is there any concern about any of this stuff. He said everything was starting to quiet down now he doesn't think that would be necessary unless he had a relapse and he does not think that would happen at this point. The outcome of the event chills was recovered, slight headache was recovering and outcome of the other events was unknown.  Follow-up attempts are completed. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of temporal headache in a 68-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). On 8th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th may 2018, several hours after receiving SHINGRIX, the patient experienced temporal headache, poor quality sleep, ear pain and jaw pain. In May 2018, the patient experienced lockjaw. On 10th May 2018, the outcome of the temporal headache was recovered/resolved. On 11th May 2018, the outcome of the poor quality sleep, ear pain, jaw pain and lockjaw were recovered/resolved. It was unknown if the reporter considered the temporal headache, poor quality sleep, ear pain, jaw pain and lockjaw to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the Office Manager. At approximately 9:15 am, the patient received SHINGRIX in the left deltoid. In the evening, the patient experienced a stabbing pain in the left temple, pain in the ear, and pain in the jaw. In the night, the patient did not sleep good. On 9th May 2018, at around 4 AM, 18 hours 45 minutes after vaccination, the patient tried to take TYLENOL for the pain, and realized her jaw was locked. The patient's symptoms began to improve the next day. Until 10th May 2018, the patient continued to have a dull headache, and the patient's symptoms were resolved at the time of the report. No emergency room or doctor's visit was required. The patient's symptoms were not considered life threatening or disabling.