chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen lymph node near left side collarbone; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 08:45 (at the age of 47-years-old) as a single dose for COVID-19 immunization. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 08:45 (at the age of 47-years-old) as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 12:00, the patient experienced swollen lymph node near left side collarbone; noticed on 15Apr2021 and it had reduced in size but was still noticeable. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as result of the event. The clinical outcome of the event swollen lymph node near left side collarbone was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient  could feel the taste of the vaccine in her mouth; Laboured breathing; Wheezing; The patient felt an itching; This is a spontaneous case from, reported by other health professional (Practice Administrator) via agency (reference number SEQ19-04325), initially received on 09-Oct-2019, concerning a 44-year-old female patient.  The patient's medical history and concomitant medications were not reported.  On 09-Oct-2019, the patient was administered Flucelvax (QIV) [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number:261210, expiry date: 30-Jun-2020] for influenza prophylaxis.  On the same date, immediately after vaccine administration, the patient experienced an itching, developed laboured breathing and wheezing. In addition, she stated that she could feel the taste of the vaccine in her mouth. The patient was brought to the emergency room, given the corrective treatment which included cocktail of drugs (including antihistamines) and sent home.  At the time of initial reporting, the outcome of the events 'itching', 'after taste', ' laboured breathing' and ' wheezing' was not recovered.  This reporter assessed the case as non-serious and did not provide causality assessment.  Non-significant follow-up reported by agency (reference number: SEQ19-05172) on 23-Oct-2019: Additional agency reference number added. No changes in narrative.; Sender's Comments: The patient developed pruritus, wheezing, dyspnoea and dysgeusia on the same date after Flucelvax (QIV) administration. Chronology is plausible. No information regarding patient's medical history and concomitant medications was provided. Based on currently provided information, causality is assessed as possibly related for all events.
pt recv vax; arm became very sore, red. hot to touch & indurated; apap & cold compress used;by 26apr sx inc;PC fr pt & was advised to put warm compresses to area; dph given & tx w/ amoxicillin for 10 days;
Arthralgia, Diarrhea, NauseaVomiting, UNCONTROLLABLE SHAKING, WEAKNESS Narrative:  Other Relevant History:
This spontaneous report was received from the office manager referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 06-FEB-2019 the patient was inadvertently administered M-M-R II (rHA) lot number R025335 and expiration date of 06-APR-2020 and lot number R001659 with expiration date of 17-JAN-2020 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 60°F for 60 minutes while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved.; Sender's Comments: US-009507513-1902USA011926: US-009507513-1902USA007818: US-009507513-1902USA011924: US-009507513-1902USA011927: US-009507513-1902USA011923:
This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 03-FEB-2014, the patient was vaccinated with dose 2 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Prior to receiving the J&J vaccine on April 1, 2021, my last menstrual period was noted in September 2019. I have an IUD in place (placed in December 2017).  The first 24 hours after receiving the vaccine,  I had mild symptoms of headache, low grade fever and aches from the neck up. 2 days after receiving my vaccine, my period began and continued as a light period until April 14, 2021.  I continued with headaches in the temporal region and experienced light headedness and blurred vision throughout the day (still continues as of today 4/19/21). I went to my primary physician on 4/15/21 and was sent for labs (CBC, CMP, and TSH level), an EKG (after hearing an irregular heart rhythm), and a MRI of my brain. All of my labs and MRI were reported as normal. My EKG showed occasional PVC's.
One week later a painful rash appeared around the area of the injection. Been having a mild headache beginning around noon on the 20th of April.
Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (658208/0886U) ZOSTAVAX on 09-JUL-2008. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
PROQUAD was administered and vaccine had expired 4 days ago. RN did not see this prior to administration.
First  dose 2/28 - was fine Second dose 3/21- that evening headache dizziness took ibuprofen around 8-9pm.  3/22 - soreness in arm, headache.  3/23 - swelling on shot area leading around to underarm, hard lump side of underarm area very sore.  Took ibuprofen  Add ice.pack
muscle spasms of back, abd, legs; rigors; unable to walk d/t spasms brought in by ambulance;
RUNNY NOSE; SORE THROAT; HEADACHE; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 250 pounds, and height was 69 inches. The patient's concurrent conditions included: non-smoker, and non alcohol user, and other pre-existing medical conditions included: The patient have No known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-AUG-2021, the patient experienced runny nose. On 12-AUG-2021, the patient experienced sore throat. On 12-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine was not applicable. The outcome of the runny nose, headache and sore throat was not reported. This report was non-serious.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Sep2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Sep2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
DEMAND ISCHEMIA 4/20/2021 ANOREXIA  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 4/22/2021 ANOREXIA  DEMAND ISCHEMIA 4/20/2021 SEIZURE, UNSPECIFIED  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 4/22/2021 SEIZURE, UNSPECIFIED  DEMAND ISCHEMIA 4/20/2021 SHORTNESS OF BREATH  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 4/22/2021 SHORTNESS OF BREATH  DEMAND ISCHEMIA 4/20/2021 PLEURAL EFFUSION  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 4/22/2021 PLEURAL EFFUSION
tested positive for COVID-19; tested positive for COVID-19; COVID bronchitis; chest tightness; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included she believed she was exposed to COVID-19 on 23Jan2021. Concomitant medications were not reported. The patient tested positive for COVID-19 on 30Jan2021. She received her second dose 41 days after the first dose because she was experiencing a cough and some chest tightness and she was told she had COVID bronchitis on an unspecified date in 2021. She received a prescription for Azithromycin (Z-pak) and methylprednisolone for COVID bronchitis. The second dose was administrated at present date. The outcome of events was unknown.   Information on the lot/batch number has been requested.
3 days after the  vaccine 1st dose, I was feeling very hot but when I took my temperature, it was normal temperature (98F). I took ibuprofen and the flushing did not go away. I also had full body aches from head to toe. I decided to call the telehealth doctor through my insurance. I was instructed to take Tylenol and rest and that it was a reaction to the vaccine. I took Tylenol and it really did not help too much. It helped with the body aches but not the flushing. It took about 3 days for the symptoms to go away.
Myalgia, Rash, UrticariaPruritus, prickly rash back,neck,chest, neck and shoulder pain Narrative:  Other Relevant History:
About 3 hours after the vaccinations (around 7:15 pm) she developed  urticaria, feeling of warmth,   itching , pins/needles /tickling feeling throughout her body,  abdominal pain,  single episode of diarrhea.  Abdominal  discomfort resolved after about 45 minutes.   Mother gave Benadryl and Zyrtec at 8:00 pm.  In the emergency department she was given  dexamethasone at 10:24 pm  Her symptoms had resolved by 10:45 pm   She never had any lip, tongue, or throat swelling, no shortness of breath or difficulty breathing
Lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 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) Daily dose: Citrate free, Solution for injection in pre-filled pen. In 2021, the patient experienced DIZZINESS (Lightheaded). In 2021, DIZZINESS (Lightheaded) had resolved.            Concomitant Drugs were not reported.  On 15-Nov-2021, the patient experienced event when went to put injection foot slipped and needle came out and medicine went down leg( Device use error) with Humira, the reported causality for this event was reasonable possibility with drug Humira.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided by the reporter.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Arm Itchy; Arm Red; Rash; headache; tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Arm Itchy), ERYTHEMA (Arm Red), RASH ERYTHEMATOUS (Rash), HEADACHE (headache) and FATIGUE (tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included C-section. Concomitant products included LOSARTAN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Arm Itchy), ERYTHEMA (Arm Red), RASH ERYTHEMATOUS (Rash), HEADACHE (headache) and FATIGUE (tired). At the time of the report, PRURITUS (Arm Itchy), ERYTHEMA (Arm Red), RASH ERYTHEMATOUS (Rash) and HEADACHE (headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Took Zyrtec an hour before vaccine   This case was linked to MOD21-088590 (E2B Linked Report). This case was linked to MOD-2021-056019 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: NNI On 26-May-2021: Non-significant Follow up; Sender's Comments:  MOD21-088590:crosslinked
Information has been received from a mother of a patient referring to her child of unknown age and unknown gender who was highly functional autistic. On unknown dates the patient was vaccinated with the first and the second dose of MMR II (lot#, expiration date, dose and route were unknown). And, after receiving the second dose of MMR II, the patient experienced a loss of all fine and gross motor skills immediately. The patient was recovered from the event after three weeks, on an unspecified date. Additional information is not expected as there is no reporter's contact information.
pt recvd vax for prophylaxis; 6 hrs later exp anorexia, cramping, sores on arms,itching & boils in vagina; unresolved
This spontaneous report was received from a medical assistant referring to unspecified number of unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates starting on or after 22-APR-2016, the patients were administered an unspecified number of improperly stored doses of VAQTA (lot # K023019, expiration date 28-APR-2017) (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 32 F for 2 hours and 8 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
hives all over her body, terrible itching. started day of shot and has continued 2 days so far. Giving Benadryl, anti itch gel and 1% Hydrocortisone
Tinnits/She had a loud high pitch, unbearable sound that engulfed her head. It is now 6 months later and the sound is still there but it has lessened. She states that it is Tinnitis.; her head throbbed.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnits/She had a loud high pitch, unbearable sound that engulfed her head. It is now 6 months later and the sound is still there but it has lessened. She states that it is Tinnitis.) and HEADACHE (her head throbbed.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hives since 1993, Drug allergy (Allergy to NSAIDS), Penicillin allergy and Shellfish allergy. Concomitant products included LEVOCABASTINE HYDROCHLORIDE (ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]) from 1996 to an unknown date for Hives, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced TINNITUS (Tinnits/She had a loud high pitch, unbearable sound that engulfed her head. It is now 6 months later and the sound is still there but it has lessened. She states that it is Tinnitis.) and HEADACHE (her head throbbed.). At the time of the report, TINNITUS (Tinnits/She had a loud high pitch, unbearable sound that engulfed her head. It is now 6 months later and the sound is still there but it has lessened. She states that it is Tinnitis.) had not resolved and HEADACHE (her head throbbed.) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Added reporter information, added patient information, Added relevant history, Added suspect doses information, Added Zyrtec indication, Updated reporter's causality to Possible
My left ear is extremely swollen; My left eye lid is heavy and smiling is becoming hard on the left side due to the numbnes; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 16:45 (Lot number: 054859512640) at the age of 42 years as dose 1,single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADDERALL. The following information was reported: EAR SWELLING (non-serious) with onset 28Sep2021, outcome "not recovered", described as "My left ear is extremely swollen"; HYPOAESTHESIA (non-serious) with onset 28Sep2021, outcome "not recovered", described as "My left eye lid is heavy and smiling is becoming hard on the left side due to the numbnes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of ear swelling, hypoaesthesia.  No follow-up attempts are possible. No further information is expected.
pain during injection; feeling weak; shoulder pain and weakness; felt like a nerve was being hit; Fatigue; Bedridden; felt like a nerve was being hit; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain, feelings of weakness, shoulder pain, nerve injury, fatigue, bedridden and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, feelings of weakness, shoulder pain, nerve injury, fatigue, bedridden and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, feelings of weakness, shoulder pain, nerve injury, fatigue and bedridden to be related to Shingrix.  Additional details were provided as follows: After receiving the 1st dose of Shingrix the patient experienced pain at time of injection, described it as if it felt like a nerve was being hit also experienced feeling weak and was on the couch for three days, and since the first dose she has had persistent shoulder pain and weakness. The patient been seen by an orthopedist and had an Magnetic resonance imaging done to evaluate this issue. The reported suspected the 1st dose was administered too high on her arm and might had hit a nerve or the joint sack, which led to vaccine administered at inappropriate site. The patient emergency room visit required. On 15th November 2019, the patient received 2nd dose and she had no issues. The reporter consented to follow up.      Lab Comments: Lab test performed on an unknown date
the coughing slowly started returning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Dry cough" (unspecified if ongoing), notes: Hello I have had a dry cough for about 18 years that no one has been able to find a cure for. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), for Covid-19 immunization. The following information was reported: COUGH (non-serious), outcome "not recovered", described as "the coughing slowly started returning".  Additional information: Hello I have had a dry cough for about 18 years that no one has been able to find a cure for. When I had my first Pfizer vaccine for COVID-19 within hours I stopped coughing all together! A few months after the 2nd dose the coughing slowly started returning. I was disappointed after the booster that my coughing did not stop. What is in your dose that stopped my coughing and how can I get regular use of it?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.