chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Chills; Joint pain; Headache; Booster; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 01Nov2021, (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was unknown whether, the patient received any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 22Jan2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 12Feb2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 02Nov2021, the patient experienced sore arm, chills, joint pain and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of events. The clinical outcome of the events sore arm, chills, joint pain and headache were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
Got vaccine while in the hospital for an accident. Got discharged. A few hours later she woke itchy with hives all over her body. Went back to the hospital for the hives and was told to take Benadryl. A few days later her throat started to close and the paramedics were called out and she was taking to the hospital again. She was given a Benadryl shot and EpiPen. She was discharged. A day later the same time happened and she was rushed to the hospital again for the 3rd time after taking the vaccine for hives and her throat kept closing.
Our office became aware of the infants death by an acquaintance of the family. This person also states that cause of death was determined to be S.I.D.S.
Menactra was administered to a patient one day after the expiration date; Initial information was received on 13-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional (GMI inquiry number: 00559908).  It was reported that MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6585AB, expiry date: 11-Apr-2021) (Suspension For Injection) was administered to a 16 year old female patient one day after its expiry day on 12-Apr-2021 via intramuscular route in right deltoid for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine was administered 4 hours after being out of refrigeration, 2 hours out of the recommended window at room temperature
Pt. states that after receiving the 3rd dose of Phizer 12/07/2021, started experiencing symptoms that evening of fever (100.9), chills, headache, flu-like symptoms, incontinence (urine), and rash (left calf-area) painful. Symptoms lasting 72hrs, no noted Primary visit/communications.
day p/vax pt (pinky) began feeling like was asleep, like pins sticking in it;next day rt arm throbbing;pain rt shoulder & went to finger tips;described it as arthritic type pain;10JUL98 arm red, hard knot, swollen;fever;bruise;allerg react;
Patient developed symptoms of "heart pounding" about 10 minutes after the shots were given.  This persisted and approximately 50 minutes after the vaccines were administerd she continued to have a heart pounding sensation and then developed a "heart racing" sensation and had dry mouth and a sensation that her tongue was "getting puffy."  She did not have any wheezing or trouble breathing.  She called 911 and was taken by ambulance to the ER.  She was given IM Benadryl and symptoms subsided over a time period of about one hour.  She was discharged home in good condition.  She did not have any fever or significant soreness in the arms.  She states that the day after these events she felt tired but otherwise felt fine.
Localized erythema at the site of injection (after vaccination) -> then she developed arm pain and body weakness later like flu-like symptoms.
The day after the injection, my lips and tongue became swollen.   Saliva dwindled to near-nothing but occasionally dribbles from the left mouth corner .  Could not whistle.  Could not speak a clear 'esss'.   Speech impeded.   Mouth and lips 'puffy'.   My ability to taste became severely limited. Today, 11 days later these symptoms are reduced to perhaps 30% of the worst values  on about the second day after the injection.
Hives on upper left arm; hives on upper right arm; hives on right forearm: onset over 24 hours after injection, lasts greater than 3 days
little bit of soreness in my arm; This is a spontaneous report from a contactable consumer, the patient.  A 73-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Dec2020 (at the age of 73-years-old) as a single dose for COVID-19 vaccination. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient stated "I just got my shot yesterday and I'm 73 and I was sure that I was gonna have something but I got absolutely nothing. A little bit of soreness in my arm but I can live with that."  The clinical outcome of soreness in arm, was unknown.    Information on the lot/batch number has been requested.
sore; itching around the injection site; Headache; no energy; felt off; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy), FEELING ABNORMAL (felt off), PAIN (sore), VACCINATION SITE PRURITUS (itching around the injection site) and HEADACHE (Headache) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included No adverse event (no medical history reported ). Concomitant products included ARFORMOTEROL TARTRATE (BROVANA), FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CARVEDILOL (COREG), RALOXIFENE HYDROCHLORIDE (EVISTA), SITAGLIPTIN PHOSPHATE (JANUVIA), ATORVASTATIN CALCIUM (LIPITOR), MAGNESIUM OXIDE, LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN D [VITAMIN D NOS], FLUOXETINE HYDROCHLORIDE (PROZAC), EZETIMIBE (ZETIA), MONTELUKAST SODIUM (SINGULAIR), OXYBUTYNIN, IRON, ASCORBIC ACID (VITAMIN C ASC ACID) and ALPRAZOLAM (XANAX) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced ASTHENIA (no energy), FEELING ABNORMAL (felt off), VACCINATION SITE PRURITUS (itching around the injection site) and HEADACHE (Headache). On 24-Feb-2021, the patient experienced PAIN (sore). On 24-Feb-2021, VACCINATION SITE PRURITUS (itching around the injection site) had resolved. At the time of the report, ASTHENIA (no energy), FEELING ABNORMAL (felt off), PAIN (sore) and HEADACHE (Headache) outcome was unknown.       Action taken with mRNA-1273 in response to events was not applicable.  This case was linked to MOD21-038093 (E2B Linked Report).; Sender's Comments:  MOD21-038093:
ACUTE ABDUCENS NERVE PALSY OF SIXTH CRANIAL NERVE; This spontaneous report received from a parent concerned a 24 year old male of unspecified race and ethnicity. The patient's weight was 175 pounds, and height was 72 inches. The patient's past medical history included: covid-19 positive (In March 2021), and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 19-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-OCT-2021, the patient experienced double vision in his left eye. Consumer reported that, patient complained of double vision in his left eye for about 6 weeks, so patient went to see an optometrist. On 26-OCT-2021, patient was diagnosed with acute abducens nerve palsy of sixth cranial nerve. Consumer reported that, on 27-OCT-2021 patient was referred to ophthalmologist and scheduled for an Magnetic resonance imaging (MRI). Consumer reported that, patient had a Covid-19 in MAR-2021, so was unsure about diagnosis was due to vaccine or tumor, stroke (aneurysm) or increased cranial pressure. Patient had no other adverse effects after the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of acute abducens nerve palsy of sixth cranial nerve was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211051676.; Sender's Comments: V0: 20211051664- Covid-19 vaccine ad26.cov2.s- acute abducens nerve palsy of sixth cranial nerve. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
discomfort under the mouth, which feels; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (discomfort under the mouth, which feels) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced ORAL DISCOMFORT (discomfort under the mouth, which feels). At the time of the report, ORAL DISCOMFORT (discomfort under the mouth, which feels) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant details were not provided Treatment details include Tylenol
Vaccine was injected in right arm (Pt can't have vaccines injected in her left arm due to getting a mastectomy when fighting breast cancer). Patient reported that right arm throbs at night and disturbs her out of her sleep. Patient received the FLUAD vaccine 8/24/17. Pt is right handed so does not feel pain during the day since she uses it most of the time. She feels the pain when her arm is at rest. Today (12/01/17) is the patient's second visit to the pharmacy reporting pain in her arm. She went to see her MD about it and thinks it has something to do with the vaccine injection into the muscle. Patient would like to hear from the FDA about what she should do. She also took TYLENOL 650 mg to help with the pain. Patient never had any issues with the high dose flu vaccine and received FLUZONE in the past. This was her first time getting FLUAD.
Initial information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves unknown age and gender of child for whom at the lowest temperature for the PREVNAR 13 and TRUMENBA was -1.32 degrees/ACTHIB and DAPTACEL that the patient received on 03oct2018 was also involved in the temperature excursion was reported, while he/she received vaccines TRUMENBA, PREVNAR 13, ACT-HIB and DAPTACEL. The patient's had no past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 03-Oct-2018 at 06:47 pm, the patient received a dose  0.5 ml of suspect PREVNAR 13 not produced by Sanofi Pasteur lot T36366 expiry date: 28-Feb-2020 via intramuscular route in the left thigh. On 03-Oct-2018, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI901AAA Expiry Date: 17 Sep 2019 via intramuscular route in the right thigh. On 03-Oct-2018, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5101AA Expiry Date: 26 Nov 2018 via intramuscular route in the right thigh. On an unknown date, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. It was reported that the lowest temperature for the PREVNAR 13 and TRUMENBA was -1.32 degrees Celsius for 20 minutes. Caller states that within the 20 minutes the temperature went back to normal. There 6 patients who received the vaccines after the excursion and also stated the ACTHIB and DAPTACEL that the patient received was also involved in the temperature excursion. The patient was not visit emergency room as well as physician office. It was an actual medication error due to product storage error. There was no lab test was done. Final diagnosis was the lowest temperature for the PREVNAR 13 and TRUMENBA was -1.32 degrees/acthib and DAPTACEL that the patient received on 03oct2018 was also involved in the temperature excursion. It was not reported if the patient received a corrective treatment. The outcome of event was not applicable. List of documents held by sender: none.
Fever, Localized reaction at right arm with induration for 1-2 days, treated with amoxicillin
inappropriate administration of PENTACEL to a patient that was no longer suitable for use post excursion with no reported adverse event; Initial information received on 14-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and unknown gender patient who had inappropriate administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] that was no longer suitable for use post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Jun-2023, the patient had inappropriate administration of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ806AA, expiry date- 18-FEB-2024) via unknown route in unknown administration site for Immunization that was no longer suitable for use post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Caller reported a temperature excursion due to an unknown cause. The excursion occurred on 06JUN2023. The lowest temperature reached negative 0.92 C and the total excursion lasted 1 hour and 15 minutes. Pentacel was administered on 10JUN2023 after being exposed to NEGATIVE 0.92 C.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
could not talk because of her swollen tonsils/tonsillitis; fatigue; burning legs and toes; arm pain; swollen lymph nodes; could not talk because of her swollen tonsils; This is a spontaneous report from a contactable consumer (patient's father). A 20-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Three to four days after receiving the vaccine, the patient experienced fatigue, burning legs and toes, arm pain, swollen lymph nodes, and swollen tonsils. She could not talk because of her swollen tonsils and was diagnosed with tonsillitis. The patient received treatment with steroids and antibiotics. The outcomes of fatigue, burning legs and toes, arm pain, swollen lymph nodes, swollen tonsils, could not talk, and tonsillitis were unknown.
Mom reports that about 10AM pt started to develop fever, became cranky, whiny, & seemed to have difficulty walking; Later pt started crying; Screaming & fever persisted; pt to ER was given APAP; Also erythema @ site of inject;
Received flu shot on 10/29/04. Developed pain right after shot; noted a small ball under skin. Applied ice for several days; pain decreased after a week. Now (11/18/04) pain is worse and have slight traction elevating arm. Overall range of motion and pain is worse.
Developed swelling on right side of jaw and throat, mouth, emesis, chills, rigors.
soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and FATIGUE (Fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (soreness) and FATIGUE (Fatigue). At the time of the report, PAIN (soreness) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
A physician reported that her 2 month old daughter received her 1st dose of Prevnar, Comvax, IPV, and DTaP vaccines in January, 2001. On 02/20/01, she was treated and released from the ER for a seizure and high fever. As of 02/22/01, she continued to receive treatment with Ceftriaxone. Seizures are considered medically important. Copies of this report have been forwarded to Merck and Aventis Pasteur, manufacturers of the concomitantly administered vaccines. Follow up received from the patient's pediatrician on 04/17/2001 indicated the vaccines were administered 02/08/2001 and she was seen in the emergency room 02/21/2001. The patient recovered.
Moderna Covid19 vaccine EUA.  On January the 4th at 9:45 patient received the vaccine around in 11:45am o'clock I started having lower back symptoms. I injured my scartic nerve one year in a 1/2 ago from lifting and for some particular reason that nerve started to hurt hours after vaccine.  Today is 01/05/2021 and my scartic nerve is still aching as of today. Nerve started aching and hurting after Moderna Covid19 vaccine. I was having any problems with nerve before vaccine.
itchiness and watery eyes; itchiness and watery eyes; nipple drainage/increased again after the second dose; nipple drainage/increased again after the second dose; exhausted; nausea; low grade fever; muscle aches; This is a spontaneous report from a contactable nurse (patient). A 55-year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3247) via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (lot number: EJ1685) on 30Dec2020 for COVID-19 immunization and experienced nipple drainage, sore arm, metallic taste in mouth, itchy and watery eyes. The nipple drainage decreased before getting the second dose, and then increased again after the second dose. She noticed an increase in the drainage on 21Jan2021. It was a yellowish to clearish drainage. She was wondering if there was any correlation. She was curious if other women have noticed this. She was unsure of her weight, but would get 140 or 150 lbs. She didn't have a prescribing doctor. She got it through her employer. Also she experienced other side effects. After the second dose she experienced different side effects. She experienced a low grade fever. It started on 19Jan2021 evening into 20Jan2021 morning. It lasted for 18- 24 hours. She recovered completely, and it was not serious. She also developed muscle aches on 19Jan2021, 6-8 hours after the second vaccine. She felt better now. She had a rough night last night. She has been doing Advil, and it had helped significantly. That stated on 19Jan2021. It had improved, and it was not serious. She had also been exhausted after the second vaccine. That started 20 hours after. It started the 20Jan2021. It was ongoing, but had improved. It was not serious. She developed the nausea six hours later on the 19Jan2021. It had improved, but she was not 100%. It was not serious. She had been taking Tylenol and Advil for event low grade fever and muscle aches. She had noticed an increase in the itchiness and watery eyes (She didn't know if it was related to winter and allergies or the vaccine.). It was ongoing and persisting. The outcome of the event low grade fever was recovered on 20Jan2021, of the events muscle aches, exhausted, nausea was recovering, of the events itchiness and watery eyes was not recovered, of the other events was unknown.
This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 55-year-old female patient who received FLUARIX QUADRIVALENT (batch number AF29T, expiry date 25th June 2017). Concomitant products included ADVIL. On 4th October 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT 0.5 ml. On 4th October 2016, less than a day after FLUARIX QUADRIVALENT, the patient experienced dizziness, injection site pain, tiredness and vomiting. On an unknown date, the outcome of the dizziness, injection site pain, tiredness and vomiting were recovering/resolving. The reporter  considered the dizziness, injection site pain, tiredness and vomiting to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. The patient had planned to continue follow-up with her physician on an unknown date.