chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child received shots on 10/23/07.  Received a phone call from her mother on 10/24/2007 stating that the child had fainted in the bathtub and had to be helped out.  She also had a slight fever.  No history of fainting.
This case was reported by a physician via sales rep and described the occurrence of fever in a 59-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 9th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 9th August 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date,less than a year after receiving SHINGRIX, the patient experienced fever and general body pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever and general body pain were recovered/resolved and the outcome of the drug dose administration interval too short was unknown.  It was unknown if the reporter considered the fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced fever and body ache. This case has been linked with case US2018GSK173231, reported by same reporter for same patient.
Patient given PENTACEL instead of DAPTACELwith no reported adverse event; given an extra IPOL dose with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00759904) and transmitted to Sanofi on 08-Sep-2021.  This case involved 4 year-5-month-old male patient given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and given an extra IPV (VERO) [IPOL] dose (wrong product administered and extra dose administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE; MUMPS VACCINE; RUBELLA VACCINE; VARICELLA ZOSTER VACCINE in the right for prophylactic vaccination.   On 08-Sep-2021, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot number: UJ473AAA and expiry date: 09-Jul-2022) (Frequency = once) (Strength = standard) via intramuscular route in the left thigh for prophylactic vaccination instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and given an extra 0.5ml dose of suspect IPV (VERO) [IPOL] (lot number: T1E871M and expiry date: 10-Oct-2022) (Frequency = once) (Strength = standard) via subcutaneous route in the left thigh for prophylactic vaccination.  It was reported, "What should they do now? The Medical Information agent confirmed the spelling of demographics with the caller for accuracy. The patient is doing fine and the provider is aware".   This case was an actual medication error due to wrong vaccine administered and extra dose administered.  At the time of reporting, no adverse 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.
ED visit - COVID positive. Discussed positive Covid results with patient, he stated understanding to care plan, agreeable to trial of Tylenol for symptomatic care, will continue to drink and eat a well-balanced diet, states understanding to return precautions. Hospital admission 4 days later - Pneumonia due to severe acute respiratory syndrome coronavirus 2 - Pneumonia due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): he started having symptoms on 9/8 and diagnosed on 9/12.  He was admitted on 9/16. His respiratory status deteriorated and he was intubated.  Due to prolonged intubation he had a tracheostomy and G tube placed on 10/6. He was then slowly weaned off the vent and transitioned to a trach dome.  He continued to do well and transferred out to the floor on trach dome and started PT and OT.  He remains very weak and will need long term acute care and will be going to medical facility Hospital admission and ED visit were within 6 weeks of receiving the COVID vaccine.
swelling on the injection site; tenderness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling on the injection site) and VACCINATION SITE PAIN (tenderness on the injection site) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling on the injection site) and VACCINATION SITE PAIN (tenderness on the injection site). At the time of the report, VACCINATION SITE SWELLING (swelling on the injection site) and VACCINATION SITE PAIN (tenderness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was provided by the reporter.  No treatment information was provided.
Thumbs tingling 40 min after injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Apr2021 09:15 (Lot number: Er8727) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "injuring my elbow tendons" (unspecified if ongoing), notes: did heavy lifting for years injuring my elbow tendons at times. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE lot number: En6205 administration time: 09:15, Left arm; intramuscular route), administration date: 13Mar2021, when the patient was 38 years old, for COVID-19 immunisation, reaction(s): "Numbness of fingers", "Itchy skin", "Skin irritation", "Swelling of wrists", "Swelling of elbows", "Inflammation", "Tingling". The following information was reported: PARAESTHESIA (non-serious) with onset 03Apr2021 09:55, outcome "recovering", described as "Thumbs tingling 40 min after injection". Therapeutic measures were not taken because of paraesthesia.  Additional information: The patient did not have any allergies to medications, food, or other products. Concomitant medications included unspecified multivitamin gummies (MANUFACTURER UNKNOWN) received on unspecified date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 09:55, 40 minutes after injection, the patient experienced thumbs tingling, which was not as bad as tingling experienced by patient after dose one vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The patient had no idea how an upper arm muscle injection would do this to thumbs, did not make sense to the patient but he would report it to be safe. The clinical outcome of the event thumbs tingling 40 min after injection was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
about 4 hours after the shot I realized my heart was racing and my throat felt ticklish. I also noticed that the insides of both forearms were a bluish mottled color. Then I started uncontrollable shivering that lasted about 90 minutes. We went to the ER within 15 minutes of symptoms starting.
temperature excursion for the Pfizer BioNTech COVID-19 vaccine adult formulation; temperature excursion for the Pfizer BioNTech COVID-19 vaccine adult formulation; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Lot number: 301458A) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT STORAGE ERROR (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome unknown and all described as temperature excursion for the Pfizer BioNTech COVID-19 vaccine adult formulation.  Additional information: Reporter reported a temperature excursion for the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap). Also stated that they had undiluted vials of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) that have been on the freezer since 03NOV2021. No patients got the effected vaccines, they did not did a vaccine clinic the week of Thanksgiving and the only ones used in the health clinic were ones that were removed from the freezer in an appropriate amount of time  No follow-up attempts are possible. No further information is expected.
Fever. This case was reported by a consumer via other manufacturer and described the occurrence of fever in a female patient who received BEXSERO.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant product reported by reporter. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 190 patient received a vaccine past the beyond use date from 9 different lot number vials. No treatment medication was reported. This case pertains to the 138th patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335.   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
The afternoon of the vax, the pt experienced a fever of 100. Tylenol was given prior to receiving the vax. When Mom arrived home from work, the child ate and seemed normal except seemed sleepy. The temp at 20:30 was 99. At 10:00 pm the child was sleepy and began having a seizure. After the seizure the child was unresponsive. The parent called 911. The ambulance arrived approximately 20 minutes later. Mom gave emergency breathing because of shallow breathing. The child was non-responsive for about 25 minutes. Child was given oxygen and brought to local ER and then transferred to another facility. The child stayed in the hospital over night. and was released the following morning.
large local reactions on the arm, systemic symptoms and swelling from his shoulder to his fingertips; systemic symptoms; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from non-healthcare professional.   This case involves male patient (age not reported) who experienced large local reactions on the arm, systemic symptoms and swelling from his shoulder to his fingertips (extensive swelling of vaccinated limb)( adverse event), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the arm.  On an unknown date, the patient developed a non-serious large local reactions on the arm, systemic symptoms and swelling from his shoulder to his fingertips (extensive swelling of vaccinated limb) (adverse event)(unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported that the patient has had systemic symptoms and swelling from his shoulder to his fingertips with each Fluzone injection in the past. It is unknown how many injections of Fluzone the patient has received in the past.  Other relevant tests not reported.   Final diagnosis was extensive swelling of vaccinated limb.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for extensive swelling of vaccinated limb.  Information on the batch number was requested.
Severe body aches; Headache; Nausea; Diarrhea; Tiredness; Feeling of unwell; Lung and chest pain; Lung and chest pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Feb2021 18:30 (at the age of 65-year-old) as single dose for covid-19 immunisation. Medical history included arthritis, inflammation, covid prior vaccination on 10Mar2020. The patient was no known allergies. There were no concomitant medications. On 04Feb2021 at 09:00, patient experienced severe body aches, headache, nausea, diarrhea, tiredness, feeling of unwell, lung and chest pain. There was no treatment. The patient was not pregnant. There was no covid tested post vaccination. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Was feeling like she was having an "out of body experience" and went home, the following day (Tues) had chills, HA, body aches/pains, nausea and ST, Weds felt sl better in am but that evening felt hot and sweaty, THurs still had chills, temp, felt hot and cold, pain in all joints, HA, weak, did not had thermometer so didn't have temp recorded; now developed itchy hive rash (lasted for 1.5 days); temp 100.2 on 9/23/13.
2 inch diameter red welt at injection site,; Red welt at injection site, painful and extremely itchy; Red welt at injection site, painful and extremely itchy; This is a spontaneous report from a contactable consumer, the patient. A 66-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 07Apr2021 at 11:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included GERD (Gastroesophageal reflux disease), anemia and caffeine allergy. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), esomeprazole magnesium (NEXIUM), cyanocobalamin (B12), iron (MANUFACTURER UNKNOWN) and aluminium hydroxide gel, dried, magnesium carbonate (PEPCID) all for unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 11:00 as a single dose for COVID-19 immunisation.  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 4 weeks prior to the vaccination. On 08Apr2021 at 06:00, next day after vaccination the patient experienced 2-inch diameter red welt at injection site, painful and extremely itchy. Four days in no change in size, pain or itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events 2-inch diameter red welt at injection site, painful and extremely itchy was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient complains of severe pain in left deltoid muscle and loss of range of movement beginning July 26, 2003 and states that her shoulder continues to hurt as of August 25,2003.
Vaccine administered to left thigh but bruising to left shin. Parents stated leg was swollen with bruising went to ER.
redness at injection site; pain at injection site; swelling at injection site; injection site was very hot; hair is falling out in clumps; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-SEP-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness at injection site), injection site pain (Verbatim: pain at injection site), injection site swelling (Verbatim: swelling at injection site), injection site warmth (Verbatim: injection site was very hot) and hair loss (Verbatim: hair is falling out in clumps). The patient was treated with non-drug therapy (Ice Pack (No Medication)). The outcome of the injection site erythema, injection site pain, injection site swelling and injection site warmth were resolved and the outcome of the hair loss was not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling, injection site warmth and hair loss to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site pain, injection site swelling, injection site warmth and hair loss to be related to Shingrix.   Additional Information: GSK receipt date: 06-SEP-2023 The patient experienced pain, redness, swelling at injection site hours after receiving that lasted for about a week.  The patient also said injection site was very hot, where she had to use ice packs, that lasted about a week as well.  She reported her hair was falling out in clumps, started about a week ago and it had not resolved.  Phone number provided. The reporter consented to follow up.
On 7/3/09 patient started running a fever, that night ok on 7/4. The fever stopped. On 7/5 patient broke out with "spots". She had several - all over "they were more like pimples than anything". Mom took her to MD. He said it was chicken pox.
erythema, pruritus, edema at injection site, fever 100.1 F the day after injection.  Fever resolved on day 3, erythema and swelling diminishing on day 4.  Treatment:  ice, hydrocortisone cream 1%, Benadryl
Patient received the Monovalent Comirnaty vaccine and should have received the Pfizer Bivalent booster vaccine.  Patient contacted by clinic. No adverse outcomes noted.
Pink arm; other side effects that lasted a day and then it was over.; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Pink arm) and VACCINATION SITE REACTION (other side effects that lasted a day and then it was over.) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (Pink arm) and VACCINATION SITE REACTION (other side effects that lasted a day and then it was over.). At the time of the report, SKIN DISCOLOURATION (Pink arm) outcome was unknown and VACCINATION SITE REACTION (other side effects that lasted a day and then it was over.) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-747000 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747000:Patient 2
Increased temperature on 4/14/01 (no thermometer). Gave 2 drops of Tylenol every 4 hours; runny nose and cough started on 4/15/01 with vomiting and loose stools and decreased appetite, irritable and difficulty sleeping. Grandma called to report to us on 4/20/01. I suggested a visit to the doctor which resulted in a dx of throat and sinus infection. Treated with antibiotics and is fine now, on 4/23/01.
At 12:45 am, I had chills and got up to obtain more acetaminophen. When I was at the counter to grab the medication (about 5 min after getting out of bed), I felt suddenly nauseous and saw stars. I woke up on the floor (syncope), ran to the bathroom and started vomiting. I do not know how long I was unconscious for.
Nausea with hot flashes and severe muscle aches. Vomiting, diarrhea and passed out on the bathroom floor.