chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: After receiving the moderna booster shot the patient thought he was going to faint. He got very sweaty and needed water. After about 15 minutes he was almost back to normal and went home with his mother.  He has no reaction after his first or second moderna shots.  His mom said he does have anxiety
Extreme headache and all the other general side effects  listed on site exempt vomiting. (Feeling of vomiting) Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and fever
Mete swelled; This is a spontaneous report from a contactable health care professional. A 39-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: ER8730, Expiration date: not reported) via an unspecified route of administration, administered in Arm Left on 25Mar2021 18:00 (at the age of 39-year-old) as single dose for covid-19 immunisation. The patient medical history included allergy to mushroom. . Concomitant medication included lorazepam (ATIVAN) taken for an unspecified indication; zolpidem tartrate (AMBIEN) taken for an unspecified indication; gabapentin taken for an unspecified indication. The patient previously took diphenhydramine hydrochloride (BENADRYL), Morphine, Toradol and had allergies to these drugs. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested positive for covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 18:30 the patient experienced mete swelled. The patient received Steroid injection treatment for the event. The outcome of the event was recovering.   No follow-up attempts are possible; information about batch number cannot be obtained. ; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported 'mete swelled' cannot be completed excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
PATIENT RECEIVED THE FIRST DOSE OF PFIZER COVID 19 VACCINE IN APRIL 2021.  PATIENT  RECEIVED 2ND DOSE OF MODERNA COVID 19 VACCINE IN ERROR ON 07/23/2021 AT 10:00AM. PATIENT AND  HER DOCTOR WERE INFORMED ABOUT THE ERROR.
I had a delayed allergic reaction  on my left arm. Left me with my upper arm hot and super swollen and painful for a full week.
About 6 hours after receiving the immunization, the patient's arm and shoulder became red, swollen and painful. It continued into next day and then subsided with administration of an antihistamine and ibuprofen.
headache; body ache; redness; swelling at injection site; injection site hot to touch; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE QUADRIVALENT (INFLUENZA VIRUS VACCINE)) for prophylaxis.   On 3rd October 2020, the patient received the 1st dose of Shingrix (intramuscular) and the 1st dose of FLUZONE QUADRIVALENT (INFLUENZA VIRUS VACCINE) (intramuscular). On 3rd October 2020, 12 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. On 4th October 2020, the patient experienced general body pain. On 5th October 2020, the patient experienced headache. The patient was treated with paracetamol (Acetaminophen) and non-drug therapy (Ice Pack (No Medication)). On 6th October 2020, the outcome of the general body pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, general body pain and headache to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient reported that she experience body aches for two days after receiving Shingrix (first dose) and Fluzone on 3rd October 2020.  She also reported headache, redness and swelling at injection site.  Till the time of reporting the patient was experiencing redness, swelling, injection site hot to touch and headache.  The patient had reported taking acetaminophen as well as using an ice pack at the site of injection. The reporter did not consent to follow-up.
Pt developed large swollen area from distal of injection site 4 x 4 cm. Swelling began 2 days after injection and lasted 10 days. Treated with Prednisone.
Initial health care professional (nurse) report received on 07 Feb 2011: This patient with an unknown medical history was vaccinated with MENVEO (batch number: 022011) intramuscularly in 07 Feb 2011. But the patient received only partial dose and the lyophilized-Men A powder, was reconstituted using saline instead of Men CYW liquid component. No adverse event was reported following this under dose and drug administration error.
Patient developed deep vein thrombus 20 days after vaccine.  No significant past medical history.  No significant family history.  Patient received her vaccine on March 9.  On the weekend of March 27 patient traveled approximately 5 hours by car.  Over the course of 2 days after traveling she developed left lower extremity swelling and discomfort.  Upon returning home she went to the emergency department and was diagnosed with a deep vein thrombus.  Subsequently developed pulmonary emboli.
15 minutes post vaccine administration, the patient c/o chest heaviness and difficulty swallowing.  Patient was extremely anxious prior to getting the vaccine. She verbalized anxiety and even asked if nurse was going to "pump me full of antifreeze"  Healthcare Provider was notified that patient wasn't feeling well.  She was evaluated and told the provider she felt "worse" than when she originally reported to nursing.   patient was given ASA 81mg 3 tabs to chew, Benadryl 50mg PO and a STAT EKG was done.  patient was monitored Q5 minutes by nurse and provider. Within 15 minutes of medication administration she began to feel better.  She was monitored for another 30 minutes (60 minutes total) and was cleared by the provider to leave.
PT HAD DIFFICULTY BREATHING, CHEST TIGHTNESS AFTER INJECTION. PT TRANSPORTED TO EMERGENCY DEPARTMENT
Patient reported severe fatigue and flu like symptoms within three hours of receiving the vaccination. Within days patient had respiratory issues such as severe coughing. This lasted for up to 5 weeks. Patient reports being bedbound for over a week after receiving the vaccination-patient saw MD who ruled out other causes (per pt's spouse who also exhibited same reaction after receiving the shot that day).
CHICKEN POX LIKE RASH , HIVES STRTING THE NEXT DAY OF GETTING THE VACCINE.
heart racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing) in a male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart racing). At the time of the report, PALPITATIONS (heart racing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were unknown. Treatment information was not provided.
Redness noted to left upper arm by nurse on 3/21/03. Mom states redness was seen after injection and left hand swelled up.
A case of Shingles developed within two days of flu vaccination.  Still ongoing, 2 weeks after.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site swelling in a 75-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced significant swelling, redness and very warm to the touch at the injection site. The patient went back to physician and they determined that the patient should not receive the second dose due to the reaction. The reporter agreed to be contacted for follow up.
received Fluarix that was inappropriately stored; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 35E27, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th November 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were provided as follows: The age at vaccination was not reported. A nurse reported that, an employee might had received a dose of Fluarix that was inappropriately stored and should have been discarded.  No symptoms reported.  The nurse had not yet confirmed with site if an employee actually received the Fluarix.  The Health care professional (HCP) was unable to provide initials, DOB, gender, etc at the time of report. The reporter stated, she believed it was from 2021-2022 season and provided the NDC 58160-0887-52 LOT number 35E27, expiry date 30th June 2022.  She also reiterated that the employee may had not even received the vaccine, she was still investigating. The reporter consented to follow up.
her daughter is feeling a sore throat; This is a spontaneous report from a Pfizer-Sponsored Program. A contactable consumer (patient's mother) reported that a 17-year-old female patient (reporter's daughter) received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number and batch no were not reported) via unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported, on behalf of her daughter (patient's name withheld) A 17 years old and who will be getting her 2nd dose on 06Apr2021, but she stated that they were still waiting for the result of the exam because she mentioned that her daughter was feeling a sore throat. She was asking if it was confirmed that it was a sore throat can her daughter still get the 2nd dose vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
According to patient's MD, she experience angioedema all over her body, mouth swelled, went to ER [not sure when event occurred, but it was-not while patient at pharmacy].
NAUSEA; EYES ARE HURTING/OCULAR PAIN; A RASH ON HER LEFT FOOT AND RIGHT ARM A FEW HOURS POST VACCINATION, ALMOST LIKE THE BLOOD HAD COME TO THE SURFACE; RECURRING HEADACHES; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and several antibiotic allergies, and other pre-existing medical conditions included patient had taking aspirin occasionally as a blood thinner. no previous reactions to injections and/or immunizations.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for blood thinner. On 11-JUN-2021, the subject experienced eyes are hurting/ocular pain. On 11-JUN-2021, the subject experienced a rash on her left foot and right arm a few hours post vaccination, almost like the blood had come to the surface. On 11-JUN-2021, the subject experienced recurring headaches. On 12-JUN-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: acetylsalicylic acid, and calamine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a rash on her left foot and right arm a few hours post vaccination, almost like the blood had come to the surface on 13-JUN-2021, and nausea on 12-JUN-2021, and had not recovered from recurring headaches, and eyes are hurting/ocular pain. This report was non-serious.
5 spots of Itchy hives on her left leg and 2 hives on right leg; 5 spots of Itchy hives on her left leg and 2 hives on right leg; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (5 spots of Itchy hives on her left leg and 2 hives on right leg) and PRURITUS (5 spots of Itchy hives on her left leg and 2 hives on right leg) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced URTICARIA (5 spots of Itchy hives on her left leg and 2 hives on right leg) and PRURITUS (5 spots of Itchy hives on her left leg and 2 hives on right leg). At the time of the report, URTICARIA (5 spots of Itchy hives on her left leg and 2 hives on right leg) and PRURITUS (5 spots of Itchy hives on her left leg and 2 hives on right leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported. Patient stated that she did not experience any side effects for two days after receiving the first dose of vaccine. On Monday evening 22-Mar-2021, she stated that she found 5 spots of itchy hives on her left leg and 2 hives on her right leg.
Different side effects after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Different side effects after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 ADVERSE EVENT (Different side effects after vaccination). At the time of the report, ADVERSE EVENT (Different side effects after vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment information was unknown.
This spontaneous report was received from a medical assistant referring to a 17 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 15-SEP-2016, the patients received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes on 29-AUG-2016. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Information has been received via medical records from a licensed practical nurse and refers to a 14 month old White male patient. On 06-OCT-2009, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, lot# and expiration date were not reported). This is one of two reports concerning the same patient. Additional information is not expected. All available medical records will be provided upon request. Sender's Comments: US-009507513-1705USA009103.
she felt like her breast were sensitive and more larger like when she got her period; she felt like her breast were sensitive and more larger like when she got her period; unexpected menstrual period; unexpected vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 07Apr2021 4:00 pm (Batch/Lot number was not reported) as single dose for covid-19 immunisation. There are no patient history and concomitant medications. Prior vaccinations (within 4 weeks) was none. Patient is healthy. She hasn't had vaccines since she was a child. Patient experienced unexpected menstrual period from 13Apr2021 and ongoing. Caller thought she was having a side effect to the COVID vaccine. She was having unexpected vaginal bleeding. She got the Pfizer COVID vaccine, first dose. Caller declined email. She didn't have a prescribing doctor. This was the first dose. She got the first dose on 07Apr2021, and then started bleeding the 13Apr2021. She thought it was gone last night, but then this morning it is more like a menstrual period. She had her period for 6 days, and it ended 4 days ago. Her period ended. She has never had unexpected bleeding. Her period was always on time and normal. She was pretty sure it was another period. It was weird because she felt like her breast were sensitive and more larger like when she got her period. She was confused for 2 days because she didn't understand why she felt like that. Then, she started bleeding. She scheduled her second dose. She has misplaced the card with the NDC/lot/expiration. She only has her receipt. She would like to know the ingredients of the vaccine. No emergency room and physician office visit. But she was going to the doctor Friday to talk to her. No investigation assessment. No relevant tests. The event outcome for unexpected menstrual period was not recovered, for other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a 14 or 15-year-old female patient, who was reporting on herself, via a company representative. The patient's concurrent conditions, medical history and concomitant therapies and were not reported. On an unknown day, the patient was vaccinated with the first 0.5 ml dose of GARDASIL 9 injection (route of administration, lot number, expiration date were not provided) for prophylaxis. On an unknown day, the patient developed a rash around the injection site that got worse the next day. The patient chose not to complete the series. The outcome of the event was unknown. The causality assessment between the event and GARDASIL 9 was not provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 at 10:00 as dose 1, single (Lot number: EL9267), in left arm, on 03Mar2021 at 12:00 as dose 2, single (Lot number: EN0205), in left arm, on 28Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 05Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 75 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Anti viral details product COVID 19 Treatment, brand Pfizer, treatment start date 06Jul2022,treatment stop date 10Jul2022,indication. Treatment of COVID-19,COVID vaccine details vaccine brand=Pfizer / BioNTech, Adverse event: Fever, sore throat, congestion , cough, Adverse event start date: 14Jul2022,Adverse event start time: 04:00 PM. NO other medication in 2weeks.Seriousness criteria-Results in death: No, Seriousness criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No. AE resulted in: None of the above, If patient recovered: Recovering,If treatment Ae: No
First Vaccine , did not have any reactions other than a sore arm.  The second vaccine he started having severe chills, body aches temp of 102F and pain at the injection site.  He also had vomiting and dizziness for over 24 hours.  He took two days off work but states he has resolved to normal at this time.
No additional AE's; temperature excursion that occurred on MMR II which underwent temperature excursion was administered to multiple patients; This spontaneous report was received from an healthcare business professional, concerning to a patient's of unknown age and gender. No information was provided regarding the patients' pertinent medical history, concomitant medications and previous drug reactions or allergies.  On 18-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) as prophylaxis (lot number S039313 has been verified to be valid, expiration date was reported and validated as 04-DEC-2021 (dose, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error). The administered vaccine experienced two temperature excursion of -50 degrees Celsius (C) to 8 degrees C (9.5 degrees C) during a time frame of 0 hour, 40 minutes and 0 seconds, as recorded by data logger. There was not a previous temperature excursion. No additional adverse events (AE's) were reported.   This is one of 3 reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA006395: US-009507513-2106USA006408: