chrisvoncsefalvay/vaers-outcomes huggingface dataset:
wasn't able to sleep; felt like he was in a refrigerator; shaking; lower back pain; The patient reported receiving the Pfizer vaccine in his right arm; right arm/shoulder pain; right arm/shoulder pain; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 06Feb2021 at a single dose on the right arm for COVID-19 immunization. The patient also started to receive mirtazapine (MIRTAZAPINE, 50 mg, Capsule, soft), via an unspecified route of administration, from an unspecified date at 50 mg, once a day for sleep. Medical history included sleep (disorder). Concomitant medications included aspirin [acetylsalicylic acid], calcium, escitalopram, finasteride, lamotrigine, simvastatin, tamsulosin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), on an unspecified date for COVID-19 immunization. The patient reported receiving the Pfizer vaccine in his right arm on 06Feb2021. That evening he took his nightly medication and went to bed at 11:30 pm. He stated he wasn't able to sleep because he felt like he was in a refrigerator and he was shaking. He had lower back pain, right arm/shoulder pain, and went to the bathroom 5 times (all on an unspecified date in Feb2021), which was not normal for him. The patient added that it was the second dosage of the Pfizer (Covid-19 Vaccine) her received on 06Feb2021. And he had some negative response: a little pain in his shoulder but the worst thing that happened, he went to bed 11:30 did not sleep at all. At 11:30 night, he took his medication (Mirtazapine) and went to bed. He was shaking and he had to put another blanket on himself. Eventually, it was okay, but the problem is he was not able to sleep all night, from 11:30 to 9' O clock this morning (07Feb2021). Consumer stated, "Yesterday my wife and I had the second dose of the Pfizer and I had really strange reaction and I will tell you what it was. Last night at about 11:30 I took my night medicine (later clarified as Mirtazapine), I went to bedroom, I started shaking all over. And the worst part is from 11:30 to 10 o' clock this morning, I was not able to sleep. There is slight pain in my shoulder". When confirmed if the consumer wanted to report the same or have any questions, consumer stated, "No, we have no problem with temperature is fine, the oxygen is fine. Just I don't understand why in fact the medication (mirtazapine) is to induce sleeping, use to for sleep within half hour but it didn't help. I wanted to know what happened. So, this will eventually go away?" The action taken in response to the events for mirtazapine was unknown. Outcome of the events was unknown.  Information on batch number has been requested.
This 73 y.o. pharmacist received Fluzone flu vaccine to (L) deltoid on 10/04/07, 12 hours later noticed severe lip swelling no other symptoms. He took Benadryl p.o. on 10/05/07-a total of 8 pills (AM=3 12:10=2 PM=3); 10/06/07-Continued edema again took Benadryl 25 mg total of 8 pills (same schedule); 10/07/07 Continue edema-Benadryl-total of 4 (2 AM 2 PM) was clear of symptom on 10/08/07. No reaction at site of injection.
chills fever muscles pain joint pain headache arm pain difficulty of breathing weakness dizziness fatigue tiredness
Starting 07/22/2022, our daycare informed us of possible exposure to hand, foot and mouth disease from a classmate. Then, on 07/24/2022, we noticed blisters/lesions on her that were consistent with hand, foot and mouth disease. Today, 07/25/2022, the pediatrician confirmed the diagnosis. Today, she is irritable, having trouble sleeping, cranky and fussy. No fever. May possibly give her TYLENOL as needed for pain. She has been home today and we will keep her home tomorrow until we no longer see new lesion per her pediatrician's recommendation.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient is allergic to penicilln, sulfa and bactrim drugs. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: unknown) dose was not reported, 1 in total was administered to left arm on 30-MAR-2021 for prophylactic vaccination. Age at time of vaccination 55 years old. Concomitant medications included ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, cetirizine hydrochloride, and ergocalciferol.  On an unspecified date, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. Treatment medications included Paxlovid (route of admin, form of admin: unknown) for 5 days, from 5-JUN-2022 to 9-JUN-2022. The patient had no symptoms on 11-JUN-2022 (day 6). On 11-JUN-2022 (day 7), Laboratory data included: COVID-19 virus test Negative. On 14-JUN-2022 (day 10), Laboratory data included: COVID-19 virus test Negative.  On 15-JUN-2022 (day 11), the patient experienced a rebound after first symptoms and were much increased. On the day of reporting, the patient still had strong symptoms of congestion and cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and reference number requested.; Sender's Comments: V0: 20220651789-Covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Next day, developed high fever (104-105) for 2 days. 2 weeks later, developed Bell's Palsy (right-side).
This spontaneous report was received from a Certified Medical Assistant, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unspecified time in 2009 the patient was vaccinated with a first dose of GARDASIL (site of administration, lot #, expiry date and dose were not reported). Then, on 08-JUL-2016 the patient received GARDASIL 9 as second dose (lot # L048459, expiry date 22-FEB-2018), site of administration was not reported. Additional information has been requested.
Patient experienced swelling, redness and itching with a diameter of approximately 6-8 inches.
Myalgia, NauseaVomiting, lymphadenopathy after the first dose - 6and  7 day. second dosechills, fatigue for 24 rs Narrative:
The patient was given the Moderna vaccine.  She then felt very hot around 15 min post vaccine, felt anxious. Felt her HR was racing, so she looked at her Apple Watch, which said it was 103bpm. She let the RN know and it went up to 125 bpm. BP was 140 which is high for the patient, baseline is around 100 systolic.  She then felt shaky. The RN said she saw a few hives on her chest and it was a bit itchy. They gave her some water and juice. She felt better and the hives resolved on their own.  She then was given Zyrtec 10mg.  About 30 min post-vaccine, her HR was 85 and BP was 130 systolic. No wheezing, no SOB, O2 sat was normal the entire time. She still feels shaky and anxious.   2 h later she felt asymptomatic.
pt rcvd vax; pt devel nausea & felt feverish; pt exp tenderness & soreness at injection site;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 2:25 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 2:25 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  The age of patient was reported as 79.29.  For Lot no : 025L20A on 07-Jan-2021, excursion time was 9 AM and 10 AM and temperature was 34 and 34 respectively, total doses given for the day was 96, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Jan-2021 and was moved to clinic on  07-Jan-2021. 6 vials was sent to clinic. Vaccine BUD date was 27-Jan-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Hives within 48 hour of administering the flu mist. No fever noted. BENADRYL recommended. No reaction to injectable flu 1 year ago.
It appears my tinnitus has increased substantially after receiving the Covid vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: TINNITUS (non-serious), outcome "not recovered", described as "It appears my tinnitus has increased substantially after receiving the Covid vaccine.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
This is an initial spontaneous report from a Pfizer sales representative on behalf of a contactable nurse who reported for a patient. This male patient (age and race unknown) received PREVNAR 13 and other unspecified vaccines on an unknown date at an  unknown dose. Relevant medical history, laboratory data, and relevant concomitant medications were unknown. It was reported that on an unknown date the patient experienced swelling in his lower extremities (from hip to toes) and in his genitals. Therapeutic measures taken in response to the reported events were unknown. Clinical outcome of the reported events was unknown at the time of report.   Follow-up (11DEC2013): Follow-up attempts completed. No further information expected.
Received 2 immunizations in clinic - walked with parent thru building and out to parking lot before collapsing in parking lot with seizure activity. Evaluated by clinic staff and EMS summoned - transported to ER per EMS. Discharged from ER with instructions to make appt with neurologist.
Surrounding erythema and swelling upper L delt R arm 39cm L arm 42.5   19x16cm L deltoid.
Charge nurse called to attend to patient after receiving her second Pfizer vaccine. Family members reported she was anxious since yesterday about receiving her second Pfizer vaccine today. It was reported by patient that she had symptoms of nausea, dizziness and anxiousness today. As per her family same thing occurred with her 1st Pfizer vaccine. She denied any significant Medical hx , other than decreased vision, which she does not take any medication for. Charge nurse and vaccinating nurse, moved her to a private tent to vaccinate her and to be monitored. Charge nurse and myself elevated her feet, and had her take sips of water. Wet cool cloth was applied to the back of her neck. She confirmed she felt better after the cloth. She was left in stable condition with vaccinating nurse. I was called back at 1330, because she felt with SOB and more anxious. She did not have any emesis at any point while she was at vaccination site, and no syncope occurred. She was more relaxed after breathing exercises. She was walked over in stable condition closer to EMT to be monitored closely. Vitals were taken. At this time, she was more relaxed and denied any nausea, headaches, SOB or any other symptoms. Family members continued to give her water and she was able to sustain without any emesis. Pt left with family members at 1400, in stable condition.
Narrative:  COVID infection following COVID vaccine series 02/11, Pfizer, dose #1 Private sector 03/04, Pfizer, dose #2 Private sector 10/29 COVID swab, result: not detected 12/22 COVID swab, result: detected 12/20 pt cc: fatigue, rhinorrhea, sore throat exposure: unknown 12/22 SARS-COV-2 Variant Sequencing: pending
Received Infanrix instead of Boostrix; Received Infanrix instead of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 48-year-old male patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2022, the patient received Infanrix .5 mg/ml and Infanrix Pre-Filled Syringe Device. On 23rd August 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced adult use of a child product and wrong vaccine administered. On an unknown date, the outcome of the adult use of a child product and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: The reporter stated that, 48 year old a patient received Infanrix, instead of receiving the prescribed Boostrix. Additional Supportive Information: The patient of 48 year old received Infanrix, instead of receiving the prescribed Boostrix, which led to adult use of a child product and wrong vaccine administered.
low grade fever; headache/his head started to hurt a little bit; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program.  A (Age:62, Unit-Unknown) male patient of an unspecified age received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on 09Mar2021 as dose 1, single for COVID-19 immunization. It was reported that he received Pfizer-BioNTech COVID-19 Vaccine second dose on 30Mar2021 (first dose on 09Mar2021) Next day, everything went fine, he just had a headache for a day. People at home came back positive for Covid-19; he had no idea what happened that his head started to hurt a little bit, had a low grade fever but mainly it was just a headache. He had been careful not to have contact with them, could this be because of vaccination or could he had been infected. Patient had his second dose of the covid-19 vaccine on 20Mar2021 as reported, Patient had headaches and a fever that came and gone, Patient had questions on how long it took to become immune. On an unspecified date in 2021 patient experienced low grade fever, headache. Seriousness of the events were non serious. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUN-2016, the patient was vaccinated with the improperly stored doses of VARIVAX (it was unspecified which lot # from the following: lot # L039092 with expiration date 06-OCT-2017, lot # L043622 with expiration date 03-NOV-2017 or lot # M004326 with expiration date 25-JAN-2018; dose and route were not provided), VAQTA (it was unspecified which lot # from the following: lot # M011116 with expiration date 17-JUN-2017 or lot # K008333 with expiration date 10-MAR-2017; dose and route were not provided) and M-M-R II (albumin status rHA, it was unspecified which lot # from the following: lot # L003855 with expiration date 05-FEB-2017 or lot # L026553 with expiration date 16-JUL-2017; dose and route were not provided). No adverse event was reported. VARIVAX was stored in the maximum temperature of -5.2 degrees of Celsius for 50 hours and 17 minutes. VAQTA and M-M-R II were stored in the maximum temperature of 22.7 degrees of Celsius for 3 hours and 48 minutes in the minimum temperature of 0.2 degree of Celsius for 31 hours and 1 minute. This is one of several reports received from the same source. Additional information has been requested.
redness extended to elbowon pt's right arm but not at the injection side, warm to touch. pt c/o pain started 4 hrs post injection, and have trouble lifting arm day after injection. pt has been taking APAP for pain, and will follow up with pcp today
Patient is complaining of nausea and vomiting, not being able to keep food down. fever and chills.
Pain in arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache). In February 2021, PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Reporter did not allow further contact
Muscle sore at the beginning of 2 days. Then I got a rash near the injection site 1 week later, sore and itchy rash.
underage dose; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage dose). On 25-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-080616 (Patient Link).
feeling of hit by a train; body aches; fatigue; fever; chills; nausea; headache; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling of hit by a train), PAIN (body aches), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included INFLIXIMAB (REMICADE), METHOTREXATE, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), METHYLPREDNISOLONE, LEVOTHYROXINE SODIUM (TIROSINT), DICYCLOVERINE HYDROCHLORIDE (BENTYL), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ROSUVASTATIN CALCIUM (CRESTOR), MONTELUKAST SODIUM (SINGULAIR), FOLIC ACID, FAMOTIDINE (PEPCID AC), ONDANSETRON (ZOFRAN [ONDANSETRON]), FISH OIL and LACTOBACILLUS NOS (CULTURELLE) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced MALAISE (feeling of hit by a train), PAIN (body aches), FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (feeling of hit by a train), PAIN (body aches), FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) had not resolved and HEADACHE (headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Muscle pain, joint pain, fever, chills, nausea, fatigue, headache.
Event occurred after 2nd dose. Patient was diagnosed of COVID Ascorbic acid, Regen-Cov, Discharged home
Information has been received from the editor of an interactive online portal supported by foreign Vaccine Manufacturers concerning a daughter who on an unspecified date was vaccinated at the hospital with a dose of RECOMBIVAX HB (route, dose and lot # not provided) when she was hours old.
pt recvd vax 26DEC91 & w/in 3 hrs had fever, aches, pain; pt did complete series; pt has joint pain, swelling, nausea & vomiting, weakness, intolerance to heat; partial paralysis of throat; could not swallow;
Patient received her second Pfizer COVID vaccine yesterday.  She reports today she has a sore arm (no redness, warmth or swelling), a headache, feels tired, and has some muscles and joint aches.  She is using Tylenol (advised to not exceed 3000mg in 24 hours), gatorade, water, rest, and ice.  She questioned how long these symptoms will last and was advised that generally they lessen within the first 24-36 hours.  She was advised to call if she did not start to feel better within that time frame.
11/10/21 presents "as transfer from BH-facility" for "for IR consultation and intervention for suspected hepatic adenoma with hemorrhage". PMH "asthma, obesity, anxiety/depression, and sleep apnea".
pt recv vax & 10min p/vax pt appeared to be in rigid body position sitting upright w/arms flexed & rigid & drawn to midline of body;+blank stare &  wet episode following of clear odorless urine;total incident over 30-40sec;