chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got dose of vaccine while  Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (got dose of vaccine while  Pregnant) in a 39-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Vasovagal reaction (cannot remember when the last episode was but it is very infrequent) and Pregnancy (Outcome: Live, full term birth) from July 2018 to 28-Apr-2019. Concurrent medical conditions included Bacterial infection and Drug allergy (to cefaclor, during infancy). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 08-Jan-2021 at 11:50 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 06-Jan-2021 and the estimated date of delivery was 04-Nov-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (got dose of vaccine while  Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (got dose of vaccine while  Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Pregnancy test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medication was reported. the date of positive preganancy test was 04 feb 2021.
Dizzy and and headache the day of vaccination. When she woke up the next morning she felt very weak, body aches, chills, sweating, fever, vivid dreams, nausea, diarrhea.
patient was accidently administered VAXNEUVANCE instead of a flu vaccine; No additional AE; This spontaneous report was received from a registered nurse concerning an 81-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 10-NOV-2022, the patient was administered accidentally a dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) 0.5 ml/once, administered as prophylaxis, lot number U036156 with expiration date 25-MAY-2023 (route of administration was not provided), instead of a flu vaccine (unspecified) (Wrong product administered). No additional adverse events were reported (No adverse event).
severe arm pain a few hours after injection, and then presented this morning (11/14/2019) with blistering around the injection site; severe arm pain a few hours after injection, and then presented this morning (11/14/2019) with blistering around the injection site; Information has been received from a nurse, referring to a 75 years old female patient. The patient's historical conditions included atrial flutter, general anxiety disorder, hypothyroidism and hypocalcemia. Concomitant medications included prednisone, gabapentin, levothyroxine sodium (SYNTHROID), trazodone, fluticasone propionate (FLONASE), calcium, diclofenac sodium (VOLTAREN) and glucosamine. The patient was reported of no previous drug allergies. The patient had received a dose of pneumococcal 13-valent conjugate vaccine (PREVNAR 13) on 31-JAN-2018.  On 13-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (single dose, strength and dose detail were unknown, lot #S027047, expiration date 20-MAY-2021) intramuscularly for prophylaxis (reported as routine schedule).  On the same date after vaccination (reported as "a few hours after injection"), the patient experienced severe arm pain. In the morning of 14-NOV-2019, the patient presented with blistering around the injection site. It was reported that the patient had received treatment for the adverse events, but the type of treatment was unknown. There were no lab diagnostics was performed. The outcome of the events was reported as not recovered. The causality assessment was not provided by reporter.
Post vax, the pt developed high fever and child refused to walk for 24-48 hours.
Erythematous patches migratory, associated wheals, minor skin discomfort, itchy
Pt screamed uncontrollably for 1 1/2 hours the morning after the vaccines.
Reported HA and dizziness with 1st dose, too. For Post-2nd dose: @10 minutes, patient reported headache (7/10) and dizziness. @15 minutes reported additional pain (slight) in the left wrist (same side as vaccine) but still felt "ok". @20 minutes reported pain in the jaw and a slight throat tickle. @25 minutes, no change. @30 minutes no change. @35 minutes, headache (8/10) but did not want to go to the ER. @40 minutes, felt a little better. @45 minutes, felt better. Still has headache and pain in arm but did not want to stay any longer. Recommended to go to ER if symptoms worsen or do not resolve.
pt recv vax 12JUL95 & in mid-JAN pt was exposed to chicken pox;27JAN96 pt presented to MD office w/a rash of 10 lesions on abd & face which appeared to be chicken pox;nurse reported in f/u thea the case was unfounded;
Received a pneumonia and shingles vaccines on the same visit. That evening, I felt weakness and a paralyzing feeling in my extremities. I was very weak, had loss of coordination and attempted to get to my bedroom. I fainted and sustained total upper body bruising and a concussion. I also have had amnesia, as my room was torn up and I have no recollection of how this happened. I was bed ridden for one week then began to feel my muscle strength come back. I still have problems with days of the week, but am improving. I was too weak to call 911, as I said I felt paralyzed.
Running fever; infectious because I have low grade fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 02Feb2021 at 03:45, as 1st single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On 03Feb2021 the patient experienced running fever, infectious because patient had low grade fever. The outcome of event was unknown.  Information on about lot/Batch number has been requested.  Follow-up attempts were completed. No further information was expected.
Client's shingles shot is red and swollen, 3 inches across her right arm. The area is painless. There was no triage for this reaction, but, education was provided, with documentation and note to the provider. Client will call if any additional symptoms. The concern was: Zone of redness around the site that is over 2 inches in diameter, persists for more than 2 days, Client does not have a traveling red streak from the injection site. Please not that the time of onset is unknown. Patient was educated to use warm compresses and acetaminophen as needed (exact dose unknown). Follow up phone call with patient on 9/23: Spoke with patient and she reports that she continues with some redness at the injection site. It is significantly smaller in size down to about 1/2 from approx 3, she denies any fever or other adverse effects from the injection.
Fever over 102, unable to sleep. Administered Tylenol and Motrin throughout day.
Mother reports infant "had a febrile seizure. I went to the emergency room and that's what they said it was." Denies any current problems or lingering symptoms/effects.
Swelling of throat a few minutes after injection Aches, fever for 3 to 4 days after injection Day 5 to 8, horrible stomach and intestinal pain, lack of being able to use legs/walk, trembling nervous system, very dizzy 2 months after to present, digestive issues, dizziness, fatigue, feeling hot, palpating heart, shortness of breath, joint pain and weakness, easily bruising
Eye pain in both eyes. Swelling of left eye began 6/19/18. Right eye swelling 6/21/18-Lip swelling 6/21/18. Treatment cetirizine hydrochloride tablet 10mg daily, amoxicillin capsule 500mg 3 times daily. BENADRYL twice daily, ice for swelling, avoid heat and sunlight.
Information has been received from a pharmacist concerning an 89 year old male with allergies to GUAIFENESIN, PENICILLIN and SUDAFED, and "no pertinent medical history", who on 14-APR-2008 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 659267/1836U) for prevention of shingles.  Concomitant therapy included "all kinds of medications".  3 days ago, on 13-FEB-2009 the patient experienced shingles.  The shingles was along the dorsal root ganglia.  The patient sought medical attention at dermatologist's office.  The patient was given a prescription of VALTREX.  As of 16-FEB-2009.  The patient has not recovered.  Additional information has been requested. Follow-up information was received from the pharmacist which reported that an 89 year old retired male at 2:00 PM 14-APR-2008 was vaccinated SQ into the left arm with a first dose of ZOSTER vaccine live (MERCK) (lot # 659267/1836U).  It was reported that the AE onset date was 14-FEB-2009.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
received the entire vial contents (0.45 mL), without dilution; overdose/ received the entire vial contents (0.45 mL), without dilution; flu-like symptoms from the overdose; This is spontaneous report from the two contactable nurses, two contactable physicians, one contactable pharmacist. These reporters reported 8 similar reports. This is the first one. An unknown age and gender patient received 1st dose of BNT162B2 (LOT# unknown) at single dose for immunization. Medial history and concomitant drug were not reported. It was reported that patient experienced flu-like symptoms from the overdose. Eight healthcare workers in a long-term care (LTC) facility received the entire vial contents (0.45 mL), without dilution, for their first dose of the Pfizer-BioNTech vaccine. Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose. Outcome of the event was unknown.  Information on the Lot/batch number has been requested.; Sender's Comments: Based on the available information, the event "flu-like symptoms" is possibly relate to overdose of vaccine BNT162B2 due to product preparation error. 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.,Linked Report(s) : US-PFIZER INC-2021032448 same reporter/SD, AE/ different patient;US-PFIZER INC-2021032447 same reporter/SD/AE, different patient;US-PFIZER INC-2021032263 same reporter/SD/AE, different patient;US-PFIZER INC-2021032446 same reporter/SD/AE, different patient
Tremors started in hands - intermittently. Gradually got more frequent and then tremors in head started. Keep increasing in frequency and intensity.
within 24 hours of 2nd dose patient experienced intense pain in her heart.   Her pain was described as intense, sharp and dull at times.  She also described a sensation of her heart skipping beats or even slowing way down "stopping" a "hollow" feeling.  She also felt pain that traveled across her chest to right side.
On Saturday 1/16/21 at approximately 4:15 pm my husband and I received the Moderna vaccine, lot number 041L20A . We waited the required 15 minutes to see if we had any reaction, we did not. After checking out we drove directly home. At approximately 5:10 pm, while driving to our home, about 45 minutes after receiving the injection, we both noticed that we were having difficulty swallowing and felt a swelling in the back of our throats. My husband experienced a metallic taste. The feeling of the swelling in our throats was similar to when a dentist uses a topical numbing gel prior to a dental procedure. The difficulty swallowing and the thickness in our throats lasted about 30 - 45 minutes. We monitored ourselves at home and did not feel that we needed medical attention. Because of my angioedema I had 2 Epipens at the ready. We both experienced soreness at the injection site (left arm), my husband's sorer than mine. The swollen throat and difficulty swallowing is the only reaction I had. My husband woke on Sunday morning and his arm was very sore, more so than what he has experienced with a flu shot. At approximately 12:15 pm on Sunday, 1/17/21, and about 21 hours after the vaccine was administered, my husband began to feel achy, like he was getting a cold. He took a nap and upon waking did not feel any better. His temperature was 97.6. He felt lethargic the rest of the day and went to bed early and sleep ok but woke up not feeling any better. I used a finger pulse oximeter and it registered 94/94. His temperature remains normal. I am registering these reactions after reading about the adverse and severe reactions of persons at who received the same Moderna lot 041L201 as we did.
Got his vaccine, that evening he felt as if his face was on fire like a windburn.  The next morning had an incredible cold chill as soon as air hit him, bone shaking.  Then had cold chills/sweating with soaking of his groin area.  He can go to sleep with extreme chills and then wake up in a puddle of sweat.  He had a headache at first, took Tylenol and it went away.   Numbness in his foot like it's falling asleep, left hip hurting, left wrist pain.  Today both calves hurt./sore like workout burning pain.  Two days ago his father went to have bypass and was at the hospital with him, and walked painfully in but had difficulty hobbling along and was unable to walk back to his truck and had to borrow his dad's cane to be able to walk.  Yesterday he was going to cut the grass, knelt down to do something, and when trying to stand up was not able to walk due to the throbbing pain and had to use the cane again.  Also having swollen left ankle with discoloration.  The calf pain is extreme and throbbing, and the pain when he's not able to walk is in the calf.  The ankle has been swollen since Sunday, 4/18/21.  He spoke with the ICU nurse in the hospital and he told her about it and she grabbed his ankle and asked if he was sure he didn't have a blood clot.  He has not been able to shake the symptoms.  The issues with walking are intermittent, some days he can walk fine, the other days he has to use the cane.    He still continues with every day hot sweats/cold chills.  It's 74 where he is right now and has a sweatshirt on as he is cold.  Also the legs hurting, ankle swelling that he ices down at night but the swelling does not go away.  Feels like a hard knot in his ankle.   He has not sought any treatment for this at this point.
freezing; sweating; body ache; difficulty in breathing; no strength; chills; headache; injection site pain; Nausea; arm muscles ache; This spontaneous case was reported by a consumer and describes the occurrence of FREEZING PHENOMENON (freezing), HYPERHIDROSIS (sweating), PAIN (body ache), DYSPNOEA (difficulty in breathing) and ASTHENIA (no strength) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FREEZING PHENOMENON (freezing), HYPERHIDROSIS (sweating), PAIN (body ache), DYSPNOEA (difficulty in breathing), ASTHENIA (no strength), CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (injection site pain), NAUSEA (Nausea) and MYALGIA (arm muscles ache). At the time of the report, FREEZING PHENOMENON (freezing), HYPERHIDROSIS (sweating), PAIN (body ache), DYSPNOEA (difficulty in breathing), ASTHENIA (no strength), CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (injection site pain), NAUSEA (Nausea) and MYALGIA (arm muscles ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking Heart medication, Blood pressure medication, Take some more medication but do not remember right now. Patient treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site pain, chills, nausea, myalgia, and headache  are consistent with the product safety profile
Regarding The VSIR on the following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.
This spontaneous report as received from a health professional refers to an 8 year old patient. On an unknown date the patient was inadvertently vaccinated with a dose of oral ROTATEQ, (lot #, expiration date and dose unspecified) instead of an unspecified Influenza vaccine. The patient had already received 3 doses of oral ROTATEQ in the past as an infant so this was a fourth dose. No symptoms reported. Additional information has been requested.
Initial medication error report received on 04 December 2013 from an office person (medical assistant). A 34 months infant patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE (route, lot number and site of vaccination was not reported) on an unspecified date. Reporter stated that consumer received 0.5 ml instead of 0.25 ml. patient did not have any adverse events. List of documents held by sender: none.
cold; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient) of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: unknown) via an unspecified route of administration on an unknown date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During the call caller stated, that caller was due for second vaccine. On an unknown date patient experienced common cold. Patient did get tested and it came back negative and then doctor gave patient an antibiotic today and it was last day of antibiotic. Patient stated that, patient was due for second vaccine. The patient lab data and tests included SARS-CoV-2 test: negative. Therapeutic measures were taken with antibiotics. The outcome of cold was unknown.  Information about lot/batch number had been requested.
Patient was sitting in the waiting area post vaccine for observation.   A person noted the patient was sweating, went out to check.. Patient stated he had passed out, sweating, and his both of his hands were stuck in in a clenching position. Patient was responsive, breathing  was a little elevated,  lightheaded. After about 10 minutes, patient's hands started unclenching slowly...took 20 minutes total for the his hands to become completely unclenched. Patient was able to drink water, was cooling down with cool compresses. About 45 minutes, patient was doing fine.
Information has been received from a physician's assistant concerning a 15 year old white female, 75.9 kg and 157cm in height, who on unspecified dates was vaccinated with the first and the second doses of GARDASIL vaccine, intramuscularly, and on 08-JAN-2009 at approximately 11:30 AM, was vaccinated with the third dose of GARDASIL, intramuscularly (Lot # 661044/0548X).  The patient had sinusitis and laryngitis at the time of vaccination.  The physician's assistant reported that on 08-JAN-2009, the patient experienced syncope within 1-2 minutes after receiving immunization.  She reported that it was followed by full and complete recovery on 08-JAN-2009.  The patient was observed in clinic by parent, medical and nursing staff and left after appropriate interval on foot.  No further information is available.
Severe diarrhea and stomach/intestinal gas. Any time I eat or drink anything I expel it immediately.
Upper left arm got swollen, red 24 hours after vaccination. Patient experienced pain in the area and ended up in the ER.
COVID-19 resulting in inpatient hospitalization of a vaccinated patient.  3rd Pfizer vaccine 10/13/2021
severely sick; This case was reported by a consumer via social media interactive digital media and described the occurrence of sickness in a 4-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The patient had got the flu shot and got severely sick. This case was liked with US2021AMR216445, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR216445:same reporter
Pain and swelling in arm x 9 days. Febrile at 101F x 8 days, severe headache x 10 days, intermittent dizziness, fatigue x 10 days.
After injection began experiencing rapid heart rate and just not feeling. Rapid heart rate lasted for 3 days. Also had fever and chills for 3 days. Was wearing a Holter monitor due to unrelated issues so events were recorded.