chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lymph nodes under her armpits got so swollen; pain down her arm; pain being so sharp; It woke her up in the middle of the night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 28-year-old female patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Polycystic ovarian syndrome" (ongoing); "Rosacea" (ongoing); "Supraventricular tachycardia History" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EH9899), administration date: 24Dec2020, when the patient was 28-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EL1284), administration date: 12Jan2021, when the patient was 28-year-old, for COVID-19 immunization, reaction(s): "Nausea", "Chills"; flu shot (Vaccine Name: Flu Shot , Manufacturer: Unknown , Lot Number/ Expiry Date: Unknown Route, Anatomical Location: No. of Previous Doses: Right Arm Date: 25Oct2021), administration date: 25Oct2021, when the patient was 28-year-old. The following information was reported: SLEEP DISORDER (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "It woke her up in the middle of the night"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "lymph nodes under her armpits got so swollen"; PAIN (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "pain being so sharp"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "pain down her arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, pain in extremity, pain, sleep disorder.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201392289 same reporter/pt, different dose/event;
This spontaneous report has been received from a pharmacist concerning a 56 year old male patient. Patient's concurrent conditions included blood pressure and cholesterol (unspecified). On 10-AUG-2015 the patient was vaccinated with ZOSTAVAX, (strength and lot # were not reported with an expiry date of October 2015) 1 single shot, subcutaneous. Concomitant medications included unspecified blood pressure and cholesterol medicines. On 15-AUG-2015, 6 days after vaccination patient experienced rash on top left shoulder with pustules. The reporter stated patient did not receive treatment for the event rash pustular. The outcome of rash pustular was reported as recovering. There was no product quality complaint involved. Reporter's causality statement was not reported at the time of the report. Additional information has been requested.
Local induration (hard lump) which occurred while administering. Lump formed to the right of injection site which reduced slowly in size after course of 15 minutes. Pt has not reported any s/sxs since. Also, pt reports of left extremity tingling that hasn't gone away when they left pharmacy and warmth.  Advised to go to ER if swelling doesn't go away and tingling worsens.   Later, reports of HA worsening when they got home.
The patient is a 2-month-old male, previously healthy, who presented to ED after having an episode of pallor, possible apnea and cyanosis at home. History is per personal discussion with Dr. as well as mom and dad. The baby was in his usual state of health today and had his 2 month wellness exam. He did receive the hepatitis B vaccine, PENTACEL, PREVNAR and oral dose of ROTATEQ at about 1130 hours this morning. Mom put him in the car seat and was driving over to visit one of the friends. When she was there, mom noted that the baby was crying a lot more and she went to pacify him and he seemed to all of a sudden become quite pale in color, limp and then turned bluish around the lower part of his chin bilaterally. He also seemed to stop breathing and she is estimating that the stopped breathing was less than 10 seconds. She blew in his face for a little bit and he finally came around and became more interactive and started crying. She called 911. By the time 911 arrived, he was back to his normal mental state, but his skin still looked pretty mottled. They brought him into the ED for evaluation. In the ED he had had 2 more episodes of turning completely white and then becoming very mottly appearing on exam. These were very brief, self-resolved episodes and then he came back to his baseline. This was not witnessed by the staff. He was on pulse oximetry and CR monitor at the time and the monitors were not going off. Due to the concern, though, that there were recurrence of these episodes, it was elected to admit him and do further evaluation. History is as above, Good p.o. intake. He has had no emesis. He is stooling and urinating fine. He has had no fever, runny nose, cough, difficulty breathing. There are no ill contacts. He has had no new medications, no new foods. The only thing new was that he had his immunizations today. There is no history of trauma or falls. The rest of his review of systems is negative.
THE INDIVIDUAL RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS THE INITIAL DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 59 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced the individual received less than 0.5ml of the janssen covid-19 vaccine as the initial dose. On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the individual received less than 0.5ml of the janssen covid-19 vaccine as the initial dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211209679, 20211209706, 20211209740, 20211209775, 20211209782, 20211209816, 20211209843, 20211209874, 20211209880, 20211209884, 20211209912, 20211209921, 20211210019, 20211210058, 20211210067, 20211210106, 20211210107, 20211210112, 20211210141, 20211210143, 20211210159, 20211210165, 20211210180, 20211210350, 20211210385, 20211210408, 20211210549, 20211210555, 20211210585, 20211210588, 20211210610, 20211210662, 20211210670, 20211210733, 20211210824, 20211212082, 20211212088, 20211209551, 20211209976, 20211209551, 20211210409, 20211209798, 20211209976, 20211210160, 20211210590 and 20211210334.
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 30Mar2021 at 12:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. 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 four weeks prior to the COVID-19 vaccine. On 09Apr2021 at 15:00, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event shingles and included treatment with valacyclovir (VALTREX) and hydrocodone (MANUFACTURER UNKNOWN) on an unknown date. The clinical outcome of the event shingles was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a consumer via the internet concerning her now 5 year old son who on an unspecified date was vaccinated with a dose of MMR II. On an unspecified date the patient developed autism. It was reported that the patient underwent applied behavior analysis (ABA), hyperbaric oxygen therapy (HBOT), speech therapy, social group, acute psychotic episode (APE), sustainable development commission (SDC), regional center and physical therapy (PT) "everyday". At the time of this reporting, the patient's autism persisted. Upon internal review, autism was considered to be other important medical event. Additional information has been requested.
24 hours after the shot he had nausea, stomach pain, headache and a sore left arm. He felt completely fine by the next day, about 48 hours after the shot.
2 days post vaccination, small pimples/pock marks appeared scattered on patient arms, legs and bridge of her nose. (This was similar to a more severe rash after her first MMR vaccine that also presented with 103 fever. That reaction resolved within a day). There was no fever present,  but the pocks were itchy and She scratched them. The the pock at the bridge of her nose became lacerated from the constant scratching so I applied Neosporin to it several times a day and to other spots on her legs as needed. The bridge of her nose became red and irritated. Over the course of time, it started to swell and travel until her face, forehead, and ears were inflamed and swollen to the point of having her eyes nearly shut.   New sensitivities to previously used medications and topical cream emerged post-hospital release. This included facial swelling and redness after 5ml Robitussin in October 2019, and facial swelling and redness after Aquaphor was applied to the nostrils for chapped skin. Prior to this vaccination and subsequent required medical intervention, the patient was never ill or reactive to any environmental, food, or drug factors. All reactions are photo-documented.
Received COVID-19 vaccine while pregnant. No pregnancy complications. Due date 12/24/21. Baby born full term. Birth weight 7lb 14oz. My son was diagnosed with multiple, severe food allergies at 6 months old. No family hx of allergies.
Seriousness Criteria: Other-medically significant (OMIC). Initial report received on 07/Jul/2006 from a health care professional. A 34 year old female patient received an initial dose of Adacel, lot number C2457AA on 23/Jun/2006. Four days later the patient developed itchiness and was treated with Zyrtec by her physician. The reporter stated that "when the patient scratches skin a rash forms". The patient was placed on prednisone 40mg daily for one week. At the time of the report, the patient still had itchy palms, soles of her feet and scalp. The physician described the rash as a "lacy" reticular, red, prominent rash" and reported the patient's recovery status as unknown.
Patient received Moderna Covid-19 vaccine that was first placed in the Pharmacies refrigerator more than 30 days ago.  35 days to be exact; Beyond use date of the vaccine was 8JUL2022, and the date that the vaccine was administered was 13Jul2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Beyond use date of the vaccine was 8JUL2022, and the date that the vaccine was administered was 13Jul2022) and PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine that was first placed in the Pharmacies refrigerator more than 30 days ago.  35 days to be exact) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Beyond use date of the vaccine was 8JUL2022, and the date that the vaccine was administered was 13Jul2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine that was first placed in the Pharmacies refrigerator more than 30 days ago.  35 days to be exact). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Beyond use date of the vaccine was 8JUL2022, and the date that the vaccine was administered was 13Jul2022) and PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine that was first placed in the Pharmacies refrigerator more than 30 days ago.  35 days to be exact) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  Manufacturer expiration date of the vaccine was reported as 11-Nov-2022. The vial didn't undergo any temperature excursions.  No treatment drugs were reported   Reporter did not allow further contact
Get shingles after first vaxx; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got shingles after first vaccination. Additional supportive information: The follow-up could not be possible as no contact detail were available.
Weight gain, bone and joint pain,  swelling of hands, feet and face after receiving the COVID 19 vaccine in 05/2021
About 24hr after receiving DTP (a) #4 site of vaccine (R) upper deltoid) red; swollen, tender, temp. 102 degrees, then swelling, started to spread to lower arms decreased (R) side of face, esp. lips and ears.
Swelling, pain, that increased over the next 24 hours; itching developed; Caused patient to seek medical attention.
HBP reported that a 9 month old child received MMRII and VARIVAX at 9 months instead of 12 months.; No additional AE; This spontaneous report was received from consumer and refers to a 9-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On unknown dates, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, albumin status unspecified (both strength, dose description, lot #, expiry date, route of administration, and indication were not provided) at 9 months instead of 12 months (product administered to patient of inappropriate age). No additional adverse event (no adverse event) and no product quality complaint (PQC) was reported.
Pt walked in today 11/26/2018, reporting that she had had the vaccine administered about 5 weeks ago and she was experiencing pain, around the injection site and traveling down her arm. Right after the injection she had a bruise and the pain started as if her arm was heavy and weak. Pt says she has been to her chiropractor and massage therapist and has seen some progress from her pain. It comes and goes but notices it when she wakes up if she sleeps on that side and when she is trying to take off her shirt, she is unable to pull her arm out. She repeatedly pointed to an area that showed the injection was given on the correct location. During our counseling session the patient moved her arm and raised, she did say if she put it across her body and tried lifting it up thats when she experienced pain and discomfort.
On 06/04/2000, post-vax, the patient broke out in a varicella-like rash. Unspecified medical attention was sought. The physician noted that the patient's rash had not yet started to "scab over" after 5 days. The patient's sibling had a similar experience following exposure to varicella virus vaccine live. Follow up information from a physician reported that the patient developed chickenpox and that the course of the disease was 7-10 days. It was noted that the papules never crusted but faded. The physician reported that the "patient was considered contagious until the rash was completely gone which was a guess at best". The patient is recovered.
Child awoke with a high fever of 104 degrees.  Tylenol given and temp continued to increase up to 104.8 degrees.  Parent called the clinic's after hours phone number and was advised to take the child to ER.  Parent took child to the emergency room, temperature was taken and it had come down to 102 degrees.  Parent opted not to be seen and retuned home.  Follow-up call to parent at 2:00pm.  Parent indicated that the child's temperature continue to decrease and that he felt better.  He was eating food and drinking fluids.
Terrible arrhythmia after receiving 2nd Pfizer dose and the arrhythmia was made worse after receiving the booster on 01/11/2022. The patient is experiencing arrhythmia and tachycardia unlike anything that she has ever experienced and it lasts for hours to the point where she feels faint. Metoprolol was prescribed but we don't know if it has helped yet.
Patient was seen for a well child visit. 3 vaccines were ordered by the provider. When PENTACEL was drawn up it was unknown box came with its own diluent. It was drawn up with sterile diluent. State was contacted along w/parent to schedule dose.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unknown. Since 15-MAR-2015 doses of (Oka/Merck) VARIVAX (lot # K015971 with expiration date 23-SEP-2016; strength, dosage, frequency and route unspecified), which were exposed to temperatures outside of the recommended range, had been administered to the patients. The reporter was not aware of any adverse experiences. This is one of several reports received from the same reporter. Additional information has been requested.
She got allergic reactions; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jun2021 (Batch/Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced allergic reactions on 21Jun2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Ocular migraine.  Onset 3/2/2021 around 4 pm EST.  Started with kaleidoscopic peripheral vision, then blurry and blocked vision.  Also included headache behind left eye.  Vision problems lasted around 30 minutes.  Headache for several hours.  I took migraine OTC meds, plus Tylenol.
Started almost exactly 24 hours after shot. Extreme stomach cramps - type to bend one over. Hot sweats then cold sweats - then extreme diarrhea for hours until bowels were completely empty. Slept rest of day until following day for 2 day could not keep anything in me. Everything went straight thru me. Very weak.
The child had about 6 hours of nonstop crying, fussiness and irritability. By day two she had recovered but still with induration. No cellulitis.
tested positive for COVID-19/fever and chills; bone pain; arm pain; This is spontaneous report from a contactable consumer (patient) via Medical information team. This consumer reported similar events for herself and 1 patient (reporter's husband). This is a 1st of two reports. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient and her husband both tested positive for COVID-19 on 15Mar2021. Their second vaccination was originally scheduled for March 31, 2021. On 15Mar2021, the patient and her husband experienced fever and chills, the husband felt worse and had to go to a hospital, where he was diagnosed with COVID-19 and was prescribed "medicine for the chills." Then, the patient and one of their children also tested positive for COVID-19 but had no symptoms. They were recommended to stay isolated for 14 days. The patient experienced mild symptoms of arm pain, fever for 1 day, and bone pain after vaccination. She felt better after a couple of days, unlike her husband.The patient underwent lab tests and procedures which included COVID-19 (nasal swab) test: positive on 15Mar2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021353312 same product and event, different patient
Patient received covid 5-11 vaccine instead of a 6 month to 4 years.
Erythematous rash, maculopapular rash that started on his face and abdomen which now is covering his entire body.
slept for 9 hours (which is not normal for me); muscle aches; temperature of 100.4 F (Fahrenheit); dizziness; injection site is pink and hurts so much I cannot lift my arm; injection site is pink and hurts so much I cannot lift my arm; heart rate is elevated; slight headache; Felt cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD, HYPERSOMNIA, MYALGIA, PYREXIA, and DIZZINESS in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FEELING COLD (Felt cold). On 15-Jan-2021, the patient experienced HYPERSOMNIA, MYALGIA, PYREXIA, DIZZINESS, INJECTION SITE ERYTHEMA, INJECTION SITE PAIN, HEART RATE INCREASED, and HEADACHE. On 15-Jan-2021, DIZZINESS outcome was unknown. At the time of the report, FEELING COLD, HYPERSOMNIA, MYALGIA, PYREXIA, INJECTION SITE ERYTHEMA, INJECTION SITE PAIN, HEART RATE INCREASED, and HEADACHE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 100.4 f. (Inconclusive) 100.4 F. On 15-Jan-2021, Heart rate: 92 normal (normal) 92.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
BODY ACHES; CHILLS; LOW FEVER; EXTREME FATIGUE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, chills, low fever, extreme fatigue, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, chills, low fever, extreme fatigue and nausea was not reported. This report was non-serious.