chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received 21 April 2010 from the patient (she is also an RN). A 37 year old female patient was 7 months pregnant when she received an injection of INFLUENZA VACCINE (manufacturer unknown, lot number unknown) in "maybe" September 2009 and an injection of PANDEMIC INFLUENZA VACCINE (manufacturer unknown, lot number unknown) on an unspecified date. The patient experienced on an unspecified date, periorbital edema for approximately 5 months post vaccinations. The patient had no illness and no known allergies at the time of the vaccinations. After the vaccinations, she was diagnosed by an allergist with thimerosal allergy. Her medical history included hypothyroidism and 3 previous pregnancies with full term normal deliveries. Concomitant medications included SYNTHROID. On 29 November 2009 the patient delivered a normal full term baby (gestation and gender not reported). She received a TUBERSOL injection in February 2010. As of this report the periorbital edema had not resolved. Documents held by sender: None.
Hives focused around waistline and hips, but as far as arms, wrist, face, and ankles. Cyclic in nature appearing between 7:30-9:30 in both the morning and evening. Persisted for 5 days
twitching neck/right upper body/addomen/feet/all over body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28May2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Lyme disease" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FJ8762, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 09Dec2021, when the patient was 54-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: ER8731, Location of injection: Arm Right, Vaccine Administration Time: 02:30 PM), administration date: 16Apr2021, when the patient was 53-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 26Mar2021, when the patient was 53-year-old, for Covid-19 Immunization. The following information was reported: MUSCLE TWITCHING (non-serious) with onset 29May2022 at 02:30, outcome "not recovered", described as "twitching neck/right upper body/addomen/feet/all over body". The event "twitching neck/right upper body/addomen/feet/all over body" required physician office visit. Therapeutic measures were taken as a result of muscle twitching.  Additional information: Patient started twitching within 24 hours of getting shot first in neck. This went on for two weeks. Then it spread to her right upper body and abdomen. Eventually, it reached her feet and has been all over her body. At the same time, she had been treated for Lyme Disease. There had been series of weeks (at the most 5 once, 3 another time, a couple weeks a few times) when the twitching has abated, but it has never gone away. Patient was not tested positive for covid prior and after vaccination. Patient was treated with antibiotics to hyperbari
14:33 pm- Individ. receives flu shot injection 14:43 pm- Individ. is observed to tolerate injection well. Upon receiving verbal report of denial of symptoms she is allowed to leave designated monitoring area. 15:05 pm- Individ. returns to clinic and reports of tingling of face and indicates her lip area. Pt. is seated and vital signs taken with only abnormal reading an of elevated HR of 117 bpm.  Pt. is escorted to quiet area and is laid down on a couch and legs are elevated. Pt. reports additional symptom of " my feet were not in control in walking over".   Epi pen placed on standby. 911 phone call placed. 15:19 pm- VS> retaken and measurement of HR as 82 bpm. 15:22pm- Fire dept. and ambulance team arrives. Pt. confirms tingling of face with is now experiencing numbness of tongue. Crew takes VS with examination of possible rash- no abnormal findings.  15:30 pm- Individ. is monitored. 15:45 pm- Pt. declines ambulance transport to ER. Emergency crew departs. 14:00 pm- Pt. is escorted to Urgent Care for further follow-up by fellow RN.
More than 36 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Headache; This is a spontaneous report from a contactable consumer (patient herself).  A non-pregnant (not pregnant at the time of vaccination) 49-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3247), at age 49 years, via an unspecified route of administration on the left arm, first dose on 26Jan2021 13:15 at single dose, for COVID-19 immunization. Medical history included allergy to Neoprene and had contact dermatitis due to it on an unspecified date. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received no other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced headache 26Jan2021 20:00. Facility where the most recent COVID-19 vaccine was administered was at a workplace clinic. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of headache which includes ibuprofen (ADVIL). The outcome of the event was recovered on an unspecified date. Case was reported as non-serious.
Given a dose / without / adjuvented solution, but used a sterile diluent instead; Given a dose / without / adjuvented solution, but used a sterile diluent instead; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant at a large in service notified that, the previously given a dose of Shingrix without using the adjuvanted solution, but used a sterile diluent instead to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter left the in service before the patient could get contact info.  The patient did not had further information.
Fever 100.4 at 0100 am Chills, Body aches Took Motrin two hours later still chills and body aches Took Tylenol. Two hours later , fever gone and chills stopped, body aches a little. Not much!!
Initial unsolicited report received from a nurse on 15 June 2015. A 75-year-old male patient, whose concomitant medications were not reported, had received a dose of FLUZONE HD (batch number, expiry date, dose, dose number and site of administration were not reported) intramuscularly on an unspecified date of November 2014. Illness at the time of vaccination was reported as shoulder pain. Patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions. On an unspecified date, few weeks after vaccination, patient lost his sense of smell and taste and these senses had not returned. It was also reported that, FLUZONE HD was also received in 2013 and the same symptoms occurred, but his sense of smell and taste returned after a few months. It was also reported that the patient had required a visit to emergency room. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was not recovered. Documents held by sender: none.
Patient described flushing, lips tingling. No itching, hives or shortness of breath reported. No facial/lip swelling reported. Patient took Benadryl that she brought with her. Event improved within minutes.  No other intervention.
Expired vaccine administered to 5 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen vaccine (First dose) on 24-Jun-2021. Past adverse reactions to the above products included No adverse event with Janssen vaccine.    On 02-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. Report was received on 10-MARCH-2022 under QE-016008. No Treatment information was reported. The vial did not undergo any temperature excursions. The patient did not experience any other adverse reactions. The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2022: Follow-up received added Quality complaint number. On 11-Mar-2022: Follow-up received added additional reporter.
Bell's palsy after 2 weeks of my first dose of vaccine; Left half face feels numb and I am not able to control my left half of face.; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female non-pregnancy patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left in Apr2021 (Lot Number: EWO169, at age of 27 years old) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included: Birth control pills. The patient experienced Bell's palsy after 2 weeks of first dose of vaccine, left half face felt numb and patient was not able to control her left half of face on 08May2021 10:00. Event resulted in: Doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. The patient received treatment as Prednisone 50 mg tablet. The outcome of events was not recovered.
Patient was administered vaccines listed above at approx. 3:40pm. Right arm was done last with the HPV being the last vaccine given. After administering HPV, the patient's eyes started rolling in his head and his skin color went pale. The patient then began having seizure like activity and the nurse lowered him to the ground and called for more help. EMS was called. The patient passed out as he was being lowered to the floor. No injuries were sustained at this time. Patient came back to consciousness and felt nauseas. Ice packs were placed on patients' forehead and neck. Patient was given juice and vitals were taken @ 3:48pm. Vitals were stable. EMS arrived on scene and at that time patient was conscious and said that he felt okay. Parent declined child to go with EMS for further evaluation.
Contact stated her sister has received Moderna vaccines and now has to get a surgery on her arm.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Contact stated her sister has received Moderna vaccines and now has to get a surgery on her arm.) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Contact stated her sister has received Moderna vaccines and now has to get a surgery on her arm.). At the time of the report, IMMUNISATION REACTION (Contact stated her sister has received Moderna vaccines and now has to get a surgery on her arm.) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
Herpes virus onset and flare up with Bell's Palsy; inflammation of cranial nerve 7; Herpes virus onset and flare up with Bell's Palsy; inflammation of cranial nerve 7; Herpes virus onset and flare up with Bell's Palsy; inflammation of cranial nerve 7; This is a spontaneous report from a contactable other hcp. A 41-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via intramuscular route of administration in Arm Left on 04Apr2021 12:00(age at vaccination:41 Years) as DOSE 2, SINGLE for COVID-19 immunization. Patient didn't received other vaccines within 4 weeks prior to vaccination and patient didn't received within 2 weeks prior to vaccination. Medical history included gluten sensitivity from an unknown date and unknown if ongoing, food allergy was corn and dairy allergy from an unknown date and unknown if ongoing, papilloma viral infection from an unknown date and unknown if ongoing, epidermolysis bullosa from an unknown date and unknown if ongoing. Concomitant medication were not reported. The patient previously received first dose of bnt162b2(BNT162B2, Solution for injection, lot no: unknown) via intramuscular route of the administration in Arm left on 14Mar2021 12:00 (age at vaccination:41 Years) as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced herpes virus onset and flare up with bell's palsy; inflammation of cranial nerve 7 on 07Jul2021. The Patient didn't had COVID-19 prior to vaccination patient was tested to COVID-19 to post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25May2021 Nasal Swab. Patient had disability for the events. Therapeutic measures were taken as a result of herpes virus onset and flare up with bell's palsy; inflammation of cranial nerve 7 was antivirals and steroids. The outcome of the events bell's palsy, cranial nerve infection, herpes virus infection was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events Bell's palsy, Cranial Nerve Palsy, Herpes Viru infection and the suspect BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
its been 18 months since receiving first dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 18 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter asked what to do regarding second dose of Shingrix. It had been 18 months since receiving first dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked did he need to start over with 2 doses or was one additional dose still effective.
Information has been received from a physician concerning a patient who was vaccinated PO with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  The physician reported that the patient subsequently developed blood in their stool.  Unspecified medical attention was sought. At the time of this report, the outcome was unknown.  Upon internal review. blood in stool was determined to be an other important medical event.  Additional information has been requested. (OMIC)
sore arm-6 mon p/flu shot; @ time of shot no local rxn-no swelling-no induration; seen by pvt MD was given sterioids & ATB;
12MAY92 pt recvd vax 17MAY92 (evening) fever @ 101 R & neck swollen temp later inc 103 R; 15MAY92 seen by MD had sl red ears & gave Ceclor; 17MAY92 pt broke out w/rash on stomach, ears, face, neck & on 18MAY92; dx measles;
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW217) via an unspecified route of administration in the right arm on 07Jul2021 at 10:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included reactive arthritis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took sulfasalazine and experienced an allergy. On 07Jul2021 at 18:00 the patient experienced a sore arm. Therapeutic measures were not taken as a result of the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was recovering at the time of the report.
pt recv vax 30SEP96 & same day pt exp gen hives, of greatest intensity 6-12hr p/vax;tx oral DPH & topical calamine lotion;24hr p/vax sx were significantly improved;48hr p/vax pt reported episode of urticaria, very mild, in prev 24hr;
Admitted for Covid-19 pneumonia. Treated with dexamethasone and tocilizumab. Patient discharged home on home oxygen.
Arm was really sore, and then my neck and back became sore. I received the shot on my right arm, but my left arm became sore too. I have been having stomach problems for three days now and feeling really sick. My stomach pains feel like cramps that come and go. I have never had stomach problems until now. CIt has now been three days and I am still feeling very sick.
had multiple anxiety episodes; experiences being nervous; feels like she is going to crawl out of her skin; she cannot stand it (body feels like it is going to creep); sore arm after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (had multiple anxiety episodes), NERVOUSNESS (experiences being nervous), FORMICATION (feels like she is going to crawl out of her skin), DISCOMFORT (she cannot stand it (body feels like it is going to creep)) and PAIN IN EXTREMITY (sore arm after 2nd dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010AE1A and 019B21A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM, LEVOTHYROXINE, LISINOPRIL, GABAPENTIN and ATORVASTATIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 30-Mar-2021, the patient experienced ANXIETY (had multiple anxiety episodes), NERVOUSNESS (experiences being nervous), FORMICATION (feels like she is going to crawl out of her skin), DISCOMFORT (she cannot stand it (body feels like it is going to creep)) and PAIN IN EXTREMITY (sore arm after 2nd dose). At the time of the report, ANXIETY (had multiple anxiety episodes), NERVOUSNESS (experiences being nervous), FORMICATION (feels like she is going to crawl out of her skin), DISCOMFORT (she cannot stand it (body feels like it is going to creep)) and PAIN IN EXTREMITY (sore arm after 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Per pt's wife, pain started about 1 hour after injection, swelling in elbow below injection site started about 3 hours after injection. I advised to treat with OTC ibuprofen and ice packs, and to call his PCP if it got worse or failed to improve.
Information has been received from a physician concerning a 26 year old female (164 lbs., 62 in.) who on 15-FEB-2008 was vaccinated in the left buttocks with the first dose of GARDASIL (Lot #659655/1486U).  Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA).  On 17-FEB-2008 the patient experienced heaviness in her left arm, tightness in the left side of her chest and the veins in her left leg felt constricted.  The patient was taken to the emergency room but it was not known if she was admitted.  No additional information is available. Follow-up information was received from a physician. The physician reported " I have had a possible two adverse reactions to GARDASIL from lot #1486U" and has requested a lot check. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No additional information is expected.