chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm, it was inflamed, red and really itchy, for 3 weeks; left arm, it was inflamed, red and really itchy, for 3 weeks; left arm, it was inflamed, red and really itchy, for 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm, it was inflamed, red and really itchy, for 3 weeks), ERYTHEMA (left arm, it was inflamed, red and really itchy, for 3 weeks) and PRURITUS (left arm, it was inflamed, red and really itchy, for 3 weeks) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included METFORMIN for Diabetes.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PERIPHERAL SWELLING (left arm, it was inflamed, red and really itchy, for 3 weeks) and ERYTHEMA (left arm, it was inflamed, red and really itchy, for 3 weeks). On an unknown date, the patient experienced PRURITUS (left arm, it was inflamed, red and really itchy, for 3 weeks). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (left arm, it was inflamed, red and really itchy, for 3 weeks), ERYTHEMA (left arm, it was inflamed, red and really itchy, for 3 weeks) and PRURITUS (left arm, it was inflamed, red and really itchy, for 3 weeks) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment also included Ice.     This case was linked to US-MODERNATX, INC.-MOD-2021-049424 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049424:Crosslinked for Dose 2
5 expired doses were given; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 expired doses were given) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A/006C21A/043B21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 expired doses were given). In October 2021, EXPIRED PRODUCT ADMINISTERED (5 expired doses were given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that, first it was said these lot numbers had been granted an extension for expiration date, but then HCP  received a notice from the health department with a list of lot numbers that were truly expired, and all three were on the list.  5 expired doses of vials were administered to 5 patients (two doses administered in the current week and three doses on the last week).  The vial was initially stored in the refrigerator right before the doses were given, on the same day.  No concomitant medication details were reported. No treatment medication details were reported.  The vials with lot numbers of 040B21A, 006C21A, 043B21A have expiry dates of 02-Oct-2021, 03-Oct-2021 and 10-Oct-2021 respectively. The vials did not undergo any temperature excursions.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received contains non-significant information.
Janssen COVID-19 Vaccine EUA  Aches, chills, high fever (103.4) beginning 7 hours after injection. Fever resolved within 24 hours. Fine, itchy rash all over arms, torso, and back of neck beginning 18 hours after injection. Some bouts of dizziness noted beginning 18 hours post-injection. Rash still present as of 4 days post-injection. Some dizziness also remains.
Large Red swollen welt-like area at injection site (4 inches in diameter), hot to touch, itchy, tender
Chills, sweat, lethargic, headache, loss of appetite, sleepiness, back pain, menstruation (after none for 10+ years), body aches, hives
swelling / at the injection site / has persisted, only decreasing slightly in size / area of swelling is about / size of a golf ball; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. In April 2021, immediately after receiving Shingrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The patient received 1st dose of Shingrix in left upper arm, approximately 2 months ago from the day of reporting. The patient experienced swelling at the injection site, which began very shortly after vaccine was administered and had persisted, only decreasing slightly in size. The reporter stated that, the size of area of swelling was about he size of a golf ball and there was no pain associated with swelling, nor does it affected their arms functioning. The reporter consented to follow up.
Painful breast; Breastfeeding; Rash in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Painful breast), MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) and VACCINATION SITE RASH (Rash in the injection site) 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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (Painful breast), MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) and VACCINATION SITE RASH (Rash in the injection site). At the time of the report, BREAST PAIN (Painful breast), MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) and VACCINATION SITE RASH (Rash in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This is a case of product exposure during breastfeeding, who experienced vaccination site rash and breast pain.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The causality for maternal exposure during breast feeding is assessed as not applicable. Patient will continue to be contacted for further monitoring of AEs.
1 of 5 pts (out of 40 pts) vaxed from the same lot  who devel a local rxn consisting of rash surrounding site;rash appeared w/in 3 days of vax (varying in size in all 5 pts;largest from shoulder to elbow;area sore & tender;no fever;
Patient complained of right deltoid pain starting about 24 hours after 2nd dose. Difficulty moving the arm. Pain was still present on 5/7/21 when he presented to clinic (similar to an urgent care setting). Recommend ice, Tylenol and follow up with PCP if any worsening conditions.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 26-JUN-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R0298515 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001816: US-009507513-1907USA001815: US-009507513-1907USA001817: US-009507513-1907USA001814: US-009507513-1907USA001813: US-009507513-1907USA001812: US-009507513-1907USA001811: US-009507513-1907USA001810: US-009507513-1907USA001809: US-009507513-1907USA001808: US-009507513-1906USA011434: US-009507513-1907USA001806: US-009507513-1907USA001805: US-009507513-1907USA001835: US-009507513-1907USA001834: US-009507513-1907USA001833: US-009507513-1907USA001807: US-009507513-1907USA001848: US-009507513-1907USA001847: US-009507513-1907USA001846: US-009507513-1907USA001804: US-009507513-1907USA001845: US-009507513-1907USA001844: US-009507513-1907USA001843: US-009507513-1907USA001842: US-009507513-1907USA001841: US-009507513-1907USA001840: US-009507513-1907USA001839: US-009507513-1907USA001838: US-009507513-1907USA001837: US-009507513-1907USA001836: US-009507513-1907USA001832: US-009507513-1907USA001831: US-009507513-1907USA001830: US-009507513-1907USA001829: US-009507513-1907USA001828: US-009507513-1907USA001827: US-009507513-1907USA001826: US-009507513-1907USA001825: US-009507513-1907USA001824: US-009507513-1907USA001823: US-009507513-1907USA001822: US-009507513-1907USA001821: US-009507513-1907USA001820: US-009507513-1907USA001819: US-009507513-1907USA001818: US-009507513-1907USA000965: US-009507513-1907USA000970: US-009507513-1907USA000969: US-009507513-1907USA000954: US-009507513-1907USA000966: US-009507513-1907USA000964: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000953: US-009507513-1907USA000963: US-009507513-1907USA000988: US-009507513-1907USA000989: US-009507513-1907USA000952: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803:
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of VARIVAX dose, route and lot # not specified. On an unknown date after vaccination the patient experienced shingles. The patient was seen by the physician "a few days" after the rash developed. The physician reported that the shingles developed on the "opposite arm that was injected". The outcome of shingles was unknown. The relatedness between adverse event and VARIVAX was unknown. Additional information has been requested.
Severe headache; sick she felt after the vaccine; feeling very very dizzy; She's vomiting like crazy; she can't drink; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache), ILLNESS (sick she felt after the vaccine), DIZZINESS (feeling very very dizzy), VOMITING (She's vomiting like crazy) and DYSPHAGIA (she can't drink) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 301L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Severe headache), ILLNESS (sick she felt after the vaccine), DIZZINESS (feeling very very dizzy), VOMITING (She's vomiting like crazy) and DYSPHAGIA (she can't drink). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, HEADACHE (Severe headache), ILLNESS (sick she felt after the vaccine), DIZZINESS (feeling very very dizzy), VOMITING (She's vomiting like crazy) and DYSPHAGIA (she can't drink) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment details included Pepto-Bismol but she vomited it out.
a slight fever; chills; This is a spontaneous report from a contactable consumer(patient). A male patient of an unspecified age, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not reported) via an unspecified route of administration, on 07Apr2021 (last Wednesday), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not reported) via an unspecified route of administration, on an unknown date, as single dose for COVID-19 immunization. Patient reported that a few hours after receiving his 2nd dose of the vaccine, experienced a slight fever and chills on 07Apr2021. Outcome of the event was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Nerve damage in my right arm and hand; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (Nerve damage in my right arm and hand) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 048B21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack on 15-May-2021 and Catheterization cardiac on 15-May-2021. Previously administered products included for an unreported indication: INFLUENZA (Arm Pain. Chest Pain and Vomiting and Sinusitis) on 07-Apr-2021. Concurrent medical conditions included Type 2 diabetes mellitus (Numbers improved slighty since Adverse event) since 17-Feb-2018 and Blood pressure high (Numbers are back to normal) since 17-Feb-2018. Concomitant products included INSULIN ASPART, INSULIN ASPART PROTAMINE (NOVOLOG MIX) from 10-Apr-2019 to an unknown date and DULAGLUTIDE (TRULICITY) from 12-Dec-2020 to an unknown date for an unknown indication.   On 13-May-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NERVE INJURY (Nerve damage in my right arm and hand). At the time of the report, NERVE INJURY (Nerve damage in my right arm and hand) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Catheterisation cardiac: (normal) Performed to check if heart was normal. Nothing abnormal was found.         Patient received Influenza Vaccine on 07-Apr-2021 and experienced vomiting. Treatment information was not provided.   This case was linked to MOD-2021-154215 (Patient Link).; 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.
Patient reported to Dr's office for follow up.  Presented with nodule at site of injection.  No cellulitis, o heat, tender, inflamed, some induration per Dr. Pt recovery - I am unaware of any improvement or decline since original report.
Full body chills; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in Jan2021 (at the age of 24-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included anxiety and depression. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. In Jan2021, the patient experienced full body chills. No treatment was provided for the event body chills. The outcome of the event body chills was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021145063 same reporter/patient/vaccine, different dose/event
After the 2nd dose, that evening I went to bed with a low grade fever of 99 degrees and chills.  I woke up at 2am, feeling chills and nausea.  After I threw up, both hands started to have uncontrollable clenchings.  My legs started to feel a little numb but I could walk.  I also had pain on my left side of my stomach.  I went to the ER,  one of the nurses grabbed my hands to try to straighten them out.  They gave me an IV containing calcium, 2 TUMS orally, and Benadryl.   I did feel so much better. I did get discharged with a diagnosed with Covid vaccine allergic reaction,  low calcium levels, and allergies.   I did follow up with my PCP and they wanted to check my calcium levels which showed low calcium and high PTH (parathyroid).   I was prescribed 1200mg of calcium daily.  I am to follow up with an endocrinologist.
Dizziness, headache about 15 mins after vaccine administration. Had pt lay down, gave some apple juice. Pt reported having not eaten yet this morning. Vitals: BP 94/63, P 109, R 20, SPO2 97% RA. Pt assessed by Doctor. Pt started to feel better about 10 mins after lying down and given apple juice.
PATIENT STATED THAT SHE STARTED FEELING DIZZY, LIGHTHEADEDNESS , AND FAINT AFTER GETTING THE HIGH DOSE FLU SHOT. WE CALLED THE PATIENT'S PCP AND SHE ADVISED US TO RE-CHECK HER BLOOD PRESSURE 30 MIN AFTER THE SHOT AND HAVE HER TAKE A CLONIDINE BEFORE. SHE DIDN'T FEEL BETTER AND HER BLOOD PRESSURE WAS STILL HIGH, SO WE CALLED 911. SHE LEFT THE STORE WITH HER BP ALOT LOWER AND NOT AS DIZZY. SHE WAS TAKEN TO THE HOSPITAL BY THE PARAMEDICS.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, for routine adult health maintenance and the intended purpose for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset unknown). The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. On or about 14-JUL-2016, the patient was treated for a vesicular outbreak, which was diagnosed as geniculate herpes zoster (Ramsay Hunt Syndrome). The patient was prescribed valacyclovir for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, geniculate herpes zoster (Ramsay Hunt Syndrome) was determined to be medically significant. Additional information has been requested.
Janssen COVID-19 Vaccine EUA Fast heart rate, 115 and up, most noticeable while at rest Experienced on 5/6 and 5/7
Back and neck stiffened, fever, lethargic couldn't turn neck. Felt terrible for 2 weeks (started 2 days after).
Extreme chills (teeth chattering); low temp (100); fatigue, wheezing and couldn't move my body from my neck to the bottom of my back and "rice" sound in my ears when moved head.
Urticaria to arms, back, legs - BENADRYL/ZYRTEC. Fever 101-102 x 6 days - TYLENOL/ADVIL.
After receiving the vaccine I went and sat in a chair for the 15 minutes following the vaccine. Approximately 4-5 minutes later I started feeling really hot. Then I started getting nauseous and dizzy. I tried to get up and walk to the pharmacy desk (vaccine occurred at pharmacy) but fainted midway there. I was out less than one minute and after sitting down and having some water and putting ice packs on my face I felt better. I have never in my life fainted before. I wasn?t nervous or scared to have the vaccine.   I followed up with my regular doctor on the Monday following the vaccine and had an EKG and bloodwork done all of which came back normal.
9 days after injection, started getting a rash which got bigger for the next couple of days.  Also, I started getting dizzy. Delayed allergic reaction. Not sure I should take second injection . Started taking Benadryl and putting hydrocortisone on itchy rash.
positive COVID test on 1/25/2021 after 1st dose Pfizer.
T not measured, marked alteration in level of consciousness,hypotonic,hyporesponsive episode nausea & vomiting
felt feverish; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever and influenza-like symptoms. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the fever and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient stated that after receiving a dose of Shingrix, she had flu like symptoms that lasted for 2 days. The patient stated that she felt feverish following the dose. The call was disconnected and agent was not able to capture additional information. Attempted call back and left voicemail for the patient to call back to provide additional details. The request has been placed to the Agency for creation of additional case for the same patient who experienced an adverse event after 2nd dose as well.
On 7/17/01, 15 minutes, post vax, pt states she was nauseated and within 4 hours she was dizzy and fatigued. Seen at ER at 13:00. Pulse rate was 64 and she complained of dizziness. Did not return to work on 7/17/01 PM or 07/18/01. On 7/19/01 she went to work. Reports difficult breathing. EMS was called and she was admitted to the hospital.
Immediately after receiving vaccine I had a Vasovagal reaction and became extremely lightheaded and faint (Did not pass -out). By the next morning I noticed a muffled sound in my left ear with pressure that has still not gone away after 3 weeks as well as a tighness in my chest and having trouble catching my breath fairly regularly.
Short of breath, difficulty breathing, wheezing, Asthma like symptoms  about 2 weeks after booster shot.
Patient received 4 vaccines at apprx 11:40 AM. At apprx 11:50 AM patient had a syncopal episode in the office, complaining just prior to that he began seeing gray spots.
Fever CHILLS, NIGHT SWEATS, FATIGUE, INJECTION SITE SORENESS Narrative: PT/EMPLOYEE REPORTS MISSING ONE DAY OF WORK R/T SYMPTOMS.