chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-JUN-2012, the patient was inoculated with ZOSTAVAX at a Health Center, as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 09-JAN-2014, the patient was treated by the same Health Center for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. 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 had suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
The patient developed severe arm pain, redness and swelling one week after the vaccine. She was treated with benadryl and steroid. Since that time she has continued with some arm pain, had new onset pain in her espohagus, rash and diarrhea.
Right after giving her the vaccination while she was waiting the 15 minutes, she had nausea. She got up and walked around and felt better. She said she was ok.
pt recvd vax w/rubella vax & had antibody titer of 0.9 to 0.99 considered to be an equivocal response; it was unk whether this was 1st or 2nd dose;no further details were provided;
This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 35-year-old male patient. On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for anther event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccine (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (batch number: 11049221A) in the arm. The patient was offered blood pathogen testing, (hep B, hep C, HIV), hepatitis B vaccine and flu vaccine. On 05-OCT-2015, the patient underwent Laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antique and hepatitis C antibody. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Fever 103.5, vomiting, irritability, rash < 24 hours after DTaP.
5pm- tired, small headache, left side of neck felt like lymph nodes were swolling, laeft side of throat felt like lump in throat a little difficult to swallow, light headed. 5:15pm- ate dinner to check throat and was ok swallowing 6pm- lay down. Read and then slept after taking 1 Tylenol. 6:47- heart rate increase 109-115. on phone app registers as average 109 bpm. Heart rate decreased 5-10 min. later.  10:30pm- Left side of face felt like it was swelling but looked in mirror and it did not liook swollen. Difficulty sleeping. 4am heart rate checked again and was 67 bpm.   Took 1 Tylenol. Friday- I felt tired, still light headed at times, left side of throat still feels a little hard to swallow but very much improved.  I was active this day. Sat. some pain on left shoulder but this was not long and tired still. Sun. I  feel much better and pretty much normal.
12/01/05 Phone call: Mom states right arm swollen twice as big as left arm. Advised appt. 12/05/05 office visit: right arm redness, swelling, mild cellulitis likely vaccine related.
By middle afternoon on 11/8/19. Initially red rash near injection site. 11/9, 11/10- Had swelling to arm. 11-12-19- Pt. notified clinic of her reaction and by that time dull ache to arm & more ROM.
Patient had a fever of 101.2 He had trouble putting weight and walking on his right leg. His thigh was red and warm to the touch and very swollen(he was swollen from his upper thigh down to his knee)Called the Dr's treatment was Motrin and cold washcloth.(8/26/03) Patient still has some redness and a lump in his upper right thigh.(8/28/03)
This spontaneous report was received from a pharmacy intern referring to unspecified number of patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates since 07-JUL-2016, the patients were vaccinated with improperly stored doses of VARIVAX which had lot# K020758 with expiry date: 31-OCT-2016 (dosing details not provided). The vaccine was exposed to a temperature of 36 degree Fahrenheit for 22 hours. The vaccine had no previous temperature excursion. The call was due to data logger. No adverse effects and no product quality complaint (PQC) involved. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
Vaccination site pain; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and RHINORRHOEA (Runny nose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and RHINORRHOEA (Runny nose). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and RHINORRHOEA (Runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; 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.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Patient complaining of lightheadedness and dizziness. Patient requested blood pressure to be taken. BP WNL.Patient refused further care
This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. The pharmacist reported that unknown number of patients might have received ZOSTAVAX (lot number specified) that was improperly stored from 20-MAY-2013 to 05-JUN-2013. No adverse effects reported. It was unknown if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Follow up information has been received from a health professional refers to a 67 (also reported as 68) year old male patient. On 09-NOV-2012 at 11:08 the patient vaccinated subcutaneously in left arm with a dose of ZOSTAVAX (lot number H011048, exp. date not reported) (dose not reported) which was incorrectly stored. No adverse reactions reported. This is one of several reports from same source. Additional information is not expected.
About 1.5 weeks later he had the abrupt onset of numbness of his vertex accompanied by a blotchy  red itchy rash (explicitly non-vesicular) that affected his scalp face, trunk and extremities. This lasted for about 12 hours and resolved spontaneously. Then several days after that he noticed allodynia of his right hemicranium associated with some objective swelling (indentation of his glasses earpiece),  "like pinpricks" with even light touch. Fortunately this has subsided about "50%" by now.
Local site reaction to Hep A. Induration, red, oval size 2.5cm to left thigh. Recommend symptomatic care. Recommend against finishing this series given the significance of involvement.
The first 48 hours I experienced chills, fever, sweating, vomiting, severe headache, and body aches.  Then 2 days later I experienced severe congestion, sore throat, fatigue, coughing and plugged ears.
beginning 1/20, muscle soreness in injection arm, lasting approx 24 hours beginning 1/20, moderate joint pain in right hip joint, lasting approx 36 hours beginning 1/25, sore lymph node in right armpit, lasting approx 36 hours beginning 1/27, large red, itchy spot around injection site. Itchiness subsided after about 24 hours, the red spot is still present.
1/9 0230 bodyaches, chills, fatigue, fever, tightness in chest 1/10 2139-feels clammy and bodyaches
This initial spontaneous report was received from a nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. Reporter stated that, the patient received doses of GARDASIL injection on 24-JAN-2013, 30-DEC-2014 and 10-MAR-2015 (doses, strengths, route, lot number and expiration date not provided); which was an inappropriate schedule of drug administration. The nurse did not specify whether or not the patient experienced an adverse effect. Additional information has been requested.
tingling throughout my body,pins and needles,hands and feet, mouth, lip, and bottom of my face; Now I have it in my legs, my face, and my tongue; Can't sleep at night; Very bad headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling throughout my body,pins and needles,hands and feet, mouth, lip, and bottom of my face), PARAESTHESIA (Now I have it in my legs, my face, and my tongue), INSOMNIA (Can't sleep at night), HEADACHE (Very bad headache) and CHILLS (chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-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 PARAESTHESIA (tingling throughout my body,pins and needles,hands and feet, mouth, lip, and bottom of my face), PARAESTHESIA (Now I have it in my legs, my face, and my tongue), INSOMNIA (Can't sleep at night), HEADACHE (Very bad headache) and CHILLS (chills). At the time of the report, PARAESTHESIA (tingling throughout my body,pins and needles,hands and feet, mouth, lip, and bottom of my face), PARAESTHESIA (Now I have it in my legs, my face, and my tongue), INSOMNIA (Can't sleep at night), HEADACHE (Very bad headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided. No concomitant medications were provided.
shaking; Extreme chill; severe headache for two days after, then came back on me once a week for 7 weeks.; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (shaking), CHILLS (Extreme chill) and HEADACHE (severe headache for two days after, then came back on me once a week for 7 weeks.) in a 63-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In May 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced TREMOR (shaking), CHILLS (Extreme chill) and HEADACHE (severe headache for two days after, then came back on me once a week for 7 weeks.). At the time of the report, TREMOR (shaking), CHILLS (Extreme chill) and HEADACHE (severe headache for two days after, then came back on me once a week for 7 weeks.) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient experienced extreme chill and shaking, severe headache for two days after, then came back once a week for 7 weeks. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-750546 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750546:Same patient different dose
Patient developed hives two hours after having the varicella shot.  Seen in ER same day, seen in our office next day, mild papular rash on trunk & extremeties.  ER gave prednisone and benedryl, Our office added clariten or Zyrtec 10mg.
Has scheduled epidural with steroids for bad back; Little sore arm for a day or two; This is a spontaneous report from a contactable physician received from a Pfizer sponsored program.  A 76-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown) on an unspecified date and the first dose of BNT162B2 (lot number: unknown) on an unspecified date, both via an unspecified route of administration at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had received both doses of BNT162B2 and was due for a booster shot. The patient also had an epidural with steroids scheduled and the caller was asking if they need to postpone her booster. Caller came onto the line and verified information received from the transferring agent. Stated the epidural was for the patient's very bad back and it won't get postponed. Caller stated that the patient had all kinds of other problems. Stated her epidural was for next week. Caller stated that his gut told him they ought to postpone the booster shot. He was questioning if they should or should not and asked if there any information on how long it can be postponed for. Caller stated that he doesn't want to do the whole report thing.  Stated there was nothing wrong with the patient involving the previous 2 vaccines. Stated the patient just had a little sore arm for a day or two, nothing unexpected. Caller stated that if she got the epidural and then the booster and anything occurred he would be willing to provide more information. Caller then stated he felt the vaccine was a grand experiment. He then discussed his own experiences and declined to complete a safety report for himself. Outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Back disorder and suspect drug BNT162B2 cannot be excluded.  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.
Nausea; HA; fatigue; low back pain; diarrhea; then constipation. Low back pain lingering and pt also reports intermittent tingling in toes.
Local reaction from knee to groin; swollen, red, warm almost circumferential around thigh.
Dizziness, nausea, hot flash. This happens every 3-4 days. I get so dizzy that I need to hold onto something. I have never had any of these symptoms before I got the vaccine including when I had COVID. I had COVID Dec 2020.
my lips were tingling  followed by naushia , high blood pressure and heart rate. the ambulance was called i was then transported to hospital. where i had two sezuires.   i was given adavan  and sent home. with the instructions i was not allowed to have a follow up shot
Slurred speech, disorientation, uncoordinated movement, tingles at fingertips and toes
Started running a fever, muscle aches, headache , fatigue, coughing , wheezing and shortness of breath and Congestion being other symptom not listed on the case report form.
feeling a bit sluggish; earache on the side of the shot; arm pain; This case was reported by a consumer and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Shingrix. On 8th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 9th July 2019, the patient experienced sluggishness and ear pain. On an unknown date, the outcome of the injection site pain, sluggishness and ear pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, sluggishness and ear pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and reported local pain within 3 hours of the vaccine and general sluggishness and left earache on day of reporting. All the adverse events were ongoing.
Erythematous papular rash of face, upper extremities, and back. Rash resolved by time of visit. Only per mother's account. No symptoms/signs suggestive of anaphylaxis.
This spontaneous report as received from a registered nurse a 62 year old patient of unknown gender. The reporter stated, that in 2012 (exact date unspecified) the patient received a dose of ZOSTAVAX (subcutaneously, dose, units, anatomical location, lot number were not reported) and on 19-DEC-2014 the patient was inadvertently administered another dose of ZOSTAVAX (subcutaneously, dose, units, anatomical location, lot number were not reported). No adverse effects reported. Additional information has been requested.
lump under armpit on same side the vaccination was administered; This case was reported by a pharmacist via call center representative and described the occurrence of axillary lump in a 58-year-old patient who received Herpes zoster (Shingrix) (batch number DP2X9, expiry date 10th May 2023) and (batch number NF442, expiry date 10th May 2023) for prophylaxis.   On 10th October 2022, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. In October 2022, less than a week after receiving Shingrix, the patient experienced axillary lump. On an unknown date, the outcome of the axillary lump was unknown.   It was unknown if the reporter considered the axillary lump to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's comments: The pharmacist had reported on 13 October 2022 by a chat channel that the patient had received Shingrix on 10th October 2022 as the first dose and the patient had reported lump under armpit on same side the vaccination was administered. The Vaccine administration facility was the same as primary reporter. No details of lot number, expiration date of Shingrix were provided. No patient's identifiers were provided. The reporter had consented to follow-up. Additional supportive information: The lot for antigen was reported under DX series and for diluent was reported under series.
pt recvd vax & devel chronic rubella synd following vax in 1991; No further details were provided;
58y/o F  received 1st dose of Moderna COVID vaccine today at noon and was waiting for the requisite 15 minutes when, 5 minutes in, she noted her heart rate rose (on her Watch and by subjective report) to 120s, particularly when she stood up, though it resolved generally when she sat down. She had mild shortness of breath at the time. She has known and frequent episodes of tachycardia. Though they are often relatively transient; this lasted until and during her visit to the ED presently but she states there are no unusual features to her symptoms today. She agrees multiple Holter monitors and event monitor have found only sinus tachycardia, thought in past to be triggered by anxiety but pt denies any anxiety related to vaccine or otherwise today. She states she is eating and drinking normally today; did not fast for vaccine.  Pt states no sx today other than those of her usual tachycardia but was evaluated downstairs and sent to ED for further eval.
Soreness in (L) arm since vaccine on 5/17/17; increase in pain, swelling, warmth since 0200 AM on 5/19/17.
fever x 24 hrs-48 hrs-APAP; 6 x 3 cm erythema area below inject site; sx treatment; seen by MD 25JAN93;
Near 1 wk following 1st dose, rash on arm with blistering, subsided within 1 mo. Near 1 wk following 2 dose rash on arm with blistering, has not subsided and visibly present at time of booster. Within 1 wk following booster, rash with blistering. Currently, rash with blistering both arms, mouth, nose. Tired ALL the time, joint pain, itchy all over, hearing impairment right ear.  2nd dose  6/22/21 Booster 1/13/22
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 9:00 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  The age of patient was provided as 78.51.  On 28-Feb-2021, excursion time was 09 AM and 01 PM  and temperature was 27 and 36 respectively, total doses given for the day was 152, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vial was moved to clinic on 27-Feb-2021. Vaccine BUD date was 26-Mar-2021.  Vial was stored on cooler 1 , on 28-Feb-2021, Excursion duration At, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM : 26, 2 PM : 37, 3 PM: 43, 4 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.