chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 64 year old patient (gender was not reported). On 17-APR-2017, the patient was vaccinated with the first dose of VAQTA (lot # was not reported), intramuscular for prophylaxis. On 17-MAY-2017, the patient was vaccinated with the second dose of VAQTA lot # N002921, expiration date 08-APR-2018, intramuscular for prophylaxis. No adverse effects were reported. Additional information has been requested.
Client called HD this am and reported that she noted small red welts on neck and arms on am of 1/18/2014, two days after receiving Tdap vaccine. Today she reports appearance of welts on abdominal area, now with itching. Denied any SOB or wheezing. Instructed to follow up with her medical provider and to take antihistamines as needed. Will follow up with client in next few days.
Patient reports fever and chills at about 7pm after receiving her covid shot. She treated fever with Tylenol. She went to the doctor the following day and found out that she lost her baby. She was 5 weeks pregnant at the time of vaccination
Information has been received from a physician concerning a 26 year old female who, on an unspecified date, was vaccinated with a dose of PNEUMOVAX 23. Subsequently, on an unspecified date, the patient developed swelling of both arms. It was noted that the patient went to the emergency room. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Administered a dose of SHINGRIX to a patient with a sterile water solution instead of SHINGRIX adjuvant; Administered a dose of SHINGRIX to a patient with a sterile water solution instead of SHINGRIX adjuvant; 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 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th May 2022, the patient received Shingrix. On 7th May 2022, 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 Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: Reporter was clinic manager who reported that, a medical assistant at the office administered a dose of Shingrix to the patient with a sterile water solution instead of Shingrix adjuvant.  No symptoms were reported.  She stated, she realized on the day of reporting as she was doing inventory that they had an extra adjuvant vial with no antigen and were able to trace the administration.  Referred to healthcare professional, provided phone number for provider to contact. The reporter consented to follow up. Additional supportive information: The patient received Shingrix with a sterile water solution instead of Shingrix adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Flu I had the flu shot 3months before I got the flu; Initial information received on 12-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who reported i had the flu shot 3months before i got the flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, route, batch number, expiry date: unknown) in unknown administration site for flu (influenza vaccination).  On an unknown date the patient diagnosed with a non-serious event of flu i had the flu shot 3months before i got the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown
Headache, Myalgia & Arthralgia Narrative:  missed work following second dose due to symptoms
This spontaneous report was received from a physician refers to a 65 year old female patient. On 08-MAR-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry was not reported) in the left arm. On an unknown date in MAR-2014, the patient developed shingles. On 18-MAR-2014, the patient visited the physician. On 13-MAR-2014 (reported as 5 days ago) the patient had shingles rash on her upper right back. Patient was treated with VALTREX. The outcome of the events were unknown. The patient sought medical attention. Additional information has been requested.
shingles; super big pink scar on leg; super big pink scar on leg; 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.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 days after receiving Shingles vaccine, the patient experienced shingles, scar and skin discoloration. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the scar and skin discoloration were not recovered/not resolved.   It was unknown if the reporter considered the shingles, scar and skin discoloration to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that, he/she had shingles and did not ever want to get again, so he/she got the shingles shot to be sure, and 6 days later he/she came down with the shingles again. The patient stated this was worse than first case and left super big pink scar all up leg. The follow-up would not be possible as no contact details were available.
Sore throat, muscle aches, headaches, light-headed; Started one day after vaccine, not as bad second day after vaccine, on third day all symptoms returned
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This spontaneous report from a contactable nurse reporting same events under the same suspect product for 19 patients. This is one of 19 reports. An elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced positive with COVID-19 on 03May2021. It was reported that 19 residents in the long term care facility where the reporter work were fully vaccinated and are positive with COVID-19. Some were not doing well at all. The events was serious for being hospitalization, life threatening. The events result in Emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19 on 03May2021 with positive result. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.    There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-2021548296 same reporter, vaccine and AE, different patient
Extreme tiredness, nausea, no fever but had chills, joint pain neck and hips
Unremitting headaches after COVID-19 vaccine, day and night and worse with light.
Administered on Jan. 8, 2014, came in on Jan. 11, 2014 and arm was swollen, red and sore to touch. Patient was advised to go to the ER and diagnosed with Cellulitis.
Left upper thigh with circumferential swelling, redness, and heat. Progressed for 2 days following administration and symptoms of edema resolved spontaneously, beginning on day 3.
She got her blood levels checked for taking warfarin in which they were 500/they have never been this high/Could the vaccine be effecting her blood thinner; could the vaccine be effecting her blood thinner; Experiencing a rash and itching on arms and across the top of her back and hands; Experiencing a rash and itching on arms and across the top of her back and hands; This is a spontaneous report from a contactable consumer (patient's husband) and a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2, via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunization and warfarin via an unspecified route of administration from an unspecified date at an unknown dosage for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced a rash and itching on arms and across the top of her back and hands on 19Jan2021. The patient stated that she got her blood levels checked for taking warfarin in which they were 500. She stated that they have never been this high and nothing different had happened other than receiving the vaccine. She asked if these levels could be because of the Covid vaccine. The patient's husband stated that his wife was having some side effects, statesd she had the Pfizer Covid shot, she was having a rash problem with it, also she took Warfarin and it seemed to be effecting the blood thinner. Could the vaccine be effecting her blood thinner. The action taken in response to the events for warfarin was unknown. The outcome of the events was unknown.  Information about Lot/batch no has been requested.
p/vax pt devel fever & t104.6 & a whimper-type constant cry but not high pitched, all day;MD was contacted & said it was a virus;
In discussion with Dr., medical director at Detox, she  arrived night of 2/3/21 was quite intoxicated so was not going through any  withdrawal.  She was getting vitals and CIW  checked regularly.  First dose of  chlordiazepoxide 25mg was 2/4 at 1:25pm for CIWA 9.  She had repeat vitals at  5:50pm, CIWA 1, vitals: P 67, 118/79, 94% on RA, T 98.3.  she had complained of  some "pressure in her head" and feeling anxious, but otherwise denied other  complaints.  she was talking with others in the group, then other patients report  she suddenly started having seizure like activity around 6:45pm, med techs came  to help and found her stiff, gurgling.  they tried to get vitals on her, called  911, noticed that at 6:54pm she had lost a pulse and they started CPR.  paramedics arrived at 7:08pm and she was brought to ED.   Pt BIBA in cardiac arrest. Pt was at Detox Center when she  was reported to have seizure-like activity followed by collapse. She  was found to be pulseless and CPR initiated by staff members. EMS  arrived and performed approx 15 min of CPR and gave pt epi x 3 and  bicarb. No shocks administered but they did not report a rhythm.   In the emergency room the patient arrived and was found to be pulseless with PEA arrest, CPR was initiated, patient was intubated. ROSC ultimately achieved, patient remained very acidotic despite ventilator adjustment, head CT revealed cerebral edema. Pt also found to be profoundly anemic with a hemoglobin of 5 and platelets of 37, she was thought to be GI bleeding so medications for this were initiated. Patient then became more hypoxemic with bradycardia, consultation with neurosurgery and critical care medicine at tertiary care center deemed ongoing CPR futile. Patient arrested at 2:30AM on 2/5, pronounced dead at 2:48AM.
Sick after 2nd Covid vacinne and need to go to the emergency room; This is a spontaneous report based on the information received by Health Authority (MFR Control No. 2021US001298). A contactable 55-year-old female consumer (patient) reported for herself. A 55-year-old adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on 29Mar2021 (Therapy Dates reported as 29Mar2021/29Mar2021 and therapy duration: 1 day) (Age at vaccination: 55-year-old) as DOSE 2, SINGLE for COVID-19 immunization, it was mentioned that, product used for unknown indication and abaloparatide (TYMLOS), via an unspecified route of administration from an unspecified date (Batch/Lot Number: RT02101; Expiration Date: Jan2023) unknown route of administration and ongoing, at 80 ug, daily for an unspecified indication. Therapy Dates: Ongoing and therapy duration was unknown. Medical history included ongoing osteoporosis and coagulopathy (Clotting disorder and Taking blood thinners). Concomitant medication was not reported. On 29Mar2021 sick after 2nd COVID vaccine and need to go the emergency room. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
pt came in stating that TD site was sore all weekend w/knot and large reddened warm area noted;
This spontaneous report as received from a physician refers to a approximately 14 years old female patient. The patient had no pertinent medical history or drug reactions/allergies. The physician reported that the patient completed her first series of RECOMBIVAX HB) (Lot# and exp date unspecified)vaccination site unknown as an infant but blood titers were low at office visit in 2008 and so physician administered a second three-dose vaccine series for RECOMBIVAX HB (5/0.5; one dose 0.5ml) (Lot # 666186/1483Y; Expired date 666186/1483Y) intramuscularly in October 2008, second dose in July 2009 and third dose in July 2010. Physician stated that patient still had negative and low titers at the patient's office visit on 07-AUG-2012. The patient sought medical attention via contacting physician. The patient was performed with routine blood work and chickenpox titers diagnostics (no result provided). No treatment information was reported. The outcome was unknown. Additional information has been requested.
I was given the Shingrix vaccine by the pharmacist  in the left arm. She gave it very high near my shoulder. It felt like it was going into my shoulder joint. Approximately 3.5 hours later, I could not move my arm. I experienced extreme pain and required assistance to remove my clothing and assistance with dressing as I could not move my arm/shoulder. It is exactly 2 weeks later and I still have pain in my shoulder with movement.
Left deltoid pain, redness, and swelling much more than any prior dose. It worsened over the first week, resulting in an inability to raise my arm overhead without significant pain. I didn?t use the arm to workout for two weeks and the deltoid is still very stiff and painful to pressure at the injection site. ROM is improving. I did not see my PCP because I thought it was maybe an injury, but now I can feel the muscle and it is hard (like a rope) and still painful when I massage it. Did not happen with the two previous doses in the same arm and site.
pt recv vax & devel anxiety & hyperactivity following vax; No further details were provided;
improperly stored vaccine; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were unknown. On an unknown date, the patient was vaccinated with improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot # S007075, expiration date 06-SEP-2020 (dose, anatomical location and route of administration were not reported) for prophylaxis. Doses of suspect vaccine experienced the temperature excursion 32.5-degree Fahrenheit (F) for 8 hours. It was reported that previous temperature excursion was not done. Data logger was involved. No product quality complaint (PQC) involved.
EE to EH for Covid Vaccine afterwards stated she was feeling nauseaus.  B/p 135/87, p-116, R-20, Temp 97.8.  02 sat 98%Crackers and juice given observed for 30 minutes no emesis, EE declined further evaluaion in the ED.  EE states she is ready to go back to work.  VAERS report and IR completed RN
Less than 24 hours after second dose my left arm started to get a red rash that appeared to be hive like and very hot to the touch. It continued to grow and wrap around my arm. By day 4 the redness and soreness decreased, but yet 2 weeks later my arm still looks discolored and blotchy.
This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration in left arm on 11Jun2021 as 2nd dose, single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation and no reaction on previous exposure to vaccine. On 11Jun2021, the patient experienced couple of burns on neck and arm red patch on left arm where the patient had vaccine. The patient stated that, after second vaccination on 11Jun2021 when the patient got home had couple of burns on the neck and the patient thought they were mosquito bites and then 12Jun2021, the patient noticed burns on arm and then 13Jun2021, noticed two more burns on neck and then the patient got a red patch on left arm where the patient had the vaccine. The patient don't feel it is a serious enough to call 911 but is there something can do. The reporter asked should just keep putting alcohol or anti-itch on it or what (treatment). The outcome of the events were not resolved. Information on lot/batch number has been requested.
Admitted to hospital on 5/3 with difficulty breathing, chest pain, light-headedness/dizziness, tingling in arms, and sloght loss of motor control of hands (clenching into fists uncontrollably). CT scan on 5/5 showed sub-sectional pulmonary emboli in both lungs. Released from hospital on 5/7 with treatment course including blood thinners.
Day after 2nd dose I was weak, had chills, and this went on for 2 days. Long term: caused my period to be inconsistent for 5-6mo after shot where I got my period about 2x a month when it is always on the exact same day each month. It caused my ibs to flair up 2 mo after the shot and lasted for 3mo where I couldn't hold food for longer than 25min.
Uncontrollable shaking, vomiting, lethargy, blood pressure up and down, delirium.
Severe bilateral eye swelling and itching. Tightness in chest slight difficulty breathing SpO2 97%.  Took Benadryl and Pepcid. Monitored myself symptoms decreased.
Left eye lid significantly drooped and was swollen significantly- current eye appointment confirmed it was still 1 cm lower than the other eyelid at 6 weeks post shot.  Prior to that it was 1/3 lower and light sensitive.  No changes in vision
pt recv vax 4NOV97 & pt became pregnant;the pregnancy was confirmed by urine pregnancy test;LMP was 13OCT97;expected date of delivery is 20JUL98;13JAN98 pt had a spontaneous abortion;
Expired doses administered to 8 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 8 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 8 patients). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 8 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided  Total 8 doses from 1 vial  was administered out of 8 doses 7 was booster doses, and 1 was regular dose.
buccal swelling, swelling of lips, tongue & ear lobes; ER: HR 160, resp 24, t98.7; pt given Epi & DPH & Solumedrol;
Post administration, the patient and mother left the waiting area against recommendation to sit and wait for the recommended 15 minutes. The pharmacist, , was called to the front of the store where the patient was laying on the floor of the store between register 1 and 2. Two witnesses around the patient stated the child was leaning against the counter and fridge then fell. The child, , did not say she remembered falling but that she felt a little funny then embarrassed that she was laying on the ground. The shift leader immediately called 911. The patient felt fine and was coherent while accurately asking questions initially about demographics to about the event. The patient was able to sit up. No difficulty breathing, swelling of lips, swelling of tongue, or throat closure was ever reported. There was no physical evidence to head injury or other body injuries. There was a small red rash on the patient's wrist that may have been due to falling approximately two inches long. The patient stated this did not hurt. The patient did look pale like she had fainted. The Store Manager got the patient water and orange juice.  said she had only eaten a little ice cream and left to get her shot.  drank some of the orange juice provided.  EMS arrived and took 's blood pressure, Pulse Ox, and blood sugar. The event lasted about 30 minutes. The patient did not go to the hospital. Mom and  were both consulted by  on what to watch for throughout the day. The patient was able to stand up and walk down an aisle without any assistance.
Mother called 4/30/03 at 1430. Reports inconsolable crying from 2300 until 0630AM the following day, onset PM 04/29/03. On 4/30/03 clear runny nose, vomited 3 times and diarrhea on time, afebrile.  Gave alternating doses of tylenol and motrin.  On 4/3/03, Monther phoned said child had been exposed to another child that tested positive for Rotovirus.  There was a Varicella Vaccine given but there is no room at the bottom to enter the information and the button to add lines will not work.  Varicella     Merck   L# 0275M  Subcutaneous L Arm