chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of PNEUMOVAX 23 (lot # L019836, expiration date: 24-MAR-2017; route not reported) that were improperly stored (0.6 degree C for 11 hours and 10 minutes and 12.3 degree C for 50 minutes; data logger). No adverse effects were reported. This is the several reports from the same reporter. Additional information has been requested.
Pt returned to pharmacy an hour after receiving vaccine stating she had almost passed out in store while shopping.  She said she has difficultly breathing but could breath normally when she sat down.  Pt asked technician to call EMS.
No Adverse event. Child received full 0.5 ml flu dose prior to 36 months of age. She was 35 months of age at the time the vaccine was given.
High fever 101.8-102. Soreness at vaccine site. Achy pain in arms & back.
Redness, pain , swelling at inject site  & surrounding area 4 days after the shot.
2 am: Over 100 degree fever, extreme heat in head, neck, shoulder areas. Heart rate 102 bpm. Lasted 3-4 hours. At 6 am, temp back down to 99.6 degrees. Reoccurred the following night, but only for an hour at 99.0 degrees.
Patient experienced onset of nausea at 10:00 am on 7-15-08 approx. 19 hrs after receiving vaccine in L deltoid. Nausea waxed and wanned until she ate lunch around 12:30 pm. Denies any fever, chills, vomiting, or diarrhea. She also began having frontal throbbing headaches on and off since 10:30 am which are relieved by lying down. Took tylenol at 12:15 w/o relief. Also reports same associated lightheadedness and fatigue since the onset of nausea this am. Work up with L axillary pain that has since resolved. L deltoid is tender to touch only at right of injection. No other side effects/symptoms . No treatment necessary.
pt recv vax 10OCT95 & 14OCT95 pt broke out w/lesions;17OCT95 pt definitely had full blown chickenpox;No further details were provided;
This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant therapy was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDAIL 9 (strength, dose, interval and route of administration were not reported) lot # K026246 with expiration date of 28-JAN-2017. No adverse events or product quality complaints (PQC) were reported. This is one of several reports from the same reporter. Additional information has been requested.
Pain in right arm. Very sore. Went to Dr. Dr said to take Advil. She can only take Tylenol. Dr said it may take up to 3 months to heal.
bladder and urinary tract infection/ first one was E.coli; bladder and urinary tract infection/ first one was E.coli; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number: EN6205), via an unspecified route of administration on 01Mar2021 (received at 64-years-old) as single dose for covid-19 immunization. Medical history included diabetes mellitus (patient takes Metformin and Insulin), blood cholesterol (patient takes Lipitor for cholesterol), partially deaf. Concomitant medications included isosorbide mononitrate (ISOSORBIDE MONONITRATE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported; insulin (INSULIN) taken for diabetes mellitus, start and stop date were not reported; atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. The patient stated that in his whole life, he never had a bladder or urinary tract infection and each time after getting the shot he got a bladder, urinary tract infection. He was hospitalized once, the second time they treated him in ER (emergency room). The patient explained that he took the first dose of the Pfizer vaccine on 01Mar2021 while he took the second dose on 23Mar2021. He got hospitalized two days after he got the first shot (03Mar2021). He first went to the hospital because his symptoms were gone and were already up going on for two days (since 01Mar2021) when he checked. They checked him and they were wondering why he was getting fever and chills and they find out that he had a bladder and urinary tract infection. When probed for second dose and causes after that, the patient stated that on 23Mar2021,  he got some symptoms but the result was from a urinary track and bladder infection, the first one was E.coli and the second one they did not tell him what kind of infection it was. The patient was hospitalized for three days, from 03Mar2021 to 06Mar2021 due to the bladder and urinary tract infection. Outcome of the events was unknown.
Every year after the flu shot, she was very sick for couple of weeks; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who every year after the flu shot, she was very sick for couple of weeks 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 a  dose of suspect influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site (strength, dose, lot, formulation, frequency, and expiry date: not reported) as prophylactic vaccination.  On an unknown date the patient had every year after the flu shot, she was very sick for couple of weeks (illness) (unknown latency).  Action taken with was not applicable.  It was not reported if the patient received a corrective treatment for the event (Every year after the flu shot, she was very sick for couple of weeks).  At time of reporting, the outcome was Unknown for the event.
pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix on Monday and had experienced some pain. The reporter did not consent to follow-up. This case has been linked with US2019210316,having same reporter.
This is a spontaneous report received from a contactable reporter (physician). A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 06Apr2021 as dose 2, single (Lot number: EP7533), in left arm, on 12Sep2021 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 08Jul2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 69 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "S/P Breast Cancer" (unspecified if ongoing); "Known allergies: Cephalosporin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ibuprofen, reaction: "Known allergies: Ibuprofen". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid for treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, COVID-19 which included oral Paxlovid from 01Sep2022 to 05Sep2022. Sender's Comments: Based on available information and possible temporal relationship the causal role of suspect drug cannot be excluded for reported events. Case will be further reviewed on receipt of FU information. 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.
Information has been received from a bachelor of science in nursing concerning an eight weeks female baby, who on an unknown date was vaccinated with the first dose of ROTATEQ, oral. The bachelor of science in nursing reported that the patient regurgitated the ROTATEQ. The patient was drinking a bottle of formula at the time. A portion of ROTATEQ was administered first and then the patient regurgitated about a half a cup. Then after the patient continued to drink from the bottle, a portion of the ROTATEQ was regurgitated a second time. At the time of the report, the patient recovered. No laboratory diagnostic study was performed. The patient did not seek medical attention. Additional information has been requested.
Pt possible may have been given the NSS diluent instead of the Pfizer vaccine . Pt has no sign or symptoms of an adverse reaction. Pt was notified on 2/16/21
About 6-7 minutes after injection patient c/o an itchy throat which progressed to tightness after 2 more minutes. VS:98.5 168/102 96 16 100%. Pt stated that this feels just like when she has had an anaphylactic reaction in the past. MD consulted and an order was given for IM Benadryl. IM Benadryl given within 10 minutes of initial complaint. 5 minutes after Benadryl given pt stated that she felt much better.  Pt rechecked 30 minutes post Benadryl dose, continues to feel better.
Chills, fever, muscle aches, joints pain for the first 4 days. On 5th day cough, generalized weakness. I took Ibuprofen, vitamins, Airborne pills, Tylenol, antihistamines with some improvement.  On 5th day due to caught and low grade temperature I started Augmentin 500mg po TID.
This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose in 2020). 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 reported as follows: The age at vaccination was not applicable for this report. Till the date of reporting, the patient did not receive second dose of Shingrix, which lead to incomplete course of vaccination. The reporter did not consent to follow up.
Dizzy,lightheadedness within minutes. Was told I could stay longer if needed but all they had was the same epipen that I had. Was taken home by daughter. Lightheadedness continued and some trouble focusing continued and desire to fall asleep. Took my bp ,it was 85/61.pulse 109.I hydrated with 3 bottles of water and ate olives to increase sodium level. an hour later bp was up to 107/67,pulse 67. I continued to monitor my bp through the next 24 hrs. I skipped my blood pressure meds  for that night and continued with them the next day when my pressure was back to normal range. I did not use my epipen.  Would have gone to ER if I was unable to control my hypotension. I am an RN.
Received Heplisav-B then Energix; Initial Report Received on 18-Jul-2022  An office manager at a family practice reported that a 25-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and then Engerix as the second dose.  No medical history at the time of vaccination was reported. Allergies were unknown.  Concomitant medications at the time of vaccination were reported as unknown.  On 17-Jun-2022, the patient received the first dose of HEPLISAV-B (Lot # 935848; expiration date 02-Dec-2022, NDC # 43528-003-01) through an unknown route, and injection site.  On 18-Jul-2022, 32 days after having been vaccinated with HEPLISAV-B, the patient received Engerix as the second dose (details not provided). The patient reported no adverse reactions.  No other information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 24-JUL-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-JUL-2016, the patient was treated at a health center for a persistent and 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
PENIS GOT BIGGER; This spontaneous report received from a patient via media (Janssen) and via a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown, and expiry: Unknown) dose, start therapy date were not reported, dose 1, 1 in total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced penis got bigger (Dose number in series: 1). It was reported that "Janssen please bring a coviid booster back to market, im a healthcarehero and i had 3 jandj shots and the only side effect i had was my penis got bigger. I refuse to take a mrna vaccine. If yall dont want to lose his job please make a new omicron/flu booster. (tgj)". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of penis got bigger was not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, dose 2, 1 in total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with dose 2 covid-19 vaccine ad26.cov2.s (Dose number in series: 2). This report was non-serious. This case, involving the same patient is linked to 20220912661.  Version created to amend previously reported information on 02-SEP-2022. Upon review the following information was amended: Amendment Adverse Event (Invalid field was removed and case to be reported as Valid, as case received from JOHNSON and JOHNSON managed website (Janssen).
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0471321A and 0471321A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 06-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vaccine was given on Deltoid.  No concomitant medication were provided.  No treatment medication was provided.   This case was linked to MOD-2021-353768 (Patient Link).
dry cough, fatigue, runny nose, congestion.  Reports chills but no fever.
pt recv vax 28FEB95 & 8FEB96 it was found that the pt did not seroconvert;no further details were provided
Tested Covid 19 positive 09/06/21 with onset 08/31/21
swollen lymph nodes; pain in the area of swollen lymph nodes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes) and LYMPH NODE PAIN (pain in the area of swollen lymph nodes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes) and LYMPH NODE PAIN (pain in the area of swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) and LYMPH NODE PAIN (pain in the area of swollen lymph nodes) outcome was unknown. Not Provided          No concomitant medications reported.   No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to events was not applicable.
Evening of 11/24 mother stated she noticed red area 1/2 inch below where injection was given - area became swollen, red, soft to touch and hard- measuring 2 1/2 inches diameter - lasting 3 days.
first Pfizer shot on 06Feb2021/had a mini version of COVID after that; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 06Feb2021, as single dose, for COVID-19 immunisation. Medical history included COVID-19 on 01Jan2021 and finally tested negative on 26Jan2021. The patient's concomitant medications were not reported. It was reported that the patient received the first dose on 06Feb2021 and had a mini version of COVID after that, in Feb2021. It was also reported that the patient had a very strong reaction (unspecified, pending clarification). The patient wanted to know if it was advisable to get a COVID test and if it comes back positive, is it okay to still get the second shot. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
pt recvd MMR vax 5APR91 & on 13APR91 pt devel t103 & exp irritability; following day had rash on face; by 16APR91 rash became generalized; fever subsided on 18APR91; @ the time of the report pt recovered;
I woke up and the site of injection on my arm was very swollen and red with severe pain all the way up my arm and shoulder. Unable to life anything or do anything. I also have diarrhea and chills, fever and feel horrible. I had vaginal bleeding and I am post menopausal. I am a liver patient.
Patient stated that one day after he got first dose he started to have chills and body aches and generally feeling bad. 3-4 days later, he was still sick, so he called his doctor. They ordered antibiotics. Symptoms persisted, so he went to a ?minute clinic? and got a chest xray. When his PCP got those results, he was instructed to go to the ED immediately, where he was admitted for pneumonia. PCP told patient that pneumonia was caused by covid vaccine and has instructed patient to not get second dose.
A few days after I was given the second Pfizer shot, I started experiencing a burning sensation on the upper left side of my back, along with tingling on my left arm, pressure on my left breast and neck.
About 7 months after receiving my vaccine, I had a case of severe diarrhea that lasted for about a month. I work in a hospital and they kept me home because GI symptoms are symptoms of COVID. I needed to be symptom free for 24 hours. I was able to get it under control with a very strict diet. After that, during August as well, I started to experience headaches, other GI issues, feeling full and uncomfortable, pain in my upper abdomen, fatigue and nausea which still exists today.
11 PM the night of my vaccine I have a severe burning sensation in both legs that lasted for hours.  By morning it was gone and I just had a headache .   Leg burning sensation has been gone since that episode. Strange !
Patient is 14 years of age.  Patient presented with other family members for covid 19 vaccination.  At the time of administration the pharmacy only had moderna vaccine available.  The patients age was overlooked and due to them not being greater than 18 years of age should not have received.  Patient guardian has been contacted.  Per CDC guidelines patients between ages 12-17 should receive second dose.  Identification was not able to be provided.  For future use we will verify twice that patient is 18 or greater when administering moderna vaccine.
Patient felt dizzy after having walked to the waiting area after receiving vaccinations. Client's mother able to catch child before falling. No sustained injuries noted. Patient appeared dazed, lips were pale and with period of disorientation saying he did not know what happened. 911 was called by other personnel upon seeing the client on the floor.
Patient stated on evening of vaccine, patient showed signs of pain and swelling--continuing the next day. On 10/23/02 came into office with swelling in left deltoid across mid left arm with erythema, itching, warm to touch and painful. Ice application and to take Benadryl PO PRN.