chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine administered after temperature excursion.; No adverse event; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 24-SEP-2021, the patient was vaccinated with an improper stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # U015689 and expiration date 18-MAY-2023, 0.5 milliliter for prophylaxis (strength, route, frequency and anatomical location were unknown).      The administered dose of the vaccine was stored with a temperature of 25.9 degrees Fahrenheit, with a time frame of 1 hour and 30 minutes. There was no previous temperature excursion. No adverse event reported (product storage error and no adverse event).
ADMINISTRATION ERROR OF A VACCINE DOSE FROM A PUNCTURED VIAL THAT WAS LEFT 3 HOURS AT ROOM TEMPERATURE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 23/JUN/2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced administration error of a vaccine dose from a punctured vial that was left 3 hours at room temperature. On 09-JUN-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error of a vaccine dose from a punctured vial that was left 3 hours at room temperature and out of specification product use was not reported. This report was non-serious.
Patient has been diagnosed with psychosis. Since taking the covid-19 vaccine he is now paranoid, delusional and memory lapse. Patient leaves the house with the front door open . He sits on the steps and screams saying the police is coming to get him and the helicopters are following him. He thinks my phone is taking pictures of him and I am uploading his information on the internet. He has disconnected the cable and landline. He has his things packed in bags as if he is going to go somewhere but has no where to go. He thinks "they are stealing his identity," I don't know who he is referring to when he says 'they.' He bought a PO box, changed all of his bank information and bought 5 cell phones. He went missing for a week and was found at a hotel and refused to leave, which resulted in the cops having to be called to take him to Hospital. They diagnosed him with psychosis and sent him to another hospital. I am in dire need of help because they want to discharge him from hospital on Tuesday, August 17. I do not have anyone to help me take care of him because I work during the day and I am unsure of his capabilities. Please reach out to me ASAP.
2200 - headache 2230 - headache worsens, nausea 2300 - headache + vomiting + chills, afebrile 2330 - Tylenol 1000mg  0100 - woke up with body aches, chills, headache 0300 - body aches worsen, nausea returns 0730 - body aches, armpits very tender, headache 0800 - Tylenol 1000 mg 0900-2200 fatigue, body aches, armpits tender, neck tender, headache 2200 - Tylenol 500mg, sleep  0500 - minor joint pain, minor armpit pain  0600 - Tylenol 500mg 0600-2200 - pain resolves
5-1-12 ER an hour after vaccine - BENADRYL. 5-4-12 ER - BENADRYL, steroids, ZANTAC. Throat swelling and tightness in chest. Red at injection site and swollen.
had her booster and then tested positive for Covid; had her booster and then tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 87-year-old female patient received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 87 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had her booster and then tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with PAXLOVID (lot number FY6859; Expiry Date: Jan2023). The patient reported she will be 88 next month and that she had her booster and then tested positive for COVID; she had the booster and the line on the test came up very faint. Follow-up received on 11May2022 from product quality group providing investigation results concluded the complaint for lack of effect of the Pfizer-BioNTech Covid-19 Vaccine Injectable lot FH8020 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported lot FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause  were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Tachycardic, Elevated BP, Tingling feeling in body/arms/hands, Flushing, Nausea
Information has been received from a pharmacist concerning 4 patients (ages and genders not reported) who on unspecified dates in September 2007 during a vaccination clinic, were vaccinated with doses of PNEUMOVAX.  Concomitant therapy included influenza virus vaccine (unspecified).  In September 2007 one or two days following vaccination with PNEUMOVAX the patients presented to the pharmacist with injection site reaction described as red, swollen and warm.  The pharmacist considered most of these events as "minor".  The relationship of the event to therapy with PNEUMOVAX was reported as unknown.  The outcome of the event was not reported.  No product quality complaint was involved.  Additional information has been requested.
Client complained on left extremity feeling tingly, achiness, flushing, and wheezing. Client's HR 130s and BP 150/90s. Pulse ox 98% RA. Client remained alert and oriented during event. Nurse noted mild wheezes in upper lung. Client stated she was feeling flushed off and on. Benadryl given to client. Ambulance arrived on scene at 1350 and pt refused transport. Went home with a family member.
Just had a low grade fever of about 99.2. Took some tylenol and it is gone
This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (I can't taste anything) and VACCINATION SITE PAIN (pain and tenderness in my arm where they gave me the injection) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced AGEUSIA (I can't taste anything) and VACCINATION SITE PAIN (pain and tenderness in my arm where they gave me the injection). At the time of the report, AGEUSIA (I can't taste anything) and VACCINATION SITE PAIN (pain and tenderness in my arm where they gave me the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant and treatment product was reported For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Headache (migraine); body aches, muscle soreness, temperature (chills), fatigue
Pt recvd Td vax & 2 days later devel a sore throat, red spots on the tongue, difficulty swallowing; sx have persisted;
Patient called 7/31/18 to report she has a bright, brilliant, blotchy rash on her trunk and under her arms. She stated that it doesn't itch and she feels fine otherwise - she can everything that she usually does. She said that she forgot to tell pharmacist when she got the second shot that she had a reaction to the first shot she received 3/15/18. Her neck and trunk were red and 2 days after shot she had a full body rash that itched. She said that her current rash does not currently itch. Last time her injection side was sore, it is not this time. I told her to contact us and her doctor if her symptoms worsen or do not go away after a few days.
Right after first shot I had a metallic tast so strong it made me sick to my stomach. My daughter also had this reaction. Mine went away three days after my daughters lasted a day.
metallic taste in the mouth/mouthful of dirty nickels; metallic smell; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in the mouth/mouthful of dirty nickels) and PAROSMIA (metallic smell) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced DYSGEUSIA (metallic taste in the mouth/mouthful of dirty nickels) and PAROSMIA (metallic smell). At the time of the report, DYSGEUSIA (metallic taste in the mouth/mouthful of dirty nickels) and PAROSMIA (metallic smell) had not resolved.            Concomitant product use was not provided. Treatment information was not provided.  Patient used to like coffee but now he cannot stand it.
12-19-2022 PENTACEL GIVEN FOR THE FIRST TIME AT 4 MONTHS. PATIENT HAD PEDIARIX AT 2 MOS. OLD ON 10-17-2022. 10:20 AM, 12-19-2022 PENTACEL GIVEN. 12:20 PM MOTHER CALLS & SENDS PICTURES OF HIVES TO RIGHT SIDE OF BODY. SAID HIVES ARE GOING AWAY SLOWLY. BREATHING OKAY. NO FUSSINESS OR SCRATCHING. 12-19-2022, 2:56 PM PHONE CALL W/MOTHER. SAID REDNESS/HIVES, MOST OF IT HAS GONE AWAY. BREATHING ALRIGHT
At the time of vaccination, patient was 15 weeks of age. Patient was scheduled for influenza vaccine appointment along with siblings. Patient received influenza vaccine before 6 months of age. Unnecessary dose given.
pt recvd vax & approx 15 min after vax, pt devel hives at inject site;
Sometimes it itches and sometimes it doesn´t; Rashes in different places of her body; It itches everywhere; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (It itches everywhere), RASH PRURITIC (Sometimes it itches and sometimes it doesn´t) and RASH (Rashes in different places of her body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 048A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), BALSALAZIDE, CARBAMAZEPINE, CLONAZEPAM, APIXABAN (ELIQUIS), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), METHOTREXATE and CALCIUM for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (It itches everywhere). On an unknown date, the patient experienced RASH PRURITIC (Sometimes it itches and sometimes it doesn´t) and RASH (Rashes in different places of her body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (It itches everywhere), RASH PRURITIC (Sometimes it itches and sometimes it doesn´t) and RASH (Rashes in different places of her body) had not resolved.            Patient stated that since she received the booster dose, her life had been hell and also stated that she never had something like this. Patient also stated that she had consulted several doctors and was given prednisone but it did not helped.   This case was linked to MOD-2022-467166, MOD-2022-467153 (Patient Link).
Very sore arm in injection area for first and second day. First day caused mild tiredness with slight headache.
Client reports today that after first COVID shot 1/5/21 had swelling and redness at the site, after #2 on 2/5/21 had increased pain, redness and rash "COVID arm" after that injection. After the third or booster doses on 11/5/21 had the pain, rash, redness and the whole arm from the deltoid to the elbow swelled up and had a "softball" sized lump at the injection site.
12 hours after receiving the shot at approx 3:30 am I woke up with aching pain throughout my entire body and intense headache that persisted the entire next day. The 2nd day was 50% improved. Ibuprofen didn't help. Couldn't sleep for a couple of nights, aches diminished and then started sleeping 10 hours a night which is not typical. Extreme fatigue and muscle weakness persisted for 10 days and was gone by day 11.
Patient had weak, lethargic legs, also achy. Patient also was overall tired and a slight headache.
chills; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was unknown.   The reporter considered the chills to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had chills from shingrix. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Tendonitis in knee; It feels sore; Twisted groin muscle pain again; My muscles were so weak; I took a fall on my knee; This spontaneous case was reported by a consumer and describes the occurrence of GROIN PAIN (Twisted groin muscle pain again), MUSCULAR WEAKNESS (My muscles were so weak), FALL (I took a fall on my knee), TENDONITIS (Tendonitis in knee) and MYALGIA (It feels sore) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced GROIN PAIN (Twisted groin muscle pain again), MUSCULAR WEAKNESS (My muscles were so weak), FALL (I took a fall on my knee) and MYALGIA (It feels sore). On an unknown date, the patient experienced TENDONITIS (Tendonitis in knee). At the time of the report, GROIN PAIN (Twisted groin muscle pain again), MUSCULAR WEAKNESS (My muscles were so weak), FALL (I took a fall on my knee), TENDONITIS (Tendonitis in knee) and MYALGIA (It feels sore) outcome was unknown.            No concomitants were reported. No treatment was reported.   This case was linked to MOD-2021-229992 (Patient Link).
Pt became nauseated following vaccination, patient vomited.  Pt diaphoretic, face flushed, vitals checked, cool cloth placed on back of neck
Headache, Myalgia, Arthralgia, Tachypnea,  With both doses, sore arm, HA and fatigue. After 2nd dose sx lasted longer plus SOB.  Narrative:
3min gen sz evening 15JAN98;2min gen sz morning 16JAN98;
Passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was unknown.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Swelling of entire upper left leg 2 days after DTAP.  Told to come in to office. Told there was no treatment option. Swelling continued into night and next day. Doctor said he had seen this reaction once every 10 years (32 years in practice)  Told to monitor and measure it. Child complained of pain in relation to swelling. Bright red blotches on upper left leg.
After Moderna booster on 12/15/21 pt started to experience systemic hives, generalized. Are resolving with use of daily claritin.
RED RASH AT SIGHT OF INJECTION, ABOUT 3 INCHES IN DIAMETER,  LASTING OVER ONE MONTH
After receiving the COVID 19 vaccine (which was mandated as a military member),  within 24 hours I felt extreme fatigue.  By Tuesday early morning I had began having severe coughing fits that were dry and uncontrollable. I was also short of breath both while moving (going up a flight of stairs) and while sedentary at times and had instances where my heart felt like it was fluttering. My chest/lungs felt like a small child was sitting on them aside from the burning, raspy cough.  I took several cough suppressants to minimize the symptoms but as the coughing fits were keeping me up at night I went to my primary care physician on 10/5/2021. The nurse practitioner and I went over my symptoms and I was diagnosed with severe bronchial spasms with the potential for an asthma diagnosis. Having no issues with breathing previously, I asked that we rule other things out like bronchitis or an infection. The coughing fits continued with cough suppressants not minimizing the symptoms. I was told if I had an upper respiratory infection there was not much that could be done and that I should return in 6-8 weeks if the symptoms persist. On 11/2/2021 I received the second dose of the vaccine (again due to the military mandate and my unit's deadline of being fully vaccinated by 12/2/2021), and experienced the same extreme fatigue. At this point, the symptoms still had not subsided so I scheduled another appointment for 11/19/2021. The nurse practitioner indicated that it could still be an upper respiratory infection, perhaps indigestion (with zero previous issues with indigestion), or if I was not better in a month that we needed to seriously consider asthma and that based on the timing of my symptoms it appeared that the vaccine was the culprit as I had exhibited none of the symptoms prior to these events. I was prescribed an albuterol inhaler to aid in the coughing fits and shortness of breath. We scheduled a follow up visit for mid January to complete the diagnosis. As of 12/5/2021 I still have the symptoms described above. I remain short of breath and even long conversations often put me out of breath despite being previously moderately healthy and fit- per military requirements. The cold air exacerbates the coughing fits.
Strange side effect, I hate this sounds, sounds very mild but it was a sore throat; Kind of mild bacterial; had mild cough; nasal congestion like Asthma symptoms; Kind of mild bacterial; had mild cough, nasal congestion like Asthma symptoms; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (BNT162B2, Pfizer BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in arm on 06Apr2021 (Lot Number: EP7533) as single dose for covid-19 immunisation. Medical history included asthma. Concomitant medication included umeclidinium bromide, vilanterol trifenatate (ANORO ELLIPTA) taken for asthma. The patient experienced strange side effect, patient hated this sounds, sounded very mild but it was a sore throat, kind of mild bacterial; had mild cough, nasal congestion like asthma symptoms on Apr2021. No treatment received. The outcome was recovered.  No follow-up attempts are needed. No further information is expected.
BASED UPON CONVERSATION WITH OFFICE OF medical professional AT HOSPITAL ON 4/21/21, PATIENT MANAGED TO RECEIVE COMPLETED SERIES OF BOTH PFIZER AND MODERNA COVID-19 VACCINATIONS.  PATIENT HAS NOT YET BEEN REACHED BY EITHER INSTITUTION, BUT OUTGOING CALLS HAVE BEEN MADE (AS OF 4/21/21) TO CONFIRM THE SAME INDIVIDUAL DID RECEIVE DOSE AT BOTH LOCATIONS (3/24/21, 4/21/21 MODERNA,  3/15/21, 4/12/21 PFIZER).  TELEPHONE NUMBER PROVIDED BY PATIENT.  BASED UPON CONSENT FORM FILLED OUT BY PATIENT, HE HAS ONLY RECEIVED THE PFIZER VACCINE--UNCLEAR IF SAME INDIVIDUAL ARRIVED AT BOTH CLINICS.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted about 5 minutes post vaccination
7 1/2 hrs p/vax numbness in lips on lt side;progressed to numbness & tingling in entire lt side of body;pain in lt ear,weakness on entire lt side;effected vision on lt side;2 sz,effected speech & walking ability,muscle control
injection site pain; nausea; tiredness; This is a spontaneous case is received from a contactable consumer, a patient. A 70-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Left arm on 15Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included allergies to Penicillin from an unknown date and unknown if ongoing. Historical vaccine included first dose of COVID vaccine on Jan2021. Concomitant medications included ibuprofen and vitamins. on 15Feb2021 14:15, the patient experienced injection site pain, tiredness, nausea. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. Patient did not receive any treatment for the events. The reported assessed the event as non-serious. On unspecified date, outcome for the events was recovered.  Information about lot/batch number has been requested.