chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 50 minutes post vaccination (20 minutes after leaving the clinic), the client reported that while driving to work, she felt as if her lips were swelling and she had an unusual pain in her left middle finger. She decided to return to the clinic to have us "check her out." On arrival the client was talkative, did not appear to be in any acute distress. Her lips did not appear to be swollen, but she reported that the felt that way. She also reported that they were starting to tingle. VSS. HR 72, BP 152/80, 20 regular, non-labored, O2 sats 98%.  Advised Client to be seen in ED and walked her across parking lot to ED triage desk. Client returned to clinic following ED visit and reported that she was treated w/Benadryl and Pepcid (ED report reviewed). She reported no further symptoms and thanked everyone for their assistance.
Started getting a fever around 7pm the same day as receiving the vaccine. Went to ER around 4am. Dangerously high fever of 104°. Received Torodol and IV fluids.
fever; chills; This is a spontaneous report from a contactable consumer.  A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as the second single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced fever and chills on an unspecified date.  The outcome of fever and chills was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
left arm sore; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (left arm sore) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sluggish thinking (Fell, Sluggish Memory). Concurrent medical conditions included Vitamin D deficiency, Sickness (relapse), Diarrhea, Multiple sclerosis (Stage 1) and Dysgraphia (Hazy Memory). Concomitant products included OCRELIZUMAB (OCREVUS), LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), VITAMIN D2, VITAMIN B12 [VITAMIN B12 NOS], FERROUS SULFATE and PARACETAMOL (TYLENOL) for an unknown indication.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (left arm sore). At the time of the report, PAIN IN EXTREMITY (left arm sore) had not resolved.            No treatment information provided.
Right arm cellulitis developed at immunization site 2 days after immunization given. Pt initially treated with Keflex and Bactrim but cellulitis worsened so patient treated with Clindamycin.
Reported sharp pain to the left arm, heart palpitations. Symptoms resolved. Will follow up with PCP.
Large area of swelling, redness and warmth to entire upper arm, around and below the injection site.
pt recv vax 5MAR98 & 23MAR98 elevated temp 103-104;fever cont up & down;27MAR went to ER 3AM;blood work drawn @ that time;fever;noc sweats;
Complained of heart beat being extremely accelerated, exacerbated the premature heart beat illness, felt clammy, extreme mental confusion, flu like symptoms after 24 hours from the injection and soreness at injection site. Flu like symptoms went away after 48 hours. Patient says symptoms are better but continues to have some mental confusion at times since vaccine.
No lightheadedness after vaccination but in the car became sweaty and then took a gasp and passed out.
Headache since about 15 minutes after injection. Injection site pain started about 10 minutes after injection and stopped after day 2. Tiredness started a few hours after injection and got better after day 4. Muscle pain and chills started the same day and stopped on day 4. Injection site swelling started on day 2 and went down on day 4. Injection site redness started as pink but is now purple. Nausea started within 10 minutes of injection but went away the same day. Feeling unwell started the same day of the injection and has been ongoing off and on since. My whole arm felt swollen on Saturday. The same day, I started noticing blood blisters on my fingertips on my left hand. More and more have shown up since then.
pain in injection area, generalized pruritus. Self treated with one dose of Epi-pen.
Narrative:  76yo male inpatient with hypotension in setting of hemodialysis & septic shock transfered to MICU on Nov 1, 2021. Pt with hx of anemia, ESRD, DM-II, hyperkalemia, Afib, pacemaker, HF, Central stenosis of LUE, CAD, OSA, hypothyroidism, NSCLCancer s/p chemo/radiation, SCC, & dysphagia. Pt coded on 11/1/2021 & died. Death was caused by: septic shock secondary to unknown cause. Pt had received covid vaccines on 1/30/21 & 2/21/21. Death is not related to covid vaccines.
Patient went to the ER after getting a flu injection. Patient was in for a flu shot at 10:00 on Oct 9th. Patient was taken to Medical Center by ambulance. Patient's spouse reported at ER that at 15:30 on Oct 9, that the patient was sitting on the couch when she went to the bathroom and had an episode of emesis. When she returned to the couch, she was "glassy-eyed" and soon began seizing. Her arms were convulsing and she was "breathing hard". This lasted for 30 seconds and then the patient spouse call 911.
HCP applied booster shots with expired vials; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP applied booster shots with expired vials) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.   No Medical History information was reported.  On 21-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP applied booster shots with expired vials). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (HCP applied booster shots with expired vials) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  No treatment information was provided.  Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow up received contains non significant information.
2 hours after 1st vaccine waist down to toes, wrist and hands have pain. Sharp pains, lasts about 2-6 hours. Rating a 9 on a scale 1-10.
Worsening of her cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Worsening of her cough) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination.     Concurrent medical conditions included Chronic bronchitis and Sinusitis. Concomitant products included FLUTICASONE and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced COUGH (Worsening of her cough). The patient was treated with GUAIFENESIN (MUCINEX) ongoing since an unknown date for Cough aggravated, at an unspecified dose and frequency. At the time of the report, COUGH (Worsening of her cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment medications included: Essential oils (inhaled and drank on tea).
About one week after getting 3rd/Booster dose of Moderna, I started to develop a skin rash/hives and still continue to experience them. They are not isolated to my injection site, they appear randomly all over my body, at the worst are visibly raised/swollen and hot to the touch and very itchy. I have a history of skin allergies to various soaps and metals, and I got a new body wash around the same time but I still continue to experience the hives after discontinuing the use of that soap. My roommate is not experiencing any skin issues.
Patient had a headache for a few days. Onset of headache 2 days post immunization. Feels fine 7 days post immunization.
The patient has a quarter-sized red or pinkish skin discoloration at the site of injection that has not gone away after 6 weeks.  There is no pain, itching, or hardness to it.
Arm soreness site starting on 12th hour to 36th hr post the 1st dose; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age (reported as age: 37, unit: unspecified) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had 1st dose of COVID 19 vaccine on an unspecified date and that the only thing he experienced was "arm soreness site starting on 12th hour to 36th hr (hour) post the 1st dose". The outcome of the event arm soreness site was unknown.   No follow up attempts are possible. Information about Lot and batch number could not be obtained. No further information is expected.
I had my first shot in another country in June 21th, I got the Astra Zeneca vaccine. I started havind heart beating but not breathlessness nor feeling bad. I arrive in the country for my course on July 4th. I went to take my 2nd shot on August 25th. My symptoms started getting worse, I was complaining to friends about that and decided stop jogging afraid of having some heart problem. I asked my friends about free hospitals to go to do exams. Before that, they told me I should take 2 vaccines here of the same brand. So I got 1 more shot of Pfizer on September 16th. This was my 3rd shot. I started getting worse of achycardia, breathlessness and feeling as I'm going pass out. Every stairs up or down I feel bad. When I walk to the subway too, and also when I'm talking. It happens more than once a day. I haven't related these symptoms to the vaccine till today, when I told my mother I'm feeling very bad and need to go back home.  She told me it could be the vaccine, so I did a research  and found that the vaccine can give heart inflammation.
Weakness; Nausea; Body aches; Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG 202) via an unspecified route of administration in the left arm on 25Feb2021 at 02:30 (at the age of 67-years old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. . The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021, the patient experienced weakness, nausea, body aches and arm soreness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events weakness, nausea, body aches and arm soreness was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick). At the time of the report, ILLNESS (Got sick) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-319587, MOD-2021-319591 (Patient Link).
Pt was driving when she told a friend of a flashing light. Friend stated patient jerked back and forth, eyes rolled back, foaming at mouth. Occurrence was witnessed and was resolved.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 13-Jul-2022; No adverse event; Administered the vaccine to patient after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 13-Jul-2022).    No concomitant product was reported. Patient administered half dose of Moderna vaccine.  Number of doses/vials was 35.  Vial did not undergone any temperature excursions.  No treatment information was provided.
got the flu every season anyway; bad reaction; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves unknown age and gender patient who got the flu every season anyway and bad reaction while receiving vaccine influenza vaccine (Flu 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 (lot number and expiry date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious got the flu every season anyway (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient developed a non-serious bad reaction (adverse reaction) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, stopped getting flu shot 15 years ago (approximately 2007) after a bad reaction. Always got the flu every season anyway. Since I stopped getting the vaccine, I haven't gotten the flu since. Before getting vaccinated every year only had the flu twice. Crazy! Not against vaccines, but now feel the flu vac is more about making money than anything else.  Action taken: INFLUENZA VACCINE was discontinued due to bad reaction and not applicable for event influenza.  It was not reported if the patient received a corrective treatment for the events (got the flu every season anyway, bad reaction).  At time of reporting, the outcome was Unknown for the event got the flu every season anyway and was Unknown for the event bad reaction.
Information has been received from a mother concerning her 12 year old daughter with mild allergies who on 13-JUL-2007 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). In Oct 2007 the patient was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) at the County Health Department. On 18-Oct-2007, the patient fainted and hit her nose when she fell after receiving the vaccine. The mother stated that the child was lethargic and wanted to sleep. The mother contacted the County Health Department and it was recommended that she take her daughter to the emergency room. The child did not have the same experience post vaccination with the first dose. The child did receive unspecified medical attention at the time of incident and per the mother lethargy and wanted to sleep persist. It was also reported that the child received varicella virus vaccine live (MSD) and hepatitis B vaccine, recomb (manufacturer unknown) but date that the vaccines were given were not reported at time of this report. Additional information has been requested.
Headache; Was real sleepy, I slept for all the night and then next day I slept, although I was awake with a headache about midday; Had a fever of a 101.7; This is a spontaneous report from two contactable consumers. Both consumers (Husband and wife) reported for female patient (Wife) that:  A 67-year-old female patient received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Batch/Lot number was not reported) dose 1 single via an unspecified route of administration on 11Mar2021 (at the age of 67-year-old) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension from an unknown date and unknown if ongoing. Patient reported that she does not take diabetes medication. Concomitant medications included lisinopril (LISINOPRIL) taken for high blood pressure, start and stop date were not reported. On 11Mar2021, the patient had headache. On an unspecified date in Mar2021, the patient had a fever of 101.7 and was really sleepy, slept for all the night and then next day she slept, although she was awake with a headache about midday. That was all the side effects the patient had. The patient underwent lab tests and procedures which included body temperature: 101.7. The patient took Ibuprofen for headache. The clinical outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
About a week after shot  #2 I noticed I could not smell coffee brewing any more.  The taste was also lessened.  I have not noticed any other smells that are gone.  I am also not sure if this was happening after shot #1, but definitely after shot #2.
Initial unsolicited report received from physician on 21-Aug-2018. This case involves a patient who was vaccinated with IMOVAX RABIES. (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to Caller states a patient went off schedule for his IMOVAX vaccine post exposure and received injection on day 0 and day 7 but missed day 3 (inappropriate schedule of vaccine administered). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Itchy, slightly reddened, raised rash at injection site; approx 2 inch x 4 inch rectangular area. Onset 6-7days after injection. Lasting 2 days...so far
bad headache on the left side; Hurting my left eye; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache and eye pain. On an unknown date, the outcome of the headache and eye pain were not recovered/not resolved.   It was unknown if the reporter considered the headache and eye pain to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but was selected as an adult as per vaccine indication. The patient was vaccinated on left arm. The patient had bad headache on the left side and hurted his/her left eye too.
Hard of hearing; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she was hard of hearing that was one of her problems on an unspecified date. Patient reported she made an appointment to receive the bnt162b2 vaccine but now she realized it was 45 minutes away from her house. She wanted to change it. Investigation Assessment was not provided. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Case number PHEH2014US021810, is an initial spontaneous report from a nurse received on 28 Oct 2014. This report refers to a 24-year-old male patient. Medical history and concomitant medications were not reported. On 28 Oct 2014, the patient received an intramuscular dose of MENVEO (batch number: unknown) that was reconstituted improperly. It was reported that Men A vial was mixed with a vial of sterile water for injection erroneously. No adverse event was reported following this medication error (inappropriate preparation of medication).
One month after COVID vaccine, she began having headache and blurry vision.  She went to optometrist who referred her to neurophthalmology for papilledema due to increased intracranial pressure.  She was seen on 1/20/2022 and Dr.  ordered CTA head with and without contrast.  CTA done 1/24/2022 showed "Nonocclusive thrombus within the right transverse sinus, sigmoid sinus and the visualized proximal right jugular vein. "