chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a positive covid test results; had a positive covid test results; This is a spontaneous report from a contactable physician.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization.On 22Dec2020 he started to experience COVID like symptoms. On 26Dec2020, he had a positive COVID test results. On 28Dec2020, he received the Regeneron antibody infusion. Patient wants to know more about receiving the 2nd dose based on his positive diagnosis/antibody treatment. Outcome of the event was unknown.    Information on 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 SARS-CoV-2 test positive and suspected LOE due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   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.
I have never had the flu except when I got the flu shot; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media and was transmitted to sanofi on 14-Dec-2020.  This case involved a patient of unknown age and gender who never had the flu except when patient got the flu shot (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported for prophylactic vaccination.  On an unknown date, latency unknown, it was reported patient never had the flu except when patient got the flu shot (influenza).  No laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown for influenza.  There will be no information available on the batch number for this case.
Took dose too early-16 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took dose too early-16 days) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took dose too early-16 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took dose too early-16 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant drugs were given No Treatment medication was added  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Reporter details, patient details and second dose details were updated.; Reporter's Comments: INAPPROPRIATE SCHEDULING OF DRUG..TOOK DOSE 16 DAYS EARLY
DIARRHEA, DIFFICULTY SWALLOWING, FEVER 99.4F. MUSCLE WEAKNESS, A/P abnormal tone, stopped talking, decreased muscle control, decreased energy, increased sleeping, numerous pustules in groin area, BP 144/81, Pulse 160-170.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media (facebook) and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. It was stated that the patient got shingles shots but still experienced shingles back in January. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: In the end of May 2018, the patient received SHINGRIX. The following day after the injection, the patient experienced a lot of pain in her upper arm that lasted a couple of weeks. About a couple of weeks after the injection, the patient did not know for sure, she started having pain when raising her arm and she still had it. The patient provided contact details of physician who was her husband and a retired physician.
48 hours after shot in left arm I started to have a earache on left side, traveled down the left side of face, into jaw area and down left side of my throat like tonsils and into neck area.  Into 72 hours after shot my face, neck and throat area started swelling.  At that time I went to ER for assistance due to the swelling and pain.  The ER after taking  review thought it a infected saliva gland and treated me for that.  As told by ER if no large progress contact my local Dr. and see ENT.  On Tues. (one week from Covid injection) I was in touch with my local  Dr. they had me come to their office for some care and scheduled me with a ENT.  They have been able to get the profuse swelling down out of the left side of my face, neck and throat.  I'm scheduled for a CT scan on March 5, 2021 to see where the original problem started.  I'm contacting  you for two reason's  1.  I have a March 10th. appointment scheduled I need to cancel and am having issues doing this.  Even in light of all this I want to reschedule for late April for my second shot and am not able to do that as well.   2.  Can you assist with any information if this has happened to other folks and if I should be clear to take my second dose.  This has been quite a nightmare and hard to bring under control.  I believe in the vaccine and this maybe just a quirk in how it happened but any information you can give me would be welcome.  I have looked on the website and it does say that there have been people who have also had symptoms like this from the shots where the side they get the shot on reacts.  Thanking you in advance for your time and assistance.
Swelling in left side and neck; Swelling in left side and neck; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in left side and neck) and VACCINATION SITE SWELLING (Swelling in left side and neck) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling in left side and neck) and VACCINATION SITE SWELLING (Swelling in left side and neck). At the time of the report, SWELLING (Swelling in left side and neck) and VACCINATION SITE SWELLING (Swelling in left side and neck) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to US-MODERNATX, INC.-MOD-2021-080378 (E2B Linked Report). This case was linked to MOD-2021-080364 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080378:
Severe arm pain, arm tenderness, arm swelling, all in the arm that the vaccination was given, hurt enough to keep up at night/wake up at night
This case was reported by a nurse and described the occurrence of wrong vaccine administered in a female patient who received HAVRIX (batch number 793JR, expiry date 15th February 2016). Co-suspect products included ENGERIX B (batch number 35F27, expiry date 1st February 2016) and TWINRIX. Previously administered products included TWINRIX (dose 1) and TWINRIX (dose 2). On 28th October 2014, the patient received the 1st dose of HAVRIX 1 ml and the 1st dose of ENGERIX B 1 ml. On an unknown date, the patient received the 3rd dose of TWINRIX. On an unknown date, an unknown time after receiving HAVRIX, ENGERIX B and TWINRIX, the patient experienced wrong vaccine administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the wrong vaccine administered and inappropriate schedule of vaccine administered were unknown. Additional information received: Patient received TWINRIX 2 doses in March and then in April. Now wants the third dose, however the minute clinic does not have TWINRIX. The nurse gave HAVRIX and ENGERIX B on 10/28/2014. Instead of 3rd dose of TWINRIX, the patient received a dose of ENGERIX B and a dose of HAVRIX. These were the wrong vaccine administered and therefore the patient received the wrong schedule of TWINRIX.
Administered a Dose of Heplisav-B to a 17 Year Old; Initial Report Received 28-Sep-2021  A pharmacist reported that a 17-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.  The patient had no known allergies.   No concomitant medications were reported.  On 23-Aug-2021, a dose of HEPLISAV-B (Lot # 934967, Expiration Date 11-Apr-2022, NDC # 43528-000-305) was administered in the left arm by a pharmacist.   No adverse reactions were reported by the patient at the time of report.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
harder to breathe; smell of food made me sick later that day; blood pressure went down; cold chills; Shaking; This is a spontaneous report from a contactable consumer (patient reported for herself). A 78-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982) administered in left arm via an unspecified route of administration on 27Feb2021 at 10:00AM as SINGLE DOSE for covid-19 immunization. Medical history included arthritis, known allergies to sulfa and Tetanus shots. The patient's concomitant medications were not reported. The patient previously took first dose of historical vaccine of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported) via an unspecified route of administration on 06Feb2021 at 10:00 am as SINGLE DOSE for covid-19 immunization and experienced no adverse event. Other historical vaccine in 4 weeks included Prolia on 21Jan2021 in doctor office. On 28Feb2021 at 12:30 am, the patient was harder to breathe, smell of food made me sick later that day, blood pressure went down, cold chills and shaking. The patient reported as Shaking was so hard as she could not hold glass of water or get the pills out of the bottle because they flew all over the place. This lasted for 2 hours. Then smell of food made the patient sick later that day and then with the cold chills. It took heating pad and other heating products to stop from shaking. patient blood pressure went down to 98/60 and harder to breathe for just a short time. Treatment received for the event shaking and no treatment received for other events. The outcome of the events was recovering.   No follow up attempts were possible. No further information was expected.
Received Pfizer vaccine on 2/4/21. Was mistakenly given  Moderna vaccine on 3/11/21
joint pain in fingers and toes the day of the shot. then reported swelling in right hand- knuckles on index, middle and ring fingers (not in thumb or pinky) on 6/11/2021
10NOV94 6PM started sneezing about 200 times that evening; next day had sore throat, h/a, felt awful; nose had a steady drizzle of water had to plug nose so could eat; had bad cough-very bad case of flu; pt still exp hang over from flu;
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Expired Moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last 20 Oct 2021 to 29 Nov 2021. The Lot Number of vaccine are as follows, 006C21A (10-10-2021), 026B21A (09-17-2021), 031B21A (9-22-2021). The vaccine was stored in freezer, taken out one to two vials and place in fridge each day as needed.
Patient experienced chills and chest pain. Went to bed and slept from 4pm to 12:30am woke up feeling better. Patient contacted doctor, but did not go into clinic or hospital.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Tachycardia-Medium
Headache, fever.  On 06/05/2003: Reported to have hives, but feeling better.
This case was reported by a nurse and described the occurrence of macular rash in a 4 month old male patient who received DTAP, Hep B recombinant and IPV combined Pediarix for prophylaxis.  The patient had no known drug allergies, relevant medical history, concurrent conditions, concurrent medications, or adverse experience following receipt of the first dose of Pediarix.  On 06/17/2003 the patient received the 2nd dose of Pediarix.  On that date, he also received injections of 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs) and Hib vaccine (manufacturer unknown).  One day post-immunization, on 06/18/2003, the patient experienced a red, macular rash on his upper chest and lower abdomen, and low-grade fever.  The patient was seen by the physician.  The events resolved on 06/22/2003.  The reporter considered the events to be possibly related to Pediarix, or to a "viral illness-but not typical to viral exanthem".
Pt. reports intense right shoulder pain within 4 hours of receiving the vaccine and inability to move her right shoulder properly.  The pain extends into the neck bilaterally, right trapezius, and into the right hands. Pt. reports she feels like she can't grasp things properly with her right hand.
Tired on day 2, just felt off.  Couldn't take a walk as I normally would.  I felt like i just couldn't put one foot in front of the other without concentrating.   Noticed a balance issue when I was doing my normal day to day activities.  Noticed I had to balance myself in the house holding onto walls and furniture.  Still struggling with balance.  Never a problem before the COVID vaccine.
Immediately after receiving shots, the pts left leg would swell an inch bigger than the right leg. This would last for days. All three times the pt went to the MD, they advised him to come back if it happened again. Pt also developed knots in arm that lasted for weeks
Swelling of R arm, hot to the touch. Pt vomiting x 1, fever 101.1.
24DEC91 devel vigors & chills, felt anxious & weak; 25DEC91 rigors & chill & diaphoretic; unable to sleep; 30DEC91 EKG-atrial fibrillation; 4JAN92 very weak, seen in ER, arreflexia of legs & followed by neurologist for GBS;
Immediate onset of slight dizziness, subsided within 30 min,. Pain  at injection site for 24 hours and sore upper arm followed by headache for 2 days Within 24 hours severe swelling of lymph nodes under left arm with pain.  Remained sore for 4 days and swollen for 7 plus days
Woke up with fever/chills, and oddly, hands (palm of hands and palm-side of fingers, not back) felt like they were on fire. Had to sleep with them outside of anything/not touching anything because were so hot. Next day hands were slightly swollen and *very* sore to the touch.  Felt outsized, not quite numb. Feeling of heat faded about 7 hours after first occurrence. Swelling went down within 29 hours. Soreness went down within 31 hours.
This spontaneous report as received from a physician. The physician reported that 40 - 50 patients with renal disease at their dialysis facility have had Hepatitis B antibody titers with negative (non-immune) results, over an unspecified time period. The patients were vaccinated with RECOMBIVAX HB (Lot# unspecified) on an unknown date. No other co-suspects were reported. No treatment information was reported. The outcome of hepatitis B antibody titers with negative (non-immune) results is unknown. Additional information has been requested.
Explosive diarrhea, volume depletion and orthostatic syncope requiring EMS, emergency room visit and 2 liters of IV fluids
The patient developed body chills after injection; The patient developed body diarrhea after injection; This is a spontaneous case from initially received from a pharmacist (case ID: SEQ19-01740) on 09-Aug-2019, concerning an 89-year-old, female patient (race and ethnic group were not provided).   It was not reported whether the patient had relevant medical history and drug reactions or allergies.  On 07-Aug-2019, the patient was administered intramuscularly Fluad [influenza vaccine, inactivated influenza virus surface antigen (subunit) egg-derived, MF59, batch number: 260382, expiration date: 30-Apr-2020, in deltoid] for influenza prophylaxis.   On the same day, the patient developed diarrhea and body chills after injection.   On 09-Aug-2019, the patient's daughter reported that they were at urgent care and the patient was hospitalised, but details were not specified.  At the time of reporting, the events of diarrhea and chills were resolved.  The reporter assessed the case as serious. Causality to Fluad was not reported.  Company comment: The patient developed chills and diarrhoea on the same day after administration of Fluad (influenza vaccine, inactivated influenza virus surface antigen (subunit) egg-derived). Chronology is plausible. No information regarding medical history or concomitant drugs was provided. Reportedly, the patient was hospitalised, and the events resolved. Based on this information, causal relationship between the suspect product and both events is assessed as possibly related.   Follow up received from the initial reporter on 27-Aug-2019: Seriousness criteria hospitalization was provided for both events and case was upgraded from non-serious to serious. Date of hospitalization was added. The outcome for diarrhea and chills was changed from not reported to resolved. The narrative was amended accordingly.; Reporter's Comments: The patient developed chills and diarrhoea on the same day after administration of Fluad (influenza vaccine, inactivated influenza virus surface antigen (subunit) egg-derived). Chronology is plausible. No information regarding medical history or concomitant drugs was provided. Reportedly, the patient was hospitalised, and the events resolved. Based on this information, causal relationship between the suspect product and both events is assessed as possibly related.
Narrative: Patient with history of uncontrolled hypertension. Received Pfizer booster several days before he reported to ER with uncontrolled hypertension. Correlation/causation unclear
Alteration in hearing. Seen by EMT on site  BP: 99/68  HR: 85  O2: 99%  Released at 17:16
pt presented w/T103 on 30MAY;31MAY devel urticaria of face & trunk;
Breakthrough case admission after 5 vaccines Moderna 2/10/21 Lot# 038K20A;  Moderna 3/12/21 Lot# 030A21A;  Moderna 11/19/21 Lot# 012H21B;  Moderna 6/29/22 Lot# 016B22A;  Moderna 12/10/22 Lot# 024H22A
Systemic: arm has continuous "cold sensation" and a magnet sticks to arm-Medium, Systemic: Tinnitus-Medium, Additional Details: patient reports cold sensation at site of injection even 10 days later. also reports site of injection being "magnetic" where a magnet will stick to his arm
Stinging throat; Swollen neck; Sore arm; Nausea; Dizzy; Very weak; Ear ache; Light sensitivity; Body aches; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733), via an unspecified route of administration in the left arm on 03Apr2021 at 14:30 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid. Concomitant medication included levothyroxine sodium (SYNTHROID 175), vitamin B+ (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), vitamin E (MANUFACTURER UNKNOWN), all taken from unknown dates for unspecified indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Mar2021 at 15:00, the patient experienced stinging throat, swollen neck, sore arm, nausea, dizzy, very weak, ear ache, light sensitivity and body aches. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events stinging throat, swollen neck, sore arm, nausea, dizzy, very weak, ear ache, light sensitivity and body aches was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient claims her arm swelled 2 times the normal size. She said it was red all the way around arm and was very sore. She also stated her skin was peeling off from where the Band-Aid was.