chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a male patient of unknown age. No relevant medical history or concurrent conditions were reported. On an unknown date in March 2015 the patient was vaccinated with the first dose of GARDASIL (lot number, expiration date, dose and route were not reported). On an unknown date in May 2015 the patient was vaccinated with the following dose of GARDASIL 9 (lot number, expiration date, dose and route not reported). The outcome of the event was unknown. Additional information is not expected due to lack of contact information.
APAP given had temp of 102 mom reports inconsolable for 2 days; seen by pvt who advised DT for subsequent immun;
LEFT SHOULDER PAIN; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (LEFT SHOULDER PAIN) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On 09-Dec-2021, the patient experienced ARTHRALGIA (LEFT SHOULDER PAIN). In December 2021, ARTHRALGIA (LEFT SHOULDER PAIN) had resolved.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624862 (Patient Link).
This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 24Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient and her husband received the first dose of the COVID-19 vaccine on 24Mar2021, that same day at 12 she took a COVID-19 test and tested negative, three hours later she and her husband received the first dose of the vaccine, that night(24Mar2021) she started to develop chills, next day(25Mar2021) she woke up sick presenting the following symptoms: headache, body aches, sneezing, these side effects lasted for over 5 days on which she stayed in bed, at the time patient thought this was a reaction to the vaccination. Patient also had loss of the sense of smell and fatigue. From 8 to 10 days after receiving the first dose of the vaccine they both took a COVID-19 test (on Monday) and tested positive, none of them had any social contact after the vaccination. Patient wants to know if the Pfizer COVID-19 vaccine could make patients test positive for a COVID-19 test. Outcome of events Sick, headache, body aches and sneezing resolved on 30Mar2021 and for other events outcome was unknown.No follow-up attempts are possible; information about lot/batch cannot be obtained.
Sons and daughter tested positive for COVID-19. Two days afterwards tested positive for COVID-19. Took a home COVID test and it was negative. Next day took another home test and it was positive. Became very ill and developed rash throughout body. Went to ER and was examined, Dr. said that a rash has become common. Dr. advised to take BENADRYL. Since having COVID heartrate has increased. While having COVID, my heartbeat raised to 120 BPM at the highest. Still tested positive after 10 days. Slowly recovering. Breakthrough case.
Body aches, extreme fatigue, headache, chills, low-grade fever. Body aches started at approx. 5:45 pm,, followed by fatigue. About 9:30 pm, chills started, low-grade fever. Fatigue slightly less following day, still body aches, low fever.. 2nd day still had body aches, chills, although less. Symptom-free that evening.
3 inches width and length severe redness, hard, swollen and hot to touch on the left arm where injection was.
had blotches on her arm; This is a spontaneous report from a contactable consumer reported for herself. A 78-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 for Covid-19 Immunization. The patient experienced had blotches on her arm on Apr2021. She went to the dermatologist Friday and she didn't think it was that. She stated now that she knows some people might have this, she might mention it to her. The dermatologist prescribed her with a cream. She stated the internet was saying take Allegra or Benadryl. How long does this last. She stated this was with her second dose of the vaccine on 01Apr2021, but this didn't show up until Thursday, 2 weeks later. Therapeutic measures were taken as a result of had blotches on her arm. Outcome of the event was unknown.    No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
No additional AE reported; Customer reported expired RECOMBIVAX HB got administered to a patient today (11/15/2022). No additional AE reported. No PQC reported. No further information was provided.; This spontaneous report was received from a nurse, referring to a 13-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 15-NOV-2022, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number T032918, expiration date reported and validated as 12-NOV-2022) as prophylaxis (expired product administered). No additional adverse event reported.
Patient presented to the ER with SOB. She was febrile at 102 degrees and hypoxic with saturating 87% on 4 L. Chest x-ray showed pneumonia. Patient started on dexamethasone and cefepime IV.  Patient received bronchodilators mucolytics. She was on 6 L of oxygen tapered down to 4 L in 24 hours. Patient was more alert and mental status improved. She also received IV fluids.
p/vax became shaky, feverish; had rigors; lasted 3hr; next day muscle aches; pain over entire body; low grade fever;MD decided not to give 2nd dose of vax due to react
This spontaneous report was received from a medical assistant and refers to a 66-year-old male patient. The patient medical history included vaccination with a dose of PREVNAR 13 on an unknown date in 2015. There was no information about his concurrent conditions, drug reactions or allergies provided. On an unknown date in 2016, the patient was vaccinated with a dose of PREVNAR 13 instead of prescribed PNEUMOVAX 23 (dose, route of administration, anatomical location, lot# and expiration date were not reported) as an effect of miscommunication between the physician and medical assistant. No symptoms were reported. Product quality complaint (PQC) was not reported. Additional information has been requested.
56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and MI agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Around post-vaccine day 7, he 'felt bad'. Experienced body aches, fever and chills, nausea and vomiting x 'couple of days'. Required ER visit for rehydration and antiemetics. Around 31 August, pt didn't feel well. He had new onset dull pain in the center of his chest lasting about 30 minutes. Over the next few days, he experienced another 3-4 episodes of similar pain. He denies accompanying symptoms. He tried to reproduce the pain by exercising moderately on 3 Sept. The pain was not reproduced, but he did go in for evaluation. he is a firefighter and had no prior cardiac history. Evaluated at medical center and had Bicycle ergometry test at cardiology and Int Med at Medical center (RESULTS: ECG stress codes-horizontal depression on ST segment: 1 min V6 and between 0.5 mm and 1 mm in II, III, AVF within 5 minutes. Medical Conclusion: Coronary insufficiency, functional rate II). He has had a normal cardiac w/u at medical center with normal nuclear perfusion study, and a normal echo. He has not had an enzyme leak with the symptoms and his ecg is normal.
Patient experienced nausea and vomiting the evening after receiving the vaccine. She also developed a rash on bilateral forearms and hands. Patient states that symptoms resolved after 25mg of oral benadyl. Patient states she did not seek medical attention.
march 5 sever throbbing headache  relieved with a 1000 mg of tylenol. march 6 headache return but nagging just enough let yuo know it tis there and feel of blah and depression runny nose, march 7 systems persist . march 8 mild headache and sniffles march 9 a cough still the feel of blah and headache  with sniffles
headache for ~15hours body aches  for ~15 hours fever 100.1 - 7 hours
Consistent headache (everyday) Consistent body ache  Constant Chest pain  Heart pounding  Irregular heartbeat  Stomach pain
PENTACEL ordered, PEDIARIX given. Patient has not received Hib doses.
102 degree fever the night of getting the shot along with full body aching, weakness, and a fever for the following day. Fine by 2 days after the shot.
G47.33 ADULT OBSTRUCTIVE SLEEP APNEA 4/24/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I21.4 ACUTE NON ST ELEVATION MI 4/13/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 5/3/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/15/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.20 ACUTE AND CHRONIC POSTTRAUMATIC RESPIRATORY FAILURE, UNSPECIFIED TYPE 5/3/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED G47.33 ADULT OBSTRUCTIVE SLEEP APNEA 4/24/2023 DIASTOLIC HEART FAILURE, UNSPECIFIED ACUITY I21.4 ACUTE NON ST ELEVATION MI 4/13/2023 DIASTOLIC HEART FAILURE, UNSPECIFIED ACUITY J96.00 ACUTE RESPIRATORY FAILURE 5/3/2023 DIASTOLIC HEART FAILURE, UNSPECIFIED ACUITY J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/15/2023 DIASTOLIC HEART FAILURE, UNSPECIFIED ACUITY J96.20 ACUTE AND CHRONIC POSTTRAUMATIC RESPIRATORY FAILURE, UNSPECIFIED TYPE 5/3/2023 DIASTOLIC HEART FAILURE, UNSPECIFIED ACUITY
Induration near injection site on Right upper thigh the size of a 50 cent piece and redness the size of a nickle near injection site.  As reported by patient mother.
Redness, slight swelling, & itchiness of the right arm near injection site circular in shape, area of redness about the size of a baseball
She has not yet received her second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of in August of 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: She has not yet received her second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-OCT-2023 The patient self-reported this case. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that the patient was administered a M-M-R II series on an unspecified dates when was younger (doses, route and lot numbers not provided); however they did not have documentation of these vaccinations. On 27-JAN-2014 the patient was at the pharmacy and the pharmacist would be administering a dose of M-M-R II (dose, route and lot number not provided). No adverse effects were reported. Follow up information as received from the pharmacist refers to the approximately 38 year old female patient. The patient was unsure whether or not she received M-M-R II in the past. She had immigrated and she did not have a vaccination record. The pharmacist administered one dose of M-M-R II on 27-JAN-2014. Additional information is not expected.
3 week after of the 2nd vaccine a rash on his upper back (left) vesicular/papular lesions in crops (looked like HSV or HZV) Dx: Dermatitis Herpetiformis Moderna Vaccine given at convention center 4/1/21
Redness at injection site - about 2 inches across - persisted for 3 days. Pain at injection site and all throughout arm for 2 days. Itching at injection site after pain subsided (day 2 post vaccine) that persisted for 2 additional days. No other reactions at this time.
Two hours post vaccination, patient began experiencing joint pain on injection side. Also experienced neck soreness, nausea, dizziness, and headache.
I went to ER exp redness around the right eyebrow, rash, cheek was swollen. I was placed on Steriods and Benadryl finished the treatment on 12/26. The rash kind of came and went cheeks was swollen and I felt jittery. I started to feel better on 12/27 and placed a call to my PCP to make sure receiving the second vaccine. My PCP is reaching out to a allergist and contacted Phizer about concerns of the second vaccine. I haven't be able to wear makeup due to my fair skin complexion and don't wont to irritate the rash on my face. I have missed 2 days of work
By four hours after receiving the high-dose flu vaccine, I started feeling extremely tired with general malaise, then within the next hour I started feeling glands swelling just under my jawbone, beginnings of a headache and sore throat.  Within the next hour I had a full-blown sore throat, lost my voice, had a low-grade temperature and was shaking, headache became more severe and there was upper sinus congestion.  I took two aspirin and two immune booster capsules (Mannatech AO), drank a hot cup of lemon juice in water and honey and went to bed.  Within 24 hours, the symtoms started to subside.  I was back to normal on the next day and was feeling fine.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 on 20-AUG-2012. Lot# was reported as 0493AE, expiration date: 08-DEC-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6 C for total of 19 hours (2 excursions), -4.8 C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reported received from same source. 1209USA00725, 1209USA008597, 1209USA008598, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
* pain in shoulder even when not moving arm - might be able to move arm but too much pain * pt thinks RPH injected too high
Mother reported fever of 102F for 4 days after shots given on 8/12/02. Doctor told her Morgan's immune system was lowered "after getting getting those shots and he caught a cold."
PATIENT STARTED WITH A FEVER 6/27 ON THE MORNING OF 6/28 BROKE OUT WITH A RASH WHICH CONSISTED OF ABOUT 10-20 ERYTHEMATOUS MACULPAPULES EACH ABOUT 5 - 10 MM A FEW WITH A CENTRAL PAPULE NONE WITH A CLEAR VESICLE.
Left thigh with redness, itching, warm to touch, swelling at inj site. Size is 14 cm x 17 cm.
Complete hearing loss in right ear on March 26th , 8 days after vaccination. Upon vaccination he first felt congestion in the right ear the next day. Congestion progressed to what we thought was an ear infection or sinus infection that had gone to the ear. Was treated on March 28 with Prednisone dose pack. On March 30th Z-pack antibiotic was added. On April 2, PCP changed antibiotic to doxycycline and upped the Prednisone. On April 5th referred to ENT specialist. On April 8th appointment with ENT, extensive hearing tests performed and diagnosis of complete hearing loss. Loss presented similar to "viral hearing loss."
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a male patient who received BEXSERO for prophylaxis. Co-suspect products included MENVEO for prophylaxis. Previously administered products included BEXSERO (received 1st dose 6 months prior to 2nd dose). On an unknown date, the patient received the 2nd dose of BEXSERO and MENVEO at an unknown dose. On an unknown date, unknown after receiving BEXSERO and MENVEO, the patient experienced pain in arm and drug dose administration interval too long. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO and MENVEO. Additional details were reported as follows: The age at vaccination was not reported. At the speaker program the reporter presented at last night, several nurses shared that they had attended an Immunization Conference and were told that BEXSERO should be given at 0 and 6 months so they had been administering BEXSERO on this schedule, which led to lengthening of the vaccination schedule. A different nurse reported that her son reported that his arm hurt with both MENVEO and BEXSERO. The nurse was not concerned and reported that the pain did not last very long. The reporter did not agree to follow up from GlaxoSmithKline. This was 1 of 3 cases reported by the same reporter.
Reported Symptoms: 10046735:URTICARIA; Narrative:  A 43yo female patient was reported with a historical ADR of Covid-19 vaccine induced Urticaria by PCC attending physician. His report included "
Fever eports fever of 100.3-102F, body aches, runny nose,  left sore arm. Plans to call sick to work.   Narrative:
3 hrs after vaccine, 4 hrs after 50 mg Benadryl & 20 mg Famotadine I had chest pressure and couldn't tell if I was having trouble breathing and heart rate was 112. I took another 50 mg Benadryl, 20 mg Famotadine and added 240 mg Magnesium 4 hrs after initial dose. 3 hrs later pulse came down to the 90s. I had chest pressure for 3 days after but couldn't tell if it was asthma, allergy or gerd or a reaction to the vaccine.
Severe diarrhea; Stomach pain; Light headed off and on; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhea), ABDOMINAL PAIN UPPER (Stomach pain) and DIZZINESS (Light headed off and on) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced DIZZINESS (Light headed off and on). On 17-Feb-2021, the patient experienced DIARRHOEA (Severe diarrhea) and ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, DIARRHOEA (Severe diarrhea), ABDOMINAL PAIN UPPER (Stomach pain) and DIZZINESS (Light headed off and on) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
he started to have high levels of Vitamin B12, enough for him to stop receiving Vitamin B12 injections since 3-4 months ago; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (he started to have high levels of Vitamin B12, enough for him to stop receiving Vitamin B12 injections since 3-4 months ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Vitamin B12 deficiency.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (he started to have high levels of Vitamin B12, enough for him to stop receiving Vitamin B12 injections since 3-4 months ago). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (he started to have high levels of Vitamin B12, enough for him to stop receiving Vitamin B12 injections since 3-4 months ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin B12: high (High) high levels of Vitamin B12.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.   It was reported that patient was not able to absorb Vitamin B12 through food therefore received Vitamin B12 injections for 10 years. Patient started to have high levels of Vitamin B12, enough for him to stop receiving Vitamin B12 injections for 3-4 months ago.  No treatment medication information was given.
Persistent crying after waking from nap approx 4 hrs after vaccination. LUQ of thigh (left) erythema and swelling w/ sl. induration at site of injection. Right thigh, RUQ minimal erythema. Txt: Tylenol and local cold compress.