chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 16 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 30-NOV-2016, the patient was vaccinated with a dose of improperly stored MMRII (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: Original Case : 1701USA004150 US-009507513-1701USA007912: Original Case : 1701USA007906 US-009507513-1701USA007922: Original Case : 1701USA007910 US-009507513-1701USA007881: Original Case : 1701USA007910 US-009507513-1701USA007913: Original Case : 1701USA007910 US-009507513-1701USA007882: Original Case : 1701USA007916 US-009507513-1701USA004150: Original Case : 1701USA007916 US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
pt recv vax FEB99 & exp body rash;pt sought unspecified medical treatment;
Weakness, fever, Swelling and redness in the area of the injection with itching . All this happened the day after the vaccine until now and all still there.
I started to experience chills, fever of 102, a headache. These symptoms last a couple of days then they subsided. A couple days after that my headache, My lymph node under my left arm started to swell and I had a sore back. After about a week I went to see my doctor. He had me get Cat Scan and the results were normal. He did give me an anti-inflammatory for my back pain. After about a month I felt better. A month after that I started to notice hair loss. It was shedding a lot July through August. I did see the dermatologists three times and they ruled out alopecia and stated it could have been a shock to the system. The only thing I have had in the previous months was the vaccine. I still experience some hair loss and shedding, but it is not as intense.
On 02-10-21 at 6 PM I started having a reaction when both my ears felt plugged and within a short time noted decreased hearing.  By 9 PM I also had a severe headache with eye pain and dizziness and started to have chills and fever. The chills and fever lasted during the night even with the use of tylenol and ibuprofen. The highest the fever was 100.6. On 02-11 continued with ear problems, headache and eye pain and dizziness. Also at about 10 AM I thought I had an episode of hallucinating when I saw a man walk into our house. When I asked who he was he disappeared. I have had no more episodes like this. This morning I continue with headache and eye pain, dizziness and ear problems. My left arm  at the site is pink about quarter size and itches.  The symptoms are less painful than 02-11-21.
Right arm swelling, increased redness and increased warmth.  Keflex 250 mg 4x/day x 5 days and Bactrim DS 1 tab BID x 10 days.  Probiotic daily
Started with chills and then low grade fever; generalized weakness with no strength had to lay in bed and could not get up for 2 1/2 days; severe headaches requiring ice packs and Tylenol. This lasted the better part of 48 hrs. She also had nausea and stomach/abdominal ache that lasted for almost 96 hrs during which she barely ate. No diarrhea or vomiting
Patient is a 68 yr/o male with a history of small cell lung cancer with bone and liver mets, seizure disorder, COPD, who presents to the emergency department complaining of abdominal pain, bloating, acute on chronic back pain, constipation. Wife at bedside supplements most of the history. Patient is a poor historian. He is in palliative care being followed by Dr and on palliative chemo. They deny fever or vomiting. Indicates his last bowel movement was on Saturday, continue treatment for C. difficile. He indicates generalized fatigue and feeling of unwellness. In triage he was noted to "which she was dead ". He has not here for SI denies SI now. He mearly indicates that he is miserable in his state of health. Symptoms started Saturday and have been constant. Symptoms are worsened by nothing and made better by nothing. Pt denies tobacco, alcohol or drug use.
He has a rash which is around his mouth area; It looks like an allergic reaction. It''s not very itchy, it''s not life threating or anything like that but it''s rash; It looks like an allergic reaction. It''s not very itchy, it''s not life threating or anything like that but it''s rash; It''s couple inches long and about half a inch wide almost like ''mangochi'' except it''s red rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Nov2021 (Lot number: FK5127) at the age of 7 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "he has allergies" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, administration date 12Oct2021.  The following information was reported: ORAL MUCOSAL ERUPTION (non-serious) with onset Nov2021, outcome "unknown", described as "He has a rash which is around his mouth area"; HYPERSENSITIVITY (non-serious), PRURITUS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "It looks like an allergic reaction. It''s not very itchy, it''s not life threating or anything like that but it''s rash"; RASH ERYTHEMATOUS (non-serious) with onset Nov2021, outcome "unknown", described as "It''s couple inches long and about half a inch wide almost like ''mangochi'' except it''s red rash". Therapeutic measures were taken as a result of oral mucosal eruption, hypersensitivity, pruritus, rash erythematous.  Additional information: Reporter stated that his 7 year son received COVID-19 vaccine on Thursday. Reporter went online not seeing what was happening with him, asked if it was an adverse reaction. There was nothing else that was making sense. Everything else was standard in his life. On paraphrasing the concern: Reporter stated that Yes he did. It was a day after, so it was a delayed reaction. Like no new food, no new allergy, no nothing. It was strange. He was not stressed, which we were curious about because he was a kid was there a different set of symptoms or side effects that we can find. Prior vaccination (within 4 weeks) included Flu shot about 4 weeks ago."  No follow-up attempts are possible. No further information is expected.
Left upper eye lid swelled up for 3 days. Slight itchiness. Went down slightly after taking  Acetaminophen
Diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medications were not provided.
Funny taste in her mouth and increase fatigue. She slept for 9hrs. She had muscle aches. Low grade fever.
Scratchy throughout, heightens allergies leading to  severe asthma ataccks that have lasted 2 days keeping me out of work. I used my inhalers and stay inside and I don't have attacks. It's still hard to breathe in air-conditioning. If I go out side I have an asthma attack.  I also work in a metal shop Wich makes it so I can't go to work cause I would be in a load of polutents
pt recv vax;immediate local rxn;c/o itching & redness & swelling;no induration or difficulty breathing;dph given w/ good effect;
Patient appeared normal before the vaccination. After administering the vaccine, she was able to walk out of the immunization room to go have a seat in the waiting area. About a minute later her grandma shouted that something was wrong and upon looking at the patient, I saw that her arms were up and rigid, her eyes were rolled to the back of her head, and she was slouched over to one side. I told the technician to call EMS and I went to grab our emergency bag, but she regained consciousness and an epi-pen was not administered. I gave her a coke to drink in case her sugars were low and the patient drank it but then threw up everything about a minute later. The paramedics arrived and took her vitals. They said her blood pressure was about 70/50 so they took her on the stretcher to the hospital to administer fluids to raise her blood pressure.
Moderna COVID-19 Vaccine EUA  Slightly itchy Pinkish Red Rash approximately 2" x 2" around Injection Site
she had not been eating properly; she was found lying on floor of her house - likely having been there for 3 hours. Next morning found lying on the floor of the bathroom; On helping up she was confused but otherwise ok; she was found lying on floor of her house - likely having been there for 3 hours. Next morning found lying on the floor of the bathroom; This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose of bnt162b2 (Formulation: Solution for injection, Lot number: EK1768), via an unspecified route of administration, on 15Jan2021 at single dose for COVID-19 immunisation. Medical history included t2diabetes, hypertension, arthritis, previous episodes of falling. The patient's concomitant medications included rampril, glimepiride, gabapentin, sitagliptin, atorvastatin, tolterodine l-tartrate (PREBLACON) all at unspecified doses. It was reported that on 16Jan2021 at around 6pm she was found lying on floor of her house - likely having been there for 3 hours. On helping up she was confused but otherwise ok (as reported). She remained ok for several hours before going to bed. Next morning found lying on the floor of the bathroom. It was reported that ambulance was called but did not go to hospital due to COVID risk and overcrowding. It was reported that blood sample was taken on an unknown date in 2021 and analysed. The doctor called and reported no abnormal findings in blood sample. Suggested possibility that she had not been eating properly. The outcome of the event she had not been eating properly was unknown, while for other events was recovering.  The events occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event Syncope cannot be completely excluded given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
A report was received from a health care professional on 11/04/03 concerning a unspecified number of vaccinees who inadvertently received expired Fluvirin on an unspecified date. It was unknown whether or not any vaccinees had experienced any adverse events. There was insufficient information to determine the reporter causality assessment. Follow up pending. Update 1, 12/10/03: A follow up report received from a health care professional indicated that a 62 year old female vaccinee inadvertently received expired Fluvirin on 11/03/03. No side effects were observed at the time of the report. Follow up pending.
Patient's caregiver reports patient's right arm as bruised, swollen, and red 2 days after receiving flu shot.
Patient received COVID-19 vaccine on 02/02/2021.  Patient reports the following adverse reactions @1155 Tingling of lips and bilateral arms. Returned to clinic after leaving and walking down hall and started feeling tingling in arms/ flushing of face and slight tingling in lips. No c/o breathing difficulty or swelling of lips/tongue. No swelling evident. Slight redness of cheeks. No hives noted. BP 143/90. SaO2 99%, Heart rate 98. Seated and given H2O for observation and states tingling of lips and arms has lessened. @ 1210 States still has some tinging of lips, but no increase in s/s. States tingling in bilateral arms in now just in hands 'a little' . Benadryl 50 mg given p.o. per Dr order.     1210: States feels better. No further c/o tingling in lips or fingers. No c/o. Manager sitting with her  And is going to walk to unit/office with here. Instructed Benadryl may cause drowsiness and states will have ride home  after work .
Information has been received from a physician concerning an 11 year old female with no medical history or allergies who on an unspecified date, was vaccinated with GARDASIL (lot# not reported). There was no concomitant therapy. On 31-JUL-2010 the patient experienced syncope, fell and split her lip open. Subsequently (in 2010), the patient recovered from syncope, fell and split her lip open. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Severe body aches, severe migraine, fevers of 101-102, vomiting, enlarged lymph nodes on right arm with severe tenderness
This spontaneous report was received from the consumer's wife, concerning her husband, a male patient of unknown age. The patient's medical history included shingles on an unspecified date. On an unknown date, the patient was vaccinated with ZOSTAVAX (Lot No., dose, frequency and route were not reported). No concomitant therapy was provided. On an unknown date, the patient presented the shingles again (herpes zoster). No Product Quality Complaint (PQC) was involved. The outcome of herpes zoster was unknown. Additional information is not expected, no contact details were provided.
Pt returned back to the vaccination room within 2-3 minutes from the lobby. She had a feeling of rush all over her body, she mentioned that she felt her tongue was swollen. She felt very anxious and nervous at the moment. I didn't notice any lips swollen,  I asked a staff call 911 and monitored her closely. She calmed down after few minutes and then in 5 mins paramedics showed up. They checked her and she was totally fine. They send her home after 10 mins or so.
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 41-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Dec-2022, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Treatment medications were not reported.   Reporter did not allow further contact
headache; body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (body ache) and PYREXIA (fever) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A. and 011A21A.) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (headache), MYALGIA (body ache) and PYREXIA (fever). At the time of the report, HEADACHE (headache), MYALGIA (body ache) and PYREXIA (fever) outcome was unknown.            Treatment Advil 2 tablets morning and 2 tablets afternoon   Reporter did not allow further contact
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: Patient c/o itching in right throat, right neck, along left hair line. Patient took own hydroxyzine 50 mg.
mom called & reported pt had fever of 103.5 x 2 days after vax; pt had knot at inject site 30SEP; pt instructed to go to er if fever recurs; appt co/pmd to evaluate inject site;
Experienced a single episode of altered mental status on Sunday, 2/21/21. I was not able to form short-term memories for a few hours; diagnosed with Transient Global Amnesia at Hospital that day. Symptoms resolved that day.
hernia; This case was reported by a consumer via call center representative and described the occurrence of hernia in a 76-year-old male 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 hernia. On an unknown date, the outcome of the hernia was not recovered/not resolved.   It was unknown if the reporter considered the hernia to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-MAY-2022 Reporter's comment: The patient reported this case. The patient was 76 years old and was in construction all his life and never had a hernia. The patient got a Shingrix shots, two of them and now had a large hernia in two places. The patient's doctor said it was a hernia. The patient asked if these shots could do this.
Information has been received from a Pharm. D. concerning a female who was vaccinated with hep A virus vaccine inactivated. Subsequently the pt developed elevated liver function tests. The outcome of the elevated liver function tests was unknown. The pt sought unspecified medical attention. Additional info has been requested.
Vaccine was adminstered on 12/20/14. Patient reports a golf ball size know that has gotten larger over the past 24 hour. It is red and and warm to touch.
ACUTE DVT, UNSPECIFIED VEIN CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/1/2022 &  1/21/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Disorientation while at post office, sudden headache and some difficulty seeing. He stated he was seeing spots with more difficulty from right eye. Medical Record received on 1/06/2005 states hypercholesteremia.
Employee reported tingling of lips at approximately 16:15 and warmth throughout body. Employee walked to ED
Pt had requested HD vaccine. Nurse gave the regular quadrivalent vaccine by mistake. After consulting with the nursing supervisor, she administered the HD vaccine.  2 flu shots were given.  No immediate adverse effects occurred.
Sudden and brief severe headaches right side of head since vaccine - started approx 18 hours after vaccine administration and continues every 10-15 minutes.
Member states that he had the following symptoms on/off for two weeks:  High fever, headaches, nausea, vomiting, minimal current erythema to arm.
Macular papule, Rash on trunk + Back 10 days post immu.
her alopecia getting worse; hardness; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (her alopecia getting worse) and INDURATION (hardness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001821a and 007821a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Alopecia since 2001. Concomitant products included METFORMIN, SIMVASTATIN, LISINOPRIL, FLUOXETINE HYDROCHLORIDE (PROZAC) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced ALOPECIA (her alopecia getting worse) and INDURATION (hardness). The patient was treated with VITAMINS NOS for Adverse event, at an unspecified dose and frequency. At the time of the report, ALOPECIA (her alopecia getting worse) and INDURATION (hardness) outcome was unknown.